The following contribution to our gene-patenting symposium comes from Christopher M. Holman, Associate Professor of Law at the University of Missouri Kansas City School of Law.
In 2005, the Supreme Court granted certiorari in Laboratory Corp. v. Metabolite Laboratories to decide the patent eligibility of a patent claim broadly directed towards the clinical application of a biological discovery. However, after the case had been fully briefed and argued, the Court dismissed the writ of certiorari as “improvidently granted.” Although the Court did not explain its action, I suspect that the decision to dismiss was based on the fact that the issue of patent eligibility had not been addressed in the lower courts, and thus was not ripe for resolution by the Supreme Court.
In 2012, the Court granted certiorari in Mayo Collaborative Services v. Prometheus Laboratories, an appeal from the Federal Circuit raising essentially the same issue as LabCorp. The difference this time was that the question of patent eligibility had been addressed squarely in the decisions below. In Mayo, the Supreme Court answered the question it had set aside in LabCorp, invalidating the claim and apparently constricting the scope of patent-eligible subject matter. The ultimate impact of Mayo on the patenting of innovation in the life sciences, particularly with respect to personalized medicine and diagnostics, awaits further development in the courts, but could be substantial.
In Association for Molecular Pathology v. Myriad Genetics, history is in a sense repeating itself. The question presented is quite similar to that presented in LabCorp and Mayo – that is, the patent eligibility of patent claims originating in a biological discovery of clinical significance. The major difference is that LabCorp and Mayo involved process claims, while Myriad involves product claims directed to compositions of matter. As was the case in LabCorp, the Myriad appeal was, in my view, improvidently granted because the patent eligibility issue was not sufficiently developed in the lower courts. Although the Federal Circuit did decide the question of patent eligibility in Myriad, it did so without adequately construing the language of the claims, and as a consequence failed to delineate the scope of the claims. Without having laid this groundwork, it is impossible to make a principled determination of patent eligibility, because there is no clarity as to the subject matter covered by the claims and the sorts of products or activities that could potentially be infringing.
The fundamental role of the patent claim cannot be overstated. As legendary patent jurist Judge Giles Sutherland Rich pithily observed, when it comes to patents, “the name of the game is the claim.” In the Federal Circuit’s recent decision in CLS Bank International v. Alice Corporation Pty. Ltd., (which the court subsequently decided to rehear en banc), the majority noted that a determination of patent eligibility “requires this court to consider the scope and content of the claims.” The court went on to observe that “it is fundamentally improper to paraphrase a claim in overly simplistic generalities in assessing [patent eligibility]. Patent eligibility must be evaluated based on what the claims recite, not merely on the ideas upon which they are premised.”
In part, the problem in Myriad stems from the unusual posture of the lawsuit. In most cases, patent litigation is precipitated by an allegation that one or more patent claims are infringed by some tangible product or activity. It is necessary to construe the scope of the claims in order to assess infringement, as well as claim validity. Both LabCorp and Mayo, for example, arose from a lawsuit filed by the patent owner raising specific allegations of infringement. In contrast, Myriad Genetics was literally dragged into the court by the ACLU and the Public Patent Foundation. In fact, many would argue that the lower courts should have dismissed the case for lack of any real controversy, given that none of the named plaintiffs face any real likelihood of being sued for infringing the challenged patent claims.
With no specific allegation of infringement, the lower courts resorted to speculation as to the scope of the claims. Not surprisingly, some of the statements made by the judges in the Federal Circuit decisions reflect a fundamental misunderstanding of the science, and the nature, of the claimed “isolated DNA.” The confusion was evident, for example, during oral argument before the Federal Circuit, when Judge Bryson asked the attorneys arguing the case whether whole genome sequencing would infringe the isolated DNA claims. The ACLU attorney said yes, Myriad’s attorney responded no, but in fact it seems clear that neither could answer the question knowledgeably because the scope of the claims had never been adequately construed. In fact, as Robert Cook-Deegan (Duke University) and I explained in an amicus brief we filed with the Federal Circuit, it seems highly unlikely that Myriad’s isolated DNA claims that are the subject of the current appeal would be found valid and infringed by DNA sequencing, in the unlikely event the claims were ever asserted in court.
Moreover, based on my empirical research on human gene patent litigation in the U.S., there does not appear to be a single example of a patent owner asserting in court that an isolated DNA claim is infringed by DNA sequencing, or for that matter any form of genetic diagnostic testing. The controversy over gene patents in recent years has been driven largely by wildly exaggerated assumptions as to the scope and impact of so-called “gene patents.” In fact, these sorts of patent claims have been around for decades, and the concern that they will impede research and genetic diagnostic testing remains largely unsubstantiated.
Unfortunately, in its recent patent decisions the Supreme Court has failed to follow Judge Rich’s maxim, largely ignoring claim construction and the significance of claim limitations. In Quanta v. LG Electronics, for example, the Court’s analysis focused repeatedly on the nebulous concept of a product “embodying” a method claim. In Mayo, the Court flipped this idea around, referring to patent claims as “embodying” research or natural laws. The same disregard for the language of the claims is evident in Bilski v. Kappos, another patent eligibility case recently decided by the Supreme Court. Explicit claim limitations, which define the boundaries of the subject matter covered by the patent, are given short shrift in this sort of analysis. Perhaps Justice Scalia is not the only member of the Court with little interest in “getting into the weeds of patent law” (referring to a statement, perhaps only half-joking, made recently by Scalia during oral arguments in Gunn v. Minton). But the devil is in the details: before declaring a patent claim to be patent ineligible, a court should construe the claim to the extent necessary to specifically identify the purportedly ineligible subject matter falling within the scope of the claim.
For years, unfounded assumptions regarding the scope of isolated DNA claims have led to exaggerated, and in my view unwarranted, concerns regarding their potential impact on research and medicine. For example, misinterpretation of a single journal article has led to a widespread and pervasive belief that twenty percent of human genes are patented in the U.S., and that as a consequence any research or diagnostic testing involving these genes inevitably results in patent infringement. Indeed, one of the Federal Circuit judges who decided Myriad appears convinced that patents claiming isolated DNA sequences threaten to block promising new technologies such as whole genome sequencing and multiplex genetic testing. In fact, when one reads the claims of the patents that form the basis for the myth that twenty percent of human genes are patented, as I have, it becomes readily apparent that few (if any) of these patents pose any substantial obstacle to these technologies.
For a variety of reasons, including the sequencing of the entire human genome that occurred over a decade ago, and the impending expiration of a host of so-called “gene patents” (including the patents at issue in this case), I predict that any policy concerns associated with these sort of isolated human DNA claims will only diminish over time. It seems unlikely to me that the prospective availability of isolated DNA claims will be particularly crucial for the next generation of biotechnology innovators. But they probably did play a role in providing an incentive for investment during the early days of biotechnology, and it is believed that thousands of patents containing claims of this sort have issued. I worry about the message the Supreme Court would be sending to innovators and investors if in deciding Myriad it in effect tells them that the host of patents that they have spent millions of dollars in obtaining over the last thirty years, and that probably have served as the basis for investment in the billions of dollars, have actually been invalid all along.