David B. Abramowitz

David Abramowitz is Co-Chair of Locke Lord's FDA Regulatory Group and focuses his practice 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.

David 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, David worked in academic laboratories, where he gained research experience in the areas of organic chemistry, biochemistry, cell biology, material science, polymer science and nanotechnology.

David's representative experience includes:

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®, Briviact® and Vimpat® (anticonvulsants), Eloxatin®, Revlimid® and Xtandi® (chemotherapy), Zymar® and Zymaxid® (ophthalmic antibiotic solutions), Axiron® (testosterone therapy), Viberzi® (treatment of IBS), Bridion® (anesthetic reversal); 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, and biotechnology industries on a wide range of subjects, including cGMP compliance, safety and tracking, importation guidelines, regulatory exclusivities, approval requirements and advertising. David has particular expertise in counseling companies in the cosmetics industry regarding regulatory requirements associated with FDA compliance, including issues associated with the requirements of the Modernization of Cosmetics Regulation Act (MoCRA). He regularly interacts with clients and the FDA on key issues, including the preparation of citizen'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. David was a key player in seminal litigation over the Architectural Works Copyright Protection Act. 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.