With an in-depth understanding of the industry and a hands-on approach to the complex litigation and unique compliance issues his clients face, Cliff Katz represents generic pharmaceutical companies in a wide range of matters.
Cliff complements his meticulous attention to detail with a perspective that incorporates broader business concerns into individual case strategies. Able to collaborate effectively and efficiently with c-suite executives and front-line workers alike, Cliff consistently positions his pharma clients for favorable outcomes that align with their short and long-term goals.
Cliff’s litigation practice includes defending generic pharmaceutical manufacturers in matters involving pharmaceutical pricing, antitrust, breach of contract, federal and state false claims acts, consumer protection laws, fraud, class actions, products liability, opioid-related claims, and Hatch-Waxman patent litigation.
With a focus on minimizing costs and disruption without sacrificing thorough evaluation, analysis, and preparation, Cliff has earned the trust of clients who know he will always have matters well in hand.
Cliff also leverages his deep industry knowledge outside the courtroom, counseling his generic pharmaceutical clients on consequential transactions and strategic initiatives. His thoughtful, informed, and actionable guidance helps clients identify and address potential compliance and financial pitfalls in transactions with business partners, customers, and vendors.
His counsel extends to wholesaler agreements, chain pharmacy agreements, GPO agreements, CMO agreements, ANDA purchase agreements, receivables purchase agreements, employment agreements, Medicaid and Medicare issues, pricing and antitrust policies, and opioid-related obligations and liabilities as well.
Represented generic pharmaceutical company through trial in breach of contract action relating to the acquisition of a company.
Represented generic pharmaceutical companies in breach of contract actions involving the manufacturing, supply and marketing of drugs.
Represented generic pharmaceutical company in breach of contract action involving the development of a drug.
Represented generic pharmaceutical company in breach of contract action involving alleged force majeure issues.
Represented generic pharmaceutical company in breach of contract action involving the supply of a medical device.
Represented generic pharmaceutical companies in breach of contract actions relating to employment of temporary and permanent employees.
Representing generic pharmaceutical companies in the negotiation of contracts with wholesalers, pharmacies, group purchasing organizations, suppliers and other customers and vendors.
Representing generic pharmaceutical company in negotiating co-development agreements.
Representing generic pharmaceutical company in negotiating sale of assets.
Representing generic pharmaceutical company in negotiating manufacturing and supply agreements.
Represented generic pharmaceutical company in negotiating financing transactions.
Assisted in successfully defending a major alarm service company in actions seeking damages for losses sustained as the result of the alarm company’s alleged gross negligence and breach of contract.
Represented a national life insurance company in a variety of actions alleging fraud, breach of contract and negligence.
Represented a life insurance trade association as amicus curiae in the Delaware Supreme Court. Assisted life insurance companies in obtaining a decision by the Delaware Supreme Court holding stranger-originated life insurance (STOLI) illegal and against public policy, and permitting life insurance companies to challenge STOLI policies as void ab initio after the expiration of the two-year statutory contestability period.
Antitrust and Pricing
Representing a generic pharmaceutical company in the multidistrict antitrust litigation, In re Generic Pharmaceuticals Pricing Antitrust Litigation. This MDL includes actions brought by private class action plaintiffs and state attorneys general.
Represented a generic pharmaceutical company in an action concerning the enforcement of a Hatch-Waxman settlement agreement.
Represented a generic pharmaceutical company in a “pay-for-delay” antitrust investigation.
Counseling generic pharmaceutical companies on pricing and antitrust policies.
Counseling generic pharmaceutical companies on reporting of prices under state drug price transparency laws.
Products Liability and Opioids
Obtained a dismissal of all claims against a generic pharmaceutical company in the multidistrict litigation, In re: Zantac (Ranitidine) Products Liability Litigation.
Representing a generic pharmaceutical company in the multidistrict litigation, In re: National Prescription Opiate Litigation.
Counseling generic pharmaceutical companies on insurance coverage for opioid-related claims.
Counseling generic pharmaceutical company on policies relating to controlled substances.
Fraud / False Claims Acts / Consumer Protection Acts
Represented multinational pharmaceutical manufacturers in numerous federal and state actions across the country, concerning alleged violations of federal and state false claims acts, state consumer protection and deceptive trade practices acts, false advertising acts, and common law fraud in connection with the Medicaid and Medicare programs and health plans. These actions have included qui tam litigation, class action litigation, as well as cases brought by the United States Department of Justice and state attorneys general. In these actions, Cliff has taken and defended more than 75 depositions of qui tam relators, federal Medicare and Medicaid officials, state agency officials from more than a dozen states, present and former pharmaceutical company employees, wholesalers, pharmacies, pharmacy associations, pharmaceutical industry publishers, Medicaid fiscal agents and industry consultants.
Represented eligible telecommunications carriers (ETCs) in investigations by the Office of Inspector General (OIG) of the Federal Communications Commission (FCC) with respect to the federal Lifeline program.
Member of the team that prosecuted claims for approximately $1.2 billion on behalf of JPMorgan Chase Bank, against 11 insurance companies over surety bonds written in connection with transactions that the bank entered into with Enron Corp. A favorable settlement was achieved after closing arguments following a month-long trial.
Represented multinational generic pharmaceutical manufacturers in Hatch-Waxman patent litigation, trials and appeals, including:
- Forest Laboratories, LLC v. Breckenridge Pharmaceutical, Inc., Civil Action No. 14-1504-SLR (D. Del.), and Appeal No. 2017-2369 (Fed. Cir.) (asenapine maleate)
- Novartis Pharm. Corp. v. Natco Pharma Ltd., Civil Action No. 1:15-cv-00987-LPS (D. Del.) (imatinib)
- Eli Lilly & Co. v. Lupin Ltd., Civil Action No. 1:15-cv-673 (S.D. Ind.) (prasugrel)
- Daiichi Sankyo Company, Ltd. v. Accord Healthcare Inc., USA, IPR201501881, IPR201501882 (PTAB), and Appeal No. 171052 (Fed. Cir.) (prasugrel)
- Endo Pharmaceuticals Solutions Inc. v. Paddock Laboratories, LLC, Civil Action No. 14-1422-SLR (D. Del.) (testosterone undecanoate)
- AstraZeneca AB et al. v. Lupin Limited, Civil Action No. 3:15-cv-6092 (D.N.J.) (esomeprazole)
- Forest Laboratories, LLC v. Lupin Limited, Civil Action No. 1:14-cv-01058-LPS (D. Del.) (memantine XR)
- Otsuka Pharmaceutical Co., Ltd. v. Lupin Atlantic Holdings SA, Civil Action No. 1:14-cv-07105-JBS-KMW (D.N.J.) (aripiprazole)
- G.D. Searle LLC v. Lupin Pharmaceuticals Inc., Civil Action No. 13-CV-121 (E.D.Va.) and Appeal No. 2014-1476 (celecoxib)
- Sciele Pharma, Inc. v. Lupin Pharmaceuticals, Civil Action No. 09-CV-0937 (D. Del.) and Appeal No. 2012-1228 (Fed. Cir.) (metformin ER)
- Orexo AB v. Mylan Pharmaceuticals Inc., Civil Action No. 11-CV-03788 (D.N.J.) (zolpidem)
Representing a media company in actions involving ad insertion technology.
Represented a national testing laboratory in actions concerning patent infringement and breach of contract.
Represented disabled children and parents in actions against the New York City Department of Education under the Individuals with Disabilities Education Improvement Act.
Represented A Foundation Building Strength for Nemaline Myopathy.