Patent linkages allow the connection of marketing approvals (MA) for generic pharma products to the patents covering an innovator company’s original/reference drug. Their purpose is to ensure that MAs are not given to patented products; and to allow generic makers to plan their launches without infringement risk, and also to invalidate weak patents. It also allows the innovator company to take action for infringement of relevant patent(s) to prevent MAs issuing to generic products too. In some countries, innovator company must list relevant patents so a generic company knows which patents cover the original/reference drug. Encouragement for generic pharma companies to seek MAs is sometimes provided by giving a period of market exclusivity to a generic company who invalidates a blocking patent.
In SE Asia only Singapore has a patent linkage system in place now. For the MA, the generic applicant must file a declaration stating whether its product infringes any relevant patents. This is a self declaration system, whereby it is up to the applicant to ensure there is no infringement. The generic applicant may also be required to notify the patentee of its MA application. The innovator company is entitled to take action for infringement, which stops the MA process until the patent issues have been decided.
Under the CPTPP treaty Malaysia and Vietnam will have to implement a patent linkage system, and possibly Singapore may amend theirs. The CPTPP requires for the MA, prior notice to the patent holder and a period for the patent holder to take legal action if needed. Unsurprisingly given the CPTPP's roots, this is a system based on the US one, which in essence allows the patent owner to intervene to prevent the MA issuing, and avoids the risk of infringing products getting to market (and leading to expensive litigation). The CPTPP however also allows alternative systems that make the MA dependent on non- infringement (Singapore's current approach).
Vietnam’s Ministry of Science and Technology is circulating a draft outline of the amendments to their IP Law. The draft outline mentions a new Article on patent linkage. However the specific provisions have not yet been drafted.
The discrepancy in the approaches reflects a worldwide debate on the scope of patent linkages. Should they be preventative like the US or informational like Singapore. The EU has no patent linkage rules and only some national laws require an informational type approach to MAs.
The other major regional IP treaty in Asia is the RCEP which is driven by China. That has no patent linkage provisions in the IP chapter. All ASEAN countries are planning to join this. It will be interesting to see how 3 of the 10 ASEAN countries fare with patent linkages while the other 7 do not have them.