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 [...]

No Standing for ANDA Partner to Appeal Unfavorable IPR Ruling

The Federal Circuit recently dismissed an appeal of an adverse IPR decision by a generic pharmaceutical company for lack of Article III standing, finding that the company—which had yet to file an ANDA—had not suffered an injury-in-fact. The underlying IPR, originally filed by Apotex, involved U.S. Patent No. 9,187,405 (directed to methods of treating multiple […]

Clinical Trials Showing that a “Sufficient Percentage” of Prescriptions Will Practice Claimed Method Held to Prove Induced Infringement

Judge Du of the District of Nevada recently issued findings of facts and conclusions of law in a patent trial related to the drug Vascepa®.  Amarin Pharma, Inc. v. Hikma Pharma. USA Inc.  The court ultimately held that the asserted claims were all invalid as obvious.  But first it held that defendants proposed labels would […]


Last month, the Federal Circuit affirmed per curium U.S. District Judge Colm F. Connolly’s order denying Genentech’s request for either a temporary restraining order or a preliminary injunction.  Genentech sought a preliminary injunction to prevent Amgen from selling a generic version of Genentech’s blockbuster cancer drug, Herceptin®.  Amgen launched on the same day the district court […]


Recently, the PTAB denied Gilead Sciences, Inc.’s (Gilead) request to institute an inter partes review of two patents relating to HIV-prevention, U.S. Patent No. 9,044,509 (the ’509 patent) and U.S. Patent No. 9,579,333 (the ’333 patent). One key reason for the denial was because Gilead failed to adequately address unexpected results in its Petition. The […]

Federal Circuit Holds Claim Can Be Obvious Where a Combination of References Would Inherently Meet Claim Element

Just before the New Year, the Federal Circuit affirmed a decision from the District of Delaware finding patent claims related to using Zohydro ER in patients having hepatic impairment (liver disfunction) invalid as obvious. Persion Pharm. LLC v. Alvogen Malta Oper. Ltd. Some of the claims at issue included pharmacokinetic limitations requiring that the serum […]

MAGIC: Would Circumventing the Biosimilar Approval Process Expedite the Availability of Generic Insulin?

Part of the ACA’s sweeping healthcare reform was the Biologics Price Competition and Innovation (BCPI) Act of 2009, which re-classified certain drugs that had previously been regulated under the Food, Drug and Cosmetic Act. Insulin, for example, has historically been treated as a drug product, but will be classified as a biological product (and, therefore, […]