AbbVie still can’t escape Boehringer’s claim that its Humira patent-thicket was wrongful.
We previously wrote about AbbVie’s ($ABBV) biosimilar patent case against Boehringer Ingelheim. The case stands out like a sore thumb compared to the multitude of other biosimilars who have filed BLAs for Humira® biosimilars. Other companies—including Amgen, Sandoz, Samsung Bioepis, Pfizer, among others—filed BLAs, but after AbbVie waved around its 100-plus patents covering Humira®, the biosimilars struck deals delaying their entry until at least 2023.
By contrast, Boehringer has the been the lone hold-out. Rather than falling in line, Boehringer has raised an argument that lots of people have been thinking, but no one yet had the opportunity to press. Boehringer seeks to circumvent AbbVie’s patent estate for Humira® by tagging it a wrongful patent-thicket.
Boehringer asks, isn’t there something wrong about a company holding over 100 patents on a single drug? Especially when many of those patents cover overlapping inventions with only minor tweaks among them? Especially when most of those patents did not even issue until years after Humira® was launched? Especially when the protein patent covering adalimumab has already expired? Doesn’t all this create a thicket that is nearly impossible for aspiring biosimilars to either design or litigate around? And isn’t a thicket like that essentially wrongful and anticompetitive?
Likewise, Boehringer continues to litigate. Boehringer’s hope is to do the seemingly impossible with a silver bullet—namely, knock out the entire portfolio in one swift cut. This would avoid having to litigate each individual patent one-by-one, a Herculean task, in terms of time, money and resources, with a low probability of gaining a better outcome than what AbbVie is offering for settlement. That is most assuredly why all the other biosimilars have taken the deal.
Boehringer has styled its counterclaim one for unclean hands, but that is because there isn’t really a name for the type of argument Boehringer is making. Recently, the federal court in Delaware presiding over AbbVie’s patent case against Boehringer made some more findings. Last year, Boehringer sought documents regarding AbbVie’s plans, strategies and tactics for using its patents to keep out biosimilar entry. AbbVie initially resisted producing all of the applicable documents. The Court eventually compelled AbbVie to do so. Yet, despite that order, Boehringer subsequently complained that AbbVie was still not forthcoming enough with its documents.
More recently, Boehringer complained to the Court that AbbVie has continued to withhold relevant documents related to its patenting strategies to keep out biosimilars, including internal meetings and consultations with McKinsey and BCG. In a recent order, the Delaware Court once against ordered AbbVie to come clean with all relevant, non-privileged documents about patenting around Humira® to mitigate biosimilar competition.
As part of this order, the Court made some interesting comments. While the Court stopped well short of suggesting whether or not Boehringer is going to prevail on its unclean hands defense, the Court nonetheless signaled that it is not going to dispense with Boehringer’s counterclaim at this stage. Rather, it wants all the discovery to come out so that a more thorough examination of AbbVie’s conduct can be made.
The Court found that it “seems clear enough” that AbbVie had a patenting program designed to mitigate biosimilar entry for Humira®. Though AbbVie clearly danced around ways to avoid producing much of its behind-the-scenes strategizing for building a patent estate sizeable enough to practically coerce settlements, the Court has ordered AbbVie to pull up its skirt.
The Court stated:
AbbVie chose to fight the ‘unclean hands’ discovery to the last ditch. I am declaring the fight over. AbbVie will produce the documents. The parties may fight over the viability of the unclean hands defense at summary judgment, with all the available and potentially relevant facts. That is where the fight belongs, and that is how it will be conducted.
(AbbVie, Inc. v. Boehringer Ingelheim, 17-cv-1065 (D. Del.) (Dkt. 410 at 8).
It remains to be seen how Boehringer’s patent-thicket argument will eventually play out. In and of itself, it is not surprising that AbbVie had a patenting program for delaying biosimilar competition for Humira®. But the implications of this recent decision should already redound to patenting strategies for innovators faced with encroaching biosimilar competition.
The case is important not just for Humira®, but for many other biosimilars. As we previously discussed, AbbVie is not the only biologic to have built a wall of patents around its drug as a strategy for staving off biosimilar competition. Indeed, for a variety of reasons, it is one of the smartest tactics available for doing so. That is, unless succeeding too well—and getting too many patents, as in Humira®’s case—is deemed to be wrongful. Hence, the potential read-through to other drugs.
Here, the Delaware court has essentially held that that biologics companies cannot escape these broad-based attacks on their purported patent-thickets at the discovery stage. Rather, their internal maneuvering is going to come out. That alone may alter conduct, especially in-house at the drug companies.
Moreover, Boehringer’s limited success to date on its patent-thicket argument—if only in terms of being permitted to collect its requested discovery—is itself important. On its face, there is not necessarily any rule, statute, regulation or precedent that says, you’re not allowed to have too many patents. That, however, does not mean it is not wrongful. Indeed, to date, Boehringer is making some hay by arguing that at some point, enough grains of sand eventually make a heap.
The political climate today is concerned about high drug prices. The solutions seem evasive. And yet many of the reasons for seemingly endless delays to generic drugs in the U.S., which are for some reason already available in Europe, have a lot to do with patents. Attacking the problem at its core, as Boehringer is attempting to do, may just yield some progress.