Regulatory Exclusivities, Hatch-Waxman, and Similar Statutes

Representative experience

Submitted landmark citizen petitions to the FDA on bioequivalence standards for narrow therapeutic range drugs under sections 505(b)(2) and 505(j) of the Food, Drug, and Cosmetic Act.

Developed a strategy and drafted the necessary FDA documents for a protocol that our client, who sought “pediatric exclusivity” of a complex and toxic drug product, could complete within the statutory timeframe.

Counseled a client on the FDA orphan drug standard for "clinical superiority," allowing the same drug to go to market during another drug’s seven-year marketing exclusivity period.

Conduct due diligence for the likely outcome under the standards in EU orphan medicinal products law.

Interpreted Bolar laws, in result of the EU vs. Canada World Trade Organization (WTO) case.

Wrote policy papers and presentations on U.S. and WTO law in the area of regulatory data exclusivity to officials in Latin American and Asian countries on behalf of a major trade association and officials.

Helped persuade the Mexican government to stop approving generic products that infringe patents and/or exclusivity periods.