Alston & Bird’s Biotechnology, Pharmaceutical & Life Sciences Patent Litigation Practice has litigated Hatch–Waxman matters for nearly two decades. While focusing on the industry heavyweight districts of New Jersey and Delaware, our group has also represented clients in the Northern District of West Virginia, Middle District of Florida, Northern District of California, Southern District of New York, Southern District of Indiana, and District of Maryland, among others. We have also developed a robust practice in strategically challenging patents before the Patent Trial and Appeal Board in inter partes review proceedings, where we regularly work hand-in-hand with our clients to achieve leverage in reaching ultimate, and successful, dispute resolution.
Our group is composed of attorneys with advanced technical backgrounds in many areas, including molecular biology, pharmaceutical engineering, biomedical engineering, polymer science & engineering, and chemistry. Whether it be representing clients before the Federal Circuit, defending clients during bench and jury trials at the district court level, or obtaining favorable settlements, our group is well equipped to serve the needs of your business.
Biotechnology, Pharmaceutical & Life Sciences Patent Litigation
Our Biotechnology, Pharmaceutical & Life Sciences Patent Litigation Practice has decades of experience with Hatch–Waxman and biosimilar litigation through our representation of some of the world’s largest generic pharmaceutical companies. We integrate our extensive litigation, regulatory, and business capabilities in this dynamic space to meet and exceed the specific, business-driven objectives of your company.
Hatch–Waxman ANDA Litigation Experience
- Representing Sandoz Inc. and Lek Pharmaceuticals Inc. in Hatch–Waxman patent litigation involving ibrutinib. Pharmacyclics, et al. v. Sandoz Inc., et al., No. 1:18-cv-00275 (D. Del).
- Representing Mylan Pharmaceuticals Inc. in PIV Hatch–Waxman litigation involving DPP-IV inhibitors and metformin for the treatment of Type 2 diabetes. Boehringer Ingelheim Pharmaceuticals Inc. v. HEC Pharm Co. Ltd., et al., No. 3:15-cv-05982 (D.N.J.).
- Representing Mylan Inc. in ANDA litigation regarding pemetrexed injections. Eli Lilly and Company, et al. v. Nang Kuang Pharmaceutical Co. Ltd., et al., No. 1:14-cv-01647 (S.D. Ind.).
- Represented Actavis Laboratories Fl. Inc. in ANDA litigation regarding extended-release oxycodone and acetaminophen tablets. Mallinckrodt LLC, et al. v. Actavis Laboratories Fl. Inc., No. 2:15-cv-03800 (D.N.J.).
- Represented Watson Laboratories Inc. in two separate PIV Hatch–Waxman litigations involving the drug ticagrelor. AstraZeneca LP, et al. v. Watson Laboratories Inc., No. 1:15-cv-01002 (D. Del.); AstraZeneca LP, et al. v. Watson Laboratories Inc., No. 1:16-cv-00338 (D. Del.).
- Represented Orient Pharma Co. Ltd. in ANDA litigation regarding pitavastatin tablets. Kowa Company Ltd, et al. v. Orient Pharma Co. Ltd., No. 1:14-cv-03336 (N.D. Ill.).
- Represented Mylan in PIV Hatch–Waxman litigation involving the invalidity of multiple patents directed to treating fibromyalgia using Milnacipran (Savella®). Forest Laboratories Inc., et al. v. Mylan Inc., No. 1:13-cv-01603 (D. Del.).
- Represented Watson Laboratories Inc. in two separate PIV Hatch–Waxman litigations involving four patents related to compositions containing dronedarone (Multaq®), and the use thereof, for treatment of patients with atrial fibrillation. Sanofi, et al. v. Watson Laboratories Inc., No. 1:14-cv-00265 (D. Del); Sanofi, et al. v. Lupin Atlantis Holdings SA, No. 1:15-cv-00415 (D. Del.).
- Represented Actavis in PIV Hatch–Waxman litigation involving noninfringement, invalidity, and unenforceability of multiple patents directed to treating acne using clindamycin phosphate/tretinoin (Ziana®). Medicis Pharmaceutical Corporation, et al. v Actavis Mid Atlantic LLC, No. 1:11-cv-00409 (D. Del.).
- Represented Actavis in PIV Hatch–Waxman litigation involving the noninfringement, invalidity, and unenforceability of multiple patents directed to treating actinic keratosis using imiquimod. Medicis Pharmaceutical Corporation, et al. v Actavis Mid Atlantic LLC, No. 1:12-cv-01091 (D. Del.).
- Represented Mylan in PIV Hatch–Waxman litigation involving the invalidity of multiple patents directed to treating symptoms of Parkinson’s disease using entacapone (Comtan®). Orion Corporation v. Mylan Pharmaceuticals Inc., No. 1:11-cv-00078 (D. Del.).
- Represented Mylan in PIV Hatch–Waxman litigation involving the noninfringement and invalidity of multiple patents directed to treating certain pulmonary diseases using prednisolone (Orapred ODT®). Cima Labs Inc., et al. v. Mylan Pharmaceuticals Inc., No. 1:10-cv-01077 (D. Del.).
- Represented Mylan in PIV Hatch–Waxman litigation involving the noninfringement and invalidity of multiple patents directed to treating the symptoms of schizophrenia using Clozapine (FazaClo®). Cima Labs Inc., et al. v. Mylan Pharmaceuticals Inc., No. 1:10-cv-00625 (D. Del.).
- Represented Actavis in PIV Hatch–Waxman litigation involving the noninfringement, invalidity, and unenforceability of multiple patents directed to treating excessive sleepiness using armodafinil (Nuvigil®). Cephalon Inc., et al. v. Actavis Group, et al., No. 1:09-cv-00940 (D. Del.).
- Represented Mylan in litigation involving multiple patents directed to treating gastroesophageal reflux disease using dexlansoprazole (Dexilant®). Takeda Pharmaceutical Company Limited, et al. v. Mylan Pharmaceuticals Inc., et al., No. 5:13-cv-04001 (N.D. Cal.).
- Represented Mylan in litigation involving multiple patents directed to the inhibition of platelet aggregation using a combination of prasugrel and aspirin (Effient®). Eli Lilly and company, et al.v. Mylan Pharmaceuticals Inc., et al., No. 1:14-cv-00389 (S.D. Ind.).
- Represented Mylan in litigation involving two patents directed to the reduction of elevated total cholesterol using ezetimibe and simvastatin (Vytorin®). Merck Sharp & Dohme Corp., et al., v. Mylan Pharmaceuticals Inc., et al., No. 2:09-cv-06383 (D.N.J.).
- Represented Agila in Section 505(b)(2) Hatch–Waxman litigation involving two patents directed to an intravenous formulation of acetaminophen (Ofirmev®). Cadence Pharmaceuticals, et al. v. Agila Specialties Inc., et al., No. 1:14-cv-01499 (D. Del.).
- Represented Mylan in litigation involving multiple patents directed to treating schizophrenia, bipolar disorder, depression, and autism spectrum disorders with aripiprazole (Abilify®). Otsuka Pharmaceutical Co., Ltd. v. Mylan Inc., et al., No. 1:14-cv-04508 (D.N.J.).
- Represented Alphapharm in PIV Hatch–Waxman litigation involving the noninfringement, invalidity, and unenforceability of multiple patents directed to treating migraine headaches using naproxen sodium and sumatriptan (Treximet®). Pozen Inc. v. Alphapharm Pty. Ltd., No. 6:09-cv-00003 (E.D. Tex.).
- Represented Mylan in PIV Hatch–Waxman litigation involving the noninfringement, invalidity, and unenforceability of a patent directed to a method of treating ADHD using atomoxetine hydrochloride (Strattera®). Eli Lilly and Company v. Mylan Pharmaceuticals Inc., et al., No. 2:07-cv-03770 (D.N.J.).
- Represented Abrika in PIV Hatch–Waxman litigation involving the noninfringement and invalidity of patents directed to an extended release formation of bupropion hydrochloride (Wellbutrin XL®). Biovail Laboratories Inc. v. Abrika Pharmaceuticals Inc., No. 0:04-cv-61704 (S.D. Fla.)(Post-MMA Rules).
- Represented Mylan in PIV Hatch–Waxman litigation involving the noninfringement and invalidity of multiple patents directed to paroxetine hydrochloride extended-release tablets (Paxil CR®). Smithkline Beecham Corp., d/b/a GlaxoSmithKline, et al. v. Mylan Laboratories Inc., et al., No. 2:07-cv-02939 (D.N.J.).
- Represented Mylan in litigation involving multiple patents associated with the treatment of early-stage idiopathic Parkinson’s disease and moderate-to-severe restless legs syndrome using rotigotine (Neupro®). UCB Inc., et al. v. Mylan Technologies Inc., et al., No. 1:17-cv-00322 (D. Del.).
- Represented Mylan in litigation involving a patent directed to cinacalcet (Sensipar®), which purports to treat secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. Amgen Inc. v. Mylan Pharmaceuticals Inc., et al., No. 1:16-cv-00853 (D. Del.).
- Represented Mylan in litigation involving five patents directed to a controlled release of budesonide (Uceris®). Cosmo Technologies Ltd., et al. v. Mylan Pharmaceuticals Inc., No. 1:16-cv-00152 (D. Del.).
- Represented Mylan in litigation involving patents directed to a delayed and extended release of mesalamine (Apriso®). Salix Pharmaceuticals Inc., et al. v. Mylan Pharmaceuticals Inc., et al., No. 1:15-cv-00109 (N.D. W. Va.).
- Represented Mylan in litigation involving a patent directed to a controlled release of mesalamine (Lialda®). Shire Development LLC, et al. v. Mylan Pharmaceuticals Inc., No. 8:12-cv-01190 (M.D. Fla.).
- Represented Mylan in litigation involving multiple patents directed to methylnaltrexone bromide formulation for subcutaneous injection (Relistor®). Valeant Pharmaceuticals International Inc., et al. v. Mylan Pharmaceuticals Inc., et al., No. 2:15-cv-08180 (D.N.J.).
- Represented Mylan in litigation involving multiple patents directed to treating moderate to severe dementia of the Alzheimer’s type with memantine (Namenda XR®). Forest Laboratories Inc., et al. v. Mylan Pharmaceuticals Inc., No. 1:14-cv-00508 (D. Del.).
- Represented Micro Labs in litigation involving multiple patents directed to treating itching associated with allergic conjunctivitis with bepotastine (Bepreve®). Bausch & Lomb Inc., et al. v. Micro Labs Limited, et al., No. 1:14-cv-01974 (D.N.J.).
- Represented Mylan in litigation involving numerous patents associated with the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery using a bromfenac ophthalmic solution (Prolensa®). Senju Pharmaceutical Co. Ltd., et al. v. InnoPharma Licensing Inc., et al., Nos. 1:14-cv-06893, 1:15-cv-03240 (D.N.J.).
- Represented Apotex in litigation involving multiple patents associated with the treatment of overactive bladder with mirabegron (Myrbetriq®). Astellas Pharma Inc., et al. v. Apotex Inc., et al., No. 1:16-cv-00976 (D. Del.).
- Represented Apotex in litigation involving three patents associated with the treatment of patients with relapsing multiple sclerosis using teriflunomide (Aubagio®). Sanofi-Aventis U.S. LLC, et al. v. Apotex Inc., et al., No. 1:16-cv-01312 (D. Del.).
- Represented Mylan in litigation involving multiple patents associated with linaclotide (Linzess®) capsules, approved in adults for the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation. Forest Laboratories Inc. v. Mylan Pharmaceuticals Inc., et al., No. 1:16-cv-01114 (D. Del.).
Other Biotech, Pharma, and Life Sciences Litigation
- Representing patentee Merial, a/k/a Boehringer Ingelheim Vetmedica Inc. in patent litigation against Merck & Co. Inc. and Intervet Inc. a/k/a Merck Animal Health. Technology relates to vaccines for porcine virus, type II. Boehringer Ingelheim Vetmedica Inc. v. Merck & Co. Inc. et al., No. 2:18-cv-09534 (D. N.J.).
- Representing Merial as patentee/plaintiff in patent litigation against Ceva U.S. Holdings Inc. Technology relating to recombinant protein animal vaccines. Merial Inc., et al. v. Ceva U.S. Holdings Inc., et al., No. 1:16-cv-00171 (D. Del.).
- Represented Merial as patentee/plaintiff in patent litigation against Ceva Sante Animale SA. Technology relates to insecticidal cominations to control mammal fleas. Merial Inc., et al. v. Ceva Santé Animale SA, et al., Nos. 3:15-cv-00039, -00040 (M.D. Ga.).
- Represented patentee Merial against Biomune in declaratory judgment patent infringement litigation. Technology relates to recombinant protein animal vaccines. Biomune Company v. Merial Limited, et al., No. 2:14-cv-02567 (D. Kan.).
- Represented Merial as patentee/plaintiff in patent litigation against Ceva Animal Health LLC. Technology related to flea and tick medicine. Merial Ltd., et al. v. Ceva Animal Health LLC, et al., No. 3:12-cv-00154 (M.D. Ga.).
- Represented complainant/patentee Merck & Cie in a patent infringement investigation and related district court litigation involving folate nutraceutical products against direct competitor Gnosis SpA and Macoven Pharmaceuticals. Certain Reduced Folate Nutraceutical Products and L-Methylfolate Raw Ingredients Used Therein, ITC Inv. No. 337-TA-857; Merck & CIE, et al. v. Macoven, et al., No. 6:12-cv-00027 (E.D. Tex.).
- Represented MiMedx as patentee/plaintiff in patent litigation against direct competitor Nutech Medical Inc. Technology concerning medical tissue grafts. MiMedx Group Inc. v. Nutech Medical Inc., et al., No. 2:15-cv-00369 (N.D. Ala.).
- Represented patentee Merial in a series of patent litigations against direct competitor Velcera. Technology related to flea and tick medicine. BASF Agro B.V., et al. v. Cipla Ltd., et al., No. 3:07-cv-00125 (M.D. Ga.); Merial Ltd., et al. v. Velcera Inc., et al., No. 3:12-cv-00075 (M.D. Ga.).
- Represented MiMedx in patent litigation involving two patents directed to human amniotic tissue wound grafts and related technologies. MiMedx Group Inc. v. Nutech Medical Inc., et al., No. 2:15-cv-00369 (N.D. Ala.).
- Represented MiMedx in multiple patent litigations involving six patents directed to human amniotic human tissue wound grafts and related technologies. MiMedx Group Inc. v. Liventa Bioscience Inc., et al., No. 1:14-cv-01178 (N.D. Ga.); MiMedx Group Inc. v. Tissue Transplant Technology Ltd., et al., No. 5:14-cv-00719 (W.D. Tex.).
- Represented Merck in patent litigation involving stereoisomers of methylfolate (Metafolin®). Merck Eprova AG v. Brookstone Pharmaceuticals LLC, No. 1:09-cv-09684 (S.D.N.Y.).
- Represented Merck in patent litigation involving stereoisomers of methylfolate (Metafolin®). Merck Eprova AG v. Gnosis SpA, et al., No. 1:07-cv-05898 (S.D.N.Y.).
Inter Partes Review
Representing MiMedx Group Inc. in the following inter partes proceedings.
- No. IPR2017-01220 involving patent number 8,709,494 entitled “Placental tissue grafts.”
- No. IPR2015-00669 involving patent number 8,323,701 entitled “Placental tissue grafts.”
- No. IPR2015-00664 involving patent number 8,372,437 entitled “Placental tissue grafts.”
- No. IPR2015-00420 involving patent number 8,597,687 entitled “Methods for determining the orientation of a tissue graft.”
- No. IPR2015-00320 involving patent number 8,709,494 entitled “Placental tissue grafts.”
Representing Merial Ltd. in the following inter partes proceedings.
- No. 2018-00919 involving patent number 8,008,001 entitled “PCV-2 vaccine.”
- No. IPR2016-00798 involving patent number 8,614,244 entitled “Spot-on pesticide composition.”
- No. IPR2015-00254 involving patent number 6,517,843 entitled “Reduction of porcine circovirus-2 viral load with inactivated PCV-2.”
Representing Mylan Pharmaceuticals Inc. and Mylan Institutional Inc. in the following inter partes proceedings.
- No. IPR2017-01035 involving patent number 9,320,716 entitled “Controlled release and taste masking oral pharmaceutical compositions.”
- No. IPR2017-01034 involving patent number 8,784,888 entitled “Controlled release and taste masking oral pharmaceutical composition.”
- No. IPR2017-00645 involving patent number 9,006,289 entitled “Levothyroxine formulations.”
- No. IPR2017-00644 involving patent number 9,168,239 entitled “Levothyroxine formulations.”
- No. IPR2017-00643 involving patent number 9,168,238 entitled “Levothyroxine formulations.”
- No. IPR2016-00626 involving patent number 8,784,789 entitled “Aqueous liquid preparations and light stabilized aqueous liquid preparations.”
- No. IPR2016-01163 involving patent number 8,877,168 entitled “Aqueous liquid preparations and light stabilized aqueous liquid preparations.”
- No. IPR2016-01563 involving patent number 8,673,927 entitled “Uses of DPP-IV inhibitors.”
- No. IPR2016-01564 involving patent number 8,846,695 entitled “Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor.”
- No. IPR2016-01565 involving patent number 8,853,156 entitled “Treatment for diabetes in patients inappropriate for metformin therapy.”
- No. IPR2016-00318 involving patent number 7,772,209 entitled “Antifolate combination therapies.”
Representing InnoPharma Licensing Inc. in the following inter partes proceedings.
- No. IPR2016-00091 involving patent number 8,927,606 entitled “Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid.”
- No. IPR2016-00090 involving patent number 8,871,813 entitled “Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid.”
- No. IPR2016-00089 involving patent number 8,754,131 entitled “Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid.”
- No. IPR2015-00903 involving patent number 8,129,431 entitled “Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid.”
- No. IPR2015-00902 involving patent number 8,669,290 entitled “Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid.”
Highlights
Alston & Bird Earns Broad Recognition in 2023 IAM Patent 1000
For the twelfth consecutive year, Alston & Bird has been recognized as a global leader in patent law by Intellectual Asset Management in its annual IAM Patent 1000 – The World’s Leading Patent Professionals.
Managing Intellectual Property Names 13 Alston & Bird Attorneys as “IP Stars”
Thirteen Alston & Bird attorneys have been named “IP Stars” by Managing Intellectual Property in its 2023 rankings of the world’s leading intellectual property (IP) practitioners and practices.