Previously Exercised Discretion Eliminated by SAS

While most remember the Cuozzo appeal as challenging the Patent Trial & Appeal Board’s (PTAB) claim construction practices, it also challenged the Board’s discretion to institute claims on grounds not presented in the IPR petition. But, the High Court deemed this issue unreachable given the appeal bar of 35 U.S.C. § 315(b). Still, the Federal Circuit has expressly endorsed the Board’s ability to modify the grounds presented in trial petitions.

Today, the Federal Circuit has made clear in Sirona Dental SystemsGMBH v. Institut Straumann AG (precedential) that the Supreme Court’s decision in SAS Institute eliminates any ability of the Board to modify a petitioner’s trial grounds. Continue Reading CAFC: PTAB Must Not Reformulate Petition Grounds

Senator Hatch Proposes PTAB Exception for Orange & Purple Book Patents

As explained earlier this week in a study by my partner Filko Prugo, Orange & Purple Book patents fare no worse at the PTAB than in the courts. That said, some believe that the ability to challenge such patents in a faster, cheaper expert forum upsets the balance of power in the existing drug innovator landscape.

Today, Senator Orrin Hatch (R-UT), the Chairman of the Senate Republican High-Tech Task Force and co-author of the Hatch-Waxman Act, filed an amendment in the Senate Judiciary Committee to in his words “restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development.” Senator Hatch’s amendment, the Hatch-Waxman Integrity Act of 2018, is argued to  prevent alternative procedures for challenging drug patents from tilting the playing field contrary to Hatch-Waxman’s design. It is also argued to ensure that brand-name and generic manufacturers alike have the proper incentives to develop life-saving medications. Continue Reading Senate Moves to Exclude Orange & Purple Book Patents from PTAB

Key Bio/Pharma Assets at the PTAB

Through more focused strategy, patent owners have ensured that Patent Trial and Appeal Board (PTAB) proceedings are not overwhelmingly fatal to Orange and Purple Book patents. In fact, patent invalidity rates at the PTAB now rival those in district court litigation.

Ropes and Gray’s IP Litigation (Life Sciences) Chair Filko Prugo conducted a study that examines institution rates and final written decision outcomes for each Orange and Purple Book-related PTAB petition filed since the inception of the PTAB to May 1, 2018, as well as every validity decision rendered by a federal district court in Hatch-Waxman litigation between Jan. 1, 2013 and May 1, 2018.

I hope you find these insights helpful.

You can find the full study (here)

CAFC Has Jurisdiction Where SAS Relief Waived

The impact of the Supreme Court’s decision in SAS Institute has been immediate and far-reaching. As explained last week, the courts have quickly realized the import of this Patent Trial & Appeal Board (PTAB) practice change on motions to stay. As for the PTAB itself, the agency is currently grappling with the unexpected expansion of roughly 50% of its current caseload. With a significant number of PTAB trial appeals on the docket of the Federal Circuit, questions remained as to how the Court might resolve the SAS questions in the cases pending before it.

Today, the court issued a precedential decision in PGS Geophysical AS v. Iancu in which the Court found outstanding SAS issues did not deprive it of appellate jurisdiction. Continue Reading CAFC Clarifies SAS Impact on Pending Appeals

Two PTAB Boardside Chats This Week

Today from noon to 1 PM (EST), Chief Judge David Ruschke will provide additional information about the impact of SAS on AIA trial proceedings. He will also share new information about motion to amend practice, and discuss the recently published Notice of Proposed Rule-making on the claim construction standard to be applied during AIA trials.

The webinar is free and open to everyone to attend. Access (here)

Later this week, a second Chat will be held on Thursday from noon to 1 PM (EST). The Thursday Chat will discuss “Motions to Exclude and Motions to Strike in AIA Trial Proceedings.” PTAB Judges Justin Arbes and Kevin Cherry will present and address audience questions.  Access (here)

Aqua Products Results in De-designation of Previous Amendment Precedent

In view of the decision from the United States Court of Appeals for the Federal Circuit in Aqua Products, Inc. v. Matal, 872 F.3d 1290 (Fed. Cir. 2017), regarding motion to amend practice and procedure in AIA trials, the Patent Trial & Appeal Board (PTAB) has de-designated as precedential MasterImage 3D, Inc. v. RealD Inc., Case IPR2015-00040 (PTAB July 15, 2015) (Paper 42) and has de-designated as informative Idle Free Sys., Inc. v. Bergstrom, Inc., Case IPR2012-00027 (June 11, 2013) (Paper 26). Both decisions have been removed from PTAB’s Precedential and Informative Decisions web page.

Concurrently, the PTAB has designated as informative the following order in Western Digital Corp. v. SPEX Techs., Inc., which provides guidance on motion to amend practice in AIA trials such as: (1) contingent motions to amend; (2) the burden of persuasion that the Office applies when considering the patentability of substitute claims; (3) the requirement that a patent owner propose a reasonable number of substitute claims; (4) the requirement that the amendment respond to a ground of unpatentability involved in the trial; (5) the scope of the proposed substitute claims; (6) the requirement that a patent owner provide a claim listing with its motion to amend; (7) the default page limits that apply to motion to amend briefing; and (8) the duty of candor.

SAS Weighs in Favor of Stay Pre-Institution

At the time SAS Institute first raised its challenge to the partial institution practices of the Patent Trial & Appeal Board (PTAB), I explained that should this argument ultimately prevail that it would be bad news for Patent Owners. Patent Owners facing a motion to stay pending PTAB review frequently leveraged partial institutions to defeat the stay. Such motions were denied because one of the factors considered in the motion analysis is the potential for “simplification of issues for trial.”  And where a trial would eventually be conducted regardless of PTAB outcome — the case when there was a partial institution — this factor weighed strongly in favor of Patent Owners continuing the district court litigation .

Post-SAS, this argument is now gone. The impact of SAS on common stay scenarios is already being felt by Patent Owners. Continue Reading New SAS Reality Impacts Motion to Stay Analysis

IPO Chat Channel Provides Final Word on SAS

This Thursday the IPO Chat Channel will feature the Chief Judge of the Patent Trial & Appeal Board (PTAB) on the program entitled: A New PTAB Landscape: The Impact of SAS, Recent Federal Circuit Decisions, and the Proposed Change to the BRI Standard. The program will explore the path ahead after SAS Institute and other recent developments impacting PTAB practice. (register here)

Pro-Patent Owner Options

The new Director of the U.S. Patent & Trademark Office (USPTO) has issued a Notice of Proposed Rulemaking (NPRM) in record time. With only a few weeks on the job, the Director issued a NPRM to switch the Broadest Reasonable Interpretation (BRI) currently used in Patent Trial & Appeal Board (PTAB) trial proceedings to a Phillips claim construction. The proposal was quickly lauded by Patent Owners believing that the application of the Phillips standard by the PTAB will lead to narrower claim constructions, and thus, more patents being upheld by the agency. But, as I pointed out previously, in practice, BRI is rarely different from a Phillips construction. In fact, utilizing the same standard at the PTAB as in the courts might only make matters worse for Patent Owners from a monetization perspective.

Impact of the proposed claim construction change aside, the speed at which the Director has acted speaks to his keen interest in improving the PTAB playing field for Patent Owners. With the Director expected to issue further proposals to aid Patent Owners, below are some likely candidates. Continue Reading How Might the Director Improve the PTAB for Patent Owners?

Government Brief Faults Tribal Immunity Logic

On June 4th, the Federal Circuit will hear arguments in Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc.  As a reminder this case will explore whether principles of sovereign immunity prevent the Patent Trial & Appeal Board (PTAB) from conducting an Inter Partes Review (IPR) of a patent owned by a Native American tribe.

In advance of the upcoming hearing, the U.S. Dept. of Justice has filed its amicus brief supporting the agency’s decision to deny immunity.  The government brief explains that “[n]o principle of sovereign immunity entitles an Indian tribe to withhold a public franchise from reconsideration by the superior sovereign that granted it.” Continue Reading PTAB’s Sovereign Power Superior to State/Tribes