Letter to the Senate Subcommittee on Intellectual Property on Pharmaceutical Competition and Patents
June 11, 2019
The Honorable Thom Tillis
Chairman
Subcommittee on Intellectual Property
Committee on the Judiciary
U.S. Senate
224 Dirksen Senate Office Building
Washington, D.C. 20515
The Honorable Chris Coons
Ranking Member
Subcommittee on Intellectual Property
Committee on the Judiciary
U.S. Senate
152 Dirksen Senate Office Building
Washington, D.C. 20515
Dear Chairman Tillis and
Ranking Member Coons,
The undersigned are organizations and individual experts[1] working to promote access to medicines and medical treatments in the United States and worldwide, including by stopping monopoly abuses of the pharmaceutical industry that delay generic competition. We are deeply concerned by draft legislation released on May 22 that would effectively eliminate historic restrictions on patent eligible subject matter.[2]
Broadening the
ability of prescription drug companies to obtain patents in this way would
create new barriers to medical innovation and facilitate greater patent evergreening,
thus reducing access to affordable medicines. We call on you to cease efforts
to advance this legislation, and instead work with colleagues on curbing drug
industry abuses of our patent system and on lowering prescription drug prices.
Patients in the United States and elsewhere face a crisis of high drug prices that put critical treatments out of reach, especially for disadvantaged communities. Three out of ten American patients report not taking a medicine as prescribed due to cost.[3] Taking action to lower prescription drug prices consistently ranks as the top policy demand of Americans.[4]
The excessive
granting of patents, which unduly conveys exclusive rights that prevent
generics and competitors from lowering prices, has long been known to be a root
cause of this drug pricing crisis. Indeed, on May 7 the Senate Judiciary
Committee held a hearing on “Intellectual Property and the Price of
Prescription Drugs,” in which Chairman Graham stated that he intends “to do
something on patents and prescription drugs this year,” because “doing nothing
is unacceptable.”
The draft
legislation here is thus a step in exactly the wrong direction. By eliminating
historic restrictions on patenting, private companies will be able to obtain
patents on human genes and basic scientific research. This radical change will
impede drug development and access to medicines.
First,
the draft legislation would increase drug prices. Patent “evergreening,” in
which a drug company obtains a series of patents to prolong its monopoly, is a
well-known cause of high drug prices. Multiple bills have been introduced in
the 116th Congress to combat this anticompetitive tactic. But by opening the
door to a wide class of previously foreclosed patents, the draft legislation
would make patent evergreening easier and more common. Drug companies would
undoubtedly obtain more patents in efforts to extend the duration of their
exclusivity periods, preventing price-lowering competition for years or even
decades.
Second,
the draft legislation would impede the development of new drugs and medical
treatments. Numerous scientists have recognized, for example, that gene patents
stifle research and innovation that produces lifesaving tests and treatments.
The Department of Health and Human Services reported in 2010 that gene patents
prevented testing for conditions such as breast cancer, hearing loss,
Alzheimer’s, long QT syndrome, Canavan disease and spinocerebellar ataxia. Gene
patents further discourage researchers from developing new tests—a 2003 study in
the Journal of Medical Diagnostics found that 53% of laboratory
directors backed out of developing a new test or service because of a gene
patent. The Supreme Court’s 2013 Myriad decision put an end to these
harms, and the draft legislation would bring them all back.
Third,
there is no reason to believe that the incentive value of patents permitted
under the draft legislation will be nearly sufficient to counteract these harms
to accessible, affordable medicines. As the 2010 HHS report on gene patents
concluded, “patents do not appear to be necessary to stimulate research and
test development,” because scientists have multiple reasons to pursue research
already. The draft legislation would thus create severe disincentives for
researchers developing next-generation drugs and medical treatments, with
likely little benefit.
For these
reasons, we oppose the draft legislation, and would oppose any legislation that
would permit the patenting of genes, natural laws and products of nature.
Instead of taking us backward, please join your colleagues in advancing
legislation that would help lower prescription drug prices and expand access to
affordable medicines.
Very truly yours,
ACT UP
Philadelphia
AFL-CIO
AIDS Action
Baltimore
AIDS Coalition To
Unleash Power
Alliance for
Retired Americans
American Family
Voices
American Medical
Student Association
Association for
Accessible Medicines
Campaign for
Sustainable Rx Pricing
Center for
Popular Democracy Action
Chronic Illness
Advocacy and Awareness Group
Citizen Outreach
Coalition to
Protect Patient Choice
Community
Catalyst
Consumer Action
Doctors for
America
End AIDS Now
Families USA
Health Care for
America Now
Healthcare NOW of
Maryland
Health GAP
(Global Access Project)
Housing Works
Initiative for
Medicines, Access & Knowledge (I-MAK)
Interfaith Center
on Corporate Responsibility
Just Care
Kaiser Permanente
Knowledge Ecology
International
Lincoln Network
Marina Tsaplina,
Patient Advocate #insulin4all
National
Coalition on Health Care
NETWORK Lobby for
Catholic Social Justice
Other98
People’s Action
Positive
Malaysian Treatment Access & Advocacy Group
Professor Brook
K. Baker, Northeastern University School of Law
Professor Joel
Lexchin, M.D., School of Health Policy and Management, York University
Professor Michael
A. Carrier, Rutgers Law School
Public Citizen
R Street
Institute
Social Security
Works
Society for
Patient Centered Orthopedics
Treatment Action
Group
Universities
Allied for Essential Medicines
cc: Lindsey Graham,
Chairman, Senate Judiciary Committee
Dianne Feinstein, Ranking Member, Senate Judiciary Committee
[1]This
letter updates one sent on June 3, 2019, to add several additional signatories.
[2]The
draft legislation would specifically overturn the Supreme Court’s decisions in Association
for Molecular Pathology v. Myriad Genetics that rejected patenting of
genes, and in Mayo Collaborative Services v. Prometheus Laboratories
that rejected patenting of naturally-occurring diagnostic test correlations.
[3]Ashley
Kirzinger et al., “KFF Health Tracking Poll—February 2019: Prescription Drugs,”
The Henry J. Kaiser Family Foundation, Mar. 1, 2019,
https://www.kff.org/health-costs/poll-finding/kff-health-tracking-poll-february-2019-prescription-drugs/.
[4]Politico
and Harvard T.H. Chan School of Public Health, Americans’ Priorities for
the New Congress in 2019 (Dec. 2018), p. 2,
https://cdn1.sph.harvard.edu/wp-content/uploads/sites/94/2018/12/Politico-Harvard-Poll-Dec-2018-Priorities-for-New-Congress-in-2019.pdf;
Rachel Roubein and David Brown, “Politico–Harvard Poll: New Congress Should
Fight Hate Crimes, Tackle Drug Prices,” Politico, Jan. 3, 2019,
https://www.politico.com/story/2019/01/03/politico-harvard-poll-hate-crimes-drug-prices-1077879.
