Federal judge kills patent infringement charge against Hologic

January 29, 2010 by MassDevice staff

A federal judge in Ohio threw out one patent infringement charge made against Hologic Inc. (NSDQ:HOLX) by Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon Endo-Surgery Inc., but ruled that four other claims in the suit must be sorted out at trial.

Ethicon sued Hologic in 2007, accusing the Bedford, Mass.-based women's health products maker of violating a quartet of patents related to Ethicon's Mammotome breast biopsy system with Hologic's ATEC system, and of violating false advertising laws. Hologic asked Judge Michael Barrett of the U.S. District Court for Southern Ohio to rule two of the Ethicon patents invalid.

Barrett granted Hologic's wish on one of the patents, "Surgical Device For The Collection Of Soft Tissue," finding that Ethicon failed to meet the "function-way-result" test," which "allows the Court to focus on the function served by a particular claim element, the way that element serves that function, and the result thus obtained by that element," according to court documents.

Although neither side disputed that the function and result of the ATEC system is "substantially equivalent" to the patent, Barrett wrote, "the way that the claim element serves the function is disputed." The judge agreed with Hologic's argument that Ethicon failed to show that the way the ATEC device operates is equivalent to the description in the patent.

Barrett also ruled that Ethicon failed to explain why any differences between the Hologic device and the device described in the Ethicon patent are insubstantial and found that Hologic's statements to the Food & Drug Administration in its 510(k) application for the ATEC system aren't relevant to the case.

"Several district courts have held that it is not proper to consider statements made in a FDA 510K notification," Barrett wrote. "In addition, the Federal Circuit has stated that 'FDA equivalence is irrelevant to patent law because it involves fundamentally different inquiries.' Therefore, since the statements made by [Hologic] were done so in further support of the 510K notification, this Court will not consider those statements. However, even if the Court did give consideration to those statements, they do not prove infringement."

Ethicon also accused Hologic of violating the Lanham Act, which prohibits false advertising if the following can be proved:

1. The defendant has made false or misleading statements of fact concerning his own product or another's;
2. The statement actually deceives or tends to deceive a substantial portion of the intended audience;
3. The statement is material in that it will likely influence a deceived consumers' purchasing decisions;
4. The advertisements were introduced into interstate commerce;
5. There is some causal link between the challenged statements and harm to the plaintiff.

Ethicon claimed that a Hologic whitepaper and video violated the statute. Barrett found that although Hologic's claims in the whitepaper were false, neither side proved or disproved whether the deception was willful, ruling that question a matter to be settled at trial (along with the question of whether the video harmed Ethicon).

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