Alden Abbott

The European Commission (EC) is at it again, threatening to regulate standard essential patent (SEP) licensing relationships, despite a lack of evidence that such regulation is appropriate. The economically harmful nature of this regulatory framework (and its prior draft) has been highlighted by many expert commentators, including contributors to IPWatchdog (see here, here, and here) and Truth on the Market (see here and here). Fortunately, the EC’s proposed regulatory framework is still open for public comments. Mindful of that opportunity, on May 23, Mercatus Center scholars Christine McDaniel, Satya Marar, and I filed a public interest submission with the European Commission, focusing on three sets of problems posed by the framework. I summarize our submission below.

The U.S. Court of Appeals for the Seventh Circuit agreed with a district court earlier this week that neither a settlement agreement between AbbVie and a number of generic biologics companies, nor the 132 patents owned by Abbvie covering its blockbuster drug, Humira, violate the Sherman Antitrust Act. This holding, which is significant in its own right, also has broader implications for patent-antitrust analysis.

In a recent surprise decision, the U.S. Department of Justice (DOJ), U.S. Patent and Trademark Office, and the National Institute of Standards and Technology officially withdrew their 2019 Policy Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments and declined to advance an alternative policy statement as a replacement. While the withdrawal of the 2019 policy statement was seen as a foregone conclusion (given the far more SEP-restrictive nature of a December 2021 draft policy statement (DPS) circulated by the agencies), moving forward without any guidance was not on anyone’s DOJ policy bingo card for 2022. The slim guidance that this withdrawal announcement does provide, however, paints a murky picture for the ability of SEP holders to obtain injunctive relief.

The Justice Department’s December 6, 2021 Draft Policy Statement on Licensing Negotiations and Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments (“2021 DPS”) badly misses the mark and merits a failing grade. By contrast, the 2019 PS (issued by the Justice Department, NIST, and the U.S. PTO) is eminently sound, and merits being reaffirmed. The DPS should be viewed in the context of the benefits conferred on society by patents that read on standards, commonly referred to as standard essential patents (SEPs). Given the economic importance of SEPs, public policy should encourage investment in them and ensure that they receive adequate legal protection. Such sound policies inform the New Madison Approach (NMA), publicly described by Assistant Attorney General for Antitrust Makan Delrahim in 2018.

On December 6, the Department of Justice – Antitrust Division (DOJ), U.S. Patent and Trademark Office (USPTO), and National Institutes of Standards and Technology (NIST) issued for public comment a “draft revised statement on remedies for the infringement of standards-essential patents (or SEPs) that are subject to a RAND or F/RAND licensing commitment, which also provides guidance on what demonstrates good-faith negotiation in this context.” The 2021 SEP Licensing Draft Statement responds to President Biden’s Executive Order on Competition, which called on the agencies to review the 2019 Trump Administration Statement dealing with SEP infringement remedies. The 2019 Statement in turn excised the anti-IP language from a 2013 Obama Administration Statement on this topic.

In “big IP cases that count,” the U.S. Federal Trade Commission (FTC) has had a mixed record lately, going one-for-three – good in baseball but bad in government appellate litigation. (The biggest recent FTC loss that counts, the Supreme Court’s unanimous April 2021 AMG decision (see here), did not involve IP, but had major negative implications for the FTC’s future ability to obtain monetary relief in IP-related prosecutions). In August 2020, the Ninth Circuit vacated a district court “finding that Qualcomm had engaged in unlawful licensing practices, and reversed a permanent, worldwide injunction against several of Qualcomm’s core business practices.” (The full Ninth Circuit subsequently denied the FTC’s request for rehearing en banc, and the FTC threw in the towel in March 2021, electing not to seek Supreme Court review).

The judicial undermining of patent eligibility, in defiance of the clear language in Section 101 of the Patent Act, poses a clear and present danger to the pace of American innovation…. Fortunately, a recently released report by a bipartisan congressionally-established  commission lends powerful support to Section 101 reform initiatives. The National Defense Authorization Act of 2019 created a 15-member National Security Commission on Artificial Intelligence (NSCAI)…. On March 1, 2021 the NSCAI released its final Report to the President and Congress (NSCAI Final Report) (see the press release). Of particular note, the NSCAI’s Final Report includes a chapter underscoring the importance of a strong intellectual property law system to U.S. national security interests tied to technological advancement.

In a major 2018 speech, Justice Department Assistant Attorney General for Antitrust Makan Delrahim enunciated a “New Madison Approach” (NMA) (a tribute to James Madison’s support for a strong patent system) designed to restore greater respect for efficiency-seeking patent transactions in antitrust enforcement (a 2020 law journal commentary discusses the NMA and the reactions it has elicited, both positive and negative). Consistent with the NMA, the Trump Administration Antitrust Division took a number of initiatives aimed at reducing perceived new antitrust risks associated with widely employed patent licensing practices (particularly those touching on standardization). Those new risks stemmed from Obama Administration pronouncements that seemed to denigrate patent rights, in the eyes of patent system proponents (see here, for example). Given this history, the fate (at least in the short term) of the NMA appears at best uncertain, as the new Biden Administration reevaluates the merits of specific Trump policies. Thus, a review of the NMA and the specific U.S. policy changes it engendered is especially timely. Those changes, seen broadly, began a process that accorded greater freedom to patent holders to obtain appropriate returns to their innovations through efficient licensing practices – practices that tend to promote the dissemination of new and improved technologies throughout the economy and concomitant economic welfare enhancement.