Previously published in The Legal Pulse
After the Supreme Court decided that the personalized medicine method claims at issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc. did not satisfy the patent eligibility requirements of 35 USC § 101, it was not surprising that the Court asked the U.S. Court of Appeals for the Federal Circuit to take a second look at Association for Molecular Pathology v. Myriad Genetics, Inc.(the ACLU "gene patenting"/BRCAI case; watch my Washington Legal Foundation "Legally Brief" video on the remand here). Although Myriad's "isolated DNA" claims raise different patent eligibility issues than Prometheus's method claims, both patents relate to technology that is applied in the medical diagnostic/therapeutic space. It was more puzzling when the Supreme Court also asked the Federal Circuit to reconsider Ultramercial, LLC v. Hulu, LLC, where the claims at issue relate to methods of distributing copyrighted content over the internet. True, the patent eligibility of the Ultramercial claims is at issue, but how can the Supreme Court's explication of the non-patent eligibility of natural phenomena impact the Federal Circuit's decision that the Ultramercial methods were not disqualified from patenting as merely claiming abstract ideas?
One possible—and, in my opinion, frightening—explanation is that the Supreme Court disapproves of the Federal Circuit's entire approach to patent eligibility. Recent Federal Circuit decision have emphasized the broad language used in § 101 and have cited passages from the Supreme Court decisions in Bilski and Chakrabarty supporting an "expansive" view of patent eligible subject matter. Notably, the Supreme Court's Prometheus decision did not dwell on the statutory language, but rather focused on its own jurisprudence that sets forth "important" exceptions to patent eligibility.
In Ultramercial, Chief Judge Rader (the author of the panel opinion) described the patent eligibility requirement of § 101 as a "coarse filter," with the substantive requirements of § 112, § 102, and § 103 placing more important limits on patentability. But the Supreme Court rejected the premise that those other statutes can safeguard against improper patents, dismissing the government's arguments along those lines. Indeed, in one of the most ironic passages of Prometheus, the Supreme Court expressly "decline[d] the Government's invitation to substitute §§102, 103, and 112 inquiries for the better established inquiry under §101."
The question now is whether the Federal Circuit will read the remands of Myriad and Ultramercial as sending § 101 smoke signals that the court is expected to interpret and apply when it revisits these cases, or whether the court will view the remands as nothing but a smokescreen that they can wade through using their own jurisprudence.
Speaking of abstractions, Myriad filed a paper in the Federal Circuit on May 30, 2012, asserting that the entire case should be dismissed because it "presents only abstract, philosophical questions of no immediate relevance to the parties." Myriad raises this issue now because the person that the Federal Circuit previously found to have a "case or controversy" that supported subject matter jurisdiction has since changed employment, and now works at institutions with which "Myriad never had any communications." Myriad suggests that the court dismiss the case and vacate the district court decision, or at least remand for the district court to decide subject matter jurisdiction under the current facts.
While many are concerned about the impact that a decision invalidating Myriad's claims could have on the biotechnology industry, it is not clear that a longer period of uncertainty surrounding this issue would benefit the industry overall. At least once the Federal Circuit and Supreme Court render their final decisions, we will have additional jurisprudence to guide patent strategies and investment decisions.
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