Ross Zaurrini, Ashurst - Abuse of Dominance in the Pharma Sector


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Ross Zaurrini delivered the presentation at 2014 Pharmaceutical Law Conference.

The Pharmaceutical Law Conference is the foremost meeting place and networking hub of the pharmaceutical law industry, and the only pharmaceutical law event in the Asia-Pacific region. The 2014 event highlights included pharma law reform, IP, competitive strategies, industry transparency, sustainable drug pricing and patenting life sciences and more.

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Ross Zaurrini, Ashurst - Abuse of Dominance in the Pharma Sector

  2. 2. 1 The misuse of market power prohibition in the CCA 2 The ACCC v Pfizer case 3 Identifying and managing risk Today 2
  3. 3. The misuse of market power prohibition in the CCA
  4. 4. 4 Section 46 of the Competition and Consumer Act 2010: • 46(1): A corporation that has a substantial degree of power in a market shall not take advantage of that power in that or any other market for the purpose of: a) eliminating or substantially damaging a competitor; b) preventing the entry of a person into that or any other market; or c) deterring or preventing a person from engaging in competitive conduct in that or any other market. (a) – (c) are "proscribed purposes" • 46(1AA): A corporation that has a substantial share of a market must not supply, or offer to supply, goods or services for a sustained period at a price that is less than the relevant cost to the corporation of supplying the goods or services, for a proscribed purpose. Misuse of market power
  5. 5. 5 Misuse of market power (cont.) Element Test applied by the Court (s46) Market Power • The ability to act in a manner not constrained by competitors, potential competitors or customers • Factors: • ability to raise prices above supply cost without rivals taking away customers over time • market share • barriers to entry • vertical integration • ability to engage persistently in exclusionary practices Taking advantage • Would a corporation without market power have engaged in the conduct as matter of commercial judgment? • Other possible indicators: • whether conduct was materially facilitated by corporation's market power • whether corporation engaged in the conduct in reliance on its market power • whether conduct is otherwise related to corporation's market power Purpose • An intention to achieve a particular result • Established by direct evidence or inferred from the nature of the conduct, the circumstances of the conduct and/or its likely effect Predatory pricing • No question of prospect of recoupment arises • Market share / cost / sustained period
  6. 6. The ACCC v. Pfizer case
  7. 7. 7 • ACCC claims that in the period leading up to the expiry of its atorvastatin patent, Pfizer engaged in conduct intended to prevent or deter generic atorvastatin products entering the market in Australia • ACCC considers that this conduct: – was a misuse of market power in breach of section 46 of the CCA; and – amounted to exclusive dealing with a purpose of substantially lessening competition in breach of section 47 of the CCA. ACCC has sued Pfizer
  8. 8. 8 • Pfizer's Australian patent for the atorvastatin molecule used in Lipitor was due to expire on 18 May 2012 • Pfizer expected generic atorvastatin products to rapidly enter the market and compete aggressively with Lipitor • Pfizer had also entered a patent settlement agreement in 2008 with Ranbaxy under which Ranbaxy could launch its generic atorvastatin product from 18 February 2012  Pfizer took a range of steps in response to the upcoming loss of exclusivity Factual background
  9. 9. 9 What did Pfizer do? Pfizer stopped selling through wholesalers in 2010 and supplied Lipitor direct to pharmacies Pfizer set up an Accrual Fund Scheme in 2011 (more than 5000 pharmacies; $35m in rebates as at April 2012) Pfizer released branded generic version of atorvastatin in January 2012 Pfizer made the "Pfizer Atorvastatin Offer" in January 2012
  10. 10. 10 Offer type Proportion of the Accrual Fund released to the pharmacy Required upfront purchase volume of Atorvastatin Pfizer Nominated Conversion Rate Atorvastatin Pfizer Discount Lipitor Discount Platinum 100% 75% of 12 months' total generic atorvastatin volume <60% 60% 20% 60-75% 70% 10% >75% 75% 5% Gold 75% 75% of 9 months' total generic atorvastatin volume <60% 60% 15% 60-75% 65% 10% >75% 70% 5% Silver 50% 75% of 6 months' total generic atorvastatin volume <60% 55% 10% 60-75% 60% 8% >75% 65% 5% Alternate 0% No minimum volume requirement n/a 40% 5% until 1 June 2012, then 1.5% Pfizer Atorvastatin Offer
  11. 11. 11 Timeline 24 February Pharmacies required to accept Platinum, Gold or Silver Offer in order to have Lipitor Rebates released as a credit on their April 2012 statement Jan Feb Mar Apr May Jun 2012 Pharmacy must have accepted delivery of entire nominated volume of Pfizer Atorvastatin in order to have Lipitor Rebates released as a credit on their April 2012 statement 30 April Ranbaxy permitted to enter market 18 February 18 May Pfizer's atorvastatin patent expires and other suppliers of generic atorvastatin permitted to enter market January Pfizer begins offering "Pfizer Atorvastatin" and makes Pfizer Atorvastatin Offer
  12. 12. What is the relevant market? A market is the area of close competition between firms, where there is strong substitution between one product and another if given a sufficient price incentive 12 • ACCC alleges a market in Australia for the supply of atorvastatin to community pharmacies.  Community pharmacies in Australia demanded and acquired atorvastatin. That demand derived from prescriptions issued by medical practitioners  No other pharmaceutical was substitutable for atorvastatin
  13. 13. Did Pfizer have market power? Market power is the absence of constraints from competitors, potential competitors, suppliers or customers 13 • ACCC alleges that Pfizer had substantial market power in a market in Australia for the supply of atorvastatin.  Until 18 February 2012, Pfizer was the only company that could legally supply atorvastatin products in Australia  Until 1 June 2012, only Pfizer's atorvastatin and Ranbaxy's atorvastatin could be supplied to the public through the Pharmaceutical Benefits Scheme
  14. 14. Did Pfizer take advantage of its market power? The test is whether Pfizer could or would have engaged in the alleged anti-competitive conduct if it did not have substantial market power 14 • Pfizer did not face any competition at the time it established the Accrual Fund and made the Pfizer Atorvastatin Offer • The ACCC says Pfizer used its market power to establish the Accrual Fund and make the Pfizer Atorvastatin Offer because it could not and would not have engaged in that conduct without its privileged market position
  15. 15. Did Pfizer have an anti-competitive purpose? There is no prohibition simply on having market power Purpose is a subjective test, but can be inferred from circumstances and effect of conduct ACCC and courts will carefully review internal documents, including board papers, strategy documents and planning materials 15 • ACCC says Pfizer made the Pfizer Atorvastatin Offer to prevent or deter suppliers of generic atorvastatin from competing in the atorvastatin market  Incentivised pharmacies to stockpile Pfizer Atorvastatin before Lipitor lost exclusivity, thereby limiting subsequent demand (and shelf space) for generics  Sought to secure Pfizer's market share by entrenching Pfizer Atorvastatin before Lipitor lost exclusivity
  16. 16. 16 The ACCC' s key arguments The Pfizer Atorvastatin Offer was designed to be "too good to refuse" – it allowed pharmacies to access the Lipitor Rebate, and to receive attractive discounts on both Lipitor and Pfizer's generic atorvastatin The Pfizer Atorvastatin Offer was made at a time when no other company could legally supply atorvastatin to pharmacies The Pfizer Atorvastatin Offer was intended to limit generic competition at the critical point where customers were changing from Lipitor to generic products, with a view to transitioning a large proportion of customers from Lipitor to Pfizer's own generic atorvastatin The fact that Pfizer's generic product had the same "look and feel" as Lipitor, combined with "the inherent difficulty in, and limited incentive for" a pharmacy to switch customers between generic brands, was expected by Pfizer to secure its market share
  17. 17. 17 Pfizer filed its defence on 1 April 2014 denying any misuse of market power: What is Pfizer's defence? Relevant market is a market for the wholesale supply of pharmaceutical products and over the counter products to community pharmacies in Australia Pfizer does not have substantial market power in the supply of atorvastatin. It is subject to vigorous competition across a range of products supplied to community pharmacies Manufacturers and wholesalers were promoting supply of atorvastatin ahead of loss of exclusivity In many cases Pfizer waived or varied requirements to comply with the dates by which things had to be done by community pharmacies
  18. 18. 18 Pfizer filed its defence on 1 April 2014 denying any misuse of market power: What is Pfizer's defence? (cont.) Pfizer's aim was not anti-competitive, it was to maximise its sales of atorvastatin following expiry of its patent Pfizer perceived a first mover advantage for its generic atorvastatin product as some community pharmacists may be reluctant to then switch from Pfizer's generic to another generic Pfizer was equal first to market with Ranbaxy The Pfizer Atorvastatin Offer did not prevent any competitor from making an equally compelling offer
  19. 19. 19 The ACCC' s lay evidence was due to be filed last week Pfizer's lay evidence is due in early July and the parties' expert evidence in late July and August Tentatively set down for hearing for 4 weeks in October 2014 Next steps in the proceeding
  20. 20. 20 What happens if the ACCC wins? • The ACCC seeks substantial financial penalties • Each of the alleged contraventions carries a maximum fine of the greater of:  $10 million; or  3 times the benefit gained from the conduct (if quantifiable); or  10% of annual group turnover
  21. 21. Identifying and managing risk
  22. 22. 22 Forms of potentially abusive conduct Conduct Examples Refusal to deal Australia: • Queensland Wire Industries v Broken Hill Pty Ltd • NT Power Generation Pty Ltd v Power & Water Authority • ACCC v Cabcharge European Union: • Microsoft United States: • Verizon v Trinko Price or margin squeeze No Australian case European Union: • Deutsche Telecom • Telefonica United States: • Pacific Bell Telephone Co v Link Line Communications
  23. 23. 23 Forms of potentially abusive conduct (cont.) Conduct Examples Predatory pricing Australia: • Boral Besser Masonry Ltd v ACCC • ACCC v Cabcharge • ACCC v Eurong Beach Resort European Union: • France Telecom United States: • Brooke Group v Brown & Williamson Tobacco Predatory bidding or buying Australia: • ACCC v Cement Australia United States: • Weyerhaeuser
  24. 24. 24 Forms of potentially abusive conduct (cont.) Conduct Examples Exclusive dealing Australia: • Melway Publishing v Robert Hicks European Union: • Intel United States: • Microsoft Loyalty discounts, conditional rebates, bundling and tying Australia: • ACCC v Baxter Healthcare Pty Ltd (bundling) • ACCC v Pfizer Australia (loyalty discounts/rebates) European Union: • Tomra (loyalty discounts/rebates) • Intel (loyalty discounts/rebates) • Bristish Airways (loyalty discounts/rebates) • Microsoft (tying) United States: • Le Page's v 3M (bundling) • Cascade Health Solutions v PeaceHealth (bundling)
  25. 25. Managing risk • Take ACCC enforcement risk seriously • Think about your position in the market • Consider the timing and other terms of your offer • Ensure your offer is above cost • Clearly articulate your purpose • Educate your people on conduct that may raise concerns • Seek advice 25
  26. 26. AUSTRALIA BELGIUM CHINA FRANCE GERMANY HONG KONG SAR INDONESIA (ASSOCIATED OFFICE) ITALY JAPAN PAPUA NEW GUINEA SAUDI ARABIA SINGAPORE SPAIN SWEDEN UNITED ARAB EMIRATES UNITED KINGDOM UNITED STATES OF AMERICA This presentation material is intended to provide a summary of the subject matter covered for training purposes only. It does not purport to be comprehensive or to render legal advice. No reader should act on the basis of any matter contained in this presentation without first obtaining specific professional advice. 229914358.02 Questions?