Tomorrow morning, a three-judge panel of the Court of Appeals for the Federal Circuit will hear arguments in the appeal of Association for Molecular Pathology v. U.S. Patent and Trademark Office - better known as the Myriad gene patent case.* It has the patent and genetic blogospheres in a bit of a tizzy, and the mainstream media is picking up on it too. See, for example, this Atlantic article by Andrew Cohen, this Nature.com editorial by my friend Shobita Parthasarathy, and even a "Spectator's Guide to the Myriad Oral Argument" by Genomics Law Report -- which has a dedicated icon and category just for posts about the Myriad litigation!
Why is this such a big deal? Last spring, Judge Sweet of the Southern District of New York issued an opinion** which held, in part, that Myriad Genetics's patents on the breast cancer genes (BRCA1 and BRCA2) were invalid because genes are unpatentable products of nature.
Judge Sweet said,
The identification of the BRCA1 and BRCA2 gene sequences is unquestionably a valuable scientific achievement for which Myriad deserves recognition, but that is not the same as concluding that it is something for which they are entitled to a patent. . . Because the claimed isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter under 35 U.S.C. § 101.
Judge Sweet was referring to a longstanding judicial principle that "products of nature" - that is, things found in nature, like wild plants or minerals - are not patentable subject matter. However, a new plant variety or a synthetic chemical compound could be patentable, if it met all the other statutory requirements. The Supreme Court emphasized in Chakrabarty that the relevant question wasn't if a biotechnological innovation (in that case, a transgenic bacterium) was alive or not, it was whether it was "made by man" - perhaps not the most PC way of phrasing it, but indicating that compounds or organisms that are not "made by man" aren't patentable.
Sweet's opinion draws on Chakrabarty in holding that there is simply not enough difference between naturally occurring genomic DNA in a cell and a piece of genomic DNA in an Eppendorf tube to warrant patent protection. In addition, Sweet emphasized the informational aspect of DNA - an angle which makes intuitive sense to a biologist, but was a very unusual twist (no pun intended) for patent law, which treats DNA like other chemical compounds.
Sweet's opinion ran counter to longstanding PTO policy, under which "isolated" and "purified" genes have been patentable. The "isolated" and "purified" requirements are especially important because the issue of gene patents is often misunderstood by the general public, who may mistakenly believe that gene patents mean a company "owns" the DNA in our bodies. To the contrary - no one seriously suggests a patent holder has rights to the naturally occurring DNA in our bodies. However, depending on the type of patent, a patent holder may have the right to exclude scientists from isolating or copying pieces of genomic DNA (or cDNAs) and/or using them for research, therapy, or clinical diagnosis. That's the crux of the Myriad case: Myriad used its patent rights over the BRCA1 and BRCA2 genes to build a monopoly within the US*** on the most important diagnostic test (BRACAnalysis) to determine women's genetic susceptibility to breast cancer. The plaintiffs suing Myriad include women who cannot afford and/or don't have insurance to cover the high price of Myriad's test (which is around $3K).
This appeal could have a huge impact on Myriad Genetics. According to a recent post over at Genomics Law Blog,
For the moment, Myriad remains the exclusive commercial provider of targeted BRCA diagnostic testing in the United States. A major concern, however, is the company's extreme reliance on the sales of a single product (BRACAnalysis) in a single market (the United States). Thus far, Myriad has achieved comparatively modest success developing a market for its other products (which include diagnostic tests for colorectal and uterine cancer, melanoma and pancreatic cancer) within the United States and for any of its products (including BRACAnalysis) outside of the United States. Currently, BRACAnalysis testing accounts for a striking 88% of the company's nearly $400 million in annual revenues, with only 2% of those sales occurring ex-US.
In other words, Myriad has all its eggs in the BRCA basket, so if Judge Sweet's ruling were affirmed by the Federal Circuit, it could be very bad for them.
However, the appeal could have much broader ramifications. While many patient advocacy groups would like more access to genetic diagnostic tests like the BRCA tests, and many scientists would like to eliminate gene patents and their potentially chilling effect on research, some industry organizations argue that without patents, it will be too big a risk to invest in developing not only new diagnostics, but also new drugs (which may also be "products of nature"). Companies prefer to develop molecules that are patent protectable, so they know they can have a period of market dominance to earn back their R&D investment (and make substantial revenue, of course). If it is really true that inability to patent genes would chill pharma R&D, and pharma couldn't find any other way to protect its investment, the decrease in R&D could be a bad thing for patients in the long run. To people concerned about incentives for innovation, whether or not Myriad specifically deserved its BRCA patents isn't necessarily the issue - it's whether we need gene patents in general, to drive a healthy pharma/biotech industry. That's much debated.
Various estimates suggest that about 20% of the human genome is patented, with tens of thousands of different patents related to human genes. Not all of these gene-related patents are patents on the actual DNA itself (so-called "composition of matter" patents) - some of them are for methods of using the genes or ways of diagnosing illness or risk using the genes. A few diagnostic method claims are also at issue in the Myriad case, and in light of Bilski, another recent Supreme Court decision, it will be interesting to see how the Federal Circuit handles those. But everyone's attention is really going to be focused on how the judges (we don't know yet which three they'll be, but that could be very important) Lourie (a chemist), Bryson and Moore (an electrical engineer) respond to the various arguments that gene patents, at least on naturally occurring genomic DNA,**** should not be granted in the first place. That's what I'm going to be waiting all morning tomorrow to hear - even though we won't get the Federal Circuit's full opinion for some time to come.
I'll keep you posted!
*The case is confusingly named. The US Patent and Trademark Office (PTO) is no longer a party in the case on appeal, because the claims against them were dismissed. That leaves Myriad as the defendant. AMP, like the ACLU, is one of the plaintiff groups that filed suit, along with several individual patients who sought breast cancer testing.
**To read Judge Sweet's full (~160 page) opinion: 702 F.Supp.2d 181 (S.D.N.Y. 2010)
***It didn't go quite like that in the UK. If you want all the details of how the different healthcare systems in the two countries played a role in Myriad's ability to dominate the market, read my friend Shobita Parthasarathy's book, Building Genetic Medicine: Breast Cancer, Technology, and the Comparative Politics of Health Care
****The Department of Justice has filed an amicus brief (a "friend of the court" brief filed by a non-party) which, very generally, takes the position that those molecules of DNA (like plasmids) that result from human intervention (splicing, ligating, reverse transcription, etc.) should be patentable, but molecules with genomic sequences should not. The Acting Solicitor General of the United States will be appearing tomorrow to argue for this interpretation of the law.
Full disclosure: I'm not an unbiased party - I worked on the issues in this case last summer. :)
More resources:
An amicus brief by Chris Holman and Robert Cook-Deegan
More detail from Chris Holman on exactly what DNA sequences Myriad's patents claim
Kevin Noonan's Patent Docs post - with a gigantic list of prior posts and references
Dan Vorhaus and John Conley on whether gene patents are incompatible with genomic sequencing
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