PHARMACEUTICAL PATENTING IN INDIA-PROBLEM OF PUBLIC ACCESS TO HEALTH BY - SETIKA PRIYAM & AJITA AWASTHI
PHARMACEUTICAL PATENTING IN
INDIA-PROBLEM OF PUBLIC ACCESS TO HEALTH
AUTHORED BY - SETIKA PRIYAM &
AJITA AWASTHI
ABSTRACT: -
Laws pertaining to intellectual
property rights (IPRs) have been more well-known in recent years, providing
confidence to inventors that their creations, concepts, or discoveries would be
safeguarded. One of the most important parts of intellectual property rights is
patent law. Nonetheless, patent limits might make it more difficult for
everyone to get necessities like medication.
This research paper explores the
importance of pharmaceutical drugs, their patenting in India, and the
challenges they pose in terms of public health access.
India has long been commended for
modifying its pharmaceutical regulations to meet local health demands, putting
the welfare of its people first and coordinating them with the country's
economic progress. With a high proportion of the population living in poverty
and the majority of medical costs being paid for out of pocket, India is
experiencing a serious health crisis with issues with medicine supply,
affordability, and healthcare access.
In order to reconcile India's commitment
to ensuring that the impoverished have access to medications with its
responsibilities under the Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPS), Section 3(d) of Indian patent law grants exclusivity.
This is a significant change from the TRIPS implementation. Currently, one of
the main concerns is India's system for pharmaceutical patents. The Indian
pharmaceutical industry and the Indian market are vital sources of reasonably
priced generic medications, which are critical for maintaining public health. The
Doha Declaration on TRIPS and Public Health (2001), to which India was a
signatory, has had a major impact on drug access globally. India's prosperity
depends on having a pharmaceutical sector that is export-oriented and actively
involved in civil society. The nation has led the area in worldwide access The
country has been a regional leader in the global access to medicines campaign,
showcasing the potential for an alternative pharmaceutical industry.
The Supreme Court's judgement in the
Novartis case, like other recent rulings under Indian patent law, demonstrates
India's ongoing dedication to public health. The patent system for
pharmaceuticals does, however, impede generic competition, which drives up
costs and restricts access to medications in underdeveloped nations.
KEYWORDS: - Intellectual Property Rights, Pharmaceutical
Drugs, Patenting, TRIPS, Public Health.
Introduction: -
Background on pharmaceutical patenting in India
Since 1970, the question of whether
pharmaceutical innovations in India can be patentable has been hotly contested.
Sections 2(1)(j), 2(1)(a), and Section 3 of the Patents Act 1970 (hereinafter
referred to as the Act), in particular Sections 3(d), 3(e), and 3(i), provide
guidance for the understanding and interpretation of patentability for certain
innovations in India. Examiners of pharmaceutical innovations might also refer
to the 'Guidelines for Examination of Patent Application in the area of
Pharmaceuticals' published by the Office of the Controller General of Patents,
Designs, and Trademarks. In the 1970s, India became a major supplier of
reasonably priced pharmaceuticals to several emerging and impoverished
countries. The Indian pharmaceutical industry became almost self-sufficient
between 1970 and 1994, and it was one of the top exporters of generic drugs.
India was a major supplier of reasonably priced generic pharmaceuticals to many
developing nations. However, there was no incentive for innovation in the
business because of India's patent regulations at the time, which did not
permit patenting pharmaceutical items.
India reached an agreement with the
World Trade Organisation (WTO), and it became operative on January 1, 1995.
Article 27 of the TRIPS agreement (Trade-Related Aspects of Intellectual
Property Rights) mandates the adoption of both process and product patenting in
all technical domains, including food, medicine, chemicals, and microorganisms.
The TRIPS agreement is located in Annex 1C of the WTO agreement. India has to
change its patent rules to provide for the protection of pharmaceutical product
patents in order to comply with TRIPS.
The Supreme Court of India cited a
letter dated December 17, 2004, from the WHO's HIV/AIDS Director to the then-Minister
of Health and Family Welfare, Government of India, during the legislative
process pertaining to pharmaceuticals. The letter emphasised India's position
as a major global supplier of reasonably priced antiretroviral medications and
essential pharmaceuticals, and it urged India to continue providing these drugs
to the world's poorest countries without enacting needless restrictions that
aren't required by the TRIPS Agreement and could impede their access. Consequently,
in 2005, the Indian Parliament amended Section 3(d) of the Patents Act to
ensure that India's patent laws complied with TRIPS while also safeguarding
public health and interests. This amendment is reflected in the data provided
in the Annual Reports of the Indian Patent Office, showing a significant 60.17%
increase in the grant rate of pharmaceutical inventions from 2012 to 2017.[1]
Importance of public access to medicines
i)
Health and Well-being: It is necessary to preserve health
and well-being to have access to critical medications, which is a fundamental
human right. Drugs are necessary for the diagnosis, treatment, and management
of illnesses as well as the reduction of pain and suffering.
ii)
Reducing Mortality and Morbidity: Death and morbidity rates can be
considerably lowered by having access to medications. When illnesses are
treated appropriately with necessary medications, health outcomes are improved
and disease progression can be stopped.
iii)
Poverty Alleviation: Because medical expenses are so
high, illnesses and diseases have the potential to drive people and families farther
into poverty. Having access to reasonably priced medications might lessen this
cost and save families from becoming impoverished.
iv)
Enhancing Productivity: Due to diminished capacity to work
and absence, illnesses can lower production. Having access to medications can
hasten recovery and allow individuals to return to their regular activities,
which boosts the economy.
v)
Preventing Public Health Crises: Pandemics and other public health emergencies
must be prevented and controlled, and this requires access to medications. Access to medications in a
timely manner can prevent
the spread of infectious illnesses
and perhaps save lives.
vi)
Promoting Social Justice: Ensuring
that all individuals, irrespective of their financial background, have access
to the necessary medical treatment is a means of advancing social justice.
vii)
Fulfilling Sustainable Development
Goals: Achieving
a number of Sustainable Development Goals (SDGs), such as eliminating poverty
(SDG 1), promoting equality (SDG 10), and maintaining excellent health and
well-being (SDG 3), depends on having access to medications. In addition to being
a question of public health, public access to medications also affects social
justice, human rights, and sustainable development. To guarantee that vital
medications are accessible, inexpensive, and available to everyone in need,
governments, pharmaceutical firms, civil society, and international
organisations must work together.
"Pharmaceutical
patenting in India, while fostering innovation and research, poses significant
challenges to public access to medicines. This paper examines the impact of pharmaceutical
patents on access to affordable healthcare in India, explores the effectiveness
of existing mechanisms such as compulsory licensing, and proposes policy
recommendations to strike a balance between intellectual property rights and
public health needs."
Pharmaceutical Patenting in India: A Historical Perspective
·
Evolution of Patent Laws in India and
Importance of TRIPS agreement on Indian Patent Regime
The Patents Act, 1970 is the main
piece of law that controls the patent system in India. This statute originally only
permitted process patents, not product patents for inventions pertaining to medicines,
foods, or chemicals. Nonetheless, India has allowed product patenting since
2005. India joined the
TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement in 1995
as a World Trade Organisation (WTO) member. TRIPS lays forth the minimal
requirements for intellectual property legislation that each member nation must
adhere to. India was required to modify the Patents Act in order to comply with
the terms of TRIPS as a signatory.The Patents (Amendment) Act, passed in 1999,
brought about the first modification to the Patents Act. This amendment introduced
the issuance of Exclusive Marketing Rights (EMRs) on certain patents and
allowed the filing of new applications for product patents in the fields of
medicines and agrochemicals starting on January 1, 1995.
In order to meet its responsibilities
under TRIPS, India modified the Patents Act once again in 2002. A consistent
term of 20 years for all kinds of innovations was adopted by this amendment.
Along with adding a clause enabling inverting the burden of evidence in
infringement lawsuits involving process patents, it also brought the concept of
"invention" into compliance with the TRIPS agreement.
The Patents (Amendment) Act of 2005
brought about the third set of changes to the patent legislation. The Indian
product patent system was established by this legislation. Under some
restrictions, it permitted the patenting of novel characteristics, applications,
or forms of well-known chemicals. It also modified provisions related to
pre-grant and post-grant oppositions and introduced the grant of compulsory
licenses for the export of patented pharmaceutical products under certain
conditions.[2]
·
Criteria of Patentability:
Inventions that satisfy certain
requirements—referred to as the criteria of patentability—are awarded patents.
The Indian Patent Act defines a patentable invention as "a new product or
process involving an inventive step and capable of industrial
application." Therefore, the basic requirements for an invention to be
patentable are as follows:[3]
a) Novelty: An invention's subject matter must be unknown as of the date
of patent filing in order for it to be eligible for patent protection. If an
innovation hasn't been utilised globally or published in any document, it's
deemed new.
b) Inventive Step: For an invention to be considered innovative, it must either
represent a significant breakthrough in technology above what is already known,
have practical applications, or both. A person with expertise in the relevant
subject shouldn't be able to tell.
c) Industrial Applicability: The innovation needs to be able to
be produced or used in a commercial setting. For instance, a novel and creative
way to extract cancer cells from a patient's body could not have industrial
application and hence be unpatentable.
The Process of Pharmaceutical Patenting in India
The pharmaceutical sector is heavily
dependent on information, yet research is expensive and uncertain. New,
creative, and practical items or procedures are frequently the results of
research projects. Pharmaceutical businesses must seek patent rights over their
created goods or methods to safeguard their ideas from unapproved commercial
usage in this fiercely competitive sector. Pharmaceutical patents in India can
be categorized as follows, based on the list provided by the Indian patent
office on its website:
1) Drug
compound patents:
These patents assert the medicinal compound's structure. These patents frequently
make use of Markush type claims, which permit the presence of many
"functionally equivalent" chemical entities in one or more medicinal
compound components. Patents on drug compounds provide the most protection for
a company's product since, until the patent expires, other firms are not
allowed to produce or sell any formulation containing the medicine or prepare
it using any synthesis method.
2) Formulation/composition patents: These patents address certain technology for formula
preparation and ingredient quantification. For instance, an ayurvedic
anti-retroviral substance for the treatment of acquired immunodeficiency
syndrome was claimed in Indian Patent No. 203986.This composition included:
·
Guduchi
or Giloe (cordifolium): 5 mg-2 gm
·
Panash
or Kathal (jack fruit): 2 mg-5 gm
·
Tulsi
or Krishna Tulsi (Holy Basil): 5 mg-5 gm
·
Kuda
or Kutaja (Kurchi): 2 mg-2 gm
·
Bhui
Amla or Bahu Patra (Gooseberry): 5 mg-2 gm These ingredients were combined with
pharmaceutical acceptable excipients.
3) Synergistic combination patents: It involves the interaction of two or more medicines,
amplifying or intensifying their effects. These patents describe novel
medication combinations that demonstrate synergy. For example, roflumilast and
salmeterol were claimed to work synergistically in Indian Patent No. 206328. A
medication including a ?2 adrenoceptor agonist (like salmeterol) and a PDE
inhibitor (like roflumilast) from the PDE4 inhibitors group was detailed in the
patent, either in a fixed or free combination.
4) Technology Patent: A pharmaceutical formulation with a masked taste, the masking of which
persists during administration of the formulation, in particular in the form of
a suspension in an aqueous vehicle, characterised in that it comprises at least
the following elements: "These patents are based on the techniques used to
solve specific technology-related problems, like taste masking, increase in the
solubility, etc." a methacrylic polymer that is soluble in acidic media
and practically insoluble at neutral or alkaline pH; a cellulosic polymer that
is soluble in organic solvents but practically insoluble in water, regardless
of pH; an active ingredient that is dispersed evenly and in the molecular state
throughout the mixture, which takes the form of an atomized matrix.
5) Polymorph patents: It includes altering a known compound's crystal structure or physical
form; this is frequently done to improve stability or lower impurities. For
example, the crystalline form B4 of atorvastatin magnesium was claimed in
Indian Patent No. 237261. This form was identified by a certain X-ray powder
diffraction pattern and purity of more than 98%. Section 3(d) of the Patents
Act, 1970, as revised in 2005, is the primary statute that governs the granting
of polymorph patents in India. According to this provision, a substance's new
form cannot be patented if its existing effectiveness is not improved or if a
new property or application is not discovered. This section's goal is to stop
"evergreening of patents" and make sure that new forms are only patented
when they are genuinely worthy.
6) Biotechnology Patents: In order to create pharmaceutical goods, live things
or biological components are used. A vast variety of medicinal, immunological,
and diagnostic items are covered by these patents. An aqueous, human serum albumin-free
interferon solution, for example, was claimed in Indian Patent No. 234072. It
contained interferon-alpha, a non-ionic detergent, a buffer for pH adjustment
to 4.5–5.5, benzyl alcohol, and optionally an isochronizing agent. It's
interesting to note that, following the establishment of the product patent
system in 2005, Indian Patent Office issued this invention, number 234072, as
its first product patent. Switzerland's F. Hoffmann-La Roche Ltd. is the owner
of it.
On the other hand, process patents do
not claim the product itself but rather cover a new and inventive process for
producing a specific product.[4]
·
Patent Application Process
The patent application
process for pharmaceuticals in India involves several key steps. Here's an
overview:
i)
Preparation of the Patent
Application: The
first stage is to draft a patent application that contains the invention's
complete description, any relevant illustrations, and claims that specify the invention's
parameters.
ii)
Filing the Application: The Indian Patent Office (IPO)
accepts online or in-person filings for the application. The patent
specification, a request for inspection, and the required payment must all be
included in the application.
iii)
Publication: After 18 months from the priority date,
if sooner, or the filing date, the application is published in the Indian
Patent Journal. If requested, an applicant may, nonetheless, ask for early
publication.
iv)
Examination: A patent examiner reviews the
application to assess its industrial usefulness, inventive step, and originality.
Within the allotted time, the applicant must address any concerns made by the
examiner.
v)
Grant or Refusal: The patent is awarded if the
examiner finds the application satisfactory and all objections are resolved.
The application could be rejected if it isn't. The applicant receives written
notice of the judgement.
vi)
Opposition: Pre-grant objection may be filed
against the patent within six months of the date of publication after the
patent's issuance. Anyone may submit an objection on the basis of predetermined
reasons.
vii)
Sealing of the Patent: The patent is sealed and the
applicant receives a patent certificate once all conditions are satisfied and
any objection is addressed.
viii)
Maintenance of the Patent: The patentee must pay renewal fees
periodically to maintain the patent in force for the entire term of 20 years
from the filing date
·
Post-grant Opposition:
From
grant, the patent is subject to post-grant objection for a year from the day
the award was published in the official patent publication.
Role of Indian
Patent Office:
As a branch of the
Controller General of Patents, Designs and Trademarks (CGPDTM) agency under the
Department of Industrial Policy and Promotion, Ministry of Commerce and
Industry, Government of India, the Indian Patent Agency (IPO) is responsible
for managing the country's patent award procedure. Over the course of its
150-year history, the Patent Office has undergone a number of significant
changes.
The Patents Act of 1970
was amended to conform to the terms of international agreements and treaties to
which India became a party. With large expenditures in human and physical
infrastructure over the last 10 years, the Indian government has created a strong
foundation for intellectual property rights in the country. Following its
designation by the PCT as an International Searching Authority and
International Preliminary Examining Authority, the Indian Patent Office
commenced its functions on October 15, 2013. We have access to a large corpus
of patent and non-patent material that addresses the PCT minimum documentation.
Our skilled and highly educated Examiners are our greatest advantage. IPO has
developed a quality management system that encompasses both technical and
administrative office tasks. A fully computerised processing system guarantees
prompt information distribution and disposal on real time basis.[5]
Impact of Pharmaceuticals Patents on Access to Medicines:
Since the establishment of
Trade-Related Aspects of Intellectual Property Rights (TRIPS) in 1995, there
has been growing concern over the relationship between stronger intellectual
property rights (IPR) and pharmaceutical market monopolies as well as the delayed
entrance of less priced generic medications. In poor nations, inadequate access
to necessary medications is already an issue that has become worse. Despite a
considerable quantity of research and debate on the topic, there aren't many
empirical studies on the issue. In this study, we examined the effect of IPR on
pharmaceutical availability and catastrophic medical cost using data from the
World Health Surveys conducted in 2002 and 2003. The Ginarte and Park (1997)
index of patent rights was used to determine the level of IPR protection in
each country. Estimates were changed to take into consideration national and
individual factors. In the results of Despite a considerable quantity of
research and debate on the topic, there aren't many empirical studies on the
issue. In this study, we examined the effect of IPR on pharmaceutical
availability and catastrophic medical cost using data from the World Health
Surveys conducted in 2002 and 2003. Ginarte and Park's (1997) patent rights
index was used to evaluate each country's level of intellectual property rights
protection. Estimates were adjusted to take both personal and societal aspects
into consideration. Multilevel logistic regression analysis revealed that
higher levels of IPR significantly increased the likelihood of not having
access to prescription pharmaceuticals, even after controlling for national and
individual socioeconomic status indicators connected to medication
availability. The study's findings, which demonstrate that intellectual
property rights (IPRs) negatively impact pharmaceutical access, call for more
proactive supranational policymaking to improve access for low- and
middle-income countries.
High Drug Prices and affordability
issues:
International human rights concepts
are based on the fundamental right to health. Ensuring equal access to
pharmaceuticals has been a recurring concern, since it continues to be
essential for further advancement in healthcare. The Sustainable Development
Goals 2030 (SDG 2030) have been announced by the UN, and one of the main goals
under the "Good Health and Well-Being" aim is Universal Health
Coverage (UHC). Diverse legitimate interests are sought to be balanced in the
administration, enforcement, and regulation of intellectual property in order
to advance equitable access to drugs and improve overall well-being.
Both wealthy and developing nations
are deeply concerned about the rising costs of medical care and prescription
drugs. Healthcare expenses can be significantly impacted by pharmaceutical
prices, which frequently make up a sizable amount of the entire cost of
treatment. Public healthcare spending is often low in developing nations, and
health insurance coverage is scarce, especially for the unorganised and
informal sector's members who do not have social security.
The majority of the public lacks
knowledge and there are economic concerns, which contribute significantly to
the limited coverage of private health insurance. People now face greater
healthcare expenses as a result of the shift from communicable to chronic,
non-communicable diseases, as public health systems are ill-equipped to handle
these emerging health issues.
Because of this, households in
developing nations frequently rely significantly on out-of-pocket (OOP)
healthcare expenses, which have the potential to drive many families into
poverty. Two of the main causes of this phenomena are the high cost of vital
medications that can save lives and the high cost of healthcare.
Healthcare costs are greatly impacted
by the expansion, structure, and associated laws, regulations, and pricing tactics
of the pharmaceutical business. Nonetheless, the pharmaceutical industry's
economic viewpoint frequently minimises these negative consequences,
highlighting the sector's innovation-heavy structure and the life-saving
qualities of its goods as grounds for unrestricted pricing policies.[6]
·
Availability of Generic medicines
Access to
cheap healthcare is greatly facilitated by the availability of generic
medications, particularly in underdeveloped nations where household costs
associated with healthcare are frequently high. Despite being bioequivalent to
their branded counterparts, generic medications are sometimes offered for a
much cheaper price because of reduced marketing and R&D expenditures.
Several factors influence the availability of generic
medicines:
i)
Regulatory Environment: The supply of generic medications
may be impacted by the regulatory environment around pharmaceuticals. Access to
these medications is often greater in nations with well-established legislation
governing generic drugs.
ii)
Intellectual Property Rights: Generic medication availability may
be restricted by patent protection. Generic versions of copyrighted medications
may take longer to become available in nations with strict patent laws.
iii)
Market Competition: Generic medication availability is
encouraged by a competitive market environment. Prices typically drop when
numerous producers create generic copies of the same medication, increasing
accessibility to the medications.
iv)
Procurement and Distribution Systems: Having effective mechanisms for
distribution and procurement is crucial to guaranteeing the supply of generic
medications. Shortages and restricted availability can result from poorly
managed supply chains.
v)
Public Health Policies: Generic medications may be more
widely available if government policies support their usage. This covers
actions like rules for generic prescription and generic replacement.
vi)
Quality Assurance: The availability of generic
medications depends on their quality being guaranteed. Enforcing quality
standards is crucial for regulatory bodies to uphold customer confidence in
generic products.
vii)
Awareness and Education: Increased knowledge regarding the
efficacy and safety of generic medications among patients and healthcare
professionals may also help to increase their accessibility.
The availability of generic
medications is often influenced by a confluence of commercial, policy, and
regulatory variables. In order to increase the availability of and encourage
the use of generic medications as a cheap substitute for branded ones, efforts
are frequently made to increase access to affordable healthcare.
·
Case studies or examples illustrating
the impact: -
Here are some case studies and
examples illustrating the impact of generic medicines on healthcare access and
affordability:
i)
India's Generic Drug Industry: Several commercial, policy, and
regulatory factors typically interact to affect the accessibility of generic
drugs. Efforts to improve access to inexpensive healthcare are sometimes
undertaken in an attempt to promote the use of generic pharmaceuticals as a
less expensive alternative to branded ones and to enhance their availability.
ii)
The Impact of Generic Competition on
Drug Prices: Price
reductions for branded medications can be substantial when generic competition
enters the market. For instance, the entry of generic versions of cholesterol-lowering
statin medications resulted in a significant drop in cost, making these medications
more accessible to patients.
iii)
Generic Drug Use in the United
States: The
adoption of generic medications has contributed significantly to lower
healthcare expenditures in the US. The FDA claims that between 2008 and 2018,
generic medications helped the American healthcare system save $1.68 trillion.
iv)
Generic Drug Access in Low- and
Middle-Income Countries: Low- and middle-income nations now have easier access to
reasonably priced generic copies of copyrighted medications because to
initiatives like the Medicines Patent Pool (MPP). For instance, the MPP's
contracts with pharmaceutical firms have made it possible to produce and market
generic versions of medications for hepatitis C, TB, and HIV/AIDS.
v)
Generic Drug Shortages: Although generic medications are
often less expensive, shortages can happen for a number of reasons, such as
problems with production or legal obstacles. Access to and the cost of
healthcare may be impacted by these shortages, especially for necessary
medications.
vi)
Government Policies Promoting Generic
Drug Use: Generic
substitution and generic prescription rules are among the measures that some
nations have put in place to encourage the use of generic medications. These
regulations have improved patient access to medications and assisted in
lowering healthcare expenditures. These illustrations show how important it is
to ensure the availability of and encourage the use of generic medications by
highlighting the substantial influence they may have on healthcare
affordability and access.
Measures to improve Access to Medicines
Increasing drug availability, with
particular emphasis on countries of the developing world, is a complex problem
that is to be solved by disseminating the proper policy, regulations, and
market-based solutions.
Here are some measures that can help improve access to medicines:
i)
Generic Drug Promotion: Lowering drug costs and enhancing
access to reasonably priced medications can be achieved by encouraging the use
of generic medications through programmes like generic substitution and generic
prescribing.
ii)
Price Regulation: Ensuring that medications are
accessible and affordable for all demographic groups can be achieved through
the implementation of price regulation mechanisms, such as reference pricing or
price controls.
iii)
Compulsory Licensing: Compulsory licences for essential
medications can enable generic producers to manufacture and market patented
drugs at reduced costs, thereby expanding the availability of these
medications.
iv)
Health Technology Assessment (HTA): By determining the value of medications and providing
information for pricing and reimbursement decisions, HTA can help make sure that resources
are distributed effectively to increase access to affordable treatments.
v)
Public Procurement and Supply Chain Management: Enhancing supply chain management and
public procurement procedures can help guarantee a consistent supply of medications,
lower stockouts, and increase accessibility to necessary medications.
vi)
Intellectual Property Flexibilities: Access to reasonably priced generic
medications can be facilitated by making use of intellectual property law
flexibilities, such as those permitted under the TRIPS Agreement, particularly
during emergencies or public health crises.
vii)
Health Insurance Coverage: Increasing the number of people
covered by health insurance, especially the most disadvantaged groups, can
lower prescription drug costs out of pocket and increase access to medical
care.
viii)
Capacity Building and Technology
Transfer: Enhancing
local manufacturing capabilities and promoting technology transfer can contribute
to a rise in domestic medicine production, lowering reliance on imports and enhancing
accessibility.
ix)
Public-Private Partnerships (PPPs): Participating in PPPs can assist in
utilising the resources and knowledge of the public and private sectors to
enhance access to medications, particularly in underprivileged areas.
x)
Patient Education and Awareness: Improving patient knowledge about
medication availability and usage can enhance treatment compliance and enhance
overall health results.
By implementing these
measures, policymakers can enhance global population health outcomes and
enhance access to necessary medications by putting these recommendations into
practice
Compulsory Licensing and its Implications
There is no definition for
"compulsory licencing" in the Indian Patents Act. It is generally
understood to refer to a scenario in which a government allows another party to
manufacture a patented good or method without the patent owner's permission or
with the intention of using the patented invention itself. Crucially, the
patent holder retains all rights related to the patent, including the right to
payment for any products copied using the compulsory licence.
Sections 84 and 92 of the Act specify
the requirements for issuing a compulsory licence, and Chapter XVI of the Act
contains the provisions pertaining to compulsory licencing in India. Under
Section 84, any person, regardless of whether they hold a license for the
patent, can request a compulsory license from the Controller after three years
from the grant of the patent if:
i)
The
reasonable requirements of the public regarding the patented invention are not
being met.
ii)
The
patented invention is not available to the public at a reasonably affordable
price.
iii)
The
patented invention is not being worked in the territory of India.
Furthermore, under Section 92(1) of
the Act, the IPO suo motu may grant compulsory licences in response to a
notification from the Central Government in situations involving extreme
urgency, national emergency, or public non-commercial use.
The objectives of the section 84 are
to make it harder for patents to be abused as monopolies and to make it easier
for interested parties to commercialise inventions. The nature of the
invention, the efforts made by the patentee to use the invention, the
applicant's capacity to use the invention for the benefit of the public, and
the applicant's attempts to secure a reasonable licence from the patentee are
among the factors listed in Section 84(6) that the IPO considers when awarding
a compulsory licence. These provisions reflect the Indian Parliament's effort
to strike a balance between the interests of innovators and the wider public
interest to create an environment conducive to creativity and innovation.[7]
In addition to granting patentees the
ability to enjoy a monopoly, Section 83 of the Act makes clear that patent
rights are not misused in order to unjustly restrict trade or negatively impact
the transfer of technology.
The IPO pointed out that patent
rights entail obligations to the public and that it is essential to strike a
balance between these rights and obligations when evaluating applications for
compulsory licencing.
·
Price control Mechanism
Governments impose price
control mechanisms as regulatory measures to manage the costs of necessities,
such as prescription drugs, in order to guarantee accessibility and affordability.
These are a few typical pharmaceutical industry price control techniques:
i)
Price Ceilings: The highest prices that
pharmaceutical companies may charge for their goods may be set by governments.
This can guard against price gouging and guarantee the continued affordability
of necessary medications.
ii)
Cost-Plus Pricing: A fair markup is added to the cost
of production to determine the price of a pharmaceutical product under this
mechanism. This keeps prices from being too high while guaranteeing that businesses
can pay their expenses.
iii)
Reference Pricing: The process of reference pricing
entails determining the cost of a pharmaceutical product by comparing it to
similar products in other nations or areas. This can guarantee that prices are
fair and competitive and help avoid price disparities.
iv)
Price Monitoring and Reporting: To make sure that drug prices stay
fair and reasonable, governments may set up systems to track and report on drug
prices. Price gouging and other pricing abuses may be easier to spot as a
result.
v)
Price Regulation Authorities: Certain nations have instituted
autonomous regulatory bodies tasked with overseeing the prices of
pharmaceuticals. These authorities have the power to impose rules, keep an eye
on compliance, and set prices.
vi)
Subsidies and Price Caps: Governments can guarantee that
necessary medications are within the financial means of low-income groups by
imposing price caps or offering subsidies. For vulnerable populations, this can
help increase access to medications.
All things considered, price control
measures are vital to maintaining the affordability and accessibility of
necessary medications for every member of the public. To prevent unforeseen
consequences like limiting innovation or decreasing the availability of medications,
they must be implemented cautiously.
·
How Patent hinders Right to Health
In developing nations,
access to branded and patented medications is frequently hampered by their high
costs. New drug patents enable the inventor to gradually recover their R&D
expenses. Sponsors can, however, exploit several legal snags to increase the
scope of their patent protection, such as charging more for novel ideas.
Bilateral trade
agreements, for instance, could be used by businesses to set the price of new
medications according to their economic worth, which considers aspects like
cost-effectiveness, safety, and efficacy in comparison to current treatments.
These strategies may result in patented medications being out of reach for
citizens of low-income nations. As a result, access to necessary medications
and healthcare services is now significantly impacted by international trade
agreements.
Furthermore, the World
Health Organisation (WHO) only has non-voting observer status in the main
political bodies of the WTO because of the Trade-Related Aspects of
Intellectual Property Rights (TRIPS) Agreement. As a result, WHO has less
influence over significant WTO decisions pertaining to social, economic, and
health rights.
·
Balancing intellectual property
rights with access to medicines
First and foremost,
creating new medications necessitates large financial outlays, highly developed
methods, and information availability. Second, the global pharmaceutical
industry depends on Intellectual Property Rights (IPRs) like patents to
safeguard their investment. By passing these costs on to end consumers, they
reap significant profits. Thirdly, under the WTO agreement on Trade-Related
Aspects of Intellectual Property Rights (TRIPS), nations having the capacity to
manufacture vaccines are required by international trade agreements to offer
patent protection.
·
IP
laws are therefore required to encourage innovation in the R&D of novel
medications or vaccines. However, the worldwide pharmaceutical industry creates
a monopoly over life-saving drugs because of these intellectual property rights
laws. Investors profit billions of dollars because of this. But it also makes
it more difficult for new producers to enter the pharmaceutical research
market.
·
TRIPS covering Public Health
The necessity to strike a
balance between patent rights and other significant interests, like public
health, is acknowledged by the TRIPS agreement. Governments are permitted to
enact laws that conform to TRIPS standards while also taking the necessary steps
to safeguard public health. These guidelines might not always be appropriate
for developing nations with underdeveloped infrastructure for healthcare and
unfulfilled development needs. Developing nations may, nevertheless, make use
of some TRIPS provisions to safeguard public health, especially about obtaining
necessary medications. These alternatives include the promotion of generic
medications, parallel importation, compulsory licencing, exclusions from
patentability, and exceptions to patent rights.
Despite these clauses,
there have been worries about how TRIPS will affect the availability of
necessary medications, particularly in developing nations. These issues were
brought up during the June 2001 WTO Ministerial Conference in Doha, Qatar. The
TRIPS Agreement will be interpreted and implemented in a way that promotes
public health and medical access, as agreed upon by WTO Ministers. The Doha
Declaration on TRIPS and Public Health, which reiterates nations' sovereign
rights to enact laws pertaining to compulsory licencing and parallel imports to
safeguard public health and give precedence to intellectual property, reflects
this commitment.
Interpreting Article
31(f) of the TRIPS Agreement—which stipulates that compulsory licences should
be used "predominantly for the supply of the domestic market"—is
particularly interesting. While paying fair royalties to patent holders,
governments can grant licences to regional producers. Due to increased
competition in the market for patented goods, this may result in lower consumer
prices. The WTO has also decided to modify the TRIPS clause regarding mandatory
licences, acknowledging that many developing nations lack the internal
resources necessary to produce patented medications. August 2003 saw the
introduction of a temporary waiver that permitted nations possessing the means
of manufacturing to grant mandatory licences and export pharmaceuticals to
nations in which local production was not feasible.
If member states satisfy the minimal
requirements outlined in the TRIPS Agreement, they are free to choose how best
to incorporate the agreement's requirements into their own national legal
frameworks.
Case Laws:
NOVARTIS AG VS. UNION OF INDIA (UOI) AND ORS[8]
In an appeal of the IPAB's denial of
Novartis' patent application for a "Crystal Modification of an N-
Phenyl-2-Pyrimidineamine derivative, processes for its manufacture and its
use," the company filed a special leave petition before the Supreme Court
of India, citing Section 3(d) of the Act as justification for the denial.
The IPAB's ruling was upheld by the
Supreme Court, but pharmaceutical patent applicants should take note of its
conclusions. The Court clarified a few important points, one of which is
incremental inventions. It was declared that patent protection for all
incremental inventions involving pharmaceutical substances should not be
excluded by the interpretation of Section 3(d). The Court made clear in its
decision that it did not mean to reverse the fundamental shift in the patent
regime that the removal of Section 5 from the Patent Act. The Court further stated that the Applicant's
materials and data, which did not support the claimed invention's therapeutic
efficacy, served as the basis for its decision. The Court emphasised that such
claims must be backed by research data but did not rule out the possibility
that improved bioavailability could improve therapeutic efficacy. The Applicant
failed to provide evidence to support its claim of 30% higher bioavailability
in free base form when compared to imatinib; as a result, the Court determined
that the claimed invention did not disclose enhanced therapeutic efficacy.
Therefore, it would be against the
intended outcome to interpret the judgement as discouraging inventions related
to pharmaceuticals. The IPO and Indian Courts have continuously preserved the
innovators' interests while upholding the sanctity of Section 3(d) since the
Given ruling in 2013.
RANBAXY LABORATORIES LTD. VS.
PFIZER HEALTH AB[9]
Ranbaxy Laboratories Ltd.'s pre-grant
opposition against Pfizer Health AB's patent application for a pharmaceutical
formulation was denied by the Indian Patent Office in 2007. Despite the
opposition, Pfizer was awarded the patent.
As for Ranbaxy's claims under Section
3(d) of the Act, the Controller concluded that Pfizer had proven therapeutic
efficacy by showing a 71% decrease in weekly episodes of urge incontinence when
compared to a placebo. Furthermore, the Controller responded to the
opposition's claim made in accordance with Section 3(e) of the Act, asserting
that the invention qualified for patent protection because of the
specification's disclosure of the synergistic effect. As a result, the
Controller gave Pfizer the patent.
The opposition had contended that the
composition claimed in the patent application was not patentable under Section
3(d) because it was a mixture of well-known substances with no appreciable
variation in efficacy. Additionally, they argued that Section 3 should not
allow a patent to be granted for a composition that lacks a synergistic effect
(e). The Controller, on the other hand, disagreed, claiming that the
composition was creative, innovative, and applicable to industry, and that it
had a synergistic effect as evidenced by the weekly decrease in urge
incontinence episodes. As a result, the Controller awarded Pfizer the patent
after finding that the modified claims complied with Sections 3(d) and 3(e) of
the Patents Act.
Conclusion: -
The impact of pharmaceutical
patenting in India on public health access is a complicated and
multidimensional issue. Patents are necessary to encourage innovation and
investment in the pharmaceutical sector, but they can also make it more
difficult for people to obtain necessary medications, particularly in
underdeveloped nations. India's Patents Act aims to achieve a balance between
encouraging innovation and guaranteeing that everyone has access to medications
through its provisions for mandatory licencing and other protections.
Considering Section 3(d) of the
Patents Act, the case studies of Novartis and Pfizer underscore the
difficulties faced by pharmaceutical companies in obtaining and defending
patents in India. These cases also highlight how crucial strong patent laws and
regulatory frameworks are to maintaining public health and facilitating the
availability of reasonably priced medications.
To address the issues raised by
pharmaceutical patenting, legislators, pharmaceutical companies, and civil
society must keep up their positive communication going forward. In addition to
improving access to medications, policies like supporting generic drugs,
bolstering regulatory frameworks, and improving healthcare infrastructure can
also foster innovation in the pharmaceutical industry.
In conclusion, resolving the complex
issues surrounding pharmaceutical patenting and guaranteeing universal access
to necessary medications require a balanced strategy that considers the
interests of innovators and the public.
[1] Phillipe Cullet,” Patent and
medicines: The Relationship between the TRIPS and The Human Right to Health” (2003)
79 International Affairs.
[2] Nilesh Zakharias, ‘Patents and The
Indian Pharmaceutical Industry – Intellectual Property – India’
(Mondaq.com,
2019) available at: https;//www.
Mondaq.com/india/patent/865888/patents-and-the-indian-pharmaceutical-industry
(assessed on October 16, 2021)
[3] The Patents Act, 1970 (act no.30
of 1970)
[4] Vipin Mathur, “Patenting of
Pharmaceuticals: An Indian Perspective”30 IJDDR (2012)
[6] Marion Motari, “The Role of
Intellectual Property Rights on access to Medicine” BMC Public Health 490
(2021)
[7]The Patent Act,1970, India,
available at:
[8] Novartis AG vs. Union of India
(UOI) and Ors. 1 Apr. 2013
[9] Ranbaxy Laboratories Ltd. VS. Pfizer Health AB (2007)