AN OVERVIEW OF PATENTING

AMIDST COVID-19

By,

Ross Denny

rossdenny19@gmail.com

Ph No: 9645274813

https://www.linkedin.com/in/ross-denny-69329a54/

National University of Advanced Legal Studies (NUALS), Kochi

Submitted on 03/12/2021
 ABSTRACT

It is undoubted that the pandemic has disrupted human life. So, the effect of it in the
dominion of patenting is also paramount. This paper aims to collect the latest information
regarding the stand of patents in the current pandemic. It analyses the affect, the
contemporary issues and the prospective associations of it in the near future. A number of
annual reports from the IPO site of India and WIPO site has been taken as reference to back
the data provided in the paper. It is found that the pandemic has only positively affected the
numbers of patent applications and the grant of the same. The necessity of waiving of patent
rights is also closely looked into. A proposed solution is a method of open licensing. An
example of how the sole aim of pharmaceutical companies in manufacturing COVID related
medicines and methods should not be monetisation is also elaborated.

Keywords: COVID-19, pandemic, patent, vaccine, compulsory licensing

 INTRODUCTION

The main objective of patenting is to protect and preserve the rights to an invention that is a
result of rigorous research. The pandemic that has erupted and is still spreading, has given
scope for a number of inventions ranging from the strains of COVID-19 viruses to its
diagnostic methods. So much so that, India in the last 5 years has managed to go from the
81st position to the 48th position in the Global Innovation Index (GII)1. Considering the
enormous number of inventions and patent applications, exclusive rights to the invention and
its utilisation for the welfare of the public is of great importance. The pandemic is a time that
has immensely caused a widespread economic disruption. It has affected people from the
smallest of the street vendors to the largest of the companies. So, the effect of it in the realm
of patenting is undeniable. This paper will look deeply into the impact of COVID -19 in
patent regulations, patent filings and infringements.
How has COVID-19 affected patent filings?

It is safe to say that the intellectual property filings in India have not been negatively
impacted but has significantly increased especially in the realm of patenting. And considering
the ever-evolving pharmaceutical sector, it is no surprise that this sector has bagged the
greatest number of filings. Even in a situation of economic turmoil, the resilience of
innovation is showing a positive graph. Moreover, according to WIPO data, India is proud to
be the 8th largest country for IP filing activity as of the year 2020. Rendering to the DPIIT
data, there has been an increase of 2.9% of patent filings in the year 2020 when compared to
the same in the year 2019.

In the international Scenario, according to the data in World Intellectual Property Indicators
2021, India has been one of the main drivers of growth in the year 2020 with 3144 patent
filings.2 India has also seen a 5.9% growth in applications in the same year.

One could infer a number of reasons for this increase in filings. The pandemic disrupting the
system of physical courts has come out to be a boon for the prospective patent grants. This
has led to the emergence of electronic filing system and video conferencing for the hearings
which has in turn increased the pace of patent processing, examination and grant. The Patent
rules, 2003 that was amended in September 2019 also allows to transfer patent applications
from any branch to another.

Scope of patenting of COVID-related technologies

In the biomedical sciences, the law on what constitutes patented technology differs
significantly between countries. In some nations, a misunderstanding of what is protectable
may result in a loss of protection and money.

It is not feasible to patent ways of treating the human or animal body for Covid-related
inventions in the United Kingdom, Europe, or Canada. Inventions that can be patented in the
United Kingdom, Europe, and Canada includes:

• Drugs against COVID-19, its uses and effects

• The procedure for its manufacturing
• Sequencing of genes that helps in the generation of antibodies
 • COVID-19 testing methods and diagnostic devices

However, with the changing jurisdictions, there is a change in the patentability of the
invention too. For example, sequencing of genes extracted from a human body is patentable
in Canada but not in UK or Europe. Likewise, a diagnostic method performed on a patient
may be patentable in Canada but not in UK and Europe where the same performed on a
patient sample may be patented.

How has COVID-19 affected the limitation period of Patents?

In reference to the Supreme Court Order in March 2020, the Indian Patent Office had
extended the limitation period for all deadlines till March 2021 which was once again
extended in the wake of the 2 nd wave of COVID-19. The Office of the Controller General of
Patents Designs and Trademarks put out a notice that this extension will remain until there is
any further notice with respect to the same. However, this stands altered as in reference to the
Supreme Court order dated 23rd September, 2021, the extension for limitation period ended
on October 2nd and that the deadline that ran within this date automatically gets an extension
until January 1,2022 and the deadlines after the said date will operate as usual3.

Changes in the regulations of Patenting during pandemic

Working Statement: A working statement is the Patent office’s way of ensuring that a patent
granted is fully commercialised and utilised. A working statement is one that is filed every
year the failure of which will result in a penalty and the patent being easily gullible to
infringements and compulsory licenses. By the virtue of the Patent (Amendment) Rules,
2020, the working statement has to now be filed for financial years as opposed to calendar
years in the earlier regime which should be via Form 27. Also, the new form has deleted
certain components like the quantity of the patented product that is manufactured or imported
to India, the licenses and sub-licenses granted in the particular year etc.

Change in fee of small entity applicants: The small entity applicants are now considered at
par with a natural person or a start-up and thereby has to pay the same amount of fee only and
nothing more as was the case earlier.
Start-ups Intellectual Property Protection (SIPP): The SIPP scheme that was introduced for
the welfare of the start -ups was also extended for another 3 years i.e., up to March 2023.

Abolition of the Intellectual Property Appellate board: It is during the pandemic that the
Central government abolished IPAB via ‘The Tribunals Reforms (Rationalisation and
Conditions of Service) Ordinance, 2021’. The pending and the future case of IPAB would
now be under the jurisdiction of the respective High courts.

Flexibilities in TRIPS provisions in the wake of the pandemic

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is a

multilateral international regulation on Intellectual Property. One of the main changes in
regulations or relaxation of regulations due to COVID-19 can be seen in the case of TRIPS
agreement provisions.

Firstly, the aspect of compulsory licensing that is also present in the Indian Patent Act, 1970.
The TRIPS agreement allows compulsory licensing of medical technologies, vaccines,
diagnostics etc. under certain conditions without the authorization of the owner. In the light
of this, some countries have requested for compulsory licensing to their respective
governments and some countries have altered their own regulations to facilitate the same.
Earlier, according to Article 31(f), a compulsory licensing can be granted mainly for the
supply of the domestic market, but a waiver was granted with respect to this in the year 2003
which was later incorporated into the agreement as Article 30 bis (special compulsory
licensing). It was granted with a motive to facilitate import of medicine and other equipment
for countries who completely depend on importation of the same.

Further, under Article 73(b) of the TRIPS Agreement, a country can take the necessary steps
in an event of a national emergency. By virtue of this Article, India can take up steps like
suspending the patent protection to make a drug or a diagnostic method rather than wait for
the grant of a license.

Under Article 6 of the TRIPS agreement, India could also parallelly import the necessary
COVID-19 equipment from other countries.

Under Article 30 of the TRIPS agreement, two exceptions to Patent rights that are significant
in the pandemic era are the research and experimental use exception and the regulatory
review (or "Bolar") exception. The former one allows the use of a patented product or
procedure for the purposed of scientific experimentation. This exception exists so that the
researchers can work on the patented product to improve it without the fear of infringement.
The latter exception allows competing companies to use the patented product by obtaining
marketing approval for a prospective generic product.4

Additionally, by Article 27.3 of TRIPS, the member nations on their own discretion can
exclude patenting of “diagnostic, therapeutic and surgical method for the treatment of
humans and animals”

Patenting of Covid Vaccines

1. The case of compulsory licensing of COVID-19 vaccines

Ideally, the use of a patented product or process by a third person requires availing of a
license. Under certain circumstances the said consent from the patent owner is not necessary,
the government itself allows the patented product or process to be used. That is called
compulsory licensing. The concept being mentioned in the Indian Patent Act, 1970 and
TRIPS agreement has recognition both nationally as well as internationally. Compulsory
licensing in India was first granted in 2012 for the production of generic version of Bayer’s
Nexavar, an anti-cancer agent used in the treatment of liver and kidney cancer. Compulsory
licensing does not always have to be justified by an emergency. In fact, the TRIPS agreement
allows the partaking countries to decide the compulsory licensing mechanism for their own
country. However, it suggests that the patent owner be remunerated adequately irrespective
of the license being compulsory or not.

The pandemic has led to the strengthening of the compulsory license regime in most of the
countries since it is the only way one can make sure that even the most vulnerable population
receives adequate treatment, either by importing or production in the home country. Under
the Indian Patents Act, the government is allowed to grant a compulsory license in the event
of a national emergency or extreme emergency which corresponds to WHO declaring the
COVID-19 as a pandemic.

Gilead, a pharmaceutical company that has patented the anti-viral drug Remdesivir, has
issued voluntary licenses to 5 countries. What is impressionable is that the company has
agreed not to charge royalty unless the global health emergency issued by WHO ceases. This
way, both the company as well as the public is immensely benefitted.

In India, compulsory license is granted under section 84 of the Patent Act under certain pre
requisites such as the public not being accessible to the invention at an affordable price or the
invention is unsatisfactory. A compulsory license can only be granted after the expiry of 3
years from the date of grant of Patent. The same can also be granted by the controller under
section 92 of the said Act wherein the controller after much consideration of the following
questions:

• Nature of invention
• Ability of the applicant to fully utilise the invention.
• The public advantage generated by the said use of the applicant
• How long has it been since the patent elapsed?

There are also provisions under the Indian Patent Act to check on the commercial utility of
the said patent as well as the licenses granted thereby

However, one can see that a negotiation of voluntary license is way more practical than the
government granting a compulsory license since it is the very effort of the inventor and
withholding what they deserve will only degrade the incentive to future inventions.
Therefore, this privilege must be granted only judiciously. Nevertheless, compulsory
licensing has become a developing country’s hope to make accessible the treatment for
COVID-19 even to the most vulnerable. So, the government’s must analyse their situation
and fight the present pandemic by capturing a middle ground.

Currently, India has a stand of not granting compulsory license despite the Supreme Court
recommendation to do so. The reason given by the government for this was that the shortage
of vaccines was due to the non-availability of raw materials and thereby, granting additional
licenses for the same would not make a positive difference in the availability of vaccines.

2. Another way to go: Waiving of Patent rights of COVID vaccines and related
equipment

The disparity between rich countries and developing countries is evident in the respect of
manufacturing and accessibility to the vaccine. It is the rich countries that have the resources
for R&D and is undeniably ahead of the curve in manufacturing and patenting vaccines. It is
most obvious that each country’s leader wants their own people vaccinated first, but what is
not okay is the hoarding of the vaccines. After all, one must realise that unless and until the
whole of the planet is vaccinated, there is always a chance of emerging of new and more
dangerous strains. Thus, equitable access to COVID vaccine is the need of the hour.

And this is exactly why India and South Africa persuaded the fellow WTO member countries
to endorse the waiving of IP rights of all COVID related products and procedures for a
limited period of time. This will not only improve accessibility of COVID-19 vaccines but
also can accelerate the end of the pandemic.

Initiatives like COVAX has been introduced, the objective of which is to enable equity of
vaccines by vaccinating at least 20% of each country’s population, managing the access to
vaccines as soon as it is available, end the dreadful phase of the pandemic and thereby rebuild
economies.

Waiving of IPR right can not only be with respect to vaccines or products, but also research
and study about the virus, its variations, effects of medicine on it etc. This will undoubtedly
help further research and collectively will result in developing more effective vaccines and
medicines which will in turn help end the pandemic.

Over and above, a very good argument supporting the waiving of patent rights would be that
the system of patenting was designed with the objective of generating an incentive for
invention and is not equipped for handling an emergency situation like the pandemic that is
happening now. And therefore, appropriate concessions in the already existing system in such
a scenario cannot be done away with.

3. History of Vaccine Patents

The case of Polio Vaccine: Polio was a disease that caused Paralysis and was highly
contagious. The polio vaccine was not patented by its inventor, American physician Jonas
Salk. He refused patent right for this invention because the very research that led to the
invention of the Polio vaccine was funded by the American Public and he felt it only right
that the vaccine be easily accessible at a less cost as opposed to it being unaffordable if it was
protected by a patent.

The case of Meningitis Vaccine: Meningitis is the inflammation of the meninges which be
caused by a virus or a bacterium and can even lead to death in the most serious of cases. The
case of patenting of the Meningitis vaccine is different from that of the Polio vaccine. The
first vaccine for meningitis was discovered in the year 1978 and due to it being less effective,
another vaccine for the same disease was discovered and patented in the year 2005.
Subsequently in the year 2010, a similar but stronger one was patented. As of 2020, a
stronger and yet more improved vaccine MenQuadfi was discovered whose patent is pending.
One can observe here, the trend of improvement by each developed vaccine, one being more
advanced and effective than the other. Therefore, the possibility of this happening in case of
COVID-19 vaccines also cannot be disregarded. Also considering that, as time passes, the
world is seeing new and more dangerous variants of the COVID-19 virus, this aspect of
patenting vaccines could be beneficial.5

4. Prospective Solution

A prospective solution to address the issue of patenting of covid vaccines versus not
patenting covid vaccine issue could be by taking a middle ground by a method of imposing
certain restrictions on the rights of the patent holder. An example would be a method of
differential pricing i.e., allowing the patent holder to charge a higher price for the patented
product in countries with higher income as opposed to charging a lower price for the same
product in countries with lower income. The reason for the suggestion of this middle ground
is because, an instance of no patent rights at all will disincentivise the inventors. Them not
being able to commercialise at least the costs of R &D will further degrade the system of
patenting. Then the whole purpose of the Patenting system is defeated. At the same time a
rigid patent regime will lower the chances of the product or process being useful to the target
audience and thereby, a state of balance between the both is highly preferred.

Again, a method of open licensing used in the realm of technology can be applied in the case
of vaccines too. By this method, prospective developers will be able to manufacture the
vaccine and sell exclusively to the developing countries. By this, the inventor can monetise
on his/her invention while other developers can distribute the vaccines at a lower cost in
underdeveloped countries thereby increasing its accessibility.

The latest case of Molnupiravir

Molnupiravir is an antiviral drug that can be taken orally against COVID-19 and is currently
waiting US FDA approval. The drug works by a mechanism in which the components of the
drug make the virus cause errors while replicating its own DNA- a process requisite for the
multiplication of the virus. Disrupting this mechanism of multiplication of the virus will
inhibit its replication and thereby not increasing the count of virus in the host. Experts
suggest that the drug can also potentially interfere the replication of even the newest variant
of COVID-19 – Omicron.

The manufacturers of the drug- Merck, Ridgeback Biotherapeutics and Emory University
said that they would not receive royalties arising from the sales of the drug until WHO ceases
to classify COVID-19 as public health emergency of international concern.

The Medicines Patent Pool (MPP) entered into a voluntary licensing agreement with the
drug’s manufacturer- Merck or MSD for the purpose of supplying the drug in 105 low- and
middle-income countries including India. MPP is a UN backed organisation that has
previously been known to facilitate the sublicensing of patents closely related to the realm of
public health. By doing so, the generic manufacturers can sell lower cost generic versions of
the medicine.

It is clearly evident that the manufacturers in this case have taken an appropriate action by
rendering their social responsibility and can be considered as a role model for other COVID-
19 drug manufacturing companies.

How has pandemic affected patent infringements and filing of suits?

The filing of IP infringement suits in Delhi and Mumbai has maintained its growth. As of the
year 2020, the High Court of Delhi has seen around 299 infringement suits in the different
branches of intellectual property rights being trademarks, patents, copyrights and designs.
Out of that, the Court has also granted injunction in around 65% of the cases. The High Court
of Delhi Rules Governing Patent Suits, 2020 (Rules) aims to bring about uniformity in the
filing of patent suits pertaining to infringement under Section 48 of the Patents Act, 1970,
declaration of non-infringement by virtue of Section 105 of the Act, relief for groundless
claims of infringement as under Section 106 of the Act and as under Section 64 of the Act,
the counterclaim w.r.t to revocation of the patent.

Patenting before and after pandemic

A notable shift during the covid era as opposed to pre covid era was the concept of video
conference hearings. The use of online platforms that has enabled this for hearing of cases
poses a potential threat of misuse and contempt of court. Therefore, on exercising its power
under Article 226 and 227, the Delhi High Court established “High Court of Delhi Rules for
Video Conferencing for Courts 2020”. The rules are not only applicable to the Delhi HC but
also other sub courts and tribunals. All the courtesies that were followed in physical courts
are followed for online hearing as well. Interrogation of witnesses, creation of reports during
questioning and the advanced accessibility of the whole legal record for preliminary have
been worked with via said rules. The principles also require the presence of a coordinator
appointed by the court at the location of the witness. The obligation of the co-ordinator is to
get the computerized legal record, guarantee compliance with the standards and make sure of
a fair conduct of hearing. The Code of Civil Procedure, the Criminal Procedure Code, the
Indian Evidence Act and the Information Technology Act, 2000 – apply to hearings directed
through videoconferencing as much as they apply to the original proceedings.

One can also see that a large number of manufacturers have found a market for Covid
equipment like masks, sanitisers, PPE etc. Even companies who do not specialise in the
production of such equipment were seen manufacturing and selling them. One such example
is of the textile industry who has adjusted with the need of the hour and also monetised from
the same.

To deal with the present epidemic, to help avoid the next one, and to respond to changes in
consumer behaviour and company practices owing to travel limitations and social distancing,
new technology is being created and deployed at a rapid pace. Scientists and engineers are
developing solutions to address these needs, and advancements in a wide range of other
technologies are also probable, simply because contemporary circumstances provide
inventors more time to create. Some concepts will be new, no obvious, and valuable, but they
will require extensive testing and development, which frequently necessitates the assistance
of investors and commercial partners. Patents allow for exclusive rights and licensing, which
encourages innovation and entrance of new business partners.

Why Are Patents Important in A Post-COVID World?

During the lockdown, all businesses had to be digitalized to a more prominent degree than
they were before the pandemic. Indeed, even in the most far off activities, this guaranteed a
positive outcome. This happened at such a fast speed that they fundamentally rushed the
digitalisation of businesses. The public may not know about every one of the technological
developments that have empowered the shift to remote working, yet they are a lot present.

The individuals who are responsible for such demonstrations of unique advancement and
creation are, obviously, legitimately approved to seek after any IP privileges that might be
accessible. A patent application is, as a general requirement for any creator. Not being able to
apply ang acquire a patent grant poses a number of threats to any potential patent proprietor
to bear, including mass duplication and the degrading of market potential

The COVID-19 epidemic highlighted the world's relative vulnerability even further.
Countries like New Zealand, Vietnam, and Cuba, have been successful in analysing and
acting accordingly thereby reducing the number of cases. However, it is difficult to determine
whether any nation was truly prepared, particularly given the pandemic's tremendous
economic impact.

Current global issues pertaining to climate change and globalization will along with
pandemic, continue to have a long-term impact. These events, particularly the first,
necessitate ingenuity in the same way as COVID-19 does. The following patentable
development is probably not going to be the way to tackling hazardous carbon emissions or
relieving a lethal illness, however it could pave a way for different thoughts that draw us
nearer to answers for these worldwide issues.

As a result, one can only imagine how crucial it is for every inventor in every industry to
continue developing and expanding their patent portfolio. Though supply-chain constraints
may make it more difficult to develop new products, the COVID-19 situation does not appear
to have had a significant detrimental influence on creativity

IP Awareness Programmes during pandemic

India’s Department for Promotion of Industry and Internal Trade (DPIIT) under its wings has
established Cell for IPR Promotion and Management (CIPAM) with the aims of furthering
IPR awareness, rationalizing IPR processes, commercialisation and enforcement. CIPAM has
been successful in conducting 100 IPR awareness programmes in schools and colleges in the
FY 2020-20216. Additionally, there has also been efforts to institute IPR cells in colleges and
Universities. Likewise, IPR has even held a place in NCERT’s curriculum in the year 2021.
 CONCLUSION

According to government data, there are around 134 million beneficiaries who are yet to get
the second dose of vaccines and the time period for it is lapsed. This is due to many reasons
ranging from accessibility to affordability. In such a situation the efficiency of the vaccine
also comes to question. One of the current issues is that the virus generates its variants at a
faster rate than COVID vaccines reaching the remotest of the areas. The pandemic is a
competition between the humanity and the COVID-19 virus and not a race between
companies to commercialise the situation. And as WHO stated, nobody wins the race until
everybody wins and therefore this is to be seen as an opportunity for countries to come
together and fight COVID-19 not individually but collectively.
1
Soumitra Dutta, Bruno Lanvin, Sacha Wunsch-Vincent, GLOBAL INNOVATION INDEX 2020 Who Will Finance
Innovation?, Cornell SC Johnson [ii], [xxiii] 2020.
2
World Intellectual Property Office, https://www.wipo.int/edocs/pubdocs/en/wipo_pub_941_2021.pdf (last visited Dec. 3,
2021)
3
Suo Motu Writ Petition (Civil) No. 3 of 2020, (2021) 13654/2021/O/O CGPDTM.
4
World Trade Organization, https://www.wto.org/english/tratop_e/covid19_e/trade_related_ip_measure_e.htm (last visited
Dec. 3, 2021).
5
ZOË HAGGERTY, PATENTABILITY OF COVID-19 VACCINES, BC IPTF [2], [3] 2021.
6
Department for Promotion of Industry and Internal Trade, Ministry of Commerce and Industry, Government of India,
https://dpiit.gov.in/sites/default/files/annualReport-English2020-21.pdf (last visited Dec. 3, 2021).