Novartis hits Regeneron with IP suit over manufacturing process for eye treatment

lawsuit and book
Regeneron believes it has a strong defense against Novartis’ claim. (Shutterstock)

Novartis is suing Regeneron for patent infringement over the manufacturing process used to produce its Eylea and Zaltrap eye treatments that Novartis says infringes on its Lucentis patents.

The lawsuit (PDF) was filed in the U.S. District Court for the Southern District of New York and seeks compensatory damages for Regeneron’s infringement together with interest and costs. Novartis’ claims are related to a vector for expression of a polypeptide in a mammalian cell. Vectors are used routinely in developing biologic drugs. 

In a response (PDF) to the suit, Regeneron said it believes it has a strong defense against Novartis’ claim.

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“We note that in 2011, Novartis had brought litigations alleging infringement of the ‘688 (U.S. Patent 5,688,688 owned by Novartis) against Biogen Inc., MedImmune and Alexion Pharmaceuticals, Inc.” Regeneron said in a statement. It noted that those cases were later resolved by settlement.

Earlier this month, Regeneron reported it conducted a thorough review of its manufacturing processes and supply chain as part of its investigation into a spike in a rare side effect that was discovered with some patients taking Eylea. Though the company said it found no issues with the drug or its manufacturing, it did uncover an association between the problem and some Becton Dickinson syringes that were distributed in the U.S.

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