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Senate committee backs 12-year IP protection status

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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.

- check out the report from Dow Jones
- read the story from Reuters

Related Articles:
Tempers rise as biosimilar debate reaches a boil
Obama offers "generous compromise" on biosimilars
FDA talks biogenerics at DIA 2009
FTC: 12-14 years too much protection for biologics
Biosimilar bill offers 12 years of market exclusivity


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More stories about patent   biosimilar   Biogenerics   healthcare reform  

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BIO supports 14 years of data exclusivity – which differs from market exclusivity and IP protection. Data exclusivity is the time during which other companies may not rely on an innovator company’s safety and efficacy data. Any company, so long as it does not violate any patents, can conduct clinical trials and seek FDA approval – so there is not currently market exclusivity for biologics. None of the pending bills would provide market exclusivity. There is currently competition among innovator biologics for various indications.

Since a biosimilar will be similar to, but not the same as, the innovator biologic, it could be possible for the biosimilar manufacturer to engineer around the innovator biologic’s patents (to avoid patent infringement) yet still try to rely on the innovator’s data – hence the need for data exclusivity.

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