Drug Company Sues Over Exclusivity Loss for Generic Tecfidera

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By Dana A. Elfin

Lachman Consultant Services Inc. mishandled filing Pharmathen SA’s application to make a generic version of the blockbuster multiple sclerosis drug Tecfidera, according to a new lawsuit.

The suit, filed Nov. 21 in the U.S. District Court for the Southern District of New York, alleges the consulting firm negligently caused Pharmathen to lose out on first-to-file exclusivity rights on generic Tecfidera. The first generic applicant to challenge the patent on a drug is eligible for six months of market exclusivity on the generic ( Pharmathen S.A. v. Lachman Consultant Services Inc. , S.D.N.Y., No. 17-cv-09127, complaint filed 11/21/17 ).

The suit is one of the first of its kind, according to a Matt Hyams, spokesman for Pillsbury Winthrop Shaw Pittman LLP, which filed the complaint for Pharmathen. Branded Tecfidera, made by Cambridge, Mass.-based Biogen Inc., is projected to generate $4 billion in 2018 sales, making the rights for six months of market exclusivity on the first generic version of the blockbuster exceedingly valuable.

Pharmathen, a Greek drug company, hired Lachman to assist it with filing an abbreviated new drug application to make a generic version of Tecfidera (dimethyl fumarate) with the Food and Drug Administration. Its complaint alleges breach of contract, gross negligence, and negligent performance of services. According to Pharmathen, Lachman didn’t submit Pharmathen’s ANDA on time, causing it to forfeit any potential marketing exclusivity rights in generic Tecfidera.

Several other generic filers filed by the required deadline, Pharmathen said, but Lachman didn’t file Pharmathen’s ANDA until a day after the deadline to be eligible for the marketing exclusivity rights.

“Lachman’s failure to file the ANDA by the required deadline is incurable, and Pharmathen has forever lost its potential first-to-file marketing exclusivity rights for a generic version of Tecfidera as a result,” the complaint said. Pharmathen estimates its loss to be “tens if not hundreds of millions of dollars of revenue.”

Pharmathen is also seeking attorneys’ fees.

Bloomberg Law contacted Westbury, N.Y.-based Lachman for comment but no one was available to respond.

To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bloomberglaw.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bloomberglaw.com

For More Information

The complaint is at http://src.bna.com/ut4.

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