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Wistaria Krigger Email
Director Human Resources Department . Greenblum and Bernstein P.L.C
Reston, VA
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The attorneys at Greenblum & Bernstein have the knowledge and skills necessary to help our pharmaceutical clients navigate the tangled web of Hatch-Waxman. Our clients include both generic and innovator companies. Drug companies face intellectual property hurdles that are unique compared with all other industries because of a linkage forged between patent and FDA law. These unique aspects of the law were first implemented in 1984 through the Hatch-Waxman amendments and then substantially changed by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. The major provisions include certain exemptions from patent infringement; generic drug exclusivity and forfeiture; patent term extension; Certification, Notice, and lawsuit provisions; and non-patent exclusivities (New Chemical Entity, New Clinical Investigation, Orphan Drug, and Pediatric Exclusivities). Greenblum & Bernstein has represented pharmaceutical clients for over 25 years. The firm's Pharmaceutical team assists clients with product design-around, strategic planning, due diligence, patent portfolio development and management, and studies. We also specialize in strategies for the submission of Abbreviated New Drug Applications ("ANDAs") and 505(b)(2) applications ("paper NDAs"). When matters lead to litigation, the firm aggressively and creatively fights for clients' rights, including patent rights and rights to market both generic and new drug products. Members of the firm's Pharmaceutical team are intimately familiar with the statutes, regulations, and case law and strategically advise our pharmaceutical clients to predict and plan for tactics employed by market competitors, with careful attention to exclusivity issues. Attorneys on the Pharmaceutical team are recognized internationally and regularly speak at domestic and international conferences. Senior partner Neil Greenblum is the U.S. Legal Update editor of the Journal of Generic Medicines and the head of the firm's litigation department. Among other events, the firm organizes and presents workshops for pharmaceutical companies on intellectual property and Hatch-Waxman at the yearly conferences. The firm's monthly newsletter, the Greenblum & Bernstein Update, has been in demand since 1996 to recipients on nearly every continent. The newsletter is a testament to the firm's commitment and longevity in the pharmaceutical arenas. The length and breadth of our experience with patents and Hatch-Waxman makes Greenblum & Bernstein an ideal choice for today's pharmaceutical companies.Greenblum and Bernstein P.L.C Address
1950 Roland Clarke PlaceReston, VA
United States