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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A terminal disclaimer cannot be withdrawn once filed.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?

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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

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Boardside Chat This Thursday

The next Patent Trial and Appeal Board (PTAB) Boardside Chat webinar will be this Thursday, September 21, from noon to 1 p.m. ET. The Chat this month will be a discussion with in-house counsel on their perspectives on America Invents Act (AIA) trial proceedings before the PTAB. The panel will touch…

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Amended Rule Moves Focus to Admissibility

Back in April the Supreme Court approved changes to FRE 702 (Expert Witness Testimony) that will take effect on December 1st. These changes clarify that the preponderance of evidence standard controls the evaluation of expert testimony while also providing structural changes designed to refocus the trial court on admissibility.

Enhancing the gatekeeping function of the courts moves current practice away from erring on the side of admissibility. This also avoids fact finders needing to assign an appropriate weight where reliability is in question; such practices are especially confusing for juries.

But, what does the change to FRE 702 mean for declarant testimony at the PTAB? Continue Reading FRE 702 Amendment & The PTAB

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Critical U.S Industry Depends on the PTAB – Not China

The so-called PREVAIL Act (here) was floated some weeks back to “to ensure the United States does not cede technological supremacy to our foreign competitors and adversaries.” As the accompanying materials insist, fighting China is the rationale behind the bill’s proposed patent reforms. That is, the U.S. Patent system must be made stronger to rival the Chinese threat by weakening the USPTO’s Patent Trial & Appeal Board (PTAB).

If this “stronger patents” argument sounds familiar, it should. Before its reinvention as the Prevail Act, the same “litigation first” ideas were packaged to the American public as the so-called Stronger Patents Act. But, the “Stronger” Bill went absolutely nowhere despite being introduced every year for the past six years (maybe 7, I lost count).

Not surprisingly, increasing patent litigation expense and unnecessary liability for successful U.S companies in the name of “stronger patents” didn’t resonate on the Hill. This is because the America Invents Act (AIA), which created PTAB trial was passed into law a little more than a decade ago for the purpose of reducing wasteful litigation over improvidently issued patents— and is working exactly as intended. Few legislators (aside from sponsors) were interested in a proposal to effectively repeal the AIA. So, after years of failure, this perennially failed effort has been newly-minted as the PREVAIL Act.

While the new spin also argues for stronger patents, it presents the need as a necessary tool to “prevail” against the growing technological threat from communist China. Ironically, the blatant dishonesty of this new spin only serves to highlight the critical importance of the PTAB to U.S. interests.Continue Reading The Prevail Act – Harm U.S. Industry to Fight China?

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Failed PTAB Bill Reemerges For a 6th Time

Yesterday, U.S. Senators Chris Coons (D-Del.),Thom Tillis(R-N.C.), Dick Durbin (D-Ill.), and Mazie Hirono (D-Hawaii) introduced the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act (here). Also yesterday, some of the very same senators introduced the Patent Eligibility Restoration Act of 2023. 

The co-introduction of these bills suggests a plan to drive compromise on patent eligibility.Continue Reading New PTAB Bill to Drive 101 Compromise?

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Bill to Reset Analysis

Today, U.S. Senators Thom Tillis (R-NC) and Chris Coons (D-DE) introduced the Patent Eligibility Restoration Act of 2023. You can find the text of the bill (here).

The bill is a slightly refined version of the proposal floated last summer. Most of the changes seem directed to assessing the relevance of a mathematical formula as part of the claim, and making clear that otherwise patent ineligible subject matter cannot be saved by mere computer implementation. Presumably these changes are directed to addressing the concerns of those stakeholders in the predictable arts. (The lobbying force behind the effort has always been Bio/Pharma).

The bill essentially wipes the slate clean on 101 jurisprudence by eliminating all so-called “judicial exceptions.” As well it should. Despite those that would counsel otherwise, there is absolutely no rhyme or reason to the food-fight mess that is 101 jurisprudence.Continue Reading New 101 Bill to Avoid Case Law Morass

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The ANPRM Proposals That Should Drop Out of the Process

Yesterday I highlighted the ANPRM proposals that are likely to make it into the NPRM this coming fall. Today, I’ll walk through the ones that I expect to be dropped, or at least heavily revised.

The vast majority of these “misfires” suffer from the same fatal deficiency — only Congress can provide for such modifications to the AIA. While the agency has substantive rule-making authority to implement the AIA, it does not have authority to implement regulations that effectively rewrite the AIA statutes themselves.

Given the push back from Congress on the apparent overreach of many of the ANPRM proposals, it is highly unlikely that the agency will carry such proposals forward to the NPRM. Continue Reading PTAB ANPRM – Misfires & Overextensions

CLE Provided

This coming Thursday at 12PM (EST), IPWatchdog will host the free webinar entitled: PTAB Rules: The Good, The Bad & The Ugly. The webinar will cover the recent Advanced Notice of Proposed Rulemaking (ANPRM), preview stakeholder reactions, Congressional concerns, and discuss the most likely outcomes. Register (here)

With comments due from…

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Unnecessarily Ambitious

Late last week the USPTO issued an Advanced Notice of Proposed Rulemaking (ANPRM) that floated numerous rule proposals and requests for feedback — too numerous. Proposals addressing current 314(a) and 325(d) practices were not only expected, but long overdue. While these expected proposals were included in the sprawling Notice, the rule-making process will undoubtedly be bogged down by the remaining collection of controversial ideas and administrative over-reach.

Keep in mind that 314(a) Fintiv practices could soon be struck down as improper circumvention of APA rule-making. Stalling the issuance of those rules for at least another 12-18 months – if not longer – seems like a bad idea. My guess is political pressure from outside the agency led to the laundry list of additional proposals. Especially as they relate to for-profit entities in the wake of the Open Sky debacle.

Regardless, of how or why the expansive ANPRM came to be, I’ll walk through each proposal/idea in detail below (ANPRM here)Continue Reading PTAB Rule Ideas – The Good, The Bad, & The Ugly