Monday, December 3, 2012

Supreme Court Grants Certiorari in Myriad Gene Patent Case

On November 30, the Supreme Court granted certiorari in AMP v. Myriad (commonly referred to as the "Myriad" case), as reported on other blogs such as Patently-O, Patent Docs and Pharmapatentblog. There were three questions presented in the plaintiff's petition for certiorari, but the Supreme Court granted the petition with respect to only one -"Are human genes patentable?"

The other questions presented in the petition, but not taken up by the Supreme Court, addressed the Federal Circuit's decision upholding the patent eligibility of Claim 20 (a method of using genetically modified cells to screen for drug candidates) and the issue of standing. The Courts decision to let the Federal Circuit's decision regarding claim 20 stand comes as welcome news, because were the Supreme Court to declare the claim patent ineligible it could have had potentially serious negative ramifications for innovation in health sciences.

It will be interesting to see what the Supreme Court does with the case. The manner in which the plaintiff's framed the question for appeal is somewhat misleading. It has long been well established that human genes per se (as they exist naturally in the human body) are not patent eligible.  The Myriad "gene patent" claims at issue in the case do not encompass human genes as they exist in the body, but rather are limited to "isolated" DNA molecules corresponding structure to naturally occurring gene sequences. So the question is, to what extent might the Supreme Court decide the case in a manner which imposes new constraints on patent eligibility relative to the conventional understanding of the patent office and most patent practitioners, i.e., that naturally occurring biomolecules, including DNA, are patent eligible in their isolated form.

The Supreme Court could find some of Myriad's isolated DNA patent claims patent ineligible without invalidating most issued isolated DNA claims. In particular, the US Solicitor General’s amicus brief at the Federal Circuit argued that claims encompassing isolated genomic DNA sequences are patent ineligible, while claims to isolated cDNA sequences should be considered patent eligible.  I have argued that the Solicitor General's distinction between isolated genomic DNA and cDNA is not supported by the science, but were the Court to adopt it, it would likely result in patent eligibility for most gene patent claims. I have conducted empirical research looking at hundreds of gene patents, and the vast majority of isolated DNA claims appear to be directed towards cDNA, not isolated genomic DNA.

Of course, the Supreme Court could go further, and find that not only isolated genomic DNA, but also isolated cDNA claims are patent ineligible. Or it could go further still, and find that claims to isolated/purified biomolecules in general are patent ineligible. As I have discussed previously, there are many important patents directed towards isolated proteins and other naturally occurring biological molecules. The Biotechnology Industry Organization (BIO) provided numerous examples in their amicus brief filed with the Federal Circuit. Under the rationale used by the District Court in finding Myriad’s isolated DNA claims patent ineligible, it would seem that mere purification/isolation of a naturally occurring molecule would be insufficient to render it patent eligible.

In Judge Lourie’s majority opinion for the Federal Circuit, he made a point of distinguishing between isolated DNA molecules and purified naturally occurring molecules. He found it significant that, according to his understanding, isolation of DNA inherently involves cleaving covalent bonds, rendering Myriad’s claimed isolated DNA structurally distinct from its naturally occurring counterpart. This allowed him to conclude that Myriad’s isolated DNA claims are patent eligible, while leaving undecided the question of whether purification of a naturally occurring molecule (without cleavage of covalent bond or other structural change) would be sufficient to render it patent eligible. I have suspected that perhaps he made this distinction in order to narrow the scope of his ruling, and hopefully avoid the Supreme Court taking the case. After the Prometheus decision, it would not surprise me if at least some Justices on the Supreme Court would reject the notion that purification of a naturally occurring molecule renders it patent eligible.

The irony is that, in my view, the whole furor over isolated DNA claims is something of a tempest in a teapot. In 2012, I just don't believe that claims to isolated human DNA are that relevant. In 2007, I published the results of a study I conducted which looked at all instances of human gene patent litigation in the United States (using a relatively broad definition of "human gene patent"). In that study, I only found two cases in which an isolated DNA claims was successfully asserted against an infringer. One of these cases was Amgen v. Chugai (claim 2 of US Patent No. 4,703,008), decided in 1993, and the other was Promega v. Lifecodes, a relatively obscure case from the 1990s with claims directed towards specific, non-protein encoding genomic sequences useful as "DNA fingerprints" for forensics and paternity testing (US Patent No. 4,963,663).

Significantly, in Amgen v. Chugai claims 4 and 6 were also found valid and infringed, and these claims are directed towards recombinant cells transformed or transfected with the claimed erythropoietin gene. In subsequent cases, Amgen again prevailed against competitors based on infringement of claims directed towards recombinant cells and vectors, the protein product of the gene, and methods of using and producing the product (see Amgen v. Hoechst Marion Roussel and Amgen v. Hoffman-La Roche).  In other words, the isolated DNA claim was probably not necessary in order for Amgen to effectively protect its invention.

Since I conducted my study, I have seen a few subsequently filed cases involving genetic testing and gene patents, but invariably the asserted patent claims are method claims, not isolated DNA claims. I think these method claims are much more relevant for innovation in diagnostics and personalized medicine. Of course, the patent eligibility of these sorts of methods has been called into question by the Supreme Court's recent decision in Prometheus.

As far as product claims go, it should be possible for innovators to draft claims that have some value and which would be patent eligible regardless of how the Supreme Court decides Myriad. For example, Amgen did not just obtain a patent claim to the isolated erythropoietin gene, but also to recombinant vectors comprising the gene, recombinant cells comprising the gene and/or vector, claims to the therapeutic protein product, and a variety of method claims, all of which will very likely remain patent eligible.

As Myriad has long pointed out, the publication of the sequence of the human genome and other developments since the last century will make it difficult going forward to obtain new patents claiming isolated human genes. Method claims will likely be much more important for protecting future genetic discoveries. Most of the human gene patents in existence probably arise from work conducted prior to the turn-of-the-century, and they are already beginning to expire. Despite the ongoing concern, there is little to suggest that isolated DNA claims of the type at issue in this case have been a problem, or will develop into a problem, warranting Supreme Court intervention. But it's not too surprising that the Court took the case, given the number of amicus briefs filed in support of the petition, by groups such as the National Woman's Health Network and American Medical Association, as discussed on a post to Patent Docs.


Anonymous said...

If isolating a product of nature doesn't involve a significant alteration (is that the legal term?), then it shouldn't be patentable, and that holds for a diagnostic or pharmaceutical product.

By the way enjoyed your nature article.


Good old supreme court.