Because the patent failed to disclose the absence of a loading dose, the no-loading-dose limitation was without adequate written description support.

A divided Federal Circuit panel has reconsidered and reversed a prior decision finding that a patent owned by Novatis for administering a drug to treat relapse multiple sclerosis was not invalid for lack of written description support. Upon reconsideration of expert testimony and the prosecution history, the panel concluded that the district court’s finding that the no-loading-dose limitation met the written description requirement was clearly erroneous. The court granted a petition for rehearing filed by HEC Pharm Co., Ltd. and HEC Pharm USA Inc., vacated its prior decision, and reversed the district court’s judgment that the claims of patent at issue were not invalid (Novartis Pharmaceuticals Corporation. v. Accord Healthcare, Inc., June 21, 2022, Moore, K.).

Case date: 21 June 2022
Case number: No. 2021-1070
Court: United States Court of Appeals, Federal Circuit

A full summary of this case has been published on Kluwer IP Law.


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One comment

  1. I am quite surprised that the EPO hasn’t cottoned on to the logic behind this decision with regard to amendments to replace “comprising” with “consisting of” where there is no explicit mention in the description that there are no other components present. Such an amendment could well be considered, according to EPO “gold standard” logic, added subject matter.

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