Canada: Pharmaceuticals

Ongoing expansion and development in the pharmaceutical sector is shaping, and transforming, the competitive landscape globally. The industry’s markedly dynamic nature is reflected in a range of activity, from the development of innovative products that are redefining pharmaceutical markets to large-scale mergers with potential competitive effects in multiple jurisdictions. Not surprisingly, this has attracted the attention of competition authorities worldwide.

For its part, the Canadian Competition Bureau (the Bureau), in its administration and enforcement of the federal Competition Act (the Act), has turned its eye to the competitive implications of activity in the industry in Canada. Key recent developments include the release, in 2016 and 2019, of updates to the Bureau’s Intellectual Property Enforcement Guidelines (IPEGs), which cover the interface with intellectual property (IP) laws generally but now include extensive guidance specific to the pharmaceutical industry. Through these guidelines and other commentary, the Bureau has become more vocal in identifying the potential anticompetitive effects of specific conduct such as pay-for-delay settlements and product-switching, while fielding a significant number of merger review applications. In addition to providing much-needed clarity on the Bureau’s approach to IP, these developments signify an intensifying focus on pharmaceuticals, even as the Bureau pursues a stated interest in supporting innovation. Specific reference to the pharmaceutical industry in a 2018 parliamentary report calling on the Bureau to investigate industry practices may mean that a higher percentage of complaints will result in investigations in future, ¹ and indeed following the closure of recent investigations involving pharmaceutical companies, the Bureau has expressed an intention to keep a watchful eye on the sector. As such, the potential for scrutiny under competition laws will continue to be a key consideration for stakeholders as the industry evolves.

IP and the Act: the Bureau’s updated IPEGs

On 13 March 2019, the Bureau released final updated IPEGs, which were first published in 2000 and previously substantially updated in 2016.

The IPEGs’ primary focus is on the interface between IP law and competition law – a common theme in recent public statements by the Bureau, ³ The general provisions of the Act relating to cartels and horizontal agreements, pricing and distribution practices, abuse of dominance and mergers address the former, while section 32 (special remedies) addresses the latter. ⁴ In a recent decision involving the Toronto Real Estate Board, the Federal Court of Appeal further confirmed that a defence under a separate provision of the Act, which protects acts engaged pursuant ‘only’ to the exercise of an IP right, does not allow a party to rely on its IP right to shield ‘what would otherwise be an anticompetitive act’. ⁵ That is, this defence is unavailable in circumstances involving something more than the mere exercise of an IP right.

A core principle underpinning the Bureau’s approach above is that the unilateral exercise of an IP right is not an anticompetitive act in itself. The Act does not prohibit the exercise of IP rights generally. Rather, it imposes limitations on the IP owner under the general provisions of the Act when IP rights form the basis of agreements or arrangements between independent entities and when competitive harm stems from such an agreement. ⁶

The IPEGs serve as an important notice to stakeholders in the IP-centric pharmaceutical industry of how their activities may be assessed under the Act. Notably, the IPEGs include guidance on the Bureau’s approach to settlement agreements reached pursuant to proceedings under the Patented Medicines (Notice of Compliance) Regulations (the PMNOC Regulations). They also include specific examples relevant to the pharmaceutical sector, including product-switching activities, patent pooling and payments by brands to generics either before or after patent expiry for the purpose of delaying the generic’s entry (in the former case) or potentially for the purpose of allocating markets (in the latter case).

Pharmaceutical industry focus areas: product-switching and settlement agreements

Product-switching or ‘product hopping’ and settlement agreements are two areas of conduct that continue to draw the Bureau’s attention to the pharmaceutical industry. The Bureau has shown an ongoing interest in these areas, which feature prominently in the updated IPEGs, indicating that the Bureau is actively working to identify and address the potential concerns that may arise from such conduct.

Product-switching and the Bureau’s investigation

Product-switching or hopping generally refers to the introduction by a brand-name pharma­ceutical manufacturer of a new product with limited or no therapeutic advantage over its original product (eg, a change in dosage or form), where the drug’s characteristics are modified enough to qualify for a new patent while maintaining enough of the original characteristics to rely on previous clinical trial results for the purpose of pharmaceutical regulatory approval. Prior to the expiry of the original patent, the brand drug company withdraws its original product from the market, by either recalling its supply or by raising its price significantly higher than the reformulated drug, causing physicians and consumers to switch over to the reformulated brand drug. As a result, generic versions of the original product cannot be automatically substituted for prescriptions written for the new product. ⁷ The strategy is considered to be a means of enabling the brand company to maintain its market exclusivity by preventing generic manufacturers from entering the market. ⁸

The updated IPEGs include an example involving product-switching by a pharmaceutical company, indicating that where such conduct is engaged in for the purpose of excluding a generic pharmaceutical firm, the Bureau may investigate the innovator’s conduct under section 79 of the Act as a possible abuse of dominance. As a qualification to this commentary, however, the IPEGs also indicate that ‘soft’ product-hopping, referring to the circumstance where a brand pharma­ceutical company does not withdraw a pre-existing product from the market entirely but instead stops promoting it to physicians when a new product is introduced, would not necessarily raise an issue, provided it does not undermine the prescription base of the original product.

In late 2013, the Bureau was already showing a growing interest in the strategies and practices employed by pharmaceutical firms, such as pay-for-delay settlements, product-switching and other ‘life cycle management’ strategies, when it held a workshop (‘Antitrust Issues in the Pharmaceutical Sector’) featuring international perspectives from the United States and Europe, jurisdictions that had already brought significant attention to these practices.

In May 2014, the Bureau announced that it had discontinued an inquiry into whether Alcon Canada Inc (Alcon), an allegedly dominant firm in the supply of certain prescription drugs, had engaged in anticompetitive conduct by disrupting the supply of a drug soon to be off-patent, Patanol, and replacing it with a successor drug, Pataday, for which there was initially no generic substitute.

The Bureau had commenced an inquiry in November 2012 as a result of concerns that Alcon’s behaviour would delay or prevent entry of generic versions of Patanol and instead lead patients to buy Pataday at a higher price. After the inquiry had been commenced, Alcon reintroduced Patanol into the Canadian market. After it had done so, competitors entered the market with generic versions of the drug and subsequently captured a significant market share from Alcon. The Bureau ultimately discontinued its inquiry because Alcon ceased the conduct that raised the initial concerns, the reintroduction of Patanol appeared to have restored the competitive dynamic in the market, and the temporary product-switching strategy employed by Alcon did not appear to have actually delayed any generics from entering the Canadian market.

The Alcon case marked the Bureau’s first public investigation of unilateral practices in the pharmaceutical industry. Although the case suggests that remedies will not be applied in the absence of actual or likely anticompetitive effects, the Bureau has clearly demonstrated its willingness to investigate concerns associated with industry-specific practices in this instance and in more recent inquiries discussed further below.

Settlement agreements and the Bureau’s White Paper

‘Pay-for-delay’ describes a form of patent settlement (reverse payment settlements) whereby a brand-name pharmaceutical manufacturer and a generic manufacturer agree that the generic will delay the launch of a competing generic product in exchange for a value transfer, such as a direct payment, lucrative agreement for services or other form of compen­sation. ⁹ The brand-name company thereby effectively delays potential generic competitors from entering the market.

The Bureau comments extensively on pay-for-delay and certain other settlement agreements in the IPEGs. Recognising that there are ‘significant differences’ in the regulatory regime in Canada relative to other jurisdictions and that these may have implications for the incentives behind and content of settlements, the IPEGs outline three ‘unique’ features governing settlements reached under the PMNOC Regulations:

• the absence of a six-month exclusivity period for the first generic filer, a feature that may limit the ability of settlements involving the first generic challenger to delay the entry of subsequent firms;
• the possibility of claiming ‘section 8’ damages against the patentee under the PMNOC Regulations, which is relevant to the evaluation of a brand’s payment to the generic firm in a settlement agreement; and
• the possibility of ‘dual’ or follow-on litigation (in the form of an infringement action against a generic firm after it has successfully defended a prohibition proceeding if it chooses to launch prior to patent expiry, or proceedings against a brand firm for impeachment of its patent after it has succeeded in a prohibition application).

The IPEGs also include specific examples reflecting the following enforcement approaches to settlements reached under the PMNOC Regulations:

• ‘Entry-split’ settlements, which do not involve the payment of consideration from a brand to a generic other than allowing the generic to enter the market before the patent expires, generally will not raise any concerns under the Act.
• Settlements with a payment to the generic firm pursuant to which the generic enters the market prior to patent expiry will be reviewed under section 90 of the Act (reviewable agreements between competitors) or possibly section 79 (abuse of dominance).
• A settlement will be reviewed under section 45 as a criminal conspiracy only in ‘very limited circumstances’, if there is evidence that the intent of the payment was to fix prices, allocate markets or restrict output.

Prior to the release of the updated IPEGs, on 23 September 2014, Canada’s Commissioner of Competition released a White Paper (the White Paper) discussing patent litigation settlement agreements between brand-name pharmaceutical manufacturers and generic pharmaceutical manufacturers. The White Paper expresses particular concerns with pay-for-delay agreements, referencing recent legal developments in the United States that have brought such arrangements more closely under the eye of the antitrust agencies, partly owing to a 180-day exclusivity period that temporarily prevents other generics from entering after the entry of the first generic filer, and that in all cases must be reported. Though no such exclusivity period applies in Canada, the Bureau indicated through the White Paper that this type of agreement, though not subject to mandatory notification, nonetheless raises potential competitive concerns.

The White Paper indicates that agreements between brands and generics will generally attract the Bureau’s scrutiny only where there is a transfer of payment that is significant – if the payment to the generic exceeds the potential profit the generic could have made by competing in the market, if the payment exceeds any damages that the generic could have obtained through litigation or if the payment exceeds the brand’s expected litigation costs.

Abuse of dominance: other recent investigations in the pharmaceutical sector

Beyond cases specific to product-switching and pay-for-delay agreements, the Bureau actively investigates other potential competitive concerns in the pharmaceutical industry under the abuse of dominance provisions. Two recent inquiries, which closed in late 2018 and early 2019, focused on manufacturers of brand-name drugs (regarding generic drug manufacturers) and biologic drugs (regarding biosimilar (generic biologic drugs, previously known as subsequent entry biologics in Canada) drug manufacturers), respectively. In both cases, the Bureau considered whether the firms’ activities could constitute an abuse of a dominant market position.

The first inquiry involved attempts by three brand-name drug manufacturers to restrict access to samples of drugs required to prove the bioequivalency of generic products. The Bureau eventually closed the investigation, but stated that evidence it obtained supported the generic manu­facturers’ position that they faced barriers impeding their access to the branded drugs. The second inquiry involved the possible predatory or exclusionary impact of various activities on the part of a biologic drug manufacturer with regard to biosimilar firms. ¹⁰

In its statements following the closure of these investigations, the Bureau indicated that it would continue to monitor practices and dynamics within the pharmaceutical industry, particularly where the activities of brand-name or biologic drugs are involved, and that such conduct may warrant further enforcement or advocacy in the future. ¹¹

Merger reviews in the pharmaceutical sector

Pharmaceutical sales in Canada represent approximately 2 per cent of the global market, placing Canada among the 10 largest world markets. From 2002 to 2017, total pharmaceutical sales in Canada doubled, reaching C$27 billion. ¹² The growth and increased activity in the pharmaceutical sector in Canada have driven mergers and acquisitions, ¹³ and the Bureau has been involved in reviewing an ever-growing number of pharmaceutical transactions.

Recent merger reviews

In April 2016, the Bureau entered into a consent agreement with the world’s largest generic pharma­ceutical company relating to its proposed acquisition of another company’s generic pharma­ceuticals business, having found that the proposed acquisition would likely have resulted in a substantial lessening or prevention of competition for the sale of two pharmaceutical products in Canada. ¹⁴ The consent agreement required the purchaser to divest either its own or the target’s Canadian assets relating to the two products.

In December 2016, the Bureau entered into a consent agreement with the Canadian subsidiary of the largest wholesaler of pharmaceutical products in Canada and a large pharmacy retail chain, to resolve concerns related to the wholesaler’s proposed acquisition of the retail chain’s corporate group, which also owns a healthcare claims adjudication business. ¹⁶ Two others involved the proposed transactions discussed above, which were cleared pursuant to consent agreements in April and December 2016 respectively. ¹⁸

The former case comprised a three-part, inter-conditional transaction involving the creation of a joint venture between the parties for their over-the-counter (OTC) and consumer healthcare products, the acquisition of one party’s global vaccine business and the acquisition of the other party’s portfolio of oncology products. Only the OTC joint venture was technically notifiable, although all three components were subject to substantive review by the Bureau.

According to the Bureau’s position statement, the review examined the effects of the proposed transaction on the parties’ products that are currently marketed, as well as pipeline products. The Bureau’s focus was on whether the proposed transaction was likely to increase prices in the relevant markets or decrease another dimension of competition, such as innovation.

Ultimately, the Bureau concluded that neither the OTC joint venture nor the vaccine acquisition would result in a substantial lessening or prevention of competition in Canada on the basis that products offered by the companies to treat similar ailments were not close substitutes. ¹⁹ In the case of the oncology product acquisition, the Bureau found that the acquisition was likely to have a substantial effect on competition. However, the Bureau considered that a consent agreement entered into in the United States, which required the acquiring party to sell certain assets to another pharmaceutical industry participant, effectively resolved any potential competitive concerns in Canada.

The April 2016 consent agreement led to a different result. The Bureau’s statement in that case took the position that where parties’ products contain the same molecule or active ingredient and are supplied in the same format, in general they should be considered within the same relevant product market, but that it may be appropriate to differentiate products based on other factors such as dosage strength. ²⁰ The Bureau took a forward-looking approach by considering both the remaining suppliers of equivalent generics and any likely future generic suppliers in its assessment of whether there would be effective remaining competition after closing. In keeping with its collaborative approach to international deals, the Bureau indicated that it cooperated with a number of its international counterparts (including the US Federal Trade Commission and the European Commission), in addition to engaging in extensive market contacts and consultations with Health Canada.

Regarding the December 2016 consent agreement, the Bureau commented that the deal was ‘largely vertical in nature’ and that for this reason the Bureau sought to address the potential unilateral effects of the proposed merger (in particular, the acquiring wholesaler’s ability to influence independent pharmacies operating under its retail banners). Additionally, the Bureau sought to address the potential coordinated effects of the proposed deal given that the acquiring party obtains commercially sensitive information in serving its wholesale customers, including direct rivals to the target retail chain, and the Bureau’s determination that the combined competitive intelligence of the merged entity would likely enable it to ‘alter the competitive dynamics’ and ‘significantly increase the likelihood of coordination among retail pharmacies’ in the retail markets in which the target competes.

Finally, in April 2018, the Bureau entered into a consent agreement relating to the proposed acquisition by a food retailer and distributor, which also (through a wholly owned affiliate) provides distribution and franchise services to independent pharmacists in Quebec, of a provider of distribution and franchise services to pharmacies in that province, which also owns a generic pharmaceuticals manufacturer. The Bureau’s analysis focused on the companies’ competing pharmacy distribution and franchise services. As the Bureau concluded that the transaction would likely result in higher prices or a decrease in services for consumers, under the consent agreement, the acquiring company agreed to sell certain properties or leases to another supplier of distribution and banner services and to take steps to terminate agreements relating to pharmacies located in the relevant markets in Quebec.

Looking ahead: supporting competition and innovation in a changing industry

Industry trends point to continued ground-breaking changes in the pharmaceutical sector, which the government of Canada has referred to as ‘one of the most innovative industries in Canada’. For example, recent reports reflect ongoing significant research and development (R&D) expenditures, even as shifts in the industry’s business model mean that relatively more R&D is being conducted externally and through partnerships rather than directly by Canadian pharmaceutical companies.21 In this context, the Bureau’s sharpened focus on pharmaceuticals, notably through its approach to the interface between IP and competition law in the updated IPEGs, suggests that increased enforcement in the industry may be on the horizon. At the same time, the Bureau has repeatedly expressed an interest in supporting the development of both competition and innovation in recent publications and public comments, and in committing to regularly reviewing (and updating, as needed) the IPEGs to keep apace of the changing ‘IP environment’ and business conduct.22 These developments seem to ensure that pharmaceuticals will remain top-of-mind going forward as both the industry and the Bureau’s approach continue to evolve.

* The authors would like to thank Yana Ermak, Randeep Nijjar and Sarah Mavula for their contributions to the original and updated versions of this chapter.

Notes