WASHINGTON, D.C. (June 17, 2013) – Pharmaceutical Research and Manufacturers of America (PhRMA) Executive Vice President and General Counsel Mit Spears issued the following statement on the decision issued today by the U.S. Supreme Court in the case of Federal Trade Commission v. Actavis, Inc.:
“We are pleased that the Court unanimously rejected the FTC’s position that patent settlement agreements between innovator and generic pharmaceutical companies should be viewed as presumptively unlawful under the antitrust laws. In that respect, the Court recognized that patent settlements are a vital aspect of a patent owner’s ability to protect intellectual property and are common in numerous industries.
"At the same time, we are disappointed that the majority failed to provide clear and unambiguous guidance as to how patent settlements could be structured to avoid antitrust exposure short of litigating a patent dispute to the end. Fully litigating patent disputes can result in substantial costs for both innovator and generic companies, create business uncertainty, and can result in delayed availability of generic drugs. Patent settlements allow generics to come on the market before innovator pharmaceutical company patents expire, thereby increasing patient access to lower cost generic drugs.
“Unfortunately, the Court’s decision creates a degree of uncertainty that will make it less likely that innovator pharmaceutical and generic companies will be able to settle these disputes in the future. This will negatively affect patients and discourage investment in future biomedical research.
“Intellectual property, and the ability to manage patent litigation, is critical to research-intensive biopharmaceutical companies, which rely on their patents as a major incentive for the research and development necessary to produce the next generation of innovative medicines. Since 2000, PhRMA member companies have invested approximately $550 billion in the search for new treatments and cures, including an estimated $48.5 billion in 2012 alone.”
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research and biotechnology companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested approximately $550 billion in the search for new treatments and cures, including an estimated $48.5 billion in 2012 alone.
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For information on how innovative medicines save lives, visit: http://www.innovation.org
For information on the Partnership for Prescription Assistance, visit: http://www.pparx.org
For information on ensuring the flow of medicines during public health emergencies, visit http://www.rxresponse.org