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.


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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.
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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