SUPPLEMENTARY INFORMATION:

35 U.S.C. 156 generally provides that the term of a patent may be extended for a period of up to five years, if the patent claims a product, or a method of making or using a product, that has been subject to certain defined regulatory review. 35 U.S.C. 156(d)(5) generally provides that the term of such a patent may be extended for no more than five interim periods of up to one year each, if the approval phase of the regulatory review period (RRP) is reasonably expected to extend beyond the expiration date of the patent.

On July 7, 2026, Otsuka Pharmaceutical Co., Ltd., the agent of the owner of record of the `196 patent, i.e., Otsuka America Pharmaceutical, Inc., timely filed an application under 35 U.S.C. 156(d)(5) for a first interim extension of the term of the `196 patent. The `196 patent claims the drug product centanafadine hydrochloride. The application indicates that a RRP as described in 35 U.S.C. 156(g)(1)(B)(ii) for centanafadine hydrochloride is ongoing before the Food and Drug Administration for permission to market and use the drug product commercially.

Review of the application indicates that, except for permission to market or use the drug product commercially, the `196 patent would be eligible for an extension of its term under 35 U.S.C. 156. Because it appears reasonable to expect that the RRP will continue beyond the original expiration date of the `196 patent, i.e., July 25, 2026, interim extension of the patent's term under 35 U.S.C. 156(d)(5) is appropriate.

A first interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 8,461,196 is granted for a period of one year from the original expiration date of the patent.

91 FR 46412