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 Application considered withdrawn.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.
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.
Thursday
Questions Related To Chemical Process Applications
A. Patentability of intermediate compounds
Question 1
Where an inventive chemical process (which may consist of one or more chemical steps) is concerned, are claims directed to novel intermediates thereof automatically considered inventive?
Answer 1
NO, not necessarily so.
Question 2
If the answer to question 1 is NO, how is the inventiveness of an intermediate compound, which is part of an inventive chemical processes, considered?
Answer 2
The inventiveness will be examined based on, if the intermediate compound provides a solution to a technical problem, which have been sought by others but have not been successfully resolved. Additionally, the intermediate compound should involve a series of steps to achieve or arrive at the desired result and is not merely one step away from a prior art. If above requirements is met, then the intermediate compound shall satisfy the inventiveness requirement.
On the contrary, the intermediate compound cannot be considered inventive if it is just a mere modification of an existing product or process or a mere substitution of an existing equivalent which is commonly known.
Question 3
If the answer to question 1 is NO, what is the state of the art to be considered for judging the inventiveness of the intermediates?
(a) Is it the “close-to-the-intermediate” state of the art, namely state of the art relating to compounds identified from their chemical composition as lying close to the intermediates?
or
(b) Is it the close-to-the-product” state of the art, namely the state of the art relating to compounds identified from their chemical composition as lying close to the product onto which the intermediate is converted to?
Answer 3
The answer is (a) due to the fact that the protection is sought for the intermediate (and not the product itself which might have been disclosed in prior art).
Question 4
If the answer to question 1 is NO, would the intermediate be seen to contribute to the inventiveness of the process because its “structural difference” provides an “effect” (e.g. increased yield, decrease in the number of chemical steps) without which the advantageous complete process is inconceivable?
Answer 4
Yes, the intermediate should be “structurally different” from the prior art and the difference should provide the desired effect, and such inventive step would not have been obvious to a person having ordinary skill in the art.
Question 5
If the answer to question 1 is NO, would the intermediate be patentable because it opens the way to a new and inventive process for preparing the known end product?
Answer 5
YES.
Question 6
If the PCT publication of the application in question contains independent process claims directed to a chemical process and also independent compound claims directed to intermediates of the chemical process, and at national phase entry or when filing the request for examination, the Applicant omits all of the process claims (e.g. in an attempt to reduce the claims fees, or the examination fee), can the independent compound claims directed to the intermediates be granted in the absence of any process claim? In other words, can the inventiveness of the independent compound claims directed to the intermediates be acknowledged in the absence of evaluating the inventiveness of any claims directed to the chemical process where such intermediates are part of? Please consider this question in particular, in the context of a situation where the inventiveness of the intermediates is to be supported on the basis to their contribution to the inventiveness of the process, which will not be evaluated if there are no process claims.
Answer 6
It is advisable to claim both the intermediate and the process claims. In the event that the applicant would like to reduce the number of claims due to reducing the claim fee, then the applicant should consider claiming the process.
If the patent is granted in respect to a process, the patentee receives exclusive right to (i) use the process; and (ii) doing any of the acts referred in above paragraph in respect to of a product obtained directly by of the granted process. Therefore, the process claims provides wider coverage in terms of its protection.
Based on your question above, the inventiveness of the claims relating to the intermediate can still be examined by the Examiner and if the requirement of novelty, inventiveness and industrial applicability is met, the claims relating to the intermediate will be granted, but as mentioned in our opinion above, the protection is rather limited.
B. Disclosure requirement for chemical process patents
Question 1
When is the subject matter of a claim to a chemical process considered to be sufficiently disclosed?
Answer 1
The subject matter is considered to have been sufficiently disclosed if it can be understood and in a manner sufficiently clear and complete for the invention to be evaluated and to be carried out by a person having ordinary skill in the art and it shall state any advantageous effects of the invention with reference to the prior art. The matter must also be claimed.
For a process claim, it shall find support in the description by means of examples, and all the process parameters shall be disclosed in a manner that the process can be performed by the person having ordinary skill in the art.
Question 2
Is it necessary to include process parameters (e.g., molar proportion, solvent, temperature, reaction time) in the claim to the chemical process?
Answer 2
YES.
Question 3
Is there a need to restrict the meanings of the radicals (e.g. R, R1 and R2 in starting materials, intermediates or products) on the basis of the particular examples provided as experimental support?
Answer 3
YES.
C. Patent term extensions of process patents
Question 1
Is it possible to extend the term of a patent covering a chemical process for preparing a pharmaceutical product?
Answer 1
In Malaysia, there is no provision for patent term extension.
Question 1
Where an inventive chemical process (which may consist of one or more chemical steps) is concerned, are claims directed to novel intermediates thereof automatically considered inventive?
Answer 1
NO, not necessarily so.
Question 2
If the answer to question 1 is NO, how is the inventiveness of an intermediate compound, which is part of an inventive chemical processes, considered?
Answer 2
The inventiveness will be examined based on, if the intermediate compound provides a solution to a technical problem, which have been sought by others but have not been successfully resolved. Additionally, the intermediate compound should involve a series of steps to achieve or arrive at the desired result and is not merely one step away from a prior art. If above requirements is met, then the intermediate compound shall satisfy the inventiveness requirement.
On the contrary, the intermediate compound cannot be considered inventive if it is just a mere modification of an existing product or process or a mere substitution of an existing equivalent which is commonly known.
Question 3
If the answer to question 1 is NO, what is the state of the art to be considered for judging the inventiveness of the intermediates?
(a) Is it the “close-to-the-intermediate” state of the art, namely state of the art relating to compounds identified from their chemical composition as lying close to the intermediates?
or
(b) Is it the close-to-the-product” state of the art, namely the state of the art relating to compounds identified from their chemical composition as lying close to the product onto which the intermediate is converted to?
Answer 3
The answer is (a) due to the fact that the protection is sought for the intermediate (and not the product itself which might have been disclosed in prior art).
Question 4
If the answer to question 1 is NO, would the intermediate be seen to contribute to the inventiveness of the process because its “structural difference” provides an “effect” (e.g. increased yield, decrease in the number of chemical steps) without which the advantageous complete process is inconceivable?
Answer 4
Yes, the intermediate should be “structurally different” from the prior art and the difference should provide the desired effect, and such inventive step would not have been obvious to a person having ordinary skill in the art.
Question 5
If the answer to question 1 is NO, would the intermediate be patentable because it opens the way to a new and inventive process for preparing the known end product?
Answer 5
YES.
Question 6
If the PCT publication of the application in question contains independent process claims directed to a chemical process and also independent compound claims directed to intermediates of the chemical process, and at national phase entry or when filing the request for examination, the Applicant omits all of the process claims (e.g. in an attempt to reduce the claims fees, or the examination fee), can the independent compound claims directed to the intermediates be granted in the absence of any process claim? In other words, can the inventiveness of the independent compound claims directed to the intermediates be acknowledged in the absence of evaluating the inventiveness of any claims directed to the chemical process where such intermediates are part of? Please consider this question in particular, in the context of a situation where the inventiveness of the intermediates is to be supported on the basis to their contribution to the inventiveness of the process, which will not be evaluated if there are no process claims.
Answer 6
It is advisable to claim both the intermediate and the process claims. In the event that the applicant would like to reduce the number of claims due to reducing the claim fee, then the applicant should consider claiming the process.
If the patent is granted in respect to a process, the patentee receives exclusive right to (i) use the process; and (ii) doing any of the acts referred in above paragraph in respect to of a product obtained directly by of the granted process. Therefore, the process claims provides wider coverage in terms of its protection.
Based on your question above, the inventiveness of the claims relating to the intermediate can still be examined by the Examiner and if the requirement of novelty, inventiveness and industrial applicability is met, the claims relating to the intermediate will be granted, but as mentioned in our opinion above, the protection is rather limited.
B. Disclosure requirement for chemical process patents
Question 1
When is the subject matter of a claim to a chemical process considered to be sufficiently disclosed?
Answer 1
The subject matter is considered to have been sufficiently disclosed if it can be understood and in a manner sufficiently clear and complete for the invention to be evaluated and to be carried out by a person having ordinary skill in the art and it shall state any advantageous effects of the invention with reference to the prior art. The matter must also be claimed.
For a process claim, it shall find support in the description by means of examples, and all the process parameters shall be disclosed in a manner that the process can be performed by the person having ordinary skill in the art.
Question 2
Is it necessary to include process parameters (e.g., molar proportion, solvent, temperature, reaction time) in the claim to the chemical process?
Answer 2
YES.
Question 3
Is there a need to restrict the meanings of the radicals (e.g. R, R1 and R2 in starting materials, intermediates or products) on the basis of the particular examples provided as experimental support?
Answer 3
YES.
C. Patent term extensions of process patents
Question 1
Is it possible to extend the term of a patent covering a chemical process for preparing a pharmaceutical product?
Answer 1
In Malaysia, there is no provision for patent term extension.
Use Of Registered ®-Sysbol In Malaysia
Question 1
Is the use of the ®-symbol to indicate that a trademark in Malaysia is still optional?
Answer 1
Yes. There is no provisions in the Trade Mark Act or any other related laws that requires the mandatory use of the ®-symbol in use of a registered trade mark. By using the ®-symbol with the registered mark, the competitors should be on notice of the registered trademark to respect the registered Intellectual Property.
Question 2
I also wonder if using the ®-symbol or not using the ®-symbol to indicate if the trademark is registered, if there are any legal consequences or benefits. For example in some countries, by lack of using the ®-symbol to indicate that a trademark is registered can prevent damage claim compensation.
Answer 2
The benefit of depicting the ®-symbol in a registered mark is the infringer cannot argue that he was not aware of the fact that the mark is registered. Other than that, the ®-symbol does not bring any direct legal consequences in a trade mark related matters.
Question 3
Whether there are any (other) criminal consequences when you use ®-symbol for trademarks that are not registered.
Answer 3
As you are aware, it is illegal in Malaysia to use the registered trademark ®-symbol, unless the proprietor have received the certificate of registration and is liable on conviction to a fine not exceeding RM 500 or a term of imprisonment not exceeding two months, or both. Besides that, the person may also be taken legal action for misrepresentation under the laws of contracts.
Is the use of the ®-symbol to indicate that a trademark in Malaysia is still optional?
Answer 1
Yes. There is no provisions in the Trade Mark Act or any other related laws that requires the mandatory use of the ®-symbol in use of a registered trade mark. By using the ®-symbol with the registered mark, the competitors should be on notice of the registered trademark to respect the registered Intellectual Property.
Question 2
I also wonder if using the ®-symbol or not using the ®-symbol to indicate if the trademark is registered, if there are any legal consequences or benefits. For example in some countries, by lack of using the ®-symbol to indicate that a trademark is registered can prevent damage claim compensation.
Answer 2
The benefit of depicting the ®-symbol in a registered mark is the infringer cannot argue that he was not aware of the fact that the mark is registered. Other than that, the ®-symbol does not bring any direct legal consequences in a trade mark related matters.
Question 3
Whether there are any (other) criminal consequences when you use ®-symbol for trademarks that are not registered.
Answer 3
As you are aware, it is illegal in Malaysia to use the registered trademark ®-symbol, unless the proprietor have received the certificate of registration and is liable on conviction to a fine not exceeding RM 500 or a term of imprisonment not exceeding two months, or both. Besides that, the person may also be taken legal action for misrepresentation under the laws of contracts.
Wednesday
Prosecution Of Patent, Trademark & Design In Malaysia
A. PATENT
Question 1
The availability of Examiner interview, for prosecution matters such as timing for filing of divisional application or voluntary amendments, and request for extension of time to response to the office action, during the substantive examination?
Answer 1
Availability of a Examiner Interview – such a procedure is available to discuss the patent application with the Examiner.
Timing for Divisional application – can be filed anytime until the end of the 3 month after issuance of the first office action/report, provided the divisional application does not go beyond the disclosure of the initial application.
Timing for Voluntary amendments – can be filed anytime while the application is still pending. Again the subject matter of the application does not go beyond the disclosure of the initial application.
Request for Extension of time – can be requested for it the applicant is be unable to respond to the office action at the end of 3 months after the office action/report is issued.
Question 2
What is the availability of remedial measures in case of failure to timely submit a response to an office action, payment of patent maintenance fee or request for examination?
Answer 2
The remedial measure for failure to respond to an office action within time is to pay an extension fee and respond to the office action within the extension of time period applied for.
Question 3
Do you have any expedited examination (examination with special dispatch) system in Malaysia?
Answer 3
Yes, we do have a route for the applicant to expedite examination that is the Modified Substantive Examination. This option allows examination to be expedited by conforming the claims to any corresponding granted patent from the United Kingdom, European Patent Office (EPO), United States of America, Australia, Republic of Korea and Japan.
Question 4
Do you have any system to extend patent term (e.g. in case of a pharmaceutical patent)?
Answer 4
No, the protection period is 20 years from the date of filing and no extension is provided (even for pharmaceutical inventions).
Question 5
Do you have a specific rule to determine the unity of invention?
Answer 5
According to Malaysian Patent Law, the application must relate to one invention only, or to a group of inventions so linked as to form a single general inventive step.
B. TRADEMARK
Question 1
How long does it take for registration in general?
Answer 1
A Trademark registration is secured within 12-24 months from the date of filing. Unless the trade mark faces several objection from the Intellectual Property Corporation of Malaysia (MyIPO), the process of registration will be fairly expeditious.
Question 2
Opposition/cancellation action/nullification action
In what government office is the trademark opposition/cancellation action/nullification action accepted? How long it take to get the first instance (decision) in respective action?
Answer 2
(i) Opposition proceedings are accepted by the Trade Mark Division of the MyIPO, which is under the Ministry of Domestic Trade and Consumer Affairs Malaysia. Such actions are to be addressed specifically to the Register of Trade Marks who is the person appointed by the Minister to superintend all matters relating to trade marks.
(ii) As to cancellation action/nullification action, these proceedings are available in Malaysia but it has to be done in the Court.
(iii) The time taken to conduct opposition proceedings until a first instance decision is approximately is 2 years from the date of filing of the Notice of Opposition.
(iv) The time taken to conduct rectification proceedings (cancellation/nullification) until a first instance decision is 1 year from the date of filing the Notice of Originating Motion.
Question 3
Is there any bailout (restoration measure) of the lapsed trademark registration due to failure of renewal application (after expiration of the grace period)?
Answer 3
There is a procedure to restore the trademark. A trademark which has been removed from the Register for non-payment of renewal fees will still be treated as being registered for a period of one (1) year from the date of expiration of the last registration. Once the mark has been removed from the register for non-payment of the renewal fee, it can be restored only at the discretion of the Registrar and on payment of a restoration fee in addition to the renewal fee.
C. DESIGN
Question 1
Is it acceptable for a Design application regarding :
(a) partially claimed design
(b) the computerized objects, that is “ICONIC”?
Answer 1
(a) Partially claimed design are acceptable so long as they are solely judge by the function which the article has to perform.
(b) An article been define as any article of manufacture of handicraft and ICONIC product may not be registered.
Question 2
How about the registrability and/or enforceability of
(a) design that cannot be visible in its normal use by an end user; or
(b) design for spare parts of an article?
Answer 2
(a) Design that is not visible when sold cannot be registered.
(b) Design for spare parts is also not registrable in Malaysia as the definition of industrial design does not include features of shape or configuration of an article which is dependent upon the appearance of another article of which the article is intended by the author of the design to form an integral part.
Question 3
In filing a Design application claiming the priority, if the Applicant made a small amendment for the drawings used in the priority application and submitted this amended drawings as the formal drawings in Malaysian Patent Office, can the priority be accepted? For example :
(a) for the priority application, an entirely claimed Design shown in the solid line is submitted and, on the other hand, for the application claiming this priority, a partially claimed Design shown in the dotted line is submitted. In this situation, can the priority be accepted?
(b) after the priority application, the design was very slightly changed on the actual product. In this situation, can the priority be accepted on a design application for the actual product in Malaysia?
Answer 3
No, the priority cannot be accepted, because it will consider to be different.
Question 4
Is it possible for the proprietor of Design A to make the enforcement against the similar Design B which belongs to the different class from Design A.
Answer 4
It is possible for the proprietor of Design A to enforce their rights against the proprietor of similar Design B which is of a different class from Design A, because class is not a issue in design enforcement.
Question 5
Whether the relevant Design registrations discovered by a search may be similar or not to the search subject based on your experience?
Answer 5
Based on our experience it is possible to make our comment as to whether the relevant Design registration discovered by a search may be similar or not to the search subject.
Question 6
Please let us know the landmark case of the design infringement in Malaysia?
Answer 6
The landmark design infringement case is Besalon International v. South Strong Industries [1997] 2 MLJ 131:
The 1st Plaintiff was the lawful assignee and registered proprietor of registered design No. 1,001,901 under the Registered Designs Act (1949) UK for a roofing tile design as of 10.08.1981, renewed until 10.08.1996.
The defendant was the registered proprietor of registered design No. 2,043,178 for a roofing tile design as of 9.11.1994 whose design was identical to that of the 1st Plaintiff.
The 1st Plaintiff took and action against the Defendant as persons prejudicially affected by the defendant’s tile design and claimed the following :
(i) That the despite being granted registration in the UK, the defendant did not acquire the rights afforded by such registration in Malaysia; and
(ii) The defendant’s registration was invalid due to prior publication of the tile design by the plaintiffs and prior use of the design in Malaysia.
At the hearing, the issue to be decided by the Court was whether the defendant’s registered design was enforceable in West Malaysia, Sabah and/or Sarawak and whether the Plaintiff’s were entitled to relief.
It was held that :
The prior publication of the registered tile design, consisting of the prior use or manufacture of goods or objects to which the design had been applied and/or the prior disclosure to the Malaysian public to the design destroyed any claim to novelty and rendered the defendant’s registered design No. 2,043,178 unenforceable in Malaysia.
The Plaintiffs and Defendant had manufactured, promoted and/or sold differently branded tiles bearing the dispute design in Malaysia prior to the Defendant’s registration of the design on 9.11.1994 in the UK. Thus the design lacked novelty and was unenforceable in West Malaysia, Sabah and/or Sarawak.
Question 1
The availability of Examiner interview, for prosecution matters such as timing for filing of divisional application or voluntary amendments, and request for extension of time to response to the office action, during the substantive examination?
Answer 1
Availability of a Examiner Interview – such a procedure is available to discuss the patent application with the Examiner.
Timing for Divisional application – can be filed anytime until the end of the 3 month after issuance of the first office action/report, provided the divisional application does not go beyond the disclosure of the initial application.
Timing for Voluntary amendments – can be filed anytime while the application is still pending. Again the subject matter of the application does not go beyond the disclosure of the initial application.
Request for Extension of time – can be requested for it the applicant is be unable to respond to the office action at the end of 3 months after the office action/report is issued.
Question 2
What is the availability of remedial measures in case of failure to timely submit a response to an office action, payment of patent maintenance fee or request for examination?
Answer 2
The remedial measure for failure to respond to an office action within time is to pay an extension fee and respond to the office action within the extension of time period applied for.
Question 3
Do you have any expedited examination (examination with special dispatch) system in Malaysia?
Answer 3
Yes, we do have a route for the applicant to expedite examination that is the Modified Substantive Examination. This option allows examination to be expedited by conforming the claims to any corresponding granted patent from the United Kingdom, European Patent Office (EPO), United States of America, Australia, Republic of Korea and Japan.
Question 4
Do you have any system to extend patent term (e.g. in case of a pharmaceutical patent)?
Answer 4
No, the protection period is 20 years from the date of filing and no extension is provided (even for pharmaceutical inventions).
Question 5
Do you have a specific rule to determine the unity of invention?
Answer 5
According to Malaysian Patent Law, the application must relate to one invention only, or to a group of inventions so linked as to form a single general inventive step.
B. TRADEMARK
Question 1
How long does it take for registration in general?
Answer 1
A Trademark registration is secured within 12-24 months from the date of filing. Unless the trade mark faces several objection from the Intellectual Property Corporation of Malaysia (MyIPO), the process of registration will be fairly expeditious.
Question 2
Opposition/cancellation action/nullification action
In what government office is the trademark opposition/cancellation action/nullification action accepted? How long it take to get the first instance (decision) in respective action?
Answer 2
(i) Opposition proceedings are accepted by the Trade Mark Division of the MyIPO, which is under the Ministry of Domestic Trade and Consumer Affairs Malaysia. Such actions are to be addressed specifically to the Register of Trade Marks who is the person appointed by the Minister to superintend all matters relating to trade marks.
(ii) As to cancellation action/nullification action, these proceedings are available in Malaysia but it has to be done in the Court.
(iii) The time taken to conduct opposition proceedings until a first instance decision is approximately is 2 years from the date of filing of the Notice of Opposition.
(iv) The time taken to conduct rectification proceedings (cancellation/nullification) until a first instance decision is 1 year from the date of filing the Notice of Originating Motion.
Question 3
Is there any bailout (restoration measure) of the lapsed trademark registration due to failure of renewal application (after expiration of the grace period)?
Answer 3
There is a procedure to restore the trademark. A trademark which has been removed from the Register for non-payment of renewal fees will still be treated as being registered for a period of one (1) year from the date of expiration of the last registration. Once the mark has been removed from the register for non-payment of the renewal fee, it can be restored only at the discretion of the Registrar and on payment of a restoration fee in addition to the renewal fee.
C. DESIGN
Question 1
Is it acceptable for a Design application regarding :
(a) partially claimed design
(b) the computerized objects, that is “ICONIC”?
Answer 1
(a) Partially claimed design are acceptable so long as they are solely judge by the function which the article has to perform.
(b) An article been define as any article of manufacture of handicraft and ICONIC product may not be registered.
Question 2
How about the registrability and/or enforceability of
(a) design that cannot be visible in its normal use by an end user; or
(b) design for spare parts of an article?
Answer 2
(a) Design that is not visible when sold cannot be registered.
(b) Design for spare parts is also not registrable in Malaysia as the definition of industrial design does not include features of shape or configuration of an article which is dependent upon the appearance of another article of which the article is intended by the author of the design to form an integral part.
Question 3
In filing a Design application claiming the priority, if the Applicant made a small amendment for the drawings used in the priority application and submitted this amended drawings as the formal drawings in Malaysian Patent Office, can the priority be accepted? For example :
(a) for the priority application, an entirely claimed Design shown in the solid line is submitted and, on the other hand, for the application claiming this priority, a partially claimed Design shown in the dotted line is submitted. In this situation, can the priority be accepted?
(b) after the priority application, the design was very slightly changed on the actual product. In this situation, can the priority be accepted on a design application for the actual product in Malaysia?
Answer 3
No, the priority cannot be accepted, because it will consider to be different.
Question 4
Is it possible for the proprietor of Design A to make the enforcement against the similar Design B which belongs to the different class from Design A.
Answer 4
It is possible for the proprietor of Design A to enforce their rights against the proprietor of similar Design B which is of a different class from Design A, because class is not a issue in design enforcement.
Question 5
Whether the relevant Design registrations discovered by a search may be similar or not to the search subject based on your experience?
Answer 5
Based on our experience it is possible to make our comment as to whether the relevant Design registration discovered by a search may be similar or not to the search subject.
Question 6
Please let us know the landmark case of the design infringement in Malaysia?
Answer 6
The landmark design infringement case is Besalon International v. South Strong Industries [1997] 2 MLJ 131:
The 1st Plaintiff was the lawful assignee and registered proprietor of registered design No. 1,001,901 under the Registered Designs Act (1949) UK for a roofing tile design as of 10.08.1981, renewed until 10.08.1996.
The defendant was the registered proprietor of registered design No. 2,043,178 for a roofing tile design as of 9.11.1994 whose design was identical to that of the 1st Plaintiff.
The 1st Plaintiff took and action against the Defendant as persons prejudicially affected by the defendant’s tile design and claimed the following :
(i) That the despite being granted registration in the UK, the defendant did not acquire the rights afforded by such registration in Malaysia; and
(ii) The defendant’s registration was invalid due to prior publication of the tile design by the plaintiffs and prior use of the design in Malaysia.
At the hearing, the issue to be decided by the Court was whether the defendant’s registered design was enforceable in West Malaysia, Sabah and/or Sarawak and whether the Plaintiff’s were entitled to relief.
It was held that :
The prior publication of the registered tile design, consisting of the prior use or manufacture of goods or objects to which the design had been applied and/or the prior disclosure to the Malaysian public to the design destroyed any claim to novelty and rendered the defendant’s registered design No. 2,043,178 unenforceable in Malaysia.
The Plaintiffs and Defendant had manufactured, promoted and/or sold differently branded tiles bearing the dispute design in Malaysia prior to the Defendant’s registration of the design on 9.11.1994 in the UK. Thus the design lacked novelty and was unenforceable in West Malaysia, Sabah and/or Sarawak.
Monday
Software Patents
Question
What are the procedures on patenting software applications for mobile phones in Malaysia?
Answer
We would like to answer your question by explaining the following about software patents in Malaysia:
First of all, it should be noted that the Malaysian patent system generally follows the rulings of the European Patent Office, and its stand on software patents is no different.
Software per se cannot be patented in Malaysia. A simple program or code is unpatentable in that it is considered a mathematical method, and is therefore more suited to protection under Copyright.
However, please note that importantly, when software is combined together with one or more mechanical component(s), the whole can be patented as a system. Accordingly, Agents have been able to patent software when it is being used to provide a material effect of some kind.
With regard to determining the existence in Malaysia, we are able to perform a search for you at the Intellectual Property Corporation of Malaysia (MyIPO). If you know the exact details of the patent in question, we can conduct an “equivalent search”. If you do not know the details, or are interested to know whether your invention will come into conflict with anything out there in the market, we can perform a much more detailed “Subject Matter” search, to look for anything resembling your software. We would then provide you with a professional opinion as to whether your software will come into conflict (infringe) another patent. The subject matter search is strongly recommended for such matters, as there may be several similar and damaging patents in force that could potentially cause you problems.
To be able to provide you with more comprehensive answer, we would require you to provide us with more details, including the history of the software invention, details on the offending patent, details of the software invention etc.
What are the procedures on patenting software applications for mobile phones in Malaysia?
Answer
We would like to answer your question by explaining the following about software patents in Malaysia:
First of all, it should be noted that the Malaysian patent system generally follows the rulings of the European Patent Office, and its stand on software patents is no different.
Software per se cannot be patented in Malaysia. A simple program or code is unpatentable in that it is considered a mathematical method, and is therefore more suited to protection under Copyright.
However, please note that importantly, when software is combined together with one or more mechanical component(s), the whole can be patented as a system. Accordingly, Agents have been able to patent software when it is being used to provide a material effect of some kind.
With regard to determining the existence in Malaysia, we are able to perform a search for you at the Intellectual Property Corporation of Malaysia (MyIPO). If you know the exact details of the patent in question, we can conduct an “equivalent search”. If you do not know the details, or are interested to know whether your invention will come into conflict with anything out there in the market, we can perform a much more detailed “Subject Matter” search, to look for anything resembling your software. We would then provide you with a professional opinion as to whether your software will come into conflict (infringe) another patent. The subject matter search is strongly recommended for such matters, as there may be several similar and damaging patents in force that could potentially cause you problems.
To be able to provide you with more comprehensive answer, we would require you to provide us with more details, including the history of the software invention, details on the offending patent, details of the software invention etc.
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