In Gilead Sciences, Inc. v. Rea, the U.S. District Court for the Eastern District of Virginia upheld the USPTO Patent Term Adjustment (PTA) rule that provides for a PTA deduction when an applicant files a “supplemental reply or other paper” after a reply has been filed. In the case at issue, the applicant had filed an Information Disclosure Statement (IDS) after filing a response to a Restriction Requirement. The court upheld the USPTO’s PTA calculation that charged the applicant 57 days of delay for that submission.Continue reading this entry
The hearing on Myriad’s motion for a preliminary injunction against Ambry Genetics is scheduled for September 11, 2013, before Judge Robert A. Shelby at the U.S. District Court for the Central District of Utah. The primary question before the court is whether it should issue a preliminary injunction to stop Ambry from selling its allegedly infringing genetic screening tests while the patent infringement case proceeds.
In Versata Development Corp. v. Rea, the U.S. District Court for the Eastern District of Virginia dismissed Versata’s challenge of the PTAB’s decision to institute post grant review of its patent for lack of jurisdiction. The court based its decision on alternative grounds, finding that the America Invents Act (AIA) “precludes judicial review of the PTAB’s decision to institute post-grant review,” and, alternatively, that the decision to institute post-grant review was not a “final” agency decision that could be reviewed under the Administrative Procedures Act (APA). Continue reading this entry
On January 28, 2013, Judge Brinkema of the U.S. District Court for the Eastern District of Virginia issued a decision in a different Exelixis v. Kappos Patent Term Adjustment (PTA) case (1:12cv574) (Exelixis II) that affirms the USPTO’s interpretation of 35 USC § 154(b)(1)(B)(i). Judge Brinkema’s decision in Exelixis II is in direct conflict with the decision issued by her colleague, Judge Ellis, III, in Exelixis v. Kappos (1:12cv96) (Exelixis I) on November 1. 2012. As I wrote previously, the USPTO already has appealed Exelixis I. I expect Exelixis to appeal Exelixis II.Continue reading this entry
As expected, the USPTO has filed a Notice of Appeal in the Exelixis patent term adjustment (PTA) case. As I summarized in this article, in a decision issued November 1, 2012 in Exelixis, Inc. v. Kappos, the U.S. District Court for the Eastern District of Virginia found that the USPTO’s interpretation and application of the “RCE carve-out” provision of the Patent Term Adjustment (PTA) statute is contrary to law. Under the district court’s interpretation, 35 USC § 154(b)(1)(B)(i) only comes into play if a Request for Continued Examination (RCE) is filed within the three-year period from the application’s filing date. Under this interpretation, a significantly greater number of patents may be entitled to significantly greater PTA awards. It will be interesting to see if Exelixis or amici urge a fall-back interpretation of the RCE carve-out, such as the interpretation discussed in this article.
In another significant Patent Term Adjustment (PTA) case decided last week (Novartis AG v. Kappos, Civ. Action No. 10-cv-1138 (Nov. 15, 2012)), the U.S. District Court for the District of Columbia found that Novartis could benefit from “ordinary tolling” but not “equitable tolling” in its efforts to obtain additional PTA for 23 patents. This decision by Judge Huvelle addresses several interesting issues that may arise in other PTA cases.Continue reading this entry
In University of Massachusetts v. Kappos, the United States District Court for the District of Colombia held that an Office Action that was “fundamentally flawed” still stopped the Patent Term Adjustment (PTA) clock that was running against the USPTO under 35 USC § 154(b)(2)(A). The court distinguished this case from the Oncolytics case, where it was the USPTO itself who decided that a vacated Office Action would not be counted for PTA purposes. This case indicates that it may be difficult to challenge PTA awards for A-type delay based on alleged inadequacies in an Office Action, or on other factual grounds. Continue reading this entry
Although 35 USC § 21(b) provides that a response that falls due on a weekend or Federal holiday is timely when filed on the next business day, we often try to file a response before such a deadline because the USPTO has interpreted the relevant provision of the Patent Term Adjustment (PTA) statute as not being subject to that grace provision. That practice can come to an end for three month response deadlines, because the District Court for the District of Columbia has determined that the USPTO’s interpretation is not correct, and the USPTO did not appeal that decision.Continue reading this entry
In a decision that sent The Medicines Company’s stock prices soaring, the District Court for the Eastern District of Virginia determined that the USPTO’s rejection of The Medicines Company’s application for Patent Term Extension was based on an incorrect—and unreasonable and unfair —interpretation of the governing statute. The patent at issue relates to Angiomax®, an anticoagulant that is generating revenue of about $100M per quarter. Unless the USPTO appeals, The Medicines Company patent will be extended to December 2014. (Without the extension, the patent will be expired as of March 23, 2010.) In addition to representing a significant victory for The Medicines Company, the decision strikes a blow against the USPTO’s policy of strictly and rigorously applying the statute, sometimes to the detriment of patent holders who miscalculated the filing deadline and suffered potential losses of millions of dollars.