Overcoming Intellectual Property Monopolies in The COVID-19 Pandemic

MSF Briefing Document
July 2020
Overcoming intellectual property monopolies

in the COVID-19 pandemic
Médecins Sans Frontières (MSF) is responding to the global COVID-19 pandemic, providing treatment and care for
people with COVID-19, protecting people living in vulnerable conditions, and ensuring uninterrupted essential
health services for people suffering from other diseases. 1 Having universal access to existing and future tools for
treatment, diagnosis and prevention is critical.
MSF has repeatedly witnessed how exclusive rights and monopolies granted to pharmaceutical corporations,
resulting in high prices and blocking generic competition, have had a negative impact on our medical actions in
different countries.2 For example, in the past, high prices for patented medicines have undermined the capacity
of countries to provide access to treatment for HIV/AIDS, tuberculosis (TB), hepatitis C and cancer to all patients
who need them. However, the impact of intellectual property (IP) monopolies is not limited to drugs. The
availability of more affordable pneumococcal conjugate vaccine and human papillomavirus vaccine in low- and
middle-income countries has been delayed due to unmerited patents on key technologies blocking follow-on
producers. 3
Intellectual property monopolies in the COVID-19 pandemic

While several of the drugs being trialled as COVID-19 treatments are now off patent, patented drugs and
experimental drugs are also being trialled, and some of which are under patent protection in many developing
countries. 4 With control over the market as a result of patents or other exclusive rights, pharmaceutical companies
could determine how global production and supply chain are organised, who ultimately has access, who can
produce medicines and where they can be supplied. Furthermore, lack of access to know-how, data and IP can
impact technology dissemination and delay of scale-up of more affordable generic and biosimilar products.
Patent term extension and “evergreening”
Companies often apply for secondary patents on known medicines to seek new monopolies or prolong current
market control. This business strategy is known as “patent evergreening”. In some countries, patents could also
be granted on second medical use of a repurposed medicine. Given that many of candidate therapeutics for
COVID-19 are repurposed medicines, it is in the public interest of all countries to refrain from allowing “patent
evergreening” by restricting the grant of secondary patents on known medicines and excluding from patentability
second medical uses as being mere methods of medical treatment.
Issues of voluntary licensing
The terms and conditions of licensing agreements between pharmaceutical companies are often negotiated
confidentially and kept secret. These agreements may allow only a few generic companies to supply to a limited
number of low- and middle-income countries. 5 For example, pharmaceutical corporation Gilead Sciences, after
ignoring demands calling for non-enforcement of its patents on COVID-19 candidate drug remdesivir, 6 proceeded
to secretly sign voluntary licensing agreements with only a few manufacturers of its choosing from India, Pakistan
and Egypt. The voluntary licensing agreements excluded nearly half of the world’s population, including most
South American countries and many countries with manufacturing capacity, some of which have supported
COVID-19 treatment clinical trials. 7 Currently suffering from some of the highest infectious rates in the world,
thousands of patients in the 10 South American countries excluded from the license territory could potentially
benefit from remdesivir-based treatment. This dangerous precedent must alert governments that voluntary
actions of companies are not reliable.
1
Data and market exclusivity
Data exclusivity 8 prohibits regulatory agencies, within a fixed period of time, from registering generic or biosimilar
products even if they do not directly rely on the test data submitted by the originator company. Moreover, some
countries allow for data exclusivity for a new medical indication for an old repurposed medicine. Market
exclusivity associated with orphan drug status and other designations prevent any alternative producers from
supplying the concerned medicine for a certain period of time. Both data exclusivity and market exclusivity provide
additional monopoly power alongside already granted patents and can thus represent a barrier for access to and
scale-up of COVID-19 treatment.
Policy and legal actions to overcome patent barriers

To overcome these barriers of market dominance and access patented health technologies and products needed
for COVID- 19 treatment, diagnosis and prevention, countries can make use of a range of public health safeguards.
In particular, flexibilities are contained in the Agreements on Trade-related Intellectual Property Rights (TRIPS)
and the Doha Declaration on TRIPS and Public Health. Already some countries have taken a lead in recognising
COVID-19 as a public health emergency and have taken measures to overcome any future IP barriers.
Measures that can be adapted at national, regional and international levels include but are not limited to:
• Suspending the application and enforcement of patents and other IP on essential health technologies,
materials and products concerning COVID-19.
• Issuing compulsory licenses and government-use licenses to allow production, supply, importation and
exportation of patented products, materials and technologies, including exploring a regional approach
and adopting expedited procedures to allow fast-track compulsory licenses for all COVID-19 related
technologies.
• Applying strict patentability criteria by excluding from patentability second medical uses as being
methods of medical treatment and new forms and derivatives of known medicines.
• Suspending the application of data exclusivity, other market exclusivities and patent linkage (or
providing waivers if existing in national or regional regulations), to enable rapid regulatory approval of
generic and biosimilar products.
• Applying a ‘Bolar exemption’ 9 that allows alternate manufacturers to undertake development and seek
marketing and regulatory approval of generic and biosimilar versions of patented medicines even during
the patent term.
• Suspending certain obligations under bilateral or regional trade and investment agreements that may
constrain a country’s ability to issue a compulsory license, undermine strict patent examination criteria,
and facilitate data or other exclusivities on medicines.
• Stop all free trade agreement (FTA) negotiations during the pandemic. 10 If FTAs are negotiated,
restrictive IP provisions that could hinder timely and affordable access to medical technologies must be
excluded. Before engaging in bilateral FTA negotiations, it is important to assess the impact of the
restrictive IP provisions that are likely to be tabled on access to affordable medicines including for
COVID-19 treatment.
The global impact of the COVID-19 pandemic also presents challenges and limitations of relying only on national
strategies to ensure an effective global response. In this regard, countries should explore effective international
collaborations and binding agreements to facilitate open sharing and the right to use of technologies, know-how,
data, and global non-exclusive rights to use and produce COVID-19 medicines. In the event of the need to pool
technologies, data and intellectual property, mandatory measures and essential considerations including non-
exclusive and worldwide coverage should be adopted. 11
2
REFERENCES
1 MSF. Coronavirus COVID-19 pandemic. [Online]. 2020 [Cited 2020 May 11]. Available from: https://www.msf.org/covid-19
2MSF Access Campaign. Gilead’s tenofovir ‘access program’ for developing countries: a case of false promises? [Online]. 2006 Feb 6
[Cited 2020 May 11]. Available from: https://msfaccess.org/gileads-tenofovir-access-program-developing-countries-case-false-promises
3MSF Access Campaign, A fair shot for vaccine affordability: understanding and addressing the effects of patents on access to new
vaccines. [Online]. 2017 Sep [Cited 2020 July 16]. Available from: https://msfaccess.org/sites/default/files/2018-
06/VAC_report_A%20Fair%20Shot%20for%20Vaccine%20Affordability_ENG_2017.pdf
4MedsPal: the medicines patents and licenses database, Patent status of selected COVID-19 candidate drugs in low-and-middle-income
countries. [Online]. [Cited 2020 July 23]. Available from: https://www.medspal.org/?disease_areas%5B%5D=COVID-
19+(drug+candidate)&page=1
5MSF Access Campaign. MPP License Agreement with AbbVie for Glecaprevir/Pibrentasvir (G/P): Analysisand Recommendations.
[Online]. 2019 Mar [Cited 2020 May 11]. Available from: https://msfaccess.org/sites/default/files/2019-03/HCV_Brief_MPP-AbbVie-
Voluntary-License_2019.pdf
6MSF Access. Open letter: Civil society urges Gilead to take immediate action to ensure access to potential COVID-19 treatment. [Online].
2020 Mar 30 [Cited 2020 May 11]. Available from: https://msfaccess.org/open-letter-civil-societyurges-gilead-take-immediate-action-
ensure-access-potential-covid-19
7Gilead Sciences. Voluntary Licensing Agreements for Remdesivir. [Online]. [Cited 2020 May 15]. Available from:
https://www.gilead.com/purpose/advancing-global-health/covid-19/voluntary-licensing-agreements-for-remdesivir
8WHO. Briefing note: Access to medicines. [Online]. 2006 Mar [Cited 2020 July 16]. Available from:
http://origin.searo.who.int/entity/intellectual_property/trips-plus.pdf
9South Centre. Bolar exception: legislative model and drafting options. [Online]. [Cited 2020 July 20]. Available from:
https://www.southcentre.int/wp-content/uploads/2016/03/RP66_The-Bolar-Exception_EN1.pdf
10 Third World Network. Open letter to trade ministers and World Trade Organization. [Online]. [Cited 2020 July 20]. Available from:
https://www.twn.my/announcement/StopNegotiationsFocusOnSavingLives/Letter-StopNegotiationsFocusOnSavingLives%202020-04-
17.ENG.pdf
11MSF Access Campaign. Position paper on the sharing of technologies for COVID-19 to ensure equitable access for all. [Online]. [Cited
2020 July 20]. Available from: https://msfaccess.org/msf-access-campaign-position-paper-sharing-technologies-covid-19-ensure-
equitable-access-all

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MSF Briefing Document

Overcoming intellectual property monopolies

Intellectual property monopolies in the COVID-19 pandemic

Policy and legal actions to overcome patent barriers

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