IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
Case Name: Celgene Corp. v. Mylan Pharms., Inc., No. 2021-1154, 2021 WL 5143311 (Fed. Cir. Nov. 5, 2021) (Circuit Judges Prost, Chen, and Hughes presiding; Opinion by Prost, J.) (Appeal from D.N.J., Salas, J.) Drug Product...more
The question of the proper court for a branded pharmaceutical maker to bring suit against an Abbreviated New Drug Application filer under the Hatch-Waxman Act is surprisingly unsettled seeing as the Act was enacted in 1984. ...more
Since the Supreme Court’s ruling in TC Heartland, there has been increased litigation over appropriate venue in patent litigation, including Hatch-Waxman cases. 28 U.S.C. § 1400(b) provides that venue in patent infringement...more
In Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., No. 2019-2402 (Fed. Cir. Nov. 5, 2020), the Federal Circuit clarified the venue analysis of 28 U.S.C. § 1400(b), which controls venue for patent...more
On November 5, 2020, the United States Court of Appeals for the Federal Circuit, in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., No. 19-2402, resolved a split among district courts over what constitutes...more
Last week was argument week at the Federal Circuit, which as usual meant the Court issued several Rule 36 affirmances and short non-precedential decisions. But tucked in between those was at least one case—a Hatch-Waxman...more
Somewhat remarkably, there is no settled Federal Circuit precedent regarding where a patentee can bring suit against a generic competitor in Hatch-Waxman litigation under 35 U.S.C. § 271(e)(2). While recognizing that this...more
The Federal Circuit Thursday issued a decision that narrows the venue options available to patent owners bringing suit against generic drug manufacturers under the Hatch-Waxman Act. In a unanimous decision, the court held...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
On April 17, 2019, Judge Gilstrap of the United States District Court for the Eastern District of Texas, in Apicore v. Beloteca, No. 19-cv-00077, held that while the court could exercise personal jurisdiction over a generic...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
A Complaint Identifying Infringing Products and the Patents Allegedly Infringed, Accompanied by Statements that the Products Meet All Elements of at Least One Claim of the Asserted Patents, May be Sufficient to Meet the...more
The US District Court for the Northern District of Texas found that venue was not proper under 28 USC § 1400(b) because Teva Pharmaceuticals USA did not commit any act of infringement in the Northern District of Texas, nor...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
The issue of venue—where geographically a case can be brought—and jurisdiction are a pair of principles to determine in which forum a case can properly be brought. Jurisdiction in personam concerns whether a particular party...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