By Tom Engellenner
The en banc Federal Circuit decision in 2017 in Aqua Products v. Matel, 872 F. 3d 1290 (Fed. Circ. 2017) threw out the original USPTO rule that the patent owner had the burden of persuasion regarding patentability of claim amendments. The Aqua Products decision was based somewhat on a technicality – that USPTO had failed to engage in formal rule-making and, hence, its interpretation of the America Invents Act (AIA) was not entitled to deference.

For a while, it was not clear whether the USPTO would proceed with a formal rule-making process and try to maintain its rule on burden of proof.  However, early in 2019, the PTAB issued a “precedential” opinion in Lectrosonics, Inc. v. Zaxcam, Inc., IPR2016-01120 (Feb. 25, 2019) explicitly adopting the new practice of placing the responsibility on the petitioner who challenges a patent to also show that any new claims presented by the patent owner by amendment are invalid.

This was followed by proposed formal rules in October, 2019 codifying the Lectrosonics holding that the petitioner who initiates a patent challenge will not only have the burden of persuading the PTAB that a patent owner’s claims as issued are invalid but will also have the same burden with regard to new claims that the patent owner may present by amendment during the proceeding.  The USPTO is expected to finalize this rule shortly.

At least one patent owner that had initially had its motion to amend denied has taken advantage of the Aqua Products decision.  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).

The PTO also appears to be taking proactive steps to help patent owners navigate the amendment process. On March 15, 2019, a notice of a pilot program was published for “motion to amend practice and procedures in trial proceedings under the America Invents Act (AIA) before the PTAB.”

The pilot program provides patent owners with two options not previously available. The first option is that a patent owner may choose to receive preliminary guidance from the Board on its motion to amend. The second option is that a patent owner may choose to file a revised motion to amend after receiving petitioner’s opposition to the original motion to amend and/or after receiving the PTAB’s preliminary guidance (if requested). If a patent owner does not elect either of those options, the motion to amend practice is essentially unchanged from current practice. The notice sets forth the details of the pilot program, including motion to amend procedures that will be in effect for the duration of the pilot program.

It is not clear whether the pilot program will pay off for patent owners. In one recent decision (Mylan v. Sanofi-Aventis IPR2018-01679, 01680, & 01682), the patent owner did avail itself of the pilot program and did receive preliminary feedback from a PTAB panel – unfortunately for the patent owner, the advice from the PTAB was that the amended claims would still not pass muster due to obviousness.

According to PTAB Chief Judge Scott Boalick, who spoke at an AIPLA-sponsored PTAB Roundtable in Boston on December 10, 2019, there were 13 motions to amend filed by patent owners in pending AIA trials during FY 2019 and of the 13, ten have signed up for the pilot program and almost all of them have also availed themselves of the preliminary guidance option.

In addition to the Mylan case, one other pilot program advisory opinion has been issued on an amendment so far – and the PTAB panel again found that proposed amendment to be lacking.  Of course, the patent owners in both cases now has an opportunity to present alternative amendments so it is too early to tell if they or any other pilot program participants will ultimately be successful in amending their claims.