The Post-Grant Strategist

(Co-authored by Elisabeth Hunt)

Discretionary denial has been a hot topic at the PTAB. On Wednesday, February 24^th, Wolf Greenfield hosted a webinar to discuss discretionary denial at the PTAB, and in particular, discretionary denial based on parallel infringement litigation in district court or the ITC.

Although judicial review of decisions during IPR typically occurs through appeal after the PTAB’s Final Written Decision, a growing number of cases are exploring other means of judicial review. Questions remain about whether those other means can provide a way to overcome the statutory limits on the appealability of IPR decisions, which we previously discussed. This post, which is the third in a series about judicial review of IPR, addresses a third trap for the unwary: the availability of alternatives to appeal.

Mandamus: Perhaps the most well-known alternative to appeal from and IPR is petitioning for a writ of mandamus. Ever since the Supreme Court’s first decision on IPRs, Cuozzo v. Lee, 136 S. Ct. 2131 (2016), left open the possibility of judicial review of constitutional and statutory rights related to institution, some have speculated that mandamus may be the best route to present those arguments. Indeed, the Supreme Court’s most recent decision on IPRs, Thryv v. Click-To-Call, 140 S. Ct. 1367 (2020), declined to foreclose the use of mandamus in “extraordinary cases.”

A series of Supreme Court cases has clarified that not all issues that arise in IPR are appealable. Thus, in addition to considering the issue of standing, which we previously discussed, a party considering appeal must also determine whether the issue it would want review can even be appealed. This post, which is the second in a series about judicial review of IPR, addresses a second trap for the unwary: the limited scope of permitted appeal.

Section 314(d) prohibits appeal of the PTAB’s decision “whether to institute [IPR] under this section.” Some interpreted that as limiting appeal only of the Institution Decision’s determination under Section 314(a) that the petition’s unpatentability arguments are sufficiently strong to deserve institution. The Supreme Court rejected that interpretation in Cuozzo v. Lee, 136 S. Ct. 2131 (2016), applying the appeal bar to the related determination under a different section that the petition was written with sufficient “particularity.”

(Co-authored by Elisabeth Hunt)

In the time since the America Invents Act (AIA) created the Patent Trial and Appeal Board (PTAB), inter partes review (IPR) and other PTAB proceedings for challenging patents’ validity have proven to be powerful tools for those accused of infringement. But increasingly, the PTAB’s exercise of its discretion to deny institution of review for non–merits-based reasons has become a powerful counter-defense for patent owners. Although discretionary denial has been a feature of PTAB proceedings since their inception, the range of circumstances in which the PTAB discretionarily denies institution and the frequency with which it does so are increasing. Discretionary denial has thus become a disputed issue in an increasingly large proportion of PTAB proceedings.

Seeking judicial review of an IPR decision can be a trap for the unwary. Section 319 permits a “dissatisfied” party to appeal. And while the language may seem simple, it can lead parties astray. This post, which is the first in a series about judicial review of IPR, addresses the first trap for the unwary: the constitutional requirement of standing.

Although Section 319 might be misread to allow any “dissatisfied” party to appeal, the party must still have standing to appeal. Thus, in Droplets v. E*TRADE, 887 F.3d 1309 (Fed. Cir. 2018), the Federal Circuit held that a petitioner that won but was “dissatisfied” with the PTAB’s reasoning still could not appeal. And in SkyHawke v. Deca, 828 F.3d 1373 (Fed. Cir. 2016), a potentially analogous decision concerning reexamination, the court rejected an appeal by a winning patent owner that wanted a different claim construction.

Per the express language of 35 U.S.C. § 311, a petitioner in an IPR may request cancellation of a claim “only on a ground that could be raised under section 102 or 103.” In other words, an issued claim can only be canceled via IPR on the basis of anticipation or obviousness grounds. But once an IPR is instituted, can the PTAB also make eligibility determinations pursuant to section 101 and/or written description or enablement determinations pursuant to section 112? The answer is, in certain circumstances, “yes” according to the Federal Circuit in Uniloc 2017 v. Hulu, No. 2019-1686 (Fed. Cir. July 22, 2020).

In Uniloc 2017, the petitioners challenged the patent owner’s claims as anticipated and obvious. The patent owner defended the claims and also filed a contingent motion to amend requesting that, in the event certain claims were found unpatentable, the PTAB issue substitute claims pursuant to section 316(d). The petitioners opposed the motion to amend, arguing that the proposed substitute claims were directed to patent ineligible subject matter.

Even when certain elements in a claimed method are not expressly disclosed in the prior art, the claim can still be held obvious if the missing elements are supplied in the form of an inherent property. In the pharmaceutical context, the PTAB decision in Dr. Reddy's Laboratories, Inc. v. Pozen Inc. (IPR2018-00894; PTAB 2019) illustrates the continuing difficulty in claiming methods of administering a known two-drug pharmaceutical composition with an expected pharmacokinetic and pharmacodynamic (PK/PD) profile. The patent at issue covers methods of administering morning and afternoon daily doses of the arthritis pain reliever Vimovo®. Specifically, the claims recite particular PK/PD profiles, including the highest plasma concentration of the drug following administration, drug bioavailability, and amount of drug exposure for compositions of naproxen (a nonsteroidal anti-inflammatory drug “NSAID”) and esomeprazole (a proton pump inhibitor (PPI)). Esomeprazole is used in conjunction with naproxen to reduce the risk of gastrointestinal injury from naproxen by raising the gastrointestinal tract pH.

(Co-authored by Stuart Duncan Smith)

This blog post is part of Wolf Greenfield's COVID-19 Resource Center. To access the full resource center, click here.

A stay is an important mechanism for many defendants to consider when filing an IPR. Due to the ongoing pandemic, courts have had to shift resources to address COVID-19-related concerns. In some instances, that is changing how courts evaluate motions to stay pending IPR.

Courts often consider three factors when determining whether to grant a stay pending IPR of a patent. These factors include:

1. The stage of the proceedings
2. Whether the stay will simplify the case before the court
3. Whether a stay would result in undue prejudice to the nonmoving party

Invalidity grounds in IPR that are not based on patents must be based on printed publications. But the nature of the evidence required at the time of institution to show that a non-patent reference is a printed publication has long been uncertain. The PTAB’s Precedential Opinion Panel (POP) in Hulu v. Sound View Innovations, IPR2018-01039 (Dec. 20, 2019), provided some clarity and left other issues for future PTAB panels to resolve.

This blog post is part of Wolf Greenfield's COVID-19 Resource Center. To access the full resource center, click here.

Appearing before the Patent Trial and Appeal Board (PTAB) looks different as a result of COVID-19. The PTAB recently held a “Boardside Chat” to talk about how PTAB practice has changed. Here are some important changes practitioners should know regarding case management, CARES Act extensions and remote hearings at the PTAB.