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PATENT EXTENSIONS


Book). Te FDA will not approve an Abbreviated New Drug Application (ANDA) for a generic product that may infringe a patent listed in the Orange Book. For innovator drugs with Orange Book patent protection, patent linkage is an effective mechanism to protect market exclusivity pending the resolution of patent disputes.


In contrast, under EU law, patent linkage is considered a clear abuse of the EU regulatory system, and marketing authorisations may not be linked to the patent status of an innovator company’s reference product.


The situation in China


Patent term extensions are not available in China. In


addition, although China’s Implementing


Regulations of the Law of Drug Administration provide for six years of “data protection” for an innovator company’s clinical and testing data, in practice China’s Food and Drug Administration (SFDA) only requires a generic manufacturer to submit limited data for marketing approval, rendering the regulations ineffective from a data exclusivity standpoint.


Further, China does not have a US-type patent linkage system. Te SFDA requires that a generic applicant declare that its marketing of the generic drug will not infringe any third party patents, and a generic drug application can only be submitted within two years of the expiration of patents covering the innovator drug. Also, the SFDA is not supposed to approve a generic application before the patents covering the innovator drug expire. In practice, however, unless the patent covering the innovator drug is a compound patent, once the SFDA has the generic applicant’s declaration of patent non- infringement, the SFDA will move


forward


with the generic application’s review despite the potential for patent disputes.


China implements a “monitoring period” for new drugs manufactured in China during which the SFDA will not accept or approve new applications for the same drug. Although intended mainly as a mechanism to monitor the safety of the new drug in the interests of public health, this monitoring period can, in effect, provide a level of market exclusivity for a new drug. Te monitoring period can be for three to five years, depending on the nature of the drug in question.


Innovator drug companies face serious challenges in extending market exclusivity in China due to ineffective data exclusivity and patent linkage, as well as lack of patent term extension. Although the monitoring period may be useful in obtaining partial market exclusivity, the requirement that the drug be manufactured in China may


be impractical for many foreign-originated


innovator drugs. As such, a strong patent portfolio and an effective monitoring and enforcement programme remain vitally important to achieving market exclusivity in China.


The situation in Taiwan


Under Taiwan’s current Patent Act, if regulatory approval is obtained more than two years aſter the patent grant, the patentee may apply for a patent


term extension for up to five years.


Te two-year threshold is eliminated under the amended Patent Act (which is reported to become effective later in 2012). Under the new Patent Act, a patentee may apply for patent term extension if regulatory approval is obtained any time aſter the patent grant.


Taiwan also provides for a data exclusivity period effective for five years from the date a drug licence for a new drug with new ingredients is granted. A generic company may apply for a drug licence three years aſter the date the innovator company drug licence is granted, and the generic drug licence can be granted upon expiration of the five-year data exclusivity period.


Taiwan has no patent linkage mechanism. Te brand holder must file a patent infringement lawsuit against the generic manufacturer for civil remedies, including an injunction and damages. Taiwan’s Department


of Health announces


disclosed patent information provided by a drug applicant but will still issue a drug licence to generic companies even if a patent infringement dispute is ongoing.


With the availability of patent term extension and data exclusivity, Taiwan’s regulatory regime for market exclusivity is rather strong. Strong patents plus any available patent term extensions are a highly effective means to obtain and maintain exclusivity.


The situation in Japan


In Japan, a patent can be extended for up to five years if the patent cannot be exploited due to governmental examination for drug approval. Te scope of patents eligible for extension is broader than in the US and EU, as all related compound, use, and process patents are extendable.


Although Japan does not have a data exclusivity mechanism, a similar effect is achieved through its “re-examination period”. Japanese authorities may request continuous investigation of the newly approved drug for a certain period aſter regulatory approval. A generic drug applicant cannot refer to the innovator company’s data until aſter the re-examination period of the original drug.


36 World Intellectual Property Review July/August 2012


Haitao Sun’s practice focuses on patent and regulatory matters in Greater China, including litigation, due diligence, licensing, and strategy. He has also had substantial general corporate law experience. With a PhD in molecular biology, and having worked as director of patents for a European multinational pharmaceutical company, he has extensive knowledge and experience in the life sciences industry.


Dr Isabella Liu advises on the creation, exploitation and protection of IP rights, with particular focus on the pharmaceutical and healthcare sectors. She is experienced in IP portfolio management, including trademark and patent


prosecution,


copyright and Internet-related matters, technology transfer, licensing and IP enforcement and litigation. She frequently advises on regulatory matters relating to market entry and post-market activities.


Mackenzie DeWerff’s primary areas of practice are patent prosecution and portfolio advising, IP litigation and enforcement, technology agreements, and China-related IP matters. She prepares and prosecutes patents in the US and various foreign countries, and has experience working with a variety of technologies.


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