June 22, 2012

Gene Patent Litigation Returns to Federal Circuit After Remand

The high-profile gene patent litigation is back in court this summer. The Supreme Court responded to a petition for certiorari in AMP v. USPTO (involving the Myriad Genetics patents on the BRCA1 and BRCA2 breast and ovarian cancer genes) by granting, vacating and remanding the case for reconsideration by the Federal Circuit in view of the recent Mayo v. Prometheus case. The plaintiffs have challenged the patents as invalid for lack of patentable subject matter under 35 U.S.C. 101. In Mayo, the Supreme Court unanimously invalidated a patent for a method of optimizing drug dosage by making use of a natural correlation between a drug metabolite and effectiveness. The Court decided that the patent claims essentially claimed the underlying natural correlation for exclusive use, a result that it contrary to the norm in patent law that patents not issue for “laws of nature, natural phenomena and abstract ideas.” Note the language of Mayo: “And so there is a danger that the grant of patents that tie up their use will inhibit future innovation premised upon them, a danger that becomes acute when a patented process amounts to no more than an instruction to ‘apply the natural law,’ or otherwise forecloses more future invention than the underlying discovery could reasonably justify.” However, Mayo involved a method patent.  In AMP, the plaintiffs challenged both the DNA/gene patent claims as well as the genetic testing method claims. After the trial court invalidated both types, the Federal Circuit affirmed the method claim decision but reversed on the DNA claims. That result was then appealed to the Supreme Court. So the case is now focused chiefly on the DNA claims (and one method claim for a drug screening technique). All parties have now filed their briefs at the Federal Circuit for the rehearing on July 20 (ACLU heading the plaintiffs' coalition here; Myriad Genetics here). I filed an amicus brief last week in support of the plaintiffs; I argue that the Mayo decision is quite emphatic in its insistence that products or laws of nature not be encompassed by  patent claims – with the result that the isolated DNA claims in the patents very clearly cover naturally occurring genes and naturally occurring mutated genes (which have deleterious consequences for breast and ovarian cancer patients). My view is that Mayo strengthens the challenge to the DNA patent claims because it looks closely at patent claims which relate to “natural” subject matter and asks whether an inventive contribution has occurred to justify a patent. Furthermore, Mayo also posed the inquiry this way: “[T]he underlying functional concern here is a relative one: how much future innovation is foreclosed relative to the contribution of the inventor.” There is little doubt that the Myriad patents have cast a severe chill on the development of the genetic testing field for BRCA1 and BRCA2, and since these patent claims provide minimal inventive enhancement to the basic scientific subject matter, the patent claims would appear to be invalidated by Mayo. The oral argument at the Federal Circuit is on July 20.

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