Macleods Loses Bid to Get Amgen Sensipar Suit Spiked

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By Dana A. Elfin

Biotech giant Amgen Inc. can move ahead with its patent infringement suit against Macleods Pharmaceuticals Ltd. over its proposed generic version of Amgen’s lucrative kidney drug Sensipar.

Because the case is at a preliminary stage, it’s too early for the court to make a decision tossing the suit, Chief Judge Gregory M. Sleet of the U.S. District Court for the District of Delaware said Dec. 19. The court also tossed Macleod’s bid for sanctions against Amgen as similarly premature.

Amgen is likely to do everything it can to protect its valuable Sensipar franchise. Sensipar (cinacalcet), a drug used to treat chronic kidney disease in adults undergoing dialysis, pulled nearly $1.6 billion into Amgen’s coffers in 2016.The prosecution history of Amgen’s U.S. Patent No. 9,375,405 (Rapid dissolution formulation of a calcium receptor-active compound), the patent at issue in the suit, is highly technical and hotly disputed by the parties, Sleet said. Accordingly, it’s inappropriate to terminate the action at this early pleadings stage, the judge said.

The case is set for a five-day bench trial in late April 2019, according to information in the court docket.

Amgen Suing FDA

In addition to its infringement suit against Macleods over its abbreviated new drug application to make a generic version of Sensipar, Amgen is suing the Food and Drug Administration over the agency’s refusal to award it an extra six months of market exclusivity for testing Sensipar in children ( Amgen, Inc. v. Hargan , D.D.C., No. 17-cv-01006, complaint filed 5/25/17 ).

The agency denied pediatric exclusivity for Sensipar May 22. Three days later, Amgen sued the FDA in the U.S. District Court for the District of Columbia, alleging the agency’s denial was arbitrary and conflicted with statutory language governing pediatric exclusivity awards.

The FDA can award pediatric exclusivity—an extra six months of market exclusivity—to a drug sponsor in return for testing the drug in children. Once Sensipar’s patent protection and any associated exclusivity grants run out, the FDA is free to approve generic competitors.

An extra six months on the market without generic competition would be quite lucrative for Thousand Oaks, Calif.-based Amgen.

A hearing in the Sensipar exclusivity case over the parties’ dueling motions for summary judgment seeking to resolve the case in their favor is scheduled for Jan. 11, 2018.

Representing Amgen were the law firms of Fitzpatrick, Cella, Harper & Scinto and Morris, Nichols, Arsht & Tunnell LLP.

Macleods Pharmaceuticals is an Indian corporation based in Mumbai. Co-defendant Macleods Pharma USA Inc., a subsidiary of Macleods Pharmaceuticals, is based in Plainsboro, N.J.

Representing Macleods were the law firms of Amin Talati Upadhye LLP and Stamoulis & Weinblatt LLC.

The case is Amgen, Inc. v. Alkem Labs. Ltd. , 2017 BL 453563, D. Del., Nos. I7-CV-815-GMS C.A. I7-CV-8I7-GMS CONSOLIDATED, 12/19/17 .

To contact the reporter on this story: Dana A. Elfin in Washington at

To contact the editor responsible for this story: Brian Broderick at

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