PHARMACEUTICAL REGULATORY LAW
1 What is the applicable regulatory framework for the authorisation, pricing and marketing of pharmaceutical products, including generic drugs?
The legislative framework for the marketing, authorisation and pricing of pharmaceutical products in India (including generic drugs) consists of:
- the Drugs and Cosmetics Act 1940 (DCA), the Drugs and Cosmetics Rules 1945 (the DCA Rules) and the Drugs (Control) Act 1950, which regulate the manufacture and distribution of pharmaceutical products;
- the Drugs (Price Control) Order 2013 (DPCO), framed under the Essential Commodities Act 1955, which regulates the pricing of certain essential medicines listed there;
- the Pharmacy Act 1948 and the Pharmacy Practice Regulations 2015 (the Pharmacy Regulations), which prescribe conditions and qualifications, upon satisfaction of which a person can be authorised to handle or dispense medicines;
- the Medicinal and Toilet Preparations Act 1955, which levies an excise duty on medicinal preparations that contain alcohol, narcotic drugs or narcotics;
- the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954, which controls the advertisement of drugs in India; and
- the National Pharmaceuticals Pricing Policy 2012, which seeks to regulate the pricing of essential drugs as laid down in the National List of Essential Medicines 2011 based on market prices.
2 Which authorities are entrusted with enforcing these rules?
These rules are enforced through a dual regulatory control system. The central regulator for pharmaceutical products is the Central Drugs Standard Control Organisation (CDSCO), which undertakes approval of new drugs, clinical trials, standard setting, import licensing and licensing for the manufacture of certain categories of drugs. However, drug regulatory authorities at the state level assume responsibility for issuing licences for manufacture, distribution and sale of drugs, and monitoring these activities.
3 Are drug prices subject to regulatory control?
Drug prices in India are subject to the regulatory control of the National Pharmaceutical Pricing Authority (NPPA), which is the governing authority under the DPCO. Among other things, the NPPA is entrusted with the task of fixing and revising prices of controlled drugs and formulations; enforcing of the DPCO; and monitoring prices of both controlled and decontrolled drugs in the country.
Notably, price controls are applicable to ‘scheduled formulations’ (ie, drugs mentioned in Schedule I of the DPCO). Once a drug has been notified as a scheduled formulation, the NPPA may only revise (ie, increase or decrease) the ceiling retail prices as per the wholesale price index. These scheduled formulations also include drugs from the National List of Essential Medicines 2015 (NLEM), which contains an exhaustive list of vital drugs that are subject to regulatory control. The Ministry of Health and Family Welfare (MOHFW) determines the drugs that are to be included within the NLEM by way of a consultation process.
‘Non-scheduled formulations’, namely, formulations that are not mentioned in Schedule I of the DPCO, are not under a price control. However, under the DPCO, the retail prices of these formulations can only be increased by a maximum of 10 per cent year on year.
Further, in extraordinary circumstances and in the public interest, the government of India may fix the ceiling price or retail price of any drug, whether scheduled or non-scheduled, or of a new drug for such period as it may deem fit.
4 Is the distribution of pharmaceutical products subject to a specific framework or legislation? Do the rules differ depending on the distribution channel?
The legislative framework for the distribution of pharmaceutical products consists of:
- the DCA and the DCA Rules, which regulate the import, manufacture, distribution and sale of drugs in India – according to the DCA Rules, a licence is required to ‘sell, stock, exhibit or offer for sale or distribute drugs’ and an application must be made to the appropriate authority designated by the state government, which may issue a retail, restricted or a wholesale licence (a sale and distribution licence);
- the Narcotic Drugs and Psychotropic Substances Act 1985, which regulates the purposes for which, and quantity and price at which, certain drugs may be sold;
- the Pharmacy Act and the Pharmacy Regulations, which prescribe conditions and qualifications upon the satisfaction of which a person can be authorised to handle or dispense medicines – a pharmacy is also required to satisfy the conditions under Schedule N of the DCA Rules to be eligible for a sale and distribution licence; and
- the Draft Guidelines on Good Distribution Practices for pharmaceutical products-Reg 2018 were introduced by the CDSCO for consideration and comments of stakeholders.
The legislative framework described above makes no distinction based on the distribution channel. In addition to this, in January 2019 the MOHFW notified the Drugs and Cosmetics (Amendment) Rules 2019. These rules relate to streamlining the regulation of the sale of drugs through online portals or ‘e-pharmacies’.
Intersection with competition law
5 Which aspects of the regulatory framework are most directly relevant to the application of competition law to the pharmaceutical sector?
Competition rules and the pharmaceutical sector-specific laws on marketing, authorisation and pricing of pharmaceutical products must be read in conjunction with each other. More specifically, the following aspects of the regulatory framework are most relevant to the application of competition law in the pharmaceutical sector:
- the DPCO empowers the government to set ceiling prices for certain scheduled formulations on the basis of which manufacturers may set maximum retail prices, after accounting for local taxes. For new drugs, manufacturers may set maximum retail prices on the basis of retail prices determined by the government and local taxes;
- the Essential Commodities Act, which empowers the government to regulate the production, supply and distribution of essential commodities, including pharmaceutical products; and
- the Pharmacy Act, which prescribes the conditions and qualifications upon the satisfaction of which a person may be authorised to handle or dispense medicines.
The Competition Commission of India (CCI), as per its advocacy mandate in October 2018, issued a policy note titled ‘Making Markets Work for Affordable Healthcare’ covering: the role of intermediaries in drug price build-up; quality perceptions behind the proliferation of branded generics; vertical arrangements in healthcare services and lack of transparency and regulation of the pharmaceutical sector and competition. The CCI has also submitted an advocacy note to the Organisation for Economic Co-operation and Development addressing the issue of excessive pricing in pharmaceutical markets in India.
COMPETITION LEGISLATION AND REGULATION
Legislation and enforcement authorities
6 What are the main competition law provisions and which authorities are responsible for enforcing them?
The Competition Act 2002 (CA02) and its associated regulations constitute the framework for competition law in India. The CA02 is primarily enforced by the Competition Commission of India (CCI). The orders of the CCI can be appealed to the National Company Law Appellate Tribunal (NCLAT). A further appeal lies to the Supreme Court of India.
The main provisions of CA02 governing the pharmaceutical sector are:
- anti competitive horizontal agreements and anti competitive vertical restraints (section 3 of the CA02);
- abuse of dominant position (section 4 of the CA02); and
- combinations (sections 5 and 6 of the CA02).
For guidance, the CCI also issued its policy note titled ‘Making Markets Work for Affordable Healthcare’ (the Healthcare Policy Note) in October 2018, focusing on issues leading to anti competitive concerns in the healthcare and the pharmaceutical sector in India.
Public enforcement and remedies
7 What actions can competition authorities take to tackle anticompetitive conduct or agreements in the pharmaceutical sector and what remedies can they impose?
The CCI can direct enterprises to cease and desist from their involvement in anticompetitive agreements or conduct. The CCI can also impose monetary penalties for anticompetitive conduct that can extend up to 10 per cent of a company’s average (relevant) turnover for the preceding three financial years. In the case of cartels, the fine can be up to three times the profit made for each year for which the cartel was in existence, or 10 per cent of the (relevant) turnover for each year of continuance of the cartel, whichever is higher. Additionally, the CCI may impose fines on individuals responsible for anticompetitive conduct.
In relation to the penal powers of the CCI, the Supreme Court in Excel Crop Care Limited v Competition Commission of India and Another (2017 (8) SCC 47) has now limited the scope of turnover to only ‘relevant turnover’ (ie, at the time of determining the quantum of penalty in the case of a multi-product company, the CCI should only consider the turn- over of the infringing product or service, and not the total turnover of the enterprise found guilty of contravening the provisions of the CA02).
Further, under the provisions of section 48 of the CA02, individuals in charge of an enterprise contravening the provisions of the CA02, or individuals aiding the commission of such contraventions, shall be liable to be proceeded against and punished under section 27 of the CA02.
In M/s Arora Medical Hall, Ferozepur v Chemists & Druggists Association, Ferozepur (Case No. 60 of 2012), the CCI imposed a penalty of an amount equal to 10 per cent of the average income of the preceding three years on an individual office bearer of the Chemists and Druggists Association, Ferozepur, for entering into an agreement to limit supply of drugs and medicines. This set a trend, and the CCI has adopted equally stringent approaches in subsequent cases, such as Rohit Medical Stores v Macleods Pharmaceutical Limited and Ors (Case No. 78 of 2012), where the CCI imposed a penalty equal to 10 per cent of the average income of the preceding three years on an office bearer of the Himachal Pradesh Society of Chemists and Druggists Alliance (HPSCDA) for his active involvement in anticompetitive practices carried out by the HPSCDA. An identical standard of penalty (10 per cent) was imposed against office bearers of chemist and druggist associations who were found to be involved in anticompetitive practices in recent decisions such as Nadie Jauhri v Jalgaon District Medicine Dealers Association (JDMDA) (Case No. 61 of 2015) and Madhya Pradesh Chemists and Distributors Federation (MPCDF) v Madhya Pradesh Chemists and Druggist Association (MPCDA) & Ors (Case No. 64 of 2014).
However, in Suprabhat Roy v District Secretary of Murshidabad & Ors (Cases Nos. 36 of 2015, 31 of 2016 and 58 of 2016) the CCI issued cease-and-desist orders and did not impose monetary penalties after taking into account mitigating factors.
The CCI also has the power to modify anticompetitive agreements (whether horizontal or vertical), order the division of a dominant enterprise or pass any other order it may deem fit. Where an enterprise found to be in contravention of the CA02 is a member of a group and the CCI finds other members of such group to also be responsible for or have contributed to such contravention, it may pass orders against such members of the group as well. ‘Group’ is defined as ‘two or more enterprises, which directly or indirectly are in a position to exercise 50 percent or more of the voting rights in the other enterprise; appoint 50 percent of the members of the board of directors in the other enterprise; or control the management and affairs of the other enterprise’.
Private enforcement and remedies
8 Can remedies be sought through private enforcement by a party that claims to have suffered harm from anticompetitive conduct or agreements implemented by pharmaceutical companies? What form would such remedies typically take and how can they be obtained?
The NCLAT is empowered to allow compensation from any enterprise, for any loss or damage that is shown to have been suffered, as a result of any contravention of the provisions of Chapter II of the CA02 (anticompetitive agreements, abuse of dominant position and merger control). Claims for compensation may be filed by the central government, state government, local authority or any enterprise or person.
The claim may arise from the final findings of the CCI or the NCLAT (in an appeal against the findings of the CCI). Compensation may also be sought for contravention of orders of the CCI or the NCLAT. There have been few cases in which compensation applications have been filed, with none relating to the pharmaceutical sector.
9 Can the antitrust authority conduct sector-wide inquiries? If so, have such inquiries ever been conducted into the pharmaceutical sector and, if so, what was the main outcome?
The CCI, under its advocacy mandate, commissions market reports and conducts sectoral studies from time to time to determine whether industry practices contravene the CA02. In July 2010, the CCI commissioned a study titled ‘Competition Law and Indian Pharmaceutical Industry’. The study, conducted by the Centre for Trade and Development in New Delhi, concluded that although there was exponential growth in the industry, there was limited price competition among retailers. In 2013, the CCI initiated another study on the domestic pharmaceutical industry to look into issues relating to the patents regime, pricing, the process of manufacture and the terms and conditions for the sale of drugs through chemists and druggists in India.
In February 2014, the CCI issued a press release listing anticompetitive practices in the pharmaceutical sector as identified in its orders. These included calls for boycotts by trade associations, the fixation of trade margins for the sale of drugs or formulations by trade associations and the issuance of no objection certificates by the trade associations as a precondition for appointing stockists.
The CCI, in its 12 years of enforcement of the CA02, has received over 55 cases relating to the pharmaceutical and healthcare sector. While deciding these cases, the CCI has observed that information asymmetry in this sector restricts consumer choice and as such felt the need for a closer examination of this sector. Accordingly, the CCI has implemented a number of initiatives in this sector, culminating in a workshop on ‘Competition Issues in Pharmaceutical and Healthcare Sector in India’ in August 2018. The issues identified and recommendations suggested by the relevant stakeholders in this workshop have been documented in the Healthcare Policy Note.
The CCI has also invited entities to carry out a study on the pharmaceutical and healthcare industry in India to look into public and private hospitals, insurance companies, pharmaceutical firms and their associations, and doctors and their associations, to understand if there are any anti competitive practices prevalent in these industries. The Healthcare Policy Note covers the role of intermediaries in drug price build-up; quality perceptions behind the proliferation of branded generics; vertical arrangements in healthcare services; and lack of transparency and regulation of the pharmaceutical sector and competition.
In August 2018, the CCI, while analysing the allegations of unfair and excessive pricing against Max Super Speciality Hospital, directed its investigative wing to widen its scope of investigation to cover all aftermarket healthcare products and services provided by all super specialty hospitals across Delhi. Therefore, the investigation order in this case is akin to a sector-wide inquiry covering all super specialty hospitals in Delhi.
In October 2020, the CCI launched a new market study to assess the competitive landscape in the pharmaceutical sector. The objective of the study is to assess antitrust concerns in the drug supply chain and engage in an efficient and productive consultative process with the relevant stakeholders. The CCI has indicated that the study would primarily focus on the distribution segment of the pharmaceutical market, with a view to understanding:
- discounts and margin policies at the wholesale and retail levels of the distribution system;
- the role of trade associations in relation to various aspects of the distribution business;
- regulatory rationalisation of trade margins and its impact on price and competition; and
- the impact of e-commerce on price and competition.
The study also aims to investigate the proliferation of branded generic drugs in India and how this may affect competition, and to assess potential hurdles relating to the entry of biosimilar drugs in India.
Health authority involvement
10 To what extent do health authorities or regulatory bodies play a role in the application of competition law to the pharmaceutical sector? How do these authorities interact with the relevant competition authority?
The CCI has the power to make a reference to other statutory authorities on issues emanating from legislation whose implementation is entrusted to separate authorities established under various laws, such as sectoral regulators. Similarly, statutory authorities may also refer issues that may be related to competition law to the CCI, should the need arise. We are not aware of any such reference in the pharmaceutical sector. However, while analysing a pre-merger notification concerning television channel broadcasting (including through cable TV services and Direct-2-Home services), the CCI sought the opinion of the Telecom Regulatory Authority of India (TRAI) and the Ministry of Information and Broadcasting. Further, recently in In re: Ajinder Singh v Vodafone Idea Limited & Ors (Case No. 32 of 2019), information filed against certain telecom service providers for alleged anticompetitive conduct and abuse of dominance under sections 3 and 4 of the CA02, respectively, the CCI sought the opinion of the TRAI on allegations in the information that fell within TRAI’s jurisdiction, and relied on their opinion while dismissing the information.
11 To what extent do non-government groups play a role in the application of competition law to the pharmaceutical sector?
Non-government groups can play a role in the application of competition laws in two ways: they may give information to the CCI regarding anti- competitive conduct, based on which an investigation may be initiated; and they may be asked for their views as third parties during an ongoing investigation. There have been instances of investigations being initiated by the CCI based on information provided by trade or consumer associations.
The CCI consults many stakeholders for its market studies. On 19 February 2021, it invited relevant stakeholders to participate in its 2020 market study, especially pharmaceutical companies, stockist, chemists, sector experts, trade associations, doctors and regulators.
REVIEW OF MERGERS
Thresholds and triggers
12 What are the relevant thresholds for the review of mergers in the pharmaceutical sector?
The Competition Act 2002 (CA02) has not prescribed sector-specific merger review thresholds. The assets and turnover value-based notification thresholds specified under the CA02 are applicable across all sectors. (Notification thresholds are available online.)
13 Is the acquisition of one or more patents or licences subject to merger notification? If so, when would that be the case?
The CA02 requires the mandatory notification of acquisitions of shares, voting rights, assets or control, when the relevant jurisdictional thresholds are satisfied and the transaction does not benefit from any exemption.
Intellectual property rights, including patents, have also been held as being assets. The Competition Commission of India (CCI) has also considered exclusive licences as assets. Accordingly, the acquisition of one or more patents or licences (only when exclusive) may be subject to merger reporting requirements.
14 How are the product and geographic markets typically defined in the pharmaceutical sector?
The CCI has typically accepted relevant product markets, which have been defined using the European Pharmaceutical Market Research Association’s anatomical therapeutic chemical (ATC) classification for pharmaceutical products. Markets have been defined at both ATC3 (therapeutic) and ATC4 (chemical/molecular) levels.
The CCI’s decisional practice reveals the adoption of differing approaches given the complexity of each case. In Procter and Gamble Company/Merck Consumer Health Holding Germany GmbH (C-2018/06/579), Sanofi/Boehringer Ingelheim International GmbH (C-2016/07/413) and in GSK/Pfizer (C-2019/03/654), the CCI assessed overlaps at both ATC3 and ATC4 levels. However, in Sun Pharmaceutical Industries Limited/Ranbaxy Laboratories Limited (C-2015/05/170) (Sun/Ranbaxy), the CCI analysed overlaps only at the molecular level, in other words ‘medicines and formulations based on the same API’.
Geographic markets are typically defined as pan-India.
15 Are the sector-specific features of the pharmaceutical industry taken into account when mergers between two pharmaceutical companies are being reviewed?
The CCI has indeed taken certain sector-specific features of the pharmaceutical industry into consideration while reviewing transactions in the pharmaceutical space. A relevant example is the pervasive level of government regulation in the sector, especially with respect to prices. The CCI, in Sun/Ranbaxy, assessed a total of 51 molecules for potential competition concerns, out of which it determined that seven were likely to result in an appreciable adverse effect on competition (AAEC). However, no AAEC was determined with respect to four of the formulations, even though they had relatively high combined market shares owing to the fact that they were covered in the National List of Essential Medicines 2015 and were subject to price control.
Addressing competition concerns
16 Can merging parties put forward arguments based on the strengthening of the local or regional research and development activities or efficiency-based arguments to address antitrust concerns?
The CA02 prescribes several factors that the CCI must consider when determining if any conduct or agreement results in an AAEC. These factors include:
- the creation of barriers to new entrants in the market;
- the driving of existing competitors out of the market;
- foreclosure of competition by hindering entry into the market;
- accrual of benefits to consumers;
- improvements in production or distribution of goods or provision of services; and
- the promotion of technical, scientific and economic development by means of production or distribution of goods or provision of services.
Accordingly, while analysing the effect of a merger, the CCI is bound to consider positive factors such as benefits to consumers, the promotion of technical development and increased efficiency in production or distribution of goods.
Further, section 3(3) of the CA02 provides for a carve-out to the presumption that anticompetitive agreements among competitors cause AAEC, if such agreements demonstrably increase the efficiency of, inter alia, the production, distribution or supply of goods and services.
17 Under which circumstances will a horizontal merger of companies currently active in the same product and geographical markets be considered problematic?
The CA02 and its associated regulations do not specify any thresholds for overlap that may automatically be considered problematic. The relevant test is whether the overlap between the merging parties is likely to cause an AAEC in India. The CCI has typically used high combined market shares in the relevant markets as a primary indicator of whether a horizontal merger is likely to cause an AAEC. Also included in this assessment are factors such as the presence of strong competitors, barriers to entry in the market (such as the presence of patented products) and (especially for pharmaceutical mergers) the level of governmental regulation.
In Sun/Ranbaxy, the CCI determined overlaps between Sun Pharmaceutical Industries Limited (Sun Pharma) and Ranbaxy Laboratories Limited (Ranbaxy) at the ATC4 (molecular) level. Of the 51 overlapping or competing formulations, the CCI deemed seven as being problematic. The parties had high combined market shares (upto 90–95 percent) in the market for these seven formulations. Sun/ Ranbaxy thus became the first transaction for which the CCI ordered divestments in certain products. Similarly, in GSK/Pfizer, the CCI assessed overlaps between the parties both at ATC3 and ATC4 levels. However, because the combined market shares of the parties were at maximum in the range of 25–30 per cent and owing to the presence of several credible competitors, the CCI granted unconditional approval to the transaction.
18 When is an overlap with respect to products that are being developed likely to be problematic? How is potential competition assessed?
The CCI requires information on pipeline products and services to be disclosed in respect of transactions that involve high market shares to be able to examine whether there is likely to be a concern. Specifically, the Competition Commission of India (Procedure in regard to the transaction of business relating to combinations) Regulations 2011 clarify that where the combined market share of the parties in horizontal overlap markets exceeds 15 per cent or 25 per cent in vertically linked markets, it is preferable for parties to notify the proposed combination in the more detailed Form II. At the time of providing information in Form II, parties are required to disclose whether any of the parties have ‘pipeline products or services’ (ie, products or services likely to be introduced in the market in the near future). If so, parties are then required to provide an estimate of projected sales and market shares over the course of the following three to five years.
The CCI typically assesses such pipeline products to determine whether the transaction in question would have an AAEC in the relevant markets for such pipeline products. In Sun/Ranbaxy, the CCI assessed two pipeline products of Ranbaxy in the therapeutic category for ‘oral anti-diabetics’, which overlapped with certain formulations sold by Sun Pharma in India. As part of its assessment, the CCI considered whether the transaction would stall the release of these pipeline products by Ranbaxy. However, given the likelihood of new entry into the market for such products in India, the CCI did not conclude that this led to any AAEC in India.
19 Which remedies will typically be required to resolve any issues that have been identified?
Post its assessment of a notified transaction, the CCI may approve it unconditionally, disapprove it or approve it subject to certain modifications. The CCI has, in the past, directed both behavioural as well as structural modifications aimed at mitigating the competitive effects of the transaction. In Sun/Ranbaxy, which was the first instance of a detailed Phase II investigation in India, the CCI ordered Sun Pharma and Ranbaxy to divest seven brands and appointed PriceWaterhouseCoopers to super- vise the divestment process. The purchase of the divested assets by Emcure Pharmaceuticals was approved by the CCI in March 2015.
Further, the CCI has, on at least three occasions, modified the terms of long-term non-compete clauses entered by the parties to transactions in the pharmaceutical space. The duration of these non-compete obligations was reduced to three to four years to ensure that they did not unreasonably hinder entry into the market.
ANTI COMPETITIVE AGREEMENTS
20 What is the general framework for assessing whether an agreement or concerted practice can be considered anticompetitive?
Under the Competition Act 2002 (CA02), any agreement in respect of the production, supply, distribution, storage, acquisition or control of goods or the provision of services that causes or is likely to cause an appreciable adverse effect on competition (AAEC) within India shall be void. Specifically, horizontal agreements that fix prices, limit or control production or supply of goods or services, share markets or sources of production or result in bid-rigging are presumed to be anti competitive.
This presumption is rebuttable, though it is quite difficult to do so. Efficiency-enhancing joint ventures are not subject to the presumptive rule that is otherwise applicable to horizontal anti competitive agreements.
Vertical restraints, including tie-in arrangements, refusal to deal, resale price maintenance (RPM) arrangements, exclusive supply and exclusive distribution agreements are prohibited only if they cause or are likely to cause an AAEC in India. The Competition Commission of India (CCI) considers the following factors while determining whether an agreement causes or is likely to cause an AAEC:
- creation of barriers to entry;
- market foreclosure;
- removal of competitors;
- benefit to consumers;
- improvement in production or distribution of goods or services; and
- promotion of technical, scientific and economic development.
The above provisions relating to anticompetitive agreements do not apply to reasonable and necessary conditions or restrictions imposed for the protection of intellectual property rights (IPRs) that have been registered under identified IPRs in India. Moreover, agreements exclusively relating to the export of goods or services are also exempt from the scope of anticompetitive agreements.
Technology licensing agreements
21 To what extent are technology licensing agreements considered anticompetitive?
Technology licensing agreements may be considered anticompetitive if they cause or are likely to cause an AAEC in India.
Restrictive terms in technology licensing arrangements are likely to be examined as vertical restraints under the CA02. Absent market power, restrictions in technology licence agreements are less likely to raise concerns. When the licensor enjoys significant market power, the restrictions it imposes in licensing agreements, regardless of whether the underlying technology is protected by IPRs, may be susceptible to scrutiny by the CCI. For instance, any attempt by a licensor to determine or influence the pricing decision (for the licensed IP) of the IP licensee may be scrutinised as potentially anticompetitive RPM.
Licensors may also impose territorial or customer-specific restrictions as part of a licensing arrangement (ie, by forbidding the sale of the licensed product to a set of customers or territory). Such territorial or customer-specific restriction may be scrutinised as potentially anti- competitive ‘exclusive distribution’ or an anticompetitive ‘refusal to deal’. A licensor may also restrict licensees from dealing with any competing licensor, a restriction that may be examined as a potentially anticompetitive ‘exclusive supply’ arrangement. Any attempt by the licensor to make the grant of the IP licence conditional on the IP licensee purchasing the IP licensor’s other products, services or licences would be treated as a potentially anticompetitive tie-in arrangement.
In India, a refusal to grant a licence altogether or the imposition of unreasonably restrictive licensing terms may be examined as a potentially anticompetitive vertical restraint. For instance, in Shamsher Kataria v Honda Siel India Ltd & Ors (Case No. 3 of 2011) (Autoparts case), the CCI viewed certain automobile companies’ refusal to license their diagnostic (software) tools and repair manuals to independent repairers and workshops as an anticompetitive (vertical) refusal to deal.
Importantly, the CA02 provides a limited carve-out allowing owners of IP duly registered under an identified IP statute in India, including restrictions accompanying their licensing arrangements, which are both reasonable and necessary to prevent the infringement of their existing IP rights. In the Autoparts case, the automobile companies under investigation were unable to benefit from this limited exception as many were unable to adequately demonstrate either that their IP was registered in India, or that the restrictions in question were both reasonable and necessary for protecting their IP rights (presuming they were validly registered).
Finally, restrictive conditions or the imposition of unfair royalty rates in technology agreements, where the licensor has sufficient market power to be held dominant, may be scrutinised as an abuse of dominance under section 4 of the CA02. The limited carve-out for IP holders under the CA02 is not available for such unilateral conduct.
In sum, the CCI may examine licensing practices that lead to anti- competitive restraints, refusals to license, and unfair and discriminatory licensing. In 2018, the CCI held that a restriction imposed by the manufacturer on a distributor of smartphones not to engage with its competitor to contain the leaking of IP and technical know-how of the manufacturer to be a reasonable restriction (Tamil Nadu Consumer Products Distributors Association v Vivo Communication Technology Company (Case No. 15 of 2018)).
The validity of terms and conditions under a licence agreement were examined by the CCI in Micromax Informatics Limited v Telefonaktiebolaget LM Ericsson (Publ) (Case No. 50 of 2013). Key takeaways from CCI’s prima facie order include:
- the licensor cannot charge different royalty rates or offer different commercial terms to licensees belonging to the same category;
- the royalty rates charged by Ericsson had no linkage to patented product since the technology resided only within the chipset, but Ericsson calculated its royalty on the retail price of the entire phone; and
- a licensor may not impose onerous clauses on the licensee.
Similarly, while initiating an investigation against Monsanto Inc, United States (Monsanto), the CCI reached a preliminary view that it had charged ‘unfair’ royalty rates since its trait value (a kind of recurring royalty fee) was a percentage (16–18 per cent) of the maximum retail price (MRP) of the seed packet, which is determined in advance of each crop season.
In M/s Atos Worldline India Pvt Ltd v M/s Verifone India Sales Pvt Ltd and Anr (Case No. 56 of 2012), the CCI held that Verifone (manufacturer of point of sale (POS) terminals) imposed unfair and discriminatory conditions on service providers while granting licences for its software development kits to operate POS terminals. It observed that the practice of restricting the licensee from using any third party to develop or assist in developing any software using the licensed software, without first obtaining prior permission from Verifone, was unfair and discriminatory. The CCI’s decision was recently upheld by the National Company Law Appellate Tribunal.
Co-promotion and co-marketing agreements
22 To what extent are co-promotion and co-marketing agreements considered anticompetitive?
Co-promotion and co-marketing agreements may raise both vertical and horizontal anticompetitive concerns. A vertical relationship is created when the owner of the patented drug (owner) grants another entity (partner) the right to distribute, sell or market the product by way of the co-marketing agreement. If such an agreement incorporates vertical restraints contemplated in section 3(4) of the CA02 (such as tie-in arrangements or RPM), concerns would also arise.
Co-marketing or co-promotion arrangements also create a horizontal relationship between the contracting parties, since the owner typically retains the right to manufacture, distribute, sell and market its product while it grants similar rights to manufacture, distribute, sell and market to the counter-party. In such a case, the owner and the partner become competitors in the downstream market for manufacture, sale, distribution and marketing, as the case may be. Accordingly, any provision in the agreements that results in directly or indirectly fixing prices, limiting production or supply, market allocation or sources of production or any form of bid-rigging will be presumed to be anticompetitive. For instance, a non-compete clause in a co-marketing agreement that restricts the partner from selling any other pharmaceutical product that is similar to the subject of the co-marketing arrangement is likely to be viewed as an agreement (between entities engaged in the same level of trade) to limit the supply of the product in the market, and will be presumed to cause an AAEC under the CA02. Similarly, a non-compete clause that essentially precludes the partner from selling the subject products to a particular kind of customer (eg, hospital dispensaries) or certain markets (certain regions within India) is likely to be viewed as a horizontal arrangement to allocate markets, and will be presumed to result in an AAEC under the CA02. While the CCI is yet to reach a finding on horizontal anticompetitive concerns arising out of co-promotion or co-marketing agreements, the parties to such agreements will have the opportunity to present counter evidence to rebut the presumption of AAEC usually associated with anti- competitive horizontal agreements.
It has been reported that the CCI is currently investigating Novartis, Abbott, Emcure and USV for possible collusion in the sale of Vildagliptin (an anti-diabetic drug). It has been alleged that Novartis, the patent holder and drug manufacturer, has engaged in price-fixing through co-marketing arrangements with Abbott, Emcure and USV. Abbott had challenged the CCI’s prima facie order before the Delhi High Court, stating that the document submitted by the National Pharmaceutical Pricing Authority was inaccurate and that the email purportedly submitted by one of Abbott’s employees was forged. The Delhi High Court did not find merit in the contentions and dismissed the writ petition. However, no other orders in the matter have been passed by the CCI and it is difficult to ascertain the status of this investigation.
23 What other forms of agreement with a competitor are likely to be an issue? How can these issues be resolved?
Agreements between actual or potential competitors, including buyer– seller agreements (between entities that otherwise compete), that directly or indirectly result in fixing prices, limiting supplies and allocating markets (by division of geographic areas or customer base) are prohibited on the basis of the presumption that they cause an AAEC in India. Implementing firewalls to prevent the exchange of confidential and sensitive business information (which would make it difficult to fix prices or coordinate supplies) may mitigate, but not eliminate, the risk of scrutiny by the CCI for potential anticompetitive conduct.
Apart from co-marketing agreements, agreements in the nature of ‘pay-for-delay’ or reverse settlement agreements (where patent-holding pharmaceutical companies enter into private agreements with generic companies to delay the entry of generics for a consideration) are likely to raise concerns under the CA02. It is likely that the CCI will see a pay-for-delay arrangement as an anticompetitive agreement between competitors to restrict the supply of goods in the market. However, the CCI will also likely examine the application of the limited IP carve- out under section 3(5) of the CA02 to such agreements. Even while the patent holder may have entered into a pay-for-delay agreement with a generic company during the term of the patent (which, under the Indian Patents Act 1970, gives exclusive rights to the patentee for, inter alia, making, using and selling the patented drug), the possibility that the CCI will consider the pay-for-delay arrangement a reasonable and necessary condition for protecting IP rights under section 3 of the CA02 appears to be low.
Similarly, the CCI may also examine settlement agreements between patent-holding pharmaceutical companies and generic companies to settle patent infringement proceedings. Agreements to settle such patent infringement litigation may be viewed as anticompetitive agreements to limit or restrict the supply of products under section 3 of the CA02 if they have been entered into either with the objective of, or result in, the delay or thwarting of the entry of a potential competitor in the market. Such delay or restriction on the entry of a competitor would effectively extend the benefit of the patent protection beyond the statutory lifespan of the patent and hence not benefit from the limited carve-out provided under section 3(5) of the CA02.
In these cases, much as in the United States and European Union, the CCI is likely to focus on whether the purpose of these agreements or settlements is to delay the entry of a generic drug in the market, which would otherwise have competed with, and been available at, a fraction of the cost of the patented drug. In this respect, in August 2014, it was reported that the CCI was likely to review a patent deal between Hoffmann-La Roche and Cipla in respect of lung cancer drug, Erlotinib, as well as one between Merck Sharp and Dohme Corp (MSD) and India’s Glenmark Pharmaceuticals Ltd on the antidiabetic drug, Sitagliptin. The same report also mentioned that the CCI would investigate the market impact of ex parte injunctions secured by Novartis AG and MSD against a dozen local drug makers, blocking them from launching copies of the diabetes drugs Vildagliptin and Sitagliptin. However, apart from an inves- tigation into an alleged cartel arrangement between Novartis and its co-marketing partners, Emcure, USV and Abbott, in respect of a diabetes drug, there has since been no further report or order from the CCI on these issues.
Issues with vertical agreements
24 Which aspects of vertical agreements are most likely to raise antitrust concerns?
Vertical restraints are not, per se, anticompetitive, unless they cause or are likely to cause an AAEC in India. The CA02 identifies an inclusive set of vertical agreements such as tie-in arrangements, refusal to deal, RPM arrangements, exclusive supply and exclusive distribution agreements, which would be anticompetitive if they cause or are likely to cause an AAEC in India.
Patent dispute settlements
25 To what extent can the settlement of a patent dispute expose the parties concerned to liability for an antitrust violation?
Antitrust issues arising out of the settlement of patent disputes have yet to be considered by the CCI. However, settlements of patent infringement litigation between parties may be reviewed by the CCI to examine whether the object or effect of the agreement is to delay or thwart the entry of a potential competitor in the market, to the detriment of consumers. The Supreme Court of India noted in Samir Agrawal v Competition Commission of India (Civil Appeal No. 3100 of 2020) that the proceedings under the CA02 are proceedings in rem and the CCI is empowered to act in the public interest. Accordingly, a patent dispute is unlikely to escape antitrust scrutiny simply because it has been settled between the parties.
Joint communications and lobbying
26 To what extent can joint communications or lobbying actions be anticompetitive?
Joint communications or lobbying actions by way of a trade association or otherwise, to the extent that they relate to industry-wide issues such as government policies, taxes, etc, and not individual conduct, are unlikely to raise anticompetitive concerns. However, communications or actions that would facilitate any form of collusive practice (eg, on prices, territory of sales or the introduction of new products) are likely to be examined under the provision on cartels.
Specifically, in the context of the pharmaceutical industry, in a large number of cases involving various chemists’ and druggists’ associations, the CCI found the obligation imposed by trade associations on pharmaceutical companies to pay mandatory product information service charges at the time of launching any new products to be anti- competitive to the extent they result in output restrictions, limitation of supply and price-fixing (Varca Druggists case (MRTP 127/2009/DGIR), Sandhya Drug Agency v Assam Drug Dealers Association & Ors (Case No. 41 of 2011) and Nadie Jauhri v Jalgaon District Medicine Dealers Association (Case No. 61 of 2015)).
Similarly, the following have been identified as anticompetitive conduct to the extent that they were found to limit supplies in the market and have the effect of determining prices:
- requiring new stockists to obtain a no objection certificate from the association before being eligible to be appointed to a pharmaceutical company (Belgaum Chemists & Druggists (Case No. C-175/09/ DGIR/27/28-MRTP), Santuka Associates v All India Organisation of Chemists and Druggists & Ors (Case No. 20 of 2011), Vedanta Bio Sciences, Vadodara v Chemists and Druggists Association of Baroda (Case No. C-87/09/DGIR) and Madhya Pradesh Chemists and Distributors Federation v The Himayalan Drug Company and Ors (Case No. 64 of 2014);
- fixing industry-wide minimum trade margins (Peeveear Medical Agencies, Kerala v All India Organisation of Chemists and Druggists (Case No. 30 of 2011)); and
- giving instructions to boycott pharmaceutical companies or stock- ists for non-compliance with the associations’ norms (Inre: Bengal Chemists & Druggists Association (Suo Moto Case No. 2 of 2012) and Arora Medical Hall v Chemists and Druggists Association, Ferozepur (Case No. 60 of 2012)).
However, in All India Tyre Dealers’ Federation v Tyre Manufacturers Association (MRTP case: RTPE No. 20 of 2008), the CCI held that trade associations may adopt measures that are necessary to protect the interests of its members, as long as they are not in contravention of the CA02. The CCI found that the discussion around low prices, increase in input costs, petition for levy of anti-dumping duties, blacklisting importers and export realisation, among the members of the tyre manufacturers’ association, fell within the realm of legitimate lobbying conduct, as they were not undertaken with the aim of determining the individual conduct of any of its members.
27 To what extent may public communications constitute an infringement?
Public communications that are aimed at or facilitate collusion, for example, of prices or production quantity, are likely to be examined under the provision dealing with cartels. For instance, announcements by an enterprise indicating a possible increase in its price, followed by other players in the market, may indicate collusion and invite scrutiny. The CCI, however, will have to prove that the public announcement of prices indeed led to an agreement among all competitors to fix prices. However, public announcements, joint press statements or press releases setting out common and legitimate industry concerns (eg, in respect of a government policy) are unlikely to be considered anticompetitive. In In Re: Cartelisation in respect of zinc carbondry cell batteries market in India (Case No. 2 of 2016), the coordinated prices were communicated through press releases. One of the cartelists would issue a press release announcing an increase in price, which would be immediately followed by price increases by the other cartelists.
Exchange of information
28 Are anti competitive exchanges of information more likely to occur in the pharmaceutical sector given the increased transparency imposed by measures such as disclosure of relationships with HCPs, clinical trials, etc?
The current Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002 prohibit any form of relationship between pharmaceutical enterprises and healthcare practitioners (HCPs). However, in practice, the interaction between pharmaceutical companies, device manufacturers or their agents and HCPs has always been opaque. It would, therefore, be difficult to determine the likelihood of anticompetitive information exchanges between pharmaceutical companies and HCPs.
The government requires all clinical trials to be compulsorily registered with the Clinical Trial Registry India. Additionally, in 2020 a group of medical professionals and activists petitioned the Health Minister to provide more transparency on how India’s pharmaceutical industry is regulated, including the conduct of clinical trials and approval of drugs. The petitioners have also asked for increased transparency in inspections conducted into pharmaceutical products and their quality, asking that the details and results of these inspections be made available in the public domain. However, it is unclear whether disclosure in relation to clinical trials would facilitate any information exchange between pharmaceutical companies. In addition to these regulations and rules, there are several other regulations that require pharmaceutical companies to disclose confidential information to third parties.
Such information exchange would not in itself constitute a contravention under the CA02. The CCI held in In Re: Alleged Cartelisation in Flashlights Market in India (Suo Moto Case No. 1 of 2017) that the mere exchange of information between competitors did not constitute enough evidence to conclude that the parties were acting in a concerted manner contrary to the provisions of the CA02. Rather, such evidence has to be considered in conjunction with other evidence (such as contemporaneous increases in prices) to establish a contravention.
Notably, the CA02 does not expressly exempt conduct undertaken in compliance with any other regulation (other than the relevant exemption for IPRs). Therefore, if the information exchange between pharmaceutical companies mandated by other regulations results in any collusive conduct, the enterprises may still be liable under the provisions of the CA02.
ANTI COMPETITIVE UNILATERAL CONDUCT
Abuse of dominance
29 In what circumstances is conduct considered to be anticompetitive if carried out by a firm with monopoly or market power?
The Competition Act 2002 (CA02) lists certain conduct, which, if practised by a firm in a dominant position, shall be considered an abuse of dominant position. This includes the following:
- imposing unfair or discriminatory conditions or prices on sale of goods;
- limiting or restricting the production of goods, or technical or scientific development;
- denying market access;
- making the conclusion of contracts subject to the acceptance of obligations that have no connection with the subject matter of the contract; or
- using its dominant position in one relevant market to enter into or protect another.
De minimis thresholds
30 Is there any de minimis threshold for a conduct to be found abusive?
Under the CA02, once it is determined that the enterprise is dominant, there is no de minimis threshold for abusive conduct. Given the Competition Commission of India’s (CCI) propensity to define the markets narrowly, the conduct in question may be found abusive even if the market size is very small or the number of customers being affected is insignificant.
For instance, in House of Diagnostics LLP v Esaote SpA & Anr (Case No. 9 of 2016), the CCI defined the relevant market as the market for ‘dedicated standing/tilting MRI machines in India’, distinguishing this market from regular MRI machines on account of its unique tilting system. Esaote, being the only manufacturer of dedicated tilting MRI machines, was found to have a 100 per cent market share, and thus a dominant enterprise, in spite of the fact that Esaote had sold very few machines in India. Esaote’s alleged conduct (refusal to perform contractual obligations and unilaterally changing the essential terms of the contract) was examined only in respect of the informant (and no other consumers) and one supply order. On this basis alone, the CCI reached a finding that Esaote had abused its dominant position in the identified relevant market and imposed a penalty of 0.9 million rupees.
Similarly, in Shamsher Kataria v Honda Siel Cars India Ltd & Ors (Case No. 3 of 2011), the CCI defined the relevant market as the market for sale of spare parts in respect of each original equipment manufacturer’s (OEM) brand. The CCI found each OEM to be dominant in the supply of spare parts pertaining to their brand, and concluded that each enterprise had abused its dominant position in that relevant market by, inter alia, charging excessive prices for spare parts and denying market access to multi-brand workshops and independent repairers.
31 Do antitrust authorities approach market definition in the context of unilateral conduct in the same way as in mergers? If not, what are the main differences and what justifies them?
The CA02 makes no distinction in its approach towards market definition in the context of unilateral conduct and mergers. It states that the relevant market must be determined with reference to the relevant product market and the relevant geographic market. To this extent, the CA02 lists certain factors that must be considered by the CCI while determining the relevant product market and the relevant geographic market, such as:
for the relevant product market:
- physical characteristics or end-use of goods;
- price of goods or services;
- consumer preferences;
- exclusion of in-house production;
- existence of specialised producers; and
- classification of industrial products; and
for the relevant geographic market:
- regulatory trade barriers;
- local specification requirements;
- national procurement policies;
- adequate distribution facilities;
- transport costs;
- consumer preferences; and
- need for secure or regular supplies or rapid after- sales services.
Notably, the decisional practice of the CCI thus far leans in favour of relatively narrow market definitions. For instance, in Naveen Kataria v Jaiprakash Associates Limited (Case No. 99 of 2014) , the CCI defined the relevant market in the narrowest possible way as the market for ‘market for the provision of development and sale of independent residential units such as villas, estate homes, town homes and row-houses in integrated townships in Noida and Greater Noida’. In Sun Pharma/ Ranbaxy (Combination Registration No. C-2014/05/170), the CCI defined the relevant market at the narrowest ATC4 level for each formulation. The CCI in The Federation of Hotel & Restaurant Associations of India v MakeMyTrip India Pvt Ltd & Ors (Case No. 14 of 2019) defined the relevant market narrowly as ‘market for online intermediation services for booking of hotels in India’ for MMT and ‘market for franchising services for budget hotels in India’ for the other opposite party, OYO.
32 When is a party likely to be considered dominant or jointly dominant? Can a patent owner be dominant simply on account of the patent that it owns?
An enterprise is considered dominant if it enjoys a position of strength that allows it to act independently of competitive forces in the market, or can affect the relevant market, competitors or consumers in its favour. The CA02 lists certain factors that the CCI must consider while assessing whether a firm is in a dominant position, including:
- market share of the enterprise;
- size and resources of the enterprise;
- size and importance of the competitors;
- economic power of the enterprise, including commercial advantages over competitors;
- vertical integration of the enterprises or sale or service network of such enterprises;
- dependence of consumers on the enterprise;
- monopoly or dominant position whether acquired as a result of any statute or by virtue of being a government company or a public sector undertaking or otherwise;
- entry barriers, including barriers such as regulatory barriers, financial risk, high capital cost of entry, marketing entry barriers, technical entry barriers, economies of scale, high cost of substitutable goods or service for consumers;
- countervailing buying power;
- market structure and size of market;
- social obligations and social costs;
- relative advantage, by way of the contribution to economic development, by the enterprise enjoying a dominant position having or likely to have an appreciable adverse effect on competition (AAEC); and
- any other factor the CCI may consider relevant for the inquiry.
The CCI has often considered high market shares as a proxy for dominance (Belaire Owners Association v DLF (Case No. 19 of 2010)). However, the CCI noted in Meru Travel Solutions Pvt Ltd v ANI Technologies Pvt Ltd & Ors (Case No. 25-28 of 2017) that while market shares are theoretically an important indicator for lack of competitive restraints, it is not a conclusive indicator of dominance. Similarly, in National Stock Exchange v Competition Commission of India & MCX (Appeal No. 15 of 2011), the Competition Appellate Tribunal (COMPAT) held that one had to consider a whole host of factors in addition to market share, including the size and resources of the enterprise, the extent of vertical integration and the economic power of the enterprise. The COMPAT concluded that, given the enormous economic strength of the National Stock Exchange (NSE), its high market share in other segments of the market for trading and its ability to leverage its market power in
other segments to protect its position in the currency derivatives (CD) segment, it could be said to be dominant in the CD segment. Notably, the COMPAT held the NSE to be dominant in the CD segment even though the NSE’s market shares had drastically fallen over the past few years owing to the operations of other enterprises present in the segment.
Lastly, the CA02 does not recognise the concept of joint dominance. In In Re: Mr Arjun and Viacom 18 & Ors (Case No. 57 of 2017), the CCI dismissed allegations of joint dominance against a group of digital cinema equipment suppliers because section 4 of the CA02 did not allow more than one enterprise to hold a dominant position within a given relevant market. More recently, the CCI has reiterated this view in a number of cases, including investigation orders in In Re: Delhi Vyapar Mahasangh v Flipkart and Amazon (Case No. 40 of 2019), Fast Track Call Cabs Pvt Ltd v Meru Travel Solutions Pvt Ltd (Cases Nos. 6 and 74 of 2015) and The Federation of Hotel & Restaurant Associations of India v MakeMyTrip India Pvt Ltd (Case No. 14 of 2019).
33 To what extent can an application for the grant or enforcement of a patent or any other IP right (SPC, etc) expose the patent owner to liability for an antitrust violation?
The CA02 does not prohibit or identify the mere application for the grant of a patent or the initiation of enforcement actions as anticompetitive. In practice, the CCI has opened the door for antitrust claims against IP holders’ enforcement actions, including by way of injunctions.
Notably, the CA02 provides a limited carve-out for patent holders from antitrust liability in respect of anticompetitive agreements to the extent that the patentee’s conduct is necessary for the protection of its patents under the Patents Act. However, the same conduct may expose the patent holder to antitrust liability if it is found to be in a dominant position.
For instance, in the context of enforcing copyright and designs, in Bull Machines Pvt Ltd v JCB India (Case No. 105 of 2013), Bull Machines alleged that JCB had initiated bad faith litigation claiming infringement of its copyright and designs against it and, by doing so, had abused its dominant position in the market for backhoe loaders in India. The CCI, in its preliminary order, found merit in the argument and ordered an investigation, noting that ‘predation through judicial processes presents an increasingly [sic] threat to competition, particularly due to its low anti- trust visibility’. By ordering an investigation into the actions of JCB, the CCI demonstrated that vexatious infringement suits might be capable of being construed as an abuse of dominant position.
More recently, however, the CCI appears to have adopted a more cautionary approach while considering the use of court proceedings to enforce legitimate intellectual property rights as abusive. For instance, while directing an investigation in Biocon Limited & Mylan Pharmaceuticals Private Limited v F Hoffmann-La Roche AG & Ors (Case No. 68 of 2016) (Biocon v Roche), the CCI, in its preliminary order, noted that recourse to legal proceedings is a right of every party and, as a general principle, cannot be viewed as being sham litigation except under exceptional circumstances. In sum, the CCI is likely to test whether the actions of an IP holder, including by way of an application for the grant or enforcement of a patent, are genuine or merely the means to foreclose competition.
34 When would life-cycle management strategies expose a patent owner to antitrust liability?
The application of competition law to intellectual property is still at a relatively nascent stage in India. Complaints filed with the CCI involving the implementation (or non-implementation) of fair, reasonable and non- discriminatory disputes or vexatious litigation following infringement claims are being challenged on jurisdictional issues (ie, whether the CCI, as an antitrust regulator, has requisite jurisdiction to determine these issues when sector-specific regulators exist). That said, the CCI is unlikely to intervene if the restriction or strategy in question is within the scope of the legitimate exercise of the patent right (as under the relevant IP statute). Moreover, where the strategy in question is both reasonable and necessary to protect such right, it is likely to pass muster under the CA02. In Shri Anand Prakash Agarwal v Dakshin Haryana Bijli Vitran Nigam (Case No. 1 of 2016), the CCI recognised that objective commer- cial justifications were an effective defence against allegations of abuse of dominant position. However, more recently in Matrix Info Systems Private Limited v Intel Corporation (Intel) and Anr (Case No. 5 of 2019), the CCI ordered an investigation for abuse of dominance by Intel for enforcing warranty service through authorised dealers and rejected the justifications such as the selling of under-invoiced products through unauthorised dealers, ensuring quality service to the customers, etc.
A common strategy implemented by pharmaceutical companies to increase the life of their patents is ‘product hopping’. This involves discontinuing a patented drug towards the end of its patent term and introducing a reformulated ‘second generation’ drug, which may or may not offer distinct improvements over the first-generation drug. Under the CA02, while the introduction of a new product is not per se anticompetitive, while examining whether this strategy is a legitimate use of its patent rights from a competition perspective, the CCI is likely to examine the overall conduct of the patent holder in launching a new product (whether and how often this practice is adopted) and the effect on the ultimate consumer and the market.
Other life-cycle management strategies, such as creating a ‘patent cluster’, are likely to be scrutinised more closely by the CCI. Patent clus- ters involve the coming together of multiple companies to create new products by tying the product-creation process with existing patents. While the cluster arguably reduces research and development costs for each of the contributor patentees, it equally has the effect of precluding companies outside the cluster from using patents within the cluster, subject to the terms of exclusivity. To the extent that this collaboration is between competing pharmaceutical entities, the CCI may examine whether the ultimate object of the collaboration is to exclude other players or determine prices. The CCI may also examine whether and to what extent these arrangements create efficiencies in ultimate consumer benefits (eg, the launch of new products that may not have been possible absent such collaboration).
35 Can communications or recommendations aimed at the public, HCPs or health authorities trigger antitrust liability?
Communications or recommendations by pharmaceutical companies or trade associations may be considered anticompetitive if they result in the denial of market access or limit production or supply. For instance, in Biocon v Roche, the CCI initiated an investigation against Roche for abusing its dominant position by making representations to various state health authorities and drug controllers against Biocon’s prod- ucts. In its prima facie order, the CCI equated such representations to ‘abusive denigration’ that could result in denial of market access for Biocon’s products. Similarly, in In Re: InPhase Power Technologies Pvt Ltd (InPhase) v ABB India Limited (ABB) (Case No. 12 of 2016), a letter sent by ABB to customers claiming to be the true owner of certain intel- lectual property was alleged to have resulted in the denial of market access for InPhase. However, the CCI concluded that since ABB was not dominant in the relevant market, no case arose for examination under section 4 of the CA02.
36 Can a patent owner market or license its drug as an authorised generic, or allow a third party to do so, before the expiry of the patent protection on the drug concerned, to gain a head start on the competition?
The CCI is yet to deal with cases involving ‘product switching’ (ie, when patent holders either market a generic version of their drug or authorise a third party to do so towards the end of their patent protection). However, as in other cases involving the interplay between IP and antitrust, the CCI will be required to balance the legitimate rights of patent holders to take steps to protect and use their IP, including possibly by engaging in product switching with the likely restriction on new market entry.
Examining cases of product switching from an antitrust lens is likely to be more complex. During the term of its registered patent, an IP holder has the legitimate right to exclude others from making use of its underlying patent used in the drug. During this exclusivity period, a patent holder is free to decide how best to use its patent. Licensing its drug as an authorised generic before the expiry of its patent term would fall squarely within the scope of its rights. However, where the CCI believes that such product switching is being employed with a view to deny market access to other generic manufacturing companies (the patent holder uses its legitimate first-mover advantage to market a generic drug as a cheaper alternative to its more expensive patent well in advance to gain a stronghold in the generic market for the same drug, by the time its patent expires), the CCI may consider whether this conduct may be viewed as an anticompetitive market-leveraging conduct, where the patentee uses its dominant position in the patented market to gain entry, and market share, in the alternative market for generic versions of that drug. Such anticompetitive leveraging may fall foul of section 4 of the CA02, which addresses abuse of dominance conduct.
While abuse of dominance provisions under the CA02 do not specif- ically require an effects test, the CCI has endorsed an effects-based approach in its more recent decisions, and has considered objective justifications as well (Indian National Shipowners’ Association v Oil and Natural Gas Corporation Limited (Case No. 01 of 2018)). Accordingly, the CCI may consider whether the benefits of introducing a generic drug before the expiry of the patent (greater availability at cheaper price during the term of the patent) outweighs any potential market denial that such conduct may otherwise entail. Where such pre-term licensing is an outcome of collusive conduct (between the patentee and a generic manufacturer) to pre-empt the entry of an otherwise strong generic manufacturer, the risk of antitrust infringement would increase.
Restrictions on off-label use
37 Can actions taken by a patent owner to limit off-label use trigger antitrust liability?
Actions by a patent holder against off-label drug use are yet to be considered by the CCI. However, the CCI will apply a similar filter (that of balancing the rights of the IP holder with the effect such conditions have on competition in the market) to determine whether such conduct would fall foul of the CA02. Additionally, patent owners may also avail the statutory ‘meet the competition’ defence, which allows dominant firms to defend claims of discriminatory conditions or prices if they have been adopted in response to competitor conduct.
Where there is sufficient evidence to demonstrate that steps taken by the patent holder to limit off-label drugs are legitimate (eg, to limit potential product liability law suits or potential hazardous or unknown effects of alternative uses that may damage the patent holder’s reputa- tion), the CCI is unlikely to consider such action as being problematic under the CA02. In fact, such restrictive conditions may benefit from the safe-harbour provisions under the CA02 that allow IP holders to impose such conditions as are reasonable and necessary to protect its patent rights.
However, where such restrictions on off-label use have been employed without any legitimate or reasonable basis, and only with a view to deny market access to possible competitors or downstream players (eg, to preserve such benefit for itself), it is possible for the CCI to scrutinise this conduct as being anticompetitive.
38 When does pricing conduct raise antitrust risks? Can high prices be abusive?
Pricing conduct under the CA02 may be examined as follows:
- anticompetitive horizontal agreements (ie, collusive price-fixing conduct under section 3(3) of the CA02);
- anticompetitive vertical restraints (ie, resale price maintenance (RPM) under section 3(4) of the CA02); and
- abuse of dominant position (ie, unfair or predatory pricing under section 4 of the CA02).
If two or more competitors or potential competitors enter into an agreement to directly or indirectly fix prices or margins, it is presumed to result in an AAEC and is prohibited under the CA02. This would include any agreement to fix bid or tender prices or sales prices of drugs that are the subject of a co-marketing agreement. For instance, the CCI found that the practice of determining trade margin percentages for resale by the trade associations for chemists and druggists qualifies as an anti- competitive horizontal agreement under section 3(3) of the CA02.
The imposition of a condition by a seller to sell goods on the condi- tion that the buyer will resell goods at a fixed price and not below it may be construed as an anticompetitive RPM agreement. For RPM agree- ments to be treated as anticompetitive, the CCI will need to determine whether the condition results in an AAEC in the relevant market. The CCI has held in the past that, where a party has sufficient market power in the relevant market, the chances of an RPM causing an AAEC increases.
39 To what extent can the specific features of the pharmaceutical sector provide an objective justification for conduct that would otherwise infringe antitrust rules?
The pharmaceutical industry is driven by innovation and significant investment in the form of research and development activities. IPR protection for proprietary products helps in fostering innovation and attracting investment in research and development. The CA02 recognises the need for balancing the rights of IPR holders and hence provides the limited safe harbour to IP holders for imposing restrictions that are reasonable and necessary to protect rights granted under the IP.
UPDATES AND TRENDS
40 Are there in your jurisdiction any emerging trends or hot topics regarding antitrust regulation and enforcement in the pharmaceutical sector?
In October 2020, the Competition Commission of India (CCI) launched a market study to assess the competitive landscape in the pharmaceutical sector. The CCI indicated that the objective of the study is to assess antitrust concerns in the drug supply chain. The CCI has indicated that the study would primarily focus on the distribution segment of the pharmaceutical market, with a view to understanding:
- discounts and margin policies at the wholesale and retail levels of the distribution system;
- the role of trade associations in relation to various aspects of the distribution business;
- regulatory rationalisation of trade margins and its impact on price and competition; and
- the impact of e-commerce on price and competition.
The study also aims to investigate the proliferation of branded generic drugs in India and how this may affect competition, and to assess potential hurdles relating to the entry of biosimilar drugs in India. The market study is being conducted in consultation with relevant stakeholders, including pharmaceutical companies, stockists, chemists, sector experts, trade associations, doctors and regulators.
41 What emergency legislation, relief programmes and other initiatives specific to your practice area has your state implemented to address the pandemic? Have any existing government programmes, laws or regulations been amended to address these concerns? What best practices are advisable for clients?
In April 2020, the CCI issued a document titled ‘Advisory to Business in Time of COVID-19’. By way of the advisory, the CCI has recognised the need of businesses (including those that provide critical healthcare and essential commodities) to coordinate certain activities, including sharing data in relation to stock levels, timings of operations, distribution networks and infrastructure, production, transport and logistics to ensure continued supply and fair distribution of products.
Instead of providing any specific exemptions, the CCI emphasised that the CA02 has the following ‘built-in safeguards’ to protect businesses from sanctions for coordinated conduct, and that these will continue to guide the decisions of the CCI: (1) the presumption of an anticompetitive agreement does not apply to efficiency-enhancing joint- venture agreements; and (2) the CCI is required to review factors such as accrual of benefits to customers, improvement in production or distribution and provision of goods and services, and economic development while assessing competition law issues.
The CCI also noted that it will only consider coordinated conduct that is necessary and proportionate to address concerns arising from covid-19 as benefiting from the above-mentioned safeguards. The advi- sory further states that businesses that use the covid-19 pandemic to contravene the CA02 will be unable to claim protection from sanctions. In In re: Chief Material Manager, South Eastern Railway v Hindustan Composites Ltd and Anr, decided in July 2020 (Case No. 03 of 2016), the CCI was cognisant of the issues faced by businesses on account of covid-19 and refrained from imposing monetary penalties. The CCI noted, among other factors, the economic impact of covid-19 on the credit needs and liquidity of micro, small and medium-sized enterprises as a mitigating factor.
As such, clients are recommended to continue to comply with the CA02, unless any deviation is necessary to deal with the pandemic and can be justified accordingly.
Bharat Budholia, Partner
Toshit Shandilya, Senior Associate
Atish Ghoshal, Associate
Kshaema Susan Mathew, Associate