GENERICally Speaking Hatch Waxman Bulletin

The Summer 2021 issue of the GENERICally Speaking email campaign provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation.

A few of the relevant court decisions highlighted in this issue:

• UCB, Inc. v. Catalent Pharma Solutions, Inc.
  Vimpat® (lacosamide)
  No preliminary injunction when Defendant contract manufacturer’s actions of importing, testing, and manufacturing lacosamide products were reasonably related to the submission its customer’s 505(b)(2) drug application with the FDA and protected under the Safe Harbor provision of the Hatch-Waxman Act.
• Silvergate Pharms. Inc. v. Bionpharma Inc.
  Epaned® (enalapril maleate)
  Prosecution-history estoppel and the disclosure-dedication doctrine foreclose plaintiff’s infringement claims.
• Vifor (Int’l) AG v. Mylan Labs. Ltd.
  Vimpat® (lacosamide)
  While the asserted patent claim may have contained an error, it was not obvious that a POSA easily could recognize it, and therefore the PTO, not the court, should consider and deal with any correction determination.
• Mitsubishi Tanabe Pharma Co. v. Sandoz, Inc.
  Invokana® and Invokamet® (canagliflozin),
  Court rejects defendant’s lead-compound analysis and double-patenting arguments, finding the patents-in-suit not invalid.
• UCB, Inc. v. Actavis Labs. UT, Inc.
  Neupro® (rotigotine)
  When a previous covered product, and the patents covering it, shared the same weight ratio claimed in the asserted claims, the court found that the patent-in-suit was anticipated, presumed obvious, and therefore invalid.

Relevant ANDA Updates highlighted in this issue:

• ANDA Approvals
• ANDA Litigation Settlements
• Generic Launches
• New ANDA Cases