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®?
AbbVie ($ABBV) sells Humira, which is most likely the biggest selling drug of all time. In December 2016, Humira’s protein patent expired. Since then, a number of biosimilars have tried to enter the market. Amgen ($AMGN) was the first to file for FDA approval for its biosimilar. That led to patent litigation under the BPCIA. But early in the litigation, Amgen settled for an entry date of January 2023. After that, two other biosimilars, Samsung Bioepis and Mylan ($MYL), also struck deals with AbbVie for entry dates in June 2023 and July 2023, respectively. They each did so without even trying to litigate Humira’s patents.
This raises the question why these biosimilars have not tried actually litigating AbbVie’s patents for earlier entry date? Part of the reason is that AbbVie has surrounded Humira with more than 70 patents. This has made it nearly impossible for any biosimilar to feasibly litigate all of these patents.
Two latest biosimilar candidates, Boehringer Ingelheim and Sandoz, respectively, have so far refused to cut a deal with AbbVie. Sandoz’s case commenced recently, on August 10. But Boehringer’s patent litigation commenced nearly a year ago, in August 2017, and Boehringer is still fighting AbbVie’s patents.
One reason that Boehringer is still fighting may that it has a asserted a unique defense. Boehringer has accused AbbVie of deliberately creating a patent thicket, and that is a wrongful use of the patent system for the purpose of delaying competition. (See AbbVie v. Boehringer Ingelheim, Case No. 17-cv-1064 (D. Del.) (Dkt. 20)).
Boehringer’s theory goes like this: The Humira® antibody (adalimumab) was originally developed and disclosed in a patent application filed in 1996. Humira® received FDA approval in 2002. At the time of that approval, Humira® was only covered by one patent—the adalimumab protein patent, (which is the same patent that eventually expired in December 2016.) Over the next several years, while Humira® was on sale and faced no biosimilar competition, AbbVie accumulated upwards of 75 patents covering the drug. (Indeed, AbbVie contines to prosecute and procure patents surrounding Humira®, and in its latest lawsuit against Sandoz, filed on August 10, AbbVie claims that Humira® is now protected by approximately 100 patents.)
Boeringer claims that the problem is not just that AbbVie has acquired so many patents, but that so many of the patents cover the same thing. According to Boehringer, the original adalimumab patent already covered the protein itself, as well as formulations and methods of making and using it. And yet, despite that, Boehringer claims that AbbVie “engaged in a pattern of pursuing numerous overlapping and non-inventive patents for the purpose of developing a ‘patent thicket.’” Boehringer alleges that this is wrongful, anticompetitive conduct, and AbbVie has used “the patenting process itself as a means to seek to delay competition against its expensive and lucrative adalimumab product.”
Boehringer claims that most of AbbVie’s patents come from a limited number of patent families. Many of the patents, Boehringer argues, share the same disclosure and cover essentially the same inventions. Given that each patent must be contended with by the biosimilar individually—and it is difficult to knock down groups of patents at once—this increases the time and transaction costs for any biosimilar entry. And time is on AbbVie’s side. The longer any patent case under the BPCIA takes, the longer the delay for biosimilar entry, which inures to the innovator company’s benefit.
Boehringer’s defense is very unique, and technically falls under the doctrine of “unclean hands.” It is relatively rare for a brand pharma company to bring 70+ patents to the table for a single drug. (A drug covered by 15-20 patents in the Orange Book is considered a lot, and it is typically very rare for the brand company to assert so many of those patents against the generics. Two possible exceptions may be Celgene’s Revlimid® and Jazz’s Xyrem®.)
Boehringer’s defense is essentially untested. A discovery order from the case shows the Court acknowledging that it remains unclear whether there is anything per se improper about creating a patent thicket. (See AbbVie v. Boehringer Ingelheim, Case No. 17-cv-1065 (D. Del.) (Dkt. 112 fn3)).
But has AbbVie really done anything wrong? AbbVie’s principle retort will likely be that, in the absence of any allegation of fraud, if the PTO gave us these patents, how can we be accused of acting improperly? There is nothing per se wrongful about having lots of patents that share the same disclosure and essentially cover inventions with very minor distinctions. Indeed, there are scores of precedence for that throughout the patent system. Further, acquiring patents while the drug has been on sale is also not, in itself, anything wrongful. Many of AbbVie’s patents claim priority back to original patent applications filed in 2000 or 2001, before the drug went on sale. Accordingly, the fact that AbbVie continues to receive issued patents is more a technical function of how the patent system works, where a series of continuation applications are often filed serially, rather than all at once in parallel. Again, AbbVie will rather rightly argue this is hardly an uncommon tactic.
All that may be true, and some patent practitioners eyeballing AbbVie’s portfolio may likely concur that, on its face, AbbVie may not necessarily done anything wrong. But that is not the whole story. The term “patent thicket” was traditionally used by Big Tech, outside of the pharma context, to justify an efficient infringement strategy. Now, however, it may be taking on meaning within a different context—as a tactic used to delay lower-cost pharmaceutical drugs. Importantly, the FDA has recently suggested that patent thickets, just like that used by AbbVie, are crushing the burgeoning market for biosimilars in the U.S.
In July 2018, the FDA’s Commissioner, Scott Gottlieb, issued remarks in connection with the agency’s release of the Biosimilars Action Plan. In those remarks, Gottlieb lamented that competition for biosimilars in the US is “anemic,” and he specifically called out the case being patent litigation due to “patent thickets.” Gottlieb stated that biosimilar competition is “anemic because litigation has delayed market access for biosimilar products that are, or shortly will be, available in markets outside the U.S. several years before they’ll be available to patients here. These delays can come with enormous costs for patients and payors.” He did not mention Humira® by name, but the given the limited number of approved biosimilars to date, the suggestion was clear.
Will Gottlieb’s comments make a difference? On the one hand, the FDA generally has no power to regulate patents, including which patents should have been allowed, and whether a certain patent estate is or is not wrongful. The Patent Office has yet to weigh in patent thickets in the biologics context, but even still, it would be highly unusual for the Patent Office to circumscribe how patents can be used, or to put limits on the number of patents that can be acquired within a given industry. Given that this issue sprawls across different regulatory agencies, resolving it at a legislative level would likely take an act of Congress. And it is not clear there is the political appetite for something of that magnitude right now.
On the other hand, Commissioner Gottlieb’s comments, while perhaps debatable, may nonetheless telegraph a resetting of the political climate around drugs and patents. Today, pharmaceutical drug prices are perhaps one of the few issues on which there is bipartisan agreement, even if the proposals for tackling high prices are not the same. What that means is that the most likely source of change may not be legislative or regulatory, but rather in the courts.
Given Commissioner Gottlieb’s comments, will the Courts be more willing to give some traction to defenses such as Boehringer’s claims that AbbVie has wrongly created a patent thicket? That remains to be seen. Even if such a defense can surmount a motion to dismiss, that might give future biologics pause about the number of patents stock-piled around a given drug. This could impact biologics sold by Roche, including Avastin®, Herceptin® and Rituxan®, which has also arguably pursued the strategy of fortifying against biosimilars with patent thickets.
Something similar is playing out in the Remicade® context, with respect to the effect of exclusionary contracts and bundled rebates on a biosimilar. Exactly how well Boehringer’s patent thicket defense fares in its case against AbbVie may set an important precedent impacting how useful patents can be at stalling biosimilar competition.