Published Online: Sunday, October 1, 2006

In the wake of concerns raised by generic drug industry leaders, Sen Patrick Leahy (D, Vt) has indicated that he is ready to at least discuss amendments to key provisions of his pending patent reform legislation. In a statement to the Senate, Leahy said there would be continued "discussion on this issue as the year progresses"—a concession that the Generic Pharmaceutical Association (GPhA) called "encouraging."

GPhA has been urging both Leahy and the bill's cosponsor, Sen Orrin Hatch (R, Utah), to make substantial changes in the bill, because the current version "could allow patentees to commit inequitable conduct before the Patent and Trademark Office without penalty." Specifically, the association is concerned that the legislation may reduce or eliminate existing penalties for branded drug companies that use fraudulent statements and misconduct to secure patents for their pharmaceuticals.

Although Leahy did not agree to any specific changes in the bill, he did acknowledge that lawmakers need to be concerned about the possibility of improper activities by patent holders. Congress "should expect the highest caliber of behavior by those who are seeking patents," he said.

GPhA officials said they welcomed continued dialogue to pass meaningful patent reform legislation but gave no indication that they are willing to compromise on the penalty issue.

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