Broadening the conversation on the TRIPS agreement: Access to medicines includes addressing access to medical devices

• Author: Hembadoon Iyortyer Oguanobi
• Date: 01 March 2018
• DOI: http://doi.org/10.1111/jwip.12091
• Published date: 01 March 2018

DOI: 10.1111/jwip.12091

ORIGINAL ARTICLE

Broadening the conversation on the TRIPS

agreement: Access to medicines includes

addressing access to medical devices

Hembadoon Iyortyer Oguanobi

Centre for Research on Educational and Community Services (CRECS), University of Ottawa, Ontario, Canada

Correspondence

Hembadoon I. Oguanobi, Centre for Research

on Educational and Community Services

(CRECS), University of Ottawa, 136 Jean

Jacques Lussier, Vanier Hall, Room 5002,

Ottawa, K1N 6N5 Ontario, Canada.

Email: hogua080@uottawa.ca

Patent laws determine access to medicines and medical

devices, and all members of the World Trade Organization

(WTO) are obligated to introduce minimum standards of

intellectual-property protection into their national patent

laws. In the negotiations that led up to the Trans-Pacific

Partnership Agreement (TPP), in 2016, the United States

attempted to introducepatents for diagnostic, therapeutic,

and surgical methods to promote the interests of its

pharmaceutical and medical-device industries. These at-

tempts were unsuccessful;however, these actions demon-

strate the determination of thosewho advocate for higher

standards of intellectual-property protection to push fora

TRIPS-plus agenda. The United States has sought to limit

the use offlexibilities in the TRIPS Agreement,including the

use of compulsory licenses which allows the generic

industry to produce cheaper pharmaceuticals. Despite

these US actions, many developingcountries are becoming

emboldened and are issuing compulsory licenses. The

position of this paper is to show that, while access to

pharmaceuticals and the ability to issue compulsory

licenses is crucial to administering proper health care to

people living in developing countries, medical devices are

equally essential. Therefore, the conversation around

access to medicinesshould be broadened to include access

to medical devices in developing countries.

© 2018 The Authors. The Journal of World Intellectual Property © 2018 John Wiley & Sons Ltd

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KEYWORDS

access to medical devices, access to medicines, organizations

and agreements, trans-pacific partnership agreement (TPP),

TRIPS Agreement

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BACKGROUND

The aim of this paper is to revisit the problem that developing countries faced in their quest to ensure access to

medicines under the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) Agreement in a post-

TRIPS era. The paper's focus is to ascertain whether the effects of the patent structures within the TRIPS Agreement

should be re-conceptualized to include medical devices and technologies. Medicines and medical devices are among

the foundations of human progress: they reduce morbidity and mortality and improve the quality of life for millions of

people around the world. However, gaps in access to both exist within and among nations. Patents grant innovators a

monopoly to sell their products without incurring competition from generic manufacturers for a set period. It also

allow inventors to charge high prices for medicines and medical devices; this, in turn, limits access for those who

cannot afford to pay for expensive medical products.

Patents are territorial and are issued by nations on a case-by-case basis. Before the TRIPS Agreement came into

being in 1995, some developing and developed countries exempted pharmaceutical products and processes from

being patented, regardless of whether they met the criteria of being novel, innovative, and nonobvious (Bhalla, 2013;

Brown, Yamey, & Wamala, 2014). The TRIPS Agreement changed that. Today, all member states of the WTO are

obligated to incorporate the TRIPS Agreement into their national patent laws, this includes providing patents for new

products and processes.

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According to Article 27 (1) of the TRIPS Agreement, pharmaceutical medicines fall within the

scope of patentable subject matters. However, under Article 27 (3), the same TRIPS Agreement excludes diagnostic,

therapeutic, and surgical methods for the treatment of humans and animals.

2

This dichotomy calls for discourses

around patents and their effects on pharmaceuticals and medical devices.

While the TRIPS Agreement and national patent laws on pharmaceutical products and processes are relatively

straightforward, the rules surrounding the patentability of medical devices are not (Gold, Kaplan, Orbinski,

Harland-Logan, & Sevil, 2010). For example, Josef Billie, who won the European Inventor of the Year Award in

2012, was granteda patent from the European Patent Office for a device that revolutionizedeye surgery (EPO, 2013).

The patent for Josef Billie'sinvention was granted, even though Article 53 of the EuropeanPatent Convention (EPC)

excludes the patenting ofmethods directed toward surgery, therapy, or diagnosis. The rationale for the exclusionof

patentsfor medical methods is that physicians requirethe freedom to use their knowledge and skills to provide the best

possiblecare for their patients,without having to worry aboutwhether or not a patent covers the use of a medicaldevice.

At the same time, theEPC allows inventors of medical devices to be rewardedin some exceptional cases. Such patents

depend on the technical detailsof the device, and the EPC decides on this on a case-by-case basis.

The granting of patents on medical devices is not a position that the majority of WTO members take. Over 80

countries prohibit the patenting of medical procedures (Rastogi, 2014). However, the United States and Australia

have taken a liberal approach to the patenting of medical devices and methods. And in recent years, the U.S. Patent

Office has issued more patents for medical devices than ever before. Between 2009 and 2014, the number of US

patents granted for medical devices rose from 7,443 to 19,992 (Phillips, 2015). Interestingly, in some instances US

case law has demonstrated a distaste for granting patents for medical procedures. In the case of Mayo Collaborative

Services v. Prometheus Laboratories Inc. (2012), the Supreme Court unanimously held that diagnostic testing was not

a subject matter that could be patented. Australia is perhaps the most liberal country in the world in terms of allowing

the patentability of medical treatments.

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Following the decision of the Australian High Court in Joos v. The

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