September 1-30, 2020

Hatch-Waxman and IPR Strategy

Hatch-Waxman and IPR Strategy

Register FreeIn recent years, inter partes review (IPR) proceedings at the Patent Trial and Appeal Board (PTAB) have created an alternative path to challenge those same patents. Supporters of the Hatch-Waxman regime view IPRs as upending the careful Hatch-Waxman balance. Still, the IPR process seems here to stay, having only recently been created by Congress as part of the American Invents Act of 2011.

This panel will explore the latest thinking and best practices for defending and challenging pharmaceutical patents in federal court and at the PTAB.

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In the United States, in order for a new drug to receive market approval, a New Drug Application, known as an NDA, must be submitted to the Food and Drug Administration (FDA). To lessen the burden on generics, the Drug Price Competition and Patent Term Restoration Act, known as the Hatch-Waxman Act of 1984, allows a company can seek approval from the FDA to market a generic drug before the expiration of a patent relating to the brand name drug. In the event that the generic manufacturer can establish that the drug mentioned in the Abbreviated New Drug Applications (ANDA) is the bioequivalent of a drug approved in a NDA, the generic manufacturer can rely on the studies previously submitted as a part of the NDA. The whole purpose of Hatch-Waxman was to make it easier for a generic drug manufacturer to piggyback on the studies previously submitted by the original creator of a new drug and facilitate the faster market entry of generics.

An ANDA applicant must make one of four certifications regarding each patent that applies to the drug for which approval is being sought: (I) no such patent information has been submitted to the FDA; (II) the patent has expired; (III) the patent is set to expire on a certain date; or (IV) the patent is in valid or will not be infringed by the drug covered in the ANDA. It is the paragraph IV certifications that are the most interesting from the patent perspective. Although making a paragraph IV certification is not an active act of infringement, Hatch-Waxman deems a paragraph IV certification an act of infringement allowing the patent owner of the drug covered by the NDA to immediately institute infringement proceedings, which often occurs.

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