Tag Archives: Novartis

USPTO Proposes Revised Patent Term Adjustment Rules For RCEs Under Novartis

The USPTO has published proposed rules for calculating Patent Term Adjustment (PTA) for applications in which a Request for Continued Examination (RCE) has been filed, after the Federal Circuit held in Novartis v. Lee that the USPTO’s original rules were not consistent with the PTA statute. While the proposed rules appear to follow the Federal … Continue reading this entry

USPTO Finally Updates Patent Term Adjustment Calculator--Sort Of

In a Federal Register Notice issued May 15, 2014, the USPTO announced that its Patent Term Adjustment (PTA) calculator finally has been updated to implement the changes to the PTA statute embodied in the Technical Corrections Act which was enacted on January 13, 2013, but has not yet been updated to implement the changes required … Continue reading this entry

Federal Circuit Splits The Baby In Patent Term Adjustment Decision

The Federal Circuit issued its decision in the pending Patent Term Adjustment (PTA) appeals, resolving the issues raised in Exelixis I, Exelixis II and Novartis, in a precedential decision issued in Novatris AG v. Lee, Nos. 2013-1160, -1179 (Jan. 15, 2014); see also Exelixis v. Lee, Nos. 2013‑1175, -1198 (Jan. 15, 2014) (per curiam). The court interpreted 35 … Continue reading this entry

District Court Again Rejects Equitable Tolling For Patent Term Adjustment Case

In Daiichi Sankyo Co. v. Rea (D. D.C. Dec. 3, 2013), the U.S. District Court for the District of Columbia rejected the plaintiff’s arguments that equitable tolling should apply to permit its claim for additional Patent Term Adjustment (PTA) under Wyeth. In so doing, the court followed much of the reasoning in Novartis AG v. Kappos … Continue reading this entry

HR 6621 Would Add New Barriers To Patent Term Adjustment (PTA) Appeals

Although most of HR 6621 (introduced by Rep. Lamar Smith on Nov. 30, 2012) would make changes “[t]o correct and improve certain provisions of the Leahy-Smith America Invents Act,” the bill includes other provisions that are entirely unrelated to the AIA and that would dramatically impact patent term. The provision receiving the most public attention would … Continue reading this entry

District Court Denies Equitable Tolling, Fifth Amendment Taking In Novartis Patent Term Adjustment Case

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 … Continue reading this entry

Federal Circuit Says Regulatory Patent Term Extension Prolongs Life of Entire Patent

I wrote previously about the patentability issues raised in Genetics Institute, LLC v. Novartis Vaccines & Diagnostics, Inc., and Novartis’ ability to rely on unexpected results discovered after the filing date to support non-obviousness.  Here, I look at another interesting issue in the case, related to the scope of a patent term extension under 35 USC § 156 … Continue reading this entry

Federal Circuit Permits Post-Filing Date Unexpected Results To Support Non-Obviousness

The Federal Circuit decision in Genetics Institute, LLC v. Novartis Vaccines & Diagnostics, Inc. is interesting in several respects. In this article, I look at the court’s decision to permit unexpected results discovered after the patent applications at issue were filed to support non-obviousness.… Continue reading this entry