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« BIO CEO Provides Update on Follow-on Biologics Legislation | Main | NCHC Sends Letter on Biosimilars to Senate Health Committee »

July 09, 2009

Comments

The Kennedy proposal does not provide 13.5 years exclsuvity. It provides 9 years with possible extensions. Moreover, a product would only receive 9 years if it is approved after enactment--existing products receive no data protection. Additionally, only new "major subtsanceS" are allowed exclusivty; if a similar product has been approved previously, you also receive zero years of protection. No exclusivity if the application for the new product relies on any clinical study from any other approved application. No exclusivty for products that may deliver major therapeutic changes but only have "minor" post-transaltion or structrual changes...the list goes on.

There are also 20 pages laying out a new patent notification and show-tell system; no precedent for this.

Dear Influence:

Absolutely correct, Influence, but that is the meaning of the modifier "up to." In view of the rather tentative existence of Senator Kennedy's proposal (described by Senate staffers as a "placeholder"), we thought it best to wait until we could get a copy of the proposal from thomas.gov before we went into the nitty-gritty. Also, in view of the other issues on the Senate's plate (healthcare reform, a possible additional stimulus package, the Sotomayor confirmation), it seemed like the better tack was to give our readers the punchline - "up to 13.5 years" - which could then be compared with 12, or 9, or 7, or 5.5, or 3.5 or zero, depending on the bills/proposals/recommendations of others).

We will certainly do a more thorough review if any of these bills starts to get sufficient traction to have a meaningful chance of passing.

Thanks for the comment.

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