As readers of this blog are well aware, one of the most controversial issues in the Trans Pacific Partnership was the length of data exclusivity for biologic drugs. The U.S. sought a twelve year period (which would be consistent with current U.S. law) during which competitors would be unable to enter the market to compete with innovator firms unless they duplicated safety and efficacy data to obtain regulatory approval. Other countries sought lesser terms, arguing that long periods of data exclusivity raised the price of biologic medicines by blocking generic competition.
[Cross posted from Heesob’s IP Blog, Link] One of the controversies in implementing the KorUS FTA is whether biological products are subject to the patent linkage obligation of the KorUS FTA. The debate was provoked by the Korean government’s proposal which applies the patent linkage to biologics. But it is unclear if the FTA text imposes such an obligation.
Chapter 18 (IPRs) has no definition of pharmaceutical products for the patent linkage, only the provision of patent term extention defining a “new pharmaceutical product” as “a product that at least contains a new chemical entity that has not been previously approved as a pharmaceutical product in the territory of the Party.” See Article 18.8:5 FN21. In contrast, Chapter 5 (Pharmaceuticals and Medical Devices) makes clear that “pharmaceutical product or medical device means a pharmaceutical, biologic, medical device, or diagnostic product.”