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The Curious Case of Compulsory Licensing in India - Antitrust Writing Awards 2013

The Curious Case of Compulsory Licensing in India

Naval Satarawala Chopra and Dinoo Muthappa, Competition Law International, Vol 8 No 2, August 2012. In a move that has alarmed the pharmaceutical industry, in March 2012 the Indian Patents Office granted its first compulsory licence, for the manufacture and sale of Bayers patented drug Nexavar, in Natco Pharma Limited v Bayer Corporation (Natco v Bayer). [1] This article analyses the compulsory licence issued in Natco v Bayer and discusses the possibility of a similar compulsory licence being issued under the provisions of Indias competition legislation, the Competition Act, 2002 (Competition Act). In doing so, we debate the scope of a potential refusal-to-license abuse under the Competition Act and outline a possible approach for the Competition Commission of India (CCI) to adopt if it should decide to issue compulsory licences. Intellectual property and competition law: inherent conflict? The relationship between competition law and intellectual property (IP) rights can be best described as a tale of uneasy bedfellows. The application and enforcement of competition law to IP rights is highly topical and hotly debated. The reason for the debate is that while IP laws, such as patent laws, confer exclusive rights, competition law seeks to ensure a competitive market place. The monopoly granted to a holder of an IP right can create barriers to entry and give rise to market power, the abuse of which is prohibited by competition law. As a result, some courts, academics and practitioners see an inherent conflict between these two bodies of law and have traditionally sought to balance the need for incentivising innovation through exclusivity protection with the efficiency benefits of open access competition. This view, however, is overly simplistic and shortsighted. Whilst IP laws grant exclusivity and, in doing so, may inhibit competition, both IP and competition law share the common aim of encouraging innovation, enhancing consumer welfare and encouraging allocative efficiency. Academic literature on the subject has recognised IP and competition law as being mutually complementary and re-enforcing. [2] Moreover, competition law does not seek to prohibit exclusivity per se; it aims to prevent the misuse or abuse of exclusivity in certain circumstances. This is evidenced by the prohibition of exclusivity agreements only where enterprises in a vertical relationship enjoy market power or where exclusivity arrangements are imposed by a dominant enterprise. This is also illustrated in the seminal judgment of Consten & Grundig, [3] where the European Court of Justice (ECJ) distinguished between the existence of an IP right and the improper exercise of the same. Accordingly, IP and competition laws are being viewed as complementary. Natco v Bayer IP laws in India have long made provision for the grant of a compulsory license. However, section 84 of the Patents Act, 1970 (Patents Act), the provision under Indian patent law that provides for the issue of a compulsory licence, was enforced for the first time in Natco v Bayer, in relation to Bayers patented drug sorafenib tosylate. Bayer sells sorafenib tosylate, which is used for the treatment of the advanced stages of kidney and liver cancer, under the brand name Nexavar. Nexavar is a life-enhancing and not a life-saving drug; it seeks to extend the life of a patient afflicted with the last stages of kidney or liver cancer. Bayer launched Nexavar in 2006 and was granted a patent by the Indian patents authority on 3 March 2008. Bayer then sold the drug to patients in India suffering from the advanced stages of kidney and liver cancer at a cost of Rs 280,428 (approximately US$5,278) per month. [4] Natco, an Indian pharmaceutical company, had applied to Bayer for a voluntary licence to manufacture and sell the drug, and proposed to sell sorafenib tosylate at a price of Rs 8,800 (approximately US$167) for a months therapy, a fraction of the price being charged by Bayer. However, Natcos request was refused by Bayer. Three years after the grant of Bayers patent for sorafenib tosylate, Natco filed an application for the grant of a compulsory licence at the Indian Patents Office. Under the Patents Act, a compulsory licence may be granted after the expiration of three years of the grant of a patent, on any of the following grounds: [5] (i) that the reasonable requirements of the public with respect to the patented invention have not been satisfied; or (ii) that the patented invention is not available to the public at a reasonably affordable price; or (iii) that the patented invention is not worked in the territory of India. In Natco v Bayer, the Controller General of Patents, Designs and Trademarks of the Indian Patents Office (Controller) concluded that all three grounds on which a compulsory licence could be granted under section 84 of the Patents Act were satisfied. [6] A compulsory licence for the manufacture and sale of sorafenib tosylate was granted to Natco for the balance term of the patent, subject to the payment of a royalty of six per cent of the net sales of the drug to Bayer. Many in India believe that Bayers failure to substantiate the costs involved in developing Nexavar was one of the principal reasons why the Controller found reason to issue the compulsory licence. Accordingly, IP law practitioners in India were not surprised that the Controller relied on grounds (i) and (ii) above, as Nexavar was accessible to only two per

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The Curious Case of Compulsory Licensing in India - Antitrust Writing Awards 2013
cent of the total number of potential patients, despite four years having lapsed since the grant of the patent. [7] However, the Controllers reliance on ground (iii), that is, that the patented invention is not worked in the territory of India, has caused much consternation. The Controller interpreted the expression worked in the territory of India to imply that a patented product must be manufactured in India to a reasonable extent or that the patentee must grant a licence to third parties to manufacture the patented product in India. However, this interpretation sets a dangerous precedent, where the availability of a patented product solely by imports as opposed to domestic manufacturing justifies the grant of a compulsory licence under the Patents Act, even if the reasonable requirements of the public are being satisfied at a reasonable price. It is also relevant to note that the Controller found that Bayer failed to contribute to the transfer and dissemination of technology, so as to counterbalance the exclusive rights granted by a patent with the obligations of a patentee that arise under the Patent Act. [8] It appears, therefore, that similar to a competition authority, the Controller balanced the interests of a patent holder, on the one hand, with the interests of promoting and sustaining competition, on the other hand. Interestingly, whilst Bayer has filed an appeal before the Intellectual Property Appellate Board, the Controllers decision triggered a price war in the cancer-drug market. Cipla, [9] an Indian pharmaceutical company, has slashed the price of its cancer drugs, including sorafenib tosylate, which it now offers at Rs 6,840 (approximately US$128) per month. The Swiss company Roche has also slashed prices of some of its life-saving drugs. Natco, of course, as recorded in the Controllers decision, is committed to sell the drug at no more than Rs 8,880 (approximately US$167) for a months dosage, the initial price Natco offered in its earlier application to Bayer for a voluntary licence for the drug. News reports suggest that Bayer is itself considering a price reduction for Nexavar. Compulsory licensing and competition law Just as it is generally considered appropriate for a competition authority to order a divestiture of physical assets as a condition to approving an otherwise anticompetitive merger, a divestiture of IP assets could be considered as a remedy for anti-competitive behaviour. However, the history of non-merger compulsory licensing by competition authorities, both in the EU and in the US, has been inconsistent and at odds with the current global approach to IP and competition laws. Competition authorities in foreign jurisdictions have granted compulsory licences under the competition provisions of their respective statutes, notwithstanding similar provisions in IP laws. [10] Compulsory licences have been issued in cases concerning an abusive refusal to supply, to correct the anti-competitive practices resulting from the exclusivity granted by an IP right, and where the refusal prevents demand for a new product. This is done after a careful comparative analysis between the need to encourage innovation and the goal of promoting and fostering competition, as will be discussed below. In the Indian context, whilst there is currently no guidance on whether, and under what circumstances, the CCI would grant a compulsory licence, such a remedy appears to be within the CCIs ambit. In addition, recent decisions of the CCI and the Preamble to the Competition Act, which will be discussed in detail below, raise concerns that the CCI may follow the approach of the Controller in Natco v Bayer. Before we discuss the possible Indian approach, we outline the approach in the European Union (EU) and the United States (US) in issuing compulsory licences under competition law. The EU approach Generally, the holder of an IP right has no obligation to license their intellectual property and, in most circumstances, will not be held to violate EU competition law by unilaterally refusing to licence their IP right to competitors. The circumstances that characterise the exercise of exclusive rights as abusive conduct were discussed by the Court of First Instance (CFI, now the General Court) in the Magill TV guide case. [11] On appeal, the ECJ [12] held that it is only in exceptional circumstances that the exercise of an exclusive right by the holder of an IP right results in an abuse of dominance. Such exceptional circumstances were said to exist when: the refusal relates to a product or ser vice indispensable to the exercise of a particular activity on a neighbouring market; the refusal is of such a kind as to exclude any effective competition on that neighbouring market; and the refusal prevents the appearance of a new product for which there is potential consumer demand. [13] Once it is established that such exceptional circumstances are present, a dominant undertakings refusal to grant a licence may constitute an abuse of dominance, unless such refusal is objectively justified. These conditions were reiterated by the ECJ in IMS Health, where a refusal to license IP rights was held to 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 potential consumer demand. [14] In Microsoft, [15] where the CFI was again confronted with the issue of a compulsory licence for a protected IP right, the CFI did not require the European Commission to follow a strict application of the new product on a neighbouring market test. Instead, the CFI observed that if competitors were granted access to Microsofts copyright, far from merely reproducing the Windows systems already on the market competitors would offer products which will be distinguished from those (Microsoft) systems with respect to parameters which

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The Curious Case of Compulsory Licensing in India - Antitrust Writing Awards 2013
consumers consider important. [16] Thus, the CFI found that the new product test was readily satisfied, insofar as the products offered by competitors differed from those offered by Microsoft in terms of advanced performance, security and functionality. Consequently, the CFI judgment in Microsoft waters down the new-product test, as it held to be sufficient that such new products var y from the existing products in terms of certain capabilities. It was not necessary to show the creation of an entirely new product on a separate market. The CFIs benign application of this new product requirement in Microsoft has been criticised by academics and practitioners alike. [17] In contrast, in Magill TV guide, there was clearly a new product, different in conception to all existing guides. In IMS Health, the ECJ found that refusal to licence intellectual property may be regarded as abusive only where the undertaking which requested the license does not intend to limit itself essentially to duplicating the goods or services already offered on the secondary market by the owner of the intellectual property right, but intends to produce new goods or services not offered by the owner of the right and for which there is potential consumer demand. [18] The newproduct requirement stems from the balance that needs to be achieved between protecting IP rights and the incentives to innovate versus the protection of free competition. [19] The secondary market requirement thus serves as an additional condition when IP rights are at stake and provides an additional ground of protection to the dominant undertaking holding the IP right, in order to ensure that the compulsory licence is not merely issued to duplicate goods or services offered by the dominant undertaking. However, the CFIs lenient approach to the new product test seems to suggest a lesser degree of protection of IP rights than previously afforded in Magill TV guide and IMS Health. The American approach In the US, compulsory licensing is a well-established remedy to address competition concerns arising from proposed mergers, as it involves the consent of parties and usually the grant of only a single licence. US cases involving compulsory licences outside the merger context have a long but contradictory history. The general rule under US antitrust law is that there is no general duty to deal with competitors. [20] However, liability under section 2 of the Sherman Act (provisions governing abuse of dominance in the US) will accrue when the refusal by a holder of an IP right enjoying a dominant position in the relevant market constitutes exclusionary conduct. The more recent judgments of Trinko [21] in 2004 and Linkline [22] in 2009 endorse the view that under certain circumstances, refusal to cooperate with rivals can constitute anti-competitive conduct but that courts should be very cautious in recognising such exceptions to the general rule that even monopolists may choose with whom they deal. [23] It must be noted that though Trinko and Linkline did not involve intellectual property, they condition US jurisprudence on refusals to license IP. [24] Though US Courts of Appeal have considered whether a unilateral refusal to license would amount to a violation of section 2 of the Sherman Act, their decisions have been divergent. In Kodak, the Ninth Circuit Court of Appeals found that if the patent holder is not genuinely exercising their IP rights and if the intent is not to enforce such rights, the presumption of the legal exercise of IP rights will not apply. [25] In contrast, in Xerox, the Court of Appeals for the Federal Circuit questioned the benefit of examining intention and imposed a different standard in holding in the absence of any indication of illegal tying, fraud in the Patent and Trademark Office or sham litigation, the patent holder should be immune from antitrust law. [26] Thus, a firm would not be held to abuse its dominance unless: the refusal was a part of an illegal tie-in; the patent was obtained by fraud; or the patentee instituted litigation with the intent to interfere with a competitors business. The US precedents on abusive unilateral refusal to license are, therefore, inconsistent. The Trinko and Linkline judgments may indicate that courts would be more likely to endorse the Federal Circuits view in Xerox than the Ninth Circuits view in Kodak. [27] Accordingly, the likely standard may be one that finds an abuse in very narrow circumstances, when a patentee attempts to enlarge the scope of their IP right. Some jurisdictions take a broader approach to defining anti-competitive behaviour than the EU and the US. [28] While Western jurisdictions consider the protection of IP rights as sacrosanct and may find that too much regulation amounts to protectionism, this is not necessarily true of the developing world. Competition law in developing economies may be guided by objectives that are inherently dissimilar from the aims of antitrust in Western jurisdictions. In fact, there is a school of thought that suggests that in a developing economy, too much competition may impair development. [29] Therefore, there is a genuine concern that competition authorities in developing countries may issue remedies they deem appropriate to promote development, notwithstanding years of competition jurisprudence and case law from more mature jurisdictions, especially where IP exclusivity results in economic inequity and negligible social contribution. India: the curious case In enacting the Competition Act, India has come a long way from the days of the prior Monopolies and Restrictive Trade Practices Act regime. Whilst under the old regime, big was bad, the Competition Act, in line with regimes around the world, focuses on companies only when they are dominant and prohibits an abuse of such dominance. This change in approach is reflective of the changing social, economic and political attitudes in India. However, India remains a country with socialist goals. This is reflected in the Preamble to the Competition Act, which provides for the establishment of a Commission to prevent practices having adverse effect on competition, to promote and sustain competition in markets, to protect the interests of consumers. The CCI, in its decisions as well as public statements,

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The Curious Case of Compulsory Licensing in India - Antitrust Writing Awards 2013
places greater emphasis on the interests of the common man than on competitors or the competitive process. Such an approach, especially in light of the Controllers decision in Natco v Bayer, gives rise to serious concern that the CCI may consider the grant of a compulsory licence even in the absence of exceptional circumstances and that consumer welfare/socialist considerations may skew the balance between the protection of IP and free competition. Compulsory licences under IP laws are generally granted on public interest considerations, whereas compulsory licences under competition law are typically based on the need to restore effective competition in the market place. However, the CCI would certainly note with interest the change in market dynamics following the Natco v Bayer decision. [30] As was highlighted earlier, the compulsory licence granted to Natco triggered a price war, [31] resulting in enhanced competition in the cancer drug market a result a competition authority may seek to achieve through remedies. However, by no means do we imply that this would be a correct approach. Under the Competition Act, an enterprise is guilty of abusing its dominant position if, inter alia, it imposes unfair prices, limits the production of goods or services, restricts the technical or scientific development of goods or services, or denies market access. [32] Whilst there have been no CCI decisions to date dealing with a refusal to license IP rights, the CCIs approach in the cases discussed below appears to suggest that the CCI may evolve novel concepts to address perceived consumer harm. As stated earlier, the Controller in Natco v Bayer granted a compulsory licence, inter alia, on the ground that Nexavar was not available to the public at a reasonably affordable price. In doing so, the Controller in Natco v Bayer construed the term reasonably affordable price predominantly with reference to the price to the public and not with reference to Bayers costs. It is not inconceivable that a complaint could potentially be filed against a dominant pharmaceutical company, alleging that the price charged is an unfair price, as it is unaffordable to the public or because other manufacturers could produce and make available the same drug at cheaper prices, in violation of section 4(2)(a)(ii) of the Competition Act. In fact the CCI has, in MCX Stock Exchange Ltd & Ors v National Stock Exchange of India Ltd & Ors, [33] interpreted the term unfair pricing in relation to the costs of competitors. Similar to the Controllers decision, in arriving at its conclusion that NSE abused its dominant position, the CCI failed to consider the cost structure of the NSE. Contrary to international principles, the CCI abandoned the as-efficientcompetitor test. Instead, the CCI held that NSEs prices were unfair vis--vis its competitor, MCX-SX, who, despite having a larger market share in the relevant market, in the CCIs view would be unable to compete. [34] It should be noted that the CCI did not find NSE to have engaged in predatory pricing, but simply unfair pricing, implying a new abuse of non-predatory low pricing. If the CCI were to follow a similar approach in relation to the prices of drugs of a dominant pharmaceutical company, it could lead to disastrous results and potentially encourage the CCI to follow an approach similar to that of the Controller. A refusal to license IP exclusively held by a dominant enterprise may also be considered as a constructive refusal to supply under the provisions of the Competition Act. Such a refusal may be construed to limit the production of goods or provision of services or market, or restrict the technical or scientific development relating to goods or services to the prejudice of consumers, or result in the denial of market access, all three of which amount to abusive conduct under sections 4(2)(b)(i), 4(2)(b)(ii) and 4(2)(c) of the Competition Act, respectively. As discussed earlier, in the EU such a refusal would be considered abusive only in exceptional circumstances, when the refusal prevents the emergence of a new product on a secondary market for which there is potential consumer demand. Such a refusal would be subject to a stricter standard still in the US. Whether the CCI will follow either the EU or US approach remains to be seen; however, both the Controllers Natco v Bayer decision and the general attitude of the CCI seem to suggest a more consumer-oriented approach in India. The CCIs concern over the exploitation of the Indian consumer by dominant enterprises was especially highlighted in Belaire Owners Association v DLF Limited and HUDA, [35] where the CCIs primary concerns revolved around the treatment of apartment allottees by the dominant real estate enterprise, DLF. The CCI was particularly critical of the terms and conditions imposed by DLF in the contracts that the company had signed with apartment allottees. [36] In the Natco v Bayer decision, Bayers inability to make Nexavar available to nearly 98 per cent of the Indian public [37] was held by the Controller to amount to a failure to satisfy the reasonable requirements of the public. In the absence of the requirements of the exceptional circumstances test in India and given the consumer welfare focus of the CCI, it is not inconceivable that the CCI would adopt a similar approach and find that the exercise of IP rights in such a scenario limits the production of goods in violation of section 4(2)(b)(i) of the Competition Act. Further, the Controller had observed that a patentee can contribute towards the transfer and dissemination of technology by either manufacturing the product in India itself or by granting a licence to a third party to manufacture the product in India, and that Bayer had failed to do so. [38] The CCI could potentially construe such failure by a dominant pharmaceutical company to limit or restrict the technical or scientific development of goods or services in India to the prejudice of consumers, an abuse in contravention of section 4(2)(b)(ii) of the Competition Act. The decision in Natco v Bayer also states that the patentee (Bayer) thus took no adequate or reasonable steps to start the working of the invention in the territory of India on a commercial scale and to an adequate extent. [39] The CCI may also be sympathetic to arguments based on failure to work a patent, given that exclusivity is reserved and that competing enterprises are not granted the opportunity to access the patented product and compete with the dominant enterprise. The CCI could potentially adjudge such failure to work a patent as amounting to a denial of market access, an abuse listed under section 4(2)(c) of

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the Competition Act.

The Curious Case of Compulsory Licensing in India - Antitrust Writing Awards 2013

In the authors view, such an approach would indeed be highly controversial, albeit not impossible, given the social and economic constraints faced by developing countries such as India. Moreover, the compulsory licence would be issued, not in order to enable competitors to provide a new product on a neighbouring market, but to enable companies to provide the same product at a fair price in order to satisfy demand. However, it is strongly recommended that even if the CCI were to proceed on this basis, compulsory licences be issued with great caution. It is critical that the royalty determined is based on FRAND (fair, reasonable and non-discriminatory) terms and that the duration of the licence is limited and constantly reviewed, so as to only remedy inadequate supply. The CCI must also exercise caution to avoid falling into the trap of becoming a price regulator, a concept that competition authorities around the world find disconcerting. The better approach would be for the CCI to refer any case dealing with compulsory licensing to the relevant IP authority in India. In fact, section 21A of the Competition Act explicitly provides the CCI with the power to make a reference to a concerned statutory authority, where the CCI is faced with a decision whose implementation is entrusted to such other statutory authority. Relevant IP authorities in India would have the requisite expertise to grant such licence and determine equitable terms thereof. This would also remove the problem of the CCI becoming a price regulator. In this regard, it is important to remember that competition law is not a panacea. There are other modes of redress available to parties seeking a compulsory licence and, perhaps, adequate remedies lie elsewhere. Finally, a decision by the CCI to issue a compulsory licence could have other implications. Such decisions may cause IP-reliant firms to either abandon operations in India or refrain from entering the Indian market 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 Indias 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. The Natco v Bayer decision sets the precedent for making expensive patented drugs available for compulsory licensing under the Patents Act. However, questions remain as to whether competitors of dominant undertakings holding patent rights may use section 4 of the Competition Act to enable them to compete on the same market as the IP owner. The CCI may be tempted to intervene when a patent monopoly fails to address social and developmental concerns and where public demand for a life-saving drug has not been met. Though competition law is a tool used for the attainment of economic freedom and prosperity in developed economies of the EU and the US, in a nation such as India, competition law may be motivated by other considerations, including access to healthcare. Pharmaceutical countries may find great risk in operating in India if competition intervention is used to remedy social inequity rather than to ensure a competitive market place. It is, therefore, recommended that compulsory licensing as a remedy to anti-competitive conduct should only be used where the dominance of the defendant is unquestionable, no other equitable remedy is available and where the interests in favour of a licensee are so strong, they trump any harm that could be caused to the innovation incentives of IP right holders.

Footnotes
[1] Natco Pharma Limited v Bayer Corporation, Compulsory Licence Application No 1/2011. [2] See generally, Micheal A Carrier, [2009], Innovation for the 21st Century: Harnessing the Power of Intellectual Property and Antitrust law, New York OUP; J Newberg and T Willard, [1997], Antitrust and Intellectual Property: From Separate Spheres to Unified Fields, 66 Antitrust L J 167. [3] Joined cases 56/24 and 58/64, Consten & Grundig v Commission, [1966] ECR 299, at p 346. [4] All conversions from INR to USD in this document have been calculated at the rate US$1 = 52.6084 INR, the exchange rate as on 08 May 2012. [5] Section 84(1), Patents Act, 1970. [6] Note the conditions listed under section 84(1) of the Patents Act are alternative and not cumulative. [7] If Bayers data on the number of patients eligible for treatment by Nexavar (8,842 per year) were accepted, given the number of boxes sold and the duration of treatment required, the Controller observed that only a little over 200 patients (or two per cent) had received the drug; Natco v Bayer, see note 1 above, at p 22. [8] Section 83, Patents Act, 1970.

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The Curious Case of Compulsory Licensing in India - Antitrust Writing Awards 2013
[9] Cipla is currently defending a patent infringement claim filed by Bayer, in relation to Nexavar, in the Delhi High Court. [10] For a list of national statutory provisions under IP laws that provide for the grant of a compulsory licence, see: Survey on Compulsory Licenses granted by WIPO Member States to Address Anticompetitive uses of Intellectual Property Rights, CDIP/4/4 Rev/STUDY/INF/5. [11] Case T-69/89, Radio Telefis Eireann v Commission, 1991 ECR II-485. [12] Cases C-241 & 242/91P, Radio Telefis Eireann v Commission, 1995 ECR I-743. [13] Ibid, at paragraphs 5256. [14] Case 418/01, IMS Health GmbH & Co OHG v NDS Health GmbH & Co KG, [2004] ECR I-5039. The ECJ found that refusal to licence intellectual property may be regarded as abusive only where the undertaking which requested the license does not intend to limit itself essentially to duplicating the goods or services already offered on the secondary market by the owner of the intellectual property right, but intends to produce new goods to services not offered by the owner of the right and for which there is potential consumer demand, at paragraph 49. [15] Case T-201/04, Microsoft Corp v Commission, 2007 ECR II-03601. [16] Ibid, at paragraph 656. [17] R Whish and D Bailey, [2012], Competition Law, Oxford University Press, at p 801. See generally: J Vickers, [2008], A Tale of Two EC Cases: IBM and Microsoft, (2008) 4 Competition Policy International 3; I Forrester, [2005], Regulating Intellectual Property via Competition? Or Regulating Competition via Intellectual Property? Competition and Intellectual Property: Ten Years on, the Debate still Flourishes. [Online] Available at: www.eui.eu/RSCAS/Research/Competition/2005/200510CompForrester.pdf. [18] See note 14 above, at paragraph 49. [19] Indeed, in IMS Health, the ECJ observed that in the balancing of the interest in protection of the intellectual property right and the economic freedom of its owner against the interest in protection of free competition, the latter can prevail only where refusal to grant a licence prevents the development of the secondary market to the detriment of consumers at paragraph 46 [emphasis added]; also, note 14 above, at paragraph 49. [20] Also known as the Colgate doctrine, as held in United States v Colgate & Co, 250 US 300, 307 (1919). [21] Verizon Communications Inc v Law Offices of Curtis V Trinko, 540 US 398 (2004). [22] Pacific Bell v linkLine Communications, 03 F.3d 876 (Fed Cir 2009). [23] See note 21 above, at p 408. [24] R Coco, [2008], Antitrust Liability for Refusal to License Intellectual Property: A Comparative Analysis and the International Setting, 12 Marquette Intellectual Property Law Review 1(2008) at p 6. [25] Image Tech Servs v Eastman Kodak, 125 F.3d 1195 (9th Cir 1997). [26] CSU v Xerox Corp, 203 F.3d 1322 (Fed Cir 2000). [27] Antitrust Issues in Intellectual Property Licensing Transactions [2012], ABA Section of Antitrust Law at p 32. [28] E Fox, [2003], We Protect Competition, You Protect Competitors, 26(2) World Competition 149. [29] See generally: J Stiglitz, [2002], Globalization and its Discontents, W.W. Norton & Company; Jenny F. [2002], Globalization, Competition and Trade Policy: Convergence, Divergence and Cooperation in Chapter 16, C A Jones and M Matsushita (Eds), Competition Policy in the Global Trading System: Perspectives from the EU, Japan and the USA [2002], Kluwer Law international. [30] D Rajagopal, [2012], Cipla shocks rivals by slashing cancer drug prices up to 75%, [Online] Available: http://articles.economictimes.indiatimes.com/2012-05-04/news/31573060_1_cancer-drugiressa-sorafenib . [31] S Chatterjee, [2012], On cue, Roche to cut cancer drug prices, [Online] Available: www.dnaindia.com/money/report_on-cue-roche-to-cut-cancerdrug-prices_1666622 . [32] Sections 4(2)(a)(ii), 4(2)(b)(i), 4(2)(b)(ii), and 4(2)(c) of the Competition Act, respectively. [33] Case 13/2009, MCX Stock Exchange Ltd & Ors v National Stock Exchange of India Ltd & Ors. Please note, the authors have advised, and continue to advise, The National Stock Exchange in relation to this case. [34] Ibid, at paragraph 10.73. [35] Case No 19/2010, Belaire Owners Association v DLF Limited and HUDA. [36] Ibid, at paragraphs 12.10312.111. [37] See note 1 above, at p 22. [38] See note 1 above, at p 53. [39] See note 1 above, at p 53.

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