New Guidance for Statutory Bars, Foreign Depositions & Confidentiality

Earlier this week, the Patent Trial & Appeal Board (PTAB) designated several IPR decisions as “informative.” As a reminder, an “informative” opinion, while not binding PTAB authority, illustrates norms of Board decision-making for the public, the patent examining corps, and future Board panels. Informative opinions may explain best practices, address recurring problems, identify developing areas of the law, exemplify types of decisions under-represented in commercial case reporting services, or report cases of public interest. Continue Reading PTAB Designates AIA Decisions Informative

Political Theater & Patent Reform

The Stronger Patent Act has failed to gain traction for several years now. The Bill is deemed to one-sided, proposing legislative changes that would effectively kill AIA trial proceedings. Strangely, a new bill was introduced last week that goes even further.

The so-called Restoring America’s Leadership in Innovation Act (here) proposes to disband the Patent Trial & Appeal Board (PTAB) and with it, AIA trial proceedings. The new bill also seeks to convert the U.S. system back to a first-to-invent system. The Bill is sponsored by Rep. Thomas Massie (R-Ky.) and co-sponsored by Reps. Marcy Kaptur (D-Ohio) and Dana Rohrabacher (R-Calif.). Some may recall Reps. Rohrabacher and Kaptur as being opponents of the post-grant mechanisms of the AIA.

While perhaps heartening to critics of the PTAB, the latest bill is little more than political theater. With mid-term elections on the way, and a Supreme Court nomination battle, attempts at patent reform will have to wait until 2019 – assuming a balanced bill ever emerges.

325(d) Compliments SNQ Standard

The popularity of AIA trial proceedings at the Patent Trial & Appeal Board (PTAB) has caused a corresponding nosedive in patent reexamination filings. Not surprisingly, when faced with a high-value patent dispute, patent challengers greatly prefer the more robust inter partes options of the PTAB as compared to ex parte reexamination. But, that is not to say that patent reexamination is no longer important. Indeed, there are situations where patent reexaminations are conducted in parallel to AIA trials, or at the conclusion of such a trial.

A question that has lingered in recent years is the relationship of the Substantial New Question (SNQ) standard of patent reexamination to the AIA’s “same or substantially the same prior art or arguments” of 35 U.S.C. § 325(d). The statute makes clear that it applies to Chapter 30 statutes (reexamination), and includes the language “petition or request” to further clarify that patent reexamination is covered. But, there has been little guidance from the agency on the use of 325(d) analysis in patent reexamination, or how it might operate together with the seemingly redundant SNQ standard.

A recent decision of the Office of Patent Legal Administration (OPLA) provides a very comprehensive discussion of the various moving parts (here).  (Given my firm’s involvement, I am limiting my commentary to a simple introduction of the issues discussed).

Upcoming PTAB Conferences Across All USPTO Locations

Next Thursday, June 28th, the USPTO (Alexandria-HQ) will host its 2018 Patent Trial & Appeal Board (PTAB) Judicial Conference. If you are unable to attend the Alexandria kick-off, the same program will be making its rounds to the regional offices: Detroit (7/9), Denver (7/11), San Jose (7/26), and Dallas (7/31).

The Conferences are designed to educate the public about aspects of Board practice as well as providing a forum to enhance the dialogue between the public and the Board. During the morning sessions, the PTAB will focus on best practices for written and oral advocacy with a judge panel discussion followed by practicum exercises for attendees. During the afternoon sessions, the PTAB will host small group discussions to address hot topics, such as patent subject matter eligibility and motion to amend practices. The conference will conclude with an interview with Chief Judge David Ruschke led by members of the local IP community to explore other recent PTAB developments and potential future changes.

The agenda at each location will be identical (here).

Hope to see you there.

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.