Monthly Archives: November 2019

SANOFI WINS RARE MOTION TO AMEND AT THE PTAB AFTER FED. CIR. REMAND

By Siew Chong
On remand from the Federal Circuit, the Patent Trial and Appeal Board (PTAB) has granted a motion to amend in a patent directed to methods of treatment using cabazitaxel, a taxane compound. Mylan Labs. Ltd. v. Aventis Pharma S.A., IPR 2016-00712, Paper 112 (Oct. 22, 2019).

Mylan filed a petition requesting inter partes review of claims 1-5 and 7-30 of U.S. Patent No. 8,927,592 (the ‘592 patent) on Mar. 14, 2016. After the PTAB instituted review of all challenged claims on obviousness grounds, Sanofi (the parent of Aventis Pharma) filed a contingent motion to amend in conjunction with the Patent Owner’s Response. In a final written decision, the PTAB held that the challenged claims were unpatentable and denied Sanofi’s motion to amend the claims after finding that Sanofi had not met its burden of proving that the proposed amended claims were patentable. Mylan, Paper 99 (Sep. 21, 2017).

The Board’s decision was based on its construction of Sanofi’s proposed amended claim, which recites, “[a] method of increasing survival comprising administering to a patient in need thereof . . . .”   Sanofi argued that the preamble “increasing survival” is a limitation that confers patentability to the claim as the prior art did not suggest that the recited method of treatment would increase patient survival. The Board instead held that the preamble merely provides an additional description to the claim and does not give an “intentional purpose” for performing the method of treatment.

Shortly after, the Federal Circuit issued an en banc decision holding that the petitioner in an IPR, not the patent owner, bears the burden of persuasion on the patentability of challenged claims, original or amended. Aqua Products, Inc. v. Matal, 872 F.3d 1290, 1325 (Fed. Cir. 2017). Sanofi then appealed the Board’s claim construction and denial of the motion to amend to the Federal Circuit.

On review, the Federal Circuit vacated the Board’s denial of Sanofi’s motion and remanded for further proceedings. Writing for the panel, Judge O’Malley held that the Board improperly placed the burden on Sanofi to prove patentability of the proposed amended claims. Sanofi Mature IP v. Mylan Labs. Ltd., 757 Fed. Appx. 988, 991 (Fed. Cir. 2019). Continue reading →

TRICK OR TREAT: PTAB JUDGE APPOINTMENTS ARE UNCONSTITUTIONAL

By Tom Engellenner
A Halloween decision by the U.S. Court of Appeals for the Federal Circuit ruled has concluded that the way administrative patent judges (APJs) are appointed to the Patent Trial and Appeal Board (PTAB) is unconstitutional and vacated the decision before the court with a remand that the case be heard again by another PTAB panel. The case is Arthrex v. Smith & Nephew No. 2018-2140 (Fed. Cir., Oct. 31, 2019).

The decision cures this problem going forward by severing a portion of the enabling legislation that prevents the administrative judges from being fired except for cause. The Fed. Circuit decision essentially makes all PTAB judges subject to dismissal by the secretary of Commerce without cause.

The Arthrex decision, however, does appear to create a class of litigants who have already received a final written decision on a patent challenge and are still in their pre-appeal period. Those parties — if they choose to appeal and raise this “appointments” issue — may also be able to get their decisions vacated and remanded.

According to the Fed. Cir. decision by Judges Moore, Chen and Reyna, PTAB judges do not receive enough oversight and supervision from the Director of the U.S. Patent and Trademark Office (USPTO) to be considered “inferior” officers under the U.S. Constitution and, hence, exempt from the Senate confirmation process. (“Principal” officers must be appointed by the president and confirmed by the Senate, while “inferior” officers can be appointed by heads of departments.)

The Fed. Cir. Panel chose the “narrowest remedy” by stripping the PTAB administrative judges of their exemption from dismissal without cause, rather than applying its ruling to the entirety of cases rendered so far by the PTAB:

Thus, we conclude that the appropriate remedy to the constitutional violation is partial invalidation of the statutory limitations on the removal of APJs. Continue reading →