Federal Circuit Upholds Inequitable Conduct Defense Against Apotex Patent

In Apotex Inc. v. UCB, Inc., the Federal Circuit upheld the district court’s finding that Apotex’s patent is unenforceable due to inequitable conduct. While affirming on the ground of “but-for materiality,” the Federal Circuit noted that the inventor’s conduct “at a minimum, come[s] close to the type of affirmative misconduct” that can “justify finding inequitable conduct without showing but-for materiality.” This case also serves as a reminder that the USPTO still has not acted on its proposal to align Rule 56 with TherasenseContinue reading this entry

First Post Grant Review Petition Shows That Amending Claims Is Not Child's Play

The first Post Grant Review petition visible to the public was filed August 5, 2014, against U.S. Patent 8,684,420. The patent was granted from an application filed July 26, 2013, but claims priority through a series of continuation applications to an application filed September 8, 2011, and to a provisional application filed November 5, 2010. The Petitioners, LaRose Industries, LLC and Toys “R” Us-Delaware, Inc., allege that the patent is subject to post grant review because the granted claims allegedly are not supported by the original disclosure, and so have an effective filing date later than the March 16, 2013 critical date for post grant review. Continue reading this entry

Federal Circuit Finds That FDA Citizen Petition Could Give Rise To Antitrust Liability

In Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the Federal Circuit remanded-in-part for the district court to determine whether Tyco’s citizen petition to the FDA gave rise to antitrust liability. Judge Newman wrote a dissenting opinion warning against the chilling effect that antitrust liability could have on a citizen’s right to communicate with the FDA on matters relating to drug safety and efficacy. Continue reading this entry

Visiting The USPTO Without A REAL ID

As announced on the “USPTO Locations” page of its website, the USPTO has implemented a new policy for members of the public visiting the USPTO relating to the REAL ID Act. Under the REAL ID Act, the USPTO may no longer accept driver’s licenses from certain states and instead will require an Enhanced Driver’s License or Federal-issued identification to grant access to secured areas of the USPTO. This means that members of the public visiting the USPTO for an examiner interview or board hearing may need to bring their passports with them.  Continue reading this entry

The USPTO Patent Subject Matter Eligibility Guidance TRIPS Over Treaty Requirements

With thanks to my colleague Dr. Christopher Swift for his expert advice on the intersections of US and international law.

The “Myriad-Mayo” patent subject matter eligibility guidance issued March 4, 2014 reflects the USPTO’s interpretation of Supreme Court cases interpreting and applying 35 USC § 101 to claims involving laws of nature, natural phenomena, and natural products, but the USPTO appears to have issued the Guidance without considering whether it comports with the United States’ obligations under international treaties, such as the Uruguay Round Agreements Act (URAA) and  the Trade-Related Aspects of Intellectual Property (TRIPS). Here, I highlight how the Guidance is inconsistent with both the requirements of TRIPS in particular and U.S. trade policy in general. Continue reading this entry