Delaware federal court Judge Richard Lloret recently ordered AbbVie to immediately produce important Humira® documentation to defendant Boehringer Ingelheim (BI) in what is turning out to be a dramatic legal thriller. The stakes are big. Humira® is a $20 billion drug and has brilliantly utilized the patent system to protect its revenue from competition until 2023. A dramatic turn of events, to say the least, would occur should BI be the ultimate victor.
As it turns out, German-based BI is the only company left taking on AbbVie and their formidable Humira® patent thicket. BI’s Humira biosimilar was approved in 2017 by the Food and Drug Administration. Several other companies also secured biosimilar approvals, but AbbVie approached each one of them–with its 100-plus patents covering Humira®–and the entire group of big pharma companies backed-off and negotiated in favor of AbbVie’s position. Afraid of astronomical legal fees and the high probability of loss AbbVie now enjoys monopoly conditions until 2023. But the privately-held, family-owned business from the Rhein River Valley appears to have more courage than many of its larger peers. The German company has taken an aggressive stance to battle for what they believe is the right thing to do.
Despite the highly complex nature of this entire affair (100+ patents), BI’s makes a pragmatic argument—essentially appealing to common sense virtues of right and wrong. Starting with a fundamental stance that AbbVie’s developed a “wrongful patent thicket.” BI has openly questioned the legitimacy of a commercial sponsor filing and managing over 100 patents for one drug. They note that in many cases, the patents overlap in ways that raise suspicion. In some cases, patents were issued years after Humira was launched. Moreover, a core patent covering adalimumab long ago expired. The Germans argue that the dense web of overlapping intellectual property rights has been done in such a way as to deviate from rational legal intentions for valid intellectual property protection in exchange for non-competitive blocking of legitimate competition. They may be on to something.
BI recently argued to the court that AbbVie consistently hid material documentation that it had been ordered by the court to provide. These include documents summarizing patent strategies and associated artifacts from meetings with high-end consultancies such as McKinsey and Boston Consulting Group Apparently, the federal Judge isn’t buying AbbVie’s arguments and again ordered AbbVie to produce the required Humira® documentation involving Humira and biosimilar competition.
TrialSite News will monitor this litigation carefully. Biosimilar competition has already started in Europe and in some cases the Humira price point is dropping by as much as 80%. Because of the AbbVie patent thicket, the Illinois company has all but secured a monopoly position for Humira until 2023—unless, of course, Germany-based BI chops it down in American courts.Source: Big Molecule Watch