Hatch-Waxman Litigation
Hatch-Waxman Litigation
Our highly skilled Hatch-Waxman team has over 20 years of experience representing generic pharmaceutical companies in patent litigation and PTAB proceedings. 

We provide our clients with comprehensive advice and guidance on all stages of Paragraph IV disputes, including strategic assessment of Abbreviated New Drug Applications (ANDAs), Paragraph IV opinions and notice letters, litigation, appeals and settlements.

Our patent litigators, many of whom have strong technical and scientific backgrounds, have represented our generic pharmaceutical clients in over 30 Hatch-Waxman matters, with numerous successes in litigation and settlements for our clients. 

  • Abbott Laboratories v. Mylan Inc. (N.D. Ill.) (lopinavir/ritonavir)

  • AstraZeneca LP v. Lek Pharmaceuticals (S.D.N.Y.) (omeprazole)

  • AstraZeneca Pharmaceuticals LP v. Sandoz, Inc. (D.N.J. and Fed. Cir.) (quetiapine)

  • Daiichi Sankyo Company, Ltd. v. Accord Healthcare Inc., USA (PTAB and Fed. Cir.) (prasugrel)

  • Endo Pharmaceuticals Solutions Inc. v. Paddock Laboratories, LLC (D. Del.) (testosterone undecanoate)

  • Forest Laboratories, LLC v. Breckenridge Pharmaceutical, Inc. (D. Del.) (asenapine maleate)

  • Forest Laboratories, LLC v. Lupin Limited (D. Del.) (memantine HCl extended release capsules)

  • Fresenius Kabi USA, LLC et al. v. Mylan Laboratories Limited et al. (ropivacaine HCl injection)

  • G.D. Searle LLC v. Lupin Pharmaceuticals Inc. (E.D.Va. and Fed. Cir.) (celecoxib)

  • Kowa Co. Ltd. et al. v. Lupin Limited et al. (S.D.N.Y.) (pitavastatin calcium tablets)

  • Orexo AB v. Mylan Pharms. Inc. (D.N.J.) (zolpidem tartrate sublingual tablets)

  • Otsuka Pharmaceutical Co., Ltd. v. Lupin Atlantic Holdings SA (D.N.J. and Fed. Cir.) (aripiprazole tablets)

  • RCT v. Ben Venue Laboratories (D.N.J.) (cisplatin)

  • Sanofi v. Sandoz, Inc. (D.N.J. and Fed. Cir.) (oxaliplatin)

  • Schering-Plough v. Geneva Pharmaceuticals (D.N.J. and Fed. Cir.) (loratadine)

  • Sciele Pharma, Inc. v. Lupin Pharmaceuticals (D. Del. and Fed. Cir.) (metformin ER)

  • Spectrum Pharm., Inc. et al. v. InnoPharma, Inc. et al. (D. Del.) (levoleucovorin injection)

  • Taro Pharmaceuticals v. Synerx Pharma, LLC (D.N.J.) (malathion lotion)

  • Vanda Pharms. Inc. v. Inventia Healthcare Pvt. Ltd. (D. Del.) (iloperidone tablets)

 
 

Overview

Our highly skilled Hatch-Waxman team has over 20 years of experience representing generic pharmaceutical companies in patent litigation and PTAB proceedings. 

We provide our clients with comprehensive advice and guidance on all stages of Paragraph IV disputes, including strategic assessment of Abbreviated New Drug Applications (ANDAs), Paragraph IV opinions and notice letters, litigation, appeals and settlements.

Our patent litigators, many of whom have strong technical and scientific backgrounds, have represented our generic pharmaceutical clients in over 30 Hatch-Waxman matters, with numerous successes in litigation and settlements for our clients. 

Experience

  • Abbott Laboratories v. Mylan Inc. (N.D. Ill.) (lopinavir/ritonavir)

  • AstraZeneca LP v. Lek Pharmaceuticals (S.D.N.Y.) (omeprazole)

  • AstraZeneca Pharmaceuticals LP v. Sandoz, Inc. (D.N.J. and Fed. Cir.) (quetiapine)

  • Daiichi Sankyo Company, Ltd. v. Accord Healthcare Inc., USA (PTAB and Fed. Cir.) (prasugrel)

  • Endo Pharmaceuticals Solutions Inc. v. Paddock Laboratories, LLC (D. Del.) (testosterone undecanoate)

  • Forest Laboratories, LLC v. Breckenridge Pharmaceutical, Inc. (D. Del.) (asenapine maleate)

  • Forest Laboratories, LLC v. Lupin Limited (D. Del.) (memantine HCl extended release capsules)

  • Fresenius Kabi USA, LLC et al. v. Mylan Laboratories Limited et al. (ropivacaine HCl injection)

  • G.D. Searle LLC v. Lupin Pharmaceuticals Inc. (E.D.Va. and Fed. Cir.) (celecoxib)

  • Kowa Co. Ltd. et al. v. Lupin Limited et al. (S.D.N.Y.) (pitavastatin calcium tablets)

  • Orexo AB v. Mylan Pharms. Inc. (D.N.J.) (zolpidem tartrate sublingual tablets)

  • Otsuka Pharmaceutical Co., Ltd. v. Lupin Atlantic Holdings SA (D.N.J. and Fed. Cir.) (aripiprazole tablets)

  • RCT v. Ben Venue Laboratories (D.N.J.) (cisplatin)

  • Sanofi v. Sandoz, Inc. (D.N.J. and Fed. Cir.) (oxaliplatin)

  • Schering-Plough v. Geneva Pharmaceuticals (D.N.J. and Fed. Cir.) (loratadine)

  • Sciele Pharma, Inc. v. Lupin Pharmaceuticals (D. Del. and Fed. Cir.) (metformin ER)

  • Spectrum Pharm., Inc. et al. v. InnoPharma, Inc. et al. (D. Del.) (levoleucovorin injection)

  • Taro Pharmaceuticals v. Synerx Pharma, LLC (D.N.J.) (malathion lotion)

  • Vanda Pharms. Inc. v. Inventia Healthcare Pvt. Ltd. (D. Del.) (iloperidone tablets)

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) 808-7624(212) 808-7624
Beth Jacob’s practice has focused on the representation of generic pharmaceutical companies in Hatch-Waxman litigation for more than 15 years, where she has appeared on behalf of her clients...
Partner
Email (212) 808-7609(212) 808-7609
Cliff Katz represents generic pharmaceutical companies in complex commercial litigation.  He has extensive experience with Hatch-Waxman patent litigation, pharmaceutical pricing, federal and s...
Partner
Email (312) 857-7099 (312) 857-7099
Steven Yovits is a partner in the firm’s Intellectual Property group in Chicago. His practice focuses on patent litigation and counseling. Steven has litigated numerous high stakes patent ca...
Special Counsel
Email (312) 857-2579(312) 857-2579
Christine Dudzik is special counsel in the firm’s Chicago office.  She has legal experience representing companies in patent litigation involving a number of technical fields including ...
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 ...
Associate
Email (312) 857-2311(312) 857-2311
Sarita Mutha is an associate in the firm’s Intellectual Property group in the Chicago office.  Her practice focuses on patent litigation and counseling with a particular focus on Hatch-...
Associate
Email (212) 808-7556(212) 808-7556
Molly Rao is an associate in the firm’s New York office. Her practice focuses on complex commercial litigation involving patent and trademark law.
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 ...

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