Constitutional Law - Bill of Health

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

December 20, 2023December 8, 2023 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.

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

October 16, 2023October 12, 2023 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.

Guadalupe, Ariz. / USA - October 31, 2020: As covid-19 cases rise across the country, Pascua Yaqui tribal council signs encourage people to take precautions and stay safe during the epidemic.

Sovereignty, Federalism, and Native Nations: Tribal Nations in a Public Health Emergency

March 7, 2023March 6, 2023 The Petrie-Flom Center Staff Leave a comment

By Victoria Sutton

Native American Nations are sovereigns and acknowledged in the U.S. Constitution. The U.S. Supreme Court has further established the sovereignty of Native Nations in early cases that form the foundation of Federal Indian Law.

Improving the Future of Public Health by Applauding Appropriate Judicial Oversight

March 2, 2023February 28, 2023 The Petrie-Flom Center Staff Leave a comment

By Marshall B. Kapp

During the COVID-19 pandemic, the Public Health Establishment (PHE)/legal enterprise collaborative fell short of constitutional standards in a number of situations, resulting in adverse judicial rulings of which the PHE and its like-minded academic advocates now complain.

This unhappiness with judicial oversight is an opportunity for introspection. Rather than blaming nefarious or deplorable other forces, a better approach to rehabilitating and enhancing public health law in the future lies instead in the PHE taking stock of itself and committing to a more open-minded, humility infused, and objective approach to the definition of science, the role of expertise, and the better targeted and clearly justified employment of legal force in the next major public health emergency context.

President Joe Biden at desk in Oval Office.

Federalizing Public Health

February 28, 2023February 27, 2023 The Petrie-Flom Center Staff Leave a comment

By Elizabeth Weeks

The most promising path forward in public health is to continue recognizing federal authority and responsibility in this space. I carefully choose “recognizing,” rather than “expanding” or “moving” because it is critical to the argument that federal authority for public health already exists within the federalist structure and that employing federal authority to address public health problems does not represent a dimunition of state authority. Rather than a pie, of which pieces consumed at the federal level necessarily reduce pieces consumable at the state level, we should envision the relationship as a Venn diagram, where increasing overlap strengthens authority for promoting and protecting public health broadly.

The United States Capitol building at sunset at night in Washington DC, USA

The End of Public Health? It’s Not Dead Yet

February 27, 2023February 24, 2023 The Petrie-Flom Center Staff Leave a comment

By Nicole Huberfeld

Once again, health law has become a vehicle for constitutional change, with courts hollowing federal and state public health authority while also generating new challenges. In part, this pattern is occurring because the New Roberts Court — the post-Ruth Bader Ginsburg composition of U.S. Supreme Court justices — is led by jurists who rely on “clear statement rules.” This statutory interpretation canon demands Congress draft textually unambiguous laws and contains a presumption against broadly-worded statutes that are meant to be adaptable over time. In effect, Congress should leave nothing to the imagination of those responsible for implementing federal laws, i.e., executive agencies and state officials, so everything a statute covers must be specified, with no room for legislative history or other non-textual sources.

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

Is a Federal Medical License Constitutional?

January 3, 2023December 15, 2022 Timothy Bonis Leave a comment

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.

Is Preemption the Cure for Healthcare Federalism’s Restrictions on Medication Abortion?

November 30, 2022November 28, 2022 The Petrie-Flom Center Staff Leave a comment

This post is an adaptation of an article published in the Harvard Social Impact Review.

By Allison M. Whelan

On June 24, 2022, the U.S. Supreme Court issued its decision in Dobbs v. Jackson Women’s Health Organization, overruling almost fifty years of precedent established by Roe v. Wade and reaffirmed by Planned Parenthood v. Casey. The tragic consequences of Dobbs are many, and all require urgent attention.

Post-Dobbs, states have complete control over the regulation of abortion, including medication abortion. Now more than ever, a person’s access to abortion and other essential reproductive health care services depends on their state of residence and whether they have the means to travel to a state that protects access to abortion care. As a result, the question of whether states can restrict or ban pharmaceuticals approved by the U.S. Food and Drug Administration (FDA) is now top of mind for lawyers, scholars, policymakers, and the public

The consequences that result from state bans and restrictions on medication abortion reverberate across the U.S. healthcare system, representing just one example of “healthcare federalism” — the division of power between the federal and state governments in the regulation of health care.

Austin, Tx/USA - May 23, 2020: Family members of prisoners held in the state prison system demonstrate at the Governor's Mansion for their release on parole due to the danger of Covid-19 in prisons.

Federal Failures to Protect Incarcerated People During Public Health Crises

September 30, 2022September 30, 2022 The Petrie-Flom Center Staff Leave a comment

By Rachel Kincaid

As the COVID-19 pandemic persists, and as we face the reality that future pandemics are coming (or have already begun), it’s a fitting time for the United States to take stock of how the carceral system has exacerbated the harms of COVID-19, and for policymakers to seriously consider what can and should be done differently going forward.

LISBON, PORTUGAL - 7 NOVEMBER 2017: Dr. Oz, heart surgeon & television personality speaks at the Web Summit, Lisbon.

The Dr. Oz Paradox

September 21, 2022September 21, 2022 The Petrie-Flom Center Staff Leave a comment

By Claudia E. Haupt

Why does the law sanction giving bad advice to one patient, while it permits giving bad advice to millions of YouTube or television viewers, which may result in significant physical harm?

We might call this the “Dr. Oz paradox.” Dr. Mehmet Oz, the Republican candidate in Pennsylvania’s U.S. Senate race, is a famous television personality as well as a licensed physician. But, according to one study, half of his publicly disseminated medical advice is wrong. Yet, his sizable audience may very well follow it anyway, and perhaps suffer harm as a result. Such bad advice, which could get any doctor in legal trouble if disseminated to their patients, may be given to the public at large without fear of sanction. The consequences of this sharp doctrinal distinction can be quite jarring.

Tag: Constitutional Law