The attorneys in Budd Larner's Intellectual Property Group have broad experience and expertise in all key practice areas of intellectual property law relating to patents, trademarks, copyrights, trade secrets, false advertising, unfair competition and antitrust (patent misuse). The firm offers clients a full range of legal services in the intellectual property area including litigation; patentability, validity and infringement opinions; licenses and technology transfer agreements; intellectual property counseling; due diligence reviews and IP audits.
Most of our work is in the pharmaceutical industry where we assist clients with product development, design around work, opinions, and litigation. We recognize that the success of our clients' product portfolios turn on early market entry at a reasonable legal cost. To that end, we work with our clients' development teams to design non-infringing API processes and finished dosage formulations to avoid litigation and permit early market entry. Our success for these clients is marked by the absence of litigation with respect to the many products for which we have provided advice and assistance.
Litigation is often required, however, and our team members have many years of experience representing both brand name and generic companies in cases involving small molecule and biotech products. Our Hatch-Waxman practice now focuses, however, on representing only generic pharmaceutical companies.
Success in litigation is not, of course, an end in and of itself, but only a means to achieve a particular business goal, generally market entry for a product. We are therefore proactive in working with our clients to utilize such cases to obtain early market entry agreements. We have negotiated numerous agreements of this type, some arising out of litigation and some without any litigation.
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. We also litigate exclusivity disputes.
Our representation in the pharmaceutical industry goes well beyond product development, litigation and settlements which flow from that development and litigation. We also assist our clients with the entire range of agreements concerning new chemical entities, finished dosage forms, bulk API, intermediates and medical devices, including license agreements, product development agreements, joint venture agreements and supply agreements.
Our Intellectual Property Group members, which include a full time staff of Ph.D., scientific and technical advisors, have specialized degrees in such fields as medicinal and organic chemistry; biochemistry; pharmacology; pharmaceutics; genetics; electrical, aerospace, mechanical, chemical and biomedical engineering; computer science and mathematics. Many Group members have also worked in the pharmaceutical industry in positions ranging from API and formulation development to General Counsel.
Our attorneys’ expertise is not limited to the pharmaceutical industry. The attorneys in Budd Larner's Intellectual Property Group have represented the intellectual property needs of corporations and individuals in the electrical, petroleum, medical device, software, e-commerce, financial services, chemical and mechanical fields.
For more information, please contact:
Andrew J. Miller