Michael J. Gaertner

Michael Gaertner represents pharmaceutical, biotechnology and chemical companies in intellectual property litigation, regulatory and antitrust matters. Michael has appeared as lead trial counsel in courts across the United States and has argued appeals before multiple courts, including the U.S. Court of Appeals for the Federal Circuit. Previously, Michael served on the Firm's Executive Committee.

IP Pharmaceutical & Biotechnology; Hatch-Waxman Litigation

Michael has significant experience representing clients in patent infringement litigation arising under the Hatch-Waxman Act and providing advice on related regulatory matters before the Food and Drug Administration, such market exclusivity issues and Citizen Petitions.

He represents clients in litigation and counseling matters involving:

• Pharmaceutical dosage forms, such as tablet and capsule, injection, liquid, lotion, ointment, patch, solution and suspension
• Active pharmaceutical ingredients
• Medical devices
• Manufacturing processes
• Methods of treatment

Michael's clients have included brand and generic pharmaceutical companies, biotechnology companies, API manufacturers and research organizations.

Antitrust

Michael represents clients in complex antitrust matters and litigates antitrust/unfair competition litigation claims in federal and state courts and before the Federal Trade Commission.

He acts as counsel in litigation and counseling matters involving:

• Allegations of price-fixing and collusion
• Exclusive dealing arrangements
• Allegations of abuse or unlawful acquisition of monopoly power
• Acquisitions of corporations or assets

Intellectual property litigation among actual and potential competitors often involves antitrust counterclaims, ranging from claims based in allegations of fraud on the patent office to sham litigation. Michael has significant experience representing pharmaceutical companies in connection with antitrust claims involving anticompetitive conduct specific to the pharmaceutical industry, such as allegations of improper Orange Book listings, product switching, improper citizen petitions and misuse of Risk Evaluation and Mitigation Strategies (REMs).

Business Litigation and Dispute Resolution

Michael represents clients in complex litigation matters in court and in arbitrations and mediations. Michael has experience in emergency proceedings (such as motions for temporary restraining orders and preliminary injunctions), at trial and before the appellate courts. His clients are in a variety of industries, including consumer products, financial services, insurance, manufacturing, pharmaceutical and real estate.