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pharmaceutical ingredient) patent was applied for, an application is pending, no patent was granted (e.g. abandoned, withdrawn or denied), or the patent has expired?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.
