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

Call for Papers: Wiet Life Sciences Scholars Conference

Loyola University Chicago’s nationally acclaimed Beazley Institute for Health Law and Policy is pleased to invite original research submissions for the annual Wiet Life Science Law Scholars Conference to be held on Friday, September 7, 2018.

The conference is designed to provide an intellectual venue for life science professors, scholars, and practitioners to convene and discuss current research and scholarship.  The phrase “life science law” intends to capture diverse disciplines that involve significant issues of life science research and development, spanning food and drug law, health law, intellectual property (IP) law, biotechnology law, environmental law, administrative law, and antitrust law.  Our goal is to foster recognition of life science law as a cohesive, dynamic area of legal study and strengthen connections among national life science law scholars.

Loyola is currently soliciting 750-1,000 word abstracts reflecting early or mid-stage ideas for the purpose of workshopping with other conference scholars.  Modeled after successful events for law professors and scholars in other areas, we will organize scholars in topical panels of three to five authors with approximately 15 minutes allotted to each abstract presentation, followed by 15 minutes of intensive discussion with scholar attendees.  Author abstracts will be distributed one week prior to the conference to scholar participants; authors may also submit draft articles for distribution.  Scholars are expected to review materials of fellow panel members.

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TODAY, 12/4 at 5 PM: Health Law Workshop with Rachel Sachs

December 4, 2017 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “Delinking Reimbursement”

This paper is not available for download. To request a copy in preparation for the workshop, please contact Jennifer Minnich at jminnich@law.harvard.edu.

Rachel E. Sachs is Associate Professor of Law at Washington University School of Law (St. Louis). She is a scholar of innovation policy whose work explores the interaction of intellectual property law, food and drug regulation, and health law. Her work explores problems of innovation and access, considering how law helps or hinders these problems. Professor Sachs’ scholarship has or will have appeared in journals that include the Harvard Journal of Law & Technology, the University of California-Davis Law Review, the Yale Journal of Law & Technology, and the peer-reviewed Journal of Law and the Biosciences. Prior to joining the faculty, Professor Sachs was an Academic Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics and a Lecturer in Law at Harvard Law School. She also clerked for the Hon. Richard A. Posner of the U.S. Court of Appeals for the Seventh Circuit. She received her JD magna cum laude from Harvard Law School and a Master of Public Health from the Harvard School of Public Health. She received her AB in Bioethics from Princeton University.

REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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Roche and City of Hope Claim Pfizer Biosimilar Version of Trastuzumab Will Infringe “At Least” 40 Patents

By James Love

On November 17, 2017, Genentech, a subsidiary of the giant Swiss drug company Roche, together with City of Hope, a charity, filed a complaint in a U.S. District Court, seeking an injunction to block introduction of a Pfizer biosimilar version of Herceptin (INN: trastuzumab), as well as other remedies to infringement, including compensation for Roche’s lost profits if competition occurs. The complaint (Genentech vPfizer, 17-cv-1672, U.S. District Court, District of of Delaware (Wilmington), filed November 17, 2017) illustrates the complexity of the patent landscape on a drug placed on the market more than 19 years ago and the need for compulsory licensing of patents.

Trastuzumab is a very important drug for the treatment of breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+). My wife was treated with trastuzumab for several years, and is currently on a follow-on Roche treatment named Kadcyla, which is a combination of trastuzumab and the small molecule DM1. (DM1 is an NIH funded drug now off patent).

The early development of trastuzumab was dramatic, and documented in such accounts as Robert Bazell’s very readable book, Her-2: The Making of Herceptin, a Revolutionary Treatment for Breast Cancer, published in 1998, and the 2008 movie Living Proof, starting Harry Connick, Jr..  Bazell’s book was referred in the New York Times and the New England Journal of Medicine. The Bazell book and the Living Proof movie provide a dramatic account of the unwillingness of Genentech to invest in the research that led to the approval of trastuzmab, and the role of the Revlon Foundation to support Dr. Dennis Slamon’s critical work at UCLA.

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REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

Read More

REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

Read More

The Cost of Medications: Current Realities and the Future of Pharmaceutical Pricing Regulations in the United States

The Cost of Medications: Current Realities and the Future of Pharmaceutical Pricing Regulations in the United States
October 4, 2017 12:00 PM
Wasserstein Hall, Milstein East B (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

From “Pharma Bro” Martin Shkreli to huge price jumps for the EpiPen to the Hepatitis C treatment that costs $1000 per pill, pharmaceutical pricing is a major issue in the news and in Washington. The regular introduction of new, often expensive therapeutics as well as controversial price increases for familiar drugs attract bipartisan attention and ensure that drug costs will remain an important topic of public policy debate.

This panel of experts will discuss current laws and regulations governing pharmaceutical pricing in the United States, the impact of breakthrough therapeutics on drug pricing, and the future of drug pricing policy in the United States.

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Privacy and Confidentiality: Bill of Health at Five Years and Beyond

In honor of the occasion of the Fifth Anniversary of Bill of Health, this post reflects on the past five years of what’s generally known as “privacy” with respect to health information.  The topic is really a giant topic area, covering a vast array of questions about the security and confidentiality of health information, the collection and use of health information for public health and research, commercialization and monetization of information, whether and why we care about health privacy, and much more.  Interestingly, Bill of Health has no categorizations for core concepts in this area:  privacy, confidentiality, security, health data, HIPAA, health information technology—the closest is a symposium on the re-identification of information, held in 2013.  Yet arguably these issues may have a significant impact on patients’ willingness to access care, risks they may face from data theft or misuse, assessment of the quality of care they receive, and the ability of public health to detect emergencies.

Over the past five years, Bill of Health has kept up a steady stream of commentary on privacy and privacy-related topics.  Here, I note just a few of the highlights (with apologies to those I might have missed—there were a lot!) There have been important symposia:  a 2016 set of critical commentaries on the proposed revisions of the Common Rule governing research ethics and a 2013 symposium on re-identification attacks.  There have been reports on the privacy implications of recent or proposed legislation: the 21st Century Cures Act, the 2015 proposal for a Consumer Privacy Bill of Rights, and the proposed Workplace Wellness Bill’s implications for genetic information privacy.  Many comments have addressed big data in health care and the possible implications for privacy.  Other comments have been highly speculative, such as scoping out the territory of what it might mean for Amazon to get into the health care business. There have also been reports of research about privacy attitudes, such as the survey of participants in instruments for sharing genomic data online.  But there have been major gaps, too, such as a dearth of writing about the potential privacy implications of the precision medicine and million lives initiative and only a couple of short pieces about the problem of data security.

Here are a few quick sketches of the major current themes in health privacy and data use, that I hope writers and readers and researchers and most importantly policy makers will continue to monitor over the next five years (spoiler alert: I plan to keep writing about lots of them, and I hope others will too): Read More

Orphan Drugs Designations and Approvals have Something to Say about Risks

This brief essay examines data from the U.S. Orphan Drug Act, including specifically the FDA designations of an indication for a drug to treat an orphan disease, and the likelihood that once the designation is made, the FDA will approve the drug for that indication. This is one empirical measure of the risks associated with the development of new drugs to treat U.S. defined orphan diseases.  Note that 75 percent of all novel cancer drugs approved in the United States from 2010 to 2016 qualified as orphan products.    The essay also reports the average time between the FDA designation and the FDA approval for orphan indications.

The main findings are that since 2010, the average time from orphan designation to approval is 5.3 years, and the likelihood of FDA approval for an orphan indication, which varies over time and across business cycles, was .22 from 1990 to 2017, and since 2010, was .25.

The essay concludes with a comparison to other studies of the risks of drug development.


On January 5, 1983, the U.S. Orphan Drug Act became law as Public Law 97-414. Over the past 34 years the Act has been amended numerous times, often extending or expanding the benefits, which currently include a 50 percent tax credit for qualifying clinical trials, exemptions or discounts on prescription drug user fees, an easier and faster path to FDA approval, and seven years of marketing exclusivity for an approved orphan indication. Read More