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Patent legislation criticized by GPhA.

WASHINGTON -- Proposed language in the America Invents Act would compromise the integrity of the current patent process and would add unnecessary workload to the Patent and Trademark Offices (Fro), charges the Generic Pharmaceutical Association (GPhA). Last month the association provided a written statement to a House subcommittee that held a hearing on the act, H.R. 1249.

"GPhA has strong concerns about Section 11 of the pending bill relating to the supplemental examination of patents. 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," says the statement. "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."

The association urged the panel 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," it says. "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."

Although the association has reservations regarding that proposal, it expresses a positive view on the potential for generic drugs based on a study by Alex Brill of the American Enterprise Institute regarding overspending on multisource drugs in Medicaid. The analysis examined a large subset of 2009 Medicaid drug data from the Medicaid Drug Rebate Program and identified $329 million of unnecessary spending--an amount that could reach up to $430 million next year as a direct result of states not utilizing more genetic drugs.

"As our country works to implement the Affordable Care Act, one of GPhA's main goals this year is to provide educational materials to the public and policy makers showing that safe, effective and affordable generics are an integral part of the solution in reducing costs. Brill's latest study illustrates that some state Medicaid programs unnecessarily spend large amounts of money by reimbursing pharmacies for costly brand products when generics with identical active ingredients, strengths, dosage forms and therapeutic benefits are available at lower cost."

In a separate analysis earlier this year, it was found that states and the federal government could save $682 million each year with a one percentage point increase in Medicaid generic drug dispensing rate. The analysis was based on brand and generic prescription drug usage and cost data from the Centers for Medicare and Medicaid Services. "With states struggling to reign in budgets, it is clear generic utilization must be addressed in order to help save money and reduce health care expenditures," says GPhA.
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Title Annotation:Generic Drugs
Publication:Chain Drug Review
Date:Apr 25, 2011
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