Generic Pharmaceutical Litigation and Counseling
Generic Pharmaceutical Litigation and Counseling
Kelley Drye’s Generic Pharmaceutical Litigation Team has a deep understanding of the generic pharmaceutical industry, earned over a two-decade partnership working alongside generic companies.  We offer clients legal counsel grounded in a strong knowledge of sales, marketing, pricing practices, patents, trademarks, the inner workings of Medicare, Medicaid and private insurers, and the competitive pharmaceutical industry landscape.
Kelley Drye serves generic pharmaceutical clients in the following areas:
 
  • Antitrust and Pricing

  • Fraud, False Claims, Consumer Protection and Deceptive Trade Practices

  • Contracts

  • Opioids

  • Patents – Hatch Waxman

  • Patents – Medical Devices

  • Labor and Employment

  • Advertising Law Litigation and Counseling

  • Export Controls and Sanctions Compliance
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 state attorneys general, private class action plaintiffs, and individual private party plaintiffs.

  • Representing generic pharmaceutical companies in a “pay-for-delay” antitrust litigations and investigations.

  • Represented a generic pharmaceutical company in an action concerning the enforcement of a Hatch-Waxman settlement agreement.

  • Counseling generic pharmaceutical companies on the setting of published prices and contract prices.

  • Counseling generic pharmaceutical companies on the creation of pricing and antitrust policies.

Fraud, False Claims, Consumer Protection and Deceptive Trade Practices
 
  • Representing multinational generic 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 private insurance health plans.  These actions have included qui tam litigation, class action litigation, and actions brought by the United States Department of Justice and state attorneys general.

  • Representing multinational generic pharmaceutical manufacturers in state attorney general action concerning covered outpatient drugs.

  • Counseling pharmaceutical manufacturer on product disparagement claims.

Contracts
 
  • Representing generic pharmaceutical companies in breach of contract actions involving the manufacturing, supply and marketing of drugs.

  • Representing generic pharmaceutical companies in the negotiation of contracts with wholesalers, pharmacies, group purchasing organizations, suppliers and other customers and vendors.

  • Represented generic pharmaceutical company in negotiating co-development agreements.

  • Represented generic pharmaceutical companies in breach of contract action relating to asset purchase.

  • Represented generic pharmaceutical companies in breach of contract action with device supplier.

Opioids
 
  • Counseling multinational generic pharmaceutical manufacturers on insurance coverage, drug acquisitions, and reporting obligations.

Patents – Hatch Waxman

We have represented multinational generic pharmaceutical manufacturers in Hatch-Waxman patent litigation, trials and appeals, concerning the following drugs:
 
  • aripiprazole
  • asenapine maleate
  • celecoxib
  • cisplatin
  • esomeprazole
  • eszopiclone
  • gabapentin
  • iloperidone
  • imatinib
  • lanthanum carbonate
  • levoleucovorin injection
  • loratadine
  • memantine HCl
  • memantine HCl ER
  • levoleucovorin injection
  • loratadine
  • memantine HCl
  • memantine HCl ER
  • metaxalone
  • metformin ER
  • methylphenidate
  • mirtazapine
  • mixed amphetamine salts
  • modafinil
  • metaxalone
  • metformin ER
  • methylphenidate
  • mirtazapine
  • mixed amphetamine salts
  • modafinil
  • pitavastatin calcium
  • testosterone undecanoate
  • testosterone gel
  • omeprazole
  • oral contraceptives
  • oxaliplatin
  • prasugrel
  • quetiapine
  • ropivacaine injection
  • zolpidem tartrate sublingual

Patents – Medical Device
 
  • Represented generic pharmaceutical company in Hatch-Waxman patent litigation concerning intravenous bags used with ropivacaine HCl injection.

  • Counseled generic pharmaceutical company concerning a biosimilar drug and injection device.

  • Represented a major consumer electronics and medical device maker in patent infringement and antitrust suit involving 24 patents on pulse oximetry technology.

  • Represented one of the world’s largest manufacturers of contact lenses in an infringement lawsuit concerning a patent on extended-wear lenses.

  • Provided strategic advice and management of the worldwide patent and trademark portfolio for a client designing medical devices for use in the treatment of and operation on the body’s distal extremities.

  • Represented medical device company against claims of infringement of patents covering surgical guides used during knee implant surgery.

  • Represented manufacturer of cosmetic lasers in patent infringement litigation.

Labor and Employment
 
  • Counseling multinational generic pharmaceutical manufacturers on employee disputes and internal management of employees.
 
 

Overview

Kelley Drye’s Generic Pharmaceutical Litigation Team has a deep understanding of the generic pharmaceutical industry, earned over a two-decade partnership working alongside generic companies.  We offer clients legal counsel grounded in a strong knowledge of sales, marketing, pricing practices, patents, trademarks, the inner workings of Medicare, Medicaid and private insurers, and the competitive pharmaceutical industry landscape.
Kelley Drye serves generic pharmaceutical clients in the following areas:
 
  • Antitrust and Pricing

  • Fraud, False Claims, Consumer Protection and Deceptive Trade Practices

  • Contracts

  • Opioids

  • Patents – Hatch Waxman

  • Patents – Medical Devices

  • Labor and Employment

  • Advertising Law Litigation and Counseling

  • Export Controls and Sanctions Compliance

Experience

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 state attorneys general, private class action plaintiffs, and individual private party plaintiffs.

  • Representing generic pharmaceutical companies in a “pay-for-delay” antitrust litigations and investigations.

  • Represented a generic pharmaceutical company in an action concerning the enforcement of a Hatch-Waxman settlement agreement.

  • Counseling generic pharmaceutical companies on the setting of published prices and contract prices.

  • Counseling generic pharmaceutical companies on the creation of pricing and antitrust policies.

Fraud, False Claims, Consumer Protection and Deceptive Trade Practices
 
  • Representing multinational generic 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 private insurance health plans.  These actions have included qui tam litigation, class action litigation, and actions brought by the United States Department of Justice and state attorneys general.

  • Representing multinational generic pharmaceutical manufacturers in state attorney general action concerning covered outpatient drugs.

  • Counseling pharmaceutical manufacturer on product disparagement claims.

Contracts
 
  • Representing generic pharmaceutical companies in breach of contract actions involving the manufacturing, supply and marketing of drugs.

  • Representing generic pharmaceutical companies in the negotiation of contracts with wholesalers, pharmacies, group purchasing organizations, suppliers and other customers and vendors.

  • Represented generic pharmaceutical company in negotiating co-development agreements.

  • Represented generic pharmaceutical companies in breach of contract action relating to asset purchase.

  • Represented generic pharmaceutical companies in breach of contract action with device supplier.

Opioids
 
  • Counseling multinational generic pharmaceutical manufacturers on insurance coverage, drug acquisitions, and reporting obligations.

Patents – Hatch Waxman

We have represented multinational generic pharmaceutical manufacturers in Hatch-Waxman patent litigation, trials and appeals, concerning the following drugs:
 
  • aripiprazole
  • asenapine maleate
  • celecoxib
  • cisplatin
  • esomeprazole
  • eszopiclone
  • gabapentin
  • iloperidone
  • imatinib
  • lanthanum carbonate
  • levoleucovorin injection
  • loratadine
  • memantine HCl
  • memantine HCl ER
  • levoleucovorin injection
  • loratadine
  • memantine HCl
  • memantine HCl ER
  • metaxalone
  • metformin ER
  • methylphenidate
  • mirtazapine
  • mixed amphetamine salts
  • modafinil
  • metaxalone
  • metformin ER
  • methylphenidate
  • mirtazapine
  • mixed amphetamine salts
  • modafinil
  • pitavastatin calcium
  • testosterone undecanoate
  • testosterone gel
  • omeprazole
  • oral contraceptives
  • oxaliplatin
  • prasugrel
  • quetiapine
  • ropivacaine injection
  • zolpidem tartrate sublingual

Patents – Medical Device
 
  • Represented generic pharmaceutical company in Hatch-Waxman patent litigation concerning intravenous bags used with ropivacaine HCl injection.

  • Counseled generic pharmaceutical company concerning a biosimilar drug and injection device.

  • Represented a major consumer electronics and medical device maker in patent infringement and antitrust suit involving 24 patents on pulse oximetry technology.

  • Represented one of the world’s largest manufacturers of contact lenses in an infringement lawsuit concerning a patent on extended-wear lenses.

  • Provided strategic advice and management of the worldwide patent and trademark portfolio for a client designing medical devices for use in the treatment of and operation on the body’s distal extremities.

  • Represented medical device company against claims of infringement of patents covering surgical guides used during knee implant surgery.

  • Represented manufacturer of cosmetic lasers in patent infringement litigation.

Labor and Employment
 
  • Counseling multinational generic pharmaceutical manufacturers on employee disputes and internal management of employees.
Partner
Email (212) 808-7771(212) 808-7771
Bill Escobar is one of Kelley Drye’s leading trial lawyers.  Bill defends, prosecutes and resolves serious business disputes for both domestic and international business clients.  B...
Partner
Email (312) 857-2629(312) 857-2629
Douglass Hochstetler serves as lead counsel in patent infringement matters, especially in litigation arising under the Hatch-Waxman Act.  Selected as one of The Best Lawyers in America ©...
Partner
Email (212) 808-7609(212) 808-7609
Cliff Katz represents generic pharmaceutical companies in complex commercial litigation.  His litigation practice includes pharmaceutical pricing, antitrust, breach of contract, federal and st...
Partner
Email (212) 808-7959(212) 808-7959
Mark Konkel is co-chair of Kelley Drye's Labor and Employment practice group.  Mark is committed to protecting and maximizing the interests of employers of all sizes, from the major multin...
Partner
Email (202) 342-8841(202) 342-8841
Eric McClafferty’s practice focuses on counseling, compliance programs, internal investigations and enforcement matters related to economic sanctions and denied parties, export controls, the ...
Partner
Email (212) 808-7811(212) 808-7811
Neil Merkl is chair of Kelley Drye’s Insurance Recovery and Counseling practice group.  Neil is a commercial lawyer, litigator and trial attorney with more than thirty years of experienc...
Partner
Email (212) 808-7982(212) 808-7982
Deepak Nambiar is a partner in Kelley Drye’s New York office and the chair of the firm’s India Practice Group.  He focuses his practice on a wide range of corporate and commercial ...
Partner
Email (212) 808-7726(212) 808-7726
Philip Robben is head of the firm’s International Arbitration team.  His practice focuses on international and domestic litigation and arbitration.  Philip’s experience includ...
Partner
Email (212) 808-7586(212) 808-7586
Damon Suden is an experienced and talented litigator and trial attorney.  His practice includes commercial and complex civil litigation and class action defense in both state and federal court...
Partner
Email (212) 808-7530(212) 808-7530
John Ward has more than three decades of experience litigating intellectual property cases, including complex, high-technology patent cases, at both the trial and appellate levels.  He has ove...
Partner
Email (312) 857-7099 (312) 857-7099
Steven Yovits chairs the firm's Patent practice group. His practice focuses on patent litigation and counseling. Steven has litigated numerous high stakes patent cases in key jurisdictions acro...
Partner
Email (973) 503-5964 (973) 503-5964
Michael Zinna’s practice comprises all aspects of intellectual property, with a focus on patent matters and including complex patent litigation, patent licensing, due diligence, patent cleara...
Special Counsel
Email (312) 857-2321(312) 857-2321
Constantine (“Dino”) Koutsoubas works with generic pharmaceutical manufacturers in their efforts to bring their products to market.  In this role, he helps clients in every aspect ...
Special Counsel
Email (212) 808-7524(212) 808-7524
Sojin is a results-oriented trial lawyer who represents the firm’s clients in significant business disputes.  Her litigation practice extends to a diverse array of practice areas, includ...
Senior Associate
Email (212) 808-7513(212) 808-7513
David Lindenbaum is committed to helping businesses and individuals safeguard their valuable IP assets at all stages of development.  He is dedicated to designing multifaceted IP strategies th...
Associate
Email (212) 808-7784(212) 808-7784
Christopher Drury is an associate in the firm’s New York office.  His practice focuses on litigation. Christopher was a legal intern for the Immigration Law Unit of The Legal A...
Associate
Email (212) 808-7544(212) 808-7544
Randall Morrison is an associate in the firm’s Litigation practice.  He represents a variety of clients across a wide range of industries in connection with litigation, regulatory invest...
Associate
Email (312) 857-7096(312) 857-7096
Mark Scott is an associate in the firm’s Chicago office. His practice focuses on litigation, particularly Hatch-Waxman litigation for generic pharmaceutical companies. Previously, Mark w...
Associate
Email (212) 808-7661(212) 808-7661
Andrew Wong is an associate in the firm’s New York office.  His practice focuses on litigation. Andrew previously worked for the New York City Department of Education. He served as ...

Publications

04/26/2019 | Client Advisories
Kelley Drye Client Advisory
03/19/2018 | Client Advisories
Kelley Drye Client Advisory
03/08/2018 | Client Advisories
Kelley Drye Client Advisory