Are Biosimilar Development Efforts Enough?

In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co. (here), the Federal Circuit was poised to explore the level of biosimilar legwork that could satisfy Article III standing for appeal from an adverse Patent Trial & Appeal Board (PTAB) decision. But, business developments of Momenta since the 2017 oral argument have now spoiled all of the fun.

The question as to how much investment/business exploration is enough in the biosimilar context for Article III standing remains an open question.

Continue Reading BPCIA & FDA Steps as Article III Standing from the PTAB?

Statutory Right to Appeal for Joined Parties

In Mylan Pharmaceuticals Inc. v. Research Corp. Technologies, Inc., (here) the Federal Circuit held that parties joined to an IPR petition have a statutory right of appeal under 35 U.S.C. § 319 as “parties”, even if the original petitioner lacks Article III standing for appeal. Continue Reading Joined PTAB Parties & CAFC Appeal Rights

PatentsPostGrant.com February Webinar

The Patent Trial & Appeal Board (PTAB) discontinued its Broadest Reasonable claim Interpretation (BRI) rubric for AIA trials in the closing weeks of 2018. With the PTAB and district courts now aligned under the Phillips claim construction standard, patent litigants must now manage parallel proceedings in the face of new estoppel risks, timing challenges, and tactical pitfalls.

Please join me for an interactive webinar discussion of these new strategic considerations Thursday, February 21st@2PM (EST). Register (here).

My co-presenter for this webinar will be Matthew Rizzolo, a partner in Ropes & Gray’s IP litigation practice.

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 free 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).

Issue Joinder Practices Poised to Reset

As previously discussed, the Patent Trial & Appeal Board (PTAB) is now reconsidering its issue joinder practices. These practices were the subject of significant debate internal to the Board a few years back. The inability of the Board to arrive at a majority consensus on whether issue joinder was permitted by the AIA statutes led to the now infamous “panel stacking” decisions. These expanded panel decisions provided a brute force solution to the conflicting positions on the question of issue joinder, a de facto precedent of sorts.

With the new Precedential Opinion Panel, or “POP,” allowing for a more streamlined process for making precedent, the Board seems poised to drive official PTAB precedent on this question — but in a new direction. Continue Reading New PTAB Precedent Panel Conducts First Hearing

Full Bar Meeting + PTAB Master Class & PTAB BootCamp

The 2019 PTAB Bar Association Annual Conference will take place March 14 – 15, 2019, at the Ritz-Carlton in Washington, D.C. Pre-conference sessions will be offered March 13th.  I’m honored to once again moderate the PTAB Master Class.

The conference will bring together practitioners, in-house counsel, and members of the bench for a dynamic discussion of Patent Trial Appeal Board (PTAB) best practices, recent developments and trends, policy considerations, and more. Presentations and panel discussions will include:

• Claim Construction Final Rule: A New Complexity at the PTAB?
• Insights from the PTAB Bench
• Navigating the Interplay of Parallel Litigation with a PTAB Proceeding
• Post-grant and Life Sciences
• Party Crashers – The Role of Latent 101 & 112 Issues at the PTAB
• Current Best Practices in Ex parte Appeals
• Estoppel and the Aftershocks of SAS Institute
• The Role of Legislation and Rule Making
• View from the Federal Circuit
• Advanced Issues Related to Real Party-in-Interest and Privity Disputes
• Ethics Before PTAB
• Pre-Conference Session: Half-Day “PTAB Bootcamp”
• Pre-Conference Session: Half-Day “PTAB Master Class”
• Pre-Conference Session: Managing EPO Proceedings Alongside US Litigation

You can view the full agenda and session descriptions (here).

Court Takes Offense to Tactics Geared to PTAB Alone

Litigants beware; Judge Rodney Gilstrap (E.D. Texas) warned litigants considered to be using the district court proceedings to posture positions in co-pending CBM proceedings that ‘[t]he Court does not countenance—in fact this Court is offended by—the strategic use of an Article III Court to gain a tactical advantage in any parallel proceeding.”

But, this dispute may be a preview of things to come as the Patent Trial & Appeal Board (PTAB) aligns itself with the Phillips construction of the courts.

Continue Reading Judge Gilstrap Cautions on Tactics Directed Solely to PTAB Interests

General Plastic Factors & Follow-on Petitions

Last September, the Patent Trial & Appeal Board (PTAB) held that the advanced state of a district court proceeding militated in favor of denying a petition for IPR in accordance with the General Plastic factors (NHK Spring Co. Ltd. v. Intri-Plex Technologies Inc). Given this holding, Patent Owners may now consider speedier forums, such as the International Trade Commission (ITC) as providing incremental protection from a PTAB challenge.

Last week, the Board clarified that consideration of late stage parallel proceedings is done only in the context of assessing discretionary institution of “follow-on” petitions under 35 U.S.C. § 314(a).  In doing so, the Board also highlighted that an advancing ITC action (even in a follow-on petition scenario) may be of a lesser concern than a district court proceeding given its unique nature. Continue Reading Co-Pending ITC Action Less of an Equitable Concern for PTAB?

New Presentation of Same IPR Art Thwarted by Estoppel

Post SAS, there are fewer exceptions to IPR estoppel. Indeed, the absence of partial institutions has led to many courts finding the “reasonably could have raised” aspect of IPR estoppel to be broader than just the art of the ultimate Patent Trial & Appeal Board (PTAB) trial. As such, unsuccessful petitioners are now exploring alternative theories.

In The California Institute of Technology v. Broadcom Limited, et al., (here) the Central District of California found that IPR estoppel applies where the same IPR reference is later raised under the “known or used” prong of pre-AIA 35 U.S.C. § 102(a), rather than as a “patent or printed publication” as in the IPR. Continue Reading IPR Art Simultaneously Qualifying as Known or Used Subject to Estoppel

PTAB Success a Relevant Consideration Under 35 U.S.C. § 285

After Octane Fitness, district courts “may determine whether a case is ‘exceptional’ in the case-by-case exercise of their discretion, considering the totality of the circumstances,” looking at substantive strength of a party’s litigating position or the unreasonable manner in which the case was litigated.

As one recent decision makes clear, not only can a successful PTAB trial aid a litigation fee dispute, but the PTAB fees themselves may be recoverable. Continue Reading Leveraging Your PTAB Record to Secure Attorney Fees in District Court

Seeking More Granularity on Patent Pools?

Patent pools and groupings of standard essential patents (SEPs) facilitate one-stop shopping of patent licensees. When operated fairly, these arrangements can provide meaningful efficiencies to licensors and licensees alike. On the other hand, there is also ample room for abuse given the brute strength of such large portfolios.

While the Patent Trial & Appeal Board (PTAB) can be an appealing solution to combat improvidently granted patents, it is not a realistic option for an implementer facing a large pool that might include patents of questionable merit.  Thus, when this “big stick” leverage is abused, unreasonable license valuations/demands can go unchecked. When such undesirable economic practices are multiplied across pools, “royalty stacking” becomes especially problematic for implementers, and ultimately, consumers. Continue Reading Dealing with SEP Demands & Royalty Stacking