Torso of doctor in white coat with hands displaying in between them a rendering of an antibody.

The SCOTUS Antibody Ruling Has an Uncertain Impact for Drug Makers and Patients

How Amgen v. Sanofi will affect innovation and the pharmaceutical industry.

By Timothy Bonis

Millions of patients rely on monoclonal antibodies. The global market in 2022 was $210B with a compound annual growth rate of 11 percent. Monoclonal antibody patents are now some of the world’s most valuable intellectual property.

Monoclonal antibody patent law has been in turmoil for the past two decades. The Court of Appeals for the Federal Circuit (the “Federal Circuit”) has repeatedly raised the standards for antibody patents, forcing patentees to rethink how they protect their inventions. In April 2023, the increasingly stringent standards of the Federal Circuit were affirmed by the Supreme Court. In Amgen v. Sanofi, the justices unanimously upheld the invalidation of two antibody patents, potentially transforming patent law across biotech.

This post reviews the emerging post-Amgen literature, distilling the ruling’s likely impact on innovation and the pharmaceutical industry. A companion post addresses the ruling’s legal significance.

This post has three parts. Part I describes monoclonal antibodies and why Amgen is important. Parts II and III address innovation, first by discussing whether Amgen is reflective of modern antibody science and second by exploring how the ruling may affect the pharmaceutical industry.

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U.S. Supreme Court

Don’t Be Too Alarmed by the New SCOTUS Antibody Ruling

Amgen v. Sanofi is an important case, but it won’t transform patent law on its own.

By Timothy Bonis

Last April, the Supreme Court ruled in Amgen v. Sanofi, a closely watched patent case where the justices upheld the invalidation of two monoclonal antibody patents for lack of enablement. The ruling has attracted significant interest for two reasons.

First, Amgen involved genus claims in biological and chemical fields, which some experts believe the Federal Circuit has made unduly hard to obtain. This viewpoint, most prominently expressed by Mark Lemley, Sean Seymore, and Dmitry Karshtedt in The Death of The Genus Claim (2021), informed much of the debate about Amgen, although it has been challenged by scholars like Christopher Holman.

Second, Amgen dealt with monoclonal antibody patents, which now represent some of the most valuable intellectual property. (The global market for monoclonals in 2022 was $210B.) Moreover, the scope of antibody patent claims has been narrowed markedly by heightened standards for enablement and written description introduced over the past two decades; antibody inventors once received broad protection through functional claims, but the Patent and Trademark Office (PTO) has raised its requirements, partially in response to repeated invalidations of antibody genus claims at the Federal Circuit (see Chiron v. Genentech, 2004, Centocor v. Abbott, 2011, and AbbVie v. Janssen, 2014).

The decision in Amgen continues the trend of narrowing antibody patents and the perceived trend of limiting genus claims. Thus, how impactful Amgen will be on its own remains uncertain. Does it add new constraints to the patentability of antibodies, small molecules, and chemicals, or does it merely recapitulate the Federal Circuit’s previous rulings? This post reviews that debate. Part I examines how scholars and attorneys have reacted to Amgen, focusing on whether they think the case will have a legal and practical impact. Part II synthesizes these perspectives, arguing that Amgen’s direct impact will be limited. A companion piece summarizing the ruling’s significance for the industry and innovation will follow.

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young african american woman suffering from abdominal pain while sitting on bed

‘Below the Belt’ Exposes the Silent Crisis of Endometriosis Care

By Timothy Bonis

Premiering tonight on PBS, the film Below the Belt sheds light on endometriosis by documenting four women’s experiences with the disease.

Endometriosis is a silent crisis. One in ten women have it, yet, on average, people with the condition see seven doctors before they get diagnosed. Many experience severe pain, and the disease costs the American economy $80 billion annually in lost productivity, but the standard treatments are outdated and ineffectual.

Below the Belt exposes the failures in practice and policy that have led to the poor state of endometriosis care. Medical students usually don’t learn about endometriosis in medical school, and as a result, most general practitioners can’t recognize it. The majority of gynecologists treat endometriosis with hormones — which have serious side effects and bring little relief — and an ineffective surgery called ablation. Others continue to recommend the 20th-century approach, a hysterectomy. This dismal selection of treatments reflects the state of endometriosis research; historically, the disease has received less than $10 million in research funding per year (compared to $1 billion for diabetes, an equally common condition among women).

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Stethoscope with blue suitcase on a table with American flag as background.

Is a Federal Medical License Constitutional?

By Timothy Bonis

Although three in four doctors support scrapping state medical boards in favor of a single federal license, such sweeping reform is likely far off. It is not just state boards’ political obstructionism standing in the way. Basic constitutional federalism limits Congress’s ability to assume powers traditionally held by the states, leaving medical licensure (a state matter since its 19th-century inception) difficult to federalize.

This post will explore potential constitutional arguments for and against federal licensure, investigate the constitutionality of more moderate legislative approaches, and speculate on how the late Roberts Court might respond to reform attempts.

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