Biosimilar Approval Regulations and Intellectual Property Protection

Pharmaceutical industry, one of a high-cost, high-risk and high-revenue earning industry, is characterized by highly depending on governmental policy and regulation because of the closed relationship between pharmaceuticals and human health, and implications of scientific uncertainty. It is also characterized as the technology- intensive industry so that the pharmaceutical industry shall be based on the knowledge economy. Consequently, such natures of the pharmaceutical industry result in not only the high price of pharmaceuticals, but also the requirement for constructing drug regulation process and patent protection system. In the past, the Generic drug competition typically brings prices down and saves the cost of the health-care providers. In order to striking a proper balance among protecting the public interest, encouraging innovation and controlling medical cost, all governments implement proper norms for generic drugs approval regulations and patent protection policies.s the integration of biotechnology and medicine, biologics overcome many limitation of chemical drug therapy and have significantly advanced over traditional treatments. As a result, the share of biologics in the pharmaceutical market is increasing rapidly and the problems about the increasing drug prices and cost of medical insurance are also emerged. With many first-generation biologics off patent or soon to come off patent, there are increasing moves for “Biosimilar”, which has a similar market position with generic drugs. However, the natural differences of biologics and chemical drugs result in existing regulations unsuitable for biosimilars. Accordingly, in view of the medical demands of people and the drug price control policy, enactment of biosimilars approval regulations, the patent protection and non-patent protection regimes is a major task of all governments for promoting domestic biopharmaceutical industry. Since 2004, Europe has been pioneering legislation for the approval of biosimilars. For encouraging domestic pharmaceutical industry to develop biosimilar drugs, in 2008, Taiwan government has issued the examination guideline related to biosimilars application. However, this guideline is only a fundamental rule and this guideline does not provide details for biosimilars approval. It may result in the standards of examination being unforeseeable, and, in turn, increasing the cost of drug approval. It may also result in declining the motivation to develop biosimilars, and the purpose of decreasing the biologics prices may not be achieved. Additionally, from beginning, Taiwan government never implements the practice of linking the regulatory approval for a generic medicinal product, to the status of a patent for the reference drug. Hence, there is no consequential amendment in Patent Act as the said guildline issed in 2008. Nevertheless, the conflict occurring between development of biosimilars and patent protection of reference biologics is inevitable. Therefore, it is worthy of exploring whether the existing regulations has provide a sufficient mechanism to balance the interests of the biosimilar applicant and the patentees.n the light of the issues above, this thesis focuses on the influence on existing drug approval regulations, the patent protection and non-patent protection regimes from the nature of the biologics. By comparing the related regulations of Taiwan with those of United States and European Union, this thesis indicates that the said examination guideline, which refers to the newly guidances issued by the EU, may be acceptable for getting a balance between public health and development of biosimilars. Furthermore, for the purpose of introducing the biosimilars sooner into the market and decreasing the biologics prices, this thesis indicates that clearer, objective standards in the light of the requirements of clinical and non-clinical trial, such as the sample size for clinical trials, are necessary. In respect to the protection of brand biologics, biosimilar product that is merely required to be “similar” to the innovator reference might be similar enough under regulatory standards to obtain approval as a biosimilar, but different enough under intellectual property law to avoid infringing issued patents on the innovator product. As a result, patent protection is not sufficient in the field of biologics. Non-patent protection is relative important to the innovative biologics. In addition, the new bills introduced in U.S. Congress relating to biosimilars do not adapt the patent linkage system, but instead of creating a mechanism for information exchange between the innovator and the biosimilar applicant. These bills also restrict the patent lawsuits brought by patentee or biosimilar applicant, and the object of such litigation is limited. In these regards, these legislative measures are role models of biosimilar legislation with great policy implications, which deserve attention from policy-makers and academics in law in Taiwan.oreover, the thesis also explores the related judgements of U.S. courts for the purpose of assessing relevant judicial trends and providing Taiwan pharmaceutical companies effective defensive strategies for patent litigation under a future Biosimilars Act.