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

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

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

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