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GPhA on Patent Reform: Thoughtful, Deliberative Analysis Needed: Bill Could Have Unintended Consequences for Health Care System

ARLINGTON, Va., June 13, 2005 -- The Generic Pharmaceutical Association (GPhA) today cautioned Congress on moving too quickly on the Patent Reform Act of 2005, saying that a careful analysis is needed to ensure that the legislation does not unintentionally harm the health care system.

“Strengthening and improving the patent system is a laudable goal, but Congress must be cautious and thoughtful in its approach to reform,” said GPhA President and CEO Kathleen Jaeger. “What might appear on its face to be simple changes to the patent system could have the unintended consequences of weakening our patent system and delaying consumer access to affordable medicines.”

In its current form, some provisions in the bill could weaken the integrity of the U.S. patent system. For example, the bill would change the standards for inequitable conduct, making it harder to establish fraud on the government. It also would eliminate the practice of “best mode,” under which the inventor must disclose in the patent application the most efficient known method known for producing the invention. This would give the inventor a further monopoly as the public would have to spend time reinventing the best way to make the product after the patent has expired. GPhA is continuing to review other provisions in the legislation and their impact on the generic industry.

“As Congress continues to deliberate patent reform, it should carefully consider all provisions to enhance the integrity of our patent system and avoid measures that would dilute current standards unless there is an important and well-documented justification for doing so,” said Jaeger.

The House Subcommittee on Intellectual Property held a hearing on the Patent Reform Act today. The Senate is expected to hold hearings next week, with a vote on the bill to follow as early as the end of June.

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 53% of the total prescriptions dispensed in the United States, but only 12% of all dollars spent on prescription drugs.

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