In Wyeth v. Abbott Laboratories, the Federal Circuit affirmed the district court’s decision that the claims at issue are invalid for failing to satisfy the enablement requirement of 35 USC § 112. The court took only 10 pages to explain why a specification that describes one specific compound did not enable claims encompassing tens of thousands of compounds.
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
Although it has been over a year since the Federal Circuit decision in Wyeth v. Kappos, Wyeth-related Patent Term Adjustment (PTA) problems continue. One issue raised in several pending district court cases is whether a patentee can invoke the doctrine of equitable tolling to bring a civil action more than 180 days after the patent was granted. Schering v. Kappos raises this issue in the starkest terms, because Schering never sought reconsideration of the PTA award at issue. It will be interesting to see how the court resolves this case, and whether it opens the door for other patent holders to obtain the full patent term due under the statute.
Since the Federal Circuit decision in Wyeth v. Kappos, we have been applying greater scrutiny to the USPTO’s interpretations of the Patent Term Adjustment (PTA) statute. While we previously reviewed the USPTO’s calculations to ensure that the USPTO delays and Applicant delays were correctly counted in accordance with the rules, we find ourselves more frequently questioning whether the rules themselves are in accord with the statute. Just like the Federal Circuit determined that the USPTO’s interpretation of 35 USC § 154(b)(2)(A) was inconsistent with the statute, I think that the USPTO’s interpretation of 35 USC § 154(b)(1)(B)(ii) improperly excludes time that has nothing to do with an actual appeal to the Board.