Missouri S&T’s Peer to Peer
Volume 2 Issue 1 Article 3
May 2018
Overpriced and Under Regulated: A Crackdown on Pharmaceutical Monopolization and Malfeasance
Taryn Dewey Missouri University of Science and Technology
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Part of the Bioethics and Medical Ethics Commons, and the Pharmacy and Pharmaceutical Sciences Commons
Recommended Citation Dewey, Taryn. 2018. "Overpriced and Under Regulated: A Crackdown on Pharmaceutical Monopolization and Malfeasance." Missouri S&T’s Peer to Peer 2, (1). https://scholarsmine.mst.edu/peer2peer/vol2/iss1/ 3
This Article - Journal is brought to you for free and open access by Scholars' Mine. It has been accepted for inclusion in Missouri S&T’s Peer to Peer by an authorized administrator of Scholars' Mine. This work is protected by U. S. Copyright Law. Unauthorized use including reproduction for redistribution requires the permission of the copyright holder. For more information, please contact [email protected]. Dewey: Overpriced and Under Regulated
In 1964, Jerome Horwitz and his colleagues created an
azido analog of thymidine that would insert itself into cancer
cells and stop the DNA from replicating, but after failed testing
with mice, the drug was put on a shelf for over two decades
(see figure 1).1 In the mid-1980s, the company, Burroughs
Wellcome (now GlaxoSmithKline, or GSK), bought the rights
to the drug, and on March 19, 1987, after only three and a half Figure 1 Azidothymidine Source: J. Org. Chem., 1964 months of research and development, GSK received permission
from the Food and Drug Administration (FDA) to use azidothymidine as a treatment for human
immunodeficiency virus (HIV).2 The price was to be set at $10,000 for one year of treatment.3
After calculating for inflation, one year of treatment would be equal to over $20,000 in 2017.4
GSK and pharmaceutical companies alike are allowed to have complete control over price due to
regulations put in place by the FDA that allow “inherent monopoly rights to the drug’s
production and marketing.”5 Therefore, the distribution and cost are completely up to the for-
profit organization.
Drug monopolies caused by patent laws in turn do not allow generic versions of these
medications to be made. In 1991, GSK sued Barr Laboratory scientists who tried to sell
azidothymidine as a generic drug. The case was appealed, and in 1992 the United States Court of
1 Horwitz, J. P., Chua, J., & Noel, M, Nucleosides. V. The Monomesylates of 1-(2'-Deoxy-β-D-lyxofuranosyl) thymine (1964, July).
2 Broder, S, The development of antiretroviral therapy and its impact on the HIV-1/AIDS pandemic. (2010, January).
3 Yarnell, A. (n.d.). AZT. (2005, May) 4 CPI Inflation Calculator. (n.d.) 5 Amado, R., & Gewertz, N. M. Intellectual Property and the Pharmaceutical Industry. (2004) 295-308
Published by Scholars' Mine, 2018 1 Missouri S&T’s Peer to Peer, Vol. 2, Iss. 1 [2018], Art. 3
Appeals for the Federal Circuit ruled in favor of GSK maintaining complete control over the
drug; this paved the way for future patent lawsuits.6 The purpose of this study was to evaluate
patents, profit margins, salary increases, and lawsuits filed against pharmaceutical companies to
determine if the current state of drug patent law allows companies to take advantage of
prescription-dependent patients in order to make a larger profit.
Methods and Results
This study compared information from both lawsuits and government records as well as a
group of select research papers regarding patent layering to determine whether the current state
of drug regulation allows companies to cripple competition and use the money for financial gain.
Using the FDA as a source for all patent and market exclusivity laws, as well as university
databases for the scholarly journals, a conclusion was made on how the Supreme Court has
reacted to pharmaceutical lawsuits. More importantly, a conclusion was drawn on how
pharmaceutical companies use loopholes to extend exclusivity and the length of their patents.
Government documents such as proxy statements and files from several agencies have also
helped provide profit, salary, and lawsuits records filed against large pharmaceutical companies
for price gouging. These lawsuits have led to evidence of large pharmaceutical companies’
malfeasance; looking into these cases of executive corruption has also aided in determining the
legitimacy of the claims made by pharmaceutical companies. Finally, using the mission
statements of pharmaceutical companies and the FDA, as well as literature reviews regarding
price gouging, it is abundantly clear that these companies take advantage of loose patent laws in
order to maintain their monopolies and control price.
6 Armstrong, M., & Murphy, G. M. Inventorship and Ownership Considerations and Pitfalls with Collaborative Research. (2012), 349-351
https://scholarsmine.mst.edu/peer2peer/vol2/iss1/3 2 Dewey: Overpriced and Under Regulated
Patent Laws and Exclusivity
According to their website, the FDA’s mission statement is “protecting the public health
by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products,
and medical devices” as well as regulating the manufacturing and distribution of these items.
One part of this responsibility is writing the patent and exclusivity laws.7 Currently, the period
for a drug patent is twenty years, but by layering multiple patents and delaying the court,
pharmaceutical companies keep them much longer.8 When drug companies first apply to the
FDA for a pharmaceutical patent, the item they are trying to claim as intellectual property is
called a genus. A genus contains a set of compound subspecies that share similar characteristics,
but this means that for the next twenty years, no generic drugs can be formed from any
subspecies.9
During those twenty years, these companies can narrow down the subspecies in claims
that they have made a better commercial product and refile for a new patent; this is known as
double patenting. Although the FDA has a doctrine in place to stop companies from being
granted a second patent, “the Federal Circuit has weakened the double patenting doctrine and
removed it from its historical Supreme Court roots. This has allowed pharmaceutical companies
to obtain second patents for compositions covered by their earlier patents and in turn allows for
extension to their exclusive rights beyond the term permitted for a single patent”.10 Lilly and Co.
(the manufacturer of Prozac, an extremely common antidepressant) was recently called out by
7 U.S. Food and Drug Administration, Mission Statement/What we do (2018). 8 U.S. Food and Drug Administration, Frequently asked questions (2018) 9 Rogers, Douglas L, Double Patenting: Follow-On Pharmaceutical Patents that Suppress Competition. (2015) 10 Douglas, Double Patenting: Follow-On Pharmaceutical Patents that Suppress Competition; United States Patent and Trademark Office, M. Definition of Double Patenting. (2015, July).
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Barr Laboratories for trying to do just that.11 Their first patent “claimed a method for treating
anxiety in a human by administering an effective amount of fluoxetine or a pharmaceutically-
acceptable salt thereof,” and the second claimed “a method of blocking the uptake of serotonin
by brain neurons in animals by administering the compound fluoxetine hydrochloride.”12 The
court claimed this was obvious type double patenting and the patent was denied, yet for the
period of time before the decision was final, Lilly and Co. continued to reap the benefits of total
price control.13 When a company succeeds at this, it can delay the FDA until the patent is found
to be indistinct from previous patents. While this may only last a short time, it can still be
extremely profitable.
Exclusivity is another way of drawing out the time in which companies can retain the
rights to their drugs. The FDA recognizes multiple types of exclusivity, including orphan drug
exclusivity which lasts seven years, new chemical entity exclusivity which lasts five years,
generating antibiotic incentives now exclusivity which lasts five years, new clinical investigation
exclusivity which lasts three years, pediatric exclusivity which adds six months, and finally
patent challenge which lasts 180 days for abbreviated new drug applications only.14 An example
of new chemical entity exclusivity would be “AbbVie Inc., [who] received a patent for a broad
method of treating rheumatoid arthritis with methotrexate and an antibody, and in 2010 it
received a patent for a narrower method- within the scope of the original patent-of treating
arthritis with methotrexate and an antibody, allowing AbbVie to extend its exclusive rights to the
narrower method from 2012 to 2018.”15 By manipulating these exclusivity laws, AbbVie was
11 Cornwell, G. Post PLIVA v. Mensing liability for generic medicine manufacturers. (2013) 230-234. 12 Cornwell, Mensing liability for generic medicine manufacturers. 13 Cornwell, Mensing liability for generic medicine manufacturers. 14 U.S. Food and Drug Administration, Frequently asked questions. 15 Douglas, Double Patenting: Follow-On Pharmaceutical Patents that Suppress
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able to bypass their patent expiration date and continue their monopoly over the use of
methotrexate as a drug for arthritis.
The FDA also mentions that “exclusivity was designed to promote a balance between
new drug innovation and greater public access to drugs that result from generic drug
competition,”16 yet “the former editor in chief of the New England Journal of Medicine, wrote
that ‘the pharmaceutical industry is not especially innovative’ and added that from 1998 through
2002, the Food and Drug Administration (FDA) approved 415 new drugs, but only 14 percent
were truly innovative.”17 This data proves a lack of advancement in drug research and
development and a focus on simply extending patents. Later “the President's Council of Advisors
on Science and Technology said that ‘the pace of new therapeutic development has not kept up
with the explosion in scientific knowledge’ and observed, ‘The number of novel drugs has
remained constant for several decades, even as R&D budgets have substantially increased’”.18
This lack of development of better versions of medication, and instead a push to simply extend
the rights of a so called ‘new drug,’ show the real motivation behind pharmaceutical companies.
These submarine patent tactics have been used countless times throughout the last thirty
years to help pharmaceutical companies retain their rights over the drugs they own, so that they
can continue their monopoly over the price. While these regulations are said to be put in place
for balance between competition and recouping for research and development costs, it is clear
that they are consistently used by pharmaceutical companies to extend their rights to their drugs.
Competition. 16 U.S. Food and Drug Administration, Frequently asked questions. 17 Douglas, Double Patenting: Follow-On Pharmaceutical Patents that Suppress Competition. 18 Douglas, Double Patenting: Follow-On Pharmaceutical Patents that Suppress Competition.
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Innovations being made by these companies are not substantial enough to warrant such loose
patent laws.
Lawsuits and Scandals
Making sure patients who have debilitating illnesses can receive their medication for as
little as possible is the main incentive behind questioning the legitimacy of the use of patent law
for pharmaceutical drug companies. Delving into cases of executive corruption as well as
lawsuits filed against these companies has provided insight into figuring out the legitimacy of the
claims made by pharmaceutical companies.
In 2015, Turing Pharmaceuticals (founded by Martin Shkreli) purchased the patent rights
to Pyrimethamine (brand named Daraprim), a drug synthesized in 1983 by Gertrude Elion.19
After gaining market exclusivity by purchase, Turing raised the price of Daraprim from $13.50
per pill to $750 per pill overnight.20 At the time, Daraprim was “affordable, readily available,
and very effective at treating toxoplasmosis in people with HIV/AIDS, cancer, or other
conditions that cause compromised immune systems,” yet after purchasing the drug and putting
no funding into research and development, Turing raised the price of the drug 5,000%.21 When
Shkreli was confronted by the New York times on why this price increase took place, he said,
“This isn’t the greedy drug company trying to gouge patients, it is us trying to stay in
19 Impax Laboratories v. Turing Pharmaceuticals AG, united states district court, southern district of New York. 1:16-cv-03241(NY.2016); Vasudevan, D., Textbook of
biochemistry (2016)
20 Documents Obtained by Committee from Turing Pharmaceuticals, Committee on Government Oversight and Reform, 2016.
21 Committee on Government Oversight and Reform, 2016.
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business.”22 However, “on August 27, 2015, Mr. Shkreli sent an email to another outside contact,
writing, ‘I think it will be huge. We raised the price from $1,700 per bottle to $75,000 … So
5,000 paying bottles at the new price is $375,000,000—almost all of it is profit and I think we
will get 3 years of that or more. Should be a very handsome investment for all of us. Let’s all
cross our fingers that the estimates are accurate.’”.23 To add to this, one year prior to the price
gouge, Shkreli was indicted for misrepresenting his shareholders, stealing investment funds, and
committing investor fraud against MSMB capital.24 After the Daraprim scandal, Shkreli “used
his control over Retrophin [parent company of Turing Pharmaceuticals] to enrich himself and to
pay off claims of MSMB investors (whom he had defrauded).”25 These actions are shady
business practices whose sole interest is profit. Price gouging to pay defrauded investors and
taking advantage of patients who rely on Daraprim to survive are not actions of a company
whose primary mission is to “support programs that assist patients who may have difficulty
affording their treatment and [give] discounts to organizations that provide care to underserved
patients.”26 These instances of price gouging are certainly not ethically sound decisions for
companies claiming to serve their customers.
Shkreli does not stand alone by any means; lawsuits involving executive corruption and
price gouging are common practice among large pharmaceutical companies. In 1999, the large
company Mylan Laboratories was handed a 100-million-dollar lawsuit for increasing the price of
their drugs, including lorazepam and clorazepate. According to the accusations, some of the
22 Pollack, A. (2015, September 20). Drug Goes From $13.50 a Tablet to $750, Overnight. (2015) 23 Committee on Government Oversight and Reform 24 LLC v. SEC. U.S District Court, Eastern District of New York 1:15-cv-07175 (2015) 25 Impax Laboratories v. Turing Pharmaceuticals 1:16-cv-03241(NY.2016) 26 Vyera Pharmaceuticals, OUR MISSION. (n.d.). (2018)
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drugs prices were raised upwards of 2,000%.27 Mylan was also indicted for a price increase of
over 4,000% on albuterol sulfate tablets, a drug that had been around for more than two
decades.28 More recently, Mylan purchased the rights to Auvi-q, more commonly known as an
EpiPen. After jacking the price up more than 400%, Mylan was sued for trying to squash
competition and implement illegal price increases.29 Another example is the large pharmaceutical
company Pfizer, which was part of the largest account of healthcare fraud in history, with a
payout of over two billion dollars.30 It is clear that monetary payouts have no effect on how these
companies do business, as the countless examples of fraud and obvious manipulation of
exclusivity laws only result in a payout that is just a fraction of their yearly profit. These tactics
used by Mylan, Pfizer, and other large pharmaceutical companies show that they only have profit
in mind and are not looking out for the health and wellbeing of patients.
Effect of Profit Margins and Price Gouging
Although it is clear that currently released drugs cannot be considered innovative, there
are still problems that arise in research and development. “Only five of every four thousand
laboratory compounds ever merits human testing. Of these five, only one ever becomes a drug
for sale.”31 Many companies argue this is one of the reasons for the high prices of life saving
drugs, as the majority of their revenue goes back into research and development. In 2016, after
the EpiPen Price gouge, Mylan CEO Heather Bresch told CNBC that high costs are due to
27 Marie Price The, J. R., State to share in $100 million settlement. (2001, Feb 02). 28 Mylan Inc v. Self-Insured Schools of California. United States District Court, Eastern District of Pennsylvania. Case 2:17-cv-02158-CMR. (PA 2017).
29 MYLAN Inc.; and MYLAN SPECIALTY, L.P v. SANOFI-AVENTIS U.S. LLC. United States District Court for New Jersey. Case 3:17-cv-02763-FLW-TJB, (NJ 2017)
30 Michael L. Loucks, District of Massachusetts, JUSTICE DEPARTMENT ANNOUNCES LARGEST HEALTH CARE FRAUD SETTLEMENT IN ITS HISTORY. (2009).
31 PRESCRIPTION DRUG PRICING: HOW MUCH IS TOO MUCH? (n.d.). Harvard law.
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“manufacturing the product, distributing the product, enhancing the product, investing.”32 Yet,
over the course of 10 years, Ms. Bresch raised the price of one dose of epinephrine from $56.64
to $317.82, a 461% increase.33 According to the United States Securities and Exchange
Commission, Ms. Bresch made $2,453,456 in 2007; 10 years later after her price gouge, she was
compensated with $18,931,068 for just one year.34 From 1980 to 1990 the median profit margin
for pharmaceutical companies was 21.1%. For comparison, the median profit margin for
manufacturing companies was only 11.9%, and profit margins have only increased. The Fortune
500 list of 2014 put Pfizer’s profit margins at over 40%.35 With an average of double the profit
margin of other industries, it is clear that the sole reason for price gouging is not to recoup the
costs of research and development. Instead, pharmaceutical companies have a fixation on large
profits and personal compensation.
Price gouging drugs to reap high profit margins and personal financial growth have more
than just an effect on consumer price. “On September 30, 2015, a Turing sales account manager
sent an email about a recent meeting with Massachusetts General Hospital, writing: “‘One of the
things we discussed was Mass General’s internal analysis of the impact of Daraprim’s new price
on their inpatient pharmacy budget, which they have determined to be prohibitively expensive.
Against their clinical convictions they are currently switching patients to Bactrim.’”36 The price
of Daraprim was raised so high that one of the largest teaching hospitals for Harvard medical
32 Dan Mangan, Anita Balakrishnan. Mylan CEO Bresch: 'No one's more frustrated than me' about EpiPen price furor’.
33 MYLAN Inc.; and MYLAN SPECIALTY, L.P v. SANOFI-AVENTIS U.S. LLC. Case 3:17- cv-02763-FLW-TJB, (NJ 2017) 34 Annual Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Fiscal Year Ended December 31, 2015. Commission file number 333-199861; Mylan Inc. Proxy statement. SCHEDULE 14A (Rule 14a-101). DEF 14A 1 l39062def14a.htm DEF 14A. 35 Pharmaceutical Manufacturers in the 2014 Fortune 500 list; MYLAN Inc.; and MYLAN SPECIALTY, L.P v. SANOFI-AVENTIS U.S. LLC. Case 3:17-cv-02763-FLW-TJB, (NJ 2017) 36 Documents Obtained by Committee from Turing Pharmaceuticals, 2016.
Published by Scholars' Mine, 2018 9 Missouri S&T’s Peer to Peer, Vol. 2, Iss. 1 [2018], Art. 3
students had to switch to a medicine that is less successful at treating toxoplasmosis. The record
from the Impax v. Turing states that “Daraprim has now become prohibitively expensive,
hospital budgets are straining under the huge cost increases, patients are being forced to pay
thousands of dollars in co-pays and are experiencing major challenges obtaining access to the
drug, and physicians are considering using alternative therapies.”37 While Mylan claims to have
“medicines available to everyone who needs them,” healthcare suppliers such as hospitals are
unable to give the best care to their patients due to high price gouges created by patent laws.38
Discussion
Patent laws allow pharmaceutical companies to hold complete control over the
manufacturing and price of all species covered by the patent over the genus. This, along with
market exclusivity regulations put in place by the FDA, causes any generic competition to be
illegal. Using double patenting, patent layering, submarine patents, metabolite patents,
polymorph patents, and many more patent-extending loopholes, drug companies are able to hold
patents and market exclusivity much longer than the FDA allows.
These instances of extended market exclusivity have led to innumerable lawsuits and
scandals stemming from illegal price jacks, healthcare and investment fraud, misrepresentation,
and incorrectly filing for a second patent. These lawsuits, along with the scandals involving the
CEOs and founders of these companies, are all evidence that the regulations regarding patent
laws allow companies to take advantage of loose regulations in order to have as much fiscal
influence and financial gain as possible. When comparing companies’ high profit margins and
price gouging, and cross referencing it to salary increases over that period, it becomes clear that
the motivation behind this price gouging is profit. High profit margins are evidence that money is
37 Impax Laboratories v. Turing Pharmaceuticals AG, 1:16-cv-03241 (NY.2016) 38 Mylan Worldwide. (n.d.).
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not being properly funded back into research and development, but instead used for personal
financial gain.
All of this is a result of loose patent regulations. Tightening these laws could result in
massive influxes of competition, which in turn could cause an overall decrease in the price of
life-saving medication. In the last ten years, Pfizer and Mylan have raised the price of many
drugs and there seems to be no end in sight. Cheaper medicine could result in cheaper healthcare,
which would allow patients to pay less to keep themselves in good health. In the end, the most
important reason for studying the malfeasance of pharmaceutical companies is to not allow them
to take advantage of and profit from sick patients. More research needs to be done on how to
properly tighten the regulations put in place by the FDA to ensure double patenting and patent
layering cannot happen as frequently as it does now. Until action is taken, patients and hospitals
will continue to be strained by monopoly prices, and billion-dollar pharmaceutical companies
will continue to profit off of ill Americans.
Published by Scholars' Mine, 2018 11 Missouri S&T’s Peer to Peer, Vol. 2, Iss. 1 [2018], Art. 3
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