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ARTICLE · 13 JULY 2022

Federal Circuit Reconsiders Written Description Support For Negative Limitation

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The original Federal Circuit decision in Novartis Pharms. Corp. v. Accord Healthcare, Inc. was on the list of "written description" cases I covered in several conference programs this spring.

United StatesIntellectual Property
Courtenay Brinckerhoff
Courtenay Brinckerhoff
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The original Federal Circuit decision in Novartis Pharms. Corp. v. Accord Healthcare, Inc. was on the list of "written description" cases I covered in several conference programs this spring. It was interesting because written description support was found for a negative limitation that was not mentioned in the application, based in part on a prophetic example that did not include the step excluded from the claims. Now that the panel has granted rehearing and reached a different conclusion, I want to make sure I set the record straight here as well.

The Patent At Issue

The patent at issues was U.S. Patent No. 9,187,405, which was listed in the Orange Book for Novartis's GILENYA® fingolimod product, which is approved for the treatment of relapsing forms of multiple sclerosis. Claim 1 is reproduced below, with emphasis showing the negative limitation at issue:

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