Panoramic: Automotive and Mobility 2025
Regulatory Exclusivities, Hatch-Waxman, and Similar Statutes
Patent and exclusivity rights continue to demand global attention through the FDA various requirements and recent EMEA guidance documents.
Hogan Lovells attorneys can advise you on all aspects of the Drug Price Competition and Patent Term Restoration Act of 1984 and the Hatch/Waxman Act, and guide you on patent submissions and listings under the FDA's June 2003 rules and new Form FDA 3542. We then work closely with you to obtain all appropriate patent term extensions and non-patent statutory exclusivity periods.
We can also advise you on pediatric testing requirements and pediatric marketing exclusivity provisions, as well as the complex marketing exclusivity provisions in U.S. and EU orphan drug legislation. We can then thoroughly assist in managing your patent and exclusivity rights to secure the maximum authorized life cycle protection.
Additionally, when pioneer companies need to assess the legal and scientific validity of possible generic versions of a pioneer product, we ensure that they are able to participate in the generic drug approval process and raise meritorious objections to potential generic products in a timely manner.
With many of these issues arising in Europe, we counsel pioneer companies on the impact of innovator rights of the 2004 EU Pharmaceutical Review Legislation and the effect of recent EMEA guidance documents on comparability of various forms of "biogenerics," European Court of Justice jurisprudence (the "generics cases"), relevant European Pharmacopoeia monograph activities, and opportunities and threats posed by parallel trade cases such as Bayer Adalat and Kohlpharma.
Our capabilities at a glance
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Hear from our clients and industry leaders
The whole team is super smart. They are all really easy to work with and then know our business inside out. They come to us proactively with issues and are incredibly responsive.
Chambers & Partners, UK Guide, 2025
An intellectually brilliant and commercially astute public law team. One of the very best in the city.
Chambers & Partners UK 2025
Hogan Lovells has a high capability in solving complex issues that involve both legal and technical perspectives.
Chambers & Partners, Germany, 2025
The lawyers are just experts. They are there when you need them and happy to entertain all my questions. They understand the wider context and the politics and sensitivities of it.
Chambers & Partners, UK 2025
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.
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