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ARTICLE · 30 JUNE 2020

FDA Seeking Comments On Orange Book Patent Listing

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The FDA has published a public notice requesting comments on the submission and listing of patent information.

United StatesIntellectual Property
Richard D. Kelly
Richard D. Kelly
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The FDA has published a public notice requesting comments on the submission and listing of patent information. See the notice here. The information requested could lead to the implementation of changes having a significant impact on pharma, including combination products in the future, especially on combination products.

The FDA Has 5 categories of questions:

1. General Questions: including whether the FDA should clarify the types of patent that may be listed. This may be a reaction to the decision in In re: Lantus Direct Purchaser Antitrust Litigation, No. 18-2086, D. Mass. February 13, 2020, where the court found that an antitrust action may be based on an improperly listed patent on a syringe component where the patent nor its claims identified any specific drug. See https://www.lifesciencesipblog.com/listing-the-medical-device-part-of-a-combination-product-in-the-orange-book-may-trigger-antitrust-liability-

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