Posts Tagged: "orange book"

While the Patent Trial and Appeal Board (PTAB) has not been friendly to patent owners, to put it mildly, the PTAB has not been inhospitable to pharma patent owners according to a report issued in mid-June by BiologicsHQ, a searchable database of drugs, patents, and companies involved in PTAB inter partes review (IPR) proceedings developed by attorneys at Fitzpatrick, Cella, Harper & Scinto. The BiologicsHQ report shows a much different story in terms of drug patents facing IPR challenges at the PTAB. The report looks at a combination of data sources, including the Orange Book, Center for Drug Evaluation and Research (CDER) listed biologics and statistics on America Invents Act (AIA) trials published by the PTAB. The BiologicsHQ report draws the conclusion that, despite widespread concerns about the PTAB operating as a patent death squad in IPRs, “such concern is not justified for drug patents.”

Last week the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) instituted six separate inter partes reviews (IPRs) against patents owned by Allergan plc, which cover RESTASIS®. Each of the patents is listed in FDA’s Orange Book and are set to expire on August 27, 2024. Each of these patents, with the exception of the ‘191 patent, were previously challenged by Apotex Corporation in IPRs filed on June 4, 2015. The Apotex IPRs were settled on December 16, 2015, prior to any decision on institution.

On Thursday, October 6th, the U.S. Food and Drug Administration (FDA) published a 79-page notice in the Federal Register regarding new rules surrounding Abbreviated New Drug Applications (ANDAs) and 505(b)(2) new drug applications. Many provisions of the new rules affect information that must be submitted by applicants regarding patents which could affect the outcome of applications for new generic versions of drug treatments.

One reason the PTAB is convenient for reaching reverse payment deals is that there is no direct antitrust oversight, since its judges are administrators with very narrow legal authority. Further, while there is a statute requiring agreements between Hatch-Waxman firms to be submitted to the Federal Trade Commission (FTC) for antitrust review, the parties may attempt to evade it. The statute requires submission of agreements that relate to the manufacture or sale of either firm’s drug. The parties might therefore feel justified (rightly or wrongly) in not submitting a consent decree stating that the patent is valid and would be infringed by the proposed generic, since this does not expressly address manufacture or sales. Alternatively, it could be that the parties submit a district court consent decree (which includes no reverse payment), but not the PTAB settlement (which could include a reverse payment). After all, a PTAB settlement simply says that the parties agree to terminate the IPR – it need not declare the patent valid – and this arguably does not relate to manufacture or sales.