PATENT LINKAGE IN TAIWAN
“A GENERIC PHARMA COMPANY’S LICENCE CAN BE ISSUED EVEN IF A DISPUTE IS CONTINUING, WHICH MAY SOMETIMES TAKE A YEAR TO REACH TRIAL, NOT INCLUDING THE TIME FOR APPEALS.”
A Taiwanese version In the 2014 Taiwan white paper issued by the American Chamber of Commerce in Taipei on the issue of patent linkage, it was recommended that Taiwan should: 1) strengthen its Orange book (Taiwan proposed ‘Pink/Blue’) system; 2) implement a generic drug applicant certification process; 3) require notification by the generic drug applicant to the patent owner and health ministry when applying for a generic drug; and 4) initiate an automatic stay of the drug’s approval. Of the four recommendations, based on the
information provided during the ministry’s December seminar, the Taiwan government is likely to accept recommendations 1) to 3) and not 4). As an alternative to 4), and similar to the Korean example, in the case of any dispute it is proposed that only marketing and sales will be suspended (a seven-month period in Taiwan) and that if the generic pharma company proves that
When push came to shove In April 2014, the Taiwan government established a task force to conduct studies on the establishment of a patent linkage system. In early December 2014, the Taiwan Intellectual Property Office held a seminar on the US patent linkage system and, later that month, the Ministry of Health and Welfare held another seminar in which it announced the results of a collective study on international patent linkage systems and proposals for Taiwan. It is clear that a directive has been initiated for
the implementation of a patent linkage system and it was not until last year that government action was clearly seen. With US recommendations available on how Taiwan should go about implementing its patent linkage system, according to recent government-backed seminars the proposed Taiwan patent linkage system will likely be a mishmash of US, Korean and other countries’ systems, in the hope of satisfying any concerns about IP protection for foreign pharma companies in Taiwan.
www.worldipreview.com
Susan Wu is a senior engineer at Top Team International Patent & Trademark Office. She has practised in the IP field for a decade and served as counsel in a number of
invalidation cases. She specialises in
the medical genetics, bioscience, and biotechnology fields. She can be contacted at:
susan@top-team.com.tw
Daphne Fang is a senior engineer at Top Team International Patent & Trademark Office. She has practised in the IP field since 2006, working with inventors to prepare patent applications. She specialises in the biological science and technology, microbiology, and immunology fields. She can be contacted at:
daphne@top-team.com.tw
the patent right has not been affected or is invalid, a 12-month exclusivity period will be granted. Additionally, concerning Taiwan’s ‘Pink/Blue’
book system, it has been proposed that innovator pharma companies will have 30 days from the date that the drug licence is acquired, or the patent issue date, to register their patent with the Taiwan FDA. Meanwhile, innovator pharma companies will have up to 45 days to bring a lawsuit, should they believe that their patent has been infringed.
Proceeding with caution With public scrutiny over recent economic trade agreements with China (Cross-Strait Service Trade Agreement), as seen by the ‘Sunflower Student Movement’ of March 2014, in general the Taiwan government has moved cautiously when promoting international trade pacts to its people. However, the policy has been clear from
Taiwan’s leaders: ie, that trade pacts are needed to maintain Taiwan’s export competitiveness. Accordingly, despite local resistance to the implementation of a patent
linkage
system,
concrete steps have been taken. Political and social issues aside, as patent
practitioners we are concerned most about protecting the IP rights of our clients. However the Taiwan patent
system changes, we will
provide a clear explanation on the changes and effects on all parties involved. While a date has not been set for when implementation may occur, one thing is certain: given the current environment, implementation steps will likely continue to speed up in 2015 rather than fade away
conformity of Taiwan’s continue into the future.
and the trend towards international patent
system will
World Intellectual Property Review Annual 2015
51
ROB BYRON /
SHUTTERSTOCK.COM
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