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

CAFC: Success/Motivation Record Intertwined in Predictable Arts

As borne out by historical PTAB statistics, and not unexpectedly so, patents in the unpredictable arts are more likely to withstand PTAB scrutiny as compared to patents in the predictable arts. For example, formulating a pharmaceutical has a lot more variables and unknowns than adding a drop-down menu to a particular computer interface. The latter requiring only a change in computer code. For this reason a successful obviousness challenge in the unpredictable arts typically requires far more evidence/effort on such showings as “expectations of success” in combing prior art references.

That is not to say that Patent Owners in the predictable arts should forego potential arguments on expectation of success. Rather, such Patent Owners need to be mindful that an expectation of success argument may have a limited shelf-life.

Continue Reading Early Opportunity for PTAB Patent Owners – Expectation of Success

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 upon their past experiences and strategic considerations in handling proceedings before the Board.

The panel features:
• Yen Florczak, Chief Intellectual Property Counsel at 3M Company
• Henry Hadad, Senior Vice President and Deputy General Counsel at Bristol-Myers Squibb
• Samir Pandya, Head of IP Litigation at SAP

(Register here)

Questions can be sent in advance to PTABBoardsideChat@uspto.gov

In-Person Hearings Should Not Require the Consent of an Adversary

Last week, the PTAB published an updated Oral Hearing Guide (here) to reflect current agency practices. The changes include rather mundane clarifications on such topics as public access and demonstrative submission for ex parte hearings.

More interestingly, however, the agency highlights an all-virtual hearing “option” for America Invents Act (AIA) trials. But, in practice this option is more appropriately considered the new default.

Continue Reading PTAB Default Should Be In-Person Trial Hearings

Claim Overlap Can be a Landmine for the Uninformed

Earlier this week the Federal Circuit decided In re Cellect, LLC, affirming the PTAB’s cancellation of claims for obviousness-type double patenting (ODP) over reference claims from earlier expiring patents in the same family in which differences in expiration dates were due solely to patent term adjustment (PTA).

For those in the SEP and Bio/pharma spaces, this is a call to action.

Continue Reading Building Patent Portfolios – Post Cellect

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

APA Safeguards Rebuttal Opportunity to New Claim Construction

A fundamental safeguard of the Administrative Procedure Act (APA) is the opportunity to be heard and to present evidence. Over the years the Federal Circuit has reminded the PTAB that parties must have notice of the agency’s positions and a meaningful opportunity to rebut such positions. The same opportunity must be provided for positions of opposing parties — as long as such positions are deemed timely.

Since the SCOTUS decision in SAS institute, which explained that the petition serves to “guide the life of the litigation,” the Board has considered positions expressed in a petition to be fixed. That is, if a patent owner raises a new claim construction mid-trial, the petitioner may not stray from its original positions (typically addressing a different construction) to rebut the new position of the patent owner. As can be appreciated there is a clear tension between the due process guarantees of the APA and a rigid application of the SCOTUS explanation in SAS.

Yesterday, the CAFC issued a precedential decision to clarify that there is at least some wiggle room for petitioners.

Continue Reading CAFC Clarifies PTAB Trial Scope – Coming Practice Changes

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?

No Role For POP Post-Arthrex

As of Monday July 24th, the USPTO has discontinued the use of its Precedential-Opinion-Panel (POP) in favor of the interim Director Review (DR). This move was not unexpected as the POP panel (an early attempt to cure the Arthrex infirmity with partial Director oversight) was effectively replaced by the SCOTUS decision in Arthrex (Director Only).

In relying only on the DR moving forward, the PTAB has also decided to expand it to AIA institution decisions.

Continue Reading PTAB Drops POP Panel Review Option

Boardside Chat Thursday 7/20

The PTAB’s next Boardside Chat webinar will be held this Thursday, July 20, from noon to 1 p.m. ET. The panel of APJs will discuss issues that typically arise during an America Invents Act (AIA) trial proceeding before the PTAB. The scheduled topics include filing of multiple petitions, discretionary denial, new arguments, and deposition of expert witnesses. The panel will share practical tips and discuss strategies that may be effective before the Board.

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

Register (here)