PharmaPatents Timely Insight on Emerging Legal Developments

Tag Archives: Novartis

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

Posted in Patent Reform; Patent Term Adjustment

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 eliminate the term of patent applications filed before June 7, 1995 (“pre-GATT applications”) that are still pending. But another provision would affect all pending and new applications, as well as recently granted patents, by changing the way that Patent Term Adjustment (PTA) is calculated and challenged under 35 USC § 154(b). Continue reading this entry

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

Posted in District Court Decisions

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

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

Posted in Federal Circuit Decisions; Patent Term Extension

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 and district court jurisdiction under 35 USC § 291.

The Technology At Issue

The technology at issue relates to truncated forms of Factor VIII, an essential blood-clotting protein. As explained in the Federal Circuit opinion, the proper functioning of Factor VIII depends on its ability to bind another protein, von Willedbrand factor (“vWF”), although Factor VIII can exhibit a procoagulant effect without complexing to vWF. Truncated forms of Factor VIII are based on the discovery that certain portions of the protein are not required for its procoagulant activity, and that region a3 is critical to vWF binding.

Continue reading this entry

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

Posted in 103; Federal Circuit Decisions

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