Consulting Firm Sued Over Timing of FDA Generic Drug Application

Drug company consultants beware: A new type of lawsuit may be coming your way.

Greek company Pharmathen S.A. is suing Lachman Consulting Services Inc. for breach of contract, gross negligence and negligent performance of services in connection with its filing of an application to make a generic version of the blockbuster multiple sclerosis drug Tecfidera.

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 by not filing Pharmathen’s abbreviated new drug application on time. The first generic applicant to challenge the patent on a drug is eligible for six months of market exclusivity on the generic, which can be extremely lucrative financially.

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.

The suit is one of the first of its kind, according to Matt Hyams, spokesman for Pillsbury Winthrop Shaw Pittman LLP, which filed the complaint for Pharmathen.

Pharmathen is seeking damages and attorneys’ fees.

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

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