Compulsory License Patents
Compulsory License Patents
Compulsory License Patents
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THE CURIOUS CASE OF COMPULSORY LICENSING IN INDIA
Tn a move that has alarmed the pharmaceutical so, may inhibit competition, both IP and competition
.industry, in March 2012 the Indian Patents Office law share the common aim of encouraging innovation,
granted its first compulsory licence, for the manufacture enhancing consumer welfare and encouraging
and sale of Bayer's patented drug Nexavar, in Natco allocative efficiency. Academic literature on the
Pharma Limited v Bayer Corporation (Natco v Bayer).' subject has recognised IP and competition law as being
This article analyses the compulsory licence issued in mutually complementary and re-enforcing. 2
Natco v Bayer and discusses the possibility of a similar Moreover, competition law does not seek to prohibit
compulsory licence being issued under the provisions exclusivity per se; it aims to prevent the misuse or abuse
of India's competition legislation, the Competition Act, of exclusivity in certain circumstances. This is evidenced
2002 (Competition Act). In doing so, we debate the by the prohibition of exclusivity agreements only where
scope of a potential refusal-to-license abuse under the enterprises in a vertical relationship enjoy market
Competition Act and outline a possible approach for power or where exclusivity arrangements are imposed
the Competition Commission of India (CCI) to adopt by a dominant enterprise. This is also illustrated in the
if it should decide to issue compulsory licences. seminal judgment of Consten & Grundig,3 where the
European Court ofJustice (ECJ) distinguished between
the existence of an IP right and the improper exercise
Intellectual property and competition law:
of the same. Accordingly, IP and competition laws are
inherent conflict? being viewed as complementary.
The relationship between competition law and
intellectual property (IP) rights can be best described Natco v Bayer
as a 'tale of uneasy bedfellows'. The application and
IP laws in India have long made provision for the
enforcement of competition law to IP rights is highly
grant of a compulsory license. However, section 84
topical and hotly debated. The reason for the debate is
of the Patents Act, 1970 (Patents Act), the provision
that while IP laws, such as patent laws, confer exclusive
under Indian patent law that provides for the issue of
rights, competition law seeks to ensure a competitive
a compulsory licence, was enforced for the first time
market place. The monopoly granted to a holder of
in Natco v Bayer, in relation to Bayer's patented drug
an IP right can create barriers to entry and give rise 'sorafenib tosylate'.
to market power, the abuse of which is prohibited by
Bayer sells sorafenib tosylate, which is used for the
competition law. As a result, some courts, academics
treatment of the advanced stages of kidney and liver
and practitioners see an inherent conflict between
cancer, under the brand name 'Nexavar'. Nexavar is
these two bodies of law and have traditionally sought to
a life-enhancing and not a life-saving drug; it seeks to
balance the need for incentivising innovation through
extend the life of a patient afflicted with the last stages
exclusivity protection with the efficiency benefits of
of kidney or liver cancer. Bayer launched Nexavar in
open access competition.
2006 and was granted a patent by the Indian patents
This view, however, is overly simplistic and short-
authority on 3 March 2008. Bayer then sold the drug
sighted. Whilst IP laws grant exclusivity and, in doing
to patients in India suffering from the advanced stages
of kidney and liver cancer at a cost of Rs 280,428 It is also relevant to note that the Controller
(approximately US$5,278) per month.4 Natco, an found that Bayer failed to contribute to the transfer
Indian pharmaceutical company, had applied to Bayer and dissemination of technology, so as to counter-
for a voluntary licence to manufacture and sell the balance the exclusive rights granted by a patent with
drug, and proposed to sell sorafenib tosylate at a price the obligations of a patentee that arise under the
of Rs 8,800 (approximately US$167) for a month's Patent Act.' It appears, therefore, that similar to a
therapy, a fraction of the price being charged by Bayer. competition authority, the Controller balanced the
However, Natco's request was refused by Bayer. Three interests of a patent holder, on the one hand, with the
years after the grant of Bayer's patent for sorafenib interests of promoting and sustaining competition,
tosylate, Natco filed an application for the grant of a on the other hand.
compulsory licence at the Indian Patents Office. Interestingly, whilst Bayer has filed an appeal
Under the Patents Act, a compulsory licence may be before the Intellectual Property Appellate Board,
granted after the expiration of three years of the grant the Controller's decision triggered a price war in the
of a patent, on any of the following grounds:' cancer-drug market. Cipla,9 an Indian pharmaceutical
(i) that the reasonable requirements of the public company, has slashed the price of its cancer drugs,
with respect to the patented invention have not including sorafenib tosylate, which it now offers at Rs
been satisfied; or 6,840 (approximately US$128) per month. The Swiss
(ii) that the patented invention is not available to company Roche has also slashed prices of some of its
the public at a reasonably affordable price; or life-saving drugs. Natco, of course, as recorded in the
(iii) that the patented invention is not worked in the Controller's decision, is committed to sell the drug at
territory of India. no more than Rs 8,880 (approximately US$167) for
In Natco v Bayer, the Controller General of Patents, a month's dosage, the initial price Natco offered in
Designs and Trademarks of the Indian Patents Office its earlier application to Bayer for a voluntary licence
(Controller) concluded that all three grounds on which for the drug. News reports suggest that Bayer is itself
a compulsory licence could be granted under section 84 considering a price reduction for Nexavar.
of the Patents Act were satisfied.6 A compulsory licence
for the manufacture and sale of sorafenib tosylate was
Compulsory licensing and competition law
granted to Natco for the balance term of the patent,
subject to the payment of a royalty of six per cent of Just as it is generally considered appropriate for a
the net sales of the drug to Bayer. competition authority to order a divestiture of physical
Many in India believe that Bayer's failure to assets as a condition to approving an otherwise anti-
substantiate the costs involved in developing Nexavar competitive merger, a divestiture of IP assets could be
was one of the principal reasons why the Controller considered as a remedy for anti-competitive behaviour.
found reason to issue the compulsory licence. However, the history of non-merger compulsory
Accordingly, IP law practitioners in India were not licensing by competition authorities, both in the EU
surprised that the Controller relied on grounds (i) and in the US, has been inconsistent and at odds with
and (ii) above, as Nexavar was accessible to only two the current global approach to IP and competition laws.
per cent of the total number of potential patients, Competition authorities in foreign jurisdictions have
despite four years having lapsed since the grant of granted compulsory licences under the competition
the patent.' However, the Controller's reliance on provisions of their respective statutes, notwithstanding
ground (iii), that is, 'that the patented invention similar provisions in IP laws. Compulsory licences
is not worked in the territory of India', has caused have been issued in cases concerning an abusive
much consternation. The Controller interpreted refusal to supply, to correct the anti-competitive
the expression 'worked in the territory of India' to practices resulting from the exclusivity granted by an
imply that a patented product must be manufactured IP right, and where the refusal prevents demand for a
in India to a reasonable extent or that the patentee new product. This is done after a careful comparative
must grant a licence to third parties to manufacture analysis between the need to encourage innovation
the patented product in India. However, this and the goal of promoting and fostering competition,
interpretation sets a dangerous precedent, where the as will be discussed below.
availability of a patented product solely by imports as In the Indian context, whilst there is currently no
opposed to domestic manufacturing justifies the grant guidance on whether, and under what circumstances,
of a compulsory licence under the Patents Act, even if the CCI would grant a compulsory licence, such a
the reasonable requirements of the public are being remedy appears to be within the CCI's ambit. In
satisfied at a reasonable price. addition, recent decisions of the CCI and the Preamble
to the Competition Act, which will be discussed in from those offered by Microsoft in terms of
detail below, raise concerns that the CCI may follow advanced performance, security and functionality.
the approach of the Controller in Natco v Bayer. Consequently, the CFI judgment in Microsoft waters
Before we discuss the possible Indian approach, we down the new-product test, as it held to be sufficient
outline the approach in the European Union (EU) and that such new products vary from the existing
the United States (US) in issuing compulsory licences products in terms of certain capabilities. It was not
under competition law. necessary to show the creation of an entirely new
product on a separate market.
The CFI's benign application of this 'new product'
The EU approach requirement in Microsoft has been criticised by
Generally, the holder of an IP right has no obligation academics and practitioners alike. 7 In contrast, in
to license their intellectual property and, in most Magill TV guide, there was clearly a new product,
circumstances, will not be held to violate EU different in conception to all existing guides. In
competition law by unilaterally refusing to license IMS Health, the ECJ found that refusal to license
their IP right to competitors. intellectual property 'may be regarded as abusive
The circumstances that characterise the exercise only where the undertaking which requested the
of exclusive rights as abusive conduct were discussed license does not intend to limit itself essentially to
by the Court of First Instance (CFI, now the General duplicating the goods or services already offered on
Court) in the Magill TV guide case.i On appeal, the the secondary market by the owner of the intellectual
ECJ12 held that it is only in 'exceptional circumstances' property right, but intends to produce new goods or
that the exercise of an exclusive right by the holder services not offered by the owner of the right and for
of an IP right results in an abuse of dominance. Such which there is potential consumer demand'." The
exceptional circumstances were said to exist when: new-product requirement stems from the balance
* the refusal relates to a product or service that needs to be achieved between protecting IP
indispensableto the exercise of a particular activity rights and the incentives to innovate versus the
on a neighbouringmarket; 'protection of free competition'." 9 The secondary
* the refusal is of such a kind as to exclude any effective market requirement thus serves as an additional
competition on that neighbouringmarket, and condition when IP rights are at stake and provides
" the refusal prevents the appearanceof a new product an additional ground of protection to the dominant
for which there is potential consumer demand."3 undertaking holding the IP right, in order to ensure
Once it is established that such exceptional that the compulsory licence is not merely issued to
circumstances are present, a dominant undertaking's duplicate goods or services offered by the dominant
refusal to grant a licence may constitute an abuse of undertaking. However, the CFI's lenient approach to
dominance, unless such refusal is objectively justified. the new product test seems to suggest a lesser degree
These conditions were reiterated by the ECJ in IMS of protection of IP rights than previously afforded in
Health, where a refusal to license IP rights was held to Magill TV guide and IMS Health.
amount to an abuse only when a competitor wished
to produce new goods or provide new services on a
neighbouring market using such IP, for which there is The American approach
14
potential consumer demand. In the US, compulsory licensing is a well-established
In Microsoft,"5 where the CFI was again confronted remedy to address competition concerns arising from
with the issue of a compulsory licence for a protected proposed mergers, as it involves the consent of parties
IP right, the CFI did not require the European and usually the grant of only a single licence. US cases
Commission to follow a strict application of the involving compulsory licences outside the merger
,new product on a neighbouring market' test. context have a long but contradictory history.
Instead, the CFI observed that if competitors were The general rule under US antitrust law is that there
granted access to Microsoft's copyright, 'far from is no general duty to deal with competitors. 20 However,
merely reproducing the Windows systems already liability under section 2 of the Sherman Act (provisions
on the market' competitors would offer products governing abuse of dominance in the US) will accrue
which 'will be distinguished from those (Microsoft) when the refusal by a holder of an IP right enjoying a
systems with respect to parameters which consumers dominant position in the relevant market constitutes
consider important'.i" Thus, the CFI found that exclusionary conduct. The more recent judgments of
the new product test was readily satisfied, insofar Trinko21 in 2004 and Linkline22 in 2009 endorse the view
as the products offered by competitors differed that 'under certain circumstances, refusal to cooperate
with rivals can constitute anti-competitive conduct' but India: the curious case
that courts should be very cautious in recognising such
In enacting the Competition Act, India has come a
exceptions to the general rule that even monopolists
long way from the days of the prior Monopolies and
may choose with whom they deal.23 It must be noted that
Restrictive Trade Practices Act regime. Whilst under the
though Trinko and Linkline did not involve intellectual
old regime, big was bad, the Competition Act, in line
property, they condition US jurisprudence on refusals
24 with regimes around the world, focuses on companies
to license Ip.
only when they are dominant and prohibits an abuse of
Though US Courts of Appeal have considered
such dominance. This change in approach is reflective
whether a unilateral refusal to license would amount
of the changing social, economic and political attitudes
to a violation of section 2 of the Sherman Act, their
in India.
decisions have been divergent. In Kodak, the Ninth
However, India remains a country with socialist goals.
Circuit Court of Appeals found that if the patent
This is reflected in the Preamble to the Competition
holder is not genuinely exercising their IP rights
Act, which provides for 'the establishment of a
and if the intent is not to enforce such rights, the
Commission to prevent practices having adverse effect
presumption of the legal exercise of IP rights will not
on competition, to promote and sustain competition
apply.25 In contrast, in Xerox, the Court of Appeals
in markets, to protect the interests of consumers'. The
for the Federal Circuit questioned the benefit of
CCI, in its decisions as well as public statements, places
examining intention and imposed a different standard
greater emphasis on the interests of the 'common man'
in holding 'in the absence of any indication of illegal
than on competitors or the competitive process.
tying, fraud in the Patent and Trademark Office or
Such an approach, especially in light of the
sham litigation', the patent holder should be immune
Controller's decision in Natco v Bayer, gives rise
from antitrust law. 26 Thus, a firm would not be held
to serious concern that the CCI may consider the
to abuse its dominance unless:
grant of a compulsory licence even in the absence
* the refusal was a part of an illegal tie-in;
of 'exceptional circumstances' and that consumer
* the patent was obtained by fraud; or
welfare/socialist considerations may skew the balance
* the patentee instituted litigation with the intent
between the protection of IP and free competition.
to interfere with a competitor's business.
Compulsory licences under IP laws are generally
The US precedents on abusive unilateral refusal to
granted on public interest considerations, whereas
license are, therefore, inconsistent. The Trinko and
compulsory licences under competition law are
Linklinejudgments may indicate that courts would be
typically based on the need to restore effective
more likely to endorse the Federal Circuit's view in Xerox
competition in the market place. However, the CCI
than the Ninth Circuit's view in Kodak.27 Accordingly,
would certainly note with interest the change in market
the likely standard may be one that finds an abuse in
dynamics following the Natco v Bayer decision. As was
very narrow circumstances, when a patentee attempts
highlighted earlier, the compulsory licence granted to
to enlarge the scope of their IP right.
Natco triggered a price war," resulting in enhanced
Some jurisdictions take a broader approach to
competition in the cancer drug market - a result a
defining anti-competitive behaviour than the EU and
competition authority may seek to achieve through
the US.2 While Western jurisdictions consider the
remedies. However, by no means do we imply that this
protection of IP rights as sacrosanct and may find
would be a correct approach.
that too much regulation amounts to protectionism,
Under the Competition Act, an enterprise is guilty of
this is not necessarily true of the developing world.
abusing its dominant position if, inter alia, it imposes
Competition law in developing economies may be
unfair prices, limits the production of goods or services,
guided by objectives that are inherently dissimilar
restricts the technical or scientific development of
from the aims of antitrust in Western jurisdictions. In
goods or services, or denies market access. 2 Whilst
fact, there is a school of thought that suggests that in
there have been no CCI decisions to date dealing with
a developing economy, too much competition may
a refusal to license IP rights, the CCI's approach in
impair development. 9 Therefore, there is a genuine
the cases discussed below appears to suggest that the
concern that competition authorities in developing
CCI may evolve novel concepts to address perceived
countries may issue remedies they deem appropriate
consumer harm.
to promote development, notwithstanding years of
As stated earlier, the Controller in Natco v Bayer
competition jurisprudence and case law from more
granted a compulsory licence, inter alia, on the
mature jurisdictions, especially where IP exclusivity
ground that Nexavar was not available to the public at a
results in economic inequity and negligible social
reasonably affordable price. In doing so, the Controller
contribution.
in Natco v Bayer construed the term 'reasonably Belaire Owner's Association v DLF Limited and HUDA,35
affordable price' predominantly with reference to the where the CCI's primary concerns revolved around
price to the public and not with reference to Bayer's the treatment of apartment allottees by the dominant
costs. It is not inconceivable that a complaint could real estate enterprise, DLF. The CCI was particularly
potentially be filed against a dominant pharmaceutical critical of the terms and conditions imposed by DLF
company, alleging that the price charged is an unfair in the contracts that the company had signed with
price, as it is unaffordable to the public or because apartment allottees.36
other manufacturers could produce and make available In the Natco v Bayer decision, Bayer's inability to
the same drug at cheaper prices, in violation of section make Nexavar available to nearly 98 per cent of the
4(2) (a) (ii) of the Competition Act. Indian public 7 was held by the Controller to amount
In fact the CCI has, in MCX Stock Exchange Ltd & to a failure to satisfy the reasonable requirements
Ors v National Stock Exchange of India Ltd & Ors,3" of the public. In the absence of the requirements
interpreted the term 'unfair pricing' in relation to of the 'exceptional circumstances' test in India and
the costs of competitors. Similar to the Controller's given the consumer welfare focus of the CCI, it is
decision, in arriving at its conclusion that NSE abused not inconceivable that the CCI would adopt a similar
its dominant position, the CCI failed to consider the approach and find that the exercise of IP rights in such
cost structure of the NSE. Contrary to international a scenario limits the production of goods in violation of
principles, the CCI abandoned the as-efficient- section 4(2) (b) (i) of the Competition Act. Further, the
competitor test. Instead, the CCI held that NSE's Controller had observed that a patentee can contribute
prices were unfair vis-A-vis its competitor, MCX-SX, towards the transfer and dissemination of technology
who, despite having a larger market share in the by either manufacturing the product in India itself or
relevant market, in the CCI's view would be unable by granting a licence to a third party to manufacture
to compete.14 It should be noted that the CCI did the product in India, and that Bayer had failed to do
not find NSE to have engaged in predatory pricing, so. 8 The CCI could potentially construe such failure
but simply 'unfair pricing', implying a new abuse of by a dominant pharmaceutical company to limit or
non-predatory low pricing. If the CCI were to follow a restrict the technical or scientific development of goods
similar approach in relation to the prices of drugs of or services in India to the prejudice of consumers, an
a dominant pharmaceutical company, it could lead to abuse in contravention of section 4(2) (b) (ii) of the
disastrous results and potentially encourage the CCI Competition Act.
to follow an approach similar to that of the Controller. The decision in Natco v Bayer also states that 'the
A refusal to license IP exclusively held by a patentee (Bayer) thus took no adequate or reasonable
dominant enterprise may also be considered as a steps to start the working of the invention in the
constructive refusal to supply under the provisions of territory of India on a commercial scale and to an
the Competition Act. Such a refusal may be construed adequate extent'." The CCI may also be sympathetic
to limit the 'production of goods or provision of to arguments based on failure to 'work a patent',
services or market', or restrict the 'technical or given that exclusivity is reserved and that competing
scientific development relating to goods or services to enterprises are not granted the opportunity to access
the prejudice of consumers', or result in the 'denial of the patented product and compete with the dominant
market access', all three of which amount to abusive enterprise. The CCI could potentially adjudge such
conduct under sections 4(2) (b) (i), 4(2) (b) (ii) and failure to work a patent as amounting to a denial of
4 (2) (c) of the Competition Act, respectively. market access, an abuse listed under section 4(2) (c)
As discussed earlier, in the EU such a refusal of the Competition Act.
would be considered abusive only in 'exceptional In the authors' view, such an approach would
circumstances', when the refusal prevents the indeed be highly controversial, albeit not impossible,
emergence of a new product on a secondary market given the social and economic constraints faced by
for which there is potential consumer demand. Such developing countries such as India. Moreover, the
a refusal would be subject to a stricter standard still compulsory licence would be issued, not in order to
in the US. Whether the CCI will follow either the enable competitors to provide 'a new product on a
EU or US approach remains to be seen; however, neighbouring market', but to enable companies to
both the Controller's Natco v Bayer decision and the provide the same product at a fair price in order to
general attitude of the CCI seem to suggest a more satisfy demand.
consumer-oriented approach in India. The CCI's However, it is strongly recommended that even if the
concern over the exploitation of the Indian consumer CCI were to proceed on this basis, compulsory licences
by dominant enterprises was especially highlighted in be issued with great caution. It is critical that the royalty
determined is based on FRAND (fair, reasonable and The Natco v Bayer decision sets the precedent
non-discriminatory) terms and that the duration of the for making expensive patented drugs available for
licence is limited and constantly reviewed, so as to only compulsory licensing under the Patents Act. However,
remedy inadequate supply. The CCI must also exercise questions remain as to whether competitors of
caution to avoid falling into the trap of becoming a dominant undertakings holding patent rights may use
price regulator, a concept that competition authorities section 4 of the Competition Act to enable them to
around the world find disconcerting. compete on the same market as the IP owner.
The better approach would be for the CCI to refer The CCI may be tempted to intervene when a patent
any case dealing with compulsory licensing to the monopoly fails to address social and developmental
relevant IP authority in India. In fact, section 21A concerns and where public demand for a life-saving
of the Competition Act explicitly provides the CCI drug has not been met. Though competition law is
with the power to make a reference to a concerned a tool used for the attainment of economic freedom
statutory authority, where the CCI is faced with a and prosperity in developed economies of the EU
decision whose implementation is entrusted to such and the US, in a nation such as India, competition
other statutory authority. Relevant IP authorities in law may be motivated by other considerations,
India would have the requisite expertise to grant such including access to healthcare. Pharmaceutical
licence and determine equitable terms thereof. This countries may find great risk in operating in India
would also remove the problem of the CCI becoming if competition intervention is used to remedy social
a price regulator. In this regard, it is important to inequity rather than to ensure a competitive market
remember that competition law is not a panacea. There place. It is, therefore, recommended that compulsory
are other modes of redress available to parties seeking licensing as a remedy to anti-competitive conduct
a compulsory licence and, perhaps, adequate remedies should only be used where the dominance of the
lie elsewhere. defendant is unquestionable, no other equitable
Finally, a decision by the CCI to issue a compulsory remedy is available and where the interests in favour
licence could have other implications. Such decisions of a licensee are so strong, they trump any harm that
may cause IP-reliant firms to either abandon operations could be caused to the innovation incentives of IP
in India or refrain from entering the Indian market right holders.
altogether. A parochial approach to IP rights might
also diminish the attractiveness of the Indian market
to foreign direct investors, as weak protection of IP
rights and the threat of compulsory licensing tends
to lower the expected returns of foreign investments.
It is therefore recommended that the CCI grant a
compulsory licence only where the concerned IP
authority fails to do so or where there are over-arching
contraventions of competition law, and alternative
remedies are not sufficient. Given that the test
for establishing a refusal-to-license abuse and the
corresponding grant of a compulsory licence remedy is
itself subject to strict scrutiny in jurisdictions overseas, it
is recommended that the CCI be especially circumspect
in the exercise of such authority.
Conclusion
At a time where global pharmaceutical mergers are
subject to intense scrutiny by the Indian Government
and the marketing policies of the pharmaceutical
industry are being debated by the Indian bureaucracy,
the grant of India's first compulsory licence in this
sector has certainly raised eyebrows. The Natco v Bayer
decision has already resulted in an adverse perception
of the Indian pharmaceutical industry and may
adversely impact foreign investment in this sector.