As the global disease burden expands, the need for new, more effective treatments is greater than ever. Investing in drug research and development is, however, a costly, high-risk endeavor. Patents are intended to offer some guarantee of a return on investment, but the patent system is also designed to balance the interests of inventors with those of the public. So, after a patent expires, a patented technology may be freely exploited by anyone; although care should be taken to ensure that there are no other IP rights associated with the technology that could impede practicing an invention in this way. In the pharmaceutical industry, patents can hinder or prevent manufacturers of generic drugs from entering the market. As with the makers of brand name pharmaceutical products, generics manufacturers need to prove the efficacy and safety of their products. They can, in certain circumstances, use elements of the original manufacturer's approval if they demonstrate that their generic version is bioequivalent to the approved medicine, but may have to conduct additional trials on a protected product before its patents expire or are held invalid by a court. The generic manufacturer, therefore, runs the risk of infringing a patent held by a brand name manufacturer even if it does not plan to enter the market until after the patent expires or is found invalid. Generics manufacturers also have to set up and test manufacturing and delivery capacity before entering a market, creating additional risks of infringing a patent held by a brand name manufacturer. To overcome this problem, many countries have put into place legal exemptions (or research exemptions) from infringement for certain acts relating to the development and submission of testing data to a regulatory agency. These exemptions are often referred to as “Bolar” provisions, in reference to a US law enacted to overturn a prior court ruling holding that the US did not provide for a research exemption - Roche Products, Inc. v. Bolar Pharmaceutical Co., Inc., 733 F.2d 858 (1984).
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