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?

Change in Claim Construction Standard Provides Greater Appellate Opportunity

Some months back the Patent Trial & Appeal Board (PTAB) proposed dropping the broadest reasonable interpretation (BRI) in favor of the so-called “Phillips construction” of the courts. That final rule package, while expected to have been issued by now, is hung up in the Office of Management & Budget (OMB) for regulatory review. (While described in the proposed rule as a change that was not deemed “significant,” should OMB disagree, the final rules will be delayed until the necessary regulatory hoops can be navigated).  Nevertheless, whether in 2018 or 2019, it is clear that the agency intends to move PTAB trial proceedings away from BRI to the Phillips standard.

While this change may not move the needle very much for PTAB trials, it should provide enhanced appellate opportunity. Continue Reading What a Phillips Construction Could Mean for PTAB Appeals

Next Week: PTAB BoardSide Chat & PatentsPostgrant.Com Webinar

Next week, brings back-to-back programs on PTAB appeals, both with a unique focus.

First, up, this month’s edition of the PatentsPostGrant.com free webinar series will be held on Wednesday, January 31st @ 2PM (EST). The January Webinar is entitled: Building Winning PTAB Appeals to the Federal Circuit. The January PatentsPostgrant.com webinar is presented by R&G PTAB Practice Chair Scott McKeown & Appellate/Supreme Court Practice Chair Douglas Hallward-Driemeier who will offer their insights and experiences in building winning PTAB appeals to the Federal Circuit. Register (here). CLE credit will be provided (CA, NYC, VA).

The next day, February 1st, the USPTO will host its first bi-monthly Boardside Chat of 2018. This month’s offering is entitled: Design Patent Appeals. The chat will discuss “Design Patent Appeals and AIA Trial Proceedings.” Longtime PTAB Judges Jennifer Bisk, Romulo Delmendo, and Daniel Song will present and address audience questions. This topic is relevant for both ex parte appeal and AIA trial proceedings.

The Boardside Chat is free and open to everyone to attend. More information, including the WebEx access information, can be found at the PTAB “Boardside Chat” Webinar Series webpage (here).

Standard Operating Procedures (SOP) 9 Released

As discussed last week, a remand to the Patent Trial & Appeal Board (PTAB) may be a short-lived victory for Patent Owners.

The PTAB has now officially revised the “Standard Operating Procedure 9 (SOP9)” directed to default procedures for cases remanded from the Federal Circuit.

Some highlights:

  • PTAB has set a goal of issuing remand decisions within 6 months of the Federal Circuit’s mandate.
  • Panels will now meet with the Chief, Deputy Chief, or their delegates (i.e., one of the Vice Chief Judges) to discuss the remanded case and issues presented therein.
  • PTAB has set forth default procedures for trials and appeals regarding whether further briefing, evidence, or oral hearings are warranted in individual case and whether prosecution will be reopened.

For more details, please read the revised SOP 9 (here).