AMP v. USPTO Revisited

On Friday, the Federal Circuit heard oral arguments in AMP v. USPTO, the litigation challenging the validity of the Myriad Genetics patents on the BRCA1 and BRCA2 genes; link to audio recording. The basis of the lawsuit is whether isolated genes are patentable subject matter, so any ruling in this case affects the patenting of all genes; see earlier posts here and here. This case was previously heard at the Federal Circuit last year, where the court issued a 2-1 ruling that invalidated the method claims in the patents, but upheld the patent claims to the genes. Since then, the Supreme Court’s ruling in Mayo v. Prometheus issued, where the Court decided that a patent to a method of adjusting drug dosage relied on preempting the use of a law of nature, and therefore invalided the patent. In response to the plaintiffs' petition for certiorari on the gene patent claims, the Supreme Court issued a remand and instructed the Federal Circuit to reconsider the gene patent claims in AMP in view of Mayo. I filed an amicus brief in this case last month. One significant difference between the cases is that AMP involves the patenting of compositions of matter, while Mayo involved method claims. This theme echoed throughout the oral argument last week, where the judges (Lourie, Moore, Bryson, recreating the earlier panel) frequently challenged the attorneys to relate their arguments to Mayo and its effect on this case. Each party takes an opposite view. The plaintiffs believe that the overriding policy objective in Mayo – making sure that laws of nature or natural phenomena are not patented – can be extended here, where they argue that the isolated genes in dispute are nothing more than naturally occurring products of nature that cannot be patented. In contrast, the defendants maintain that Mayo does not change the analysis of the eligibility of the gene patent claims because the method claims there are inapposite, and so their central argument that isolated genes are human-made inventions and therefore patentable remains. An interesting exchange occurred near the end of the oral argument where Judge Moore persisted in asking defendants to precisely characterize the inventive work on the isolated genes, and the Myriad attorney recited the scientific decisions on the start and stop positions of the isolated genes as constituting invention-level work; the judge seemed skeptical of that argument. However, Judge Moore also revisited a concern that influenced her 2011 opinion, which was whether a decision invaliding gene patent claims at this point would undermine too many settled expectations and contravene the decades-long practice of the PTO; she asked why this challenge had not been brought much earlier. In my view, that question is understood by realizing the import of a patentable subject matter challenge in the context of patent litigation – the effect of a judicial ruling that certain types of inventions are not patent-eligible creates ripples effects across a technological field – and litigants in patent cases are often similarly situated competitors who do not wish to disturb general patenting expectations. Note that this litigation is unusual in that it is not a case between competitors – it is essentially a public interest challenge brought by a wide coalition (ACLU, PubPat, physicians, scientists, patients) who filed a declaratory judgment on the basis that some of the plaintiffs were directly targeted by potential patent infringement actions by Myriad (the standing issues have been litigated here as well), but the plaintiffs’ team represents many stakeholders who are collaterally affected by the patents and their effects on the BRCA1 and BRCA2 genetic testing field. At the end of the oral argument, Judge Lourie noted that “it remains to be seen whether we’ll be back,” a nod to the fact that the Federal Circuit decision this fall may simply set up the next round of appeals. It’s impossible to gauge how this court will rule, but it appeared, on balance, that the court was not convinced that it was left in possession of a clear Mayo-directed route to a decision, which is the question that they started with.