Hatch-Waxman

Hatch-Waxman

Hunton & Williams LLP offers clients access to an interdisciplinary team of lawyers with an understanding of the drug approval and development process. We skillfully guide pharmaceutical companies through litigation arising from the Drug Price Competition and Patent Term Restoration Act (the “Hatch-Waxman Amendments”), fully addressing its intellectual property, technical, regulatory and antitrust aspects.

Members of the firm’s Hatch-Waxman practice include lawyers with advanced degrees in areas such as pharmacology, biomedical engineering and organic chemistry, and former agency officials with regulatory and antitrust experience. We work closely with our clients’ legal and technical personnel and senior management to understand and meet their specific needs. This potent combination of technical, legal and regulatory experience allows Hunton & Williams to offer effective, comprehensive advice and guidance on all aspects of Hatch-Waxman matters.

Patent
Beginning with the assessment of patent portfolios and analysis of ANDA applications, and continuing through strategy and litigation, our work with pharmaceutical industry clients addresses every phase of Hatch-Waxman representation. In addition to skilled patent litigators, our team includes PhDs with specific technical experience who understand the science behind pharmaceutical and biotech products.

Our technical experience provides a powerful tool in analyzing the validity and infringement issues associated with Hatch-Waxman litigation. Team members capably assess the science behind drug applications and develop strategies tailored to each matter. We have litigated Hatch-Waxman matters in United States district courts and have argued the same before the FDA, obtaining positive results for numerous clients.

Team members are also experienced in all aspects ancillary to Hatch-Waxman litigation, including counseling and pre-litigation strategy advice, patent term extensions and non-patent exclusivities, patent settlements, patent listing issues, patent certifications and notice, 180-day marketing exclusivity, 30-month stays and follow-on biologic and complex molecules. We have counseled companies concerning Hatch-Waxman legislation, the Medicare Modernization Act, the Food and Drug Administration Modernization Act, the Food and Drug Administration Amendments Act, follow-on proteins, authorized generics and citizen petitions.

Food and Drug
Lawyers in the firm’s food and drug practice group coordinate closely with our patent lawyers on Hatch-Waxman litigation and counseling matters. Team members carefully monitor and address regulatory concerns before they arise; counsel clients on all aspects of the Hatch-Waxman Amendments, including the patent listing, certification and notice provisions, the different exclusivity provisions, the “first applicant” and forfeiture provisions, the 30-month stay provisions and the complex approval process for generic drugs; and represent clients before the FDA.

Antitrust
Hatch-Waxman litigation settlements receive a high level of antitrust scrutiny, both by private entities in class action litigation and by government agencies. Hunton & Williams is particularly well situated to provide antitrust guidance to clients in the pharmaceutical industry. We have familiarity with the FTC and its policies and procedures for assessing potentially anticompetitive conduct by drug companies, particularly related to its approach to reverse payment settlements. In addition, Hunton & Williams is one of the very few firms that can provide the services of experienced counsel who has not only litigated a reverse payment antitrust case, but who did so on behalf of the FTC during his tenure at the agency.

We have counseled several innovator companies on whether the inclusion of certain specific provisions in Hatch-Waxman patent settlements would likely be of concern to the Federal Trade Commission. In particular, we have assessed whether, in the context of a final settlement establishing a date for generic entry, the FTC would be apt to challenge additional provisions involving, for example, the payment of lawyers’ fees, the grant of a right of first refusal for certain licensing rights and/or the innovator’s agreement to refrain from marketing an authorized generic. In each instance, we conducted a fact-specific analysis of the entire settlement agreement in order to determine whether, on balance, the agreement was defensible as pro-competitive or competitively neutral. On this basis, we were able to make recommendations to our clients regarding the risks posed by these provisions, and others as well.