In 2023, pharmaceutical patent owners filed nearly 250 infringement complaints against generic drug manufacturers. More than 90% of those cases were filed in the Districts of Delaware or New Jersey. This year's filings...more
When there are multiple ANDA filers for the same drug, it may not be possible for a branded pharmaceutical company to bring Hatch-Waxman Act patent infringement suits against all of them in the same court consistent with the...more
In Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc. the Federal Circuit decided that, for the purpose of establishing venue in ANDA litigation, the place “where an act of infringement has occurred”...more
On June 17, 2019, the United States District Court for the District of Delaware, in Novartis Pharmaceuticals Corp. v. Accord Healthcare Inc., et al., No. 18-cv-01043, held that venue was not proper in Delaware over Mylan...more
Case Name: Bristol-Myers Squibb Co. v. Aurobindo Pharma USA Inc., C.A. No. 17-374-LPS (Consolidated), 2018 U.S. Dist. LEXIS 179154 (D. Del. Oct. 18, 2018) (Stark, J.)....more
The District of Delaware dismissed a Hatch-Waxman Act ANDA lawsuit that Bristol-Myers Squibb had filed against Mylan Pharmaceuticals, finding that under the new venue rules established by the Supreme Court’s TC Heartland...more
On October 18, 2018, the United States District Court for the District of Delaware, in Bristol-Myers Squibb v. Mylan Pharmaceuticals Inc., No. 17-00379, held that venue was not proper in Delaware over Mylan Pharmaceuticals...more
Addressing a motion to dismiss for improper venue following TC Heartland, a Delaware district court held that an abbreviated new drug application (ANDA) filer that intends to market an allegedly infringing drug in a certain...more
There have been two interpretations of the “acts of infringement” language in the patent venue statute regarding ANDA submissions in Hatch-Waxman litigation....more
In light of the Supreme Court’s TC Heartland decision, courts around the country have been grappling with venue-related challenges in patent cases. Under the patent venue statute, 28 U.S.C. § 1400(b), venue is proper “where...more
The U.S. District Court for the District of Delaware recently handed down two important decisions on motions to transfer for improper venue. Judge Stark presided over both cases, transferring one case and ordering further...more
Last Spring, the Supreme Court in TC Heartland LLC v. Kraft Foods Group Brands LLC held that the word "resides" in the patent venue statute, 28 U.S.C. § 1400(b), "refers only to the State of incorporation" of the alleged...more
Hatch-Waxman litigators are accustomed to cases with multiple generic drug company defendants. Brand drug company plaintiffs often sue multiple defendants in the same district court, even when those defendants are not...more