Mylan, Teva Lose Actavis Infringement Defense in Valeant Suit

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By Greg Langlois

Valeant Pharmaceuticals Inc. knocked out May 1 a defense raised by Mylan Inc. and Actavis LLC in a patent infringement suit over Valeant’s Relistor tablet, which treats opioid-induced constipation.

Mylan and Actavis can’t show U.S. Patent No. 8,552,025 is invalid due to obviousness, a New Jersey district court ruled. Valeant says the companies’ generic of the injection version of Relistor (methylnaltrexone bromide) infringes the ‘025 patent. Relistor is given to adults taking pain medication to treat constipation without reducing the painkiller’s effectiveness.

Bloomberg Terminal data show total prescription counts for all versions of Relistor (injection and tablet forms) have risen sharply since 2011. Total prescription counts jumped from 846 in February 2011 to 5,459 in March 2018 in the U.S. The tablet form, introduced in 2016, jumped to nearly 4,000 prescriptions in March.

Valeant sued Mylan in November 2015, alleging infringement of several patents, including ‘025. It also separately sued Actavis the same month, alleging infringement of the same patents. The Actavis case later was consolidated into the Mylan one.

Not Obvious

Valeant asked the court to decide Mylan and Actavis’s defense to alleged infringement of one of the patent’s claims won’t work. The defendants had alleged the claim was invalid based on obviousness.

The claim at issue cited prior art references as to, among other things, the ‘025 patent claim to a pharmaceutical preparation of methylnaltrexone comprising a pH between 3.0 and 4.0. The court held the prior art didn’t show the patented invention would have been obvious to scientists at the time.

“The heart of Defendants’ obviousness case—and the major point on which they fail—is their argument that a pH range of 3 to 4 would have been obvious to try,” Judge Stanley Chesler wrote.

Applying the legal standard to determine whether an invention such as the ‘025 patent’s is obvious, the court said that "[t]he bottom line is that Defendants have pointed to no evidence that claim 8 was either an ‘identified, predictable solution’ or an ‘anticipated success.’”

Salix Pharmaceuticals Inc., also a named plaintiff, makes Relistor. Valeant acquired Salix in 2015. Teva Pharmaceutical Industries Ltd. acquired Actavis in 2016. Actavis was Allergan Plc’s generics business.

Finnegan, Henderson, Farabow, Garrett & Dunner and Gibbons PC represent Valeant. Alston & Bird LLP and Critchley Kinum & DeNoia LLC represent Mylan. Goodwin Procter LLP, the Law Office of Jason B. Lattimore, Esq. LLC, and Howard J. Schwartz of Brookside, N.J., represent Actavis.

The case is Valeant Pharm. Int’l, Inc. v. Mylan Pharm., Inc., D.N.J., No. 15-8180, 5/1/18.

—With assistance from Christina Brady in Washington.

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