Category Archives: Patent Term Extension

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Federal Circuit Protects Novartis Gilenya Patent From Obviousness-Type Double Patenting

In Novartis AG v. Ezra Ventures LLC, the Federal Circuit addressed “the interplay between a patent term extension (PTE) granted pursuant to 35 U.S.C. § 156 and the obviousness-type double patenting doctrine.” In upholding the Novartis Gilenya patent, the court confirmed that the statute permits an extended product patent to “effectively” block the practice of an earlier-expiring … Continue reading this entry

District Court Stands By Patent Term Adjustment Tolling Decision

In a decision issued September 20, 2012, in Bristol Meyers Squibb Co. v. Kappos, the U.S. District Court for the District of Columbia denied the USPTO’s motion for reconsideration of the court’s January 27, 2012 decision that found that the statutory deadline for bringing a civil action to challenge the Patent Term Adjustment (PTA) awarded … Continue reading this entry

Federal Circuit Extends Safe Harbor To Post-Approval Drug Testing

In a decision issued August 3, 2012 in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., the Federal Circuit held that the safe harbor provisions of 35 USC § 271(e)(1) can shield the defendants from liability for patent infringement arising out of their use of patented methods to satisfy FDA testing requirements for their approved products. … 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 Upholds Many Classen Method Claims, Also Limits Reach Of Safe Harbor

On August 31, 2011, the Federal Circuit issued its second decision in Classen Immunotherapies, Inc. v. Biogen Idec, which was on remand from the Supreme Court after Bilski v. Kappos. Judge Newman wrote the opinion for the court, which was joined by Chief Judge Rader, and holds that two of the three asserted patents recite … Continue reading this entry

District Court Insists on Fairness in Patent Term Extension Application Deadline

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 … Continue reading this entry