Pharmaceutical Patent Protection and Generics in Germany Michael

Pharmaceutical Patent Protection and Generics in Germany Michael Werner, German Attorney-at-Law Generic Medicines in the Taiwanese and German Legal Systems, 03/06/2011 www. eigerlaw. com

Outline • Introduction • Patentability • TRIPS Agreement • Extent of Patent Protection and Exemptions • Supplementary Protection Certificate • Generics and Patents in Germany

Introduction • Definition generic: A generic drug is either one without a patent (generic from a patent point of view) and/or one without patent protection. • Definition patent: A patent is a legal title granting its holder the right to prevent third parties from commercially exploiting an invention without authorization • . • Patent Bargain: Patent protection in exchange for disclosure of the invention

What is patentable? • Inventions that • are new, • involve an inventive step and • are susceptible of industrial application

What is not patentable ? • inventions whose exploitation would be against “ordre public“ or morality • plants and animal varieties or essential biological processes for producing such • methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body

TRIPS Agreement • integral part of agreement establishing the WTO: "Trade-Related Aspects of Intellectual Property Rights"; • regulates a wide range of subjects from copyrights to trade secrets, amongst them patents for pharma products; • allows governments to grant exemptions to patent rights in order to meet certain social goals; • Doha Declaration: clarifies the scope of TRIPS Agreement, e. g. requests interpretation in light of the goal "to promote access to medicines for all“.

Extent of Patent Protection • Patent grants patent owner the right to prevent unauthorized persons from using the patented process and o making, o using, o offering for sale or o importing the patented product or a product obtained directly by the patented process; • Extent of protection limited by a number of exemptions which are essential to hold up the balance of the patent bargain;

Exemptions to Patent Protection in Categories • Bolar provisions for research purposes • Compulsory licenses and government use • Measures to avoid anti-competitive practices • Practices in regard to exhaustion of intellectual property rights

Supplementary Protection Certificates • Extension of maximum term of protection of 20 years for medicinal products and plant protection products by up to five years; • Introduced to compensate for long authorization process for these products; • Application must be filed within six months from authorisation to place the product on the market; • SPC takes effect at the end of the maximum term of protection of the basic patent;

Generics • may still have a patent on formulation, but not on active ingredient; • must contain the same active ingredients as the original formulation; • market entry only (independent of patent) only ten years after approval of original drug: Directive 2001/83/EC • are cost-effective in production as no costs for research and development and clinical trials to prove safety and efficacy; • play important role in keeping the health system working

Patent Protection from Generic Competition in Practice • Litigation • Reformulation • authorized generics/ licensing of subsidiaries

Generics, Patented Drugs and Antitrust Rules • attempts to resolve disputes between originators and generic companies through settlement deals; • said settlement deals frequently cause consumer harm by delaying market entry of cheaper generic medicines; • in consequence now closely monitored by the European Commission;

Thank you for your attention! michael. werner@eigerlaw. com www. eigerlaw. com