Wednesday

TOPIC : GENERAL QUESTIONS ON FILING PROCEDURE IN MALAYSIA

Question 1
If the national phase of a PCT application is entered?
(Example of fictive response: 5 years from the PCT filing date)

Answer 1
4 years from the PCT filing date.
However, on or before this deadline, should a deferment request be filed, the said deadline will be extended to 5 years from the PCT filing date.

Question 2
If the deadline for requesting examination has expired, does your national law foresee a remedy, or has the application definitively lapsed?
(Example of fictive response: 2 months after receipt of a noting of loss of rights it is possible to file a reinstatement request and to pay a surcharge).

Answer 2
No provision for remedy. Application considered withdrawn.

Question 3 (a)
Does Malaysian law foresee that a small entity status enjoys a reduction of fee(s)?

Answer 3 (a)
No.

Question 3 (b)
If yes, please mention the definition of a small status entity.
(Example of fictive response: 20 employees or less)

Answer 3 (b)
There is no provision for reduced filing fees.

Question 4
Please provide us with all blank documents in English and your national language (for patent applications) necessary for completing the entry into the PCT national phase (patent applications) in your country.
(Example of fictive response: Power of attorney form, Assignment document in English and your national language, forms P3&P26…)

Answer 4
Documents required are as follows:
(a) Power of Attorney (Form 17)
(b) Fee for Entering the National Phase (Form 2A)

Note: An assignment document will not be required. However we will prepare a “Statement Justifying the Applicant’s Right (SJAR)” at our end. For this purpose, please inform us how the Applicant derives the rights to the invention, i.e. either by way of assignment or virtue of employment contract.

All documents are provided in English only.

Question 5
Provide us with all blank documents in English and your national language (for designs) necessary for completing the filing of a design application in your country
(Example of fictive response: Power of attorney form, Assignment document in English and your national language, forms P3&P26…)

Answer 5
Documents required are as follows:
(a) Power of Attorney (ID Form 10)
(b) Application for registration of an Industrial Design (ID Form 1)

Note: An assignment document will not be required. However we will prepare a “Statement Justifying the Applicant’s Right (SJAR)” at our end. For this purpose, please inform us how the Applicant derives the rights to the design, i.e. either by way of assignment or virtue of employment contract.

All documents are provided in English only.

Question 6
What is the deadline for filing the documents mentioned in items 4 and 5?
(Example of fictive response: 2 months from the 30/31 months deadline from the PCT filing date (patent applications) / filing date (designs))

Answer 6
Patent Applications:
(a) Form 17 & SJAR: no deadline unless a communication is received from the PTO. However, we prefer to file within 3 months from the filing date of the PCT national phase
(b) Form 2A: 30 months deadline from the priority date of the PCT application
Design
(a) ID Form 10: upon filing
(b) ID Form 1: upon filing

Question 7
Kindly let us know if the deadline mentioned in item 6 has expired, is there still an extension of time possible with surcharge?
(Example of fictive response: yes, 2 months from the communication date of the PTO + surcharge)

Answer 7
Patent Applications:
(a) Form 17 & SJAR: N/A
(b) Form 2A: 2 months from the date of removal of the cause of failure to meet the deadline or 12 months after the expiration of the deadline, whichever period expires first + surcharge

Design
(a) ID Form 10: 3 months of extension of time + extension fee
(b) ID Form 1: no extension of time is possible


Question 8
If the deadline mentioned in item 7 has expired and no document has been filed, what is the legal consequence for the application regarding each document?
(Example of fictive response: assignment: application deemed withdrawn; POA: no representation possible; priority document: loss of priority date)

Answer 8
Patent Applications:
(a) Form 17: no representation possible and application considered withdrawn
(b) Form 2A: application considered withdrawn

Design
(a) ID Form 10: application considered withdrawn
(b) ID Form 1: application considered withdrawn

Priority documents must be filed within 3 months from the filing date of the PCT national phase (patents) / filing date (designs) and no extension of time is possible, failing which there will be loss of priority date.

Question 9
If it is possible to file a General Power of Attorney in Malaysia?

Answer 9
No provision for General Power of Attorney.


Question 10
Should an assignment document be notarized?

Answer 10
Yes, should the original not be available.
Note: An assignment document is not a requirement for filing patent / design applications. However, the same will be required in the case of a merger or assignment from one entity to another.

Question 11
Should an assignment document be legalized by Apostille or by the Consulate (please precise by Apostille or by the Consulate, if any)?

Answer 11
No.

Question 12
Does your PTO request the filing of original documents (POA, assignment) or is a copy sent only by fax of those documents accepted by your PTO?
(Example of fictive response: a copy sent only by fax is accepted, no original needed).

Answer 12
Only originals are accepted.

Question 13 (a)
In case the priority document is drafted in a language other than English, do you need a verified English translation of the priority document, i.e. duly verified by the translator or authorized by the applicant?

Answer 13 (a)
Yes, a verified English translation of the priority document, i.e. duly verified by the translator will be required.

Question 13 (b)
If yes, what is the deadline for filing such translation with your PTO?

Answer 13 (b)
Within 3 months from the filing date of the PCT national phase (patents) / filing date (designs) and no extension of time is possible.

Question 13 (c)
What is the legal consequence if the priority document is not filed within the deadline? (Example of fictive response: loss of priority date).

Answer 13 (c)
Loss of priority date.

Question 14
What is/are the official language(s) for filing a patent application?
(Example of fictive response: English or French only)

Answer 14
English or Malay Language (National Language)

Question 15
What is/are the official language(s) in which documents like POA, assignments must be drafted? (Example of fictive response: English or French only)

Answer 15
English or Malay Language (National Language)

Question 16 (a)
Kindly let us know if you need particulars for filing an application in your country (patent application number, copy of the office actions, responses to the office action, …) of corresponding foreign patent applications/patents?

Answer 16 (a)
Yes. This includes:
(a) prescribed information / supporting document concerning filing of any application outside Malaysia
(b) prescribed information concerning results or search / examination carried out by an International Searching Authority

Question 16 (b)
If yes, mention the countries/organization(s) (Example of fictive response: US, AU, EP)

Answer 16 (b)
Prescribed countries: US, AU, EP, KR, JP, GB

Question 16 (c)
If yes, is there a deadline for filing these particulars?

Answer 16 (c)
At the time of requesting examination.

Question 16 (d)
If yes, what is the legal consequence if we do not file such particulars despite corresponding foreign patent application(s)/ patents exist?

Answer 16 (d)
Application considered withdrawn.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Tuesday

Enforcement Of Patents Or Patentability Requirements Relating To Trips In Malaysia

Question
Whether Malaysia had/has some issues re-enforcement of patents or patentability requirement relating to TRIPS?

Answer
Malaysia is a signatory to the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), and has been since 1995 when Malaysia became a member of the World Trade Organization (WTO). The major points of TRIPS are covered in the Malaysian Patents Act (1983) & Regulations as follows :

Malaysia makes patents available for any inventions, whether products or processes, in all fields of technology without discrimination, subject to the normal tests of novelty, inventiveness and industrial applicability. Accordingly Malaysian legislation provides that patents be available and patent rights enjoyable without discrimination as to the place of invention and whether products are imported or locally produced (equivalent to Article 27.1 TRIPS).

NON-PATENTABLE INVENTIONS

In Malaysia, non-patentable inventions include inventions contrary to ordre public or morality, and those inventions which contain information that may be prejudicial to the nation. Also excluded from patentability are diagnostic therapeutic and surgical methods for the treatment of humans or animals (TRIPS Article 27.3(a)). Plants and animal varieties or essentially biological processes for the production of plants and animals, other than man- made living microorganisms, microbiological processes and the products of such processes, are also excluded.

The recent passing of the Protection of New Plant Varieties Bill 2004 has allowed Malaysia to accede to TRIPS article 27.3 (b) and gives breeders of new varieties of plants and seeds the right to receive legislative protection.

RIGHTS

The exclusive rights conferred to the owner of a patent in Malaysia include the right to exploit the patented invention; to assign or transmit the patent; and to conclude license contracts. The rights given to product patents cover making, using, offering for sale, selling, and importing for these purposes. Process patent protection rights cover not only use of the process but also products obtained directly by the process. Patent owners also have the right to assign, or transfer by succession, the patent and to conclude licensing contracts (TRIPS Article 28).

Limited exceptions to the rules do exist in Malaysia, such as the rights not extending to those acts done only for scientific research, or to the use of the patented invention on any foreign vessel, aircraft, spacecraft or land vehicle temporarily in Malaysia. Such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties (TRIPS Article 30).

In accordance with TRIPS Article 33, the term of protection available in Malaysia is a period of 20 years counted from the filing date, for all patents filed after 1" August 2001.article 33.

INVALIDATION AND INFRINEGEMENT

Invalidation, infringement and revocation rulings are possible in Malaysia.

Malaysian patent applications must be disclosed in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art and requires the applicant to indicate the best mode for carrying out the invention known to the inventor at the filing date or, in cases where priority is claimed, at the priority date of the application (TRIPS Article 29.1).

TRIPS Article 34 is covered in Malaysia as the Court overseeing an infringement case has the right to order the defendant to prove the act in question does not constitute an infringement, by for example proving that the process to obtain an identical product is different from a patented process, where certain conditions indicating a likelihood that the protected process was used are met.

COMPULSORY LICENSING

The Malaysian Patents Act does provide for compulsory licensing, but such licenses are made subject to conditions aimed at protecting the legitimate interests of the right holder. Where there is a national emergency or where the public interest in particular, national security, nutrition, health or the development of other vital sectors of the national economy as determined by the Government, or where a judicial or relevant authority has determined that the manner of exploitation by the owner of the patent or his licensee is anti-competitive, the Minister may decided to allow a Government agency or a third party the rights to exploit a patented invention. In cases not involving anti¬competitive practice, conditions include the requirement to pay adequate remuneration in the circumstances of each case, taking into account the economic value of the licence; and a requirement that decisions be subject to judicial or other independent review by a distinct higher authority. the Act also allows for importation of patented products that are already in the other countries' market (parallel import). Article 31.

ISSUES IMPORTANT TO THE PHARMACEUTICAL INDUSTRY

In Malaysia, to date there is no provision on data exclusivity to comply with TRIPS Article 39.3 that directly addresses the issue of Data Exclusivity for pharmaceuticals even though the Parliament of Malaysia has already passed amendments to several acts, such as the Copyright Act the Patent Act, and the Trademarks Act.

The Malaysian government is on working towards the complete implementation of TRIPS.

Thursday

Patent Working And Compulsory Licences In Malaysia

Question 1
Are there requirements for working a patent in your country? If so, what are they? Are there any reporting requirements required working in your country?

Answer 1
There is no requirement for working a patent in Malaysia. However, non-working patent is subject to compulsory license.

Question 2
What are the consequences to the patentee for not working a patent in your country? (Invalidity, shortened term, opens to compulsory licenses, etc.)\

Answer 2
Non-working patent is subject to compulsory license under Section 49 of the Malaysian Patents Act 1983.

Question 3
Is importation of a patent product sufficient to satisfy your country's working requirements? For process patents, must the process be executed within the country, or is importation of a product made by the patented process sufficient?

Answer 3
There is no requirement for working a patent in Malaysia. However, in accordance to Section 49 of the Malaysian Patents Act 1983, compulsory license will not be granted if there is use of the patented product or application of the patented process in Malaysia. In addition, when a patent is not worked, a third party can apply to the Intellectual Property Corporation of Malaysia (MyIPO) for a license or rights.

Question 4
Are the laws in your country in compliance with the provisions of GATT/TRIPS? If not, are there efforts to being them into line with GATT/TRIPS?


Answer 4
Malaysia is a signatory to the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) signed under the auspices of the World Trade Organization (WTO). Malaysia's Intellectual Property Laws are in conformance with international standards and have been reviewed by the TRIPs Council.

For countries with compulsory license provisions for patents:

Question 5
What is required for a third party to obtain a compulsory license? Is direct negotiation between the third party and the patentee required before application for a compulsory license (or is the fact of non-working sufficient)?

Answer 5
Direct negotiations between the third party and the patentee is required before application for a compulsory license wherein the person/ a third party shall only apply for compulsory license when the third party has made efforts to obtain authorization from the owner of the patent on reasonable commercial terms and conditions but such efforts have not been successful within a reasonable period of time.

However, subject to subsection (1) of Section 49 of the Malaysian Patents Act 1983, any person may apply to the Registrar for a compulsory license at any time after the expiration of three years from the grant of a patent, or four years from the filing date of the patent application, whichever is the later, under any of the following circumstances:

(a) where there is no production of the patented product or application of the patented process in Malaysia without any legitimate reason;
(b) where there is no product produced in Malaysia under the patent for sale in any domestic market, or there are some but they are sold at unreasonably high prices or do not meet public demand without any legitimate reason.

Question 6
Have there been any compulsory license applications in your country?


Answer 6
No.

Question 7
Have there been any compulsory licenses granted?

Answer 7
No.

Question 8
What is the compensation given to the patent holder if a compulsory license is granted?

Answer 8
In accordance to Section 52 of the Malaysian Patents Act 1983, the amount and conditions of the royalty due from the beneficiary of the compulsory license to the owner of the patent is determine by the Intellectual Property Corporation of Malaysia (MyIPO).

Question 9
What can a patentee do to counter a request for a compulsory license?

Answer 9
The patentee/owner of a patent should prove that the grounds for a request for a compulsory license have not been met.

Question 10
After grant of a compulsory license, can the patentee negate/cancel/nullify the compulsory license? If so, how?

Answer 10
The Intellectual Property Corporation of Malaysia (MyIPO) shall cancel the compulsory license upon request of the patentee/owner of the patent based on the following grounds in accordance to the provisions of subsection (2) of Section 54 of the Malaysian Patents Act 1983.

(a) if the ground for the grant of the compulsory licence no longer exists;
(b) if the beneficiary of the compulsory licence has, within the time limit fixed in the decision granting the licence, neither begun the working of the patented invention in Malaysia nor made serious preparations towards such working;
(c) if the beneficiary of the compulsory licence does not respect the scope of the licence as fixed in the decision granting the licence;
(d) if the beneficiary of the compulsory licence is in arrears of the payment due, according to the decision granting the licence.

Question 11
Are there any unusual or unique circumstances/requirements, specific to your country relating to the application for and/or grant of a compulsory license?

Answer 11
There are no unusual or unique circumstances/requirements in Malaysia which relates to the application for and/or grant of a compulsory license.

Tuesday

Information Disclosure Statement In Malaysia

Question 1
Is there a “duty of disclosure” according to Malaysian Patent Law? Is a patent application required, upon filing of an application or anytime afterwards, to actively disclose to the Malaysian Patent Office any references or Search Reports that the applicant knows about?

Answer 1
Please note that in Malaysia, there is no requirement for, or “duty of disclosure” (of references etc) by law, at the present time. The same is true for search reports, but the applicant is strongly advised to offer search reports to the Malaysian Patent Office as they will be very useful to expedite the prosecution of the application. The Malaysian patent system is rather similar to the UK system in many ways, and often dissimilar to the US system.

Compulsary Licensing In Singapore

Question 1
Our licensee is about to make a pitch to a major electronics company in order to get the tray business. We might consider sending a notice to all the electronics company. What are the rules in Singapore?

Answer 1
As far as the notice to be sent to all the electronics company:
1) it must not contain a "groundless threat" under Singapore Law
2) it is a must to mention to all the electronics company that you have recorded the licensees under Singapore Law, my written advice is as follows:
Intellectual Property Rights are often involved in transactions in the modem business environment Contracts and Agreements to assign rights are very common especially where the Patents are Part of a Intellectual Property portfolio including other forms of Property Rights. Such contracts and agreements may also include the granting of licenses.

A license for the working of the invention may be granted under a patent. The license may permit the making of sub-licenses may be even assigned or mortgaged when appropriate terms are present in a contract/agreement.

An exclusive license is a license from the proprietor of or applicant for a patent conferring on the licensee or to the exclusion of all other persons including the proprietor or applicant)' any in respect of the invention to which the patent or application relates.

An exclusive licensee has the right to bring proceedings in respect of any infringement of the patent after the date of the license agreement

Recordal of transactions:
Most transactions involving Patents must be registered with the Registrar. Section 43(3) lists the type of transactions that must be registered.
They are:
(1) an assignment of the Patent or application for a patent;
(2) a mortgage of the patent or application;
(3) the grant or assignment of a license or sub-license or mortgage of a licensee or sub-license, under the patent or application;
(4) the death of the Proprietor or one of the proprietors of the patent or application or any person having a right in or under the patent or application and the vesting by an assent of personal representatives of a patent or application or any such rights; and
(5) any order/directions of a court/competent authority transferring a patent or application or any right in or under it to any personal or that an application should proceed in the name of any person together with registration of the event under which the court/authority had the power to make the order or give the directions.

Under s 43(1), the above transactions must be registered because once a person claims not to know of an earlier transactional instrument, or event:
(1) the registration of acquisition of property in a patent or an application defeats earlier transactions, instruments or events that have not been registered (registration provides proof of ownership);
and
(2) the subsequent proprietor (from the original proprietor) of the patent or an exclusive licensee may be unable to obtain damages or an account of profits for any infringement of the patent.

Under s 75 where a person becomes the proprietor or an exclusive licensee of a patent by virtue of a transaction instrument, or event to which s 43 applies, that person shall not be entitled to recover damages or an account of profits in respect of infringement subsequent to the transaction, instrument or event if a recordal was not done with the Registrar within six months of its date. Six months is an arbitrary period, as the Registrar and courts are receptive to recordals after longer periods as long as it was shown that a recordal was not practicable to be done within six months, and the recordal was sought as soon as practicable.

This view was followed by Lee Sieu Kin JC (as he was then) Contour Optik Inc v Pearl's Optical Co Pte Ltd, Lee JC commented;
The Plaintiffs submit that although the instruments were not registered within the six month window, the registrations were done within a reasonably practicable time thereby falling within s 75รพ). However, this is a bare submission and the Plaintiffs did not adduce any evidence of their registering the instruments as soon as it was practicable to do so.

Thursday

Malaysia's Patent Law

Question 1
a) If the filing date is on or before 16 August 2006 must a petition for examination be filed 24 months from the filing date?
b) When are annuities due for a patent with a filing date on or before 31 August 1999?
c) What is the term of a patent with a filing date on or before 31 May 1967?
d) What is the term of a patent with a filing date on or before 31 July 1989?
e) What is the term of a patent with a filing date on or before 31 August 1999?
f) What is the term of a patent with a filing date on or after 1 January 1994?

Answer 1
a) Yes.
b) According to Malaysian Patent Act, annuities are only due after the patent has been granted. Therefore, for an example, if the filing date is 31 August 1999, and the patent granted on 31 August 2003, the first annuity will be on 31 August 2004.
c) d), e) and f) 20 years from the filing date or 15 years from grant date, whichever is longer.

Question 2
In a situation where the 12 month deadline for filing a Malaysian application claiming priority from an earlier application has passed (some years previously), and the earlier application ahs been published, is there any means for obtaining patent protection in Malaysia for the invention claimed in the earlier application?

Answer 2
In Malaysia, it is possible to obtain patent protection for an invention which has missed its priority deadline, dependant on the date that the subject matter was first disclosed to the public. For this purpose, we can file a ‘non-conventional’ patent application. Malaysia allows applications to be filed up to 12 months after subject matter has been disclosed to the public.
There are also other forms of protection available in Malaysia, as the patent system follows the European system closely.
Patent Protection
As mentioned above, a non-conventional Malaysia patent application can only be filed if there was no disclosure of the subject matter of the PCT or foreign application beyond the 12-month grace period calculated from the filing date of the proposed Malaysian application. If the subject matter was disclosed more that 12 months ago, we confirm that the subject matter would have lost its novelty and patent protection is not available.

Question 3
Are there any alternative forms of protection, such as design protection available in Malaysia?

Answer 3

Industrial Design Protection
The design of the external features of an object can be protected as an industrial design under the Malaysian Industrial Designs Act 1996 if the design is not purely functional.
Under the Industrial Design Act, an industrial design will not be considered as novel it was disclosed to the public anywhere in Malaysia unless the disclosure was made in an official or officially recognized exhibition or it was disclosed by a person other than the applicant as a result of an unlawful act committed by that person.

To summarize, the novelty requirement in Malaysia for an industrial design application is domestic requirement. In this case, the disclosure of a design in a trade show in the US for example is not relevant as the disclosure was in the US and not Malaysia.

However, if a PCT application with drawings were previously published and they are available online in Malaysia, there is a possibility that the industrial design would have lost its novelty. However, the issue of whether the publication of the drawings in the Internet can constitute a prior disclosure in Malaysia is yet to be tested in the Courts. Furthermore, under Section 3(b) of the Industrial Design Act, an industrial design should not include features of shape or configuration of an article which are dictated solely by the function which the article has to perform or are dependent upon the appearance of another article of which the article is intended by the author of the industrial design to form an integral part.

Please note that currently, there is no substantive examination for industrial design applications. Theoretically, we can proceed to file an industrial design application and chances are we would be able to obtain the registration, as the Examiners will not conduct a substantive examination to identify prior existing industrial designs. However, during litigation, a defendant may be able to attack the validity of a granted industrial design on the basis of novelty.

Copyright Protection
Under the Copyright Act 1987, all three dimensional articles can be protected provided that the articles are not protected under the Industrial Design Act. This applies only to articles designed after 1 September 1999 (the date the Industrial Design Act came into force).

If an item cannot be protected under the Industrial Design Act, or Patents Act, it may still be protected under the Copyright Act.

However, it must be noted that the protection provided under the Copyright Act is very much limited. For an example, the copyright protection will cease as soon as the subject design been reproduced more than 50 times by an industrial process by the owner.

Wednesday

Indonesian Patent Law

Question 1
Does Indonesian law follow the common laws (England… based on precedents) OR does it follow the German / European Patent Office (EPO) style statutory law OR constitutional law (US)?

Answer 1
Indonesia adopts the Civil Law which refers to the applicable law currently exist and therefore we can say that Indonesia follow the statutory law. The jurisprudence will be of persuasive value but not binding.

Question 2
What is the likelihood that EPO objections to granting a patent will be upheld in Indonesia? Can we argue based on EPO objections? Will our case be strong?

Answer 2
EPO objections can be used as an argument before the court. However the expert’s opinion and the evidence will also be the important consideration for the judge in making the decision.

Question 3
In particular, the EPO has a “problem solution approach” to patents. Have you heard of this in your classes? Do you know if Indonesia will follow the EPO on this one? You can google “problem-solution approach”. It’s very big in European Patent Law. Will Indonesia follow this argument?

Answer 3

Yes, Indonesian Examiner also apply the “problem solution approach” in evaluating the inventive step of an invention, which contain of 3 (three) steps:
- Determining the closest prior art
- Formulating technical problems to be solved
- Considering the obviousness based on the above closest prior art and technical problems to
be solved.

Question 4
If there are A+B+C in a parent application, will Indonesia accept A+C only in divisional? The EPO rejected A+C. They said B is an essential feature defined in the earlier application. Therefore A+C goes beyond the scope of the parent application.

Answer 4
For the above case, the Indonesian Examiner will also have the same opinion with the EPO for not accepting the A+C in the divisional, with the reason that the invention become too general, no more specific features and therefore prior art can be cited. The granting is for specific technical features A+B+C and it will not patentable when the feature is only A+B or A+C or B+C which has less specific technical features and that the invention is too general. In patent, we aware that specialty beat generality. However, please note that under current practice the above is not binding but still debatable.

Question 5
If the specific benefit of a feature X is not stated specifically in a prior art specification, but the technical effect is achieved by working this prior art invention, does that prevent a new applicant from trying to patent X, the only difference being that the new applicant said “my invention performs X”?
-The EPO’s view is that X is inherent in the working of the prior art invention anyway. So even if they didn’t exactly spell out “our invention performs X”, the benefits are achieved.
-So they rejected the new application (by another person) in which the new applicant claimed the same thing as the prior art, only this time, he spelt out the benefits of X.
-Will Indonesia follow EPO?

Answer 5
As mentioned in question no. 3 that Indonesia also apply “problem solving approach”, therefore Indonesia also follow EPO in determining a prior art. Though it is not literally mentioned in the prior art but if a person skilled in the art can constitute the obviousness of the invention then it will be considered as a prior art. Please refer to Article 2 paragraph (3) of Patent Law No. 14 of 2001.

Tuesday

Patent Protection, Enforcement And Court System In Philippines

TOPIC : PATENT PROTECTION, ENFORCEMENT AND COURT SYSTEM IN PHILIPPINES

PROTECTION

Question 1
What is the term of protection of a patent in Philippines?

Answer 1
In Philippines, a Patent last for twenty (20) years counted from the date of filing and for Utility Model, 7 years from the date of filing.

Question 2
Is it possible to extent the lifetime of a patent?

Answer 2
No.

ENFORCEMENT

Question 1
What are the types of patent enforcement action are available in Philippines?

Answer 1
a) Civil action for infringement;
b) Administrative case for infringement; and
c) Criminal action for repetition of infringement.

Question 2
How can the patent owner most effectively make his point to stop an infringement?

Answer 2
Secure a search warrant to seize the infringing goods prior to filing a civil action or an administrative action for infringement.

Question 3
Are protective orders available in Philippines?

Answer 3
Yes.

Question 4
Does the Philippines patent law require the patent owner to send a cease and desist letter to an alleged infringer before a court action can be taken against him?

Answer 4
No.

Question 5
Is it possible to seek a preliminary injunction? If so, how long would this action take?

Answer 5
Yes. Time frame from 2 – 6 months.

Question 6
Is it possible to seek seizures / inspections of suspect goods?

Answer 6
Yes.

Question 7
How long would a patent infringement / patent invalidation case take?

Answer 7
1. Infringement action duration about 36 months.
2. Invalidation action duration about 12 months.
3. Typical cost – this can vary according to complexity of case, whether it is contested and seniority of person handling the case.

Question 8
How are damages / royalties assessed?

Answer 8
Damages sustained, reasonable attorney’s fees and other expenses. The courts may treble the amount of damages awarded to the complainant if bad faith on the part of respondent is proven. Damages cannot be recovered if the infringer had not known of complainant’s patent.

Question 9
Can the alleged infringer sue for damages if the patent owner fails to prove infringement in court of Philippines?

Answer 9
Yes.

COURT SYSTEM

Question 1
Briefly describe any cases of patent invalidation or patent infringement in Philippines?

Answer 1
Smith Kline Beecham Corporation vs. CA and Tryco Pharma Corp., GR No. 126627.

Petitioner sued respondent for infringement of patent and unfair competition. It claimed that its patent covers or includes the substance Albendazole. It claimed that respondent, by manufacturing, selling, using and causing to be sold and used the drug Impregon without its authorization, infringed its patent as well as committed unfair competition for advertising and selling as its own the drug Impregon although the same contained petitioner’s patented Albendazole.

Question 2
How efficient are the courts in disposing IP litigation cases in Philippines?

Answer 2
Reasonably efficient.

Question 3
Are the judges technically qualified?

Answer 3
Yes.

Question 4
Do the courts rely on precedent cases decided in foreign countries?

Answer 4
Yes. US.

Question 5
How are foreigners treated by the courts in Philippines?

Answer 5
Same as locals.

Question 6
What is the time frame for a patent invalidation / patent infringement suit to be decided?

Answer 6
18 – 72 months.

Question 7
What step(s) must be taken to appeal a court decision in Philippines?

Answer 7
Appeal to Director General of the IPO, Court of Appeals, and Supreme Court.

Patent Protection, Enforcement And Court System In India

PROTECTION

Question 1
What is the term of protection of a patent in India?

Answer 1
In India, a Patent last for twenty (20) years counted from the date of filing and there is no Utility Model in India.

Question 2
Is it possible to extent the lifetime of a patent?

Answer 2
No.

ENFORCEMENT

Question 1
What are the types of patent enforcement action are available in India?

Answer 1
a) Injunctions;
b) Damages and
c) Account of profits.

Question 2
How can the patent owner most effectively make his point to stop an infringement?

Answer 2
Obtain an interim injunction.

Question 3
Are protective orders available in India?

Answer 3
Yes.

Question 4
Does the Indian patent law require the patent owner to send a cease and desist letter to an alleged infringer before a court action can be taken against him?

Answer 4
No for ex parte interim injunction. However, the Civil Procedure Code requires issuance of notice in Civil Suits and the Courts follow the “notice” as rule and ex parte relief as exception.

Question 5
Is it possible to seek a preliminary injunction? If so, how long would this action take?

Answer 5
Possible. Time frame from 6 – 8 months.

Question 6
Is it possible to seek seizures / inspections of suspect goods?

Answer 6
Yes.

Question 7
How long would a patent infringement / patent invalidation case take?

Answer 7
1. Infringement action duration about 24 months.
2. Invalidation action duration about 12 months.
3. Typical cost – this can vary according to complexity of case, whether it is contested and seniority of person handling the case.

Question 8
How are damages / royalties assessed?

Answer 8
Plaintiff’s loss of profits or defendant’s account of profits.

Question 9
Can the alleged infringer sue for damages if the patent owner fails to prove infringement in court of India?

Answer 9
Yes. Only for a claim for costs.


COURT SYSTEM

Question 1
Briefly describe any cases of patent invalidation or patent infringement in India?

Answer 1
Farbwerke Hoechst Aktiengesellschaft vs. Unichem Laboratories [AIR 1969 Bom 255]
An invention consisting of the production of new substances from known materials by known methods cannot be held to possess new subject matter merely on the ground that the substances produced are new, for the substances produced may serve no useful purpose, in which case the inventor will have contributed nothing to the common stock of useful knowledge (the methods and materials employed being already known) or of useful materials (the substances produced being, ex hypothesi, useless)

Question 2
How efficient are the courts in disposing IP litigation cases in India?

Answer 2
Reasonably efficient.

Question 3
Are the judges technically qualified?

Answer 3
Judges handling patent infringement cases are not technically qualified. However, in the case of patent invalidation, the Technical Members are technically qualified.

Question 4
Do the courts rely on precedent cases decided in foreign countries?

Answer 4
Yes. United Kingdom.


Question 5
How are foreigners treated by the courts in India?

Answer 5
Same as locals.

Question 6
What is the time frame for a patent invalidation / patent infringement suit to be decided?

Answer 6
2 – 3 years.

Question 7
What step(s) must be taken to appeal a court decision in India?

Answer 7
File a notice of appeal.

Patent Protection, Enforcement And Court System In Indonesia

PROTECTION

Question 1
What is the term of protection of a patent in Indonesia?

Answer 1
In Indonesia, a Patent and the Utility Model Patent has a effective period of twenty (20) years counted from the date of filing.

Question 2
Is it possible to extent the lifetime of a patent?

Answer 2
No. Supplementary protection is not available.

ENFORCEMENT

Question 1
What are the types of patent enforcement action are available in Indonesia?

Answer 1
a) Criminal action;
b) Civil action;
c) Preliminary injunction and
d) Permanent injunction.

Question 2
How can the patent owner most effectively make his point to stop an infringement?

Answer 2
Obtain a preliminary injunction.


Question 3
Are protective orders available in Indonesia?

Answer 3
Yes.

Question 4
Does the Indonesian patent law require the patent owner to send a cease and desist letter to an alleged infringer before a court action can be taken against him?

Answer 4
No.

Question 5
Is it possible to seek a preliminary injunction? If so, how long would this action take?

Answer 5
Possible. Time frame from 2 – 3 months.

Question 6
Is it possible to seek seizures / inspections of suspect goods?

Answer 6
Yes.

Question 7
How long would a patent infringement / patent invalidation case take?

Answer 7
1. Infringement action duration about 36 months.
2. Invalidation action duration about 36 months.
3. Typical cost – this can vary according to complexity of case, whether it is contested and seniority of person handling the case.

Question 8
How are damages / royalties assessed?

Answer 8
Damages are assessed based on plaintiff’s loss of profits or defendant’s account of profits.

Question 9
Can the alleged infringer sue for damages if the patent owner fails to prove infringement in court of Indonesia?

Answer 9
Possible.

COURT SYSTEM

Question 1
Briefly describe any cases of patent invalidation or patent infringement in Indonesia?

Answer 1
Honda vs. China Motorcycle
Honda sued China Motorcycle alleging infringement of its Indonesian patent no. ID 000284.

The originally filed claims were in English but soon translated into Indonesian language. The translation was not accurate. Honda alleged infringement base on the granted English claims.

The Court took the view that any patent infringement should be based on the claims in the Indonesian language and not other languages and China Motorcycle was held not infringing the patent.

Question 2
How efficient are the courts in disposing IP litigation cases in Indonesia?

Answer 2
Fairly efficient.

Question 3
Are the judges technically qualified?

Answer 3
Yes.

Question 4
Do the courts rely on precedent cases decided in foreign countries?

Answer 4
No. But courts do rely on cases decided by Indonesian Higher Courts.

Question 5
How are foreigners treated by the courts in Indonesia?

Answer 5
Same as locals.

Question 6
What is the time frame for a patent invalidation / patent infringement suit to be decided?

Answer 6
5 – 6 months.

Question 7
What step(s) must be taken to appeal a court decision in Indonesia?

Answer 7
Appeal to the Supreme Court.

Recommendations For Patent Prosecution In Malaysia

Question 1a
Questions in an effort to identify ways that we can reduce unnecessary spending and improve the efficiency of our prosecution in Malaysia? Is there a point where additional claims no longer add value?

Answer 1a
No.

Question 1b
Does it matter whether the claims are independent or dependent with respect to costs?

Answer 1b
No.

Question 2
What types of pharmaceutical-related Claims are allowable in Malaysia?

Answer 2
1. Composition claims (product claims)
2. Process claim
3. Swiss-type use claim (in the format of “Use of substance X in the manufacture of medicament for the treatment of condition Y”)

Question 3
What types of pharmaceutical-related Claims are NOT allowable in Malaysia?

Answer 3
1. Method of treatment of human or animal body by surgery or therapy (can be overcome by amending this type of claims to be read as Swiss-type use claims).
2. Omnibus claims (which is in the format of; “An X as shown Figure Y” or “Apparatus as described in the description”)

Question 4
Does the Intellectual Property Corporation of Malaysia (MyIPO) restrict the scope of claims based on the examples and/or data present in the application at the time of filing? e.g. will the Examiner require the scope of a compound claim to be restricted to exemplified examples?

Answer 4
According to Malaysian Patents Act, examples are preferred embodiments of the specification and variations are allowed so long as it does not go beyond the scope of the claims. Examples are also does not restrict scope of invention.

Question 5
Are there limitations on the scope that one can claim for a biologic or antibody?

Answer 5
Biologic materials such as therapeutic antibodies against protein or genetic sequence are generally considered to be patentable and qualify as an invention so long as the antibody gene sequence are novel, involve an inventive step, and industrially applicable. Plant or animal varieties or essentially biological processes for the production of plants or animals; other than man-made living micro-organisms, micro-biological processes and the products of such micro-organism processes; are considered not patentable, microorganisms (which are isolated from natural sources) and not subjected to any gene transfer or recombinant manipulation can be considered man-made organisms and is patentable only if it is new, involves and inventive step and is industrially applicable.

Question 6
Will the Intellectual Property Corporation of Malaysia (MyIPO) accept claims that have been granted in other countries? If yes, what countries?

Answer 6
Yes. Prescribed countries; Australia (AU), Japan (JP), Korea (KR), Great Britain (GB), USA and EPO.

Question 7
Can you delay prosecution until claims grant in one of these countries?

Answer 7
Yes, we can file for deferment of request for substantive examination; and the maximum delay is 5 years from the filing date.

Question 8
If there a pro forma response that could be filed to address nuisance oppositions filed by Generic companies?

Answer 8
In Malaysia, there is NO provision for oppositions during the prosecution of patent application stage. However, generic companies may file for Non-infringement declaration (NID) and / or revocation after the patent has been granted. In this case, there is no pro forma response as NID and / or revocation are court proceedings.

Divisional Application In USA

Question 1
If the applicant decides to elect to amend the claims to contain only 1 group, when is the deadline to file for divisional application(s)?

Answer 1
There is not a specific deadline to file a divisional application; however, the divisional application must be filed before either the parent application issues as a patent or goes abandoned.

Question 2
What is the difference in continuation in part and divisional application?

Answer 2
A continuation in part application is one that claims priority to an earlier application but also typically includes new matter that was not described in the earlier application. The priority date of the earlier application is given to any claims whose subject matter was described in the earlier application and any claims with new matter are deemed to have the priority date of when they were filed.
A divisional application is an application that is filed with respect to non-elected claims in a previously restricted application and the claims in the divisional application are given the priority date of the claims in the previously restricted application (assuming no new matter is added to the divisional application).

Question 3
Our initial proposed response will be to divide the parent application (by using claims of group 1 only) to another 2 child application (where claims of group 2 and 3 divided accordingly). Would you think this is a more viable solution. Would you take similar action?

Answer 3
Our suggestion is to elect to desired group of claims in the present application and have them examined per the standard course of action. Please also note that you will also need to elect a species of a particular compound in which the Examiner poses 4 questions and one disorder or disease must also be elected. Then we would propose that you file a divisional application or applications for any non-elected claims. This may prove to be the most efficient solution as drafting and filing fees would likely be lower that the filing of two new child applications. Additionally, it may be possible to amend some of the claims in groups 2 and 3 so as to put them into one application and avoid a future restriction requirement.