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

Follow this and additional works at: https://scholarsmine.mst.edu/peer2peer

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

to be made. In 1991, GSK sued Barr Laboratory scientists who tried to sell

azidothymidine as a . 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 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).

Published by Scholars' Mine, 2018 3 Missouri S&T’s Peer to Peer, Vol. 2, Iss. 1 [2018], Art. 3

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 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

https://scholarsmine.mst.edu/peer2peer/vol2/iss1/3 4 Dewey: Overpriced and Under Regulated

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 , 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.

Published by Scholars' Mine, 2018 5 Missouri S&T’s Peer to Peer, Vol. 2, Iss. 1 [2018], Art. 3

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 ) purchased the patent rights

to (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 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 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.

https://scholarsmine.mst.edu/peer2peer/vol2/iss1/3 6 Dewey: Overpriced and Under Regulated

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 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)

Published by Scholars' Mine, 2018 7 Missouri S&T’s Peer to Peer, Vol. 2, Iss. 1 [2018], Art. 3

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.

https://scholarsmine.mst.edu/peer2peer/vol2/iss1/3 8 Dewey: Overpriced and Under Regulated

“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.).

https://scholarsmine.mst.edu/peer2peer/vol2/iss1/3 10 Dewey: Overpriced and Under Regulated

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

References

Amado, R., & Gewertz, N. M. (2004). Intellectual Property and the Pharmaceutical Industry:

A Moral Crossroads Between Health and Property. Journal of Business Ethics, 55(3),

295-308. doi:10.1007/s10551-004-0993-z

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.

UNITED STATES SECURITIES AND EXCHANGE COMMISSION. Retrieved from

http://www.mylan.com/-/media/mylancom/files/company/corporate%20governance/184

92_10ka_bmk.pdf

Armstrong, M., & Murphy, G. M. (2012). Inventorship and Ownership Considerations and

Pitfalls with Collaborative Research. ACS Medicinal Chemistry Letters, 3(5), 349-351.

doi:10.1021/ml300084

Broder, S. (2010, January). The development of antiretroviral therapy and its impact on the

HIV-1/AIDS pandemic. Retrieved November 12, 2017, from

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2815149/table/T1/

Center for Drug Evaluation and Research. (n.d.). Development & Approval Process (Drugs) -

Frequently Asked Questions on Patents and Exclusivity. Retrieved November 12, 2017,

from:https://www.fda.gov/drugs/developmentapprovalprocess/ucm079031.htm#What_is

_the_difference_between_patents_a

Cornwell, G. (2013). Post PLIVA v. Mensing liability for generic medicine manufacturers:

Food and Drug Administration to propose rule changes creating parity between generic

and brand-name medicine manufacturers. Journal of Generic Medicines: The Business

https://scholarsmine.mst.edu/peer2peer/vol2/iss1/3 12 Dewey: Overpriced and Under Regulated

Journal for the Generic Medicines Sector, 10(3-4), 230-234.

doi:10.1177/1741134314553224

CPI Inflation Calculator. (n.d.). Retrieved November 12, 2017, from

https://data.bls.gov/cgi-bin/cpicalc.pl?cost1=10000&year1=198703&year2=201709

Dan Mangan, Anita Balakrishnan. Mylan CEO Bresch: 'No one's more frustrated than me'

about EpiPen price furor’. August 2017. Retrieved from

https://www.cnbc.com/2016/08/25/mylan-expands-epipen-cost-cutting-programs-after-

charges-of-price-gouging.html

Documents Obtained by Committee from Turing Pharmaceuticals, Committee on

Government Oversight and Reform, 2016. Retrieved from https://democrats-

oversight.house.gov/sites/democrats.oversight.house.gov/files/documents/Memo%20on%

20Turing%20Documents.pdf

Horwitz, J. P., Chua, J., & Noel, M. (1964, July). Nucleosides. V. The Monomesylates of

1-(2'-Deoxy-β-D-lyxofuranosyl)thymine1,2. Retrieved November 12, 2017, from

http://pubs.acs.org/doi/abs/10.1021/jo01030a5464

Impax Laboratories v. Turing Pharmaceuticals AG, united states district court, southern

district of New York. 1:16-cv-03241 (NY.2016) retrieved from

http://freepdfhosting.com/b55b7f4601.pdf

Marie Price The, J. R. (2001, Feb 02). State to share in $100 million settlement. Journal

Record Retrieved from http://libproxy.mst.edu:2048/login?url=https://search-proquest-

com.libproxy.mst.edu/docview/259462401?accountid=14594

Martin Shkreli, Evan Greebel, MSMB Capital Management LLC, and MSMB Healthcare

Management LLC v. SEC. United States District Court, Eastern

Published by Scholars' Mine, 2018 13 Missouri S&T’s Peer to Peer, Vol. 2, Iss. 1 [2018], Art. 3

district of New York. Case 1:15-cv-07175 (NY 2015). Retrieved from

http://freepdfhosting.com/49ebf36754.pdf

Michael L. Loucks, District of Massachusetts, JUSTICE DEPARTMENT ANNOUNCES

LARGEST HEALTH CARE FRAUD SETTLEMENT IN ITS HISTORY. (2009).

Department of Justice. Retrieved from https://www.justice.gov/sites/default/files/usao-

ma/legacy/2012/10/09/Pfizer%20-%20PR%20%28Final%29.pdf

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).

Retrieved from https://arstechnica.com/wp-content/uploads/2017/04/1-main.pdf

Mylan Inc. Proxy statement. SCHEDULE 14A (Rule 14a-101). DEF 14A 1

l39062def14a.htm DEF 14A. Retrieved from

https://www.sec.gov/Archives/edgar/data/69499/000095012310032130/l39062def14a.ht

m#130

Mylan Inc v. Self-Insured Schools of California. United States District Court, Eastern

District of Pennsylvania. Case 2:17-cv-02158-CMR. (PA 2017). Retrieved from

https://www.documentcloud.org/documents/3718731-Mylan-Sun-Albuterol-Lawsuit.html

Mylan Worldwide. (n.d.). Retrieved November 12, 2017, from

http://www.mylan.com/en/company/about-us

OUR MISSION. (n.d.). Retrieved November 12, 2017, from

https://www.vyera.com/about-us/our-mission/

Pharmaceutical Manufacturers in the 2014 Fortune 500 list. (N.d) Retrieved from

https://scholarsmine.mst.edu/peer2peer/vol2/iss1/3 14 Dewey: Overpriced and Under Regulated

http://3.bp.blogspot.com/-

WCG_1DnjlCo/U5hJ5YoDweI/AAAAAAAAFsI/Z6R9dpcaAoY/s1600/Pharmaceutical_

Manufacturers_in_the_2014_Fortune_500_List.png

Pollack, A. (2015, September 20). Drug Goes From $13.50 a Tablet to $750, Overnight.

Retrieved November 12, 2017, from https://www.nytimes.com/2015/09/21/business/a-

huge-overnight-increase-in-a-drugs-price-raises-protests.html

PRESCRIPTION DRUG PRICING: HOW MUCH IS TOO MUCH? (n.d.). Harvard law.

Retrieved from

https://dash.harvard.edu/bitstream/handle/1/8889453/Fiorenzo.html?sequence=2

Resources, M. (2015, July). Definition of Double Patenting. Retrieved November 12, 2017,

from https://www.uspto.gov/web/offices/pac/mpep/s804.html

Rogers, D. L. (2015). Double Patenting: Follow-On Pharmaceutical Patents that Suppress

Competition. SSRN Electronic Journal. doi:10.2139/ssrn.2709067

What We Do. (n.d.). Retrieved November 12, 2017, from

https://www.fda.gov/aboutfda/whatwedo/

Vasudevan, D. M., Sreekumari, S., & Vaidyanathan, K. (2016). Textbook of biochemistry

for medical students. New Delhi: Jaypee Brothers Medical (P) LTD.

Yarnell, A. (n.d.). AZT. Retrieved November 12, 2017, from

https://pubs.acs.org/cen/coverstory/83/8325/8325AZT.html

Published by Scholars' Mine, 2018 15