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LAW CHANGES


With IP laws around the world subject to frequent and sometimes unpredictable changes, it can be difficult to keep abreast of everything you need to know. Richard Gough


Is your life sciences invention—whether pharmaceutical, biologic, medical device or diagnostic—patentable? Can the term of your patent be extended? If so, what conditions apply and how long can you extend it for? Can proprietary data be used by third parties for product registration, marketing approval and market access? Can your data be used for an upcoming and competing biosimilar?


Intellectual property rights axiomatically confer monopolies, and the IP laws that provide answers to such questions frequently also delineate the cutting edge of pharmaceutical regulation around the globe. Not only do the answers differ in different countries, they are in constant flux as governments adjust their IP laws, changing the rules of the game. Tis can be for better or for worse, depending on whether you are an innovator and first to market, or a generic following the trail of the pioneers.


Tis article looks at some recent changes to IP rights in selected countries that have a particular impact on the life sciences industry. It is indicative rather than comprehensive, and the picture that emerges is quite mixed. Both innovators and generics can find cause for concern, but there are also incremental gains to be found on each side.


Starting with patents, some of the key issues relate to definitions of patentable subject matter in the life sciences field, the acts that can constitute infringement and whether it is possible to extend the life of a patent. All these themes emerge in amendments to the Taiwan Patent Act, which are expected to be approved shortly by the Legislative Yuan. A welcome development for innovators is the fact that the amendments will open the door


www.worldipreview.com


and Jane Woodhouse take a look. for the patenting of biological processes for the production of animals or plants, as these will become patentable subject matter. On the other hand, patent rights will not extend to stopping research or trials conducted for the purposes of obtaining pharmaceutical inspection and registration approval in Taiwan or to obtain market approval of a pharmaceutical from overseas. Te amendments will also clarify the scope of patent extensions for pharmaceuticals and related processes, limiting them to the particular active ingredients and uses that are covered by relevant prior government approvals.


As a result of Venezuela’s withdrawal from the Andean Pact in April 2006, the Venezuelan Industrial Property Registry stopped applying Decision 486 of the Andean Pact and began applying the 1955 Industrial Property Law. Decision 486 is TRIPS-compliant, whereas the law is not. Article 15 of the law expressly prohibits the patenting of medicines of all types, pharmaceutical preparations and chemical preparations, reactions and combinations. Article 14 of the law, however, expressly permits the patenting of new procedures for the preparation of chemical products and new methods for the elaboration, extraction and separation of natural substances. Article 14 offers the possibility of protecting the procedure for the preparation of a pharmaceutical product. In spite of this legal framework, pharmaceutical companies continue to file patents for both pharmaceutical products and new procedures for the preparation of


chemical (pharmaceutical) products. Te


rationale behind these filings includes the fact that the Industrial Property Registry is so far behind in issuing decisions on patents that by the time a decision on a patent application is reached, the legislation and circumstances could have changed in favour of pharmaceutical patents. Te


Life Sciences Intellectual Property Review 2011 15


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