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Posts tagged Gottlieb
What are the lessons from Boehringer’s settlement with AbbVie over its Humira biosimilar?

And just like that, it’s over.  Boehringer Ingelheim has thrown in the towel in its patent fight with AbbVie over Boehringer’s proposed biosimliar for Humira®.  Boehringer was a lone hold-out among a long line of proposed biosimilars for AbbVie’s blockbuster.  Boehringer’s distinction was that it had raised a unique defense, namely, arguing that AbbVie had built an unfair “patent thicket” around Humira® that was unenforceable.  We previously blogged about Boehringer’s “unclean hands” defense here and here and here.  Now that Boehringer has settled, what are the larger lessons for future biosimilar patent fights?

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Did AbbVie create a wrongful “patent thicket” around Humira®?

​​​​​​​Boehringer Ingelheim has claimed that AbbVie wrongfully created a “patent thicket” around Humira®, and it is delaying biosimilar competition.  While that defense is unique, and may be hard to prove on its face, the FDA appears to agree with Boehringer.  Did AbbVie create a wrongful “patent thicket” around Humira®?

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What are the takeaways from the Remicade® antitrust decision between Pfizer and J&J?

We previously blogged about Pfizer’s ($PFE) antitrust lawsuit against Johnson & Johnson ($JNJ) related to Janssen’s Remicade®.  In short, Pfizer launched Inflectra® in 2016, which is a biosimilar to Janssen’s Remicade®.  Yet, Inflectra® has struggled to eat into Janssen’s monopoly for Remicade®.  Pfizer claims that Inflectra®’s poor sales are due to anticompetitive rebate schemes by Janssen.  Specifically, Janssen forced hospitals and insurers to enter exclusive arrangements and bundled-rebated programs that discouraged them from stocking or covering Inflectra®.  Pfizer sued Janssen in the Eastern District of Pennsylvania.  Janssen moved to dismiss, but on August 10, the Court denied Janssen’s motion to dismiss.  What are the takeaways?

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Is J&J's Remicade® part of the "rigged" system claimed by FDA's Gottlieb? Pfizer's Inflectra® antitrust suit has the answer.

FDA’s Commissioner Scott Gottlieb said today that a “rigged” system between drug firms and insurers is stifling entry for less-expensive biosimilars.  Gottlieb stated that certain payment arrangements “raise another, perhaps even more insidious barrier to biosimilars taking root in the U.S., and gaining appropriate market share.”  Is J&J’s exclusionary contract scheme to discourage competition with Pfizer’s biosimilar for Remicade® a poster child for what Gottlieb is lamenting?  Pfizer recently sued Janssen over that very question, and the federal court is scheduled to decide a motion answering that question very shortly. 

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