FLH is poised to respond dynamically to the statutory and constantly changing regulatory guidelines set in place by Hatch-Waxman and the FDA. We have found that effective handling of these matters is critical both to the approval and market entry of any new drug, and to the fair, sustained advantage of those already deemed leaders in their field.
Frommer Lawrence & Haug attorneys are true leaders in addressing matters related to the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act. Since shortly after the passage of the Hatch-Waxman Amendments in 1984, FLH attorneys have acquired deep experience and a significant record of success in counseling both name brand and generic clients, such as Bayer, Shire, Par Pharmaceuticals, Oxford BioMedica, Mylan Laboratories, Dey Labs, Watson Laboratories and Lupin Pharmaceuticals. FLH’s unique ability to support organizations on “both sides” of the pharmaceutical industry has enabled us to extend intricate, thorough and expert knowledge to each of our clients around the world.
At FLH, our attorneys address matters in nearly every area of the Hatch-Waxman arena. These include: Paragraph IV certifications, Paragraph IV notice letters, NCE and 3-Year innovative drug product exclusivity, patent term extensions, pediatric exclusivity, ANDA requirements, 180-day generic market exclusivity (first-to-file, triggering, forfeiture), bioequivalence studies, 30-month stays, at-risk generic drug launches, settlements of Paragraph IV litigation, and generic substitution. We also are optimally situated to offer counsel on issues related to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 due to our in-house Antitrust Group, whose attorneys have specialized successfully in numerous intellectual property matters.
FLH is poised to respond dynamically to the statutory and constantly changing regulatory guidelines set in place by Hatch-Waxman and the FDA. We have found that effective handling of these matters is critical both to the approval and market entry of any new drug, and to the fair, sustained advantage of those already deemed leaders in their field. Our excellent relationships with the U.S. Patent and Trademark Office (USPTO) – strengthened by our significant presence in Washington, D.C. – allow us to serve our clients efficiently and proactively.
Beyond these critical relationships, our attorneys’ legal acumen is fortified by their accompanying experience in technical, clinical research, and engineering fields. In addition, FLH Hatch-Waxman teams are supported by scientific advisors with advanced degrees in the life sciences – including pharmaceuticals, organic, inorganic, and industrial chemistry, biochemistry, biotechnology, and genetics – ensuring that all scientific issues are understood fully throughout the product development and protection process.
This combination of “real-world” experience and scientific expertise, accompanied by unparalleled client service and legal success, has made FLH uniquely qualified to address Hatch-Waxman issues in an increasingly complex industry and global legal environment.