Following on from a recent CLIP of the month post on the lawfulness of strategic patenting under EU competition law, an amicus curiae brief recently filed by the US Department of Justice ("DoJ") provides an insight into the US position on this grey area of antitrust law. The brief was submitted in a suit against Abbvie concerning its patenting strategy relating to its monoclonal antibody Humira. This case has been followed closely by competition lawyers and biotech companies as it is the first of its kind to scrutinise potential antitrust issues relating to biologics (see our previous article here).
Background to the case
In March 2019, an antitrust suit was filed against AbbVie and biosimilar companies in the District Court (Northern District of Illinois) on behalf of indirect US purchasers of Humira (adalimumab). The plaintiffs claimed, inter alia, that Abbvie's filing of over 100 patents for Humira amounted to a patent thicket, designed to maintain its monopoly in breach of section 2 of the Sherman Act.
At first instance, Judge Manish Shah dismissed the complaint in its entirety, including the plaintiff's claim that in seeking to obtain hundreds of patents "regardless of their merits", AbbVie had violated section 2 Sherman Act. Although Judge Shah acknowledged that AbbVie's patenting strategy was likely to keep prices high, he found that AbbVie was entitled to obtain and assert its patents without being scrutinised under antitrust laws. Moreover, the plaintiffs failed to show that AbbVie had engaged in sham petitioning of the patent office, FDA licensing process and court systems, as AbbVie's rate of success in proceedings before these government bodies had exceeded 50%. This is in contrast with the position in Perindopril, in which the European Commission found that the majority of the originator's patents were not inventive.
The plaintiffs have appealed to US Court of Appeals, Seventh Circuit. On 28 December 2020 the DoJ submitted an amicus curiae brief in support of AbbVie and the other appellees.
The DoJ's brief
The DoJ's amicus curiae brief refutes the plaintiffs' allegations that AbbVie had breached antitrust law by acquiring and enforcing a large volume of patents. The DoJ argues that such allegations represent an unwarranted extension of s2 Sherman Act.
In the EU, although there is no specific rule stating whether filing for patents falls under the remit of competition law, there is a fundamental right to protect intellectual property (Article 17 of the Charter of Fundamental Rights), and previous case law suggests that patent holders are entitled to assert their intellectual property rights in all but exceptional circumstances. Competition authorities have traditionally respected the existence of patents (but have taken an interest in how they are exercised). Despite that distinction, however, they have previously intervened in relation to applications for extensions to patent protection (AstraZeneca, European Commission, confirmed by the CJEU) and practices in relation to the securing of divisional patents (Pfizer, Italian Competition Authority, confirmed by the Consiglio de Stato).
In the US, patent owners are generally protected from antitrust liability when obtaining and enforcing patents (under the so-called "Noerr-Pennington doctrine"). The DoJ confirmed this in its brief, stating that even if monopolists file hundreds of patent applications, the patenting process should be protected.
The brief states that for conduct involving patent procurements, s2 Sherman Act only applies in limited circumstances, for example:
- where sham petitioning of a government body has occurred; or
- where the patents were obtained fraudulently (the Walker Process exception);
resulting in harm to competitors. In both instances, there must have been an abuse of the application process itself, as opposed to the outcome of the process. The DoJ states that patent procurement does not qualify as sham petitioning, because the process before the US Patent and Trademark Office is ex parte and so in itself cannot impose costs and delay on competitors. The DoJ's brief emphasises that the "mere fact of asserting numerous validly obtained patents is not enough to give rise to antitrust liability", citing previous case law to support its argument.
The DoJ also makes several policy arguments throughout the brief. It highlights that patent laws promote innovation by rewarding originators, and that broadening antitrust liability for patent procurement could "discourage good-faith patenting", leading to a reduction in innovation and competition and creating tension between patent law and antitrust law. Further, the DoJ posits that if originators abandoned the patent system due to the threat of competition enforcement, they may instead rely on trade secrets to protect their investment in R&D. This could lead to a reduction in follow-on innovation, as there would be no requirement for inventions to be disclosed.
In its brief, the DoJ has clearly set out its view of the lawfulness of so-called "patent thickets". In doing so, it has contributed to the debate that continues to take place on both sides of the Atlantic about the role of competition/antitrust law in patent procurement and enforcement. In the DoJ's view, any perceived deficiencies in the patent system should not "be remedied by antitrust law".
It remains to be seen whether the appeal court aligns itself with the DoJ in its judgment, or whether it overturns the Noerr-Pennington doctrine in relation to the creation of patent thickets. In any event, we will watch with interest as case law on strategic patenting continues to develop. Just last week, the European Commission announced a new investigation into a possible abuse of dominance relating (among other things) to filings of divisional patents. While this is a little removed from a pure patent thicket case, the investigation may provide greater insight as to how closely aligned US antitrust and EU competition laws are on this complex issue.
Originally published 09.03.2021
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