IP transactions in life sciences in ASEAN countries: data exclusivity
In the final part of this three-part series, we examine data exclusivity in Association of Southeast Asian Nations (ASEAN) countries, having focused on data export controls and IP ownership and sharing in parts one and two.
Under Section 19(a) of the Singapore Medicines Act, a five-year data exclusivity period (starting from the date on which the product licence application was received by the licensing authority, ie the Health Sciences Authority (HSA)) is automatically awarded to the licence holder, provided that it is a first application for a medicinal product comprising the active ingredient, in which the latter has not been referred to in any other application as an ingredient in the manufacture or preparation of the medicinal product.
Additionally, under Section 19(d), no product licence may be granted for similar medicinal products based on the grant of an earlier licence for a five-year period (starting from the date of grant of the earlier licence), unless with the consent of the holder of the earlier approval.
The HSA may disclose exemptions or use confidential supporting information for the purpose of determining whether to grant any other application, with the consent of the applicant whom the confidential supporting information relates to, or if that disclosure or use is necessary to protect the health or safety of members of the public.
The benefit of this data and marketing exclusivity is that no subsequent third party may rely on the applicant’s data during this period.
In Malaysia, data exclusivity is governed by the Directive on Data Exclusivity, which came into force on 1 March 2011. This seeks to protect undisclosed, unpublished and non-public domain pharmaceutical test data – the origination of which involves a considerable effort – which is submitted for the purpose of scientific assessment regarding new drug products containing a new chemical entity (NCE) or a second indication of a registered drug product.
An application for data exclusivity can be made via a letter of intent, in conjunction with the application for registration. The grant and period of data exclusivity by the director of pharmaceutical services is on a case-by-case basis. Data exclusivity last for no more than five years for a new drug product containing an NCE, or three years for a second indication of a registered drug product.
Data exclusivity does not apply to cases where compulsory licences have been issued, nor does it prevent the government from taking any necessary action to allow non-commercial public use, or during a national emergency or public health crisis.
Indonesia has no specific regulations that stipulate data exclusivity at this time, possibly because it has not signed any international agreements or treaties related to intellectual property requiring such exclusivity (eg, the Comprehensive Economic Partnership Agreement). Protection of data on experiments conducted on a drug will be automatically provided by the Ministry of Health once the drug is registered.
In addition, Article 14(3) of Health Ministry Regulation 10101 MENKES/PER/XI/2008 provides that a “registration document is a confidential document which can only be used for evaluation by the relevant officer”.
There is currently no data exclusivity in the Philippines. The Philippines Intellectual Property Office and drug authorities will review the implementing rules and regulations of the IP Code to consider data exclusivity and patent linkage to strengthen the enforcement of IP rights for pharmaceutical products, but to date, the review results have not been issued.
Thailand does not offer data exclusivity protection per se. For any data submitted to the Food and Drug Administration (FDA) of the Ministry of Public Health, a limited form of data protection is provided under the Trade Secrets Act 2002, which makes the unauthorised use and disclosure of such information an actionable offence, punishable by civil and criminal remedies. The act recognises that data submitted to the FDA to obtain marketing approval for a new drug may amount to trade secrets in the form of a testing result or other information regarding its preparation or creation. In this case, the owner has the right to request the FDA to maintain the confidentiality of the data; it then has a duty to ensure that the data is not disclosed or used in unfair trading activities. The Public Health Ministerial Regulation Regarding Trade Secrets (Data Protection) was subsequently issued in 2007 – this sets out that after being notified that the data submitted is to be treated as a trade secret, the FDA shall keep such data confidential for five years. However, the FDA takes the position that it only has a duty to keep the drug originator's data confidential while it can still rely on it to assess and approve a subsequent generic application.
In Vietnam, data exclusivity is covered by a circular dated 1 March 2010 issued by the Ministry of Health, relating to both small molecule and biological pharmaceutical products. The test data will be protected if the following conditions are met:
- the data is a trade secret that fulfils the requirements of protection under the Vietnam IP Law;
- the data is a result of considerable work investment; and
- there is a specific request for data protection at the time of applying for marketing approval.
As provided for in Article 128 of the IP Law, the competent authorities have obligations to keep data submitted in the application for a business licence of a pharmaceutical product secret, if requested by the applicant. From the filing date of secret data to the expiration of the five-year period from the date on which a licence is granted, the authorities are obliged not to grant a licence to any subsequent application in which the secret data mentioned above is used without the consent of the previous applicant, except for cases where the subsequent applicant creates the secret data independently.
Sri Lanka does not provide for market exclusivity beyond the 20-year patent term. The Intellectual Property Act (36/2003) provides for data exclusivity designed to prevent unfair commercial use of data submitted for the purpose of obtaining approval and disclosure thereof. However, with regard to molecules already registered, the National Medical Regulatory Authority only requires a bioequivalence study or human pharmacodynamic study. Therefore, the test data provided by the patent holder to the authority for approval of the molecule may be used to approve the generic products.
In order to extend patent protection and effective market exclusivity, a challenge to this approval process is the only available and viable option. However, to date no such challenge has been made.
Other ASEAN region countries
There is no data exclusivity in countries such as India, Bangladesh and Mongolia.
This is an Insight article, written by a selected partner as part of IAM's co-published content. Read more on Insight
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