Celgene V. Sun Pharma Global: Satisfying Subject Matter Jurisdiction Under ' 271(e)(2)

• Published date: 29 June 2020
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law
• Law Firm: Mintz
• Author: Mr Adam Samansky, Peter J. Cuomo and Joseph D. Rutkowski

On April 6, 2020, the U.S. District Court for the District of New Jersey, in Celgene Corp. v. Sun Pharma Global FZE, No. 19-cv-10099, denied Sun's motion to dismiss Celgene's claims that Sun's generic Revlimid' (lenalidomide) Abbreviated New Drug Application (ANDA) product infringes three patents not listed in the Orange Book for Revlimid' and for which Sun did not make any Paragraph IV certifications. Sun alleged that under those facts, Celgene's claims lacked subject matter jurisdiction under the Hatch-Waxman Act. The court held that neither the lack of Paragraph IV certification nor the asserted patents' absence from the branded drug's Orange Book entry deprived the court of subject matter jurisdiction under 35 U.S.C. ' 271(e)(2).

Celgene is the maker of the cancer treatment drug, Revlimid'. On May 30, 2018, Sun provided Celgene with Paragraph IV certification letters asserting that its generic lenalidomide drug would not infringe three patents listed in the Orange Book for Revlimid', or that those three patents are invalid. Sun sued Celgene for infringement of those three patents in an earlier action on July 13, 2018. On April 16, 2019, in a new action, Celgene sued Sun under the Hatch-Waxman Act, asserting that Celgene's lenalidomide ANDA product infringes three additional patents, none of which were listed in the Orange Book entry for Revlimid' and none of which were the subject of Sun's Paragraph IV notifications.

Sun moved to dismiss the second infringement suit for lack of subject...