April Webinar to Explore Bio/Pharma Deals & Disputes in the PTAB Era

This month’s edition of the PatentsPostGrant.com free webinar series will be held on Wednesday May 2nd, 2018 @ 2PM. The April webinar is entitled: Bio/Pharma Deals & Dispute Resolution in the PTAB Era.

Register (here)

The emergence of the Patent Trial & Appeal Board (PTAB) as a forum for patent validity disputes has altered the business landscape of both innovator and generic companies alike. PTAB proceedings are now commonplace for Orange Book pharmaceutical patents and Purple Book biologic/biosimilar patents. An understanding of the business impact of these proceedings from both a transactional and litigation perspective is critical for successful, in-house navigation. Likewise, trends within and across these proceedings, including final patent validity outcomes, impact on traditional Hatch-Waxman procedures, types of patents (compound, formulation, method of use) involved, and the timing of challenges, are critical components to a successful litigation and portfolio development strategy.

Please join Ropes & Gray’s PTAB Chair Scott McKeown, Life Sciences IP Litigation Chair Filko Prugo, and IP Transactions Partner Melissa Rones for the upcoming webinar providing a holistic analysis of these important Bio/Pharma disputes.

The formal portion of the webinar will begin at 2PM Eastern and will last for approximately 50-60 minutes. After the presentation there will be a Q&A period. To attend the webinar please sign up via the link above. You will receive a registration confirmation email immediately. One hour prior to the webinar you’ll receive another email with a link and instructions for joining the presentation. CLE credit will be provided (CA, NYC, VA).

PTAB Denies Party Submissions on Remanded IPR Appeal

A successful appeal to the Federal Circuit from the Patent Trial & Appeal Board (PTAB) typically ends in vacatur and remand. As explained a few weeks back, surprisingly, the Board is not simply correcting the record on remand to maintain its earlier decision. Rather, in most cases a remand results in an eventual victory for the appealing party.

This practice gives hope to Patent Owners who may have been assuming that absent reversal, a remand was just a longer, more painful loss. Continue Reading PTAB Remands Looking More Like Eventual Wins for Patentees

One-Year Clerkship Opportunities

The PTAB has created and is hiring for a new Judicial Law Clerk Program. The PTAB modeled this program off the judicial law clerk program used in the federal courts.

Judicial law clerks will gain experience working at the PTAB for a one-year term directly with one or more administrative patent judges (APJs). Judicial law clerks will assist on cases in all jurisdictions of the PTAB, including trials under the America Invents Act and ex parte appeals. Judicial law clerk positions are available at our Alexandria headquarters and all four regional offices in Detroit, Denver, Dallas, and San Jose, California.

The judicial law clerk position currently is posted on USAJobs. Applications are due by Thursday, April 26. Interested candidates must have an engineering or science background, law degree, and bar membership in any state within 14 months of a hire date. For more information, the PTAB is hosting a free webinar on April 11 from noon to 1 p.m. ET to review the position, experience, and skills required. APJs will answer questions.

April Boardside Chat: Ex Parte Appeals

The Patent Trial & Appeal Board (PTAB) will host its next “Boardside Chat” webinar this Thursday, April 5 from noon to 1 p.m. ET. The chat will discuss “Petitionable Matters, Objectionable Matters, and New Grounds of Rejections in Ex Parte Appeals.” PTAB Judges Adriene Lepiane Hanlon, Bruce Wieder, and Anthony Knight will present and address audience questions.

Webinar Access Information for Apr. 5, 2018 at noon, E.T.: 

Click on the link:  https://uspto-events.webex.com/uspto-events/onstage/g.php?MTID=e5d19dd86cb630ad37297aa0f92d1f2af

Event/Access #:  996 735 788

Event password:  AprilChat2018

Access code: 996 735 788

New Director’s Interest in Predictability To Drive PTAB Change

As pointed out yesterday over at IPWatchdog, the USPTO Solicitor has withdrawn as Intervenor in the Federal Circuit appeal between Telebrands Corporation and Tinnus Enterprises (stemming from PGR2015-00018, challenging a patent pertaining to the well-known Bunch-o-Balloons® product on indefiniteness grounds). The USPTO intervened in the earlier appeal to defend the indefiniteness standard applied in the PGR. This is because the applied standard was stricter than that enunciated in Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120 (2014). The application of a different, stricter standard caught some by surprise that had not realized that the Federal Circuit endorsed that very standard for agency proceedings in In re Packard, 751 F.3d 1307, 1310 (Fed. Cir. 2014).

I pointed out at the time of this appeal that the Packard indefiniteness standard is grounded in ex parte examination policies and practices.  As such, it was unclear whether the Court’s holding in Packard could be properly extended to AIA trial proceedings. Yet, the Solicitor’s decision to withdraw as Intervenor in the Tinnus dispute is not a sign that the agency lacks faith in its brief. Rather, the change is indicative of a new direction for PTAB trial proceedings. Continue Reading PTAB Likely to Adopt a Philips Construction for AIA Trials in 2018

Stay To Force PTAB Outside of Statutory Time Limit?

Today, the Federal Circuit issued a stay of further Patent Trial & Appeal Board (PTAB) proceedings pending the St. Regis Mohawk Tribe’s sovereign immunity appeal. The appeal challenges the Board’s determination that the Tribe is not immune from its proceedings as a sovereign entity. As a reminder, the tribe is alleged to be the new owner of Allergan patents relating to the ophthalmic Restasis®  Continue Reading CAFC Shuts Down PTAB Pending St. Regis Mohawk Tribe Appeal

PatentsPostGrant.com + IPO’s IP Chat Channel CLE This Week

I have written extensively about the threat of PTAB estoppel to established patent prosecution practices. This Thursday, I, along with my co-panelists, will explore PTAB estoppel as well as other aspects of res judicata and issue preclusion in the IPO Chat Channel program (2-3PM EST) entitled: Patent Prosecution Estoppel from PTAB Proceedings

Register: (here).  

On Wednesday, this month’s edition of the PatentsPostGrant.com free webinar series will be held @ 2PM (EST). The March Webinar is entitled: Evolution of PTAB Trial Practices.

Register: (here)

I am looking forward to both of these programs.

Additional Informative Decisions 325(d)

Today the Patent Trial & Appeal Board (PTAB) added to its growing stockpile of cases that address the meaning of “same or substantially the same prior art or arguments” under 35 U.S.C. § 325(d). This growing body of decisions is welcome news for Patent Owners as it emphasizes the scrutiny given to AIA trial petitions that attempt to revisit prior art and arguments of a previous proceeding.

The PTAB has designated the following decisions informative.

Kayak Software Corp. v. International Business Machines Corp., Case CBM2016-00075 (PTAB Dec. 15, 2016) (Paper 16). In this decision, the Board exercised its discretion under 35 U.S.C. § 325(d) and declined to institute review of the claims under obviousness grounds because the record indicated that the cited prior art was previously presented to and extensively considered by the Office during prosecution. The Board further was not persuaded that the incremental addition of an already considered reference was sufficient to avoid § 325(d), but explained that the presence of certain factors, including a limited prosecution history, clear errors in the prosecution, and/or the cursory consideration of the prior art may weigh against the exercise of discretion to deny institution under § 325(d).

Becton, Dickinson & Company v. B. Braun Melsungen AG, Case IPR2017-01586 (PTAB Dec. 15, 2017) (Paper 8). In this decision, the Board weighed a non-exclusive list of factors and concluded to exercise its discretion under 35 U.S.C. § 325(d) and declined to institute review of the claims under certain obviousness grounds. The non-exclusive factors the Board considered were: (1) the similarities and material differences between the asserted art and the prior art involved during examination; (2) the cumulative nature of the asserted art and the prior art evaluated during examination; (3) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis of rejection; (4) the extent of the overlap between the arguments made during examination and the manner in which Petitioner relies on the prior art or Patent Owner distinguishes the prior art; (5) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art; and (6) the extent to which additional evidence and facts presented in the Petition warranted reconsidered of the prior art or arguments.

Previous 325(d) decisions designated as informative:

Unified Patents, Inc. v. Berman, Case IPR2016-01571, Case IPR2016-01571 (PTAB Dec. 14, 2016) (Paper 10)
Hospira, Inc. v. Genentech, Inc., Case IPR2017-00739 (PTAB July 27, 2017) (Paper 16)
Hospira, Inc. v. Genentech, Inc., Case IPR2017-00777 (PTAB Aug. 22, 2017) (Paper 7)

Copycat House Bill to Generate Positive Buzz?

Today, Representative Steve Stivers (R-OH) and Representative Bill Foster (D-IL) introduced H.R. 5340, the so-called “Support Technology & Research for Our Nation’s Growth and Economic Resilience (STRONGER) Patent Act.” The bill (here) is a carbon copy of the Senate Bill (save some cosmetic changes). On the Senate side, the Bill has existed in some form since 2015 but has languished. This is because its proposals would essentially legislate away the patentability trial mechanisms of America Invents Act (AIA). With the mammoth Tech and Bio/Pharma lobbies on opposing sides of that issue, a bill viewed as lopsided by Tech is a non-starter.

If nothing else, the House Bill appears to be an attempt to create some positive, political buzz.

Given the distance between powerful lobbies on these issues, I would not expect meaningful movement on the legislative front any time soon. Some of the more patent friendly changes over the past year have come from the PTAB itself. My expectation is that the agency will continue this trend and address some of these issues via notice-and-comment rulemaking later this year.

PTAB Remand Not Always Deja Vu

When appealing a decision of an administrative agency such as the Patent Trial & Appeal Board (PTAB), reversal is quite rare. This is because rarely will a pure question of law (with no facts in dispute) control the outcome of such an appeal  Rather, a typical PTAB appeal to the Federal Circuit will dispute whether the agency record fully supports its decision, or is complete with respect to required fact finding. In these cases vacatur and remand are appropriate.

Since 2016, as the volume of appeals from the PTAB has increased, so to has the number of remands to the agency. Where a PTAB record is incomplete, one might expect the agency to simply remedy the shortcoming on remand to maintain its earlier decision. However, two years of recent statistics reflect a more balanced outcome. Continue Reading PTAB Remands from the CAFC: Mixed Outcomes