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Sequenom Garners Support for Supreme Court Petition From Biotech, Pharma, Law Professors

NEW YORK (GenomeWeb) – A diverse range of groups have submitted more than 20 amicus briefs to the US Supreme Court in support of Sequenom's petition to the court, asking it to review decisions by lower federal courts that ruled some claims of one of its patents ineligible.

Sequenom filed its petition last month. The briefs in support of Sequenom were filed by Eli Lilly, Novartis, the Coalition for 21st Century Medicine, the Biotechnology Innovation Organization, various law professors and law associations, Microsoft, and others.

The petitioners asked the Supreme Court to review Sequenom's case as well as to clarify the intent of an earlier decision, Mayo Collaborative Services v. Prometheus Laboratories, which was the key prior case the courts cited for deeming Sequenom's US Patent No. 6,258,540 unpatentable.

Mayo v. Prometheus, as well as another case, Alice Corp v. CLS Bank International, established a two-step test for patent eligibility, referred to as the Mayo-Alice test, which essentially stated that if a patent claims a phenomenon of nature, the methods and applications must be novel.

The briefs, which were filed last week and can be downloaded from the law firm Kay Scholer, which represents Sequenom, all argue that the Mayo-Alice test has been applied too broadly in the Sequenom case and others. 

In one of the briefs, 19 US law professors argue that the Mayo-Alice test has "become infected with indeterminacy and is overinclusive in application, invalidating legitimate patented innovation with little predictability for inventors or patent attorneys." Furthermore, they wrote, the Sequenom case  exemplifies those problems and is a clear example of the lower courts and the US Patent and Trademark Office misapplying the Mayo-Alice test. Rather than evaluating the claim as a whole, the courts and PTO applied it to individual claim elements that "conflict with this court's existing precedents."

In addition, the law professors argue that the Supreme Court can fix the problem by providing instruction on how to apply the Mayo-Alice test.

Separately, Population Diagnostics, Avant Diagnostics, Personalis, and two individuals — one a cancer survivor and another the mother of a son who died of cancer — argued in a brief that that the lower federal courts and USPTO applied the Mayo case with a "broad brush to invalidate claims far removed" from the original case.

They wrote in the brief that judges and patent examiners "reflexively invalidate" claims that involve non-patentable material like phenomena of nature. "Such a reflexive approach indiscriminately invalidates patent-eligible diagnostic claims and, ultimately, will result in more patient deaths," they wrote.

Pharmaceutical companies Novartis and Eli Lilly also submitted separate briefs asking the Supreme Court to grant Sequenom's petition and clarify the intent of the Mayo-Alice test. Novartis wrote in its brief that there is a real risk of a never-ending expansion of patent ineligible material. The case "presents the right opportunity for this Court to retake the reins of subject matter eligibility law," it wrote.

It asks the Supreme Court to clarify the scope of patent-eligible subject matter. Without clarity, the situation could become so bad, Novartis wrote, that many pharmaceutical companies could abandon some R&D, "not because we want to, but because the costs and risks would just become too high without an incentive that enables us to recoup our investment."

The Biotechnology Innovation Organization joined forces with the Pharmaceutical Research and Manufacturers of America and the Association of University Technology Managers in its brief to ask the Supreme Court to revisit the issue. "This case affords an opportunity for this Court to articulate the circumstances under which process claims can pre-empt DNA that occurs in nature," the groups wrote.