Constitution - Bill of Health

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

December 8, 2023December 8, 2023 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.

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.

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.

The Government Needs to Construct On, Not Off, Ramps to Combat the Latest Wave of COVID

November 12, 2021November 12, 2021 Jennifer S. Bard Leave a comment

By Jennifer S. Bard

Over the past two weeks, the news coming in about the spread of COVID-19 has been eerily familiar. Cases are rising all over Europe, not just in under-vaccinated Eastern European countries, but in England, the Netherlands, and Germany — all of whom have much higher rates of vaccination than the U.S. At the same time, cases across the U.S., including in cities like LA, DC, and Chicago have stopped falling, and are rising rapidly in the Mountain West, including the Navajo Nation. Hospitals in Colorado have already reached crisis capacity.

Whether the increase is attributable to the emergence of yet another variant, or perhaps is a natural artifact of waning immunity, it is very real and demands a level of attention from our federal government that, once again, it is failing to provide.

Yet in the face of now too familiar signs of resurgence, already being called a “Fifth Wave,” not only are the usual minimizers advocating reducing existing measures to prevent spread, but cities and states are rolling back what few protections remain intact. It is in the face of this foolish movement to drop our guard that the federal government is, again, failing to use the powers it has beyond vaccine mandates to create much needed on-ramps for mitigation measures as the country heads into winter.

Herndon, USA - April 27, 2020: Virginia Fairfax County building exterior sign entrance to Mom's Organic Market store with request to wear face mask due to covid-19 pandemic.

The Current COVID-19 Surge, Eugenics, and Health-Based Discrimination

July 23, 2021July 22, 2021 The Petrie-Flom Center Staff Leave a comment

By Jacqueline Fox

COVID has shown us that the burdens and inequities that characterize everyday life for many Americans are not merely vestiges of an older time, but an honest reflection of our unwillingness to treat everyone with dignity and respect.

We have undergone an ethical stress test in the last 18 months. While many people have exhibited heroic commitments to their fellow citizens, much of our governmental response is indefensible in a society that professes to care for all of its members. This implies we are not such a society.

Rather, we are a society riddled with healthism — discrimination based on health status — and eugenics — a pseudo-science that arbitrarily elevates some human traits over others, much as we do with breeding dogs and horses.

As a result, although we are armed with the power to prevent much harm, we lack the will or inclination to use that power for our most vulnerable. Instead, we place different values on people’s lives using arbitrary definitions of quality, and treat people differently based on their health status. Examples include placing a lower value on a life because a person is older, disabled, or overweight.

What Can the Federal Government Do When States Make Dangerous Decisions?

July 15, 2021July 15, 2021 Jennifer S. Bard Leave a comment

By Jennifer S. Bard

The threat posed to the welfare, economy, and security of the United States by the rapidly spreading COVID-19 virus is as serious as any we have ever confronted.

But, at the same time that the federal government is spending billions of dollars on distributing vaccines, and exerting their authority by prohibiting evictions and requiring masks on public transportation, many individual states are not just refusing to take effective measures to stop the spread, but also are pouring gasoline on the fire by doing all they can to undermine even the remaining, weak guidelines published by the CDC. Some have gone so far as to restrict the flow of information by prohibiting public health officials from disseminating news about the vaccines provided by the federal government.

The effects of these actions not only promote the spread of COVID-19, but also fuel its mutation into new forms, and cannot be confined by any existing geographic or cartographic boundary. So how is the federal government allowing this to happen? It’s not for lack of authority.

Medicine doctor and stethoscope in hand touching icon medical network connection with modern virtual screen interface, medical technology network concept

Regulation of Access to Clinical Data in Chile’s New Constitution

October 7, 2020October 6, 2020 The Petrie-Flom Center Staff Leave a comment

By Gabriela Y. Novoa and Alexis M. Kalergis

As Chileans prepare to vote on whether or not to create a new Constitution, an issue worth considering relative to this reform concerns access to clinical data.

The Political Constitution of the Republic of Chile dates back to 1980, and, in the past decades, has undergone several amendments, including key reforms in August 1989, August 2005, and August 2019. As part of this last modification, it was agreed to organize a plebiscite to democratically decide whether or not to elaborate an entirely new constitutional text. If the alternative of generating a new constitution is adopted, it will consist of a constitution written from square one, rather than a modification to the existing text.

As part of the public discussion relative to the potential approval of the need for a new constitution, an open debate has taken place about which issues should or should not be incorporated into this new text.

Among several important themes, the need to regulate the access to clinical data of patients, also called “interoperability,” arises as a major one. Such an issue is linked to the rights to life, to health and privacy protection, individual honor and personal data and property, which are currently established as constitutional guarantees by Article 19 of the current Constitution. Further, the legal framework dealing with this issue is currently mainly found in Law No. 20,584, which regulates the Rights and Duties of individuals in connection with actions associated to their health care, and in Law No. 19,628 (on the protection of the privacy of individuals).

When Health Advice Is Hard to Come by, BIPOC Suffer the Consequences

October 6, 2020October 5, 2020 The Petrie-Flom Center Staff Leave a comment

By Claudia E. Haupt

The COVID-19 pandemic has highlighted the tradeoffs at stake for Black, Indigenous, and people of color (BIPOC) seeking reliable health advice.

While there are legal safeguards to ensure reliable health advice within the confines of the doctor-patient relationship, outside of that relationship, the First Amendment protects bad advice just as much as good advice.

Courts continue to interpret the First Amendment in an expanding, deregulatory manner and the health context is no exception. For example, one novel judicial interpretation challenges previously accepted applications of the police power in furthering public health. In a forthcoming article, “Public Health Originalism and the First Amendment,” my colleague Wendy Parmet and I explore some of the dangers associated with this deregulatory approach.

Overall, the beneficiaries of these recent developments tend to be powerful speakers. The costs have largely fallen on women, as seen for example in NIFLA v. Becerra, and those who lack access to reliable medical advice, who are disproportionately BIPOC. Current First Amendment doctrine thus has the dangerous potential to further exacerbate existing racial disparities in health.

Santiago, Chile - Crosswalk in long-exposure.

Chile’s New Constitution, the Right to Health, and Health System Reforms

September 18, 2020September 18, 2020 The Petrie-Flom Center Staff Leave a comment

By Marco Antonio Nuñez

During these months of the COVID-19 pandemic in Chile, the need to align the constitutional process with long-postponed structural reforms to the health system has become evident among public health experts.

Capitalizing on this moment might avoid the possibility of a constitutional right to health becoming a dead letter or being reduced only to the prosecution of particular cases, postponing again the aspirations of the majority of Chileans.

Although the Chilean Constitution promulgated under the dictatorship in 1980 and subsequently reformed in several of its chapters recognizes “The right to the protection of health,” it has been tainted by authoritarianism from its origin, and promotes a subsidiary role of the state in health.

gavel and stethoscope on white background

The Right to Health in the Upcoming Constitutional Debate in Chile

September 18, 2020September 17, 2020 The Petrie-Flom Center Staff Leave a comment

By Veronica Vargas

At this unprecedented COVID moment, health has been revealed as one of our most precious possessions and protecting it has become imperative. The right to health was articulated by the WHO in the Declaration of Alma-Ata of 1978. The upcoming constitutional debate in Chile is an opportunity to re-examine this concept.

The Chilean constitution specifies the right to “free and egalitarian access” to health care. Simultaneously, the constitution guarantees that “each person has the right to choose the health system they wish to join, either public or private.”

These provisions have championed a prospering private health sector, with corporate clinics and a private insurance system that represents almost half of total health spending.

However, this private sector serves less than 20 percent of the population. Nearly 80 percent of the population utilizes public sector insurance. Although the public sector has been expanding its coverage of health services, and health indicators for those with public insurance have been improving, the public sector is chronically underfunded. Public sector health care spending represents only 4% of the GDP.

Tag: Constitution