Last Thursday, the Supreme Court held that some forms of DNA are patent-eligible in its long-awaited opinion, Association for Molecular Pathology v. Myriad Genetics, Inc.. Following Chakrabarty, the Supreme Court ruled that naturally occurring DNA is not patent-eligible, however cDNA, a form of DNA artificially created in a lab to isolate particular genes, is patent-eligible.

The decision was closely watched by the genetics research community. If the naturally occurring DNA been patent-eligible, a patent on those sequences would effectively grant a monopoly to perform research on a particular genetic sequence once isolated. In effect, gene patents would have become “hunting licenses” for future research, preventing all non-licensees from doing any research at all on those genes. Further, many advocacy groups, including the ACLU, were troubled by the idea that research companies could “own” the right to test for the presence of specific genes in the human body. While the implications of this decision are still unclear, it appears that the the Supreme Court has re-opened the door to expanded genetic research.

The case comes out of a set of Myriad-owned patents that claim two human genes, BCRA1 and BCRA2, which can lead to an increased risk of breast cancer if they mutate. Myriad located these two genes among the millions of segments of DNA  that make up the human genome. It was then able to develop a diagnostic test that would compare the genetic information from a patient to the isolated BCRA1 and 2 genes. If the test detected a mutation, it would indicate that the patient had a 50-80% risk of developing breast cancer in her lifetime.

Several other organizations, including the University of Pennsylvania Genetics Diagnostic Laboratory (“GDL”), also developed tests to detect mutations in the BCRA genes. After Myriad sent demand letters to GDL and others, those recipients (and numerous advocacy groups) asked for a declaratory judgment invalidating Myriad’s patents. At first, a panel on the Federal Circuit held that the both the isolated DNA and naturally-occuring DNA patents were patent-eligible. That decision, however, was vacated and remanded for reconsideration in light of last-term’s opinion in Mayo Collaborative Svcs. v. Prometheus Labs. On remand, a divided panel of the Federal Circuit again held that both isolated DNA and cDNA were patent-eligible. Moreover, each of the three judges, Moore, Bryson, and Lourie, wrote separately to express a disagreement over whether the methods for isolating DNA were patent-eligible.

In an opinion described by some as “splitting the baby,” the court unanimously held that naturally occurring DNA sequences are not patent-eligible, while isolated DNA is patent-eligible. What this practically means is that patentees must somehow modify naturally occurring DNA in order for it to be patent-eligible.

One outstanding question from this case, however, is where the Supreme Court believes the Mayo decision fits in to isolated DNA. Recall that in the Mayo case, the Supreme Court held a diagnostic patent to be invalid because it consisted of nothing more than applying well-known methods to naturally occurring phenomena (there, measuring metabolites of certain drugs). Logically, it would seem to follow (and as the Federal Circuit decided below) that isolated cDNA, because it is created with a well-known, conventional process, would likewise be patent-ineligible under Mayo.

A further question remains as to whether the celebrations of those arguing against gene patents are premature. While naturally occurring DNA is now patent-ineligible, a cDNA patent may still mean that the gene is, for all practical purposes, covered by the patent. For example, if a naturally occurring gene, in order to be used for research purposes, must be isolated into cDNA, then a patent on the cDNA effectively prevents research of the underlying naturally occurring gene.

Finally, patent scholars may be curious as to how this opinion will affect other 35 U.S.C. 101 challenges to patent validity. The Supreme Court has suggested that 101 cases in different fields are related. For example, last term, the Supreme Court vacated and remanded Ultramercial v. Hulu, LLC, a software patentability case, for reconsideration in light of Mayo, a medical diagnostic case. Likewise, in light of the apparent tension between Myriad and Mayo, perhaps there is hope that the Supreme Court is reconsidering its misguided “inventive concept” jurisprudence. That line of thinking began with Bilski, was followed in Mayo, and then this past year, led to the sharply divided CLS Bank v. ALICE decision by the Federal Circuit.

Lots of questions regarding patent validity challenges under Sec. 101 remain unanswered, but perhaps there is hope for patentees in emerging fields. After all, this is the first 101 case since J.E.M. in 2001, in which the Supreme Court has found a challenged patent to be valid.

–Parker Hancock

Tagged with:

Comments are closed.