By Kevin E. Noonan -- As has been expected, the Director of the U.S. Patent and Trademark Office, the Honorable Kathi Vidal, has announced her resignation. Deputy Director Derrick Brent will assume her position (at least temporarily) starting in the second week of December. As Director, Ms. Vidal (at right) has been involved in a variety of efforts unlikely to survive the change in administration and her letter exhibits her awareness of these changing tides. Her announcement relates her intentions to go back to the private sector. Regarding her tenure, Ms. Vidal provides praise for the PTO wor ..read more

By Kevin E. Noonan -- The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals, wherein the District Court entered an injunction ordering Teva to delist five Orange Book-listed patents, in Teva Pharms. Inc. v. Amneal Pharms. LLC. This post concerns Amneal's response to Teva's arguments in its Opening Brief. To recap, the issues arose in litigation over Amneal's ANDA directed to its generic version of Teva's ProAir® HFA (albuterol sulfate) Inhalation Aerosol product. In this litigat ..read more

By Kevin E. Noonan -- The metes and bounds of how courts should consider indefiniteness under 35 U.S.C. § 112(b) were addressed most recently by the Supreme Court in Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014). Regardless, however, of the Court's attempts to properly construe this portion of the Patent Statute (and the Federal Circuit's attempts to comply with those rubrics), the Federal Circuit's recent decision in Vascular Solutions LLC v. Medtronic, Inc. illustrates once again that in patent law very little is simple or straightforward. And as set forth below, the Court ..read more

By Kevin E. Noonan -- The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals wherein the District Court entered an injunction ordering Teva to delist five Orange Book-listed patents, in Teva Pharms. Inc. v. Amneal Pharms. LLC. This post concerns Teva's Reply brief answering Amneal's Responsive brief to Teva's Opening Brief on appeal. To recap, the issues arose in litigation over Amneal's ANDA directed to its generic version of Teva's ProAir® HFA (albuterol sulfate) Inhalation Aer ..read more

By Kevin E. Noonan -- The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals wherein the District Court entered an injunction ordering Teva to delist five Orange Book-listed patents, in Teva Pharms. Inc. v. Amneal Pharms. LLC. To recap, the issues arose in litigation over Amneal's ANDA directed to its generic version of Teva's ProAir® HFA (albuterol sulfate) Inhalation Aerosol product. In this litigation, Teva asserted five Orange Book-listed patents: U.S. Patent Nos. 8,132,712 ..read more

The Supreme Court issued an order this morning denying certiorari in Cellect, LLC v. Vidal. A review of the arguments, pro, con, and amicus briefs submitted to the Court asking for certiorari over the Federal Circuit's In re Cellect decision can be found here and here.      Related Stories In re Cellect in View of Supreme Court's "Long Conference" – Part II In re Cellect in View of Supreme Court's "Long Conference" Loper Bright Enterprises v. Raimondo -- Justice Gorsuch's Triumphant Concurrence   ..read more

By Kevin E. Noonan -- In view of the Supreme Court's "long conference" on September 30th, it seems timely to review the arguments, pro, con, and amicus briefs submitted to the Court asking for certiorari over the Federal Circuit's In re Cellect decision. While that Court's recent Allergan USA Inc. v. MSN Laboratories Private Ltd. opinion may have made the issues (and whether the Supreme Court grants cert) less urgent, the pending U.S. Patent and Trademark Office (PTO) proposed rules limiting terminal disclaimer practice for overcoming obviousness-type double patenting and the permissible scope ..read more

By Kevin E. Noonan -- In view of the Supreme Court's "long conference" on September 30th, it seems timely to review the arguments, pro, con, and amicus briefs submitted to the Court asking for certiorari over the Federal Circuit's In re Cellect decision. While that Court's recent Allergan USA Inc. v. MSN Laboratories Private Ltd. opinion may have made the issues (and whether the Supreme Court grants cert) less urgent, the pending U.S. Patent and Trademark Office (PTO) proposed rules limiting terminal disclaimer practice for overcoming obviousness-type double patenting and the permissible scope ..read more

By Kevin E. Noonan -- Ever since the Supreme Court's decision in Dickinson v. Zurko, federal courts (including the Federal Circuit) are compelled under the Administrative Procedures Act to review factual determinations by the U.S. Patent and Trademark Office under a substantial evidence standard. The consequences of this standard are illustrated (once again) in the Federal Circuit affirming the Office's determination in an inter partes review (IPR) proceeding invalidating the challenged claims, in Novartis Pharma AG v. Regeneron Pharmaceuticals, Inc. Challenger Regeneron obtained institution o ..read more

By Kevin E. Noonan -- One of the anticipated consequences of the Supreme Court's Loper Bright decision is that it will unleash judges to impose their statutory interpretations of administrative agencies' applications of the law within their areas of purported expertise. Whether that outcome arises, (relatively) recent experience has shown that the "tyranny of the judiciary" can be and has been unleashed in other aspects of U.S. patent law; an example is the recent District Court decision (thankfully overturned by the Federal Circuit, albeit on procedural grounds) in Astellas Pharma, Inc. v. Sa ..read more