This morning the Federal Circuit released a precedential opinion in a patent case appealed from the District of Delaware, granting a petition for panel rehearing, vacating the Federal Circuit’s prior decision, and reversing the district court’s judgment that claims were not invalid for violating the written description requirement. Notably, Judge Linn dissented. Here is the introduction to the opinion.

Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. (Precedential)

HEC Pharm Co., Ltd. and HEC Pharm USA Inc. (collectively, HEC) petition for rehearing of our prior decision in this case, 21 F.4th 1362 (Fed. Cir. 2022), in which we affirmed a final judgment of the United States District Court for the District of Delaware. The district court determined that claims 1–6 of U.S. Patent No. 9,187,405 are not invalid and that HEC infringes them. Because the ’405 patent fails to disclose the absence of a loading dose, the district court clearly erred in finding that the negative claim limitation “absent an immediately preceding loading dose” added during prosecution to overcome prior art satisfies the written description requirement of 35 U.S.C. § 112(a). We grant HEC’s petition for panel rehearing, vacate our prior decision, and reverse the district court’s judgment that Novartis’ claims are not invalid for inadequate written description.

LINN, Circuit Judge, dissenting.

The majority, while recognizing that written description support is a fact-based inquiry based on the understandings of a person of ordinary skill in the art, and while ultimately recognizing that the standard for negative limitations is the same as for any other limitation, nonetheless applies a heightened written description standard to the facts of this case in requiring not only a “reason to exclude” but a showing that the negative limitation in question was “necessarily excluded.” In doing so, the majority characterizes the district court’s fact finding as clearly erroneous and concludes that written description support for the no-load limitation is lacking. In my opinion, the district court applied the correct standard and found ample support in the written description for the no-load limitation. For these reasons, I respectfully dissent.