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Covington has been extensively involved in every aspect of the Hatch Waxman legislation and implementation since its passage in 1984. We have represented virtually every major research based pharmaceutical company on product exclusivity and life cycle issues, including providing advice on non patent exclusivity, pediatric exclusivity, patent listing, patent litigation, authorized generics, and generic bioequivalence. Our attorneys are recognized leaders in assessing complex issues regarding Hatch Waxman strategies, patent settlements, generic 180 day exclusivity, and follow on biologic and complex molecules. We have represented PhRMA on all aspects of the Hatch Waxman legislation, the Medicare Modernization Act, the Food and Drug Modernization Act, and are actively engaged on behalf of the research based industry in negotiations on legislations relating to pediatric exclusivity, follow on proteins, authorized generic, and Citizen Petitions.
Representative Matters
- Represented Alza/Johnson & Johnson in obtaining pediatric exclusivity for Duragesic following patent expiry, including successful efforts at the FDA, and defense of the grant in the D.C. District Court and the D.C. Court of Appeals. This involved the successful integration of Covington’s regulatory, litigation, and patent specialists to convince the FDA and the courts to interpret the pediatric exclusivity provisions in a manner consistent with the policy underlying both Section 505A of the FDA Act and Section 271 of the Patent Laws.
- Represented Pfizer in successfully obtaining pediatric exclusivity for Diflucan and defending the exclusivity in the federal courts. Covington lawyers were able to convince the FDA to interpret the pediatric exclusivity provisions to apply where a patent expired but the pioneer had not yet obtained a court ruling against the generic applicant.
- Advised a major international client with respect to defending a complex molecule from premature generic competition in both the US and worldwide, including litigation strategy, Citizen Petitions, and representation before various regulatory bodies.
Accolades
- PLC Cross-border Super League (2005-2008)
- Ranked 1st in the Life Sciences Industry Super League
- Ranked 1st in the Life Sciences Regulatory Super League
- PLC - Life Sciences, Which Law Firm? (2006-2007)
- Leading: Regulatory firm, EU and USA
- PLC awarded Covington the Best International Practice Award 2006 in the life sciences area.
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