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BIO Submits Amicus Brief to Federal Circuit Court of Appeals in Bristol-Myers Squibb Company, Plaintiff-Appellant , v. Teva Pharmaceuticals USA, Inc., Defendant-Appellee.

The panel’s decision could significantly impair drug and biotechnology development efforts. Patents exist to ensure that innovators can recover the investments needed to develop new technology. Pharmaceuticals and biologics often present the quintessential case for patent protection. The up-front costs of bringing a new drug to market are enormous (estimates for a drug like Baraclude®, which uses a previously unknown compound, range from $800 million to $1.2 billion), while the costs of copying such an invention once it is made are low. See, e.g., Congressional Budget Office, Research and Development in the Pharmaceutical Industry 2 (Oct. 2006). “By preventing rival firms from free riding on the innovating firms’ discoveries, patents can enable pharmaceutical firms to cover their fixed costs and regain the capital they invest in R&D efforts.” FTC Report, To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy, Ch. 3, p. 4 (2003). Without patent exclusivity, many pharmaceuticals and biologics might never make it to market—few would risk such a large up-front investment for so uncertain a return. “Indeed, drug researchers who work in government and academia report that when they are looking for partners in private industry to fund the development of the drugs they discover, it is almost impossible to attract interest unless the drugs are patented.” Benjamin N. Roin, Unpatentable Drugs and the Standards of Patentability, 87 TEX. L. REV. 503, 512-13 (2009).