In what could prove a key battle in the war over IP protection, the Senate Health, Education, Labor and Pensions Committee overwhelmingly approved an amendment that would protect biotech developers from generic competition for 12 years. The vote--a lopsided 16-7 in favor--provides the biotech industry with a big win in the struggle to gain a lengthy period of marketing protection. BIO had sought at least 12 years protection, squaring off against a powerful lobbying effort by the AARP which sought a much smaller marketing preserve for the biologics manufacturers.
Senators Orrin Hatch and Mike Enzi, both Republicans, sponsored the amendment, echoing BIO's claim that the five-year exclusivity period offered by Democrat Sherrod Brown would seriously damage biotech's R&D efforts.
"A minimum of 12 years of data exclusivity establishes a fair and reasonable period to ensure continued biomedical innovation and provide the benefits of competition," said BIO President Jim Greenwood. The vote, he added, "marks a significant defeat for those who would shortchange future breakthroughs and the hope for cures for some of the most devastating diseases by providing an abbreviated period of data exclusivity."
The fight, though, is far from over. Powerful House Democrat Henry Waxman continues to insist on a five-year period of IP protection while President Obama, newly reengaged in the debate over healthcare reform after a recent trip abroad, wants to limit the protected status to seven years.