Patent linkage refers to the system or process by which a country links drug marketing approval to the status of the patent(s) corresponding to the originator’s product. This article provides a snapshot of the patent linkage position in the US vis-à-vis Asia and the Pacific.
United States. The Food and Drug Administration (FDA) maintains a list of pharmaceutical products and uses currently under patents in approved drug products with therapeutic evaluation equivalents (widely known as the Orange Book).
The FDA will not provide marketing approval for a generic copy of an innovative pharmaceutical product that would infringe patents in the Orange Book. A 30 month stay of marketing approval is engaged where generic applicants are challenging existing patents.
Australia. An applicant for marketing approval must declare whether the product would infringe an existing patent and must notify the right holder. Health authorities cannot provide marketing approval for a generic copy which would infringe an existing patent.
China. China’s State Food and Drug Administration (SFDA) must be satisfied that no patent is being infringed before it will issue marketing approval for a new product. If there has been litigation over a patent, SFDA will wait until the appeals process has been exhausted before acting.
Singapore. Applicants seeking marketing approval must declare any relevant patent and in most cases notice must be served on the rights holder. Where a patent owner issues proceedings within 45 days of service of such notice, a 30 month stay is engaged. The Trans-Pacific Partnership free trade agreement (TPP) may have an impact on the current system.
Brunei, Malaysia and Vietnam. There is currently no patent linkage system in place in these countries.
The TPP, entered into by Brunei, Singapore, New Zealand and Chile, came into force on May 28, 2006. The US, Malaysia, Vietnam, Australia and Peru are negotiating to join the group (and Japan is also interested in joining negotiations).It is thought that these negotiations may result in the introduction of a patent linkage system in these countries.
The Philippines. In 2006, a Government Administrative Order removed the patent linkage system and intellectual property protection, in general, from the responsibilities of the Food and Drugs Authority of the Philippines (FDAP).
The Order permits the FDAP to accept and process applications for product registration without the need to verify whether there is a relevant patent. Moreover, even if the FDAP is made aware of a valid patent, it is “exempted” from honouring such patent and can grant approval for marketing of the product.
Indonesia and Thailand. There is currently no patent linkage system in place in these countries.
Pharmaceutical Research And Manufacturers Of America (PhRMA) member companies would like to see Indonesia take steps to bring BPOM (the National Agency of Drug and Food Control) in line with international best practices on patent linkage. PhRMA has also encouraged Thailand to introduce an effective patent linkage system.
Doctors Without Borders has commented that patent linkage effectively requires drug regulatory authorities to take on the responsibility of policing patents and delaying generic entry into the market. Further, if linkage becomes mandatory under the TPP, it will impose on developing countries more restrictive conditions for the registration of generic medicines that are found in Europe.
The European Commission’s Pharmaceutical Sector Inquiry preliminary report of November 28, 2008, cautioned against patent linkage and referred to innovator blocking tactics in relation to generics and obstacles to innovation.
Patent linkage clearly favours patentees, protecting them from potentially infringing products being approved, and in some countries providing a 30 month stay on marketing approval applications. Innovators are able to retain their position and confidently invest in the production of new products.
The balancing act between the rights of innovators and their generic competitors is complex. Only time will tell whether patent linkage will become a global standard.