How Michael Helps Clients
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.
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.
Awards and Recognitions
- Named, No. 2 Best Performing Attorney (Defendant), No. 4 Most Active Attorney (Defendant) and No. 6 Best Performing Attorney Overall, Patexia ANDA Litigation Intelligence Report (2024)
- Named, No. 2 Best Performing Attorney (Defendant) and No. 5 Most Active Attorney (Defendant), Patexia ANDA Litigation Intelligence Report (2023)
- Named, 1st Most Active Attorney (Defendant), Patexia ANDA Litigation Intelligence Report (2022)
- Named, Top ANDA Litigator, Patexia ANDA Litigation Intelligence Report (2021-2024)
- Named, Illinois Super Lawyers®, Intellectual Property Litigation (2013-2020, 2022-2024)
- Named, Leading Lawyers℠, Commercial Litigation (2015-2020)
- Recognized, Martindale-Hubbell® AV Preeminent™ (1999-2020)
- Recognized, IAM Patent 1000 (2023-2024)
William & Mary School of Law, JD, 1989, Order of the Coif, Law Review Executive Editor
John Carroll University, B.S.B.A., 1986
- Illinois
- Trial Bar Northern Illinois
- U.S. Court of Appeals for the Eighth Circuit
- U.S. Court of Appeals for the Federal Circuit
- U.S. Court of Appeals for the Second Circuit
- U.S. Court of Appeals for the Seventh Circuit
- U.S. District Court for the Central District of Illinois
- U.S. District Court for the Western District of Pennsylvania
- U.S. Supreme Court