No Injunction Against Test for Genetic Defects

SAN FRANCISCO (CN) - A biotech company cannot block its competitor from using a prenatal test for genetic defects, a federal judge ruled, noting that an injunction would put the competitor out of business.

Sequenom asked for the preliminary injunction after Aria Diagnostics filed suit for declaratory judgment,, seeking a ruling that its Harmony test does not infringe on patents Sequenom's MaterniT21 test.

Both companies developed tests that use cell-free DNA to determine whether a fetus is likely to possess an extra copy of certain chromosomes that cause Down syndrome, Edwards syndrome and Patau syndrome. Though both tests are similar, Aria claims that its test is significantly more efficient and slightly more accurate than that of Sequenom.

Sequenom argues that the Harmony test infringes its patent because it compares maternal and fetal DNA to identify paternally inherited DNA, the method covered by its patent. Aria claims that Sequenom's difficulties in the patent-prosecution process over the paternally inherited DNA method claims makes its Harmony method clear of patent infringement.

U.S. District Judge Susan Illston rejected the call for an injunction Thursday after noting that Sequenom is no stranger to litigation over its alleged patents.

Verinata Health Inc. and Natera Inc. are currently suing Sequenom in her courtroom for declaratory judgments that their tests don't violate Sequenom's allegedly invalid patents. Verinata's case also pertains to the MaterniT21 test.

The infringement claims against Aria ignore Sequenom's own issues with the Patent and Trademark Office (PTO), Illston found.

"Sequenom's argument ignores the importance the PTO placed on 'paternally inherited' limitation and the lack of enablement for broader claims," she wrote. "The PTO rejected two rounds of applications that attempted to secure claims without the limitation, covering detection of fetal DNA by any means, rather than only by searching for what is known to be a paternally inherited sequence. Reading the patent to cover the Harmony Test's method, which does not rely on the crucial knowledge of what sequence would be different from the mother's genome in advance, would be contrary to the limitation repeatedly imposed by the PTO. The PTO insisted on the limitation in light of what is actually enabled by the specification- the patentee's a method for detecting fetal DNA by searching for a sequence known to be absent from the mother's genome, and only that method."

Aria has raised "'a substantial question' as to infringement which Sequenom has not shown 'lacks substantial merit,'" she added.

Illston said Aria also raised substantial questions about the validity of Sequenom's patent and its methods for detecting DNA. The judge pointed out that the steps used to enable the method are described as "standard" in the patent itself.

Sequenom's demand for a preliminary injunction against Aria moreover would put Aria out of business - throwing the balance of hardships out of whack.

"With respect to irreparable injury, the court recognizes that some price erosion will likely result from Ariosa's entry into the market given the significantly higher price of Sequenom's MaterniT21 test," Illston wrote. "However, the degree of that erosion - as well as the impact on Sequenom's market share - has not been adequately demonstrated by Sequenom's damages expert."

Sequenom's damages expert failed to account for the market presence of Verinata and Natera, and failed to demonstrate that any harm would be irreparable, the ruling states.

"However, the direct result of a preliminary injunction would be to put Ariosa - whose single product is the Harmony Test - out of business," Illston wrote. "This would also remove a significantly more efficient, less expensive, and allegedly more accurate test from the market and restrict the access to the noninvasive prenatal nucleic acid tests to only high-risk women."

"As such both the balance of hardships and the public interest likewise weigh against granting a preliminary injunction," Illston concluded.

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