Tagged: Patent Post-Issuance Proceedings

Last week, in what appeared to be one of the first pharmaceutical based cases brought to a decision under the IPR regime, the Patent Trial and Appeals Board (PTAB) of the US Patent and Trademark Office held that the majority of claims in a series of vitamin supplement patents were invalid. This decision turns the welcoming lights on for the generic drug industry to utilize the inter partes review (IPR) procedures under the America Invents Act to challenge proprietary pharmaceutical patents. In this matter, the challenger Gnosis, a defendant in an infringement action brought by Merck & Cie, South Alabama Medical Science Foundation and Parmlab, which was stayed pending the IPR decision, successfully defended against the four patents in issue: United States Patent Nos. 5,997,915, 6,011,040, 6,673,381 and 7,172,778 which are directed to compositions and methods of use involving chiral reduced natural folate compounds used as food supplements to prevent or treat folate deficiency diseases.

In accordance with the statutory provisions of the America Invents Act, a patent owner may at his/her option file a preliminary response to a third-party petition requesting inter partes review (IPR) of a patent. Through the first quarter of 2014, about 55 percent of patent owners opted to file preliminary responses to IPR petitions, while 45 percent of patent owners opted instead either to expressly waive or file no preliminary response.

In order to achieve the statutory requirement of rendering a final determination no later than one year following the institution of an Inter Partes Review (IPR), the Trial Practice Guidelines set forth by the U.S. Patent & Trademark Office “lay out a framework for conducting the proceedings aimed at streamlining and converging the issues for proceeding.” For example, the guidelines for oral arguments prohibit the submission of new evidence and arguments by the parties, and suggest that live testimony is generally unnecessary. The parties may however move for live testimony in “appropriate situations.”

Prior to April 22, 2014, and since the filing of the first petition for inter partes review on September 16, 2012, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO) had not granted any patent owner’s motion to amend claims of patents under review. On April 22, 2014, this record changed as the PTAB issued its first decision in International Flavors & Fragrances, Inc. v. U.S. Department of Agriculture (IPR2013-00124) partially granting the patent owner’s motion for claim amendment.