Pharmaceutical & Life Sciences
Our Pharmaceutical and Life Sciences Practice members have substantial experience representing major pharmaceutical, biotech, chemical, and medical device companies and have litigated many Hatch-Waxman cases. We have litigated across diverse technologies including pharmaceuticals, DNA microarrays and sequencing, labeling reagents, and immunochemical detection systems. We are focused on bringing our many years of experience to the representation of generic pharmaceutical companies in ANDA cases against brand pharmaceutical companies.
Why Choose Kramer Alberti for Pharmaceutical and Life Sciences Litigation?
Our team members, having deep technical expertise in all scientific disciplines touching the life sciences, hold technical degrees in medicine, chemistry, biochemistry, electrical engineering, systems engineering, and computer science.
We have repeatedly served as lead counsel handling cases and trials across the country, including in New Jersey, Delaware, the Eastern and Western Districts of Texas, and the Northern and Central Districts of California. We also successfully argue appeals before the Federal Circuit. In patent litigation, a report by Patexia recognized Kramer Alberti among the 50 best performing and most active law firms in the country representing plaintiffs and selected our lead counsel partner as among the best 30 patent litigation attorneys in the country in year 2023.
- Amarin Pharma, Inc., et al. (Plaintiffs); EPA Drug Initiative II (Movant-Appellant) v. Hikma Pharmaceuticals USA Inc., et al. (Defendants-Appellees), CAFC 21-2024, successfully argued Federal Circuit appeal, winning affirmance of district court judgment denying motion to intervene and denying motion to vacate judgment of invalidity (February 15, 2022). Decision at 2022 WL 456912.
- Almirall, LLC v. Torrent Pharmaceuticals, Ltd., 20-cv-01373 (D. Del), successfully briefed non-infringement in case-dispositive motion for judgment on pleadings (July 13, 2021). Widely reported including by JD Supra.
- Amarin Pharma, Inc., et al. v. Hikma Pharmaceuticals USA Inc., et al., 2:16-cv-02525 (D. Nev.), successful trial verdict of invalidity (obviousness) (March 30, 2020). Affirmed (September 3, 2020). Decision at 819 Fed.Appx. 932 (appeal); Decision at 449 F.Supp.3d 967 (district court case).
- Eagle Pharmaceuticals, Inc. v. Slayback Pharma LLC, 1:18-cv-01953 (D. Del), successfully won non-infringement in 4-patent case (May 9, 2019). Affirmed (May 8, 2020). Decision at 958 F.3d 1171 (appeal); Decision at 382 F.Supp.3d 341 (district court case).
- Leica Microsystems, Inc. v. The Regents of the University of Michigan, 2022-1445 (Fed. Cir. Court of Appeals) successfully won affirmance on behalf of The Regents of the University of Michigan of a final written decision finding all claims of a patent relating to fluorescence detection apparatuses valid in an inter partes review. Decision at 2023 WL 3048244.
- In re: Bendamustine Consolidated Cases, successfully won non-infringement of several patents in a motion for judgment on the pleadings. Decision at 2015 WL 1951399.
Featured Representative Matters
Amarin Pharma, Inc. v. Dr. Reddy’s, Inc., 20-1901 (D. Nev.)
Almirall, LLC v. Torrent Pharms., Ltd., 1:20-cv-01373 (D. Del.)
Azurity Pharms., Inc. v. Alkem Labs., Ltd., 1:20-cv-01094 (D. Del.)
Takeda Pharms. U.S.A., Inc. v. Granules Pharms., Inc., 1:20-cv-00812 (D. Del.)
Sanofi-Aventis U.S. LLC v. Sandoz, Inc., 1:20-cv-00804 (D. Del.)
The Regents of the University of Michigan v. Leica Microsystems, Inc., 3:19-cv-07470 (N.D. Cal.)
Kyothera Biopharmaceuticals, Inc. v. Slayback Pharma, LLC, 3:18-cv-16012 (D. Del.)
Valeant Pharms. North America LLC v. Alkem Labs., Ltd., 3:18-cv-13905 (D. N.J.)
Valeant Pharms. North America LLC v. Strides Pharma, Inc., No. 3:18-cv-13696 (D. N.J.)
Valeant Pharms. North America LLC v. Zydus Pharms. (USA) Inc., 2:18-cv-13636 (D. N.J.)
Novartis Pharms. Corp. v. Accord Healthcare Inc., 1:18-cv-01043 (D. N.J.)
Amgen, Inc. v. Sandoz, Inc., 3:18-cv-11026 (D. N.J.)
Bial-Portela & CA S.A. v. Dr. Reddy’s Labs., Ltd., 1:18-cv-00341 (D. N.J.)
Cephalon, Inc. v. Slayback Pharma Ltd. Liability Co., 1:17-cv-01154 (D. Del.)
Mitsubishi Tanabe Pharma Corp. v. Prinston Pharm., Inc., 3:17-cv-05135, 1:17-cv-05135 (D. N.J.)
Mitsubishi Tanabe Pharma Corp. v. Aurobindo Pharma USA, Inc., 1:17-05005 (D. N.J.)
Biogen MA Inc. v. Graviti Pharms. Pvt. Ltd., 1:17-cv-00846 (D. Del.)
Biogen Int’l GmbH v. Amneal Pharms. LLC, 1:17-cv-00823 (D. Del.)
Biogen MA, Inc. v. Slayback Pharma LLC, 1:17-cv-00828 (D. Del.)
Sanofi-Aventis U.S. LLC v. Dr. Reddy’s Labs., Inc., 3:16-02259 (D. N.J.)
Purdue Pharma L.P. v. Amneal Pharms. LLC, 1:15-cv-01152 (D. Del.)
AstraZeneca AB v. Dr. Reddy’s Labs, Inc., 3:15-cv-08267 (D. N.J.)
Pfizer Inc. v. Dr. Reddy’s Labs. Ltd., 1:15-cv-01067 (D. Del.)
Novartis Pharms. Corp. v. Dr. Reddy’s Labs., Ltd., 1:15-cv-01026 (D. Del.)
Horizon Medicines LLC v. Dr. Reddy’s Labs., Inc., 2:15-cv-03324 (D. N.J.)
Sheehan Genetics LLC and Benkirk, Inc. v. Jakov P. Dulcich & Sons LLC, 2-14-cv-02227 (E.D. Cal.)
Sanofi-Aventis U.S. LLC v. Fresenius Kabi USA, LLC, 3:14-cv-07869 (D. N.J.)
Cephalon Inc. v. Dr. Reddy’s Labs. Ltd., 1:14-cv-01241 (D. Del.)
Forest Labs. Inc. v. Mylan Pharms. Inc., 1:14-cv-00508 (D. Del.)
Cephalon, Inc. v. Dr. Reddy’s Labs. Ltd., 1:14-cv-00334, 1:13-cv-00282 (D. Del.)
Sentaida Int’l, Inc. v. Toyo Tire and Rubber Co., Ltd., 8:14-cv-01457 (C.D. Cal.)
Millenium Pharms. Inc. v. Fresenius Kabi USA LLC, 1:13-CV-00467 (D. Del.)
Teijin Ltd. v. Dr. Reddy’s Labs. Ltd., 1:13-cv-01780 (D. Del.)
In re: Certain Consolidated Zoledronic Acid Cases, 2:12-cv-03967 (D. N.J.)
Genomic Health, Inc. v. Incyte Corp., 3:10-cv-03643, 5:10-cv-03643 (N.D. Cal.)
Millenium Pharms. v. Sandoz, 1:12-cv-01011 (D. Del.)
Polymer Technology Systems, Inc. v. Roche Diagnostics Corp., 1:10-cv-00061 (D. Ind.)
Becton, Dickinson and Co. v. Medefil, Inc., 2:09-cv-04113 (D. N.J.)
Cubist Pharms. v. Teva Parenteral Medicines, Inc., 1:09-cv-00189 (D. Del.)
Endo Pharms. Inc. v. Impax Labs., Inc., 2:09-cv-00831, 2:09-cv-00832 (D. N.J.)
Procter & Gamble Co. v. McNeil-PPC, Inc., 3:08-cv-00251 (D. Wis.)
Endo Pharms., Inc. v. Impax Labs., Inc., 1:07-cv-00731, 1:08-cv00057 (D. N.J.)
Cima Labs., Inc. v. Orchid Chemicals and Pharmaceuticals, Ltd., 2:06-cv-04809 (D. N.J.)
Schering Corp. v. Zydus Pharms. USA, Inc., 3:06-cv-04715 (D. N.J.)
Apotex, Inc. v. Cephalon, Inc., 2:06-cv-02768 (E.D. Pa.)
AuthenTec v. Hestia Technologies (M.D. Fla.)
Janssen Pharmaceutica N V v. Purepac Pharm. Co., 1:05-cv-00382 (D. Del.)
Affymetrix, Inc. v. Illumina, Inc., 1:04-cv-00901 (D. Del.)
Roche Diagnostics GmbH v. Enzo Biochem, Inc., 1:04-cv-04046 (S.D.N.Y.)
Dey LP v. Alpharma, Inc., 8:04-cv-00279 (C.D. Cal.)
Enzo Life Sciences, Inc. v. Affymetrix, Inc., 1:04-cv-01555 (S.D.N.Y.)
TeleChem International, Inc. v. Apogent Tech. and BioRobotics Inc., 4-03-cv-01543 (N.D. Cal.)