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GPhA Leads Group in Effort to Block Changes to Inequitable Conduct Law in Patent Reform Bill

WASHINGTON, DC (MARCH 4, 2011) – The Generic Pharmaceutical Association (GPhA), which represents the world’s leading generic drug manufacturers and suppliers, this week was joined by Aetna Inc., Apotex Corporation, Hospira Inc., Mylan Inc., Teva Pharmaceuticals and Watson Pharmaceuticals in writing House Judiciary Committee Chairman Lamar Smith and Ranking Member John Conyers expressing objections to any changes to the inequitable conduct provisions in current patent law.

“As you begin efforts in the 112th Congress to reform our patent laws or enhance operations of the U.S. Patent and Trademark Office (PTO), we respectfully urge you to oppose any changes to the inequitable conduct defense and avoid legal barriers to timely access to affordable, high quality generic drugs,” the jointly signed letter read. The group also wrote letters to all Members of the Senate stating its strong opposition to inequitable conduct provisions in the Senate’s Patent Reform Act of 2011. The full Senate is expected to vote on that legislation next week.

The inequitable conduct defense allows patent challengers to expose intentional misrepresentations and omissions of material information to the PTO during the patent application process. In the context of pharmaceuticals, the defense enables a fair and timely resolution to patent litigation, which enables timely creation of a competitive pharmaceutical market. Competition from generic medicines, which now account for 76% of all prescriptions dispensed in the U.S. each year, has resulted in $824 billion in savings to consumers, patients and the health care system over the past decade.

“While we support needed changes that would enhance the efficiency of PTO, Congress must assure that the bill does not undermine the inequitable conduct defense, which would significantly delay access to affordable medicines and contribute to the increased anxiety and financial peril facing consumers and patients today,” GPhA said.

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 75 percent of the prescriptions dispensed in the U.S. but consume just 22 percent of the total drug spending. Additional information is available at gphaonline.org.

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