Gateways To Make Pharmaceutical Patenting Attractive

Introduction

The long-standing debate about patenting pharmaceutical products is akin to opening ‘Pandora’s box’ or like the malaise spread associated with health crises like HIV aids, tuberculosis, MERS 2002, smallpox and most recently, the Covid19. This debate stands between innovation and accessibility. 

The process of patenting is aimed at giving a boost to research and development and securing long-lasting health facilities for the public good at large. If we want to work towards making healthcare more affordable, we need a   more rapid process for approval of generic drugs and make them readily accessible and affordable to the public. On the other hand, it is of paramount importance for pharmaceutical companies to secure their products to recover their investments, gain profits, and re-invest for further research and development.

Effective incentives to innovate, if given to the producers, can lead to global improvements in access to affordable medicine; only if the intellectual property system is modified to accommodate such measures. The required balance between equitable distribution and economic assurance for pharmaceutical companies can be achieved through compulsory licensing or any other alternative mechanisms facilitating global access to drugs.

Therefore, making patents attractive and functioning as a fundamental incentive for innovative activities in the pharmaceuticals and biotechnology industry is essential. This article aims to promote and highlight how pharmaceutical products can be patented keeping in mind accessibility and affordability.    

Concerns about hijacking patent benefits

Historically, thinkers like Adrian Johns campaigned strongly against protecting intellectual property, almost abolishing patents. Patents were viewed as a restrictive instrument by the laissez-faire perpetrators that obstructed the free and easy flow of essential medicines and drugs. Concerns raised were particularly towards the developing nations who were unable to afford the exclusive stock of expensively produced pharmaceutical products.[1]

The process of patenting and guidelines surrounding patents are still eyed suspiciously. This is because some drug companies attempt to patent features by repetition, misdirection or by ways of repackaging partially the existing inventions in further patents. These malpractices are termed “patent thickets”. They remove competition by discouraging competitors from entering a market due to a lack of economic incentive and fair treatment. To deter these tactics, agreements to reveal probable patents promptly so that generic or biosimilar drug developers can cut through pharmaceutical patent thickets faster will be useful.

The TRIPS agreement allows members to authorize the use by third parties through compulsory licensing or for public non-commercial purposes without the authorization of the patent owner. These grounds on which licenses can be granted are not prescribed by the Agreement, but they contain several conditions that must be met to safeguard the legitimate interests of the patent owner.[2]

Transition of Patents – An Equitable Distribution Tool

There were many steps taken and suggestions made towards safeguarding the interests of the manufacturers and producers while making pharmaceutical patents more accessible and directing them toward needed use.

The ministerial conference of the World Trade Organization adopted ‘The Doha Declaration on TRIPS and Public Health’[3] and an early 21st-century discussion on the accessibility of medicines. It provided a mid-way compromise-style mechanism for compulsory licensing to supply medicines to countries with insufficient or no manufacturing capacities. 

Nobel Prize-winning scientist Sir John Sulston called for an international biomedical treaty to clear up issues over patents.[4] After this, a review was published, that less than 5% of medicines on the World Health Organization’s list of essential drugs were patented and the pharmaceutical industry had injected up to $2 billion in developing countries and has used differential pricing and easy accessibility for the underprivileged to avail pharmaceutical medicines.

Quoting a World Health Organization report, Trevor Jones (director at Wellcome Foundation 2006) argued in 2006 that patent monopolies do not create monopoly pricing. He argued that the companies given monopolies “set prices largely on the willingness/ability to pay, also taking into account the country, disease and regulation” instead of receiving competition from legalized generics.[5]

The Scottish IP scholar Boyle described the ‘promise of patent’ as a decentralized system that allows innovation through individuals and firms being able to satisfy a multitude of human needs.[6]

Advancements in medical patents and innovations within healthcare enhance the standard and provision of medical services while also elevating the quality of life for countless individuals globally. Innovations should be for serving humanity, especially in the field of medicine and patents should not have only one objective to amass profit and monopoly. 

Making Pharmaceutical Patents Attractive

The patient versus patent issue is the bane of our modern healthcare system. It can be understood that there remain certain concerns regarding free flow and easy accessibility of patents. For this, “innovative ways to secure innovations,” help in reinstating companies and people’s faith in the process of pharmaceutical patenting. Some of the existing measures facilitating affordable access to medicines and generic drugs are:

1. The Bolar Exemption

The bolar provision provides an exemption to use patented inventions for private, non-commercial use, or to promote research or experimentation.

The concept of bolar exemption originated back in 1984 in a case between Roche Products INC. v/s Bolar Pharmaceutical Co. before the Federal Circuit, USA[7]. Bolar employed a Roche-patented chemical in their experiments, seeking to assess the bioequivalence of their product to create a generic version of the patented product for specific research and development, which relied on an already patented product.

Developing a product from the lab and then filing for a patent is a very prolonged process, while the exemption acts as a stepping stone towards speedy regulatory approvals after the submission of required data.

Similarly, the UKIPO, back in the decade, amended the Act to include an exemption from patent infringement for activities involved in preparing or running clinical or field trials that use innovative drugs by complying with simple regulatory requirements such as authorizations.[8] The USA too followed this practice, especially the state laws mandating or encouraging the substitution of generic drugs for their brand-name equivalents to help lower drug prices.[9]

This exemption gives due consideration to the fact that developing countries might not have the resources to invest in research and development from scratch and allowing them to take up existing research and clinical trial results will help them develop cheaper and more sustainable alternatives. Further, the production and distribution too, will be according to their country’s economic needs. 

• Compulsory Licensing

The developing countries largely depend on generic drugs and do not focus on innovating from scratch. They prefer getting compulsory licenses for generic drugs rather than funding the research & development separately, which is often a very costly thing.

Compulsory licensing will increase the number of companies producing generic medicines.

As a result, the supply will increase, leading to reduced costs. Additionally, this will compel innovator nations to implement varying pricing strategies for their patented products in order to maintain their presence in the market.

This solution seems a promise for underdeveloped countries, especially after disastrous pandemics in the history of mankind. However, the big pharmaceutical companies do not want the compulsory licenses to be passed because it takes a lot of money and effort to create the drugs, which they invest from the start despite the potential risks. They must recover the costs of the innovation to not only make profits but also sustain and invest in further research. To avoid the possibility of issuance of a compulsory license for their product, companies must fix the cost of their patented module according to the economic status of the country to make the medicine as it is accessible.

• Medicine Patent Pool

The most recent and popular way to open access to new medicines is ‘patent pools’.

The Medicine Patent Pool will spread access to medicines and treatment by bringing medicines prices down, facilitating competition, developing of better-adapted formulations and needed fixed-dose combinations.

Through its innovative business model, MPP partners with governments, international organisations, and other stakeholders to create a mass platform of an accessible drug database. To date, Medicine Patent Pool has signed agreements with 18 patent holders for 14 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a cancer treatment, four long-acting technologies, three oral antiviral treatments for COVID-19 and 15 COVID-19 technologies.[10]

Conclusion

Intellectual property, especially pharmaceutical patents are at the base of increasing life expectancy, quality of life, and betterment of society. Medical patents and innovations in health care improve the quality and delivery of medical care and the quality of life for millions of people around the world. Innovations should be for serving humanity, especially in the field of medicine and patents should not have only one objective to amass profit. 

These inventions are to be protected, not to restrict their access but to have smooth distribution of the medicines while maintaining a standard quality. Patents encourage and provide necessary funds to the patentees to research and improvise the current invention.

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[1] Pettitt, Clare, 2013, ADRIAN JOHNS. Piracy: The Intellectual Property Wars from Gutenberg to Gates

VL. 118, The American Historical Review.

[2] Wto.org. (2016). WTO | Intellectual property (TRIPS) and pharmaceuticals – technical note. [online] Available at: https://www.wto.org/english/tratop_e/trips_e/pharma_ato186_e.htm.

[3] , Doha declarations (World Trade Organization 2002)

[4] https://imechanica.org/node/3455

[5] (Criticism of patents) <https://academic-accelerator.com/encyclopedia/criticism-of-patents> accessed 20 September 2023

[6] Boyle J. The Public Domain: Enclosing the Commons of the Mind. Yale University Press; 2008. Why Intellectual Property; pp. 5–6

[7] Dewan, R.K. and Dewan, C.-D.M. (2022). Bolar Provision in India. [online] Lexology. Available at: https://www.lexology.com/library/detail.aspx?g=2030e864-e0d0-4033-b7c7-aedfefbf755b#:~:text=Generally%2C%20the%20bolar%20provision%20or [Accessed 7 Jul. 2023

[8] https://www.legislation.gov.uk/uksi/2014/1997/pdfs/uksiod_20141997

[9] https://www.cbo.gov/publication/57126, https://doi.org/10.1002/hec.3796

[10] MPP. (n.d.). Home. [online] Available at: https://medicinespatentpool.org/.