Lives have moved ahead a million squares in the time span of a few decades.
Advancement of Science and Technology revealed a new world to the world. Even
though progress in all spheres has greatly improved quality of human life,
certain outcomes have been undesirable. In a race to provide a set rules and
laws for every kind of issue the society could ever face, the lawmaker forgot
who is to be benefitted.
This project, as the topic suggests, deals with the Pharmaceutical patenting.
With uncountable creative brains come infinite innovations, which leads to
patents for each of them. Talking about the Indian situation in terms of
healthcare, prior to the 1960s, over 85% medicine was imported from other
In 1970, the Patent Act provided for patent on process, and that immensely
helped India to provide cheaper healthcare, as the Indian companies could
reproduce them. This position, however, did not stay for long, and the TRIPS
agreement provided for a patent to the product as well, along with process.
Currently, any company that gets a patent for their product and process, has the
power to dominate the healthcare business and exploit the market. So, through
this project, the author wishes to understand whether a patent can be granted to
all medicines, if this is the case, then would be its effect on the free
healthcare services and if a patent can be denied, what would be the grounds for
Furthermore, with the COVID era, and the vaccination for the same, new questions
have surfaced. Since only a few countries have been able to successfully
manufacture a efficient and effective vaccine for the coronavirus, can the
companies get a patent on the same, considering COVID-19 is a Pandemic which has
claimed over 2 millions lives, shouldn't there be any provision to keep the
exploitation of market in check, so that the world can fight with a critical
issue at hand, instead of ignoring those who can't afford the vaccine.
- To understand how the Indian patent regime (pharmaceutical patents) is
in conflict with international regimes.
- To understand the subjectivity involved and the law with respect to
granting of compulsory license and issues affecting public health at large.
- To understand what could be the possible effect on COVID vaccines with
regards to patent.
Scope & Limitation
- How right to the health of the public has been affected by the
pharmaceuticals patent regime in India?
- What is the change in trend regarding pharmaceutical patents and in
- How can Pharmaceuticals Innovations and India's Demand for Drug be
- What is the impact of patents on the economic growth of India?
- What are the provisions in place for patenting of vaccines for a disease
spread worldwide? Suggestions as to what could be the right way forward in
such crucial times.
The authors have limited their scope with respect to jurisdiction to India. With
respect to subject area authors have limited their scope to Patent Law
The present study is essentially doctrinal study; research undertaken is
descriptive in nature with an analytical approach to the topic. Only secondary
data has been used for examining the purpose of the research.
The Middle Path To Fundamental Right To Health And Pharmaceutical Patent
The recent time has witnessed the boom in commercialisation of pharmaceuticals
which had ultimately leaded the corporations to get the product patented. The
boom has lead to the invention of novel verities of drugs which are used to cure
many medical infirmities that were earlier almost incurable. In a layman term if
we try to understand this we can say that it is a boon to mankind but as the
saying goes on that every good thing comes at a cost.
When a pharmaceutical company comes up with any drug the first thing it does is
to seek protection for its invention so that other rival companies do not copy
the same thing. These companies try to get protection under Intellectual
Property Law; more precisely they try to get patent over that product.
Talking about the present time patent can be considered as the most used as well
as abused kind of Intellectual property. On one hand patents can be considered a
reward for the creativity and hard work and work as a encouragement but on the
other hand they may also lead to abuse by the patent holder. It sometimes
leads to monopoly. When a company gets patent over a drug it in a way gets the
authority to regulate the price of that particular drug.
So, if the price of any drug is kept very high only few people will be in
position to get access to that particular drug than what about common mass, how
will they get access to those drugs. Our constitution guarantees right to health
as fundamental right under Article 21 of the Indian constitution. In this
chapter we will discuss that how a balance is to be drawn between fundamental
right and pharmaceutical patent so that there is no conflict of interest between
the any concerned parties.
The Dynamics Of Right To HealthIndian constitution came into force in 1950. Back then there was only
anticipation on induction of new ideas to the constitution which stands
absolutely true. Right to health is nowhere directly mentioned in our
constitution but through the course of judicial developments now it can be said
that right to health is the part of Article 21 which states that "No person
shall be deprived of his life or personal liberty except according to procedure
established by law".
The "Indian Supreme Court has interpreted the
constitutional right to life as requiring the State to provide timely medical
treatment to preserve human life" and as "including a right to the protection
of health at work and freedom from sexual harassment".
substantive dimensions of the right to life and liberalizing standing
requirements so that any member of the public may seek redress for a legal wrong
in the public interest, the Indian judiciary has created a uniquely hospitable
litigation culture for pursuing legal claims to the right to health. The right
to health also has an important place within international law."
Court in the case of All India drug action network v. Union of India held that
the government should take steps in order to facilitate its citizens with
As per Ayyaangar committee report, there is a high risk factor involved when it
comes to granting of patents in countries like India. The patents confer
monopolistic rights which in a way are against the interest of majority of
population which is poor. This will be against the notion of access to
medicines. The report also stated that any policy which has character of
granting monopoly right is violative of preamble and also the Article 21 of our
Pharmaceutical Patents Post TRIPSWhen TRIPS regulation came into force it worked as an encouragement for the
private players in the market but the situation was different prior to TRIPS
agreement. The patents Act, 1970 was much poorer friendly as it only granted
patent on the process and not on the product.
This was also one of the reasons
of development of more generic drug at that point of time. "The domestic players
were granted a rapid boost to reproduce and market the newly invented drugs in
the Indian market by merely changing the process of production. With such
prevailing circumstances, Indian pharmaceutical managed to produce drugs at
lower price, thus making the drugs available for the poor sections of
This situation did not prevailed for much longer time. The member countries of
WTO were compulsorily made to implement the TRIPS regulations (the maximum time
limit within which these regulations were to be implemented was different for
developed and developing countries).
Indian in the initial stage did not
implemented the regulations, it was only implemented after US made a complaint
against India that:
"It was not implementing the TRIPS properly by not providing
an appropriate procedure for the filing of patent application and secondly, by
not providing the exclusive marketing rights." As a result, India finally
changed its patent law in the year 2005.
We can easily conclude from the above discussion that the pre TRIPS era of
patent granting in the field of pharmaceuticals was less stringent as the other
company was allowed to manufacture the same drug with different process which
ultimately lead to less monopoly over the market thus in a way price was within
reach of poorer section of the society but the post TRIPS era has lead to
different situation all together.
Characteristics Of Right To Health Under Present Patent Regime TRIPS cannot be considered very stringent regulation in Toto. Few of its
clauses reflect a bit liberal approach towards the developing countries.
Some of the articles are given below:
Article 7 of TRIPS balances innovation and social and economic welfare. It
states that "The protection and enforcement of intellectual property rights
should contribute to the promotion of technological innovation and to the
transfer and dissemination of technology, to the mutual advantage of producers
and users of technological knowledge and in a manner conducive to social and
economic welfare, and to a balance of rights and obligations".
Article 8 provides that "Members may, in formulating or amending their laws and
regulations, adopt measures necessary to protect public heatlh and nutrition,
and promote the public interest in sectors of vital importance to their
socio-economic and technological development, provided that such measures are
consistent with the provisions of this Agreement."
Article 27(2) states that "Members may exclude from patentability inventions,
the prevention within their territory of the commercial exploitation of which is
necessary to protect ordre public or morality, including to protect human,
animal or plant life or health or to avoid serious prejudice to the environment,
provided that such exclusion is not made merely because the exploitation is
prohibited by their law."
Article 30 of Trips provides that "Members may provide limited exceptions to the
exclusive rights conferred by a patent, provided that such exceptions do not
unreasonably conflict with a normal exploitation of the patent and do not
unreasonably prejudice the legitimate interests of the patent owner, taking
account of the legitimate interests of third parties."
On one hand post TRIPS patent regime provided for granting of patents not only
to the process but also to the product and on the other hand the provisions
which are mentioned above provided a kind of flexibility to the country while
granting patents. Although, these provisions provide certain flexibilities
various countries faced consistent difficulties in interpreting it. To overcome
this problem Doha Ministerial Declaration was held on 14 November 2011.
members laid emphasis on implantation and interpretation of TRIPS agreement in a
way so as to promote the cause of access to medicines by all and that to without
hampering research and new developments. All the member countries were pressing
the motion of interpreting the rules of agreement as per their socio-economic
Doha Declaration affirmed that "public health took precedence over private
patent rights, and reaffirmed the rights of Governments to use inbuilt WTO
public health safeguards and other available measures to gain access to cheap
medicines". "The Declaration makes it clear that the Trips agreement's
provisions on exhaustion in effect, leave each member free to establish its own
regime without challenge but subject to the general TRIPS provisions prohibiting
discrimination on the basis of a person's nationality"
Merck Sharp and Dohme Corporation And anr v GlenmarkThe parent Sitagliptin patent was granted to Merck and Marck had licensed the
drug for retailing in India to Sun Pharmaceuticals pvt ltd.
However, An application for Phosphate salt of Sitagliptin was filed by Merck but
it was not able to fulfil the criteria for patentability and thus, was rejected
by the Patent Office. Subsequently, The plan to apply for the patent of
Phosphate salt in India was deserted by Merck. Glenmark took the advantage of
the situation of Merck and applied for a patent for the phosphate salt of
Sitaglintin under the name of Zita and Zitamet.
They wanted a 'safe harbour' for
the use of their drug in the lines with Januvia. Although, Merck has been given
Indian patent application number but the same was abandoned by Merck, the
hon'ble court of delhi while not going into merits of the suit held that this is
not a prima facie infringement of any right of Merck as the application is
pending before the patent office.
Hoffman - La Roche Ltd v. Cipla Ltd An application for patent of drug named Tarceva, which was derived from Erlotnib
was filed by Roche and Pfizer. This drug was meant for the treatment of cancer.
This drug got patented in India and was granted recognition by India
authorities. In the meantime Cipla limited announced the manufacturing of same
rug with the name Erlocip. Plaintiff filed a suit of injunction and claimed
infringement. Cipla argued that their action is in favour of public interest as
the drug in question was life saving drug.
The court denied the injunction petition, citing "the irreparable injury to the
public interest that would occur by granting the order. Significantly, the court
noted that stopping Cipla's generic production of erlotonib may lead to the
shortening of lives of several unknown persons who are not parties tothe suit.
This represents an important extension of the reasoning in Novartis AG: not only
may courts factor in the right to health in resolving patent disputes, but they
also may extrapolate from the parties' concrete harms to the more amorphous
right to health injuries that could flow to the public at large".
Bayer Corporation v. Union of India Bayer and Cipla came into conflict when Bayer challenged attempt of Cipla to get
approval from DCGI for a generic version of a drug patented by Bayer by the name
of Nexavar. This drug is used for treating liver and kidney cancer. Bayer
constantly argued that if approval is given to Cipla it will ruin the patent
granted to it. Bayer also stated that patent linkage is necessary for the
fulfilment of the purpose of patents act.
The basically relied on section 48 of
patents act 2005. Cipla on the other hand relied heavily upon the Novartis case
and argued that this would amount to creation of unwanted impediments for
generic competition and derogate public interest and welfare.
The court rejected Bayer's argument for patent linkage, holding that "linking
the regulatory and patent regimes would undermine TRIPS's Bolar early-working
exception, stifle innovation and shirk addressing India's public health
challenges. It noted that granting marketing approval for development of a drug
does not ipso facto amount to a violation of the patent holders rights to make,
use, exercise, sell or distribute his invention in India. Rather, the patent
holder must formally allege and prove such an infringement before a court of
The court adopted judicially modest posture, deferring to the legislature
to link the regulatory and patent regimes. In deciding the case on these
grounds, the court implicitly endorsed the importance of India's generic drug
industry as an instrument for remedying India's public health challenges.
Indeed, had the court sided with Bayer, it would have theoretically exposed
every Indian generic drug manufacturer to potential liability for any research
and experimentation it conducted on a name-brand drug still under patent.
likely would have had an immense chilling effect on India's dynamic generic drug
industry, discouraging early experimentation with patented drugs and stalling
the release of affordable generic replacements for otherwise unaffordable
essential medicines. Because foreclosing future experimentation with patented
drugs by generic manufacturers would exacerbate public health challenges, and by
extension, undermine the right to health, the court dismissed Bayer's claim and
reinforced the wall between India's regulatory and patent systems".
Development Of Pharmaceutical Patents: Judicial Trend
There has been an on-going effort by majority of Nations as well as by
International Organizations to be able to provide uniformity to Legislations all
over the world, with respect to the Intellectual Property laws. Though, the
hustle is in good faith, it has attracted criticism over the fact that
pharmaceutical patents have been made a priority while unifying the framework.
It is so because the Pharmaceutical companies of the Developed countries have a
upper hand over developing nations, with no capital or infrastructure to develop
their pharmaceutical industry.
Prior to becoming WTO's member, India had no laws with respect to pharmaceutical
patents, and its position was undecided. Patent rights were first recognized in
1856. Later, India became a signatory country to the Paris Convention for the
protection of industrial property, 1883 and also, The Patent Co-operation Treaty
of 1970, following which India introduced the patent Act, 1970.
With regards to pharmaceutical patent, the Patent Act, 1970, provided for
patenting the process of manufacture of drug, and not the drug itself. This was
not the position under the Patent and Design Act, 1911, but was later changed in
the above-mentioned statute to cut India's dependency on imported drugs.
The lack of Pharmaceutical patent led to widespread reverse engineering of drugs
which were patentable/patented around the globe, but not in India, aiding the
growth of the industry.. This helped in manufacturing of cheaper alternative to
domestically patented drugs and also, internationally patented drugs (once the
patent expired). This greatly helped India in establishing its place on the
TRIPS as rolled out by WTO, received a major backlash from developing countries,
including India, but as it was required for member countries to accept and
follow the Agreement, India incorporated the provisions into its Legal
Framework. To protect the Later, as according to the TRIPS agreement, India made
amendments in the Patent Act, 1970, over the years. The Trade-Related aspects of
IPR Agreement, sets a minimum standard for protection of IP. The final amendment
to the Patent Act in 2005 marked a new era for India' patent regime.
The Evolution of Intellectual property law can be divided into three phases:
firstly, 1999, when India instituted "mailbox" as per the requirement of Article
70.9, which enabled applications for patenting of pharmaceutical/agricultural
products. Secondly, 2002, which extended patent validity duration to 20 years so
as to be in sync with the requirement of TRIPS agreement. Lastly, India
conformed to TRIPS entirely and provided complete protection to pharmaceutical
products, by abolishing its previous "process" patent and accepting the Western
concept of "product" patent.
The 2005 Amendment raised serious concern regarding the affordability of the
essential drugs as reverse engineering was illegalized and copycat-drug making
companies were made to pay royalty to patent-holder. Furthermore, it also
introduce the system of Compulsory licensing for exporting of pharmaceutical
drugs to least developed countries.
Compulsory Licensing is a procedure through which, any company, agency or person
can use or manufacture a patented product without taking the consent from the
patent-holder. The license can be gained by filing an application to the
Controller, under Section 84(1) of the Amended Patent Act of 2005, after 3 years
from the grant of a patent.
"Compulsory licence shall be available for manufacture and export of patented
pharmaceutical products to any country having insufficient or no manufacturing
capacity in the pharmaceutical sector for the concerned product to address
public health problems, provided compulsory licence has been granted by such
country or such country has, by notification or otherwise, allowed importation
of the patented pharmaceutical products from India."
Certain requisites are taken into due consideration while assessing the
application, such as the capability of the applicant, the invention and the
reasonability of the patent granted to the product.
Novartis v. Union of India
Post 2005, when amendment in the Patent Act, 1970 was introduced to comply with
the TRIPS agreement, Pharmaceutical Industry went through a critical period
trying to adapt to this change and understand how much it affects the healthcare
Novartis, one such pharmaceutical company raised the issue of what is patentable
and to what degree an MNC can Get protection in the new patent regime. Novartis
wished to manufacture a drug against cancer, which would make use of
"imatinibmesylate" (glivec). It claimed that the molecule of the substance thus
forms a drug which was already patented and protected. Novartis filed for a
patent for the drug it wanted to produce as per the Indian requirement.
The case was taken up to the Madras Patent office, which rejected the
application citing the reason that requirements under Section 3(d) were not
fulfilled, furthermore, the modification was not patentable as it lacked
"inventiveness". Novartis appealed against the decision in Madras HC and
altogether challenged the validity of Section 3(d) stating that the section was
discriminatory in nature and thus, violated Article 14 of the Constituted and it
was not even in consonance with the TRIPS Agreement.
High Court upheld the decision of the Patent Office and rejected the appeal,
following which Novartis appealed in the Supreme Court of India. The contention
of Novartis was that since 'glivec' is a the only substance administered in
Cancer drugs, and is a life-saving drug, which must not be put under purview of
Section 3(d), as it would make the medicine non-affordable.
The Supreme Court, however, rejected the contention of Novartis and upheld the
constitutional validity of Section 3(d). The Hon'ble court agreed with the
Patent Office that the application lacked "inventiveness" and held that
'therapeutic efficacy' must be interpreted strictly.
Section 3(d) has helped in prevention of 'ever-greening', which would have
resulted in high prices of drug due to monopoly, which in turn would have made
India's healthcare non-affordable. Thus, the strict patent protection regime is
Pharmaceutical Patent And Indian Healthcare System: Creating A Balanced Framework
In a bid to balance the need of Pharmaceutical MNCs to be have well protected
product patents and India's healthcare system which caters to a diverse
population made majorly of people below poverty line, it has been a constant
Up until 2005, the laws were lenient and allowed for copycat products,
which did help in flourishing India's Pharmaceutical industry, but the same
won't be feasible today as the developed market demands protection to their
products as well. It is however not the case as India amended its Patent Laws in
2005 to allow for TRIPS agreement provisions to be complied with.
Outside pharma organizations presently face a deluge of disincentives in
carrying imaginative medications and speculations to India. Innovative work
costs for making new medications are excessively high. Clinical preliminaries
testing the medication's security and adequacy-which contending generics makers
can "free ride" on for administrative endorsement of their own medication
items-require huge speculations.
These significant expenses, related to the
on-going string of lawful disincentives, could well overall and smother
advancement and drive pharmaceutical MNCs for all time away from the Indian
market. Considering in thorough challenge from generics makers, pharmaceutical
organizations can't recoup Innovative work costs 
As per the chief general of the Organization of Pharmaceutical Producers of
India, an exchange bunch that speaks to major global medication organizations,
the Indian government's strategies "impart an inappropriate sign to the remote
speculators about capriciousness of the venture atmosphere in India, the effect
of which could be felt even past the pharmaceutical area of the nation."
Equalization must be struck. India must give some confirmation to remote
medication organizations that have put billions in new medications that their
speculations will be shielded from uncompensated duplicating. To accomplish
India's objective of giving minimal effort, open medications to its kin while
additionally keeping up some similarity to conviction for MNCs and security to
new medications they try to patent, India ought to grow the classifications
secured under the "adequacy" necessity of Section 3(d) of the Patents Act as
opposed to confine it to items that have a "restorative impact in mending an
Impact On Economic Development Of India
There is a direct impact of the patent laws on the economic development of the
country. We all know that our country has adequate statue governing intellectual
property and their protection. This has created a good reputation and trust and
ultimately has resulted in multinational companies showing their interest
towards research and development in India. There are numerous examples of
companies which have initiated the manufacturing process of drugs in India.
These multinational companies when set up their business in any other country,
they provide employment to the local population and pay taxes to the government
thus indirectly contributing to Indian economy. The most prominent example is of Ranbaxy which is a multinational company. This company was established in year
As per the reports it employed around 1700 people in 2005 and the number
drastically increased in 2012 and a total of 10983 people were employed in this
year. Dr. Reddy is also an India Multinational company founded in 1984. It
employed 7525 in 2006 and as per current statics the increased to 23524 in 2018.
It can be seen that the company witnessed around 200% growth in its number of
employees in just 12 years.
More number of employers shows that the company
earns a huge profit and it also means more number of taxpayers to the government
which is a indirect contribution to economy. "The total revenue generated by
intellectual property offices of India was Rs. 608.31 crore in the year 2016-17
while total expenditure was only Rs. 129.8 crore. Total revenue generated by
patent office was Rs. 410.03 crore and the remaining were generated by other
intellectual property like Trademark, Geographical Indication, Design and
Indian pharmaceutical industry is the 3rd largest in the word producing generic
drug at inexpensive rates and supplying these drugs to many Asian and African
countries. Moreover, cost of production of medicines in India is very less
compared to US. As per the report of WIPO, India is 2nd largest country when it
comes to applications of pharmaceutical patents and this number increased after
2005, when India allowed product patent. "Indian pharmaceutical industry has
grown from 6 billion US Dollar in 2005 to 30 billion US dollar in 2015 and it is
expected to go up to 55 billion US Dollar by 2020."
Intellectual Property Regime In India With Respect To Covid 19
- The Declaration of Doha.
Member countries of the World Trade Oorganization on the date of November 14th,
2001 ratified a special WTO ministerial conference at a conference held in Doha
popularly named as 'Doha Declaration'. This was done primarily so that WTO
member countries acknowledge the importance of public health infrastructure
difficulties like tuberculosis, HIV, malaria and all the remaining epidemics
which were affecting humanity at a mass scale.
The Doha declaration is also
concerned with the importance of controlling the prices of drugs and at the same
times recognising the importance to protect the intellectual property rights of
the private pharmaceutical companies. However trips agreement gives right to the
member countries to grant 'compulsory license' as and to determine the grounds
on which such licenses will be granted.
This has been done so that the member
countries can take appropriate steps to safeguard the rights of the people of
the respected countries. Member of the WTO are allowed to authorise the use of
patent without the authorization of the owner of the same, only if, such usage
falls within the ambit of the exceptions. This right has been vested upon the
member countries under A.13 of the TRIPS Agreement.
The manufacturing which can be done under article 31(f) of the TRIPS Agreement
under a compulsory license will only be allowed for the domestic market
circulation. A country which does not possess the adequate resources which will
be required to manufacture the medicines which will fall under this exception is
bound to be answered. Exceptions for those countries which are unable to
manufacturer search drugs were given.
The manufacturers were authorized to
export the drugs to the countries which cannot the drugs. However, except the
least developed countries, countries need to prove that they are not equipped
with manufacturing facilities which can produce medicinal drugs for their own
- Compulsory Licensing and Anti-trust laws: An Analysis
It can be argued that competition law does not allow a dominant player in an
industry to misuse their dominant standing to bend the industry according their
own needs. Basically, it exists so that monopolies cannot but intellectual
property law protects the monopoly of the companies which are granted with the
patents. This is a false understanding of both the laws.
The principle of
harmonious construction is applied in the case of competition law and IPR in
such a manner that the patent is "used" and not "misused" by the dominant player
under exceptions of the competition law. Hence, IP law and competition law goes
hand in hand and helps each other to create a healthy business environment for
the pharmaceutical companies in the country. Appropriate provisions allowing for
the compulsory licenses are envisaged under the competition laws and also
granted in intellectual property laws for public purpose.
- Natco v. Bayer
An application for compulsory anti-cancer drug license was filed by Natco in
2011 for a drug named Nevaxar which was to be produced by Bayer under the
Section 84(1). The Controller of patents of Mumbai accorded a compulsory license
through an official notification. It was the first license in India which Natco
secured. All the appeal which Bayer made to Intellectual Property Appellate
tribunal, the High Court and the Supreme Court was dismissed subsequently.
Although, the questions of law were remained open.
According to the Controller of Patents, the Patentee made the medication
available to only 2% of qualifying patients in 2009 and 2010 based on the
details given by the Patentee under Form-27. As a result, the complaint falls
under Section 84 (7) (a) (ii), which asserts that the prerequisites for the
proprietary article was not satisfied adequately or on fair terms.
It was also
determined that, in terms of medication pricing, the patentee had been marketing
the medicine at 2,80,000 rupees (for a one-month therapy), and it clearly did
not made the therapy economical. The Controller General of Patents ruled that
Section 84 (7) (e) of the Indian Patents Act, which states that importing
prevents or hinders the working of a patented invention on a commercial scale in
India, refers to Section 84 (1) (a) of the Act, which states that prerequisites
have not been adhered to.
Till now, only two application has been filed under S.84 Patents Act. The
earliest claim which was filed for a drug named "Dasatinib" by BDR
Pharmcaeutical for Brisitol-Myer Squibb's Cancer drug. The application was
rejecetd as they apparently failed to construct a case which is compulsory
according to S.87 of The Patents Act.
The next appeal which was applied for diabetes drug names, "saxaglintin", by Lee
Pharma to be produced by Astrazeneca. This application was also rejected due to
lack of evidence.
- The Patents Act, 1970
S.47 of the Patent Act is of significant importance as has certain
pre-requisites for the grant of patents. One primordial pre-requisite is that
the. "Broadly speaking the basic condition is any machine/apparatus/other
article/any process for which patent is granted may be imported/made by or on
behalf of the Government for merely of its own use". This allows the
government to lift the protection provided to Patents and make use of the drugs
for their own use. It comes with an assumption that governments own use means
that it would be used for public purpose.
Therefore, it is conclusive that the government can use the patterns which are
already granted for self-use. This effectively signifies that the state can only
utilise the patterns to produce the product for themselves through PSUs or to be
manufactured by other private entities but can he used by themselves only.
remedy available under the S.47 encompasses a circumstance where the company
gets no monetary benefit for drug operation under S.100 of the Act. IT also
encompasses a circumstace where the govt will not be able to scale up the
operation in case of emergency situations. Therefore, If the government wants to
scale its manufacturing operations, it has to resort to the compulsory license
which can be granted under S.84 of the Patent Act. If such a case arises., then,
license holder will be asked to pay reasonable fees as determined by the
Controller and which is further depending on judicial review.
India is a signatory of TRIPS Agreement and Paris Convention, 1883 approved
appropriate section under the Patent Act, 1970 due to the reason that India is a
member of WTO. India is expected to have a robust health infrastructure to
fulfil the obligations that the WTO expects from its member countries. A few
exceptions are carved out of the above mentioned laws in order to make sure that
these laws do not acts as an hindrance in the exceptional circumstances such as
covid era as same time acknowledging the need to protect protection.
that a member country can utilise the knowledge within the territory of member
nations. Also, they can do the same within their own territory. However,
appropriate framework for reimbursing the companies which will suffer due theses
exceptions are shut up in place by the law-makers as the interests of the
private pharma companies needs to be respected too, i.e., this decision is
subjected to the review by judiciary to boost up the morale of the private
sector pharma companies.
The biggest cause for concern is the controlling the
price of the vaccines. It is true that appropriate sections regarding the same
are enshrined in TRIPS Agreement but the effectiveness of such clauses remains
to be under dark in a world where the current superpowers are already accused to
monopolize the international markets for vaccine doses.
In order to uphold the protection to pharmaceutical industries by providing
adequate rights through patenting, but at the same time, to make healthcare
accessible and affordable especially to developing countries, it is important to
take the following suggestions into consideration:
Firstly, a separate legal framework, focussed on pharmaceutical patenting in
order to provide for necessary regulations. The existing patent regulations must
be evolved and adapted to the country-wise economic conditions. Secondly, It is
pertinent to simplify the concept of compulsory licensing, allowing a more
flexible approach towards granting the license to least developed countries.
Lastly, quintessential drugs, especially those which are live saving, must be
made part of a tiered pricing system, where the developed countries have to pay
higher than the set price to compensate for developing countries, which can pay
a lower price.
The battle between conflicting interests of developed and developing countries
may continue for long, as the complexities in development of patent laws could
take up uncountable suggestions, amendments and volumes.
Developing countries are stuck between complying with global agreements and
providing their citizens accessible healthcare. India has covered a hue distance
backwards where in Pre-TRIPS era, it had less stringent and allowed legal
re-production of patented medicines than in the Post-TRIPS era, where India
complied with TRIPS and had to illegalize reverse engineering but maintained
sufficient leniency upholding right to health, as evident in decisions in the
We need to understand that monetary interest of many big companies comes to
stake when the price of a lifesaving drug is regulated but we need to understand
that innovation and patents are the two different sides of a coin. This coin
needs to be flipped keeping in mind the public health, ultimately innovations in
pharmaceutical industry are meant to save life
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