AbbVie’s successful efforts to impede Humira’s (adalimumab) biosimilar entry are difficult for other pharma players to emulate given its relatively large patent portfolio and aggressive legal strategy, said legal experts.

An antitrust complaint brought against AbbVie was dismissed in June 2020 in a Chicago district court and is currently under appeal in the US Court of Appeals for the Seventh Circuit. While the appeal is ongoing, experts debated a potentially different outcome given the strong original judgement.

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AbbVie’s aggressive stance in pursuing a broad patent portfolio would be difficult to repeat, especially for smaller biosimilar companies with limited resources. Moreover, Humira’s relatively early entry and applicability in numerous indications has allowed for the accumulation of an extensive patent portfolio, which differentiates it from other high-profile biologics in the respective therapeutic spaces, experts said.

Humira occupies an outsized position in the biologic and biosimilar landscape, as it netted $16.11bn in 2020, an increase of 8.4% over the previous year. The drug was first approved in December 2002 to treat rheumatoid arthritis and its uses span across 16 indications for adult and paediatric patients.

AbbVie has entered into settlements with nine manufacturers to allow for a 2023 launch of biosimilars. Nonetheless, some of Humira’s manufacturing patents extend to 2034, necessitating other biosimilar manufacturers to pursue individual patent dance procedures with AbbVie in order to launch their own candidates.

In the previously mentioned antitrust suit, one of the arguments made by the plaintiffs, a group of indirect purchasers of Humira, involved AbbVie’s strategy to create a patent thicket for Humira, which prevented biosimilar manufacturers from entering the market. The other allegation notes in exchange for a monopoly in the US market, AbbVie allowed an early entry for Humira biosimilars in Europe.

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The district court decision in favour of AbbVie suggests a patent thicket with the potential to impact biosimilar competition is not in violation of antitrust laws, which supports the company’s aggressive tactic, said experts. The original antitrust lawsuit decision provided a strong argument in favour of the defendant AbbVie on both counts, they noted. While one expert said it is unlikely to be overturned, another said this is difficult to predict as three judges will now be hearing the appeal as opposed to one for the original lawsuit. AbbVie did not respond to a request for comment.

Not easy to clone Humira blueprint

AbbVie’s patent strategy regarding Humira is more of an exception rather than the rule when it comes biologics, said Joanna Brougher, principal, BioPharma Law Group, New York. If it was easy to replicate AbbVie’s Humira strategy, then there would have been more cases like it, said a patent lawyer. However, there are no more cases like it because Humira offers unique circumstances, the lawyer added. There are more than 100 patents on Humira. Most companies are not in a position to pursue such a broad patent portfolio, said Brougher, adding it is unlikely such an action or activity will be seen on every biological drug.

The scale in Humira’s case—both in terms of the patent portfolio and the drug’s market size—is a unique element, experts agreed. The global immunology market represents a $80bn value with more than 25,000,000 patients treated, according to AbbVie. Some of Humira’s approved indications include rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and Crohn’s disease. The more indications for a biologic, the more companies will try to protect each use, said Kevin Nelson, partner, Schiff Hardin, Chicago, Illinois. Despite Humira’s multitude of patents, the number alone does not necessarily reflect the strength of the discoveries representing those patents, even though they could, said Elaine Blais, Boston litigation leader, Goodwin Procter, Massachusetts.

As Humira was one of the earlier biologics in a relatively new space, AbbVie was able to patent novel uses for the biologic, said the lawyer. Each time a new feature, indication or method of manufacturing was developed, AbbVie spent resources patenting it, said Brougher. It is unlikely for a patent thicket of this scale to be built for each product by other companies, said Nelson. However, after seeing the wide patentisation of anything around Humira, it would be unsurprising if the United States Patent and Trademark Office (USPTO) applies the novelty test more vigorously, said the lawyer.

Nonetheless, Humira is an aberration because several other biologics lost exclusivity and now have biosimilar versions on the market, said Nicholas Mitrokostas, partner, Goodwin Procter, Boston, Massachusetts. More recently, other changes in the field, like the Purple Book, could also have an impact on patent litigation in terms of enhancing competition or limiting the assertion of patents, said Nelson. The FDA released an online searchable Purple Book database of licensed biological products in February 2020.

Antitrust argument difficult to prove

An ongoing appeal on the aforementioned decision is currently being heard in the Seventh Circuit in Chicago where the plaintiffs are trying to reverse the district court decision. All experts said the district court’s judgement was strong on both counts: the patent thicket and the US market monopoly.

It would be surprising if the decision is overturned on either issue, said the lawyer. However, unlike the district court, the appeal will be heard by panel of three judges, so it is difficult to predict how all three will view the case, said Nelson.

One of the arguments noted AbbVie’s generation of so many patents made it impossible for biosimilar manufacturers to review or avoid them, said Blais. Whether this indicates a flaw in the system or not leaves room for a spirited discussion on whether what AbbVie did was right or wrong, said the lawyer. Still, the district court decision did indicate developing a patent thicket is not an antitrust violation.

The second issue was whether the individual settlements by AbbVie biosimilar companies were anticompetitive, said Blais. The plaintiffs argued AbbVie asserted patents to create a monopoly in the US market, but allowed biosimilar manufacturers to market their drugs in the European market. To prove antitrust violations on this issue, the case would require illicit activities such as fraud while prosecuting the patents, or sham litigation, said Brougher. It is plausible the judge may find a persuasive argument on how individual biosimilar settlements reflected the allocated global risk, said Blais.

While Humira’s primary patent was set to expire in 2018, it now expires in 2034. An early entry in 2023 would be open to only those biosimilar manufacturers with which AbbVie has had individual settlements. Others would get an approval and launch at risk or pursue their own settlements. Any subsequent patents gained on Humira extending its exclusivity should likely not affect the entry date of those biosimilars, experts said.

However, whether individual settlements keep the door open for other manufactures to launch early remains to be seen, said Blais. The 2023 launch of biosimilars may impact AbbVie’s ability to obtain an injunction against a new company with the intention to market a biosimilar, said Nelson. Previously, in a case involving Amgen’s biosimilar version of Roche’s Herceptin (trastuzumab), a district court denied preliminary injunctive relief based on Roche’s pattern and practice of granting licenses for Herceptin’s dosing patents. The fact Roche allowed other biosimilar manufactures to enter the market through individual settlements undermined its assertion of “irreparable harm” by Amgen’s biosimilar launch. Based on this, biosimilar manufacturers could even argue there is no irreparable harm because AbbVie was willing to license Humira to others it settled with, which could lead to an earlier entry than 2023, said Blais.

Manasi Vaidya is a Senior Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.