Pharmacy Times, Volume 0, 0

In the wake ofconcerns raised bygeneric drug industryleaders, Sen PatrickLeahy (D, Vt) has indicated that he is ready to atleast discuss amendments to key provisions ofhis pending patent reform legislation. In a statementto the Senate, Leahy said there would becontinued "discussion on this issue as the yearprogresses"—a concession that the GenericPharmaceutical Association (GPhA) called "encouraging."

GPhA has been urging both Leahy and the bill'scosponsor, Sen Orrin Hatch (R, Utah), to makesubstantial changes in the bill, because the currentversion "could allow patentees to commitinequitable conduct before the Patent andTrademark Office without penalty." Specifically,the association is concerned that the legislationmay reduce or eliminate existing penalties forbranded drug companies that use fraudulentstatements and misconduct to secure patentsfor their pharmaceuticals.

Although Leahy did not agree to any specificchanges in the bill, he did acknowledge thatlawmakers need to be concerned about thepossibility of improper activities by patent holders.Congress "should expect the highest caliberof behavior by those who are seekingpatents," he said.

GPhA officials said they welcomed continueddialogue to pass meaningful patent reformlegislation but gave no indication that they arewilling to compromise on the penalty issue.