IP Hatch-Waxman Act

Experience

Our world-class Intellectual Property Hatch-Waxman Act Practice Group has been at the forefront of many of the most significant brand vs. generic battles in the pharmaceutical industry.

We regularly and successfully handle trials and appeals on behalf of generic pharmaceutical companies. We are particularly noted for our involvement in Hatch-Waxman litigation and have litigated Hatch-Waxman cases involving small molecules, complex biological products, polymorphs, salts, hydrates, formulations, processes, and methods of use in District Courts around the country, as well as at the Federal Circuit Court of Appeals.

Our attorneys’ trial advocacy skills are backed by technical degrees in such fields as chemistry, biochemistry, immunology, molecular biology, genetics, mathematics, and electrical, mechanical, aerospace, chemical and biomedical engineering. Many Group members have also worked in the pharmaceutical, chemical, or biotechnology industries in positions ranging from API and formulation development to General Counsel to marketing.

While we aim for success in litigation, we understand that our clients view litigation as a means to achieve a business goal — generally, early market entry for a generic product. We are therefore proactive in working with our clients to obtain early market entry agreements. We have negotiated numerous agreements of this type, some arising out of litigation and some without any litigation.

We also have extensive experience in patent counseling, and preparing non-infringement, invalidity, and freedom to operate opinions and paragraph IV notice letters under the Hatch-Waxman Act. We have vast technical expertise in evaluating patent portfolios to develop novel invalidity, unenforceability and non-infringement defenses.  We frequently assist clients with designing around formulation, process, and polymorph patents.  We have considerable experience in challenging the validity of patents in an inter partes review at the USPTO.

Our attorneys are also intimately familiar with and keep abreast of the rapidly changing FDA regulations and case law concerning 180-day exclusivity and the forfeiture of that exclusivity. Where necessary, we have litigated exclusivity disputes for our clients. We have also assisted our clients with license agreements, product development agreements, joint venture agreements, and supply agreements concerning new chemical entities, finished dosage forms, bulk API, intermediates and medical devices.

We recognize that our clients’ success turns on early market entry at a reasonable legal cost. To that end, we work with our clients to design non-infringing APIs, manufacturing processes, and finished dosage formulations. We are also sensitive to budgetary concerns and know how to minimize the cost of patent litigation without sacrificing quality.

Representative Matters

Our recent significant Hatch-Waxman matters include the following cases in which we represented one or more of the defendants:

• FIRVANQ^® (vancomycin hydrochloride for oral solution) Azurity Pharmaceuticals Inc. v. Alkem Laboratories Ltd., 1:20-cv-01094-MSG (D. Del), successful trial verdict of non-infringement (May 4, 2023).
• Belrapzo^® (Bendamustine HCl injection) Eagle Pharmaceuticals, Inc. v. Slayback Pharma LLC et al, 1:21-cv-01256 (D. Del), successful trial verdict of non-infringement in a rare ruling from the bench in the middle of trial (September 29, 2022). CAFC 2023-1110, per curiam affirmance of the district court decision (January 16, 2024).
• Lumify^® (Brimonidine Tartrate) Slayback Pharma LLC, v. Eye Therapies, LLC, IPR2022-00142 and IPR2022-00146, successful institution of IPR on two Orange Book listed patents (May 18, 2022).
• Vimovo^® (Esomeprazole/Naproxen): Horizon Medicines LLC and Nuvo Pharmaceuticals (Ireland) Designated Activity Company et al. v. Dr. Reddy’s Laboratories Inc., 2-15-cv-03324 (D.N.J.) summary judgment of invalidity on the basis of issue preclusion (February 24, 2022).
• Vascepa^® (icosapent ethyl): Amarin Pharma, Inc., et al. (Plaintiffs); EPA Drug Initiative II (Movant-Appellant) v. Hikma Pharmaceuticals USA Inc., et al. (Defendants-Appellees), CAFC 21-2024, affirmance of district court decision denying motion to intervene and denying motion to vacate judgment of invalidity (February 15, 2022).
• Latuda^® (Lurasidone Hydrochloride): Slayback Pharma LLC v.  Sumitomo Dainippon Pharma Co., Ltd., IPR2020-01053 (PTAB), all 75 claims of the challenged patent held invalid (December 7, 2021).
• Aczone^® (Dapsone 7.5%): Almirall, LLC v. Torrent Pharmaceuticals, Ltd., 20-cv-01373 (D. Del), Successfully argued non-infringement in case-dispositive motion for judgment on pleadings, filed before discovery had begun (July 13, 2021).
• Vascepa^® (icosapent ethyl): Amarin Pharma, Inc., et al. v. Hikma Pharmaceuticals USA Inc., et al., CAFC 2020-1723, successful appeal; summary affirmance that all asserted claims invalid for obviousness (September 3, 2020).
• Vascepa^® (icosapent ethyl): Amarin Pharma, Inc., et al. v. Hikma Pharmaceuticals USA Inc., et al., 2:16-cv-02525 (D. Nev.): successful trial verdict of invalidity (March 30, 2020).
• Vimovo^® (Esomeprazole/Naproxen): Nuvo Pharmaceuticals (Ireland) Designated Activity Company et al. v. Dr. Reddy’s Laboratories Inc. et al., CAFC 2017-2473, successful appeal; asserted claims invalid for lack of written description (May 15, 2019).
• Belrapzo^® (Bendamustine Hydrochloride): Eagle Pharmaceuticals, Inc. v. Slayback Pharma LLC, 1:18-cv-01953 (D. Del), in a 4-patent case, successfully argued non-infringement in motion for judgment on pleadings, filed before discovery had begun (May 9, 2019).
• Omeprazole OTC: Dexcel Pharma Technologies Ltd. v. Dr. Reddy's Laboratories, Ltd., 2-15-cv-08042 (D.N.J.), consolidated with 2-15-cv-08017 (D.N.J.); brand consented to judgment of non-infringement after our cross examination of their expert (August 6, 2018).
• Mucinex D^® (Guaifenesin and Pseudoephedrine): Reckitt Benckiser LLC v. Dr. Reddy’s Laboratories, Inc., 1-15-cv-04524 (D.N.J.); successful trial verdict of non-infringement (August 22, 2017); affirmed on appeal.
• Copaxone^® (Glatiramer Acetate) 40 mg/mL: Teva Pharm. USA, Inc. v. Dr. Reddy’s Laboratories Ltd., 1-14-cv-01278 (D. Del.); successful trial verdict of invalidity (Jan. 31, 2017); affirmed on appeal.
• Nasonex^® (Mometasone Furoate): Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals, LLC, 1:15-cv-00250 (D. Del.); successful trial verdict of non-infringement (Jan. 30, 2017); affirmed on appeal.
• Vimovo^® (Esomeprazole/Naproxen): Horizon Pharma, Inc. v. Dr. Reddy’s Laboratories, Ltd., 11-2317, 15-3324 (D.N.J.); summary judgment of non-infringement of lead patent granted (May 12, 2016); summary judgment of invalidity granted for follow-on patent (November 19, 2018).
• Namenda^® XR (Memantine Hydrochloride): Forest Laboratories, Inc. et al v. Amneal Pharmaceuticals LLC et al., consolidated with 1-14-cv-00121 (D. Del) (Successfully argued invalidity of the asserted claims at claim construction) (January 5, 2016) (affirmed on appeal).
• Oxycontin^® (Oxycodone): Purdue Pharma LP v. Amneal Pharmaceuticals, LLC, 13-cv-3372 (S.D.N.Y.); successful trial verdict of invalidity (April 8, 2015); affirmed on appeal.
• Diprivan^® (Propofol): Fresenius Kabi USA LLC v. Dr. Reddy’s Laboratories, Ltd., 1:13-cv-00925 (D. Del.); successful trial verdict of non-infringement (August 25, 2014) (no appeal).
• Zometa^®/Reclast^® (Zoledronic Acid): In re: Certain Zoledronic Acid Cases (Dr. Reddy’s Laboratories Ltd.), Consolidated Civil Action No. 12-3967 (D. N. J.); successfully opposed preliminary injunction motion; client launched at-risk; settled on favorable terms.
• Boniva^® (Ibandronate tablets): Hoffmann La-Roche, Inc. v. Dr. Reddy’s Laboratories Ltd., (D.N.J. 3:07-cv-4516, 3:08-cv-4055, and 3:10-cv-5623); patent held invalid sub. nom., Hoffmann-La Roche, Inc. v. Apotex, Inc. (consolidated), 2012 U.S. Dist. LEXIS 64382 (D.N.J. May 7, 2012) and 2012 U.S. Dist. LEXIS 141669 (D.N.J. Oct. 12, 2012), affirmed, 748 F.3d 1326 (Fed. Cir. 2014); client launched at-risk; summary judgment granted; affirmed on appeal.
• Accolate^® (Zafirlukast): AstraZeneca UK Ltd. v. Dr. Reddy’s Laboratories, Ltd., 3:08-cv-03237 (D.N.J.), 2010 U.S. Dist. LEXIS 120706 (D.N.J. Nov. 15, 2010); summary judgment granted; client launched at-risk; case settled on appeal.
• Nexium^® (Esomeprazole Mg): AstraZeneca AB v. Dr. Reddy’s Laboratories, Ltd., 3:05-cv-05553 (D.N.J.); case settled Jan. 2011; In re: Nexium (Esomeprazole) Antitrust Litigation, 1:12-md-02409-WGY (D. Mass.), case settled on favorable terms without the client making any payment.
• Prilosec^® OTC (Omeprazole Mg): AstraZeneca AB, v. Dr. Reddy’s Laboratories, Ltd., 07-cv-6790 (S.D.N.Y.); summary judgment granted (March 10, 2009); affirmed on appeal.