Question 1
When are Power off Attorney documents due?
Answer 1
Power of Attorney documents are required to be submitted to enable us to act for the Applicant before the MyIPO (Intellectual Property Corporation of Malaysia). The PoA can still be filed on a later date if you are unable to provide the same at the time of filing of the application. However, it is advisable to submit the PoA within two (2) months of the filing date of the Malaysian application to complete the formalities procedure. Apart from submitting the PoA for filing of new applications, PoA needs to be submitted for Recordal purposes (i.e. Recordal Of Assignment as we are required to submit the PoA to enable us to act for the Assignee). As for Recordal of Assignment, PoA needs to be submitted at the time of filing the said recordal.
Question 2
When are Assignment documents due?
Answer 2
In Malaysia, it is not required for Assignment documents to be submitted for filing of a new patent application.
Question 3
Are copies of the Assignments as recoded in the US Patent Office acceptable?
Answer 3
Copies of Assignments as recorded in the USPTO is not required to be submitted for filing of a new patent application. However, for purposes of Recordal of Assignment, if the said assignment has been recorded with the USPTO, a copy of the same can be filed for Recordal of Assignment on Malaysia.
Question 4
When are annuities due?
Answer 4
A Malaysian patent shall expire 20 years from the date of filing of the application. In order to maintain the patent, annual renewal fees are payable.
Malaysian Patents Act provides that the 1st annuity is to be paid 12 months before the expiration of the second payment term.
For example, if a patent is granted on 30 March 2007, the first year of protection of this patent starts from 30 March 2007 until 30 March 2008 whereas the second year is from 30 March 2008 until 30 March 2009. The due date for the 1st annuity payment for a patent that is granted on 30 March 2007 would be on 30 March 2008.
Question 5
When are examination request due?
Answer 5
a) For Malaysian National Phase applications, the term for requesting a full or modified substantive examination or deferment of the said examination in Malaysia is within 48 months (4 years) from the filing date of the PCT application.
b) Subject to the Patents (Amendments) Regulations 2011 which came into force on 15 February 2011, a request for substantive examination is to be made within 18 months from the filing date of the application for all Paris Convention filings (non-National Phase Application).
Tuesday
TOPIC : PLANT PROTECTION FOR NON-TRANSGENIC PLANTS IN INDONESIA, MALAYSIA & THAILAND
Question 1
According to our understanding is that :
a) in Malaysia, plant varieties and essentially biological processes for the production of plants are excluded from patentability;
b) in Indonesia, living creatures (except for micro-organisms, but including plants) and essentially biological processes for the production of plants are excluded from patentability, and that
c) in Thailand, naturally occurring plants are excluded from patentability.
We need confirmation from you in order to provide client with the required information. We also seeking information on the following aspects of Patent Law in Indonesia, Malaysia and Thailand :
i.) Are non transgenic plants which are not plant varieties (e.g. certain types of hybrids or plants which can not be stably reproduced) patentable, in particular in Indonesia and Thailand?
ii.) Can plant parts (in particular plant seeds) or plant cells be patented?
iii.) Which are the criteria which must be fulfilled in order that a process for the production of non-transgenic plants be considered non “essentially biological” and thus be patentable.
iv.) If patent protection cannot be obtained, is plant variety protection (PVP) a good alternative? Can PVP protection be obtained for plants which cannot be stably reproduced, in particular in Indonesia and Thailand?
Answer 1
We provide herewith our reply to your enquiry for Malaysia, Indonesia and Thailand as follows :
a) Malaysia : Plant varieties (including hybrids) and essentially biological processes are not patentable under Section 13(1) (b).
b) Indonesia : Article 7 (d) (i) excludes all living creatures (expect microorganisms from patentability and (ii) excludes the biological processes producing plants from patentability.
c) Thailand : Section 9 (1) excludes patentability of plants. Currently in Thailand, it is accepted that the Act exclude plant whether occur naturally or by human (including hybrid). However, section 9 (1) excludes product, but does not exclude the process or use.
We further confirm that Plant Variety Protection (PVP) is an alternative. Our response with regards to (PVP) as an alternative as an alternative as follows :
i.) Malaysia : According to the PVP regulations in Malaysia, a plant variety that is new, distinct, uniform and stable may be protected under PVP. According to the definition of stable in Section 14 of the Act, a plant variety is stable if its relevant characteristics remain unchanged after repeated propagation or, in the case of a particular cycle of propagation, at the end of each particular cycle.
ii.) Indonesia : Pursuant to PVP Law No. 29 of 2000 Article 2, varieties that may be issued PVP include those plants or species that are new, distinct, uniform and stable and given a denomination. A variety is regarded as stable when its characteristics do not experience any change after repeated cultivation or when multiplied in large quantities through specific reproductions cycles do not undergo change at the end of each reproduction cycle. In view of the above, the PVP office confirms that the hybrids or plants which cannot be stably reproduced can not be protected under PVP.
iii.) Thailand : Similar to Indonesia and Malaysia, plants which cannot be stably reproduced cannot be protected under PVP. Thus in order to obtain protection, the plant must be stably reproduced, wherein the subsequent reproduction must be the same as original in the sense that the plant must show the same essence (main character, primary essences) as recited in Section 11(2) of Act.
Conclusion
The PVP legislations in Malaysia, Indonesia and Thailand requires “Distinctness, Uniformity and Stability (DUS)”. Since stability is a clear criterion, stable reproduction is a requirement. Therefore, if the plant cannot be stably reproduced, the same cannot be protected under PVP in Malaysia, Indonesia and Thailand.
According to our understanding is that :
a) in Malaysia, plant varieties and essentially biological processes for the production of plants are excluded from patentability;
b) in Indonesia, living creatures (except for micro-organisms, but including plants) and essentially biological processes for the production of plants are excluded from patentability, and that
c) in Thailand, naturally occurring plants are excluded from patentability.
We need confirmation from you in order to provide client with the required information. We also seeking information on the following aspects of Patent Law in Indonesia, Malaysia and Thailand :
i.) Are non transgenic plants which are not plant varieties (e.g. certain types of hybrids or plants which can not be stably reproduced) patentable, in particular in Indonesia and Thailand?
ii.) Can plant parts (in particular plant seeds) or plant cells be patented?
iii.) Which are the criteria which must be fulfilled in order that a process for the production of non-transgenic plants be considered non “essentially biological” and thus be patentable.
iv.) If patent protection cannot be obtained, is plant variety protection (PVP) a good alternative? Can PVP protection be obtained for plants which cannot be stably reproduced, in particular in Indonesia and Thailand?
Answer 1
We provide herewith our reply to your enquiry for Malaysia, Indonesia and Thailand as follows :
a) Malaysia : Plant varieties (including hybrids) and essentially biological processes are not patentable under Section 13(1) (b).
b) Indonesia : Article 7 (d) (i) excludes all living creatures (expect microorganisms from patentability and (ii) excludes the biological processes producing plants from patentability.
c) Thailand : Section 9 (1) excludes patentability of plants. Currently in Thailand, it is accepted that the Act exclude plant whether occur naturally or by human (including hybrid). However, section 9 (1) excludes product, but does not exclude the process or use.
We further confirm that Plant Variety Protection (PVP) is an alternative. Our response with regards to (PVP) as an alternative as an alternative as follows :
i.) Malaysia : According to the PVP regulations in Malaysia, a plant variety that is new, distinct, uniform and stable may be protected under PVP. According to the definition of stable in Section 14 of the Act, a plant variety is stable if its relevant characteristics remain unchanged after repeated propagation or, in the case of a particular cycle of propagation, at the end of each particular cycle.
ii.) Indonesia : Pursuant to PVP Law No. 29 of 2000 Article 2, varieties that may be issued PVP include those plants or species that are new, distinct, uniform and stable and given a denomination. A variety is regarded as stable when its characteristics do not experience any change after repeated cultivation or when multiplied in large quantities through specific reproductions cycles do not undergo change at the end of each reproduction cycle. In view of the above, the PVP office confirms that the hybrids or plants which cannot be stably reproduced can not be protected under PVP.
iii.) Thailand : Similar to Indonesia and Malaysia, plants which cannot be stably reproduced cannot be protected under PVP. Thus in order to obtain protection, the plant must be stably reproduced, wherein the subsequent reproduction must be the same as original in the sense that the plant must show the same essence (main character, primary essences) as recited in Section 11(2) of Act.
Conclusion
The PVP legislations in Malaysia, Indonesia and Thailand requires “Distinctness, Uniformity and Stability (DUS)”. Since stability is a clear criterion, stable reproduction is a requirement. Therefore, if the plant cannot be stably reproduced, the same cannot be protected under PVP in Malaysia, Indonesia and Thailand.
Thursday
TOPIC : GENERAL QUESTIONS ON FILING PROCEDURE IN INDONESIA
Question 1
Kindly let us know what is the deadline for requesting examination (patents) if the national phase of a PCT application is entered?
(Example of fictive response: 5 years from the PCT filing date)
Answer 1
3 years from the PCT filing date.
Question 2
If the deadline for requesting examination has expired, does your national law foresee a remedy, or has the application definitively lapsed?
(Example of fictive response: 2 months after receipt of a noting of loss of rights it is possible to file a reinstatement request and to pay a surcharge).
Answer 2
No provision for remedy. Application will be considered withdrawn.
Question 3
Does your law foresee that a small entity status enjoys a reduction of fee(s)?
Answer 3
Yes.
Question 3 (a)
If yes, please mention the definition of a small status entity
(Example of fictive response: 20 employees or less)
Answer 3 (a)
A small entity is an enterprise with a capital below USD 500.
Question 4
Please provide us with all blank documents in English and your national language (for patent applications) necessary for completing the entry into the PCT national phase (patent applications) in your country
(Example of fictive response: Power of attorney form (Word), Assignment document (Word) in English and your national language, forms P3&P26 (Word) …)
Answer 4
Documents required are as follows:
(a) Power of Attorney (POA)
(b) Deed of Assignment (DOA)
(c) Declaration of Entitlement (DOE)
Question 5
Provide us with all blank documents in English and your national language (for designs) necessary for completing the filing of a design application in your country.
(Example of fictive response: Power of attorney form (Word), Assignment document (Word) in English and your national language, forms P3&P26 (Word) …)
Answer 5
Documents required are as follows:
(a) Power of Attorney (POA)
(b) Deed of Assignment (DOA)
(c) Statement of Industrial Design Owner (SIDO)
Question 6
What is the deadline for filing the documents mentioned in items 4 and 5?
(Example of fictive response: 2 months from the 30/31 months deadline from the PCT filing date (patent applications) / filing date (designs))
Answer 6
Item 4 (patent)
(a) A copy of the POA must be submitted at the time of national phase entry followed by submission of the original within 3 months from actual filing date in Indonesia
(b) DOA must be submitted within 3 months from actual filing date in Indonesia
(c) DOE must be submitted within 3 months from actual filing date in Indonesia
Item 5 (design)
(a) A copy of the POA must be submitted at the time of filing the design application followed by submission of the original within 3 months from actual filing date in Indonesia
(b) DOA must be submitted within 3 months from actual filing date in Indonesia
(c) SIDO must be submitted within 3 months from actual filing date in Indonesia
Question 7
Kindly let us know if the deadline mentioned in item 6 has expired, is there still an extension of time possible with surcharge?
(Example of fictive response: yes, 2 months from the communication date of the PTO + surcharge)
Answer 7
Both the patent and design applications cannot be filed without a copy of the POA.
For patents, if the original POA, DOA and DOE are not available within 3 months from the actual filing date, the same may be submitted after a 2-month extension without official fee. After the 2-month extension, a further 1-month extension with official fee can be obtained to submit the required documents.
For designs, if the original POA, DOA and SIDO are not available within 3 months from the actual filing date, a 1-month extension without official fee can be obtained to submit the required documents.
Question 8
If the deadline mentioned in item 7 has expired and no document has been filed, what is the legal consequence for the application regarding each document?
(Example of fictive response: assignment: application deemed withdrawn; POA: no representation possible; priority document: loss of priority date)
Answer 8
The application will be considered withdrawn.
Question 9
If it is possible to file a General Power of attorney, please provide us with such document in a MICROSOFT WORD format only (to enable us to fill in documents ourselves).
Answer 9
No.
Question 10
Should an assignment document be notarized?
Answer 10
If the specially drafted assignment form is available, a duly signed assignment form in original is sufficient. If a global or existing assignment is available, the same must be notarized.
Question 11
Should an assignment document be legalized by Apostille or by the Consulate (please precise by Apostille or by the Consulate, if any)?
Answer 11
No.
Question 12
If possible, please provide us with a copy (in PDF format) of any General Power of Attorney form duly signed, we sent you in the past
(Example of fictive response: General POA for Total Petrochemicals… in PDF format attached)
Answer 12
N/A.
Question 13
Does your PTO request the filing of original documents (POA, assignment) or is a copy sent only by fax of those documents accepted by your PTO?
(Example of fictive response: a copy sent only by fax is accepted, no original needed).
Answer 13
All original documents must be submitted.
Question 14
In case the priority document is drafted in a language other than English, do you need a verified English translation of the priority document, i.e. duly verified by the translator or authorized by the applicant?
Answer 14
Yes, a verified English translation of the priority document, i.e. duly verified by the translator will be required.
Question 14 (a)
If yes, what is the deadline for filing such translation with your PTO?
Answer 14 (a)
Within 3 months from the actual filing date of the patent or design application.
Question 14 (b)
What is the legal consequence if the priority document is not filed within the deadline? (Example of fictive response: loss of priority date).
Answer 14 (b)
Loss of priority date.
Question 15
What is/are the official language(s) for filing a patent application?
(Example of fictive response: English or French only)
Answer 15
Indonesian Language only.
Question 16
What is/are the official language(s) in which documents like POA, assignments must be drafted?
(Example of fictive response: English or French only)
Answer 16
Indonesian Language only.
Question 17
Kindly let us know if you need particulars for filing an application in your country (patent application number, copy of the office actions, responses to the office action, …) of corresponding foreign patent applications/patents?
Answer 17
No.
Question 17 (a)
If yes, mention the countries/organization(s) (example of fictive response: US, AU, EP)
Answer 17 (a)
N/A.
Question 17 (b)
If yes, is there a deadline for filing these particulars?
Answer 17 (b)
N/A.
Question 17 (c)
If yes, what is the legal consequence if we do not file such particulars despite corresponding foreign patent application(s)/ patents exist?
Answer 17 (c)
N/A.
Kindly let us know what is the deadline for requesting examination (patents) if the national phase of a PCT application is entered?
(Example of fictive response: 5 years from the PCT filing date)
Answer 1
3 years from the PCT filing date.
Question 2
If the deadline for requesting examination has expired, does your national law foresee a remedy, or has the application definitively lapsed?
(Example of fictive response: 2 months after receipt of a noting of loss of rights it is possible to file a reinstatement request and to pay a surcharge).
Answer 2
No provision for remedy. Application will be considered withdrawn.
Question 3
Does your law foresee that a small entity status enjoys a reduction of fee(s)?
Answer 3
Yes.
Question 3 (a)
If yes, please mention the definition of a small status entity
(Example of fictive response: 20 employees or less)
Answer 3 (a)
A small entity is an enterprise with a capital below USD 500.
Question 4
Please provide us with all blank documents in English and your national language (for patent applications) necessary for completing the entry into the PCT national phase (patent applications) in your country
(Example of fictive response: Power of attorney form (Word), Assignment document (Word) in English and your national language, forms P3&P26 (Word) …)
Answer 4
Documents required are as follows:
(a) Power of Attorney (POA)
(b) Deed of Assignment (DOA)
(c) Declaration of Entitlement (DOE)
Question 5
Provide us with all blank documents in English and your national language (for designs) necessary for completing the filing of a design application in your country.
(Example of fictive response: Power of attorney form (Word), Assignment document (Word) in English and your national language, forms P3&P26 (Word) …)
Answer 5
Documents required are as follows:
(a) Power of Attorney (POA)
(b) Deed of Assignment (DOA)
(c) Statement of Industrial Design Owner (SIDO)
Question 6
What is the deadline for filing the documents mentioned in items 4 and 5?
(Example of fictive response: 2 months from the 30/31 months deadline from the PCT filing date (patent applications) / filing date (designs))
Answer 6
Item 4 (patent)
(a) A copy of the POA must be submitted at the time of national phase entry followed by submission of the original within 3 months from actual filing date in Indonesia
(b) DOA must be submitted within 3 months from actual filing date in Indonesia
(c) DOE must be submitted within 3 months from actual filing date in Indonesia
Item 5 (design)
(a) A copy of the POA must be submitted at the time of filing the design application followed by submission of the original within 3 months from actual filing date in Indonesia
(b) DOA must be submitted within 3 months from actual filing date in Indonesia
(c) SIDO must be submitted within 3 months from actual filing date in Indonesia
Question 7
Kindly let us know if the deadline mentioned in item 6 has expired, is there still an extension of time possible with surcharge?
(Example of fictive response: yes, 2 months from the communication date of the PTO + surcharge)
Answer 7
Both the patent and design applications cannot be filed without a copy of the POA.
For patents, if the original POA, DOA and DOE are not available within 3 months from the actual filing date, the same may be submitted after a 2-month extension without official fee. After the 2-month extension, a further 1-month extension with official fee can be obtained to submit the required documents.
For designs, if the original POA, DOA and SIDO are not available within 3 months from the actual filing date, a 1-month extension without official fee can be obtained to submit the required documents.
Question 8
If the deadline mentioned in item 7 has expired and no document has been filed, what is the legal consequence for the application regarding each document?
(Example of fictive response: assignment: application deemed withdrawn; POA: no representation possible; priority document: loss of priority date)
Answer 8
The application will be considered withdrawn.
Question 9
If it is possible to file a General Power of attorney, please provide us with such document in a MICROSOFT WORD format only (to enable us to fill in documents ourselves).
Answer 9
No.
Question 10
Should an assignment document be notarized?
Answer 10
If the specially drafted assignment form is available, a duly signed assignment form in original is sufficient. If a global or existing assignment is available, the same must be notarized.
Question 11
Should an assignment document be legalized by Apostille or by the Consulate (please precise by Apostille or by the Consulate, if any)?
Answer 11
No.
Question 12
If possible, please provide us with a copy (in PDF format) of any General Power of Attorney form duly signed, we sent you in the past
(Example of fictive response: General POA for Total Petrochemicals… in PDF format attached)
Answer 12
N/A.
Question 13
Does your PTO request the filing of original documents (POA, assignment) or is a copy sent only by fax of those documents accepted by your PTO?
(Example of fictive response: a copy sent only by fax is accepted, no original needed).
Answer 13
All original documents must be submitted.
Question 14
In case the priority document is drafted in a language other than English, do you need a verified English translation of the priority document, i.e. duly verified by the translator or authorized by the applicant?
Answer 14
Yes, a verified English translation of the priority document, i.e. duly verified by the translator will be required.
Question 14 (a)
If yes, what is the deadline for filing such translation with your PTO?
Answer 14 (a)
Within 3 months from the actual filing date of the patent or design application.
Question 14 (b)
What is the legal consequence if the priority document is not filed within the deadline? (Example of fictive response: loss of priority date).
Answer 14 (b)
Loss of priority date.
Question 15
What is/are the official language(s) for filing a patent application?
(Example of fictive response: English or French only)
Answer 15
Indonesian Language only.
Question 16
What is/are the official language(s) in which documents like POA, assignments must be drafted?
(Example of fictive response: English or French only)
Answer 16
Indonesian Language only.
Question 17
Kindly let us know if you need particulars for filing an application in your country (patent application number, copy of the office actions, responses to the office action, …) of corresponding foreign patent applications/patents?
Answer 17
No.
Question 17 (a)
If yes, mention the countries/organization(s) (example of fictive response: US, AU, EP)
Answer 17 (a)
N/A.
Question 17 (b)
If yes, is there a deadline for filing these particulars?
Answer 17 (b)
N/A.
Question 17 (c)
If yes, what is the legal consequence if we do not file such particulars despite corresponding foreign patent application(s)/ patents exist?
Answer 17 (c)
N/A.
Wednesday
TOPIC : GENERAL QUESTIONS ON FILING PROCEDURE IN SINGAPORE
Question 1
If the national phase of a PCT application is entered?
(Example of fictive response: 5 years from the PCT filing date)
Answer 1
39 months from the earliest priority date, or where there is no priority date, the date of filing the application (international filing date).
Question 2
If the deadline for requesting examination has expired, does your national law foresee a remedy, or has the application definitively lapsed?
(Example of fictive response: 2 months after receipt of a noting of loss of rights it is possible to file a reinstatement request and to pay a surcharge).
Answer 2
Upon expiry of the 39 months deadline, Applicant may have up a period not exceeding 3 months to file the examination request. Over and above the 3 months extension, the Registrar may allow a further extension on such terms as he may direct and subject to the furnishing of a statutory declaration or affidavit setting out the grounds for the extension request.
The application may not be deemed lapsed even if no request for examination has been filed at all, since the Applicant may rely on the International Preliminary Report on Patentability (IPRP) or results of a foreign corresponding application for eventual grant of the Singapore patent.
Question 3
Does your law foresee that a small entity status enjoys a reduction of fee(s)?
Answer 3
No.
Question 3 (a)
If yes, please mention the definition of a small status entity
(Example of fictive response: 20 employees or less)
Answer 3 (a)
N/A.
Question 4
Please provide us with all blank documents in English and your national language (for patent applications) necessary for completing the entry into the PCT national phase (patent applications) in your country.
(Example of fictive response: Power of attorney form (Word), Assignment document (Word) in English and your national language, forms P3&P26 (Word) …)
Answer 4
In Singapore, there are no documents required such as POA, assignments etc for National Phase entry. The POA is filed online by the representing counsel.
Question 5
Provide us with all blank documents in English and your national language (for designs) necessary for completing the filing of a design application in your country.
(Example of fictive response: Power of attorney form (Word), Assignment document (Word) in English and your national language, forms P3&P26 (Word) …)
Answer 5
In Singapore, there are no documents such as POA, assignments etc for filing a Design application.
Question 6
What is the deadline for filing the documents mentioned in items 4 and 5?
(Example of fictive response: 2 months from the 30/31 months deadline from the PCT filing date (patent applications) / filing date (designs))
Answer 6
N/A.
Question 7
Kindly let us know if the deadline mentioned in item 6 has expired, is there still an extension of time possible with surcharge?
(Example of fictive response: yes, 2 months from the communication date of the PTO + surcharge)
Answer 7
N/A.
Question 8
If the deadline mentioned in item 7 has expired and no document has been filed, what is the legal consequence for the application regarding each document?
(Example of fictive response: assignment: application deemed withdrawn; POA: no representation possible; priority document: loss of priority date)
Answer 8
N/A.
Question 9
If it is possible to file a General Power of attorney, please provide us with such document.
Answer 9
No provision for POA as mentioned, thus no provision for General Power of Attorney.
Question 10
Should an assignment document be notarized?
Answer 10
NA, but we would have to submit a Statement of Inventorship online, which lets the Registry know how the Applicant derives its rights from the Inventors (e.g. assignment, employment, etc). No supporting documents are required for submission.
Question 11
Should an assignment document be legalized by Apostille or by the Consulate (please precise by Apostille or by the Consulate, if any)?
Answer 11
N/A.
Question 12
If possible, please provide us with a copy (in PDF format) of any General Power of Attorney form duly signed, we sent you in the past
(Example of fictive response: General POA for Total Petrochemicals… in PDF format attached)
Answer 12
N/A.
Question 13
Does your PTO request the filing of original documents (POA, assignment) or is a copy sent only by fax of those documents accepted by your PTO?
(Example of fictive response: a copy sent only by fax is accepted, no original needed).
Answer 13
N/A.
Question 14
In case the priority document is drafted in a language other than English, do you need a verified English translation of the priority document, i.e. duly verified by the translator or authorized by the applicant?
Answer 14
No, for all applications filed after 1 July 2004, it is no longer necessary to submit a certified copy of the priority document with its translation unless the Registrar explicitly calls for it.
Question 14 (a)
If yes, what is the deadline for filing such translation with your PTO?
Answer 14 (a)
N/A.
Question 14 (b)
What is the legal consequence if the priority document is not filed within the deadline? (Example of fictive response: loss of priority date).
Answer 14 (b)
N/A.
Question 15
What is/are the official language(s) for filing a patent application?
(Example of fictive response: English or French only)
Answer 15
English only.
Question 16
What is/are the official language(s) in which documents like POA, assignments must be drafted?
(Example of fictive response: English or French only)
Answer 16
English only.
Question 17
Kindly let us know if you need particulars for filing an application in your country (patent application number, copy of the office actions, responses to the office action, …) of corresponding foreign patent applications/patents?
Answer 17
No, not at the time of filing. However, they are needed when the Applicant chooses to rely on a corresponding application for GRANT of the Singapore patent.
Question 17 (a)
If yes, mention the countries/organization(s) (example of fictive response: US, AU, EP)
Answer 17 (a)
The patent offices prescribed in Singapore for the purposes of the definitions of “corresponding application” are —
(a) those of Australia, Canada (in respect of applications for a Canadian patent filed in the English language), Japan, New Zealand, Republic of Korea, the United Kingdom and the United States of America; and
(b) the European Patent Office (in respect of applications for a European patent filed in the English language).
Question 17 (b)
If yes, is there a deadline for filing these particulars?
Answer 17 (b)
At the time of requesting GRANT of the patent, i.e. either by 42 months or 60 months from the earliest priority date.
Question 17 (c)
If yes, what is the legal consequence if we do not file such particulars despite corresponding foreign patent application(s)/ patents exist?
Answer 17 (c)
Application considered withdrawn, if the Applicant wishes to secure grant by reliance on allowed corresponding applications, and yet Applicant fails to furnish the particulars.
If the national phase of a PCT application is entered?
(Example of fictive response: 5 years from the PCT filing date)
Answer 1
39 months from the earliest priority date, or where there is no priority date, the date of filing the application (international filing date).
Question 2
If the deadline for requesting examination has expired, does your national law foresee a remedy, or has the application definitively lapsed?
(Example of fictive response: 2 months after receipt of a noting of loss of rights it is possible to file a reinstatement request and to pay a surcharge).
Answer 2
Upon expiry of the 39 months deadline, Applicant may have up a period not exceeding 3 months to file the examination request. Over and above the 3 months extension, the Registrar may allow a further extension on such terms as he may direct and subject to the furnishing of a statutory declaration or affidavit setting out the grounds for the extension request.
The application may not be deemed lapsed even if no request for examination has been filed at all, since the Applicant may rely on the International Preliminary Report on Patentability (IPRP) or results of a foreign corresponding application for eventual grant of the Singapore patent.
Question 3
Does your law foresee that a small entity status enjoys a reduction of fee(s)?
Answer 3
No.
Question 3 (a)
If yes, please mention the definition of a small status entity
(Example of fictive response: 20 employees or less)
Answer 3 (a)
N/A.
Question 4
Please provide us with all blank documents in English and your national language (for patent applications) necessary for completing the entry into the PCT national phase (patent applications) in your country.
(Example of fictive response: Power of attorney form (Word), Assignment document (Word) in English and your national language, forms P3&P26 (Word) …)
Answer 4
In Singapore, there are no documents required such as POA, assignments etc for National Phase entry. The POA is filed online by the representing counsel.
Question 5
Provide us with all blank documents in English and your national language (for designs) necessary for completing the filing of a design application in your country.
(Example of fictive response: Power of attorney form (Word), Assignment document (Word) in English and your national language, forms P3&P26 (Word) …)
Answer 5
In Singapore, there are no documents such as POA, assignments etc for filing a Design application.
Question 6
What is the deadline for filing the documents mentioned in items 4 and 5?
(Example of fictive response: 2 months from the 30/31 months deadline from the PCT filing date (patent applications) / filing date (designs))
Answer 6
N/A.
Question 7
Kindly let us know if the deadline mentioned in item 6 has expired, is there still an extension of time possible with surcharge?
(Example of fictive response: yes, 2 months from the communication date of the PTO + surcharge)
Answer 7
N/A.
Question 8
If the deadline mentioned in item 7 has expired and no document has been filed, what is the legal consequence for the application regarding each document?
(Example of fictive response: assignment: application deemed withdrawn; POA: no representation possible; priority document: loss of priority date)
Answer 8
N/A.
Question 9
If it is possible to file a General Power of attorney, please provide us with such document.
Answer 9
No provision for POA as mentioned, thus no provision for General Power of Attorney.
Question 10
Should an assignment document be notarized?
Answer 10
NA, but we would have to submit a Statement of Inventorship online, which lets the Registry know how the Applicant derives its rights from the Inventors (e.g. assignment, employment, etc). No supporting documents are required for submission.
Question 11
Should an assignment document be legalized by Apostille or by the Consulate (please precise by Apostille or by the Consulate, if any)?
Answer 11
N/A.
Question 12
If possible, please provide us with a copy (in PDF format) of any General Power of Attorney form duly signed, we sent you in the past
(Example of fictive response: General POA for Total Petrochemicals… in PDF format attached)
Answer 12
N/A.
Question 13
Does your PTO request the filing of original documents (POA, assignment) or is a copy sent only by fax of those documents accepted by your PTO?
(Example of fictive response: a copy sent only by fax is accepted, no original needed).
Answer 13
N/A.
Question 14
In case the priority document is drafted in a language other than English, do you need a verified English translation of the priority document, i.e. duly verified by the translator or authorized by the applicant?
Answer 14
No, for all applications filed after 1 July 2004, it is no longer necessary to submit a certified copy of the priority document with its translation unless the Registrar explicitly calls for it.
Question 14 (a)
If yes, what is the deadline for filing such translation with your PTO?
Answer 14 (a)
N/A.
Question 14 (b)
What is the legal consequence if the priority document is not filed within the deadline? (Example of fictive response: loss of priority date).
Answer 14 (b)
N/A.
Question 15
What is/are the official language(s) for filing a patent application?
(Example of fictive response: English or French only)
Answer 15
English only.
Question 16
What is/are the official language(s) in which documents like POA, assignments must be drafted?
(Example of fictive response: English or French only)
Answer 16
English only.
Question 17
Kindly let us know if you need particulars for filing an application in your country (patent application number, copy of the office actions, responses to the office action, …) of corresponding foreign patent applications/patents?
Answer 17
No, not at the time of filing. However, they are needed when the Applicant chooses to rely on a corresponding application for GRANT of the Singapore patent.
Question 17 (a)
If yes, mention the countries/organization(s) (example of fictive response: US, AU, EP)
Answer 17 (a)
The patent offices prescribed in Singapore for the purposes of the definitions of “corresponding application” are —
(a) those of Australia, Canada (in respect of applications for a Canadian patent filed in the English language), Japan, New Zealand, Republic of Korea, the United Kingdom and the United States of America; and
(b) the European Patent Office (in respect of applications for a European patent filed in the English language).
Question 17 (b)
If yes, is there a deadline for filing these particulars?
Answer 17 (b)
At the time of requesting GRANT of the patent, i.e. either by 42 months or 60 months from the earliest priority date.
Question 17 (c)
If yes, what is the legal consequence if we do not file such particulars despite corresponding foreign patent application(s)/ patents exist?
Answer 17 (c)
Application considered withdrawn, if the Applicant wishes to secure grant by reliance on allowed corresponding applications, and yet Applicant fails to furnish the particulars.
TOPIC : GENERAL QUESTIONS ON FILING PROCEDURE IN MALAYSIA
Question 1
If the national phase of a PCT application is entered?
(Example of fictive response: 5 years from the PCT filing date)
Answer 1
4 years from the PCT filing date.
However, on or before this deadline, should a deferment request be filed, the said deadline will be extended to 5 years from the PCT filing date.
Question 2
If the deadline for requesting examination has expired, does your national law foresee a remedy, or has the application definitively lapsed?
(Example of fictive response: 2 months after receipt of a noting of loss of rights it is possible to file a reinstatement request and to pay a surcharge).
Answer 2
No provision for remedy. Application considered withdrawn.
Question 3 (a)
Does Malaysian law foresee that a small entity status enjoys a reduction of fee(s)?
Answer 3 (a)
No.
Question 3 (b)
If yes, please mention the definition of a small status entity.
(Example of fictive response: 20 employees or less)
Answer 3 (b)
There is no provision for reduced filing fees.
Question 4
Please provide us with all blank documents in English and your national language (for patent applications) necessary for completing the entry into the PCT national phase (patent applications) in your country.
(Example of fictive response: Power of attorney form, Assignment document in English and your national language, forms P3&P26…)
Answer 4
Documents required are as follows:
(a) Power of Attorney (Form 17)
(b) Fee for Entering the National Phase (Form 2A)
Note: An assignment document will not be required. However we will prepare a “Statement Justifying the Applicant’s Right (SJAR)” at our end. For this purpose, please inform us how the Applicant derives the rights to the invention, i.e. either by way of assignment or virtue of employment contract.
All documents are provided in English only.
Question 5
Provide us with all blank documents in English and your national language (for designs) necessary for completing the filing of a design application in your country
(Example of fictive response: Power of attorney form, Assignment document in English and your national language, forms P3&P26…)
Answer 5
Documents required are as follows:
(a) Power of Attorney (ID Form 10)
(b) Application for registration of an Industrial Design (ID Form 1)
Note: An assignment document will not be required. However we will prepare a “Statement Justifying the Applicant’s Right (SJAR)” at our end. For this purpose, please inform us how the Applicant derives the rights to the design, i.e. either by way of assignment or virtue of employment contract.
All documents are provided in English only.
Question 6
What is the deadline for filing the documents mentioned in items 4 and 5?
(Example of fictive response: 2 months from the 30/31 months deadline from the PCT filing date (patent applications) / filing date (designs))
Answer 6
Patent Applications:
(a) Form 17 & SJAR: no deadline unless a communication is received from the PTO. However, we prefer to file within 3 months from the filing date of the PCT national phase
(b) Form 2A: 30 months deadline from the priority date of the PCT application
Design
(a) ID Form 10: upon filing
(b) ID Form 1: upon filing
Question 7
Kindly let us know if the deadline mentioned in item 6 has expired, is there still an extension of time possible with surcharge?
(Example of fictive response: yes, 2 months from the communication date of the PTO + surcharge)
Answer 7
Patent Applications:
(a) Form 17 & SJAR: N/A
(b) Form 2A: 2 months from the date of removal of the cause of failure to meet the deadline or 12 months after the expiration of the deadline, whichever period expires first + surcharge
Design
(a) ID Form 10: 3 months of extension of time + extension fee
(b) ID Form 1: no extension of time is possible
Question 8
If the deadline mentioned in item 7 has expired and no document has been filed, what is the legal consequence for the application regarding each document?
(Example of fictive response: assignment: application deemed withdrawn; POA: no representation possible; priority document: loss of priority date)
Answer 8
Patent Applications:
(a) Form 17: no representation possible and application considered withdrawn
(b) Form 2A: application considered withdrawn
Design
(a) ID Form 10: application considered withdrawn
(b) ID Form 1: application considered withdrawn
Priority documents must be filed within 3 months from the filing date of the PCT national phase (patents) / filing date (designs) and no extension of time is possible, failing which there will be loss of priority date.
Question 9
If it is possible to file a General Power of Attorney in Malaysia?
Answer 9
No provision for General Power of Attorney.
Question 10
Should an assignment document be notarized?
Answer 10
Yes, should the original not be available.
Note: An assignment document is not a requirement for filing patent / design applications. However, the same will be required in the case of a merger or assignment from one entity to another.
Question 11
Should an assignment document be legalized by Apostille or by the Consulate (please precise by Apostille or by the Consulate, if any)?
Answer 11
No.
Question 12
Does your PTO request the filing of original documents (POA, assignment) or is a copy sent only by fax of those documents accepted by your PTO?
(Example of fictive response: a copy sent only by fax is accepted, no original needed).
Answer 12
Only originals are accepted.
Question 13 (a)
In case the priority document is drafted in a language other than English, do you need a verified English translation of the priority document, i.e. duly verified by the translator or authorized by the applicant?
Answer 13 (a)
Yes, a verified English translation of the priority document, i.e. duly verified by the translator will be required.
Question 13 (b)
If yes, what is the deadline for filing such translation with your PTO?
Answer 13 (b)
Within 3 months from the filing date of the PCT national phase (patents) / filing date (designs) and no extension of time is possible.
Question 13 (c)
What is the legal consequence if the priority document is not filed within the deadline? (Example of fictive response: loss of priority date).
Answer 13 (c)
Loss of priority date.
Question 14
What is/are the official language(s) for filing a patent application?
(Example of fictive response: English or French only)
Answer 14
English or Malay Language (National Language)
Question 15
What is/are the official language(s) in which documents like POA, assignments must be drafted? (Example of fictive response: English or French only)
Answer 15
English or Malay Language (National Language)
Question 16 (a)
Kindly let us know if you need particulars for filing an application in your country (patent application number, copy of the office actions, responses to the office action, …) of corresponding foreign patent applications/patents?
Answer 16 (a)
Yes. This includes:
(a) prescribed information / supporting document concerning filing of any application outside Malaysia
(b) prescribed information concerning results or search / examination carried out by an International Searching Authority
Question 16 (b)
If yes, mention the countries/organization(s) (Example of fictive response: US, AU, EP)
Answer 16 (b)
Prescribed countries: US, AU, EP, KR, JP, GB
Question 16 (c)
If yes, is there a deadline for filing these particulars?
Answer 16 (c)
At the time of requesting examination.
Question 16 (d)
If yes, what is the legal consequence if we do not file such particulars despite corresponding foreign patent application(s)/ patents exist?
Answer 16 (d)
Application considered withdrawn.
If the national phase of a PCT application is entered?
(Example of fictive response: 5 years from the PCT filing date)
Answer 1
4 years from the PCT filing date.
However, on or before this deadline, should a deferment request be filed, the said deadline will be extended to 5 years from the PCT filing date.
Question 2
If the deadline for requesting examination has expired, does your national law foresee a remedy, or has the application definitively lapsed?
(Example of fictive response: 2 months after receipt of a noting of loss of rights it is possible to file a reinstatement request and to pay a surcharge).
Answer 2
No provision for remedy. Application considered withdrawn.
Question 3 (a)
Does Malaysian law foresee that a small entity status enjoys a reduction of fee(s)?
Answer 3 (a)
No.
Question 3 (b)
If yes, please mention the definition of a small status entity.
(Example of fictive response: 20 employees or less)
Answer 3 (b)
There is no provision for reduced filing fees.
Question 4
Please provide us with all blank documents in English and your national language (for patent applications) necessary for completing the entry into the PCT national phase (patent applications) in your country.
(Example of fictive response: Power of attorney form, Assignment document in English and your national language, forms P3&P26…)
Answer 4
Documents required are as follows:
(a) Power of Attorney (Form 17)
(b) Fee for Entering the National Phase (Form 2A)
Note: An assignment document will not be required. However we will prepare a “Statement Justifying the Applicant’s Right (SJAR)” at our end. For this purpose, please inform us how the Applicant derives the rights to the invention, i.e. either by way of assignment or virtue of employment contract.
All documents are provided in English only.
Question 5
Provide us with all blank documents in English and your national language (for designs) necessary for completing the filing of a design application in your country
(Example of fictive response: Power of attorney form, Assignment document in English and your national language, forms P3&P26…)
Answer 5
Documents required are as follows:
(a) Power of Attorney (ID Form 10)
(b) Application for registration of an Industrial Design (ID Form 1)
Note: An assignment document will not be required. However we will prepare a “Statement Justifying the Applicant’s Right (SJAR)” at our end. For this purpose, please inform us how the Applicant derives the rights to the design, i.e. either by way of assignment or virtue of employment contract.
All documents are provided in English only.
Question 6
What is the deadline for filing the documents mentioned in items 4 and 5?
(Example of fictive response: 2 months from the 30/31 months deadline from the PCT filing date (patent applications) / filing date (designs))
Answer 6
Patent Applications:
(a) Form 17 & SJAR: no deadline unless a communication is received from the PTO. However, we prefer to file within 3 months from the filing date of the PCT national phase
(b) Form 2A: 30 months deadline from the priority date of the PCT application
Design
(a) ID Form 10: upon filing
(b) ID Form 1: upon filing
Question 7
Kindly let us know if the deadline mentioned in item 6 has expired, is there still an extension of time possible with surcharge?
(Example of fictive response: yes, 2 months from the communication date of the PTO + surcharge)
Answer 7
Patent Applications:
(a) Form 17 & SJAR: N/A
(b) Form 2A: 2 months from the date of removal of the cause of failure to meet the deadline or 12 months after the expiration of the deadline, whichever period expires first + surcharge
Design
(a) ID Form 10: 3 months of extension of time + extension fee
(b) ID Form 1: no extension of time is possible
Question 8
If the deadline mentioned in item 7 has expired and no document has been filed, what is the legal consequence for the application regarding each document?
(Example of fictive response: assignment: application deemed withdrawn; POA: no representation possible; priority document: loss of priority date)
Answer 8
Patent Applications:
(a) Form 17: no representation possible and application considered withdrawn
(b) Form 2A: application considered withdrawn
Design
(a) ID Form 10: application considered withdrawn
(b) ID Form 1: application considered withdrawn
Priority documents must be filed within 3 months from the filing date of the PCT national phase (patents) / filing date (designs) and no extension of time is possible, failing which there will be loss of priority date.
Question 9
If it is possible to file a General Power of Attorney in Malaysia?
Answer 9
No provision for General Power of Attorney.
Question 10
Should an assignment document be notarized?
Answer 10
Yes, should the original not be available.
Note: An assignment document is not a requirement for filing patent / design applications. However, the same will be required in the case of a merger or assignment from one entity to another.
Question 11
Should an assignment document be legalized by Apostille or by the Consulate (please precise by Apostille or by the Consulate, if any)?
Answer 11
No.
Question 12
Does your PTO request the filing of original documents (POA, assignment) or is a copy sent only by fax of those documents accepted by your PTO?
(Example of fictive response: a copy sent only by fax is accepted, no original needed).
Answer 12
Only originals are accepted.
Question 13 (a)
In case the priority document is drafted in a language other than English, do you need a verified English translation of the priority document, i.e. duly verified by the translator or authorized by the applicant?
Answer 13 (a)
Yes, a verified English translation of the priority document, i.e. duly verified by the translator will be required.
Question 13 (b)
If yes, what is the deadline for filing such translation with your PTO?
Answer 13 (b)
Within 3 months from the filing date of the PCT national phase (patents) / filing date (designs) and no extension of time is possible.
Question 13 (c)
What is the legal consequence if the priority document is not filed within the deadline? (Example of fictive response: loss of priority date).
Answer 13 (c)
Loss of priority date.
Question 14
What is/are the official language(s) for filing a patent application?
(Example of fictive response: English or French only)
Answer 14
English or Malay Language (National Language)
Question 15
What is/are the official language(s) in which documents like POA, assignments must be drafted? (Example of fictive response: English or French only)
Answer 15
English or Malay Language (National Language)
Question 16 (a)
Kindly let us know if you need particulars for filing an application in your country (patent application number, copy of the office actions, responses to the office action, …) of corresponding foreign patent applications/patents?
Answer 16 (a)
Yes. This includes:
(a) prescribed information / supporting document concerning filing of any application outside Malaysia
(b) prescribed information concerning results or search / examination carried out by an International Searching Authority
Question 16 (b)
If yes, mention the countries/organization(s) (Example of fictive response: US, AU, EP)
Answer 16 (b)
Prescribed countries: US, AU, EP, KR, JP, GB
Question 16 (c)
If yes, is there a deadline for filing these particulars?
Answer 16 (c)
At the time of requesting examination.
Question 16 (d)
If yes, what is the legal consequence if we do not file such particulars despite corresponding foreign patent application(s)/ patents exist?
Answer 16 (d)
Application considered withdrawn.
Thursday
TOPIC : QUESTIONS ON MALAYSIAN NATIONALITY FILING PATENT APPLICATION ABROAD
Question
A Chinese company has an employee who has Malaysian nationality and co-developed an invention in Beijing with other Chinese inventors. We want to file an application for this invention in European Patent Office under the name of the Chinese company. Could Patrick Mirandah Co. tell us whether we should get approval from Malaysia official for this filing?
Answer
It is necessary for a Malaysian Inventor working abroad to have a clearance from the Intellectual Property Corporation of Malaysia (MyIPO) for a patent which he is an inventor or joint inventor.
For sake of clarity, we reproduce Section 23A(a) of the Malaysian Patents Act.
23A. Applications by residents to be filed in Malaysia first.
No person resident in Malaysia shall, without written authority granted by the Registrar, file or cause to be filed outside Malaysia an application for a patent for an invention unless
(a) an application for a patent for the same invention has been filed in the Patent Registration Office not less than two months before the application outside Malaysia.
We will need to apply for a waiver from MyIPO to enable the patent application to be filed in the European Patent Office (EPO) without having it first filed in Malaysia. In order for us to request for a waiver from MyIPO, we would require:
1. a copy of the present specification or a brief description of the invention.
2. name and correspondence address of the applicant of the said invention.
3. name, correspondence address and citizenship of the named inventors.
4. applicant’s rights to the invention : by virtue of assignment/being the inventor’s employer etc.
A Chinese company has an employee who has Malaysian nationality and co-developed an invention in Beijing with other Chinese inventors. We want to file an application for this invention in European Patent Office under the name of the Chinese company. Could Patrick Mirandah Co. tell us whether we should get approval from Malaysia official for this filing?
Answer
It is necessary for a Malaysian Inventor working abroad to have a clearance from the Intellectual Property Corporation of Malaysia (MyIPO) for a patent which he is an inventor or joint inventor.
For sake of clarity, we reproduce Section 23A(a) of the Malaysian Patents Act.
23A. Applications by residents to be filed in Malaysia first.
No person resident in Malaysia shall, without written authority granted by the Registrar, file or cause to be filed outside Malaysia an application for a patent for an invention unless
(a) an application for a patent for the same invention has been filed in the Patent Registration Office not less than two months before the application outside Malaysia.
We will need to apply for a waiver from MyIPO to enable the patent application to be filed in the European Patent Office (EPO) without having it first filed in Malaysia. In order for us to request for a waiver from MyIPO, we would require:
1. a copy of the present specification or a brief description of the invention.
2. name and correspondence address of the applicant of the said invention.
3. name, correspondence address and citizenship of the named inventors.
4. applicant’s rights to the invention : by virtue of assignment/being the inventor’s employer etc.
TOPIC : QUESTIONS REGARDING INFRINGEMENT AND PROCESS PATENTS
Question
Does Malaysia law permit shifting the burden of proof to the alleged infringer to show that their process does not infringe in the following two scenarios.
(a) manufacture within the country by the alleged infringer, or
(b) importation by the alleged infringer from another country.
Answer
As far as the Patent Laws are concerned in Malaysia, the answer for scenario (1) and (2) is identical wherein, if the patent in question is granted in respect of a process for obtaining a product, the burden of proof shifts to the alleged infringer to prove non-infringement of the process, even if the process is conducted outside of Malaysia but the resulting product is then imported into Malaysia.
Does Malaysia law permit shifting the burden of proof to the alleged infringer to show that their process does not infringe in the following two scenarios.
(a) manufacture within the country by the alleged infringer, or
(b) importation by the alleged infringer from another country.
Answer
As far as the Patent Laws are concerned in Malaysia, the answer for scenario (1) and (2) is identical wherein, if the patent in question is granted in respect of a process for obtaining a product, the burden of proof shifts to the alleged infringer to prove non-infringement of the process, even if the process is conducted outside of Malaysia but the resulting product is then imported into Malaysia.
Friday
Enquiry on Redulatory Exclusivity in Malaysia, Indonesia and India
MALAYSIA
Question 1
Is any regularity exclusivity (e.g. data and/or marketing exclusivity) available upon: (i) first marketing approval of a new chemical entity; or (ii) approval of a new method of use of an approved product?
Answer 1
At present, Malaysia has not implemented Data Exclusivity (DE). However, protection of undisclosed information in Malaysia is based on common law practices where clinical trial data presented to the National Pharmaceutical Control Bureau (NPCB) during a regulatory approval process is protected under Malaysia’s Official Secrets Act 1972. Additionally, according to Sale of Drugs Act 1952, officer has to maintain secrecy of matters which comes to his knowledge or when cognisance is placed (which includes clinical trial data) and therefore, the data submitted for regulatory approval is protected, however the protection is not exclusive hence generic companies can still enter the Malaysian market as long as the compound or composition is not protected under Malaysian Patents Act 1983.
Question 2
If such exclusivity is available, does composition of matter patent protection for the active pharmaceutical ingredient affect entitlement to, or the term of such exclusivity whether or not a composition of matter (i.e. active pharmaceutical ingredient) patent was applied for, an application is pending, no patent was granted (e.g. abandoned, withdrawn or denied), or the patent has expired?
Answer 2
DE is not yet available in Malaysia, however it does not matter if composition claims are present, it will not affect DE if and when DE comes into force.
Question 3
If regulatory exclusivity is available, what are the periods of exclusivity and when do they commence?
Answer 3
Not applicable.
Question 4
What is the (i) nature and (ii) scope of protection for the exclusivity?
Answer 4
Not applicable.
Question 5
How is such right enforced and by whom?
Answer 5
If DE is implemented in Malaysia, the period of exclusivity will be for 5 years from the date of approval from country of origin (still under discussion stage and not yet approved). It will be enforced by the National Pharmaceutical Control Bureau (NPCB).
Question 6
If available, are there any substantive requirements (active steps) which must be met apart from submission of a marketing application to obtain such exclusivity?
Answer 6
Not applicable.
Question 7
Must local marketing authorization be obtained to qualify for regulatory exclusivity, or can foreign or regional marketing authorizations be effective? If so, which foreign or regional authorizations and/or supplements can be effective, and what is the time-frame for taking action to obtain regulatory exclusivity, if any, based upon such authorization?
Answer 7
Local authorization must be approved before marketing (authorization from NPCB), however this authorization does not provide any data exclusivity of the clinical trial data.
Question 8
Will a new formulation be entitled to any additional regulatory exclusivity upon approval? If so, please answer questions 1 – 7 as they apply to this new formulation?
Answer 8
Not applicable.
Question 9
What part of the manufacturing chain, if any, must occur in Malaysia to receive marketing approval (e.g. manufacture of active API, product formulation, and/or product packaging, or other)?
Answer 9
Not applicable.
Question 10
If there are no DE laws per se, are there other laws, e.g. trade secret laws that recognize the proprietary nature of registration data and preclude regulatory authorities from relying on or otherwise using the data submitted by the originator for the approval of copies of the medicine without the approval of the originator?
Answer 10
Protection of undisclosed information in Malaysia is based on common law practices (trade secrets etc.) with data presented to the NPCB during the regulatory approval process protected under Malaysia’s Official Secrets Act 1972.
General Information on DE in MALAYSIA
At the moment, DE has not yet been adopted in Malaysia. However, the Malaysian government has announced in May 2007 that by the end of 2007, five years of data protection would be provided for new chemical entities and three years for new indications, starting from the date of approval in the country of origin rather than from the date of approval in Malaysia. However, issues related to the implementation of DE such as legislative amendments are yet to be worked out and the implementation deadline has been delayed indefinitely.
Based on our interview with the officers at the National Pharmaceutical Control Bureau (NPCB) of Malaysia, the DE law most probably will take effect next year. Once again, we can’t be really sure on this, only time will tell when actually DE will be adopted in Malaysia.
Currently, there is on-going discussion between the local manufacture and the multinational companies (MNC) to come to a conclusion on DE and to present the outcome of the discussion to the Malaysian government for approval. Although, the Malaysian government has given their consent to actually adopt DE as per the requirements in World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the local manufacturer is still reluctant on the fear that they may no longer be competitive in both local and international market.
Although the Malaysian government aspires to create an enabling environment for biosciences and biomedical research by adopting DE, public outcry on the restriction on the availability of life-saving drugs at an affordable price has significantly delayed the adoption of DE as required in TRIPS in Malaysia.
Protection of undisclosed information in Malaysia is based on common law practices with data presented to the NPCB during the regulatory approval process protected under Malaysia’s Official Secrets Act 1972.
Based on above provided information, we can say that Malaysia is moving toward implementing DE in the very near future and all minute details are studied carefully by the industry players to provide win-win solution for all the parties involved. Based on latest development, DE most probably will be implemented in Malaysia by middle of next year.
INDONESIA
Question 1
Is any regularity exclusivity (e.g. data and/or marketing exclusivity) available upon: (i) first marketing approval of a new chemical entity; or (ii) approval of a new method of use of an approved product?
Answer 1
Indonesia has no specific law on Data Exclusivity (DE). At present, the undisclosed information or data in Indonesia can be protected as Trade Secret. The Indonesian Food and Drugs Agency (BPOM) as the agency who provides market authorization also do not have any specific system in place to protect DE.
Question 2
If such exclusivity is available, does composition of matter patent protection for the active pharmaceutical ingredient affect entitlement to, or the term of such exclusivity whether or not a composition of matter (i.e. active pharmaceutical ingredient) patent was applied for, an application is pending, no patent was granted (e.g. abandoned, withdrawn or denied), or the patent has expired?
Answer 2
DE is not yet available in Indonesia. However, we believe that once it is enforced it should be proactive coordination between patent office and BPOM in the implementation of such regulation.
Question 3
If regulatory exclusivity is available, what are the periods of exclusivity and when do they commence?
Answer 3
Not applicable.
Question 4
What is the (i) nature and (ii) scope of protection for the exclusivity?
Answer 4
Not applicable.
Question 5
How is such right enforced and by whom?
Answer 5
Not yet available and we are of the opinion that DE will be enforced by BPOM.
Question 6
If available, are there any substantive requirements (active steps) which must be met apart from submission of a marketing application to obtain such exclusivity?
Answer 6
Not yet available.
Question 7
Must local marketing authorization be obtained to qualify for regulatory exclusivity, or can foreign or regional marketing authorizations be effective? If so, which foreign or regional authorizations and/or supplements can be effective, and what is the time-frame for taking action to obtain regulatory exclusivity, if any, based upon such authorization?
Answer 7
Yes, marketing authorization from BPOM shall be obtained to allow a product be sold/marketed in Indonesia. However, currently this authorization does not provide protection on the data exclusivity. It is merely a market authorization for selling a product within Indonesian territory.
Question 8
Will a new formulation be entitled to any additional regulatory exclusivity upon approval? If so, please answer questions 1 – 7 as they apply to this new formulation?
Answer 8
Not applicable.
Question 9
What part of the manufacturing chain, if any, must occur in the selected country to receive marketing approval (e.g. manufacture of active API, product formulation, and/or product packaging, or other)?
Answer 9
Not applicable.
Question 10
If there are no DE laws per se, are there other laws, e.g. trade secret laws that recognize the proprietary nature of registration data and preclude regulatory authorities from relying on or otherwise using the data submitted by the originator for the approval of copies of the medicine without the approval of the originator?
Answer 10
The undisclosed information or data in Indonesia can be protected as Trade Secret. The data provided to BPOM for marketing authorization is possible to protect under Trade Secret.
General Information on DE in INDONESIA
As the member of the WTO, Indonesia is required to implement adequate data exclusivity protection in accordance with TRIPS Article 39.3. However to-date, there is no specific law or regulation on Data Exclusivity is available. Under current practice, the undisclosed information or data may be protected as Trade Secret. The BPOM (Indonesia Food and Drugs Agency) as the government agency for food and drugs market authorization also has no policy in place for protecting undisclosed information concerning to pharmaceutical data. Based on the information from BPOM, currently there is a discussion in the legislative level concerning to the importance of implementation DE protection. We believe that such regulation will be under BPOM. However, we cannot predict as when and what kind of specific regulation in DE will take enforce in this regard.
General Information of DE IN EUROPEAN UNION (EU)
DE has been implemented in EU since 1987 to provide sufficient product protection. Currently, the New EU Pharmaceutical Legislation adopted in 2004 has created a harmonized eight-year DE, two-year marketing exclusivity (ME) and one-year extension to the ME to new chemical entities (8+2+1 years).
INDIA
Question 1
Is any regularity exclusivity (e.g. data and/or marketing exclusivity) available upon: (i) first marketing approval of a new chemical entity; or (ii) approval of a new method of use of an approved product?
Answer 1
In India, there is no specific provision for Data Exclusivity. In fact, research based pharmaceutical companies have been pressing for a Data Exclusivity law relying on Article 39.3 of TRIPS.
After the topic of Data Exclusivity became a heated issue in India, a Committee was constituted to recommend a plan of action on Data Exclusivity (the Satwant Reddy Committee). Though, the Satwant Reddy Committee did recommend that there should be data exclusivity for 5 years in India, the proposal has not yet been implemented or accepted by the Government of India due to the division in opinions of various ministries. Therefore, the recommendations of the committee have no weight thus far.
This fact has even been upheld in two cases by the Hon’ble High Court of Delhi. [Syngenta India Ltd v. Union of India and Bayer v. Cipla]. The Hon’ble High Court held that though it agrees that the Satwant Reddy committee has recommended Data Exclusivity, the fact that no legislation has been passed to implement it, means that Data exclusivity does not exist in India and the Court cannot form policies through its decisions.
Therefore, to conclude, no Data Exclusivity exists in India.
Question 2
If such exclusivity is available, does composition of matter patent protection for the active pharmaceutical ingredient affect entitlement to, or the term of such exclusivity whether or not a composition of matter (i.e. active pharmaceutical ingredient) patent was applied for, an application is pending, no patent was granted (e.g. abandoned, withdrawn or denied), or the patent has expired?
Answer 2
N/A
Question 3
If regulatory exclusivity is available, what are the periods of exclusivity and when do they commence?
Answer 3
N/A
Question 4
What is the (i) nature and (ii) scope of protection for the exclusivity?
Answer 4
N/A
Question 5
How is such right enforced and by whom?
Answer 5
N/A
Question 6
If available, are there any substantive requirements (active steps) which must be met apart from submission of a marketing application to obtain such exclusivity?
Answer 6
N/A
Question 7
Must local marketing authorization be obtained to qualify for regulatory exclusivity, or can foreign or regional marketing authorizations be effective? If so, which foreign or regional authorizations and/or supplements can be effective, and what is the time-frame for taking action to obtain regulatory exclusivity, if any, based upon such authorization?
Answer 7
The market exclusivity is only granted by the grant of patent in India. For this, the regulatory authority in India is the Drug Controller, who has not been empowered with granting exclusive rights. Moreover, even if a patent is granted to a patentee and a generic drug manufacture wants to take a market approval from the drug controller, the drug controller while granting or refusing permission, will not take into account, whether the drug is protected by a patent.
Question 8
Will a new formulation be entitled to any additional regulatory exclusivity upon approval? If so, please answer questions 1 – 7 as they apply to this new formulation?
Answer 8
A new formulation can be given market exclusivity only under the patent regime and there is no link between market approval by the Drug Controller and the market exclusivity under the patent act.
Question 9
What part of the manufacturing chain, if any, must occur in the selected country to receive marking approval (e.g. manufacture of active API, product formulation, and/or product packaging, or other)?
Answer 9
If a drug has been approved in other countries and the manufacturer wants to import those drugs into India then according to the new rules (can be found at http://cdsco.nic.in/html/importdrugs.htm), an import licence will be required for all types of drugs. Import licence will only be granted after registration of overseas manufacturer and the specific drugs to be imported. This licence is valid for 3 years from the date of issue. Only Drugs with minimum 60% of retained self life shall are allowed to be imported.
Question 10
If there are no DE laws per se, are there other laws, e.g. trade secret laws that recognize the proprietary nature of registration data and preclude regulatory authorities from relying on or otherwise using the data submitted by the originator for the approval of copies of the medicine without the approval of the originator?
Answer 10
At present, there are no laws which prevent a generic drug company from relying on the clinical drug trials of a research based company to seek approval of their generic drug.
Question 1
Is any regularity exclusivity (e.g. data and/or marketing exclusivity) available upon: (i) first marketing approval of a new chemical entity; or (ii) approval of a new method of use of an approved product?
Answer 1
At present, Malaysia has not implemented Data Exclusivity (DE). However, protection of undisclosed information in Malaysia is based on common law practices where clinical trial data presented to the National Pharmaceutical Control Bureau (NPCB) during a regulatory approval process is protected under Malaysia’s Official Secrets Act 1972. Additionally, according to Sale of Drugs Act 1952, officer has to maintain secrecy of matters which comes to his knowledge or when cognisance is placed (which includes clinical trial data) and therefore, the data submitted for regulatory approval is protected, however the protection is not exclusive hence generic companies can still enter the Malaysian market as long as the compound or composition is not protected under Malaysian Patents Act 1983.
Question 2
If such exclusivity is available, does composition of matter patent protection for the active pharmaceutical ingredient affect entitlement to, or the term of such exclusivity whether or not a composition of matter (i.e. active pharmaceutical ingredient) patent was applied for, an application is pending, no patent was granted (e.g. abandoned, withdrawn or denied), or the patent has expired?
Answer 2
DE is not yet available in Malaysia, however it does not matter if composition claims are present, it will not affect DE if and when DE comes into force.
Question 3
If regulatory exclusivity is available, what are the periods of exclusivity and when do they commence?
Answer 3
Not applicable.
Question 4
What is the (i) nature and (ii) scope of protection for the exclusivity?
Answer 4
Not applicable.
Question 5
How is such right enforced and by whom?
Answer 5
If DE is implemented in Malaysia, the period of exclusivity will be for 5 years from the date of approval from country of origin (still under discussion stage and not yet approved). It will be enforced by the National Pharmaceutical Control Bureau (NPCB).
Question 6
If available, are there any substantive requirements (active steps) which must be met apart from submission of a marketing application to obtain such exclusivity?
Answer 6
Not applicable.
Question 7
Must local marketing authorization be obtained to qualify for regulatory exclusivity, or can foreign or regional marketing authorizations be effective? If so, which foreign or regional authorizations and/or supplements can be effective, and what is the time-frame for taking action to obtain regulatory exclusivity, if any, based upon such authorization?
Answer 7
Local authorization must be approved before marketing (authorization from NPCB), however this authorization does not provide any data exclusivity of the clinical trial data.
Question 8
Will a new formulation be entitled to any additional regulatory exclusivity upon approval? If so, please answer questions 1 – 7 as they apply to this new formulation?
Answer 8
Not applicable.
Question 9
What part of the manufacturing chain, if any, must occur in Malaysia to receive marketing approval (e.g. manufacture of active API, product formulation, and/or product packaging, or other)?
Answer 9
Not applicable.
Question 10
If there are no DE laws per se, are there other laws, e.g. trade secret laws that recognize the proprietary nature of registration data and preclude regulatory authorities from relying on or otherwise using the data submitted by the originator for the approval of copies of the medicine without the approval of the originator?
Answer 10
Protection of undisclosed information in Malaysia is based on common law practices (trade secrets etc.) with data presented to the NPCB during the regulatory approval process protected under Malaysia’s Official Secrets Act 1972.
General Information on DE in MALAYSIA
At the moment, DE has not yet been adopted in Malaysia. However, the Malaysian government has announced in May 2007 that by the end of 2007, five years of data protection would be provided for new chemical entities and three years for new indications, starting from the date of approval in the country of origin rather than from the date of approval in Malaysia. However, issues related to the implementation of DE such as legislative amendments are yet to be worked out and the implementation deadline has been delayed indefinitely.
Based on our interview with the officers at the National Pharmaceutical Control Bureau (NPCB) of Malaysia, the DE law most probably will take effect next year. Once again, we can’t be really sure on this, only time will tell when actually DE will be adopted in Malaysia.
Currently, there is on-going discussion between the local manufacture and the multinational companies (MNC) to come to a conclusion on DE and to present the outcome of the discussion to the Malaysian government for approval. Although, the Malaysian government has given their consent to actually adopt DE as per the requirements in World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the local manufacturer is still reluctant on the fear that they may no longer be competitive in both local and international market.
Although the Malaysian government aspires to create an enabling environment for biosciences and biomedical research by adopting DE, public outcry on the restriction on the availability of life-saving drugs at an affordable price has significantly delayed the adoption of DE as required in TRIPS in Malaysia.
Protection of undisclosed information in Malaysia is based on common law practices with data presented to the NPCB during the regulatory approval process protected under Malaysia’s Official Secrets Act 1972.
Based on above provided information, we can say that Malaysia is moving toward implementing DE in the very near future and all minute details are studied carefully by the industry players to provide win-win solution for all the parties involved. Based on latest development, DE most probably will be implemented in Malaysia by middle of next year.
INDONESIA
Question 1
Is any regularity exclusivity (e.g. data and/or marketing exclusivity) available upon: (i) first marketing approval of a new chemical entity; or (ii) approval of a new method of use of an approved product?
Answer 1
Indonesia has no specific law on Data Exclusivity (DE). At present, the undisclosed information or data in Indonesia can be protected as Trade Secret. The Indonesian Food and Drugs Agency (BPOM) as the agency who provides market authorization also do not have any specific system in place to protect DE.
Question 2
If such exclusivity is available, does composition of matter patent protection for the active pharmaceutical ingredient affect entitlement to, or the term of such exclusivity whether or not a composition of matter (i.e. active pharmaceutical ingredient) patent was applied for, an application is pending, no patent was granted (e.g. abandoned, withdrawn or denied), or the patent has expired?
Answer 2
DE is not yet available in Indonesia. However, we believe that once it is enforced it should be proactive coordination between patent office and BPOM in the implementation of such regulation.
Question 3
If regulatory exclusivity is available, what are the periods of exclusivity and when do they commence?
Answer 3
Not applicable.
Question 4
What is the (i) nature and (ii) scope of protection for the exclusivity?
Answer 4
Not applicable.
Question 5
How is such right enforced and by whom?
Answer 5
Not yet available and we are of the opinion that DE will be enforced by BPOM.
Question 6
If available, are there any substantive requirements (active steps) which must be met apart from submission of a marketing application to obtain such exclusivity?
Answer 6
Not yet available.
Question 7
Must local marketing authorization be obtained to qualify for regulatory exclusivity, or can foreign or regional marketing authorizations be effective? If so, which foreign or regional authorizations and/or supplements can be effective, and what is the time-frame for taking action to obtain regulatory exclusivity, if any, based upon such authorization?
Answer 7
Yes, marketing authorization from BPOM shall be obtained to allow a product be sold/marketed in Indonesia. However, currently this authorization does not provide protection on the data exclusivity. It is merely a market authorization for selling a product within Indonesian territory.
Question 8
Will a new formulation be entitled to any additional regulatory exclusivity upon approval? If so, please answer questions 1 – 7 as they apply to this new formulation?
Answer 8
Not applicable.
Question 9
What part of the manufacturing chain, if any, must occur in the selected country to receive marketing approval (e.g. manufacture of active API, product formulation, and/or product packaging, or other)?
Answer 9
Not applicable.
Question 10
If there are no DE laws per se, are there other laws, e.g. trade secret laws that recognize the proprietary nature of registration data and preclude regulatory authorities from relying on or otherwise using the data submitted by the originator for the approval of copies of the medicine without the approval of the originator?
Answer 10
The undisclosed information or data in Indonesia can be protected as Trade Secret. The data provided to BPOM for marketing authorization is possible to protect under Trade Secret.
General Information on DE in INDONESIA
As the member of the WTO, Indonesia is required to implement adequate data exclusivity protection in accordance with TRIPS Article 39.3. However to-date, there is no specific law or regulation on Data Exclusivity is available. Under current practice, the undisclosed information or data may be protected as Trade Secret. The BPOM (Indonesia Food and Drugs Agency) as the government agency for food and drugs market authorization also has no policy in place for protecting undisclosed information concerning to pharmaceutical data. Based on the information from BPOM, currently there is a discussion in the legislative level concerning to the importance of implementation DE protection. We believe that such regulation will be under BPOM. However, we cannot predict as when and what kind of specific regulation in DE will take enforce in this regard.
General Information of DE IN EUROPEAN UNION (EU)
DE has been implemented in EU since 1987 to provide sufficient product protection. Currently, the New EU Pharmaceutical Legislation adopted in 2004 has created a harmonized eight-year DE, two-year marketing exclusivity (ME) and one-year extension to the ME to new chemical entities (8+2+1 years).
INDIA
Question 1
Is any regularity exclusivity (e.g. data and/or marketing exclusivity) available upon: (i) first marketing approval of a new chemical entity; or (ii) approval of a new method of use of an approved product?
Answer 1
In India, there is no specific provision for Data Exclusivity. In fact, research based pharmaceutical companies have been pressing for a Data Exclusivity law relying on Article 39.3 of TRIPS.
After the topic of Data Exclusivity became a heated issue in India, a Committee was constituted to recommend a plan of action on Data Exclusivity (the Satwant Reddy Committee). Though, the Satwant Reddy Committee did recommend that there should be data exclusivity for 5 years in India, the proposal has not yet been implemented or accepted by the Government of India due to the division in opinions of various ministries. Therefore, the recommendations of the committee have no weight thus far.
This fact has even been upheld in two cases by the Hon’ble High Court of Delhi. [Syngenta India Ltd v. Union of India and Bayer v. Cipla]. The Hon’ble High Court held that though it agrees that the Satwant Reddy committee has recommended Data Exclusivity, the fact that no legislation has been passed to implement it, means that Data exclusivity does not exist in India and the Court cannot form policies through its decisions.
Therefore, to conclude, no Data Exclusivity exists in India.
Question 2
If such exclusivity is available, does composition of matter patent protection for the active pharmaceutical ingredient affect entitlement to, or the term of such exclusivity whether or not a composition of matter (i.e. active pharmaceutical ingredient) patent was applied for, an application is pending, no patent was granted (e.g. abandoned, withdrawn or denied), or the patent has expired?
Answer 2
N/A
Question 3
If regulatory exclusivity is available, what are the periods of exclusivity and when do they commence?
Answer 3
N/A
Question 4
What is the (i) nature and (ii) scope of protection for the exclusivity?
Answer 4
N/A
Question 5
How is such right enforced and by whom?
Answer 5
N/A
Question 6
If available, are there any substantive requirements (active steps) which must be met apart from submission of a marketing application to obtain such exclusivity?
Answer 6
N/A
Question 7
Must local marketing authorization be obtained to qualify for regulatory exclusivity, or can foreign or regional marketing authorizations be effective? If so, which foreign or regional authorizations and/or supplements can be effective, and what is the time-frame for taking action to obtain regulatory exclusivity, if any, based upon such authorization?
Answer 7
The market exclusivity is only granted by the grant of patent in India. For this, the regulatory authority in India is the Drug Controller, who has not been empowered with granting exclusive rights. Moreover, even if a patent is granted to a patentee and a generic drug manufacture wants to take a market approval from the drug controller, the drug controller while granting or refusing permission, will not take into account, whether the drug is protected by a patent.
Question 8
Will a new formulation be entitled to any additional regulatory exclusivity upon approval? If so, please answer questions 1 – 7 as they apply to this new formulation?
Answer 8
A new formulation can be given market exclusivity only under the patent regime and there is no link between market approval by the Drug Controller and the market exclusivity under the patent act.
Question 9
What part of the manufacturing chain, if any, must occur in the selected country to receive marking approval (e.g. manufacture of active API, product formulation, and/or product packaging, or other)?
Answer 9
If a drug has been approved in other countries and the manufacturer wants to import those drugs into India then according to the new rules (can be found at http://cdsco.nic.in/html/importdrugs.htm), an import licence will be required for all types of drugs. Import licence will only be granted after registration of overseas manufacturer and the specific drugs to be imported. This licence is valid for 3 years from the date of issue. Only Drugs with minimum 60% of retained self life shall are allowed to be imported.
Question 10
If there are no DE laws per se, are there other laws, e.g. trade secret laws that recognize the proprietary nature of registration data and preclude regulatory authorities from relying on or otherwise using the data submitted by the originator for the approval of copies of the medicine without the approval of the originator?
Answer 10
At present, there are no laws which prevent a generic drug company from relying on the clinical drug trials of a research based company to seek approval of their generic drug.
Monday
Question Regarding Entering PCT National Phase Entry Into Malaysia
Question 1
Is it true that it is possible to enter national phase in Malaysia with English specification?
Answer 1
Yes, English specification is acceptable for filing in Malaysia, no translation is required.
Question 2
If Q6 is yes, is there any prejudice during the examination stage if the specification is not translated into Malay?
Answer 2
There is no prejudice during the examination stage if only English specification is submitted.
Question 3
Please advise if there is a provision for extension for national phase entry or for submission of translation (file a request? Or to pay an extra fee?)
Answer 3
Please be advised that an English specification is required at the time of filing the application in Malaysia. There’s no extension of time available. As such, we will not be able to file the application in Malaysia without the English specification.
Please be advised further that we do not provide Japanese to English translation of specification. As such, we would require you to provide us with a copy of the English translation for us to file your application in Malaysia.
Is it true that it is possible to enter national phase in Malaysia with English specification?
Answer 1
Yes, English specification is acceptable for filing in Malaysia, no translation is required.
Question 2
If Q6 is yes, is there any prejudice during the examination stage if the specification is not translated into Malay?
Answer 2
There is no prejudice during the examination stage if only English specification is submitted.
Question 3
Please advise if there is a provision for extension for national phase entry or for submission of translation (file a request? Or to pay an extra fee?)
Answer 3
Please be advised that an English specification is required at the time of filing the application in Malaysia. There’s no extension of time available. As such, we will not be able to file the application in Malaysia without the English specification.
Please be advised further that we do not provide Japanese to English translation of specification. As such, we would require you to provide us with a copy of the English translation for us to file your application in Malaysia.
Question Regarding Entering PCT National Phase Entry Into Thailand
Question 1
Translate into Thai for PCT national phase entry application in Thailand?
Answer 1
Yes, we are able to assist you in translating your PCT application into Thai language for filing in Thailand. Please note that we will require a copy of the application in English as our translator is only fluent in English and Thai languages. Our charges for preparing the translation are USD 27 per 100 English words.
Question 2 (a)
If Q1 is yes, how many months before the entry deadline we need to request you for translation to Thai? (Please answer the nearest to the deadline.)
Answer 2 (a)
Please be advised that the Thai translation document is required to be file within the grace period of 90 days.
Question 2 (b)
In Thailand, when is the national phase entry deadline from the priority date?
Answer 2 (b)
Please be advised that the deadline for entering national phase into Thailand is 30-months from the earliest priority date. However, please note that only PCT international having filing date of 24 December 2009 or later and designate Thailand as the RO is eligible to enter National Phase into Thailand via PCT. This is the date when Thailand officially become member of the PCT.
Question 2 (c)
Please advise if there is a provision for extension for national phase entry or for submission of translation. (file a request? Or to pay an extra fee?)
Answer 2 (c)
No, currently, there’s no provision for extension for national phase entry or for submission of translation.
Question 3
If Q1 is yes, when translating to Thai, is it easier to translate with an English translation (i.e. together with Japanese specification)?
Answer 3
As our translator is only fluent in both English and Thai languages. Therefore, all document submitted for translation must be in English.
Question 4
In Thailand, is there a provision to enter national phase with other language that Thai first (ex. Japanese), then submit the Thai translation later?
(i.e. Is it possible to legally “earn time” for preparing translation?)
Answer 4
No. The current regulation does not allow the entering of national phase in other language except in Thai language. No extension of time is available for submitting the translation. As such, we will not be able to file the application in Thailand without the Thai specification.
Question 5
If Q4 is yes, when it is required to amend during the examination stage, is the base specification for amendment the first language? (ex. If the Japanese specification is submitted first, Japanese is the base specification.)
Answer 5
Please refer to Q4 above.
Question 6
Is it possible for us to correct the errors of the translation of the specifications of a Thai patent application according with its original PCT application? How and when if possible?
Answer 6
Yes. It is possible to correct the errors of the translation of specifications. The correction can be made anytime using an Amendment Application with an official fee of THB 50. The only prohibition on the correction/amendment is that it must not go beyond the original disclosure as filed or enlarge scope of protection under section 20 of Thai Patent Act.
Question 7
I think that you have an employee inventions system. Are there any remarkable points of your system?
Answer 7
The provision about Employee’s Inventions are provided in Sections 11 to 13 of Thai Patent Act. Basically, if employee invents the invention under the employment or commission work, the right to apply for the patent will be transferred to Employer. However, it is provided that the employee shall have a right to further remuneration in addition to his regular salary. However, both the employer and the employee can agree otherwise. If there is no particular provision in the employment contract, it will be understood that the right will be transferred to employer. The employee cannot transfer his right to other unless there is a provision in employment contract to allow him to do so.
Question 8
How long is the average time before we receive the first office action from Thai Patent Office (TPO) and get a grant.
Answer 8
Currently, the application generally takes about 12 months before receiving the first Office Action (OA). If no OA is raised, it application will be published by the 18 month. For those application with OA raised, it will normally take 2 years or more for the application to be published. Once, the application is published, the applicant has up to 5 years to file a request for substantive examination. After that, it will depend on how early we can have available the corresponding granted patent or report of foreign examination from the priority country. Once we have filed the report of foreign examination or the granted patent, the substantive examination will commence and it will take further 1 to 2 years before the notice of allowance will be issued. The Thai patent will generally be granted between 3 to 5 years.
However, patents related to Chemical and Pharmaceutical will often take twice as long to get granted. To my knowledge, most of patent in relation to pharmaceutical will take more than 10 years to be granted by the TPO. Under the PCT, the process may be much faster because at the time of enter national phase, a search report has been established. The search report may be submitted as a Report of Foreign Examination. However, if the current law has not been changed, we may still be required to submit a report of foreign examination or a granted patent when we request for substantive examination. Of course, this will delay the process.
Question 9
When and how could we file the amendments of the specifications of a Thai patent application and file the divisional application with TPO.
Answer 9
Amendment can be filed anytime as long as the amendment does not enlarge the scope of protection under section 20 of Thai Patent Act. The amendment can be made under the Amendment Application with an Official fee of THB50. The applicant cannot file the divisional application without prior approval from the Examiner. As such, the divisional application can only be made if there is specific instruction from the Examiner. The Divisional Application must be filed within 120-day upon receiving Examiner’s instruction under Section 26 of Thai Patent Act.
Question 10
Do we have a duty to disclose the information of a genetic source on filing a patent application before TPO?
Answer 10
Yes. The applicant has a duty to disclose all relevant information before the TPO. The disclosure must be full, concise and clear and exact terms as to enable any person ordinarily skilled in the art to make and use the invention in pursuant to Section 17 of Thai Patent Act. Further, please note that currently, the TPO has not yet accepted the filing of documents in electronic form e.g. submission of genetic sequences in CD-Rom. As such, all information submitted to TPO must be made in printed paper.
Question 11
Does TPO have any standards of judging the similarity of a trade mark?
Answer 11
The Trade Mark Office consider on the following;
- Visual appearance
- Transliteration
- Translation
- Specification
- Good Faith
However, we found that the Registrar, occasionally, consider only on Visual Appearance, Transliteration and Translation. Nevertheless, Trade Mark Appeal Board and IP Court consider 5 issues respectively.
Question 12
I think TPO has a precedent patent searching system. Is it usable for everyone or only for the registered one? What language is available on the system, only Thai?
Answer 12
Normally, conduct the search on the database of EPO, USPTO, and the Australian IPO. Therefore, the language is search is English. To our knowledge, the TPO also uses another two databases: DERWENT and WIPS. The language in search is also English. However, these databases are private databases owned by the DIP. As such, only computers located in the DIP can access this database.
Translate into Thai for PCT national phase entry application in Thailand?
Answer 1
Yes, we are able to assist you in translating your PCT application into Thai language for filing in Thailand. Please note that we will require a copy of the application in English as our translator is only fluent in English and Thai languages. Our charges for preparing the translation are USD 27 per 100 English words.
Question 2 (a)
If Q1 is yes, how many months before the entry deadline we need to request you for translation to Thai? (Please answer the nearest to the deadline.)
Answer 2 (a)
Please be advised that the Thai translation document is required to be file within the grace period of 90 days.
Question 2 (b)
In Thailand, when is the national phase entry deadline from the priority date?
Answer 2 (b)
Please be advised that the deadline for entering national phase into Thailand is 30-months from the earliest priority date. However, please note that only PCT international having filing date of 24 December 2009 or later and designate Thailand as the RO is eligible to enter National Phase into Thailand via PCT. This is the date when Thailand officially become member of the PCT.
Question 2 (c)
Please advise if there is a provision for extension for national phase entry or for submission of translation. (file a request? Or to pay an extra fee?)
Answer 2 (c)
No, currently, there’s no provision for extension for national phase entry or for submission of translation.
Question 3
If Q1 is yes, when translating to Thai, is it easier to translate with an English translation (i.e. together with Japanese specification)?
Answer 3
As our translator is only fluent in both English and Thai languages. Therefore, all document submitted for translation must be in English.
Question 4
In Thailand, is there a provision to enter national phase with other language that Thai first (ex. Japanese), then submit the Thai translation later?
(i.e. Is it possible to legally “earn time” for preparing translation?)
Answer 4
No. The current regulation does not allow the entering of national phase in other language except in Thai language. No extension of time is available for submitting the translation. As such, we will not be able to file the application in Thailand without the Thai specification.
Question 5
If Q4 is yes, when it is required to amend during the examination stage, is the base specification for amendment the first language? (ex. If the Japanese specification is submitted first, Japanese is the base specification.)
Answer 5
Please refer to Q4 above.
Question 6
Is it possible for us to correct the errors of the translation of the specifications of a Thai patent application according with its original PCT application? How and when if possible?
Answer 6
Yes. It is possible to correct the errors of the translation of specifications. The correction can be made anytime using an Amendment Application with an official fee of THB 50. The only prohibition on the correction/amendment is that it must not go beyond the original disclosure as filed or enlarge scope of protection under section 20 of Thai Patent Act.
Question 7
I think that you have an employee inventions system. Are there any remarkable points of your system?
Answer 7
The provision about Employee’s Inventions are provided in Sections 11 to 13 of Thai Patent Act. Basically, if employee invents the invention under the employment or commission work, the right to apply for the patent will be transferred to Employer. However, it is provided that the employee shall have a right to further remuneration in addition to his regular salary. However, both the employer and the employee can agree otherwise. If there is no particular provision in the employment contract, it will be understood that the right will be transferred to employer. The employee cannot transfer his right to other unless there is a provision in employment contract to allow him to do so.
Question 8
How long is the average time before we receive the first office action from Thai Patent Office (TPO) and get a grant.
Answer 8
Currently, the application generally takes about 12 months before receiving the first Office Action (OA). If no OA is raised, it application will be published by the 18 month. For those application with OA raised, it will normally take 2 years or more for the application to be published. Once, the application is published, the applicant has up to 5 years to file a request for substantive examination. After that, it will depend on how early we can have available the corresponding granted patent or report of foreign examination from the priority country. Once we have filed the report of foreign examination or the granted patent, the substantive examination will commence and it will take further 1 to 2 years before the notice of allowance will be issued. The Thai patent will generally be granted between 3 to 5 years.
However, patents related to Chemical and Pharmaceutical will often take twice as long to get granted. To my knowledge, most of patent in relation to pharmaceutical will take more than 10 years to be granted by the TPO. Under the PCT, the process may be much faster because at the time of enter national phase, a search report has been established. The search report may be submitted as a Report of Foreign Examination. However, if the current law has not been changed, we may still be required to submit a report of foreign examination or a granted patent when we request for substantive examination. Of course, this will delay the process.
Question 9
When and how could we file the amendments of the specifications of a Thai patent application and file the divisional application with TPO.
Answer 9
Amendment can be filed anytime as long as the amendment does not enlarge the scope of protection under section 20 of Thai Patent Act. The amendment can be made under the Amendment Application with an Official fee of THB50. The applicant cannot file the divisional application without prior approval from the Examiner. As such, the divisional application can only be made if there is specific instruction from the Examiner. The Divisional Application must be filed within 120-day upon receiving Examiner’s instruction under Section 26 of Thai Patent Act.
Question 10
Do we have a duty to disclose the information of a genetic source on filing a patent application before TPO?
Answer 10
Yes. The applicant has a duty to disclose all relevant information before the TPO. The disclosure must be full, concise and clear and exact terms as to enable any person ordinarily skilled in the art to make and use the invention in pursuant to Section 17 of Thai Patent Act. Further, please note that currently, the TPO has not yet accepted the filing of documents in electronic form e.g. submission of genetic sequences in CD-Rom. As such, all information submitted to TPO must be made in printed paper.
Question 11
Does TPO have any standards of judging the similarity of a trade mark?
Answer 11
The Trade Mark Office consider on the following;
- Visual appearance
- Transliteration
- Translation
- Specification
- Good Faith
However, we found that the Registrar, occasionally, consider only on Visual Appearance, Transliteration and Translation. Nevertheless, Trade Mark Appeal Board and IP Court consider 5 issues respectively.
Question 12
I think TPO has a precedent patent searching system. Is it usable for everyone or only for the registered one? What language is available on the system, only Thai?
Answer 12
Normally, conduct the search on the database of EPO, USPTO, and the Australian IPO. Therefore, the language is search is English. To our knowledge, the TPO also uses another two databases: DERWENT and WIPS. The language in search is also English. However, these databases are private databases owned by the DIP. As such, only computers located in the DIP can access this database.
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