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Sequenom Patent Invalidation May Enable Other NIPT Firms to 'Innovate' if Ruling is Upheld

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This story was originally published Nov. 18.

Last month, a federal court ruled a key patent held by Sequenom was invalid, granting Ariosa Diagnostics summary judgment in a case that centered on US Patent No. 6,258,540 and began in 2011. The judge said the patent covers a phenomenon of nature, which is unpatentable.

The '540 patent has been the subject of a suite of lawsuits between Sequenom, Ariosa, Verinata Health, and Natera for the last two years. Since launching its MaterniT21 test in October 2011, Sequenom has maintained that the '540 patent provides it broad protection in the field and that any company that offered a sequencing-based noninvasive prenatal aneuploidy test would be infringing, a declaration that prompted preemptive lawsuits by the other NIPT firms, alleging that Sequenom was overstating the bounds of its patent. Sequenom made good on its threat, suing each firm once they launched their fetal aneuploidy tests.

Now that the patent has been deemed invalid, all the litigation involving the '540 patent is over in the district court, Dianna DeVore, Ariosa's vice president of intellectual property and legal affairs, told Clinical Sequencing News.

While Ariosa and the other NIPT firms were already offering tests regardless of the '540 patent, the ruling gives those companies the "freedom to be able to innovate in the field of the use of cell-free DNA in pregnant women," DeVore said. "It allows companies to continue to offer tests using various technologies and also to enhance the test and to improve the test without the fear of infringing a patent."

Verinata and Natera declined to comment on the ruling.

Sequenom has said it plans to appeal the decision, and DeVore said the Federal Circuit will almost certainly grant Sequenom's appeal to review the decision. She said that appeals for review by the Federal Circuit tend to be automatically granted, as opposed to the US Supreme Court, which only selects a small number of cases to review.

On review, she said the court would have to decide not on the facts of the case, which she said were not disputed, but on whether the decision to rule the '540 patent invalid was a misapplication of the law.

The determination was based on couple of recent Supreme Court decisions, including a recent ruling that found a number of Myriad Genetics' patents invalid because they covered naturally occurring DNA, as well as the case Mayo v. Prometheus, which found that while an application of a law of nature may deserve patent protection, the applicant "must do more than simply state the law of nature while adding the words 'apply it.'"

Sequenom's CFO Paul Maier told CSN that the firm believes the "court's decision is wrong and misapplies the law." According to Maier, "the invention for the '540 patent was the detection method."

As such, the patent is more than just a phenomenon of nature, he said. The "prohibition against patenting a natural phenomenon doesn't prevent patenting a novel use of that natural phenomenon," which is what the '540 patent does, he said.

Maier also noted that the '540 patent was also challenged internationally and upheld.

In terms of the competitive landscape, Maier said that the ruling does not change anything. "Our competitive position in the market remains the same. We've been competing effectively, and will continue to do so. It doesn't change how we go about doing our business."

Aside from litigation involving the '540 patent, there are also pending cases between the NIPT firms that involve separate patents, and those will continue to work their way through the court system, DeVore said.

For instance, last year Verinata sued Ariosa for patent infringement, alleging the company infringes on US Patent Nos. 8,296,076, entitled, "Noninvasive diagnosis of fetal aneuploidy by sequencing," and 8,318,430, "Methods of fetal abnormality detection" (CSN 1/23/2013).

There are also several ongoing patent interference cases between Sequenom and Verinata that do not involve the '540 patent.

Last year, the US Patent and Trademark Office withdrew the issuance of a Sequenom patent application due to the anticipation of patent interference.

Then, in May, a patent interference was declared between Verinata's US Patent No. 8,195,415, which it is asserting against Sequenom, and US Patent application 13/070,266, which is exclusively licensed to Sequenom. The USPTO also declared two additional patent interferences between patent applications licensed to another unnamed party and patent applications licensed to Sequenom, and redeclared an interference between Verinata's patent No. 8,008,018 and Sequenom's patent application 13/070,275. In June, Dennis Lo of the Chinese University of Hong Kong, from whom Sequenom licenses its IP, was declared senior party of the patent interference dispute (CSN 6/5/2013).

The invalidation ruling will also not affect the inter partes review case, which is also heard by the USPTO and was brought by Ariosa against the '540 patent (CSN 4/3/2013)

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