Is Boehringer Ingelheim planning to launch its Humira biosimilar at-risk?

Zachary Silbersher

Boehringer Ingelheim has been one of the lone holdouts in AbbVie’s ($ABBV) campaign to delay biosimilar competition against Humira® until 2023.  To date, AbbVie has settled with almost all proposed biosimilars for entry dates in 2023.  Is Boehringer going to launch at-risk?

Boehringer’s biosimilar, Cyltezo®, received FDA approval in August 2017.  Meanwhile, AbbVie commenced patent litigation under the BPCIA also in August 2017.  That case continues to bumble along because, well, Boehringer has yet to join the others and throw in the towel.  

We previously wrote about Boehringer’s unclean hands defense in its patent suit against AbbVie.  Boehringer essentially argues that AbbVie amassed an unwieldy “patent thicket” that purport to cover Humira®.  Boehringer argues many of these patents cover overlapping inventions and issued long after Humira®’s original launch.  Yet, a discovery motion is currently pending before the Court pitching Boehringer’s claims that AbbVie’s “patent thicket” is keeping biosimilars off the market in a different light.

AbbVie has moved to compel Boehringer to respond to one its interrogatories.  (An interrogatory is essentially a request for information, usually in the form of written responses.)  AbbVie’s Interrogatory No. 21 asks when Boehringer plans to launch its biosimilar.  Boehringer’s response, to date, has been simple –it will provide AbbVie 180 days notice before it launches.  But Boehringer has not provided a definitive date of when it intends to launch. 

Under the BPCIA statute, a biosimilar is required to provide the innovator company 180 days Commercial Marketing Notice before its biosimilar launch.  Thus, Boehringer’s answer is a really a non-answer.  Typically, a generic or biosimilar’s launch plans is highly confidential and tightly guarded information.  But, Boehringer cannot sit back and claim its launch plans are just too confidential.  That is what protective orders are presumably for, and productions of sensitive information to outside-attorneys only, rather than to the company itself.  Thus, at some point, the Court will need to inquire into the relevance of Boehringer’s launch plans.

Here, AbbVie claims that Boehringer’s launch plans have a unique relevance to the case.  Boehringer has argued, through its unclean hands defense, that AbbVie’s purported “patent thicket” has unfairly kept it from launching its biosimilar.  But AbbVie argues, that can’t be true if Boehringer intends to launch at-risk. 

 That’s an interesting point.  AbbVie is essentially saying, if Boehringer intends to launch regardless of the patents covering Humira®, then that makes AbbVie’s alleged “patent thicket” irrelevant.  Because those patents obviously aren’t stop Boehringer from launching! 

On the other hand, AbbVie’s point is not without holes.  Boehringer received FDA approval for Cyltezo® more than a year ago.  And yet it hasn’t yet launched.  That may be because of issues wholly unrelated to AbbVie’s patents.  Or it may be because Boehringer hoped to get an early read into the Court’s views on its unclean hands defense.  In other words, even if Boehringer intends to launch at risk in 2020, that doesn’t necessarily mean that AbbVie’s alleged “patent thicket” did not delay that launch.

But the question remains: does Boheringer intend to launch at-risk?  From one perspective, that seems crazy.  AbbVie has claimed it has nearly 100 patents covering Humira®.  Those patents include indication patents, formulation patents, dosage patents, manufacturing patents, among others.  AbbVie has essentially patented every aspect of this drug, up and down, and from all sides. 

Further, some of the patents have already survived invalidity IPR challenges.  The simple odds are that any biosimilar is likely to infringe at least a few of those patents, which could spell considerable damages for an at-risk launch against one of the biggest selling drugs of all time.  Indeed, that is what appears to have brought all the other biosimilars to the table to agree to a 2023 entry date.

Yet, on the other hand, as more and more biosimilars for Humira® settle with AbbVie, there emerges a potential universe where an at-risk launch for a lone holdout, such as Boeheringer, may make sense.  First, while launches at-risk for small-molecule generics are typically rare, they are more common for biosimilars.  The principle reason for that is that a biosimilar’s potential liability for launching at risk is often less than for a small-molecule generic. 

Here, in light of the other settlements, Boehringer has comfort that no other biosimilar will likely launch until 2023.  That is important because, when more than one biosimilar launches, that typically drives down the discount, and correspondingly, raises the biosimilar’s liability for its at-risk launch.  If Boehringer is the only at-risk launch before 2023, that theoretically mitigates its exposure.  Indeed, if the discount on Boehringer’s biosimilar is small enough, it could theoretically yield profits that eclipse its exposure, in which case an at-risk launch makes much more sense.

Boehringer can further mitigate its exposure to an at-risk launch by waiting.  No biosimilars will currently launch before 2023.  Even if Boehringer launched in mid 2022, or late 2021, the upside from being the lone biosimilar for Humira®, even or a short period, could be very worthwhile. 

Further, by that time, the patent litigation between AbbVie and Boehringer will have theoretically progressed considerably.  By 2021, Boehringer may have a clearer read on whether its unclean hands argument has legs, and whether it may even prevail on that argument. 

Further, the case will likely have narrowed, thus making allowing Boehringer to more feasibly assess its risk.  While AbbVie continues to wave around 100 patents, it is unlikely any Court will let that many patents go to trial.  By 2021, the number of patents actually at-issue in its case against Boehringer may be much fewer.  We’ve seen BPCIA patent cases narrow the number of originally asserted patents before.

While Boehringer has some time to play with, what it risks by not settling is any deal that allows it to launch in 2023.  Boehringer presumably could have settled in September 2023, given that its BPCIA case commenced before Sandoz’s.  That deal is probably no longer on the table.  At this point, there will be at least six or seven other biosimilars that precede its launch.  Indeed, by now, the economics of an at-risk launch may make more sense than agreeing to a launch date at the back of the line, behind so many other biosimilars. 

Frankly, with so many biosimilars crowded into the Humira® market, you have to think that one of them would consider breaking from the pack and launching at-risk.  Right now, Boehringer appears to be the best candidate for that.