Hatch-Waxman, Orphan Drugs, and Pediatric Exclusivity
Regulatory and patent attorneys work closely together on the various Hatch-Waxman issues that surface with drug, biologic and medical device approvals. We advise clients on the marketing exclusivities which are available for new drugs and "first mover" generics, and on Orange Book issues involving patented drug products. Clients come to us for counseling and representation on "safe harbor" exemptions from patent infringement for FDA-related activities and for assistance in securing their patent term extensions for drugs, biologics and Class III medical devices. We also counsel clients on Orphan Drug approvals and pediatric exclusivity rights. Attorneys in the firm teach the Kayton Biotechnology Course, a high level 3-day program which covers all aspects of Hatch-Waxman including Federal Circuit and Supreme Court cases interpreting this complex and important statute.
Public
Emerging Weapons Against Generics, Health Law 360, April 12, 2007 (click here to view article)
Drug Labels: The New Orange Book, The Food and Drug Law Institute Update, July/August 2006 (click here to view article)
Reissue Patents and the Orange Book: A New Wrinkle, Pharmaceutical Law & Industry, March 2006 (click here to view .pdf)
The Role of Patent and Non-Patent Exclusivity Under the Hatch-Waxman Act, May 2005 (a detailed treatise covering Hatch Waxman, Pediatric Exclusivity and Orphan Drug Exclusivity - click here)
Biotechnology - Patent Prosecution, Licensing, Litigation and Hatch-Waxman; Part VI: The Role of Patent and Non-Patent Exclusivity Under the Hatch-Waxman Act, May 2005 (PowerPoint Presentation - click here to view .pdf)
Hatch-Waxman Strategies for the New Millennium, AIPLA Spring Meeting, April 2002
Orange Book Games, Update, Intellectual Property Issue, May/June 2001
Biotechnology: Patent Licensing and FDA Practice (3 day course sponsored by Patent Resources Group, taught twice yearly since 2000; course instructor on FDA regulation and Hatch-Waxman)
Patenting Drug Products: Anticipating Hatch-Waxman Issues During the Claims Drafting Process, 54 Food Drug L.J. 245 (1999) (cited by Federal Circuit in Andryx Pharmaceutical v. Biovail Corp., 276 F.3d 1368 (Fed. Cir. 2002); and 4th Circuit in Aai Pharma Inc. v. Thompson, 296 F.3d 227 (4th Cir. 2002))
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