Patent Use Code

Reprinted with permission: Article first published in Intellectual Property Management, Vol. 61 (No. 1), p. 17-22 (2011), issued by the Japan Intellectual Property Association.

This article addresses significant consequences of the decision by the Federal Circuit in Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. in April 2010. As a general rule, patents on new indications have traditionally not been successful in preventing generic entry into the market. However, the Federal Circuit decision indicates that NDA holders who have listed in the Orange Book a method of use or indication patents could successfully maintain exclusivity through the expiration date of the method of use or indication patents by broadly writing narratives in their patent use codes.

The narratives should cover not only the patented method of use, but all methods of use for the listed drug. By including such broad narratives in the patent use codes, it may be possible for an NDA holder to prevent a generic company from using the statement viii “carve out provisions” and force the generic company to challenge the patent with a paragraph IV statement. All NDA holders should review their Orange Book listings to determine whether they have method of use patents which have been properly listed in the Orange Book and whether the patent use codes should be revised in light of the decision.

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