ANPRM an Unnecessary Slog to a Small Rule Package

It has been almost a year since the Patent Trial & Appeal Board (PTAB) released its Advanced Notice of Proposed Rulemaking (ANPRM) on AIA trial practices. As a reminder, the ANPRM was a sprawling collection of rule proposals and requests for public feedback. I previously pointed out that the proposal was unnecessarily ambitious and was destined to be bogged down for proposing to exceed the agency’s regulatory jurisdiction.

Well, the wait is almost over.

Continue Reading Where are the New PTAB Rules?

Post-Amgen Claiming Techniques in Focus

Last year’s landmark decision in Amgen V. Sanofi emphasized that “the more a party claims, the broader the monopoly it demands, the more it must enable.” That is, particularly when claiming a broad genus of antibodies, the specification cannot be a research assignment to engage in trial and error as to the recited claim scope.

Since that time and perhaps dealing with inadequate specifications filed prior to Amgen, prosecutors have considered whether fallback claiming techniques such as Jepson format claiming or mean-plus-function formatted claims can at least secure some protection in the case where broader claims fail.

The USPTO is now committed to providing clarity on these topics in In re Xencor.

Continue Reading USPTO Appeals Panel to Clarify Antibody Claiming in MPF & Jepson Format

Common AIA Issues Discussed

This coming Thursday January 18th (noon to 1 p.m. (EST)) the PTAB will host its first Boardside Chat of the year. The program will discuss issues that typically arise during an America Invents Act (AIA) proceeding before the Board (PTAB). Topics will include:
• Preparing a patent owner preliminary response
• Preparing a patent owner response
• Motions to amend
• New arguments
• Motions to strike
As always, a question-and-answer session will follow the presentation. Questions may be sent in advance or during the webinar to PTABBoardsideChat@USPTO.gov.
Register (here)

Avoiding Cellect

The Federal Circuit’s In re Cellect ruling has significant implications for patent portfolios, emphasizing the need for careful planning to avoid obviousness-type double patenting (OTDP) that could compromise statutory term and patent validity. Particularly, patents with patent term extension (PTE) may face increased risk, as reference patents in the same family might have already expired during the PTE period, rendering claims incurably invalid if not addressed promptly.

What should practitioners and in-house counsel be doing right now?

Join me Wednesday, January 10th for a free CLE webinar discussing what is at risk, what should be done immediately, and what to consider going forward. Register (here)

Latent OTDP Issues & Litigation

The Federal Circuit’s decision in In re Cellect clarified that patenting obvious variants of the same invention across multiple patents—Obvious-Type Double Patenting (OTDP)—can result in the elimination/reduction of Patent Term Adjustment (PTA). OTDP was fatal to the challenged Cellect patents given the expiration of the reference patent. This was because a terminal disclaimer to remedy OTDP is not possible after expiration. Earlier this year I explained ways to proactively insulate a patent portfolio from potential Cellect vulnerabilities.

For patent owners facing newly invigorated OTDP attacks in litigation, and where a terminal disclaimer can still be filed, the potential loss of significant PTA creates a strategic quandary.

A terminal disclaimer cannot be withdrawn once filed. So, if a patent owner simply files a terminal disclaimer to moot the OTDP challenge, years of additional patent term (PTA) may be unnecessarily surrendered where the patent owner might have won. But, if the patent owner loses on OTDP without a terminal disclaimer on file, the patent is invalidated.

Recently a patent owner attempted to resolve this quandary with a contingent terminal disclaimer.

Continue Reading Contingent Terminal Disclaimers?

Claim-Based Analysis Required for Pre-AIA Patents Only

One of the more confusing developments in patent law was pronounced in Dynamic Drinkware v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). In Dynamic the Court held that a provisional application’s effectiveness as prior art under 102(e) depends on its written description support for the claims of the issued patent. In other words, if the patent claims ABC, and C is not supported in the provisional, the provisional loses 102(e) prior art status for all of its disclosure. So, if looking to use the provisional date for AB alone, which is supported, the claim-based analysis would still prevent such reliance.

The applicability of the strange claim-driven analysis of Dynamic was recently considered relative to AIA patents. Today’s precedential PTAB decision makes clear that the AIA statutory framework dispensed with this faulty claim-centric scheme.

Continue Reading Dynamic Drinkware Analysis Unnecessary for AIA Patents

Internal Procedures Discussed

The U.S. Patent and Trademark Office (USPTO) issued a Notice of Proposed Rulemaking (NPRM) on the Patent Trial and Appeal Board’s (PTAB) pre-issuance internal decision circulation and review last month. The PTAB also issued a new Standing Operating Procedure (SOP) on pre-issuance and post-issuance decision review, and updated and renumbered its SOP on handling remands from the Federal Circuit. This Thursday (11/16) the PTAB will host a Boardside Chat webinar from noon to 1 p.m. ET to discuss the NPRM and the SOP with PTAB’s Vice Chief Judge Melissa Haapala.

While this information offers increased transparency to interested members of the public on internal agency processes, it is not especially interesting from a practitioner perspective.

A question-and-answer session will follow the presentation. Questions may be sent in advance or during the webinar to PTABBoardsideChat@USPTO.gov. Register (here)

Controversial Proposals Given Air Time at Year End

The U.S Senate Judiciary Committee will hold a hearing today entitled: “Reforming the Patent Trial and Appeal Board – The PREVAIL Act and Proposals to Promote U.S. Innovation Leadership.” The hearing appears to be an effort to engender perception that the Prevail Act has some level of traction on the Hill. Yet, the Act, like all of its predecessors, remains too lopsided to advance beyond the committee stage.

The presiding chair of the Committee is Senator Coons, who just so happens to be the co-sponsor of the Prevail Act (as well as its previously unsuccessful iterations). So, this hearing appears more of a consequence of his leadership position rather than any kind of sudden legislative coalescence around previously rejected proposals.

Former Congressman Lamar Smith (of Leahy-Smith America Invents Act fame) is an invited speaker. Strangely, Smith has been a vocal opponent of the PTAB despite creating it — arguing unintended consequences. This is in stark contrast to the other legislative namesake, Senator Leahy, who prior to his retirement in 2022 attempted to “restore” the PTAB. As can be appreciated, a hearing ostensibly offered to promote dialogue and compromise seems more than a bit premature given the distance between warring viewpoints.

Given the upcoming election year in 2024 this effort will inevitably fall by the wayside regardless.

PTAB Pre-institution Procedures Codified

The USPTO published an Notice of Proposed Rulemaking (NPRM) today relating to internal procedures. The proposed rules set forth that the Director is not involved prior to issuance (of a PTAB Decision on Institution) in directing or otherwise influencing PTAB panel decisions. The proposed rules further provide that PTAB management is not involved in panel decision-making unless a panel member has requested the input of PTAB management and that adoption of any pre-issuance feedback is solely within the discretion of the panel.

For practitioners and stakeholders this is a non-event. This NPRM is more about dispelling conspiracy theories by being overly transparent. A more substantive rule package is expected this month.

Leveraging Written Description Vulnerabilities in IPR

Bio/pharma patents are rarely targeted in IPR proceedings because their technical vulnerabilities often relate to written description and/or enablement. IPR, of course, is restricted in scope to only grounds of unpatentability that are based on patents and printed publications. And claims in the unpredictable arts, even when challenged in IPR, can be relatively tougher to invalidate as compared to patents in the predictable arts.

That is not to say that 112 issues cannot be litigated in an IPR—only that 112 cannot be a stand-alone trial ground. For example, where a subject patent claims priority to one or more prior filings, the 112 support of those filings is properly litigated in IPR if the claims of the subject patent are argued as lacking support in the earlier filings. The distinction is that 112 is not being assessed as a stand-alone challenge, but rather, as part of the priority assessment to determine the applicability of intervening prior art under 102/103.

The above IPR strategy is not new. However, it might be significantly more valuable to Bio/Pharma patent challengers as a mechanism to force an Amgen analysis on older patent portfolios via IPR.

Continue Reading Amgen Analysis: An Emerging PTAB Threat For Bio/Pharma