David Abramowitz is a Partner in Locke Lord's IP Pharmaceutical and Biotechnology, FDA Regulatory, and IP Litigation practice groups. David's practice primarily focuses on complex patent litigation brought under the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act and the Biologics Price, Competition, and Innovation Act, where he has significant experience representing and counseling generic pharmaceutical and biotechnology companies in federal intellectual property litigation, and counseling food, drug, and cosmetic clients in connection with regulatory issues. He also has extensive experience litigating other intellectual property disputes concerning patents, copyrights, trademarks, rights of publicity, trade secrets, unfair competition, and defamation. Before attending law school, he worked in academic laboratories where he gained research experience in the areas of organic chemistry, biochemistry, cell biology, material science, polymer science, and nanotechnology.
Pharmaceuticals and Biotechnology Litigation
David counsels and represents pharmaceutical and biotechnology clients from the earliest stages of product development (product optimization, patent design-around, and patent invalidation strategies) and pre-litigation activities (preparation of patent opinions and Paragraph IV notice letters) through the entirety of discovery, claim construction, trial, and appeal. He has been involved in disputes concerning pharmaceutical compounds; oral, nasal, otic, and ophthalmic dosage forms; extended- and modified-release dosage forms; polymorphic drug substances; process development; analytical testing of drug substances and drug products; organic and inorganic synthesis; process chemistry; bioequivalence studies; methods of treatment; drug delivery systems; pharmacokinetics; and pharmacodynamics.
David has played a significant role in litigations involving generic equivalents of many well-known pharmaceutical products in a number of therapeutic classes, including Paxil®, Paxil® CR, Pristiq®, Effexor XR®, Trintellix®, and Zoloft® (antidepressants), Gilenya® (treatment of multiple sclerosis), Neurontin® and Vimpat® (atypical antipsychotics), Eloxatin®, Revlimid®, and Xtandi® (chemotherapy), Zymar® and Zymaxid® (ophthalmic antibiotic solutions), Axiron® (testosterone therarpy); Otezla® and Topicort® (treatment of psoriasis), Zanaflex® Capsules (antispasmylotic), Istalol® (treatment of glaucoma), Strattera® (treatment of ADHD), Xyrem® (treatment of narcolepsy), Tygacil® (antibiotic), Livalo® (statin), Prevacid® ODT (proton-pump inhibitor), Niaspan® (extended-release niacin), Uroxatral® (treatment of BPH), Daliresp® (treatment of COPD), Silenor® (treatment of insomnia), Myrbetriq® (treatment of overactive bladder), Seasonale® (oral contraceptive), Eliquis® (blood thinner), Valcyte® and Valtrex® (antivirals), Asacol HD® and Lialda® (treatment of ulcerative colitis), Meridia® (treatment of obesity), Solodyn® and Biaxin® XL (extended-release antibiotics).
FDA Regulatory Counseling
David provides counseling in connection with FDA regulatory issues in the pharmaceutical, food, beverage, cosmetic, and biotechnology industries on a wide range of subjects, including cGMP compliance, importation guidelines, regulatory exclusivities, approval requirements, and advertising. He regularly interacts with clients and the FDA on key issues, including the preparation of cititzen’s petitions and responsive correspondence with the Agency.
Other Intellectual Property Litigation
David's practice includes litigating disputes concerning copyright, trademark, trade secret, and unfair competition claims involving music, graphical, pictoral, and sculptural works, software, architectural works, jewelry, confectionary products, and various forms of media. He has also been involved in the prosecution of a number of copyright and trademark applications. David has defended a number of clients in defamation, right of publicity and invasion of privacy actions, including misappropriation of image and likeness claims.
David's patent practice also includes experience in traditional patent infringement cases, patent prosecution, and patent counseling in a variety of other areas, including electrical engineering, materials science, computer hardware, hearing devices, medical devices, dental devices, and business methods.
Professional Affiliations and Recognitions
- Named a Rising Star by Illinois Super Lawyers (2014-2019)
- Named an Emerging Lawyer by Leading Lawyers Magazine (2016-2019)
- Member, American Bar Association, Intellectual Property Section