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Sequenom Claims Favorable USPTO Decisions on NIPT Patents

NEW YORK (GenomeWeb News) – Sequenom said in a regulatory filing today that the US Patent and Trademark Office, Patent Trial and Appeal Board has made rulings favorable to the company in an ongoing dispute with Verinata Health regarding noninvasive prenatal testing technologies.

The PTAB ruled on four patent interference proceedings between patents held by the Chinese University of Hong Kong and exclusively licensed to Sequenom, and patents and a patent application licensed by Stanford University to Illumina's Verinata Health. The patents cover the use of DNA sequencing in prenatal testing for Down syndrome and other chromosomal abnormalities.

In the first interference ruling, on US Patent No. 8,008,018, which lists Stanford professor Stephen Quake as the inventor, the PTAB said that the patent "lacked sufficient disclosure to meet the written description test for the patent claims," according to Sequenom's 8-K filing with the US Securities and Exchange Commission. The PTAB entered a judgment cancelling all four claims of the patent, "thus determining that Quake is not entitled to a patent on the subject matter of this interference."

The patent is one at the center of an ongoing intellectual property suit between Sequenom and Verinata, and Sequenom said that it intends to submit the PTAB's decision to the US District Court for the Northern District of California, which is overseeing Verinata's patent infringement lawsuit against it. Sequenom further said that it believes the '018 patent is related to Quake's US Patent No. 7,888,017, also covering NIPT technology.

Sequenom also said that the PTAB had ruled that in two other interferences patent applications covering Quake inventions also lacked sufficient disclosure to meet the written description test for the patent claims. The PTAB ended those interferences, finding that Quake was not entitled to the patents, according to Sequenom, which further noted that it expects several patents held by Dennis Lo of the Chinese University of Hong Kong and licensed to Sequenom to now issue.

However, the PTAB's decisions may be appealed to the US District Court or the US Court of Appeals for the Federal Circuit, the firm said.

Finally, Sequenom said that the PTAB had ruled that a patent application held by Lo, US No. 13/070,266, had sufficient disclosure to meet the written description test for its patent claims. This patent application is part of another patent interference with Quake's US Patent No. 8,195,415, which has been asserted in Verinata's infringement suit against Sequenom. According to Sequenom, the PTAB has ordered this interference to proceed to a priority phase to determine whether Lo or Quake was first to invent the subject matter of the interference.

Sequenom noted it also is challenging the validity of the '415 patent in an inter partes review proceeding that currently is pending before the PTAB.

Illumina declined to comment on the PTAB decisions, citing the ongoing litigation.

The NIPT field has been highly litigious over the past several years with many of the competitors — including Sequenom, Verinata, Ariosa Diagnostics, and Natera — suing each other over alleged patent infringement. According to Clinical Sequencing News, last fall a federal court ruled a key patent held by Sequenom was invalid, saying the patent covers a phenomenon of nature, which is unpatentable. Sequenom previously said it would appeal that decision.

In Monday morning trade on the Nasdaq, shares of Sequenom were unchanged from a Friday close of $2.46.