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GPhA Submits Written Statement to House Judiciary Subcommittee on Intellectual Property, Competition, and the Internet Concerning “The America Invents Act”

WASHINGTON, DC (MARCH 31, 2011) – The Generic Pharmaceutical Association (GPhA) on March 30th submitted a written statement to House Judiciary Subcommittee on Intellectual Property, Competition, and the Internet Chairman Bob Goodlatte (R-Va.) and Ranking Member Mel Watt (D-N.C.) concerning pending patent reform legislation in H.R. 1249, the “America Invents Act.” A copy of the full statement is available at http://gphaonline.org/sites/default/files/Statement%20Mar30%2011.pdf.

Here is a summary of the GPhA statement:

“GPhA has strong concerns about Section 11 of the pending bill relating to the supplemental examination of patents. The proposed language would significantly weaken the inequitable conduct defense, compromise the integrity of the current patent process, add unnecessary workload to the U.S. Patent and Trademark Office (PTO), and impact the ability of generic manufacturers to bring lower-cost generic drugs to the market. While we strongly support measures to protect the integrity of the patent process, we also believe that Americans should have timely access to lower cost generic versions of brand medicines.

“Unfortunately, proposed language in H.R. 1249 includes a provision on ‘supplemental examinations’ that would allow a patent holder to ask the PTO to reconsider or correct information that was not in existence when the original patent was granted. In other words, the bill as drafted would allow a patent holder to ‘cleanse’ its patent, even if the patentee engaged in deceptive or inequitable conduct to obtain the patent. It is clear to GPhA that this language could be interpreted as allowing patent applicants to use the cleansing procedure even if they previously withheld or misrepresented information with the intent to deceive the PTO during the patent application process.

“It is imperative that Congress enact good public policy that encourages patent applicants to be truthful and honest when prosecuting the original patent and that the proposed cleansing language would weaken the integrity of the patent process. For these reasons, we urge the Committee to modify the provision before the full bill moves forward. If Congress passes legislation weakening the inequitable conduct doctrine, consumers and the federal government will pay a significant price rather than enjoy the benefits afforded under the current system. The Congressional Budget Office estimated in its March 1, 2011, score of the S. 23, the Senate’s patent reform bill, that this provision would cost $325 million over 5 years.

“GPhA strongly supports current law and urges the Committee to keep the current inequitable conduct provisions as they exist or improve the language currently in the bill. This will help preserve that duty of honesty and good faith that is essential to the proper functioning of the patent system. This will also help assure that affordable generics can come to the market.”

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