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GPhA Statement on Patent Reform Act of 2010

Arlington, VA., March 4, 2010 - The Generic Pharmaceutical Association (GPhA) today released the following statement by GPhA President and CEO Kathleen Jaeger on the introduction of the Patent Reform Act of 2010:

“We appreciate the efforts of Sens. Leahy, Sessions, Hatch, Schumer, Kyl and Kaufman to reform the nation’s patent system and pass meaningful patent reform legislation for the first time in over 50 years. Since the patent system grants an inventor a 20-year government monopoly, it is extremely important that every provision contained in the proposal is carefully crafted so that it does not upset the delicate balance of rewarding innovations while providing benefits to consumers.”

“An essential part of the discussions must be protection of the integrity of the patent process to ensure Americans continue to have access to affordable generic medicines. Unfortunately, the inequitable conduct provisions in the proposal introduced today will result in consumers being penalized by delaying the market entry of generic medicines.”

“The inequitable conduct provision will actually create incentives for some brand drug companies to act dishonestly before the U.S. Patent and Trademark Office (PTO). Currently, patent applicants are subject to a strong penalty for cheating, misleading, or deceiving the PTO in an effort to secure and maintain dubious patents. Under the doctrine of inequitable conduct, a court can render a patent unenforceable if the patent applicant made material misrepresentations or withheld information during the patent application process with intent to deceive the PTO.”

“Weakening the inequitable conduct penalty will simply result in providing brand companies with a greater incentive to be dishonest and cheat, making it harder for companies to bring affordable generic medicines to consumers sooner. That’s why organizations such as AARP, the Consumer Federation of America, Consumers Union and the U.S. Public Interest Research Group have voiced their opposition to attempts to weaken the inequitable conduct defense.”

“The U.S. patent system can be reformed without jeopardizing current protections that have enabled Americans to enjoy considerable savings from generic drugs - -a remarkable $734 billion in the last decade alone. Guaranteeing that the patent process ensures that Americans have continued access to affordable generic medicines should remain a priority for Congress.”

“We hope that Congress will not accept provisions that would impede the timely entry of new generic medicines into the market. Any attempt to limit the applicability of the inequitable conduct provisions in current law could have the unintended consequence of erecting barriers to the introduction of generic medicines that help consumers save money, particularly important in these difficult economic times.”

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals and suppliers of other goods and services to the generic drug industry. Generics represent 74 percent of the total prescriptions dispensed in the United States but only 22 percent of all dollars spent on prescription drugs. For more information about the industry, visit www.gpahonline.org.

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