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GPhA: “The America Invents Act” Supplemental Exam Provision Undermines Integrity of Patent Process

Asks Members to Oppose Bill Unless Measure is Corrected

Washington, DC (April 13, 2011) – The Generic Pharmaceutical Association (GPhA) today calls on the House Judiciary Committee to fix what is a fatal flaw in H.R. 1249, “The America Invents Act” – a provision that will hurt consumer access to affordable medicines and undermine the integrity of the patent system. The bill is currently pending before the Committee and will be the subject of Committee consideration tomorrow. GPhA will oppose the legislation unless the provision is corrected.

The current bill allows patent holders that knowingly falsify information in their original patent application with the U.S. Patent and Trademark Office (PTO) or intentionally omit material information in such filings, a mechanism to retroactively correct their filing without any consequences. The only way to correct this so called “supplemental examination” process is to strike it entirely from the bill or amend it to prevent those that knowingly lie to the PTO from using it. Anything other than those changes endorses deception and falls far short of guaranteeing a fair and honest process.

“This legislation offers a free ride for those looking to mislead and misrepresent the PTO,” said GPhA. “While proponents may try to argue that the mechanism provided in the bill merely allows patent holders to correct inadvertent mistakes, what we are talking about here is purposeful lying and any claims to the contrary are simply disingenuous.”

In a recent case before the U.S. Court of Appeals for the Federal Circuit, the PTO filed a brief as amicus curiae and discussed, at length, the importance of a patent applicant’s duty of honesty, and opined that the rules for disclosure by applicants are “clear and straight forward.” In its brief, the PTO warned that “lying with impunity” would “seriously interfere with the agency’s ability to efficiently carry out its mission of granting and issuing patents.”

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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