April 5, 2011
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The ACLU had its day in court at the Federal Circuit yesterday, with oral arguments occupying 70 minutes of the court’s time in front of an audience of “hundreds” according to coverage from The Salt Lake Tribune (Myriad’s hometown paper). This case, you will recall, is a challenge to the patentability of isolated DNA. When the District Court ruled in favour of the ACLU, I argued that the decision was not a big deal. One of the reasons — that the Federal Circuit would overturn the decision — is one step closer to being tested. In the meantime, I stand by the other four.
The arguments are online, if you want to listen to the whole thing (thanks to @genomicslawyer for the link), and FierceBiotech and The Atlantic also have coverage.
April 1, 2010
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Right in the middle of Passover, Judge Robert W. “Let my Patents Go” Sweet released his 152-page ruling (pdf), granting summary judgement to the ACLU and invalidating several of Myriad Genetics’ patents on the sequence and use of the BRCA1 and BRCA2 genes. It was greeted by some as the 11th plague, and by others as a national liberation; but the truth is it was neither.
Here are the top 5 reasons the ruling is not a big deal:
- The business model is changing. Genomics Law Report (as part of a great series on the Myriad decision) quotes the New York Times and references the Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) report (pdf) all pointing out the fact that multi-gene tests and whole genome sequencing are becoming much more common diagnostic tools than those along the lines of Myriad’s BRACAnalysis(R) test.
- The market says so. As the New York Times reports, “two major [biotech] indexes … [fell] by less than 1 percent each.” Part of the reason for this is averaging — many companies benefit if the gene patent anticommons takes a permanent hit – but even Myriad shareholders weren’t too phased. The shares dropped less than 5% on the news and are back up 1.5% today.
- Diagnostics like Myriad’s may not need patent protection to promote innovation. Although there are many areas of biotechnology in which patent protection is a crucial incentive, the New York Times quotes James P. Evans, a professor of genetics at the University of North Carolina, who says: “one does not need gene patents in order to see robust development of these tests.” BIO disagrees.
- “The Federal Circuit is likely to reverse this decision.” Dennis Crouch at Patently-O puts it succinctly. The case may one day lead to “an important Supreme Court showdown,” but that day is not today.
- The patents in suit, and many similar patents, may well expire before the case is finally adjudicated.
Keep following the case, though. It has many people thinking hard about DNA, genomics and innovation, including commentators and judges; and that’s never a bad thing.
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.
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