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GPhA Statement Regarding Introduction of Patent Reform Act of 2009

Commitment to Work with Congress to Ensure Timely Access to Generic Medicines

Arlington, VA, March 4, 2009 – The Generic Pharmaceutical Association (GPhA) released the following statement today from GPhA President and CEO Kathleen Jaeger regarding the introduction of the Patent Reform Act of 2009 (S.515) by Senator Patrick Leahy (D-VT), Senator Orrin Hatch (R-UT), and the companion legislation introduced by Representative John Conyers, Jr. (D-MI) and Representative Lamar Smith (R-Texas).

“As Congress considers the Patent Reform Act of 2009, we encourage members to protect the integrity of the patent process while also ensuring that Americans have access to affordable generic medicines. Consumers should benefit from patent reform, not pay the price. We echo Senator Leahy’s position that patent reform is ‘about jobs, it is about innovation and it is about consumers’ and we are committed to ensuring that reforms do not have the unintended consequences of erecting any barriers to the introduction of generic medicines that help consumers save money, particularly in these difficult economic times.

“We must work together to guarantee that the fundamental principle of providing truthful and complete patent applications is maintained, and that today’s penalty for such inequitable conduct is not diluted. 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.

“Under current law, brand and biotech companies are subject to a strong penalty for cheating, misleading, or deceiving 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.

“With Congress looking for ways to reduce health care costs and generic medicines costing up to 80 percent less than brand drugs, we should be doing everything possible to increase, not decrease, access to affordable generics. That’s why organizations such as AARP, the Consumer Federation of America, Consumers Union and the U.S. Public Interest Research Group voiced their opposition last year to attempts to weaken the inequitable conduct defense

“We urge policymakers to continue the momentum and stand up for quality patent applications and the current inequitable conduct provision. To do otherwise, would cause incredible harm to the nation’s healthcare system.”

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 67% of the total prescriptions dispensed in the United States, but only 20% of all dollars spent on prescription drugs. For more information about the industry, visit www.gphaonline.org.

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