当所は二月にパテント部弁理士林宗緯が書いたIP Blog第一期：
Two Things You Shall Know for Patent Linkage in Taiwan を発行しました
Two Things You Shall Know for Patent Linkage in Taiwan
Tzung-Wei, Wade, Lin
Patent Attorney
MS. in Molecular Biology
Wade.lin@taiwanlaw.com
Patent Linkage is one of the important issues in the Trade and Investment Framework Agreement (TIFA). The Taiwan Government has expressed it’s plan to enforce patent linkage system in the near future. Last year (2014), in December, the Taiwan IP Office hold a forum discussing topics related to US patent linkage and litigation. Our firm together with Haynes and Boone, LLP also hold a seminar to discuss the related issues of patent linkage. The dispute of whether Taiwan shall adopt patent linkage system and how to do so has recently drawn a lot of attention. We note two things that require special concern for implanting the patent linkage system in Taiwan: (1) the health care system; and (2) the invalidation procedure.
Health Care System
The 180-days exclusivity is the main incentive for generic drug manufacturers to challenge the validation of the patents covering the brand name drugs through paragraph IV. However, we note that the benefit of the 180-days exclusivity might be significantly diluted under Taiwanese health care system. In Taiwan, the price of a drug is not absolutely set in accordance with market mechanism but through a procedure called drug price determination in the National Health Insurance Administration. Therefore, after receiving drug license, more time would be spent for price determination and thereby the exclusivity would be diluted.
There is a further issue that would consume the time period of exclusivity. People in Taiwan, while feeling unwell, used to see a doctor rather than buying drugs from drug stores (because the medical expense in hospitals or clinics is relative cheaper than western countries). That said, major sales would be happened in the hospitals rather than in drug stores. Since that, the exclusivity would be further diluted for the time spent for drug listing procedure or listing trials in the hospital. We consider this situation as a notable issue and suggest a proper start date shall be set for the exclusivity to avoid the impact of the price determination and drug listing procedures.
Invalidation Procedure
As we know, the patent linkage system is basically a game between the brand name drug manufacturer and the first generic drug manufacturer. Invalidation procedure shall be another useful tool for the generic drug manufacturers, especially for the second and the following ones. An increase in Inter Parte Review (IPR) for ANDA issues is noted according to a presentation offered by Haynes and Boone, LLP. There are several advantages of invalidation procedure such as IPR, including lower cost and time-saving. The time needed for obtaining a decision in an IPR is about 18 months while that takes about 30 months for a trial.
Things are a lot different in Taiwan. Although, the invalidation procedure is also much cheaper than litigation, it usually takes about 2~3 years to obtain a decision. In comparison, it only takes 1-1.5 years for litigation. Such long examination time makes invalidation procedure nearly useless in ANDA dispute for the second or the following generic drug manufacturers. The long examination time of invalidation procedure has significantly pulled down the willingness of filing invalidation in Taiwan. According to a record from TIPO, in 2013, there was only 660 invalidation filings decreasing from 1500 filings in 2005. In other words, the invalidation procedure has shown less and less value for challenge a Patent concerned.
According to the experience in the United Stated, we note that an efficient invalidation procedure would be critical to support the patent linkage system. With that, the generic drug manufacturers can challenge the patent in different strategies and thereby balancing the patent right and avoid it from harming the public interest. Accordingly, we suggest the examination efficiency of the invalidation procedure shall be carefully reviewed for a significant improvement.
Suggestions
The patent linkage is set for obtaining good balance between the brand name drug manufacturers and the generic drug manufacturers. The balance can only be achieved by an elaborate arrangement of the burden and incentive of the two parties. The incentive for a brand name drug manufacturer to list patents is quire easy to make as the listing patents can be used to stay the generic drug’s registration. The incentive for a generic drug manufacturer would be vulnerable in Taiwan as the exclusivity would be diluted in many ways. We suggest it is important to set a proper start date of the exclusivity by properly considering the health care system in Taiwan. Besides, it is also important that the Government shall try to simplify the procedure of drug price determination and drug listing procedure. Furthermore, according to the experience in the United State, we believe a more efficient invalidation procedure can cooperate with the patent linkage system to better balance the dilemma between enhancing patent right protection and lowering drug price. 
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