M. Ali Ch. 20110306 | Maham Aali 21110277 | Usama Asif Ch. 21110133 | M.

Ahmed 21110042

Antibiotics and Vaccines should not be patented

Group 12

Muhammad Ali Chaudhry 20110306

Maham Aali 21110277

Usama Asif Chaudhary 21110133

Muhammad Ahmed 21110042

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M. Ali Ch. 20110306 | Maham Aali 21110277 | Usama Asif Ch. 21110133 | M. Ahmed 21110042

Antibiotics and vaccines are one of the greatest inventions of mankind. They have saved

millions of lives since their creation. We live in a world where technology and medical science

are advancing at a rapid pace. Ever since the discovery of the first antibiotic and the first vaccine,

a significant number of vaccines and antibiotics have been developed. Pharmaceutical companies

spend millions of dollars on research and development in order to come up with solutions to cure

medical problems, to be the first mover in the market and to occupy the strongest position in the

market. But, whether such companies have the right to file a patent for their inventions is

debatable. Jonas Salk, the developer of the polio vaccine, once said, “There is no patent. Could

you patent the sun?” (“The Real Reason Why Salk Refused to Patent the Polio Vaccine,” 2018)

However, it is unclear whether this statement was given due to moral reasons or other reasons.

Keeping in view the whole idea of antibiotics and vaccines being patented, we have come up

with a certain number of arguments.

Antibiotic resistance tends to increase when antibiotics become more common and

people have more access to it. As stated in the Biodiversity’s data journal, “Each year in the U.S., at

least 2 million people are infected with antibiotic-resistant bacteria, and at least 23,000 people

die as a result (Gottschling & Irimia, 2016).” Patents prevent this from occurring as they provide an

exclusive right to a company for producing an antibiotic or vaccine. We cannot expect an optimal use of

antibiotics when they are made available by every other pharmaceutical company. If patents will not be

issued, every company will have a right to produce duplicate copies of the same antibiotic. Thus, this will

just make it easier and convenient for the general public to obtain antibiotics. After a while, the antibiotics

would become ineffective to fight against a particular type of bacteria. Developing novel medicines is

also a time consuming process. With the overuse of antibiotics, people would have to endure prolonged

illnesses caused by bacteria as the existing antibiotics would become ineffective and the invention of

novel antibiotics would not occur at a rapid pace. This could also lead to a high death rate. As stated in an

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article, “Antibiotic resistance tends to increase when a patent on an antibiotic expires. Since other

companies can now sell the antibiotic, more of the antibiotic is produced and prices fall. Because

the benefits of reducing current production go to other firms, pharmaceutical companies will

have little concern about future resistance (Horowitz & Moehring, 2004).”

Patents provide recognition that the patented product is the patentee’s invention. It

establishes a sense of security for the patentees that they will get the credit that they deserve.

This is one of the biggest reasons why pharmaceutical companies patent their products like

antibiotics and vaccines so that they can be known for their research and development and the

efforts that they have done. In the pharmaceutical industry, innovation is the key to success and if

companies feel like their innovative ideas are not being protected, they most likely will not

innovate. An article on drug patents tells about the importance of innovation in the

pharmaceutical industry by stating, “While it can increase the risk involved when developing

drugs, the benefits drastically outweigh the risk, as innovation allows pharmaceutical companies

to distinguish themselves” (“Why Are Drug Patents Important: Everything You Need to Know,”

2019). Without patenting, companies might become a victim of injustice as their competitors

could get the credit of something that they invented. It would be difficult to figure out which

company is more deserving of the fame and recognition. Another essay on the benefits of

pharmaceutical patents states, “Where inventors of drugs and pharmaceutical innovations are

concerned; without the protection which patenting offers, there would be no incentive, firstly for

the inventor to devote time and effort to the formulation of their invention, since others could so

easily replicate it and secondly an absence of patenting could encourage inventors to protect their

ideas through secrecy and non-disclosure” (“Pros and Cons of Pharmaceutical Patents,” 2018).

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Furthermore, it has been observed that not much focus is paid on research and development of

new antibiotics so patent based incentives would persuade drug developers to invest in antibiotic

development. As mentioned earlier, antibiotic resistance is developing at a rapid pace so more

effective antibiotics are required. “Tedros Adhanom Ghebreyesus, director-general of the WHO,

described AMR as a global health emergency, “There is an urgent need for more investment in

research and development for antibiotic-resistant infections including tuberculosis, otherwise we

will be forced back to a time when people feared common infections and risked their lives from

minor surgery”” (“Urgent need for new antibiotics to tackle antimicrobial resistance, says

WHO,” 2017). Thus, the major issue is that pharmaceutical companies are not investing in the

development of new antibiotics. “Klaus Dembowsky, chief medical officer of Polythor says that,

“The reason why many companies dropped out from the anti-infective [field] was because of the

[lack of] return on investment”” (“Why are there so few antibiotics in the research and

development pipeline?,” 2013). Therefore, it is important that pharmaceutical companies are provided

protection in the form of patents so they are motivated to invest in research and development . Without

patent based incentives, companies would not feel the need to take huge risks which might cost them time

and resources. They need to be guaranteed financial benefits without facing any kind of competition for a

certain period of time.

Patenting also validates an antibiotic/vaccine and increases people's trust in them. People

are less likely to buy medicines which have not gone through a rigorous procedure of testing.

When an antibiotic is developed, it is passed through different research and development

processes which include hit generation and testing, lead compound identification, lead compound

optimization, preclinical testing (Which includes laboratory testing of the drug), phase one

clinical trials (Which includes testing the drug on healthy volunteers to estimate the correct

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amount of doze), phase two clinical trials (testing the drug on greater number of individuals to

refine the model), phase three clinical trials (testing the drug on greater number of patients so

that the efficiency of drug could be measured). An article on upcounsel’s website states that, “ To

obtain a medical patent, the owner company has to provide the government with enough research

and data to get the drug approved by the U.S. Food and Drug Administration” (“FDA”)

(“Medical Patents | UpCounsel 2019,” 2019). FDA is the agency in U.S.A that is responsible for

making sure that a newly produced medicine is safe to use. Thus, approval from agencies like these in the

health department of every country ensures people about the effectiveness of a medicine.

Patents related to pharmaceutical drugs such as antibiotics and vaccines are an essential

part of the economic success of a company. They provide pharmaceutical companies with

opportunities to recover all their costs related to research and development, clinical trials etc by

providing a time period during which the patented products may be sold in the market without

facing any competition. “Conaway (2003) illustrates this: ‘The Pharmaceutical Research and

Manufacturers of America, the pharmaceutical industry’s trade association, estimates that the

U.S. pharmaceutical industry spent over $30 billion just on research and development in

2001….In total, each new drug that makes it to market can cost half a billion dollars to

develop…[15]’” (“Pros and Cons of Pharmaceutical Patents,” 2018). Thus, companies invest

millions of dollars to develop these drugs and expect to earn their fair share of return. If

companies are unable to get a profitable return on their investment, they will stop investing in

new drugs and create a global health threat.

If patenting is not allowed, different companies might produce different versions of the

same antibiotic/vaccine, some of which might not be of the best quality and may be ineffective.

Thus, the image

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M. Ali Ch. 20110306 | Maham Aali 21110277 | Usama Asif Ch. 21110133 | M. Ahmed 21110042

and reputation of the original medicine would be tarnished. Making a duplicate product is easy

these days but duplicating creates error in products and decreases the quality of the product.

When different companies try to produce the same product to remain a part of the competition in

market, they try to decrease the cost of production but damage the quality of product in this

process. Thus, patenting protects people from using “SSFFC (substandard, spurious, falsely

labeled, falsified, counterfeit) medical products”. The reason why people face this problem is

stated as, “Consistent access to affordable and quality medicines is a key determinant, but many

reports have been received of very low priced medicines remaining vulnerable if that low price

can be undercut even further (Substandard, spurious, falsely labelled, falsified and counterfeit

medical products Frequently Asked Questions, 2014).” Therefore, absence of patents might lead

to reduction in prices of different versions of antibiotics. This in turn can lead to the problem of

SSFFC medical products.

Contrary to the belief of certain individuals that antibiotic resistance will increase if every

pharmaceutical company begins to develop the same antibiotic, patenting antibiotics is not the

solution to this problem. Bacteria have the ability to develop resistance against antibiotics over

the passage of time. The bacteria will still be able to develop resistance whether one

pharmaceutical company is providing the antibiotic or whether more than one company is

developing antibiotics. Patenting does not resolve the problem of antibiotic resistance. Rather

regulating the usage of antibiotics will solve this problem as Jessica P. Schulman mentions in her

article, “The most effective way to slow antibiotic resistance involves closely regulating

antibiotic use and cycling the use of certain antibiotics over a long period of time (P. Schulman,

2009).” The government can establish laws that medical shops will only provide antibiotics to

individuals if a doctor has prescribed them to use it in severe cases only. As for patenting

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M. Ali Ch. 20110306 | Maham Aali 21110277 | Usama Asif Ch. 21110133 | M. Ahmed 21110042

antibiotics, patents only act as a barrier in the way of development of new antibiotics rapidly. If

the government issues a patent to a company and grants it a patent term extension as well, other

companies might not be encouraged to develop new antibiotics. Bacteria might also be able to

develop resistance before the patent expires. In such cases, the antibiotic will become ineffective

and will provide no value to the people or the company developing it. On the other hand, if

antibiotics are not patented, other companies can employ reverse engineering and introduce

second or third generations of the same antibiotic which would result in a longer time for

bacteria to develop resistance.

Patents are usually granted for a period of 20 years. When a pharmaceutical company

develops an antibiotic and files a patent for it, it aims to generate as much revenue as it can

before the patent expires. The National Center for Biotechnology Information’s website states,

“The marketing and promotion of antibiotics in the traditional unit sale-based business model is

used to maximize sales, with the aim of recouping the high costs of R&D investment and seeking

profit. In this sense, the magnitude of the promotional activity and intended sales is largely

detached from the justified clinical need for the product (Edwards, Morel, Busse, & Harbarth,

2018).” Once the patent expires, all companies will have the permission to develop the same

antibiotic. As a result, there would be a price competition. When similar antibiotics offered by

different companies would not be highly differentiated from each other, people would obviously

opt for low priced antibiotics. However, patents give a company the power to charge a higher

price because that company will be the only player in the market. People would have no other

option. The company will try to extensively market its product before the patent expires. As a

result of the rigorous marketing, there might be a great chance of increasing antibiotic resistance

because the company will try to promote the use of the antibiotic to generate maximum revenue.

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M. Ali Ch. 20110306 | Maham Aali 21110277 | Usama Asif Ch. 21110133 | M. Ahmed 21110042

However, if no patents are filed, the antibiotics would be priced more fairly and companies

would be more focused on their long term benefits instead of giving all their attention to short

term financial incentives. They would know that if antibiotic resistance develops rapidly, their

products will have no demand in the market. Therefore, they will not promote the overuse of

antibiotics and will focus more on improving their products and differentiating them from their

competitors.

There are many developing countries in the world where people lack the financial

resources to fulfill their medical requirements. As mentioned earlier, patenting antibiotics or

vaccines gives the pharmaceutical company the power to charge a higher price. Many individuals

are not able to buy such high priced medicines. People cannot wait for the patent to expire so

they can buy the low priced versions of the same antibiotic or vaccine. Patenting a particular

antibiotic or vaccine creates a monopolistic environment in the market where there is only one

seller and people only have the option to either pay a high price for the product if they are very

desperate or to just let their illness consume them. Where patenting seems beneficial to the

company selling an antibiotic or vaccine, it creates difficulties to the majority of people who do

not have a strong financial position. If patenting is allowed, “Insurance companies would bear

the additional costs of covering the expensive brand name drugs for an extended period, and they

would pass on the increased costs to consumers via increased fees, deductibles, and co-pays (P.

Schulman, 2009).” However, if patents are not filed, each company will try to cut down its cost

so that it can offer a price that is significantly lower than its competitors. They will try to adopt a

market penetration strategy instead of a market skimming strategy. In this way, people would

have a large number of options to choose from and would buy according to their financial

resources. This would be in favor of the majority of the human population living on this planet.

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For example, “From a public healthcare policy perspective, greater availability of insulin

products will improve health care for a large population of diabetic persons previously unable to

afford the cost of this medication (Mayfield, 2016).”

One critical issue with the patent application is the complicated and comprehensive

process that companies need to go through in order to get the application filed and approved.

Several companies might be deprived of their right to produce new antibiotics or vaccines only

because of the unfair practice of giving that right to the company which files the patent first. This

too, because the company might have the resources to get the product patented which other

companies might not be able to gather that quickly. Pharmaceutical companies must ensure that

they prove the originality of their idea, and that too as quickly as possible, in order to secure the

patent. Otherwise, there might be a chance that some other company might secure the patent

before them. As mentioned earlier, patent applicants are not at the same advantage in this

process. Large organizations are at a benefit in the entire application process since they have a

wide range of employees available managing the legal process, in addition to extensive financial

resources at hand. This unfair balance of network and resources between the large and small

companies ends up being detrimental to the patent applications of the smaller companies, which

have limited capacity to go through the entire process, even though they deserve the to be

acknowledged for their novel medicines. Thus, smaller companies are at a greater risk of failing

to secure a patent and getting into practice which allows the larger companies to continue with

their hegemony. A lack of resources for the smaller companies also makes their product

vulnerable to the larger companies.

An additional cost that is associated with the process of patent seeking is the cost of the

process, where the applicants have to bear maintenance, legal and user fee in order to get a patent

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issued and keep it for a time period. The cost of making a new medicine alone is high enough as

stated on The Guardian’s website regarding “The Tufts Center for the Study of Drug

Development in Boston estimate, “The centre’s latest figure for the cost of developing a

prescription drug that gets marketing approval, published in the Journal of Health Economics in

March 2016, is a colossal $2.558bn” (Boseley, 2018).” Adding to this the cost of patenting, the

company spends most of its life cycle recovering this amount. Moreover, the principal risk in this

progression is the possibility of being threatened for patent infringement, where the costs of

litigation and securing the case are very high. As discussed earlier, such a hefty financial strain

would make it difficult for smaller companies and institutions to go forward with the patent

application and process since they might not have such a budget to deal with such possible

threats. Thus, the financial costs of securing a patent and then continuing to pay for the

maintenance are already high. In addition to these, smaller companies and institutions are also at

a threat of patent infringement, since their financial position puts them at a disadvantage, which

further discourages them from investing in this process – or rather delaying the process till they

secure enough financial resources.

Moreover, the pendency period for the biotechnology patent applications continues to be

the longest compared to all other technological patents that are issued. According to National

Centre for Biotechnology Information’s website, “However, recent congressional reports reveal

that the pendency period for biotechnology patent applications remains longer than that for any

other technology (average pendency is 36.1 months for biotechnology patents compared with an

average of 21 months for all other patents issued ((US), Mitchell, Philipose, & Sanford, 2014).”

This delay in the issuance of the patent causes uncertainty amongst competitors and also

threatens the original owner of the content about the security of their idea. A gap in the

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communication process further leads to complications in the patent applications, with repetitive

applicants competing for the same patent and being unaware of the nature of the claims made

earlier with regards to the same product or idea. Such a long waiting pendency period also

creates backlog in the biotechnology patent applications and practice, since many companies

cannot initiate practice of a certain technology until they have the patent secured. Thus,

pharmaceutical companies have to wait for a long period of time as they cannot commercialize

their products until their patents get issued. During this waiting period, some other company

might get a patent for the same product, thus wasting time and money of the other companies.

Keeping the above arguments in mind, we have concluded that even though patenting an

antibiotic or vaccine has a number of advantages for the patentee, not patenting a pharmaceutical

product benefits a larger number of people. We have provided almost all arguments from both

sides and have come to the conclusion that medical products are made for the greater good of the

society. Therefore, while making decisions regarding such products, it is better to consider all

relevant individuals associated with that product and come up with a decision that benefits all.

Hence, antibiotics and vaccines should not be patented as that would be fair for individuals using

them as well as individuals producing them.

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Work Cited

Boseley, S. (2018, November 10). Why do new medicines cost so much, and what can we do

about it? Retrieved April 22, 2019, from the Guardian website:

https://www.theguardian.com/news/2018/apr/09/why-do-new-medicines-cost-so-much-

and-what-can-we-do-about-it

Edwards, S., Morel, C., Busse, R., & Harbarth, S. (2018). Combatting Antibiotic Resistance

Together: How Can We Enlist the Help of Industry? Antibiotics, 7(4), 111.

https://doi.org/10.3390/antibiotics7040111

Gottschling, M., & Irimia, R.-E. (2016). Taxonomic revision of Rochefortia Sw. (Ehretiaceae,

Boraginales). Biodiversity Data Journal, 4, e7720. https://doi.org/10.3897/bdj.4.e7720

Horowitz, J. B., & Moehring, H. B. (2004). How property rights and patents affect antibiotic

resistance. Health Economics, 13(6), 575–583. https://doi.org/10.1002/hec.851

Mayfield, D. L. (2016). Medical Patents and How New Instruments or Medications Might Be

Patented. Missouri Medicine, 113(6), 456–462. Retrieved from

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6139778/

Medical Patents | UpCounsel 2019. (2019). Retrieved April 22, 2019, from UpCounsel website:

https://www.upcounsel.com/medical-patents

Pros and Cons of Pharmaceutical Patents. (2018). Retrieved April 22, 2019, from UKEssays.com

website: https://www.ukessays.com/essays/physiology/pharmaceutical-patents.php

Schulman, J. (2009). Public Health: The Problems with Using Patent Law Proposals to Combat

Antibiotic Resistance, 59 DePaul L. Rev, 221. Retrieved from

https://pdfs.semanticscholar.org/ed3d/775be5f76e0abbc8bf8efb81c2104e4b5680.pdf

Substandard, spurious, falsely labelled, falsified and counterfeit medical products Frequently

Asked Questions. (2014). Retrieved from

https://www.who.int/medicines/services/counterfeit/faqs/SSFFC_FAQ_print.pdf

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The Real Reason Why Salk Refused to Patent the Polio Vaccine. (2018, June 27). Retrieved

April 22, 2019, from BIOtechNow website: http://www.biotech-now.org/public-

policy/patently-biotech/2012/01/the-real-reason-why-salk-refused-to-patent-the-polio-

vaccine-a-myth-in-the-making

Urgent need for new antibiotics to tackle antimicrobial resistance, says WHO. (2017). Retrieved

April 22, 2019, from Pharmaceutical Journal website: https://www.pharmaceutical-

journal.com/news-and-analysis/news-in-brief/urgent-need-for-new-antibiotics-to-tackle-

antimicrobial-resistance-says-who/20203607.fullarticle

(US), M., Mitchell, V. S., Philipose, N. M., & Sanford, J. P. (2014). Relevant Intellectual

Property Rights Law. Retrieved April 22, 2019, from Nih.gov website:

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Why Are Drug Patents Important: Everything You Need to Know. (2019). Retrieved April 22,

2019, from UpCounsel website: https://www.upcounsel.com/why-are-drug-patents-

important

Why are there so few antibiotics in the research and development pipeline? (2013). Retrieved

April 22, 2019, from Pharmaceutical Journal website: https://www.pharmaceutical-

journal.com/news-and-analysis/features/why-are-there-so-few-antibiotics-in-the-research-

and-development-pipeline/11130209.fullarticle

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