Innovative drugmakers are celebrating this morning after a US Senate committee vote backed a 12-year patent protection plan for biologics, a move which has disappointed generics firms.
The 16-7 vote in the Senate Senate Health, Education, Labor and Pensions Committee in support of a 12-year market exclusivity proposal put forward by Sens Mike Enzi, Orrin Hatch and Kay Hagan is being seen as a victory brand-name biotechnology manufacturers. Generic companies, and several influential US politicians, not least President Obama and the House Energy and Commerce Committee Chairman Henry Waxman, believe five to seven years is more appropriate.
However the HELP committee voted 5-17 against an alternate proposed by Sen Sherrod Brown that would have started with a seven-year exclusivity period, with possible extensions. The issue still needs to be voted on by the full Senate and the House, but the branded industry has reason to be cheerful.
Jim Greenwood, president of the Biotechnology Industry Organization, said that 12 years of data exclusivity “establishes a fair and reasonable period to ensure continued biomedical innovation and provide the benefits of competition”. He added that the vote “marks a significant defeat for those who would shortchange future breakthroughs”. Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, was also pleased, saying that “the overwhelming majority of senators on the committee voted to do what is best in the end for patients and the US economy,”
That view is not echoed by the Generic Pharmaceutical Association. Its president Kathleen Jaeger was quoted as saying that “this unprecedented action strikes a huge blow to consumers at a time when many Americans are struggling to pay for the medicines they need”.
Jim Dau, a spokesman for the senior citizens lobbyist AARP, which favours seven years exclusivity for biologics, said the group can “applaud many of the aspects of the HELP Committee’s overall bill”. However, it has “great difficulty supporting legislation that would delay the availability of safe, affordable generic biologic drugs and impede consumer access to these lifesaving drugs”.
