Event Information

Time：September 23, 2014 (Tuesday) 03:00-05:00 p.m.

Place：TRPMA Conference Room
（1F, No. 465-1, Sec. 6, Zhongxiao E. Rd., Nangang Dist., Taipei City 11557, Taiwan）

The TRPMA invited Ms Wang Mei-Hua, Director General of the Taiwan Intellectual Property Office (TIPO), to give a special speech at the TRPMA. In her speech, Ms Wang mentioned that new drug development requires substantial amount of investment; hence all trial data and derived patents should be properly protected. However, the government needs to consider the development of generic manufacturers when providing protection for innovators’ rights. This issue has been a major task for the authorities in advanced countries.

After a new drug is licensed, its clinical data is under the protection of Data Exclusivity for a certain period of time. During this period, generic manufacturers cannot use the clinical data owned by the innovator to support the ANDA. The definition of new drugs (e.g. NCE new drugs, new compounds, and new therapeutic effects, etc.) and the length of Data Exclusivity vary from country to country. For example, the US FDA gives 5-year Data Exclusivity, plus 3 extra years for new indications or new compounds. In the EU, the Data Exclusivity is based on an 8+2+1 model which means that generic applicants can file applications and apply for drug licenses after the original drug has been on the market for 8 years; but, the launch of licensed generics must be delayed for 2 years until the Data Exclusivity is expired. In the meantime, if the innovator files an application of a new treatment method for this drug, then the Data Exclusivity period will be extended for another 1 year.

As for patent linkage, it refers to the linkage between a drug application and related patents. Generic manufacturers can carry out clinical trials before the patent expires; but, no licenses should be granted before patent expiration. Ms Wang briefly introduced the situation in the US. In the US, generic manufacturers need to specify the patent status. The status could be in any of the following four categories: Paragraph I: The original drug has no valid patent; Paragraph II: The original drug’s patent is expired; Paragraph 3: The original drug’s patent is soon to be expired; and Paragraph IV: The application does not infringe the original drug’s patent, or the original drug’s patent is invalid. Upon the receipt of a Paragraph IV ANDA, the US FDA will inform the original manufacturer of the application; and the original manufacturer should make a response in 45 days. If the original manufacturer decides to take legal action against the generic manufacturer, then the FDA will suspend the issuance of a license for 30 months. If the generic manufacturer wins the lawsuit, the first generic applicant will be given 180-day market exclusivity.

Again, the regulations of patent linkage and the definition of patents vary from country to country (e.g. in the US, it clearly specifies in the Orange Book). For the authority in Taiwan, the challenge is to formulate a regulation that balances the rights between innovators and generic manufacturers.

Ms Wang Mei-Hua, Director General of the Taiwan Intellectual Property Office (TIPO), was giving a special speech on “Pharmaceutical IP Rights – an overview of the development of drug patents”.