United States Court of Appeals for the Federal Circuit ______________________

PURDUE PHARMA L.P., PURDUE PHARMACEUTICALS L.P., Appellants

v.

COLLEGIUM PHARMACEUTICAL, INC., Appellee

KATHERINE K. VIDAL, UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY AND DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE, Intervenor ______________________

2022-1482 ______________________

Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in No. PGR2018- 00048. ______________________

Decided: November 21, 2023 ______________________

JENNIFER L. SWIZE, Jones Day, Washington, DC, ar- gued for appellants. Also represented by GREGORY A. CASTANIAS, JOHN R. BOULE, III; GASPER LAROSA, JOHN JOSEPH NORMILE, JR., New York, NY; PABLO DANIEL HENDLER, Potomac Law Group PLLC, New York, NY. Case: 22-1482 Document: 58 Page: 2 Filed: 11/21/2023

2 PURDUE PHARMA L.P. v. COLLEGIUM PHARMACEUTICAL, INC.

CHRISTOPHER A. PINAHS, Robins Kaplan LLP, Minne- apolis, MN, argued for appellee. Also represented by JACOB M. HOLDREITH, BRENDA L. JOLY, EMILY TREMBLAY; OREN D. LANGER, New York, NY.

FARHEENA YASMEEN RASHEED, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA, argued for intervenor. Also represented by PETER J. AYERS, MAUREEN DONOVAN QUELER. ______________________

Before DYK, HUGHES, and STOLL, Circuit Judges. DYK, Circuit Judge. Purdue Pharma L.P. (“Purdue”) appeals from a judg- ment of the Patent Trial and Appeal Board (“Board”) find- ing claims 1–17 of U.S. Patent No. 9,693,961 (“’961 patent”) unpatentable for lack of written description and anticipa- tion. The Board issued its Final Written Decision after the statutory deadline, concluding that the passing of the dead- line did not deprive it of authority. Purdue contends the Board lost jurisdiction once the deadline passed, and that, if the Board did not lose jurisdiction, the Board’s decision was incorrect. We affirm. BACKGROUND Purdue is the owner of the ’961 patent which issued on July 4, 2017. The patent is titled “Pharmaceutical Formu- lation Containing Gelling Agent” and is meant to “pre- vent[] or deter[] the abuse of opioid analgesics by the inclusion of at least one aversive agent in the dosage form.” ’961 patent, col. 5, ll. 54–56. Specifically, the addition of an aversive agent “helps to prevent injection, inhalation, and/or oral abuse by decreasing the ‘attractiveness’ of the dosage form to a potential abuser.” Id. at col. 2, ll. 59–61. Representative claim 1 recites: Case: 22-1482 Document: 58 Page: 3 Filed: 11/21/2023

PURDUE PHARMA L.P. v. COLLEGIUM PHARMACEUTICAL, INC. 3

1. A method of preparing an abuse deterrent con- trolled release dosage form comprising: combining oxycodone or a pharmaceuti- cally acceptable salt thereof as active agent, polyglycolyzed glycerides, a C12 to C40 fatty acid or a mixture thereof, car- nauba wax and beeswax, to form a homog- enous mixture, wherein the oxycodone or pharmaceutically acceptable salt thereof is the sole active agent in the dosage form; preparing particles from the homogenous mixture; and containing the particles in a capsule; the abuse deterrent dosage form providing a therapeutic effect for about 12 hours or longer when orally administered to a hu- man patient, and the abuse deterrent dosage form being abuse deterrent when subjected to tamper- ing comprising heating at a temperature greate