Category: Supreme Court

Rows of gold post office boxes with one open mail box.

Plan to See ‘Plan C’ This Year

Joelle Boxer Leave a comment

By Joelle Boxer

Tracy Droz Tragos’ new documentary, “Plan C,” follows the work of a grassroots organization dedicated to improving access to the abortion pill by mail in the U.S., while navigating an increasingly restrictive legal landscape.

There is no better time to hear the perspectives of these patients, providers, and activists. Just last month, the U.S. Supreme Court took on a case to determine the legal status of the pill, also called mifepristone. With a decision expected in June 2024, Tragos’ film shows us what’s at stake.

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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

Timothy Bonis Leave a comment

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

Timothy Bonis Leave a comment

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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Miniature of a passenger plane flying on the map of United States of America from south east. Conceptual image for tourism and travel.

The Constitutionality of Banning Interstate Travel for Abortion

Hannah Rahim Leave a comment

By Hannah Rahim

After the Supreme Court eliminated the constitutionally protected right to abortion in Dobbs v. Jackson Women’s Health Organization, right-wing states have begun enacting abortion bans and discussing the possibility of restricting interstate travel for abortion.

Although there is a general presumption against a state’s ability to regulate extraterritorially (i.e., beyond its borders), legal authority suggests that the Constitution does not clearly prohibit a state from regulating abortion travel.

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U.S. Supreme Court

Context Matters: Affirmative Action, Public Health, and the Use of Population-Level Data

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By Wendy E. Parmet, Elaine Marshall & Alisa K. Lincoln

Last June, in Students for Fair Admissions (SFFA), the Supreme Court ruled that universities could not consider race in admitting students. In support of that decision, the Court dismissed the relevance of data about the varied experiences of racial groups, insisting that admissions decisions must be based solely on the experiences and merits of individual applicants. The Court’s rejection of group-level data evinces a critical misunderstanding about the uses and limits of such data that, if applied more broadly, portends troubling implications for health equity and health policy.

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Medical Caduceus Symbol as Scales with backlight over Wall in dark room.

Gender-Affirming Care, Abortion, and the Politics of Science: A Response to Wuest’s ‘Born this Way’

The Petrie-Flom Center Staff Leave a comment

By Aziza Ahmed

On August 21, 2023, the 11th Circuit issued a decision that allowed a ban on transgender care to go into effect in Alabama. The Alabama ban, formally called the Alabama Vulnerable Child Compassion and Protection Act, is one of the most extreme of the many bans on gender affirming care. The law defines sex as the “biological state of being female or male, based on sex organs, chromosomes and endogenous hormone profiles…genetically encoded into a person at the moment of conception…” and targets physicians who might undermine this notion of sex with criminal prosecution. Their punishment could be up to ten years in prison.

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Washington, DC, USA - December 1, 2021: Abortion rights rally at the Supreme Court, Jackson Women's Health v. Dobbs.

Biological Determinism, Scientific Uncertainty, and Reproductive Rights

The Petrie-Flom Center Staff Leave a comment

By Mary Ziegler

As Joanna Wuest writes, the role played by science in the LGBTQ+ movement “is at once a celebratory and cautionary story.” Something similar could be said of struggles over reproductive rights in the half century since the Supreme Court decided Roe v. Wade.

Today, after decades of staying on the sidelines, physicians have once again been at the forefront of struggles over abortion, launching a ballot initiative in Ohio, bringing lawsuits, and speaking against state criminal bans. Physicians’ investment in the struggle — and the scientific arguments they bring to bear — seem like a possible turning point in future struggles over reproductive rights and justice. After all, medical professionals have both special expertise and political capital that could make a difference at a time when disapproval of abortion bans is already high.

But history suggests that arguments based on science have played a far messier role in struggles over reproductive rights. As often as scientific evidence has advanced reproductive rights, abortion foes have used claims about scientific uncertainty to justify new restrictions — and have harnessed claims of biological difference to assert that there is no connection between sex equality and abortion.

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MONTREAL, CANADA -16 AUG 2015- The annual Fierte Montreal parade took place on August 16, 2015 on Boulevard Rene Levesque in Central Montreal. It is the largest Gay Pride in the Francophone world.

“Born This Way,” LGBTQ+ Rights, and the Politics of Uncertainty

The Petrie-Flom Center Staff Leave a comment

By Joanna Wuest

“Medical uncertainty” is no straightforward matter when it comes to LGBTQ+ health and civil rights. Take for instance the 11th Circuit Court of Appeals 2020 decision striking down a pair of municipal ordinances in Florida that had banned so-called “conversion therapy” for minors (contemporary psychology’s preferred nomenclature is “sexual orientation and gender identity change efforts”). In an enormous blow to the evidence-based notion that such change efforts are harmful — they are indeed responsible for much trauma and death — two Trump-appointed judges declared that the science of sexual orientation and gender identity was much too uncertain to justify the bans. Gesturing to the American Psychiatric Association’s (APA) renowned 1973 removal of homosexuality from its list of disorders, the judges explained that “it is not uncommon for professional organizations to do an about-face in response to new evidence or new attitudes.” Ergo, because the APA had changed its mind once fifty years ago, it may just as easily reverse itself again. According to this view, we may one day wake up to find that mental health professionals have reclassified queerness as a malady to be cured rather than a sense of self to be embraced and protected by law.

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Austin, TX, USA - Oct. 2, 2021: Participants at the Women's March rally at the Capitol protest SB 8, Texas' abortion law that effectively bans abortions after six weeks of pregnancy.

Why Must Abortion Providers Needlessly Travel to Texas?

Carmel Shachar Leave a comment

By Carmel Shachar

This year, the American Board of Obstetrics and Gynecology (ABOG) — the organization that runs the exam doctors must take to become certified in obstetrics and gynecology (OB-GYN) — is requiring all candidates to attend in-person examinations in Dallas, Texas. By doing so, ABOG is failing its duties to its membership by asking the practitioners who are most likely to provide abortion services to travel to a state with a legal regimen that is particularly hostile to them.

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