This post continues our summary of substantive orders in patent litigation in the District of Minnesota. This summary includes a motion to compel production of chemical intermediates from an overseas manufacturer in...more
On April 25, 2023, Bristol-Myers Squibb (“BMS”) filed a complaint in the District of Delaware against AstraZeneca related to AstraZeneca’s anti-PD-L1 antibody product, IMFINZI (durvalumab), alleging willful infringement of...more
On Feb. 5, 2021, the Food and Drug Administration (FDA) granted approval for a new CAR T-cell therapy, Breyanzi® (lisocabtagene maraleucel), to Juno Therapeutics, a subsidiary of Bristol-Myers Squibb (BMS). Breyanzi® is...more
Mark your calendars – on December 9th, the Federal Circuit is slated to hear oral arguments as to whether two Amgen patents claiming a genus of antibodies meet the enablement requirement of 35 U.S.C. § 112. The court’s...more
Eliquis®/apixaban - Case Name: Bristol-Myers Squibb Co. v. Aurobindo Pharma USA Inc., No. 17-374-LPS (Consolidated), 2020 WL 4500226 (D. Del. Aug. 5, 2020) (Stark, J.)...more
September 21, 2019 was the second anniversary of the coming into force of the amended Patented Medicines (Notice of Compliance) Regulations (Regulations) heralding significant changes to the landscape for pharmaceutical...more
On August 13, 2019, the United States District Court for the District of New Jersey, in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., No. 18-cv-14305, held that venue was not proper in New Jersey over...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
The US Court of Appeals for the Federal Circuit dismissed an appeal of an inter partes review (IPR), finding that the challenger lacked appellate standing because it had terminated its attempts to develop the infringing...more
In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., the Federal Circuit dismissed Momenta’s appeal from an adverse IPR decision for lack of standing after Momenta suspended its potentially infringing biosimilar...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
On February 7, 2019, in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company, the Federal Circuit dismissed an appeal brought by a petitioner in an inter partes review (IPR) for lack of standing and mootness because...more
The Federal Circuit just issued a decision that confirms its stance on Article III standing for appeals from inter partes reviews (IPRs), making it tougher for unsuccessful IPR petitioners to obtain judicial review of U.S....more
This morning, the Federal Circuit issued a precedential opinion dismissing Momenta’s appeal from the PTAB’s final written decision upholding the patentability of Bristol-Myers Squibb’s abatacept patents against Momenta’s IPR...more
In 2017, the U.S. Supreme Court issued TC Heartland LLC v. Kraft Foods Group Brands LLC, which was a game changer for patent venue. The case drastically narrowed where defendants can be sued and shifted a significant amount...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
The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues. As we...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
Case Name: Bristol-Myers Squibb Co. v. Mylan Pharms., Inc., Civ. No. 17-379-LPS, 2017 U.S. Dist. LEXIS 146372 (D. Del. Sept. 11, 2017) (Stark, J.)... Drug Product and U.S. Patent: Eliquis® (apixaban); U.S. Patents Nos....more
Addressing venue in the context of Hatch-Waxman litigation, the US District Court for the District of Delaware held that venue is proper in Delaware if a generic drug company has permanent and continuous presence in Delaware...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
We recently reported that Chief Judge Stark of the District of Delaware interpreted the second prong of the patent venue statute, 28 U.S.C. § 1400(b), in Bristol-Myers Squibb Company v. Mylan because the first prong was no...more
The court finds that some physical presence is required to satisfy the venue standard. On September 11, 2017, Chief Judge Leonard Stark of the US District Court for the District of Delaware handed down two decisions...more
As we previously reported, Bristol-Myers Squibb Co. and Ono Pharmaceutical Company sued Merck & Co. in 2015 alleging that Merck’s sale of Keytruda® infringes a patent directed to the use of anti-PD-1 antibody to treat...more