SPECIAL ARTICLE
Prices of Patented Medicines in India
To Regulate or Not to Regulate?
Sharmila Mary Joseph, James J Nedumpara
Medicines with valid patents generally enjoy
exemption from price regulation in most countries.
In India, the Drugs (Prices Control) Order lays down the
rules for regulation of prices of medicines through a
National List of Essential Medicines, inserted as
Schedule-I of the DPCO. While any medicine that is
included in Schedule-I automatically qualifies for
price regulation, the DPCO exempts patented
medicines that have been developed indigenously
from price control for a period of five years.
Can patented molecules for emerging as well as
infectious diseases be brought under price
regulation in India?
Views expressed in this article are personal and do not reflect the views
of the government or any of its agencies.
Sharmila Mary Joseph (sharmila.mj@gov.in) is Secretary to Government
of Kerala (Finance, Expenditure, and Planning and Economic Affairs
Departments). James J Nedumpara (headctil@iift.edu) is head, Centre
for Trade and Investment and Law, Indian Institute of Foreign Trade,
Ministry of Commerce and Industry, Government of India.
Economic & Political Weekly EPW JUNE 2, 2018 vol lIiI no 22
P
harmaceutical pricing, specifically the pricing of pat-
ented medicines, is a keenly debated issue, especially
in the context of making essential medicines afforda-
ble, accessible and available to the public. While the determi-
nation of the affordability of a medicine is difficult and may
depend on local and national parameters, the World Health
Organization (WHO) holds that “‘affordable and fair’ price is
one that can reasonably be funded by patients and health
budgets and simultaneously sustains research and develop-
ment, production and distribution within a country” (WHO nd).
Providing medicines to the public at affordable prices is a key
goal driving the public health policy design in many countries
(Cockburn et al 2014).
Governments try to balance their pro-industry and welfare
roles, namely, promoting and encouraging innovation in the
discovery of new medicines, and making such new medicines
affordable by way of various legislative measures. While gov-
ernments provide incentives and protection to innovators
through the instrumentalities of patents, they also strive to
make these inventions “available at the marginal cost of pro-
duction to maximise the benefits from diffusion and dissemi-
nation” (Subramanian 2004). The trade-off between patents
and pricing controls needs to be fine and delicate, and govern-
ments need to find an appropriate balance between the rights
of patentees and the requirements of the patients (Watal
2001). This article seeks to examine the need and the rationale
for price regulation of patented medicines in India in the con-
text of the high prices of such medicines.
Innovation versus Affordability
Pharmaceutical patents grant protection to the patentee for
the duration of the patent term. The patentees enjoy the liberty
to determine the prices of medicines, which is time-limited to
the period of monopoly, but unaffordable to the public (MSF
2003). Such patent protection offered to the patentees is
believed to benefit the public over the longer term through
innovations and research and development (R&D), although it
comes at a cost, in the nature of higher prices for the patented
medicine (Hopkins 2006). While the patent regime and price
protection—through a legally validated high price for the
medicine during the currency of the patent—provide the pat-
entee with a legitimate mechanism to get returns on the costs
incurred in innovation and research (Winegarden 2014), it
puts a huge burden on the public’s purchasing power in access-
ing these patented medicines.
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SPECIAL ARTICLE
It is nevertheless held by patent supporters that patent pro-
tection, while incentivising the time and capital invested by
the innovator, also serves to put in public domain the knowl-
edge thus gained at the end of the patent period (Lybecker
2011). Notwithstanding this argument, debates in developing
countries revolve around the aspect of pharmaceutical patents
entailing substantial costs to the public.
Despite the market-distorting effect of patents manifesting
as high prices, some consider patents as “necessary incentives
for innovation” (Strand 2014). The pharmaceutical industry
perceives the right to patents and protection of intellectual
property rights (IPR s) as “essential” requirements for enabling
adequate investments for the discovery of new medicines and
new molecules, and for “empowering the development of a vi-
brant generic market” (WHO 2005). The industry, therefore,
believes that a system where IPR s do not guarantee adequate
compensation will reduce the incentive to invest and research
(Mercurio 2007).
In the pharmaceutical market setting, where the ability of
patients to buy medicines is limited on account of “third-party
decision-making” by the doctor, the entry of patented medi-
cines has caused further imperfections. The monopoly rights
enjoyed by the patentees “drive the prices up dramatically,”
much to the misery of the patients (Kapczynski 2013).
From the Lab to the Market
The drug discovery and development process is complex and
complicated (Vertinsky 2013). The long-drawn-out process
may take 15 to 20 years, beginning in the laboratory with the
discovery of a new molecule, after which there is a long pro-
cess of chemical development, optimisation and pharmaco-
logical development, which might take about two–three years
(WHO 2006). It then passes on to the pre-clinical development
stage, which may last one–two years, and later to animal trials
and several phases of clinical trials. On satisfactory comple-
tion of the trials and on reasonable establishment of therapeu-
tic efficacy and safety, the drug is ripe for marketing approval
and for launch in the market for use by patients (WHO 2006).
However, there are attritions at every stage, such that only a
small fraction of new molecules discovered actually reach the
market; most fail to reach the market (Grabowski 2002).
A recent study conducted by the Tufts Center for the Study
of Drug Development, Tufts University, Massachusetts has
computed the average cost for development and marketing
approval of new drugs as $2.6 billion, based on an examina-
tion of 106 drugs developed between 1995 and 2007 (Econo-
mist 2014; Tufts Center for the Study of Drug Development
2016). The study has been criticised as the calculations include
the cost of capital (almost $1.2 billion), and cost on account of
development of failed compounds earlier in the development
chain. Further, subsidies, research grants and tax breaks pro-
vided by governments for R&D activities have not been reck-
oned in the calculations (Avorn 2015). The “mythic costs of
R&D,” it is argued, support “a wealthy industry that gives new
medicines with few or no advantages and then persuades doc-
tors to prescribe that patients need these medicines” (Light
52
and Warburton 2011). Such unethical practices unfortunately
only serve to cause erosion of patients’ savings, rather than elon-
gate their lives or alleviate their sufferings.
Pharmaceutical Patents and TRIPS
The Agreement on Trade-Related Aspects of Intellectual Prop-
erty Rights (TRIPS) lays down specific criteria and guidelines
on the subject of patenting, “when the invention is new,
involves an inventive step and is capable of industrial appli-
cation” (Article 27).1 Article 33 of the TRIPS agreement allows a
period of 20 years of patent protection from the date that the
patent application is filed. The TRIPS agreement came into
force on 1 January 1995. Further, the declaration of “TRIPS and
Public Health” adopted at the Doha Ministerial in 2001 arti-
culated the use of compulsory licensing provisions and parallel
importing by member countries in the interest of public health.2
Developing countries like India could utilise the grace time
until 1 January 2005 to make its patent laws compliant in
accordance with Article 65.4 of the TRIPS agreement.3 The
WTO TRIPS Council on 6 November 2015 extended the grace
period for least developed countries further until 2033. The
TRIPS Council also decided to keep open the option for further
extensions beyond that date.4 This decision is in consonance
with the adoption of the United Nations Sustainable Develop-
ment Goals, which affirm the right of developing countries to
utilise the TRIPS agreement flexibilities to ensure access for
new medicines for all (WTO 2015).
Patent Regime in India
The Indian pharmaceutical industry has been able to make great
inroads into the manufacture and export of generic drugs,
through reverse engineering; India is often referred to as the
generic pharmacy of the world. The Indian pharmaceutical
companies supply antiretroviral medicines to African countries;
many of the Indian companies also have regulatory approvals
from the United States Food and Drug Administration (US FDA)
and regulatory bodies of many other countries. The Indian ge-
neric pharmaceutical industry “has carved a niche for itself” in
the global pharmaceutical market (GoI 2016).
The Indian pharmaceutical companies resorted to maximi-
sation of the grace period provided to India under the TRIPS
agreement, which enabled them to strengthen their manufac-
turing capabilities in accordance with the requirements of the
markets of the developed world, and to produce generic ver-
sions of many highly priced innovative medicines in India in
large numbers (Basant and Srinivasan 2015). In fact, the grace
period for introduction of the product patent regime in India
up to 2005 proved to be a blessing for the development of the
Indian generic pharmaceutical industry (Angeli 2014). Many
products that had patents elsewhere were manufactured in India
through reverse engineering and catered to the requirements of
the domestic and international market (Duggan et al 2012).
In the present scenario, when patent provisions in accord-
ance with the TRIPS agreement are firmly in place in India,
innovators are largely resorting to the practice of entering into
voluntary licence agreements with generic manufacturers.
JUNE 2, 2018 vol lIiI no 22 EPW Economic & Political Weekly

Under the purview of these licences, the generic companies
sell the product within the country, as well as export to low-
income countries, as is seen in the case of Gilead Science’s
Sofosbuvir (United Nations 2016).
The manufacture and marketing of patented pharmaceuti-
cal products in India is largely governed by the provisions of
the Indian Patents Act, 1970, amended in 2002 and 2005.5 The
2005 amendment paved the way for India becoming TRIPS
compliant, whereby pharmaceutical companies have been
enabled to obtain full-scale product patent protection on their
products (Gopakumar 2010). The impact of strong intellectual
property protection has been felt by the generic companies in
the post-2005 period, as they are denied the opportunity to
manufacture generic copies of patented products during the
validity of the patent period (Mueller 2007).
Certain constituents of the Indian pharmaceutical industry
have been raising concerns over the rigidity inbuilt into the
meaning, understanding and interpretation of Section 3(d) of
the patents act, and the narrow scope of Sections 2 (1)(j) and 2
(1)(ja) thereof. This sentiment is echoed by the United States
(US) pharmaceutical industry as well. The Pharmaceutical Re-
search and Manufacturers of America (PhRMA) requested in
their Special 301 submission to the office of the United States
Trade Representative (USTR) in 2014 to designate India as a
Priority Foreign Country (PFC) under the US Trade Act.
In particular, the PhRMA cited the narrow standards of patent-
ability as provided in Section 3(d) of the Indian Patents Act.
The submission even argued that Section 3(d) was inconsistent
with the framework provided by Article 27 of the TRIPS agreement,
specifically with the non-discrimination provision. The sub-
mission referred to the “overly narrow standards for patenta-
bility in India,” which undermined the incentives for innova-
tion (PhRMA 2014). This was further reflected in PhRMA’s sub-
sequent 301 submission to the USTR in 2015 (PhRMA 2015). Its
2016 submission too reiterated the earlier views and pointed out
examples of patent denial, under the provisions of Section 3(d)
of the patents act. The PhRMA recommended that India should
continue to remain on the Priority Watch List (PhRMA 2016).
Practices such as developing modified versions of existing
drugs through “evergreening” of existing formulations are
often resorted to by pharmaceutical companies. They “tend to
abuse the patent system, tweaking old molecules to extend
monopolies so that prices remain high” (Collier 2013). A cor-
rect interpretation of the statute by the Indian courts and a
proper analysis of the provisions of the patents act vis-à-vis the
claims of companies seeking patents for modified versions of
their products are essential in deciding the merits of any such
case. In Novartis AG v Union of India and Others (2013), the
Supreme Court of India on 1 April 2013 delivered a landmark
judgment denying a patent to Novartis for the beta crystalline
form of imatinib mesylate. The Supreme Court observed that
the product did not pass the test of patentability as prescribed
in Sections 2(1)(j) and (ja), and 3(d) of the Indian Patents Act
(Novartis AG v Union of India and Others 2013).
This case demonstrates how pharmaceutical companies claim
undue benefits at the expense of the health of patients, under
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SPECIAL ARTICLE
the guise of patents (Joseph 2013). Many researchers and public
health activists have acknowledged that the ruling would
have beneficial implications on affordability of medicines and
spillover effects in other developing countries too, with nations
such as the Philippines, Vietnam and Sri Lanka introducing
similar provisions in their patent laws (Turrill 2013).
Critics of this view accuse the “anti-evergreening” provi-
sions of the Indian patent law to be supportive of “reverse
engineering” of patented medicines by generic companies
(Banerjee 2013). This school of thought maintains that setting
high patentability standards will “be detrimental to innovation”
and has labelled the Novartis case as a “missed opportunity”
for pharmaceutical innovation in India (Bennett 2014).
Costly Patented Medicines
Prices, particularly of patented antineoplastic (anticancer) medi-
cines are restrictively high in India (Singh and Khanna 2015).
The public is put to much distress as most of these medicines
generally do not find any place in the essential medicine list
(Baker 2009). The “unsustainable high price” of new anticancer
medicines has become a major area of concern as “cancer has
become a money-maker” for pharmaceutical companies (t’Hoen
2016). Some researchers have analysed that the prices of anti-
cancer medicines in the US are fixed arbitrarily: “the average
launch price of anticancer medicines after adjusting for inflation
and health benefits increased by 10 percent annually or an average
of $8,500 per year from 1995 to 2013” (Howard et al 2015).
The data regarding prices of some patented anticancer
medicines in India as indicated in the database of monthly
sales data of pharmaceuticals maintained by the All India Org-
anisation of Chemists and Druggists (AIOCD–AWACS) is given
below. Erlotinib tablets, used in the treatment of locally adva-
nced or metastatic small-cell lung cancer, patented by Roche are
priced at `4,800 per 150 milligram (mg) tablet. Its patent ex-
pired in March 2016. However, the generic version of the tablet
is being sold by Cipla at `220 per tablet (data of February 2017).
Nilotinib, an antineoplastic used in the treatment of chronic
myeloid leukaemia, patented by Novartis is priced at `8,343
per 200 mg tablet. Crizotinib, patented by Pfizer and used in the
treatment of lung cancer is priced at `1,554 per 200 mg tablet
(AIOCD–AWACS monthly sales data for February 2017).6 When the
overall treatment costs for one course of treatment of a patient
are computed, the figures, no doubt, reach exorbitant levels.
While anticancer medicines account for the majority of
patented medicines, there are quite a few patented medicines
used for other therapeutic purposes too, such as antihyperten-
sives, anti-diabetics, bronchodilators, and antifungal, antiret-
roviral, and anti-hepatitis medicines. To name just a few, Inda-
caterol, a bronchodilator patented by Novartis is priced at
`2,479 per inhaler; Abatacept, an anti-rheumatoid medicine
patented by Bristol-Myers Squibb (BMS) is priced at `30,000
for a 250 mg vial; Tocilizumab, marketed by Roche for rheu-
matoid arthritis is priced at `20,274 for a 200 mg vial (AIOCD–
AWACS monthly sales data of May 2017).
In the therapeutic regimen for tuberculosis, Bedaquiline,
the only medicine that obtained a patent from the USFDA in the
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SPECIAL ARTICLE
last 40 years, faces the issue of inaccessibility in India, more than
affordability (Datta 2016). This medicine is patented by Janssen
Pharmaceuticals and is used for the treatment of multidrug-
resistant tuberculosis. Although priced high, the company
supplies the medicine “free” to patients through the Revised
National Tuberculosis Control Programme. Despite this relief
provided by the company, the medicine is available only in six
centres across the country (Economic Times 2017). Cases such as
this demonstrate the requirement for a quick solution to address
the twin issues of affordability and accessibility of patented anti-
tuberculosis medicines in India, especially when “India accounts
for one fourth of the global tuberculosis burden” (GoI 2017).
Pricing of Medicines in India
The National Pharmaceutical Pricing Authority (NPPA) under
the Department of Pharmaceuticals is tasked with the respon-
sibility of fixing the prices of medicines in India. The NPPA im-
plements the Drugs (Prices Control) Order (DPCO), 2013 which
aims at making available essential and life-saving medicines to all
at affordable prices through price control.7 The DPCO, 2013 draws
its powers from the Essential Commodities Act, 1955 (EC Act).
The DPCO, 2013 follows a market-based pricing methodo-
logy for fixing the ceiling prices of medicines. The key principle
underlying the market-based pricing methodology of the
DPCO, 2013 is “essentiality.” This principle is satisfied by con-
sidering the list of medicines included in the National List of
Essential Medicines (NLEM) declared by the Ministry of Health
and Family Welfare, and revised from time to time. The NLEM,
20118 was adopted as Schedule-I of the DPCO, 2013. Subse-
quently after the notification of the NLEM, 2015,9 it came to be
adopted as Schedule-I of the DPCO, 2013. The NPPA fixes and
notifies ceiling prices of formulations listed in Schedule-I.
Pharmaceutical companies launching products that qualify as
“new drugs”10 under the provision of paragraph 2(u) of the
DPCO, 2013 need prior price approval from the NPPA.
The DPCO, 2013 in paragraph 32 has exempted patented
medicines developed indigenously in India from the purview
of price control.11 This exemption is valid for a period of five
years from the date of commencement of commercial produc-
tion of the product. The domestic pharmaceutical industry has
not taken advantage of this provision till date. On the other
hand, patented medicines developed outside India fall under
price regulation if listed in the NLEM; if not, such medicines
remain outside the price control regime.
The National Pharmaceutical Pricing Policy (NPPP), 2012 of
the Government of India12 has not outlined guidelines regard-
ing the broad principles to be considered for determining the
prices of patented medicines. The policy has only given a plain
suggestion that a decision on pricing of patented medicines
would be taken based on the recommendations of the commit-
tee constituted by the government for the purpose.
Pricing in the NLEM
Currently, patented medicines included in the NLEM fall
under the purview of the DPCO, 2013. The NLEM, 2015
has included some patented medicines such as Entecavir,
54
Raltegravir, Sofosbuvir and Trastuzumab. These medicines
are, therefore, scheduled formulations in accordance with the
provisions of the DPCO, 2013. The NPPA has fixed the ceiling
prices of these patented medicines on market-based price
fixation methodology.
BMS enjoys a valid Indian patent running till 2021 for Ente-
cavir, an anti-hepatitis B medicine. Raltegravir—an antiretro-
viral medicine used in the treatment of AIDS patients who have
failed both first- and second-line antiretroviral treatment—
has an Indian patent valid till 2022 in favour of MSD Pharma-
ceuticals. The NPPA fixed the ceiling prices of these patented
medicines in March 2016. The ceiling price of Trastuzumab, an
antineoplastic patented by Roche was also notified by the NPPA
on a market-based methodology in May 2016.13 The patent of
Roche has since expired.
Sofosbuvir, a nucleotide analogue used in the treatment of
hepatitis C and marketed by Gilead Sciences has a valid patent
in the US and Europe, and in India. A 12-week treatment with
this drug could cost around $84,000 in the US (Hill et al 2016).
The patent story of Sofosbuvir has had its twists and turns in
India with the Office of the Deputy Controller of Patents, New
Delhi denying Gilead a patent for the product on 13 January
2015,14 as the company could not establish inventiveness and
novelty for the product. The authority rejected the patent as it
found that the product had only minor modifications compared
to the previous formulations. However, on 9 May 2016, the Of-
fice of the Deputy Controller of Patents, New Delhi dismissed
all pre-grant opposition and granted a patent to Sofosbuvir,
having found the product to be novel, inventive and therefore
patentable under the patents act.15
The reversal of the decision by the patent office has raised a
few eyebrows concerning the availability of affordable Sofos-
buvir, which is considered to have a significant therapeutic use
in the treatment of hepatitis C (Hindu 2016). It is also reported
that Gilead had entered into voluntary licence agreements
with a few Indian companies to manufacture the product for
retail sale and for export. The ceiling price of Sofosbuvir was
fixed and notified by the NPPA in May 2016 on a market-based
pricing methodology taking into account the prices of differ-
ent voluntary licensed versions of Sofosbuvir for the purpose
of computation of price.16
The possibility of exclusion of patented medicines from the
NLEM and from the ambit of general pricing regulations pro-
vides scope to the companies to launch their products at high
prices. If the patented medicine is included in the NLEM and,
hence, in Schedule I of the DPCO, 2013, then the patentee may
perhaps consider entering into voluntary licences with other
local manufacturers. This has a positive spillover effect from
the public health perspective, as it can help bring down the
prices to some level at least, as was seen in the pricing data of
some patented medicines.
Similarly, threats of compulsory licensing have prompted
innovator pharmaceutical companies to bring down the prices
of their patented medicines and even to enter into voluntary
licences in countries such as South Africa and Brazil (Scherer
2007). In India, the legal legitimacy for compulsory licences in
JUNE 2, 2018 vol lIiI no 22 EPW Economic & Political Weekly

the patent regulations has been put to use only once as of date.
In March 2012, the Controller General of Patents granted a
compulsory licence in favour of Natco Pharma, permitting it to
manufacture and market Sorafenib tosylate used in the treat-
ment of kidney cancer,17 rejecting the claims of the patentee,
Bayer. This decision sent a strong signal to the pharmaceutical
industry that patient requirements cannot be ignored when
patented medicines are priced exorbitantly high, making them
unaffordable and inaccessible (Nedumpara 2012). Thus, “if
properly calibrated, compulsory licensing can ensure an effec-
tive balance between public interest and legitimate private in-
terest of patients” (Kuan 2009).
Pricing under DPCO, 2013
Under paragraph 19 of the DPCO, 2013,18 the maximum retail
price of Sitagliptin, an oral anti-diabetic, was capped in public
interest in July 2014.19 Sitagliptin has a valid Indian patent
granted by the Controller General of Patents. The patentee,
MSD, which imports and markets Sitagliptin as Januvia, has
also entered into an agreement with Sun Pharma Laboratories,
which sells Sitagliptin under the brand name, Istavel. A group
of pharmaceutical companies had approached the Bombay
High Court seeking the quashing of the NPPA’s order whereby
prices of 106 medicines (antihypertensive and anti-diabetic
medicines) were capped by the NPPA in July 2014, under para-
graph 19 of the DPCO, 2013. (Sitagliptin was one medicine in
this list of 106.) However, the court, while dismissing the writ
petition on 26 September 2016, did not find any reason to
interfere with the notification issued by the NPPA in regulating
the price of this medicine as well as other medicines covered in
the referred notification.20 A special leave petition filed by the
above group of pharmaceutical companies too was dismissed
by the Supreme Court on 24 October 2016 (Indian Pharmaceu-
tical Alliance and Another v Union of India and Others 2016b).
Patentees not only fix the prices of their products at unaf-
fordable levels for the public, but also tend to resort to legal
recourse whenever generic manufacturers launch variants of
the patented products, without any agreement or understanding
with the patentee. In the case of Erlotinib, Cipla had launched
a modified version (a different polymorph). A series of litiga-
tions followed. The Delhi High Court in November 2015 ruled
that Cipla’s version of the product infringed upon Roche’s patent
(F Hoffmann-La Roche Ltd and Another v Cipla Ltd 2015). This
order, however, did not include any injunction in favour of
Roche as the patent was due to expire in March 2016. The
court ruled in favour of Roche in this case. Nevertheless, it re-
mains to be seen whether the case would draw attention of the
generic companies to interpret the loopholes in the patent laws
in a manner that would enable them to come out with modi-
fied and low-priced versions of the patented medicines, akin to
the evergreening tactics resorted to by the innovators.
Analysis
Such examples lead us to the important question as to whether
patented medicines need to be brought under the purview of
price control in the Indian context. When the prices are kept at
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SPECIAL ARTICLE
very high levels, automatically such medicines become out-
of-bounds for the poor. The patients literally “are at the mercy
of the patent-holders” when the products are priced high
(t’Hoen 2016). The impact becomes worse, as the cost of medi-
cines is to a large extent borne by the patient or their family in
India (Turrill 2013). Unaffordability of the medicine leaves the
patient with no option but to avoid purchasing the costly medi-
cine which would have given them an extended lease of life,
rather than get caught in a veritable debt trap. These new
“wonder medicines do not improve health unless patients are
actually able to receive them” (Outterson 2005). The conse-
quent consumer welfare loss and resultant dead-weight loss
far outweigh benefits that are secondary and likely to accrue
in future (Flynn et al 2009).
The WHO Commission on Intellectual Property Rights,
Innovation and Public Health had observed thus:
Where most consumers of health products are poor, as are the great
majority in developing countries, the monopoly costs associated with
patents can limit the affordability of patented healthcare products
required by poor people in the absence of other measures to reduce
prices or increase funding. (WHO 2006: 174)
The introduction of new highly priced patented medicines
in the Indian market has triggered discussions on the need for
price regulation of patented medicines. Some researchers,
having analysed the prices of imported patented medicines to
India, have observed that, while no real technology transfer
has happened, higher prices are levied on the Indian consum-
ers (Chaudhuri 2014). The impact on the public becomes
substantial as newer products with significant breakthrough
effects are introduced in different therapeutic regimes,
which are largely unaffordable for the common man (Grace
2005). Thus, in the imperfect patented medicine market, the
price of the patented medicine becomes the major determi-
nant of the quality of life of the patient or a life-or-death de-
ciding factor for the patient. Given this situation, it becomes
imperative that some yardsticks are firmed up to overcome
the challenges and imperfections thrown up by the patented
medicine market.
The unaffordable prices of patented medicines compromise
equitable access to them and threaten the financial sustaina-
bility not only of patients, but even that of the public health
system (Espin et al 2011). When patented medicines are ex-
cluded from the national list of essential medicines or for that
matter any essential medicine list of any state government or
any government health institution, the loser is the patient:
they lose the opportunity to purchase the patented medicine at
a price that they can afford. Medicines that have a patent tag
are those which are required by patients for specialised treat-
ments, most often when the normal or first- and second-line
treatments have failed. It, therefore, becomes important that
new-generation medicines with better potential for treatment
or cure become available at affordable prices.
Left to itself, the market will fix the prices arbitrarily for
such patented medicines. The market’s focus would only be to
recover the fixed costs of the product from the sale of the prod-
ucts, during the validity period of the patent, so as to recoup
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SPECIAL ARTICLE

the investment in R&D for discovery of the product. There are
no intrinsic checks and balances in the market when a patented
medicine is introduced, as there is no competition from any
rival pharmaceutical company for market space for the same
product. Governments in their national health programmes
will also not be able to procure such medicines even in the face
of overwhelming public demand, except in certain select cases
like that of Bedaquiline.
In a country like India, this puts undue burden on the
patients who are already impoverished by the magnitude of
the disease. There is, hence, no other alternative but to con-
sider some form of price regulation for patented medicines.
Besides, there is no express provision either in the WTO or the
TRIPS agreement that explicitly prohibits price regulation of
patented medicines (Chaudhuri 2012).
Conclusions
Keeping the interest of the citizens in mind, it is important to
firm up a blueprint for price regulation of patented medicines
in India. This will, no doubt, be a complicated exercise, the
stringency of which would depend on a multiplicity of factors,
including the outcome of a complex bargaining process be-
tween the government and the patentee (Lanjouw 2004).
Patented medicines that need to be made more affordable
from a therapeutic perspective are to be identified as a first step
for this exercise. This has to be done judiciously, after studying
the standard therapeutic protocols for the treatment of specific
diseases. Those patented medicines that have been included
in the list of essential medicines should not be exempt from
the provisions of price control. Where the medicine can be
made part of any governmental programme, as was done for
Bedaquiline, urgent steps are required for ensuring accessibility.
A move to bring in any form of price regulation of patented
medicines may not go down well with the pharmaceutical in-
dustry, as they may fear an imminent dip in their revenues.
However, economies of scale would aid the industry in in-
creasing sales and, hence, regaining lost profits. Moreover, the
patients would stand to gain financially and in clinical out-
come levels. A market study analysis by the industry will also
facilitate voluntary licence agreements with generic manufac-
turers, with a price advantage for the patient. Any governmen-
tal measure signalling a compulsory licence will indirectly
facilitate a lowering of price for the patient, while at the same
time widening the reach of the medicine. Price regulation of
patented medicines in some form would be a win–win solution
for both, patients and the pharmaceutical industry.

NOTES
1 Article 27 of TRIPS—Patentable Subject Matter
1 Subject to the provisions of paragraphs
2 and 3, patents shall be available for any
inventions, whether products or processes,
in all fields of technology, provided that
they are new, involve an inventive step
and are capable of industrial application.
Subject to paragraph 4 of Article 65, para-
graph 8 of Article 70 and paragraph 3 of
this article, patents shall be available and
patent rights enjoyable without discrimi-
nation as to the place of invention, the
field of technology and whether products
are imported or locally produced.
2 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, pro-
vided that such exclusion is not made
merely because the exploitation is prohib-
ited by their law.
2 The Doha declaration
5 Accordingly and in the light of paragraph
4 above, while maintaining our commit-
ments in the TRIPS Agreement, we recog-
nize that these flexibilities include:
[…]
(b) Each Member has the right to grant com-
pulsory licences and the freedom to deter-
mine the grounds upon which such licences
are granted.
(c) Each Member has the right to determine
what constitutes a national emergency or
other circumstances of extreme urgency,
it being understood that public health cri-
ses, including those relating to HIV/AIDS,
tuberculosis, malaria and other epidem-
ics, can represent a national emergency or
other circumstances of extreme urgency.
(d) The effect of the provisions in the TRIPS
Agreement that are relevant to the ex-
haustion of intellectual property rights is
to leave each Member free to establish its
own regime for such exhaustion without
challenge, subject to the MFN and national
treatment provisions of Articles 3 and 4.
(WTO nd)
3 Article 65.5 of TRIPS—Transitional Arrange-
ments:
A Member availing itself of a transitional pe-
riod under paragraphs 65. 1, 2, 3 or 4 shall
ensure that any changes in its laws, regula-
tions and practice made during that period
do not result in a lesser degree of consistency
with the provisions of this Agreement.
4 The WTO’s Council for Trade-related Aspects
of Intellectual Property Rights (TRIPS) decid-
ed at the meeting held on 6 November 2015
that least developed country members of the
WTO will be allowed to maintain flexibility in
their approach to patenting pharmaceutical
products until at least 2033. This is in line with
the directions set by WTO ministers in the
Doha Declaration on TRIPS Agreement and
Public Health in 2001.
5 The Indian Patents Act defines patents in Sec-
tion 2(m) of the act as any new invention
granted under the act. Invention is defined
under Section 2(1)(j) of Patents Amendment
Act, 2002 as “new product or process involving
an inventive step and capable of industrial
application.”
The Patents (Amendment) Act, 2005 defined
“inventive step” in Section 2 (i)(ja) as “a fea-
ture of an invention that involves a technical
advance as compared to the existing knowl-
edge or having economic significance or both
and that makes an invention not obvious to a
person skilled in the art.”
Section 3(d) of the Indian Patents Act is broad-
ly regarded as the provision defining the stand-
ards of Indian patentability, a section that is
widely held to be one which discourages “ever-
greening of new molecules.”
Section 3(d) reads “the mere discovery of a
new form of a known substance which does not
result in the enhancement of the known effica-
cy of that substance or the mere discovery of
any new property or new use for a known sub-
stance or of the mere use of a known process,
machine or apparatus unless such known pro-
cess results in a new product or employs at
least one new reactant,” as not falling within
the ambit of invention in accordance with the
meaning of the act:
Explanation: For the purpose of this clause,
salts, esters, ethers, polymorphs, metabo-
lites, pure form, particle size, isomers,
complexes, combinations and other deriv-
atives of known substance shall be consid-
ered to be the same substance, unless they
differ significantly in the properties with
regard to efficacy.
6 The All India Organisation of Chemists and
Druggists (AIOCD–AWACS) collects monthly
sales and price data regarding sales of pharma-
ceutical products in India. The database other-
wise called Pharmatrac maintains the price
data formulation wise and is made use of by the
National Pharmaceutical Pricing Authority for
working out the ceiling prices of medicines
listed in Schedule-I of the DPCO, 2013. The da-
tabase also captures data regarding year of
launch of the product, the maximum retail
price of the product and the quantity of the
drug sold in the market.
7 The DPCO, 2013 was notified by the Depart-
ment of Pharmaceuticals (Ministry of Chemi-
cals and Fertilizers), Government of India on
15 May 2013.
8 The NLEM 2011 was published by the Ministry
of Health and Family Welfare in 2011 and in-
cluded in the First Schedule of the DPCO, 2013
by the government through a notification in
the official gazette (para 2(t) of DPCO, 2013).
9 The NLEM 2015 was notified by the Ministry of
Health and Family Welfare, Government of
India vide notification no X. 11011/1/2015, dated
23 December 2015.

56 JUNE 2, 2018 vol lIiI no 22 EPW Economic & Political Weekly


The Department of Pharmaceuticals notified
the NLEM, 2015 as Schedule-I of DPCO, 2013 vide
notification no 701 (E), dated 10 March 2016.
10 “New drug,” as defined under para 2(u) of the
DPCO, 2013, means a formulation launched by
an existing manufacturer of a drug of specified
dosages and strengths as listed in the NLEM, by
combining the drug with another drug either
listed or not listed in the NLEM or a formulation
launched by changing the strength or dosage or
both of the drug as listed in the NLEM.
11 Para 32 of the DPCO, 2013:
Non-application of the provisions of this order
in certain cases. The provisions of this order
shall not apply to,
(i) a manufacturer producing a new drug pat-
ented under the Indian Patent Act, 1970
(39 of 1970) (product patent) and not pro-
duced elsewhere, if developed through in-
digenous Research and Development, for
a period of five years from the date of com-
mencement of its commercial production
in the country.
(ii) a manufacturer producing a new drug in
the country by a new process developed
through indigenous Research and Devel-
opment and patented under the Indian
Patent Act, 1970 (39 of 1970) (process pat-
ent) for a period of five years from the date
of the commencement of its commercial
production in the country.
(iii) a manufacturer producing a new drug in-
volving a new delivery system developed
through indigenous Research and Devel-
opment for a period of five years from the
date of its market approval in India.
12 The National Pharmaceutical Pricing Policy
(NPPP) 2012 was notified by the Government
of India on 7 December 2012.
13 The ceiling price of Entecavir 0.5 mg tablet and
Entecavir 1 mg tablet was fi xed by the National
Pharmaceutical Pricing Authority (NPPPA) at
` 71 and ` 112.81, respectively, vide price notifi-
cation No S.O.1254 (E), dated 29 March 2016.
The ceiling price of Raltegravir 400 mg tablet
was fixed by the NPPA at `139.25 vide price no-
tification No S.O.1254 (E), dated 29 March 2016.
The ceiling price of Trastuzumab 440mg/50 ml
injection pack was fixed by the NPPA at
`5,5812.29 per pack vide price notification No
S.O.1687 (E), dated 9 May 2016 (NPPA 2016).
14 The Deputy Controller of Patents, New Delhi,
rejected the patent application of Gilead Life
Sciences for its product Sofosbuvir under the
relevant sections of the patents act vide an or-
der dated 13 January 2015, in patent applica-
tion No 6087/DELNP/2005.
15 The Deputy Controller of Patents, New Delhi,
granted a patent to Gilead Life Sciences for its
product Sofosbuvir under the relevant sections
of the patents act vide anorder dated 9 May
2016, in patent application No 6087/DEL-
NP/2005.
16 The ceiling price of Sofosbuvir was fixed and
notified as `619.31/400 mg tablet by the NPPA
vide notification No S.O. 1254 (E), dated 29
March 2016 (NPPA 2016).
17 Decision of the Controller General of Patents in
Natco vs Bayer in compulsory licence applica-
tion No 1 of 2011 (9 March 2012).
18 Para 19 of the DPCO, 2013:
Fixation of ceiling price of a drug under
certain circumstances. Notwithstanding
anything contained in this order, the gov-
ernment may, in case of extra-ordinary
circumstances, if it considers necessary so
to do in public interest, fix the ceiling price
or retail price of any drug for such period,
as it may deem fit and where the ceiling
price or retail price of the drug is already
fixed and notified, the government may al-
low an increase or decrease in the ceiling
Economic & Political Weekly EPW JUNE 2, 2018 vol lIiI no 22
price or the retail price, as the case may
be, irrespective of annual wholesale price
index for that year.
19 Notification of NPPA, Department of Pharma-
ceuticals, Ministry of Chemicals and Fertiliz-
ers, Government of India -S.O. 1735 (E) dated
10 July 2014 (NPPA 2014). This notification in-
dicates that NPPA capped the MRP of Sitaglip-
tin 100 mg, an oral antidiabetic medicine at
`41.8 per tablet, “as prices of Sitagliptin tablets
in the strength of 100 mg manufactured/ mar-
keted in brand name by respective companies,
M/s MSD and M/s Sun Pharma were found ex-
ceeding the limit of simple average price of
medicine plus 25% as per market-based data
(IMS Health) for the month of April 2014.”
20 The High Court of Bombay dismissed the peti-
tion filed by Indian Pharmaceutical Alliance
(IPA) on 26 September 2016. The court observed
that the price notifications such as those of the
NPPA dated 10 July 2014 capping the prices of
106 medicines (84 cardiovascular and 22 antidi-
abetic formulations) “become necessary, espe-
cially when exploitative pricing makes medi-
cines un-affordable and beyond the reach of most
and also puts huge financial burden in terms of
out-of-pocket expenditure on health. ... The
drugs and medicines must reach all those who
can afford and all those who cannot afford.” The
court did not hold the view that the government
exceeded its power while issuing these notifica-
tions (Indian Pharmaceutical Alliance and Another
v Union of India and Others 2016a).
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—Anwesha Sengupta, Ishan Mukherjee
—Anwesha Sengupta
—Jack Loveridge
—Kaustubh Mani Sengupta
—Garima Dhabhai
—Uttara Shahani
vol lIiI no 22 EPW Economic & Political Weekly