On October 10, 2022, the Commission sent a Statement of Objections (“SO”) to Teva, maintaining that the company abused its alleged dominant position through patent misuse and disparagement practices.[1]
Background
In 2015, Teva’s patent covering glatiramer acetate— the active ingredient used in Copaxone—expired, allowing generic versions of the medicine to enter the market. Various market players accused Teva of misuses of patent procedures and disparaging communication campaigns to illegally block or delay the market entry of follow-on products. This led to several dawn raids at Teva’s premises in October 2019 and the subsequent launch of a formal probe in March 2021.[2]
Statement of Objections
On October 10, 2022, over a year and a half after the formal proceedings were initiated, the Commission sent the SO to Teva. The SO focuses on two novel concerns.
First, Teva allegedly engaged in so called “divisional patent games.” Under the IP law principle of unity of invention, a patent application may only concern one invention, or several inventions linked together in such a way that they form a single general inventive concept.
Divisional patent applications are those deriving from an earlier patent application known as the “parent”, which the applicant splits into a sequence of applications each claiming a single element of the same claimed invention. Divisional applications can give rise to further multiple divisional applications without any limitation. Each divisional patent lasts until the expiry date of the “parent” patent, but is subject to new examination procedures and, if granted, new opposition periods independent of the outcome of the parent application.
Teva allegedly sought to artificially extend its patent protection by reportedly filing and subsequently withdrawing patent applications deriving from the “parent” patent, thereby forcing its competitors to file a new legal challenge each time. While divisional patents are commonly accepted by patent offices, a repetitive filing of divisional patents could be a way for a patentee to multiply the patent barriers that a generic competitor needs to overcome to enter the market.[3]
Relatedly, the Commission’s focus on patent misuse practices is also evident from its involvement in a recent dawn raid at Novartis’ premises in Switzerland.[4]
Second, Teva allegedly implemented a systematic “disparagement” campaign disseminating false or misleading information about the safety and efficacy of follow-on competing products. Disparagement as a theory of harm has long been the exclusive domain of the French Competition
Authority (“FCA”).[5] The SO is a clear signal that the Commission is eager to establish a novel EU precedent, and the Commission has doubled down on enforcement against disparagement by opening a formal probe into Vifor Pharma in June 2022.[6] This comes against the backdrop of Commissioner Vestager’s encouragement that antitrust enforcers be “willing to explore the boundaries, and not to shy away from novel theories of harm, where these are relevant.”[7]
There is, however, potentially a long battle ahead as Teva announced that it will “vigorously defend” itself, including by challenging the Commission’s case before EU Courts.[8]
[1] Commission Press Release IP/22/6062, “Commission sends Statement of Objections to Teva over misuse of the patent system and disparagement of rival multiple sclerosis medicine,” October 10, 2022.
[2] Commission Press Release IP/21/1022, “Commission opens formal investigation into possible anticompetitive conduct of Teva in relation to a blockbuster multiple sclerosis medicine,” March 4, 2021. See also French Competition Law Review of March 2021, “Pharma Still Under The Microscope: The Commission Investigates Potentially Abusive Patent Filing Strategies.”
[3] (ii) defending such divisional patents in European Patent Office (“EPO”) opposition proceedings; (iii) enforcing such divisional patents in national courts; (iv) strategically withdrawing any earlier patent from the family, just before an EPO decision confirming it is invalid, thus avoiding the negative effects on the other divisional members of the family; (v) even when a parent patent is invalidated, there will still be a divisional patent application covering substantially the same subject matter, replicating the legal uncertainty and restarting the clock. An opposition proceeding to invalidate a divisional patent can take 3–6 years until final resolution by EPO Technical Board of Appeal.
[4] The dawn raid has been conducted by the Swiss Competition Authority, who cooperated with the Commission pursuant to the bilateral agreement between them on the application of the competition rules. See Swiss Competition Authority Press Release, “COMCO: Investigation on use of patents,” September 15, 2022, available here. The company allegedly attempted to protect its drug for the treatment of skin diseases against competing products by using one of its patents to initiate litigation proceedings.
[5] In 2013, following a complaint from Teva Santé, the FCA fined Sanofi-Aventis €40.6 million for implementing a disparaging campaign targeting pharmacists and doctors regarding the quality and safety of generic products competing with its own Plavix drug. In 2014, the FCA fined Schering-Plough €15.3 million for abusing its dominant position by disparaging Arrow’s generic product before its launch on the market. In 2017, the FCA imposed a €25 million fine, subsequently reduced to €21 million by the Court of Appeal, on Janssen-Cilag and its parent company Johnson & Johnson, for delaying entry into the market of the generic version of Durogesic, and for hindering its development through a disparagement campaign. In 2020, the FCA also fined Genentech, Novartis, and Roche €444 million for having misled public authorities regarding the risks related to the use of Avastin. That decision is currently under appeal.
[6] See Commission Press Release IP/22/3882, “Commission opens investigation into possible anticompetitive disparagement by Vifor Pharma of iron medicine,” June 20, 2022.
[7] EVP Vestager Keynote speech at the European Competition Day 2022 in Prague, “Fairness and Competition Policy.”
[8] See Nicholas Hirst and Lewis Crofts, “Teva rejects EU antitrust claims over MS drug, threatens legal fightback, MLex, October 10, 2022, available here.