Tertiary Patents: An Emerging Phenomenon

By Jonathan J. Darrow

Brand-name pharmaceutical manufacturers have long been known to try to protect and extend their market exclusivity periods by obtaining patents on a drug’s substance (“primary patents”) and also on its peripheral features, such as formulations or methods of manufacture (“secondary patents”). A new study describes an emerging phenomenon of “tertiary patents,” which have the potential to further delay and discourage market entry in the context of drug-device combination products.

Combination products are defined by the U.S. Food and Drug Administration (FDA) to include therapeutic products that combine a drug with a device, such as an inhaler or injector pen. These products can sometimes offer life-changing or life-sustaining treatment, as with naloxone (Narcan) for opioid overdose or epinephrine (EpiPen) for severe allergic reactions. In recent years, these and other similar products have been the subject of substantial controversy related to their prices and prolonged lack of generic competition.

To investigate the potential role of patents on the prices and exclusivity periods of drug-device combination products, two researchers at the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women’s Hospital and Harvard Medical School (where I hold a faculty appointment) conducted a comprehensive evaluation of drug-device combination patents registered with the FDA. They found that patents related to drug delivery devices have tripled since the year 2000 and contribute a median of five years of additional market exclusivity to those products (subject, of course, to potential judicial or administrative patent invalidation). Furthermore, the researchers identified a subset of 31 products having only device patents (i.e., having no primary or secondary patents), and found that these patents were scheduled to expire a median of 17 years after FDA approval. Read More

It’s Time to Reinvigorate the Constitutional Claim for Physician Assistance in Dying

by  Norman L. Cantor

Since 1997, when the U.S. Supreme Court rejected federal constitutional challenges to New York and Washington prohibitions of assistance to suicide, the notion that a dying patient might have a constitutional right to obtain a lethal prescription has gotten short shrift.  Even when the dying patient’s claim for physician assistance in dying (PAD) has relied on state constitutional provisions, no state supreme court has ruled that state liberty or equal protection guarantees so benefit a competent, terminally ill medical patient.  See T.M. Pope, Legal History of Medical Aid in Dying: Physician Assisted Death in U.S. Courts and Legislatures,   N. Mex. L. Rev.  (2018). At least 5 state highest courts have rejected such claims.  Yet developments and insights emerging over the last 21 years in death and dying jurisprudence provide reason to reinvigorate constitutional challenges to state prohibitions on a physician’s providing a lethal substance to a competent, fatally stricken medical patient.

The first Achilles heel in current legal doctrine relates to the “liberty” concept invoked by fatally stricken claimants.   When Chief Justice William Rehnquist rejected the patients’ liberty claim in Washington v. Glucksberg, he labeled it as seeking a “right to suicide.”  That over-simplistic formulation of the constitutional claim presaged its failure.  Of course the guides to fundamental liberty, i.e., the traditions and collective conscience of the people, do not encompass “suicide.”  Suicide, broadly viewed as a choice to “prematurely cut short a viable life, usually for reasons of a transient nature and often involving depression,” has always been disdained and discouraged.  Pope, supra, at 29.  Law has customarily allowed physical intervention to prevent suicide, and has criminally punished assistance to suicide.

Rehnquist, though, was unfairly characterizing the liberty claim of dying patients.  Those dying patients in Glucksberg were not advancing a broad prerogative to terminate a life deemed unbearably unhappy.  Rather, they were asserting a fatally stricken person’s interest in medical management of the dying process and in control of the timing of an unavoidable, lurking death.  Only in the 20th century, with development of modern medical tools, did this issue really emerge.  Only then did a fatally stricken patient incur risk of a protracted dying process with accompanying suffering or degradation.  The 21st century is witnessing an expanded incidence of medically mediated death, a phenomenon warranting renewed focus on end-of-life self-determination.

The 21st century is also witnessing development in another measure of fundamental liberty – the collective conscience of the people.  Polls in 2017 show that 67% of Americans now support the concept of physician-assisted death.  Public sentiment may not be a determinative factor, but it is relevant in shaping the meaning of fundamental liberty.  Also relevant are developments in legalization of PAD as in California, Colorado, New Hampshire, Montana, and the District of Columbia. In short, a basis exists for refining and resubmitting the constitutional claim that self-determination in management of a looming, unavoidable dying process should be deemed a fundamental aspect of liberty.  Read More

Diseases of Despair on ‘The Week in Health Law’ Podcast #2

By Nicolas Terry and Leo Beletsky 

Subscribe to TWIHL here!

In April, 2018 the Northeastern University School of Law held a conference titled “Diseases of Despair: The Role of Policy and Law.” TWIHL was asked to be the event’s podcast partner and we roped in Leo Beletsky, our friend and one of the conference organizers, to act as co-host for two special TWIHL episodes. Professor Beletsky, holds a joint appointment with the Northeastern University School of Law and Bouvé College of Health Sciences. His research examines the use of law to improve health, with a focus on drug policy, reducing the spread of infectious disease, and the role of the criminal justice system in shaping public health outcomes. Read More

Call for Proposals: Symposium – Serving the Needs of Medicaid Populations

The Beazley Institute for Health Law and Policy at Loyola University Chicago School of Law and Annals of Health Law invite original research paper submissions for presentation at our Twelfth Annual Health Law Symposium: Serving the Needs of Medicaid Populations. The Symposium will take place at Loyola University Chicago School of Law on Friday, November 16, 2018.

The Symposium will explore whether the current Medicaid system is adequately serving the needs of its target population, and how social determinants of health affect access to care in the context of Medicaid. The Symposium is intended to touch upon a wide variety of areas responsive to this overall theme.  Accordingly, we invite submissions addressing any and all aspects of Medicaid and/or its impact upon accessible, quality patient care. Possible approaches to this Call for Proposals include, but are not limited to:

  • Medicaid’s impact on the financial viability of hospital systems and physician practices and the effect this has on access to health care. Topics may explore the financial burdens and/or benefits faced by health systems after Medicaid expansion, economic viability of health systems in states that did not expand Medicaid, and corporate restructuring in the wake of Medicaid reform.
  • The current status of Medicaid in relation to access to health care. Topics may include the health access trends within states that expanded or shrunk Medicaid, state use of Medicaid waivers, Medicaid work requirements, and shifts in DHHS practices and policies.
  • Populations underserved by Medicaid. Topics may explore immigrant access to care in Medicaid, access problems surrounding individuals with medical complexities, and children with disabilities in Medicaid.
  • Proposals to reform Medicaid in order to increase access and reduce social disparities. Topics may include new proposed models that increase access to care, the ACA’s role in expanding access under Medicaid, and bridging the disconnect between health care spending and health outcomes in the United States through Medicaid reform.

Submission Information: Those interested in participating, please send a 1000-word abstract to health-law@luc.edu by June 16, 2018.  Authors will be notified of decisions no later than July 14, 2018. It is our hope presenters will submit papers for publication in the Annals of Health Law. Papers submitted for publication will be due by January 8, 2019.

NEW REPORT: Ethical Issues Related to the Creation of Synthetic Human Embryos

Report Summary Authored by Robert D. Truog, MD (Center for Bioethics, Harvard Medical School) and Melissa J. Lopes, JD (Harvard University Office of the Vice Provost for Research)

The Harvard Embryonic Stem Cell Research Oversight (the “ESCRO”) Committee, an ethics oversight committee charged with reviewing research protocols involving human embryos, human embryonic stem cells, and certain activities with non-embryonic human pluripotent stem cells, recently issued a report exploring the ethical issues related to the creation of synthetic human embryos.

Ethical committees such as the Harvard ESCRO occasionally receive inquiries to deliberate upon the ethical implications of emerging research technologies where there is no existing or established guidance to rely upon. Deliberating in these gray areas is not a simple task, but the Harvard ESCRO has developed a general framework for navigating this ethical terrain in real time. In these instances, the Harvard ESCRO generally consults with its peer oversight bodies, reviews data from the scientific and bioethical literature and from other scientists and ethicists in the field and, from time to time, convenes symposia to broaden the discussion around such emerging technologies.  Read More

TOMORROW! Our Aging Brains: Decision-making, Fraud, and Undue Influence

Our Aging Brains: Decision-making, Fraud, and Undue Influence
April 27, 2018 7:30 AM – 12:30 PM
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

With over 70 million Baby Boomers retiring, elder financial exploitation has been labeled the “Crime of the 21st Century.” In this half-day event, we will explore the neuroscience, psychology, and legal doctrine of financial decision-making in older adults. How does the aging brain make financial decisions, and when is it uniquely susceptible? How can courts best use science to improve their adjudication of disputes over “competency”, “capacity”, and “undue influence”? Is novel neuroimaging evidence of dementia ready for courtroom use? This conference will bring together experts in medicine, science, and law to explore these important questions and chart a path forward for dementia and the law.

Part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Learn more about the event here!

Insurers are making it harder for me to treat my opioid-addicted patients

By Brian Barnett, via the Washington Post

Brian Barnett is an addiction psychiatry fellow at Massachusetts General Hospital/McLean Hospital and Harvard Medical School. On February 28, 2018, he was participated in the panel discussion Addiction, Neuroscience, and the Criminal Law: Commonwealth vs. Julie Eldred” at Harvard Law School. 

I’m an addiction specialist, and my voice-mail inbox is always nearly full. Some messages are from desperate individuals looking for outpatient treatment or help finding a detoxification program. Others are from patients needing a letter confirming their treatment for a child-custody dispute or care providers informing me that my patients have been hospitalized.

It’s hard to know what to expect, but invariably one type of message awaits: voice mails from pharmacies informing me that a patient’s insurance provider will not approve payment for the medication to treat their opioid addiction unless I obtain prior authorization from the insurer.  Read More

A Roadblock in Maryland

By Zack Buck

In a 2-1 decision, a three-judge panel of the Fourth Circuit Court of Appeals has struck down Maryland’s pharmaceutical price-gouging law.

The law, which went into effect on October 1 of last year, prohibited drug manufacturers from imposing “unconscionable” price increases, empowering the state attorney general to assess civil penalties against drug manufacturers and to enjoin the sale of such drugs in Maryland.  The law applied only to essential off-patent or generic drugs, and specifically allowed the attorney general “to intervene if a generic or off-patent drug’s price increased by 50 percent or more in a single year,” in addition to acting on other “unjustified” increases.

The court, writing through Judge Stephanie Thacker, found that the law ran afoul of the “dormant” commerce clause, in that it empowered Maryland to regulate transactions that occurred completely outside of the state.

Read More

Patient Safety Failings in Independent Acute Hospitals in England

By John Tingle

One thing that strikes the UK visitor to the USA is the vast array of  large public and private hospitals that exist with many having trauma and emergency rooms. Private hospitals don’t exist on this scale in the UK. Our major hospitals are public, state run NHS (National Health Service) hospitals. Independent, private acute hospitals are generally small in size, have no emergency rooms and maintain a bespoke health care provision. The focus is on patients with a single condition and routine elective surgery. The myriad number of complex multiple conditions, dementia etc that the NHS regularly face as a norm are not covered in the independent sector here with such cases being screened out. This limited focus on the type of care provided does mean that staff within independent acute hospitals have a sheltered and more controlled work remit and environment. This is a significant patient safety issue.

The Independent Health and Social Care Regulator of England, the Care Quality Commission (CQC) have recently published their findings of independent acute hospital inspections. They inspected and rated 206 independent acute hospitals and the majority were assessed as providing high quality care. At 2nd January 2018, 62% were rated as good,16 (8%) as outstanding. The report contains some very positive findings on health care provision in these hospitals but also some major governance and patient safety failings were found which are very concerning.

The Independent Newspaper reported back in 2015 reported that private hospitals ‘lack facilities to deal with emergencies’, and quoted a study that found that between 2010 and 2014, 800 patients, including those referred by the NHS, died unexpectedly in private hospitals. Read More

Diseases of Despair on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Leo Beletsky 

Subscribe to TWIHL here!

In April, 2018 the Northeastern University School of Law held a conference titled “Diseases of Despair: The Role of Policy and Law.” TWIHL was asked to be the event’s podcast partner and we roped in Leo Beletsky, our friend and one of the conference organizers, to act as co-host for two special TWIHL episodes. Professor Beletsky, holds a joint appointment with the Northeastern University School of Law and Bouvé College of Health Sciences. His research examines the use of law to improve health, with a focus on drug policy, reducing the spread of infectious disease, and the role of the criminal justice system in shaping public health outcomes. Read More