September 27, 2011
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Guest post by Andrew Franklin, a colleague in the Pharmaceuticals and Life Sciences practice at Norton Rose.
With the passage of the America Invents Act of 2011, the United States’ patent system will change from a “first-to-invent” system to a “first-to-file” system for granting patents. Under the new system, patents will be granted to the first person to submit an application to the U.S. Patent and Trademark Office (“USPTO”) as opposed to the first person who first invented the subject matter of the invention. This is the most significant change to US patent law since 1952.
While this legal reform aligns the US patent law with the rest of the world, it has been met with mixed reaction. Read more of this post
December 31, 2009
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When we started the blog almost a year ago, we identified what we thought would be key trends for biotech investors and companies to watch. Most panned out, but a few turned out to be… not so trendy. You can call them premature (if you’re feeling generous) or call them dumb (if you’re feeling mean); but you can definitely call them losers, since they clearly failed their appointed purpose (making us look smart informing you, the reader).
Without further ado, 2009’s three biotech trends that weren’t:
- Genetically engineered animals. Way back in February, the FDA released final guidance on GE animal approvals and approved ATryn (a drug produced in the milk of GE goats). We thought 2009 would be a year of approvals and other successes in this area, but we’ve hardly herd (sic, sorry) from anyone since. We’ll keep an eye out for ewe, but this is one trend that probably won’t be baaaaack.
- Commercialization by Foundations. Despite a late-breaking story on this front about creative approaches in ALS and Diabetes communities, this “trend” has been another loser. When we kicked things off, we identified two driving forces behind this trend, and each has taught us a lesson: (1) never use the words “availability heuristic” in a blog post about biotech; and (2) a sinking tide sinks all boats. The crappy economic environment in 2009 was really no better for foundations than for anyone else, but we look forward to more creativity and private enterprise in this area next year.
- Patent Reform. It huffed, and it puffed, but with S.610 still in committee, patent reform carries over to another year. Maybe now that health care reform is almost done using up all the reform oxygen, the patent system will get another turn. Don’t hold your breath, though.
July 13, 2009
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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:
- 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
- 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.
May 19, 2009
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I was at breakfast yesterday morning with university and company members of the BIO Technology Transfer Committee. Some interesting tidbits, colo(u)red by my preception and commentary and not to be attributed to any other attendees:
- A lot of the stated support for the Senate patent reform bill is soft and is based on the assumption/condition that the House version won’t over-reach. Conversely, an equally moderate House version could consolidate support and draw new commitments.
- On follow-on biologics, the main bills have two differences: data exclusivity period, and a mechanism to challenge entrants before approval/sales begin. The structural problem that concerns people on the IP side is the risk of a product that is similar enough for FOB regulatory approval, but sufficiently dissimilar to avoid patent infringement.
- Access to medicines, both domestically (ALS New York Times article, ACLU-Myriad lawsuit) and internationally, is increasingly a point of pressure on academia and industry, and has been incorporated in AUTM’s Nine Points to Consider in Licensing University Technology document. Relatedly, there is apparently talk at the HHS Secretary’s Advisory Committee on Genetics, Health and Society about using Bayh-Dole to increase access to genetic testing.
- The SBIR/STTR program is up for renewal in the U.S., and many constituencies would like to see the programs opened up to allow venture-backed companies to receive SBIR/STTR support.
P.S. First time here at the Cross-Border Biotech Blog? Welcome! Check out who we are, check out our Trends in 2009 series, or hit the search and navigation tools on your right and see if you see anything interesting.
March 28, 2009
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HHS-Secretary elect Kathleen Sebelius will have confirmations before the Senate Health, Education, Labor and Pensions Committee on Tuesday, March 31, followed by the Senate Finance Committee on April 2. Both hearings should cover topics such as universal health care and comparative effectiveness. The first hearing would also address issues like public health preparedness and health innovation, while the latter will be more focused on Medicare/Medicaid and the uninsured.
The Senate Judiciary has a scheduled mark-up of the Patent Reform Act of 2009 on Tuesday, March 31 at 10am. Last week, Senator Feinstein expressed doubts about reaching a compromise on damages provisions in the bill, given the high tech industry’s unwillingness to negotiate. Stay tuned…an updated compromise amendment could be unveiled on Tuesday.
March 10, 2009
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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…
March 4, 2009
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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.