API Manufacturer Protected by Safe Harbor Provision for Customer’s Use “Reasonably Related” to ANDA Filing

Last week, the Eastern District of Kentucky declined to stop a third-party company from importing a key pharmaceutical compound on behalf of a generic drug developer, holding that the company was protected by the Hatch-Waxman Act’s “safe harbor” provision. Although the importer itself was not developing the generic drug, its actions were “in furtherance” of […]

Court Refuses to Correct Patent Error that Requires a Multi-Step Analysis to Uncover

The District Court of New Jersey declined Plaintiffs’ Vifor (International) AG and American Regent, Inc. request for judicial correction of what they argued was an obvious error in a patent related to Injectafer®.  Vifor (International) AG v. Mylan Laboratories Limited, 19-cv-13955 (D.N.J. April 26, 2021).  While Vifor may still seek correction at the USPTO, the […]

Amgen v. Sanofi – Federal Circuit Focuses on Functional Claim Elements in Affirming Invalidity of Antibody Patent Claims as Not Enabled

Recently, the Federal Circuit affirmed the decision of the U.S. District Court for the District of Delaware holding claims covering two Amgen-owned patents invalid for lack of enablement under 35 U.S.C. § 112.  Amgen Inc., v. Sanofi, 2021 U.S. App. LEXIS 3952 (Fed. Cir. 2021).  The patents at issue are directed to antibodies that bind […]

FEDERAL CIRCUIT SIGNALS CHANGE IN COURSE IN “SKINNY LABEL” SAGA

As predicted in our October 29th post, Teva sought rehearing en banc of the Federal Circuit’s re-instatement of a $235 million jury verdict against it for induced infringement despite its “skinny label” carve out of the patented use.  In the original ruling the Federal Circuit held that Teva was liable for damages during a period […]

FEDERAL CIRCUIT FINDS VENUE PREMISED ON FUTURE INFRINGING SALES IMPROPER IN HATCH-WAXMAN SUITS

Last week, in Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., the Federal Circuit held that venue based on “acts of infringement” in Hatch-Waxman cases must be predicated “on past acts of infringement—i.e., acts that occurred before the action alleging infringement was filed.”  In ANDA cases, “those acts occur only in districts where actions […]

“Skinny Labels” Leave the Door Open for Significant Damage Awards

On October 9th, we wrote about a potentially significant Federal Circuit decision concerning “skinny” labels in GSK v. Teva.  Today we write to discuss another important facet of this decision: guidance concerning the availability of lost profits in the generic drug context.  This case involved GlaxoSmithKline’s (“GSK’s”) patent covering the use of carvedilol (sold as […]

CAFC Limits Ability of Generics to Rely on Section viii Indication Carve-Outs

Last Friday (GSK v. Teva), a split panel of the Federal Circuit (“CAFC”) may have drastically limited the effectiveness of Section viii carve-outs when it reinstated a $235 million jury verdict against Teva, concluding that substantial evidence supported the jury’s finding of induced infringement.  Patent owner GlaxoSmithKline (“GSK”) sued Teva in the District of Delaware […]

Privilege Considerations When Engaging in Transactions for Patents Likely to be Litigated

A district court recently compelled production of numerous documents over a party’s privilege and work product claims. Although the case is not specific to Hatch-Waxman litigation, it serves as an important reminder of the standards necessary to establish privilege and work product protections. The case also highlights how transactional work, tangential to a litigation, may […]

Breadth of Noven’s Claims to “Transdermal” Drug Delivery System Leads to Holding of Invalidity Under § 112

Judge Stark of the District of Delaware invalidated three Noven patents directed to its Minivelle estrogen therapy patch under § 112, finding that each claim failed to enable and provide written description support for the full scope of the claim.  Noven Pharms., Inc. v. Amneal Pharms. LLC, No. 18-699 (D. Del. 2020).  Noven’s Minivelle product, […]

Judges Vary on Cross-Use Provisions in Protective Orders

Judge Andrews of the District of Delaware recently provided some guidance on protective order issues in Hatch-Waxman cases.  Allergan USA, Inc. v. Aurobindo Pharma Ltd.  At issue was whether Plaintiffs should be permitted to disclose one defendant’s confidential information to another defendant. While acknowledging it was a close call, Judge Andrews ultimately rejected Plaintiffs’ position [...]