Tyco Healthcare Group LP v. Mutual Pharm. Co., Inc.

An exceptional case finding is not supported when there was a genuine issue regarding how to test to determine if a claim element is present.

October 25, 2016

GENERICally Speaking

Case Name: Tyco Healthcare Group LP v. Mutual Pharm. Co., Inc., Civ. No. 07-cv-1299 (SRC)(CLW), 2016 U.S. Dist. LEXIS 95789 (D.N.J. July 22, 2016) (Chesler, J.) 

Drug Product and Patent(s)-in-Suit: Restoril® (temazepam); U.S. Patent No. 5,211,954 (“the ’954 patent”)

Nature of the Case and Issue(s) Presented: The issue before the court was to determine if the case was exceptional and, as such, to determine if attorneys’ fees should be awarded. Mutual argued that the case was exceptional because its ANDA product specifically did not have a claim limitation that the surface area of the product be less than a certain amount. In fact, Mutual’s ANDA product required a surface area significantly larger than the claimed limitation. As Tyco had lost all claim-construction arguments and the Federal Circuit had remanded the case related to one of Mutual’s antitrust causes of action, Mutual asserted that the case was exceptional.

Tyco argued that there was a genuine dispute over how to determine the surface area. While Mutual’s ANDA filing required a larger surface area, the facts showed that Mutual had difficulties obtaining a product with the required surface area, and that these developmental products fell within the claim limitation. In addition, Tyco disputed the temperature at which Mutual was performing the test. The court found that the case was not exceptional.

Why Tyco Prevailed: The district court found the case not to be exceptional because there was a genuine dispute over how to perform the test for surface area. The court found that both sides had presented credible, supported arguments for why their particular temperature was the correct one. The court rejected Mutual’s argument that Tyco’s position was frivolous simply because Tyco ultimately did not prevail. The court further relied on the fact that Mutual had challenges in its development to obtain products that did not infringe the patent as additional evidence as to why the case was not frivolous.

Lastly, the court rejected that the remand on Mutual’s antitrust claim established an exceptional case. The court found that there was no evidence that Tyco had engaged in sham litigation or bad faith. Rather, Tyco’s actions were to protect its monopoly under the patent.

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