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Will AbbVie’s latest patent suit against Sandoz mean a Humira-biosimilar before 2023?

Zachary Silbersher

AbbVie ($ABBV) has commenced its latest litigation in its campaign to keep biosimilars for Humira® at bay.  On August 10, AbbVie brought suit against Sandoz ($NVS) asserting that two of AbbVie’s patents will be infringed by Sandoz’s proposed biosimilar.  Sandoz is the fifth biosimilar to throw its hat in the ring.  Does this increase the odds of the US market seeing a biosimilar for Humira® before 2023?

To date, AbbVie has already cut deals with three biosimilars for Humira®, including Amgen, Samsung Bioepis and Mylan.  Amgen ($AMGN) can enter in the U.S. beginning in January 2023, followed by Samsung in June 2023 and Mylan ($MYL) in July 2023.  AbbVie managed to cut deals with Samsung and Mylan without recourse to litigation.  Boehringer Ingelheim’s biosimilar has received FDA approval, but the company remains embroiled in patent litigation with AbbVie under the BPCIA (Biologics Price Competition and Innovation Act.)

BI has yet to cut to deal, and fall in line behind Mylan’s entry date.  Now, Sandoz may also be playing hardball.  Sandoz’s proposed biosimilar application for Humira® was accepted in January 2018, and thus in the following months, we can assume AbbVie and Sandoz have considered a settlement.  Yet, rather than reaching a deal to date, AbbVie has nevertheless been forced to file a complaint and start a litigation. 

Interestingly, AbbVie’s suit against Sandoz asserts only two patents.  This is the result of tactical decision by Sandoz.  Under the “patent dance” as prescribed by the BPCIA, AbbVie was obligated to identify a list of patents that might be infringed by Sandoz’s proposed biosimilar.  AbbVie identified 84 patents. 

AbbVie claims that its patent estate surrounding Humira® now has more than 100 patents.  Yet, for AbbVie to identify which patents might be infringed, Sandoz was obligated to disclose its aBLA as well as manufacturing information.  AbbVie claims that Sandoz disclosed its aBLA, but did not disclose comprehensive information regarding manufacturing of its proposed biosimilar.  The result is that, left partially in the dark, AbbVie likely over-identified, out of an abundance of caution, the list of patents that might be infringed.  In other words, if this case goes all the way, it is unlikely that Sandoz will have to work its way through 84 patents.  That said, it is not unlikely that AbbVie will assert upwards of 50+ patents sometime in the future.

That nevertheless leaves open the question—why did AbbVie choose to sue Sandoz for only two patents at this point?  That is because the biosimilar (in this case, Sandoz) has unilateral discretion over the number of patents asserted in the first wave of a BPCIA patent suit.  Here, Sandoz ultimately identified one patent on which AbbVie could bring suit.  Under the statute, AbbVie was permitted to identify the same number of patents as identified by the biosimilar.  That resulted in two patents.

Technically, if the parties do not settle, AbbVie retains the right to bring another suit that asserts lots more of its patents.  But it cannot do so until Sandoz provides 6-months Notice of Commercial Marketing.  The statute requires that Sandoz provide AbbVie 180 days notice before launching, even if it chooses to launch at risk.  Sandoz has yet to receive FDA approval for its Humira® biosimilar, but under recent Supreme Court precedent, Sandoz can nevertheless give its Notice of Commercial Marketing at any time.  Sandoz does not yet appear to have done that, at least as of the date of AbbiVie’s complaint against Sandoz (August 10).  When it does, however, that will trigger the second wave of litigation, during which AbbVie can assert as many patents as it likes.

The two patents asserted by AbbVie include U.S. Patent No. 9,187,559 and 9,750,808.  The ‘559 patent is an indication patent for treating inflammatory bowel disease, and the ‘808 patent is a formulation patent adlimumab.  Sandoz previously filed numerous petitions for inter partes review against several Humira® patents.  Unfortunately for Sandoz, it appears to have lost on almost all of those challenges.  That includes a prior challenge to the ‘559 patent, which is now asserted by AbbVie in the patent suit.

The takeaway here is that Sandoz’s tactic may be to temporarily delay resolution of the patent issues for the time being.  Right now, it cannot launch because it does not yet have FDA approval.  Yet, if Sandoz does choose to launch at risk, it cannot control the FDA approval date, but it can control when the second wave of patent litigation will commence.  It can do that by unilaterally determining when to provide its 180 days Notice of Commercial Marketing.  If and when that happens, that creates the risk for AbbVie that Sandoz intends to launch at risk.  Even assuming that AbbVie asserts only 50 patents in the second wave case, there is no feasible way that a court can resolve a patent litigation with that many patents of this complexity, and a case of this magnitude, within six months.

And that may be exactly the point.  Sandoz has indirectly forced AbbVie to stuff the second wave case with lots of patents that, theoretically, could be litigated right now.  That increases the likelihood that the second wave litigation will not be resolved within six months.  That correspondingly ups the possibility that AbbVie cannot secure any sort of injunctive relief before Sandoz launches at risk (assuming the first wave case doesn’t go its way.)  And that potentially creates pressure on AbbVie to cut a better deal with Sandoz than already offered to the other biosimilars.

That said, given how the prior deals have all started in 2023, it is hard to imagine that AbbVie can feasibly offer Sandoz an earlier date without offering the same to the other biosimilars. 

Even so, the big question is whether AbbVie’s latest suit against Sandoz will increase the odds of seeing a Humira® biosimilar before 2023?  The odds of that still seem low.  First, patent litigations typically take at least two or three years, even for relatively simple cases.  This is not a simple case, and the scope of discovery, even for two asserted patents, will be large.  Moreover, both of these parties—AbbVie or Sandoz—are well-heeled and savvy in the context of patent litigation.  It not possible for either party can out-lawyer the other. 

The short of all this is that, assuming AbbVie and Sandoz cannot settle, the litigation itself is likely to take at least three years, plus another year for an appeal.  And when Sandoz provides its Notice of Commercial Marketing, that is almost certain to trigger another, bigger patent case.  Thus, given that it is now late 2018, it is unlikely all of this patent litigation is likely to resolve before 2023.  Any launch by Sandoz before that time will most likely be at-risk.