Issues

Patent Reform

GPhA Position

Generic pharmaceutical companies understand that certain reforms to the U.S. patent process are desirable. However, GPhA is committed to ensuring that any patent reform legislation considered by Congress does not contain provisions that could impede the timely market entry of new generic medicines. GPhA vigorously opposes any attempts in patent reform to:

  1. Limit applicability of current "inequitable conduct" language; and
  2. Eliminate the "best mode" requirement, under which innovators must disclose the most efficient method known for producing the patented invention.

Key Points

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Current inequitable conduct language is intended to deter innovators from cheating, misleading or deceiving the U.S. Patent and Trade Office (USPTO) for the purpose of securing new patents or preserving dubious patents. Inequitable conduct laws provide stiff penalties for misrepresenting facts and lying to the USPTO. To ensure timely market entry of new generic medicines, it is critical that generic drug companies be able to use the inequitable conduct doctrine as a defense in patent infringement suits filed by innovators under the provisions of Hatch-Waxman.

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Some brand pharmaceutical interests are seeking changes to current patent laws that effectively would limit the applicability of inequitable conduct penalties in efforts to make it more difficult for generic companies to bring products to market. Eliminating current inequitable conduct penalties could become an incentive for companies to act dishonestly before the USPTO in order to obtain patents that would be used to block generic market entry.

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As a reward for innovation, patents grant inventors temporary monopolies on their inventions. In exchange, the inventor must disclose in the patent application the "best mode" and most efficient known method of producing the invention so that the public benefits from the technical knowledge once patent protection expires. The best mode requirement is intended to guard against any unearned extension of the monopoly, which would result if the public had to spend time "reinventing" the product after legal patents had expired.

Background

The Patent Reform Act of 2007, introduced concurrently in the House and Senate, would have made the most sweeping reforms to the U.S. patent system since 1952. While the bill failed to gain congressional passage prior to adjournment of the 110th Congress, sponsors of the legislation have committed to reintroducing similar legislation in 2009. While the Patent Reform Act may have been well-intended, it contained provisions that irrefutably would have impeded the timely entry of new generic medicines into the market. If not carefully crafted, patent reform legislation could have a significantly negative impact on the generic drug industry and the public that relies upon generic manufacturers to introduce affordable medicines. As Congress deliberates patent reform, it must protect the integrity of the patent process while at the same time assure that consumer access to affordable generic medicines is not encumbered.

Related Information

Letters

March 10, 2008 - Letter from Former Patent and Trademark Office Commissioner Harry Manbeck to Sens. Leahy and Specter on Inequitable Conduct (451.93KB PDF)

Testimony & Content

March 10, 2009 - Testimony by Kathleen Jaeger, President & CEO, Generic Pharmaceutical Association (50.77KB PDF)