Life Sciences Litigation and Post-Grant Proceedings

We have extensive experience in developing case winning strategies and doing the day-to-day work that is required in complex legal disputes involving small molecule drugs, biologics, biotechnology, and medical devices. Our group has handled dozens of life sciences cases in federal district and appellate courts, including ANDA (or Hatch-Waxman) cases and cases seeking freedom to operate. We have also advocated for our biopharma clients in arbitrations, mediations, and contested PTO proceedings, including numerous post-grant proceedings before the PTAB. 

In addition, our group has years of experience coordinating global patent litigation and prosecution activities. We also have a deep understanding of the regulatory approval processes for biopharma products, which permits us to advise clients on patent regulatory strategies from the earliest stages of research through regulatory approval and commercialization.

Our professionals are remarkably versatile in their ability to master complicated subject matters in a variety of specialized fields and to use that information to develop sophisticated arguments. We also have extensive experience working with world-renowned experts to develop such arguments and to present highly technical information in an understandable way in the courtroom.

We strive to handle each case in an efficient and cost-effective manner. We assemble a team that is lean, flexible, and efficient while also representing the best that our group has to offer in terms of experience. In addition, we use WBD’s own internal document review services to significantly reduce the cost of document discovery, typically one of the most expensive phases of any litigation. 

• Ferring Pharmaceuticals Inc. et al. v. Finch Therapeutics Group, Inc. et al., D. Del. (No. 21-1694-RGA). Represent Ferring and Rebiotix in a freedom to operate litigation involving a microbiota transfer biologic.
• Ferring Pharmaceuticals Inc. et al. v. Fresenius Kabi USA, LLC, D. Del. (No. 20-cv-431-MN). Represent Ferring and Polypeptide Laboratories A/S in a Hatch-Waxman litigation involving an ANDA filed by Fresenius for a generic version of Ferring’s FIRMAGON product. Awaiting decision.
• Ferring Pharmaceuticals Inc. et al. v. Lupin Inc., D. Del. (No. 19-913-RGA). Represented Ferring in a Hatch-Waxman litigation in involving an ANDA filed by Lupin for a generic version of Ferring’s CLENPIQ product, Ferring’s low volume bowel prep for cleansing of the colon as a preparation for colonoscopy. The parties reached a settlement prior to trial.
• Ferring B.V. et al. v. Allergan Inc. et al., S.D.N.Y. (No. 12-cv-2650) & Fed. Cir. (No. 20-1098). Represented Ferring in an action related to correction of inventorship claims and counterclaims over patents directed to desmopressin. Prior to our involvement, the court dismissed on summary judgment, inter alia, Ferring’s claims challenging inventorship based on equitable estoppel. We represented Ferring in a bench trial, after which the district court entered judgment against Defendants that the named inventor was not a co-inventor of Ferring’s patent claims. We then successfully appealed the grant of summary judgment that Ferring’s inventorship claim was equitably estopped, and the remaining counterclaims were dismissed.
• Ferring Pharmaceutical Inc. et al. v. Serenity Pharmaceuticals, LLC. et al., S.D.N.Y. (No. 17-cv-09922-CM-SDA). Represented Ferring in an action seeking a declaratory judgment that Ferring did not infringe Defendants’ patent claims. After it denied Defendants’ motion for a preliminary injunction, the district court held its first fully remote trial over 9 days. The court ruled in favor of Ferring, awarded fees, and held Serenity’s patents invalid for written description, enablement, and improper inventorship.
• Ferring Pharmaceuticals Inc. et al. v. Par Pharmaceutical, Inc., D. Del. (No. 15-173-RGA) & No. 2017-2399 (Fed. Cir.). Represented plaintiff Ferring in a Hatch-Waxman litigation involving an ANDA filed by Par for a generic version of Ferring’s PREPOPIK drug product, which was indicated for cleansing of the colon as a preparation for colonoscopy. Par dropped all invalidity challenges with prejudice prior to trial, and the district court ruled that Par’s ANDA product and process infringed. Par appealed, and the Federal Circuit issued a Rule 36 affirmance of the district court’s finding. 
• Represented a pharmaceutical company in a dispute involving multiple patent infringement litigations in three jurisdictions, more than ten IPRs challenging patents asserted against our client, one IPR challenging one of our client’s patents, and multiple Federal Circuit appeals. Throughout many of these matters, our team has successfully coordinated with our ANDA litigation team on cases for two products. 
• Represented a pharmaceutical company defending against a series of IPR petitions filed by multiple petitioners seeking to invalidate a patent directed to a method of treating a medical condition. 
• Successfully represented a genomics technology company in the preparation and filing of three IPR petitions against patents asserted in litigation, resulting in settlement of the related litigation. 
• Represented an analytical technology company serving the life sciences industry in post grant challenges as both petitioner and patent owner for patents generally relating to chromatography and medical device testing.
• Represented a multinational chemical company and a global healthcare company defending patents relating to antimicrobial polymers and proteinase inhibitors.