News

CAFC Poised to Reverse PTAB in IPR Decision

Andrew B. Freistein

December 12, 2017

On December 11, 2017, the Court of Appeals for the Federal Circuit (“the CAFC”) held oral arguments for Takeda Pharmaceutical Company v. Array BioPharma Inc., IPR2015-00754, an inter partes review (IPR) handled by Wenderoth attorneys representing Patent Owner Takeda. The oral arguments demonstrated a clear victory for Takeda, as Judge Kimberly Moore bluntly stated to Array’s counsel, “You have no hope of prevailing on appeal.”

Wenderoth attorneys first prosecuted Takeda’s U.S. Patent No. 8,592,454 (“the ‘454 Patent”), directed to nitrogen-containing heterocyclic compounds and uses thereof. Array Petitioned for IPR of claims 1-7 and 12-17, alleging two references disclose various compounds that anticipate the claims. Claims 1-7 and 12 of the ‘454 Patent are directed to compounds and compositions; claims 13-16 are directed to methods of antagonizing the NK1, NK2 and/or NK3 receptors by administering the compounds; and claim 17 is directed to a method of treating vomiting, nausea, depression or anxiety with the compounds. The Patent Trial and Appeal Board (PTAB) instituted review of claims 1-7 and 12-16. The PTAB did not institute review of claim 17, which included the limitation of administering an “effective amount” of the compounds of claim 1.

During the IPR trial, Takeda responded to Array’s Petition challenging claims 1-8 and 12-16, and, contingent on the invalidity of the original claims, further proposed substitute claims 18-31 in a Motion to Amend. Proposed claims 18-25 and 30-31 narrow the scope of the compounds of original claims 1-12 to avoid the prior art compounds. Proposed substituted 26-29 are independent substitute claims of claims 13-16, which maintain the scope of the compounds of original claim 1 but include the further limitation of administering an “effective amount” of the compounds present in claim 17.

In its Final Written Decision, the PTAB found claims 1-7 and 12-16 invalid and denied Takeda’s Motion to Amend introducing proposed substitute claims 18-31. The PTAB found proposed claim 18 (a substitute claim for original claim 1) invalid for lack of written description support. The PTAB denied proposed claims 26-29, because they “depend from independent claim 18” and “are also unsupported for at least the same reasons discussed regarding claim 18”. Takeda appealed the PTAB’s Final Written Decision denying the Motion to Amend by pointing out that proposed substitute claims 26-29 are independent claims, which cannot be denied for the same reasons as proposed claim 18.

The CAFC is now expected to reverse the PTAB. During the CAFC oral arguments, Judge Moore stated, “This is such a clear error by the Board”. Several times, she expressed “frustration” with Array’s decision to fight Takeda’s appeal. In addition, Judge O’Malley pointed out that under the Court’s recent Aqua Products v. Matal decision (CAFC Oct. 4, 2017) (en banc), the burden is now on Array to show unpatentability of the proposed substitute claims.

A written reversal of the PTAB’s decision is expected in due course.

The full audio of the oral arguments can be found here:

http://oralarguments.cafc.uscourts.gov/default.aspx?fl=2017-1079.mp3