Michael J. Abernathy

IAM Patent 1000 has described Mike as follows: “At trial, Abernathy is a compelling storyteller, but never strays from the substance of his case. He is not afraid to give clients hard advice, which has earned him longstanding relationships of trust.”

With 35 years of litigation experience, Mike advises corporations on the Biologics Price Competition and Innovation Act (BPCIA), the Hatch-Waxman Act, strategic use of IP assets, post-grant review, licensing programs, and patent due diligence issues. He also has litigated emergency injunction proceedings involving pharmaceuticals and medical devices.

A frequent speaker, Mike has presented lectures on trial advocacy to the National Institute for Trial Advocacy, Northwestern University School of Law, the Practising Law Institute, the Bureau of National Affairs, PwC’s National Expert Forum, and the National Business Institute. His topics have included effective storytelling at trial, presentation of electronic demonstratives, use of electronically stored information under the Federal Rules of Evidence, and retention of technical and damages experts. 

• Trial counsel in Value Drug Co. v. Takeda Pharmaceuticals, U.S.A. Inc., No. 21-3500 (E.D. Pa.). After a weeks-long jury trial and just before closing arguments, we secured a favorable settlement for Takeda Pharmaceuticals in a suit brought by drug wholesalers alleging a conspiracy among defendants to restrain trade and monopolize an alleged market for gout drug Colcrys® and its AB-rated generics. The claims were based on separate settlements of Hatch-Waxman litigation brought by Takeda against various generic drug manufacturers. The antitrust plaintiffs claimed the generics would have won the patent litigation but, instead, Takeda and the generics conspired to delay competition through their settlement agreements. After we twice defeated the plaintiffs’ attempt to certify a class, the case proceeded to a jury trial in federal court in Philadelphia as a joinder action brought by 19 wholesalers. This was only the fourth generic delay antitrust case in history to go to trial. The terms of the settlement are confidential.
• Obtained a significant victory as lead counsel for Bausch Health in a Hatch-Waxman case, Salix Pharmaceuticals Ltd. v. Norwich Pharmaceuticals Inc., when the District of Delaware issued an opinion denying Norwich’s motion to modify a judgment blocking it from launching its generic drug under a “skinny label,” preventing Norwich from entering the market until 2029 with its generic version of Xifaxan®, Bausch’s best-selling drug.
• Lead trial counsel for Praxair Inc. (now Linde) in a two-week ANDA trial against Mallinckrodt Pharmaceuticals involving 11 patents related to pharmaceutical product (INOMAX) and associated delivery system. The district court ruled that half of the asserted patents were invalid and the other patents were not infringed, resulting in a complete victory for Praxair. The Federal Circuit affirmed, and The American Lawyer recognized Mike and others on the Morgan Lewis team as “Litigator of the Week.” 
• Lead trial counsel for patent owner Baxalta (now Takeda) in an ITC investigation regarding methods of manufacturing ADVATE—a billion-dollar recombinant factor VIII product. Successfully obtained summary determination of infringement before trial. Following trial, the case settled favorably after the ITC ruled in client’s favor on domestic industry and infringement.
• Lead trial counsel to Takeda/Baxalta in an infringement case involving Genentech’s market-leading drug Hemlibra®, a bispecific antibody treating hemophilia A, which generated $1.4 billion in sales in 2019. Baxalta’s asserted patent relates to antibody preparations to treat hemophilia patients who have developed inhibitors preventing blot clotting. 
• Lead counsel for Merck Sharp & Dohme Corp. in an arbitration against Ligand Pharmaceutical, Inc. involving Verbecestat, a drug to help Alzheimer patients.
• Secured a defense verdict as lead trial counsel for Nestlé Purina Petcare Company where plaintiff sought $73 million in damages for infringement of a patent directed to sodium bentonite formulations.
• Lead counsel for Merck KGaA and related entities in an arbitration against NantKwest and Brink Biologics involving NK-92 cell lines. Successfully moved to dismiss related district court action seeking to enjoin the arbitration.
• Secured a defense victory as co-lead trial counsel for Sigma International (now Baxter Healthcare Corp.) in a patent infringement jury trial against CareFusion Corp. in the Southern District of California over occlusion sensors for infusion pumps. CareFusion had sought $171 million in damages and a permanent injunction. 
• Secured victory as lead trial counsel for Amazon.com in Certain Wireless Consumer Electronic Devices and Components Thereof, No. 337-ITC-853, where complainants sought an exclusion order against the Kindle Fire.
• Lead counsel for Baxter Healthcare Corp. in patent litigation in the Western District of Texas involving methods for remote supervision and verification of pharmacy work. The court granted summary judgment after concluding that the asserted claims of the patent were invalid because the claims involved unpatentable subject matter.
• Obtained a $17 million damages award in the Northern District of California for infringement of three patents related to hemodialysis machines as lead trial counsel for Baxter International Inc. in a patent infringement jury trial.
• Co-lead counsel for Hexagon Metrology Inc. and TESA Technology in a successful settlement in a patent holder's attempt to obtain a preliminary injunction to enjoin the national rollout of a probing system for coordinate measuring machines.
• Lead trial counsel for International Game Technology (IGT) in a patent ownership jury trial in the District of Nevada. The case was successfully settled after the court indicated that it would likely grant IGT's motion for judgment of law upon close of plaintiff's case.