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US Court Denies Sequenom Appeal in Patent Case

NEW YORK (GenomeWeb) – The US Court of Appeals for the Federal Circuit has denied a request by Sequenom to reconsider the validity of a patent covering noninvasive prenatal DNA testing that was exclusively licensed to Sequenom and underlies the firm's MaterniT21 Plus.

The US District Court for the Northern District of California invalidated US Patent No. 6,258,540 in October 2013. Sequenom subsequently appealed the decision, but in June, a panel of judges from the US Court of Appeals for the Federal Circuit upheld the ruling. Sequenom then requested that the entire court hear its appeal, but that request has now been denied. 

In a statement, Sequenom said that the decision would have "little business impact," since it has been operating under the invalidity ruling since Oct. 2013 and because of its patent pool agreement with Illumina. In addition, patents with similar claims are issued and valid in Europe, Japan, Hong Kong, Canada, and Australia, it said.

Sequenom also said that it is considering a further appeal to the Supreme Court.

The judges largely based their decision on the case Mayo Collaborative Services v. Prometheus Laboratories, which set forth steps for distinguishing between patents that claim laws of nature and patents that claim applications of such phenomena.

Circuit Judge Alan Lourie wrote in an opinion yesterday that while he agreed with the denial to rehear the case, because there was "no principled basis to distinguish this case from Mayo," he nonetheless had concerns about deeming Sequenom's patent ineligible.

"It is unsound to have a rule that takes inventions of this nature out of the realm of patent-eligibility on grounds that they only claim a natural phenomenon plus conventional steps, or that they claim abstract concepts," he wrote.

Similarly, Circuit Judge Timothy Dyk wrote that while he too agreed with the decision, he also had concerns.

The Mayo decision is an "essential ingredient of a healthy patent system, allowing the invalidation of improperly issued and highly anticompetitive patents without the need for protracted and expensive litigation," he wrote.

However, "a too restrictive test" for patent eligibility, specifically with regards to laws of nature, "may discourage development and disclosure of new diagnostic and therapeutic methods in the life sciences, which are often driven by discovery of new natural laws and phenomena." As such, he said, "further illumination as to the scope of Mayo would be beneficial."

In a dissenting opinion, Circuit Judge Pauline Newman said that she thought the Mayo case was different enough from Sequenom's case that it did not set a legal precedent.

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