A decision handed down Tuesday in the U.S. Court of Appeals for the Federal Circuit shows the Supreme Court’s broad interpretation of the § 101 patent eligibility threshold that has made it increasingly difficult to protect patents involving natural phenomenon may not be a total killer of all patents related to diagnostic tests. In a 2-1 decision in Illumina Inc. v. Ariosa Diagnostics Inc., the Federal Circuit reversed a lower court that had invalidated two related patents – the ’751 and ’931 patents – which claim methods of preparing a fraction of cell-free DNA that is enriched in fetal DNA. Differentiating the challenged patents from Sequenom claims on a prenatal test that were tossed in 2015 because they merely cited a natural phenomenon, Judge Alan Lourie wrote for the majority, “This is not a diagnostic case. And it is not a method of treatment case. It is a method of preparation case.” Rather than simply observing that extracellular fetal DNA in maternal plasma is shorter than maternal DNA, the patents claim specific methods for exploiting the phenomenon by detailing process steps that change the composition of the mixture, resulting in a DNA fraction that is different from the naturally occurring fraction in the mother’s blood, Lourie said. Thus, the majority concluded that the claims meet the § 101 threshold for patent eligibility. Judge Jimmie Reyna came to the opposite conclusion in his dissent, agreeing with Ariosa, which is part of Roche Holding AG, that the claims were directed to a natural phenomenon, not a patentable method. “The patents’ only claimed advance is the discovery of that natural phenomenon,” he said. The March 17, 2020, opinion might not be the final word on the patents, as Lourie left the door open for challenges on other grounds such as obviousness. “We make no comment on whether the claims at issue will pass muster under challenges based on any other portion of the patent statute,” he said.

In a separate § 101 ruling Monday, another Federal Circuit panel unanimously reinstated Boehringer Ingelheim GmbH’s patent claims that had been declared patent ineligible by a lower court. In Boehringer Ingelheim GmbH v. Mylan NV, a district court had found that several claims in Boehringer’s ’156 patent were directed to an “abstract idea” – the act of administering DPP-IV inhibitors such as linagliptin (Tradjenta ) to patients with type 2 diabetes for whom normal metformin therapy isn’t appropriate – and failed to recite an inventive step. The appellate court disagreed, saying the patent claims a method of treatment, not an abstract idea. However, the Federal Circuit affirmed the district court’s decision that asserted claims of Boehringer’s ’859 and ’927 patents were invalid for obviousness and obviousness-type double patenting.

U.S. Sen. Edward Markey (D-Mass.) is introducing a resolution calling on President Donald Trump to exercise his authority under the Defense Production Act to immediately support a drastic increase in the manufacturing of critical medical supplies and coronavirus testing kits. The 1950 law gives the president broad authority to mobilize domestic industry for emergency preparedness activities. “We need a wartime mobilization of production and we need it now,” Markey said, citing the limited number of respirators in the Strategic National Stockpile. He said the Department of Health and Human Services has estimated that the U.S. could need up to 3.5 billion respirators, but the stockpile holds only 12 million.

The FDA this week issued draft guidance encouraging the use of restricted delivery systems to limit the unintentional ingestion of oral liquid drugs and biologics by children. The guidance urges manufacturers to use a restricted delivery system such as a flow restrictor as part of the packaging of their oral products as an additional measure to reduce the risk of unintended ingestion. The draft describes the elements that should be considered in developing such systems. Comments on the draft should be submitted to Docket No. FDA-2020-D-0567 by May 18, 2020.

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