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# Big Changes to Waxman-Hatch Regs Outlined
- URL: https://www.fdaweb.com/big-changes-to-waxman-hatch-regs-outlined/
- Published: 2016-10-06T12:00:00.000Z
- Updated: 2026-09-14T21:37:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137008

FDA published 10/6 a *Federal Register* [notice](http://www.gpo.gov/fdsys/pkg/FR-2016-10-06/pdf/2016-22690.pdf?ref=fdaweb.com) with final regulations to implement some of the provisions of the 2003 Medicare Modernization Act. Attorney **Kurt Karst** (Hyman, Phelps & McNamara) [writes](http://www.fdalawblog.net/fda%5Flaw%5Fblog%5Fhyman%5Fphelps/2016/10/fda-issues-final-hatch-waxman-regulations-to-implement-some-of-the-provisions-of-the-2003-medicare-m.html?ref=fdaweb.com) in his firm’s *FDA Law Blog* that the final rule “will forever alter the Waxman-Hatch landscape and will likely fuel controversies and provide fodder for litigation for years to come.”

While attorneys continue to review the final rule to prepare summaries and analyses, Karst provides highlights of the 79-page rule provided by FDA. He says that perhaps the most significant change is the agency’s decision to drop, at least for now, a proposal to defer to a 505(b)(2) or ANDA applicant’s interpretation of the scope of a patent that it does not own (and, in particular, for a method-of-use patent that is identified in the *Orange Book* with a patent use code and narrative).

Instead, Karst says, FDA will institute a patent listing dispute mechanism whereby the “NDA holder must provide a narrative description (no more than 250 words) of the NDA holder’s interpretation of the scope of the patent that explains why the existing or amended ‘use code’ describes only the specific approved method of use claimed by the patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug product.”