The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: Patent Reform Act of 2009

Trends Update — Biosimilars: Sen. Kennedy, Gov. Dean and NVCA Study all Support 12+ Years of Exclusivity

The debate over the proper data exclusivity period for innovator biologics (as protection against biosimilars/follow-on biologics/subsequent-entry biologics) had a busy week last week.

A couple of thoughts:

  1. The exclusivity period in the EU is 8 years (data) +2 years (marketing) +1 year (for new indications), and the current proposal in Canada is 6 years, so a baseline of 12-14 years’ protection would leave the U.S. system paying for exclusive pricing longer than other major markets.  I’m fine if the U.S. decides to further subsidize pharma innovation, but I’d prefer a more transparent approach with less market distortion; and
  2. It’s hard to balance rationally between data exclusivity and patent exclusivity when the patent system is in significant flux.  Having patent reform as a moving piece (or as part of biosimilars legislation) only muddies the debate.

Update: The WSJ picks these up this morning too.  Here’s the NVCA story, and here’s the one on Kennedy’s efforts and the debate it’s generating in committee.

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Patent Reform Live (Updated): Senate Judiciary Committee Hearings

You can watch the Senate Judiciary Committee hearings live here starting at 10 am.

Here’s a letter sent yesterday (pdf) by Sens. Feingold, Wyden, Bond, Brownback, Grassley, Kyl and Coburn to Sens. Leahy and Hatch expressing the writers’ concerns.

Witness list and links to the witness statements after the jump…

The Patent Reform Act of 2009: Absent Inequitable Conduct Provisions Help Biotech

The Patent Reform Act of 2009 was introduced by Senator Patrick Leahy (D-VT) Chairman of the Senate Judiciary Committee. The bill includes Senator Orrin Hatch (R-UT) as a co-sponsor. Notably missing from the list of co-sponsors is Senator Arlen Specter (R-PA), Ranking Republican on the Judiciary Committee.

Provisions relating to inequitable conduct have been removed from the previous version introduced last year. Inequitable conduct is a critical provision for the larger pharmaceutical companies. Provisions relating to apportionment of damages are of secondary importance to large pharma, but critical to biotech. The biotech industry does not favor the current damages language. The fact that inequitable conduct provisions are missing means that large pharma will focus its opposition to the patent reform bill on damages provisions.

The text of the Senate bill is not up on Thomas yet, but you can find the full text as introduced here (pdf).  See also Dennis’ Patently-O post with summary and commentary.

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