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Camouflage: Pay-for-Delay Jonathan Tickner annual savings to purchasers of drugs that would result fromeliminating reverse payment settlements could be in the region of In Gurney v Grimmer [see Endnote 1], Lawrence LJ said that when a matter has been compromised it “assumes that a mutualconcession has been made by both parties and that each party hasgot something less than he claimed”. A party who settles “foregoes the chance of total victory, but avoids the anxiety, risk, uncertaintyand expenditure of time which is inherent in almost any contestedaction, and escapes the danger of total defeat”. [See Endnote 2.] Facilitation of Generic Challenges to PharmaceuticalPatents It is with those words in mind that this chapter looks at the latestdevelopments with regard to reverse payment settlements (or pay- In order to market a new prescription drug in the US, a drug for-delay agreements), by which a pharmaceutical patent holder manufacturer must submit a New Drug Application to the Federal will agree to pay a generic manufacturer to stay out of the market Food and Drug Administration (FDA). If the manufacturer’s for its drug. In return, the brand-name company keeps its high application is successful, it will obtain marketing approval. So as pricing structure and in so doing maintains its monopoly profits, to encourage generic competition in the pharmaceutical market, the which are split with the generic company, but the loss in profits is Drug Price Competition and Patent Term Restoration Act of 1984 generally less than it would have been had the generic company (known as the Hatch-Waxman Act), introduced a mechanism entered the market. It is a win-win situation for both the brand- whereby a generic manufacturer can obtain similar approval by name manufacturer and the generic company, with the only real filing an Abbreviated New Drug Application (ANDA) specifying that the generic drug has the same active ingredients as and isbiologically equivalent to the approved drug. [See Endnote 7.] The ANDA filed by the generic manufacturer must also assure the FDAthat the generic drug will not infringe the brand-name’s patent. The For over a decade, the US Federal Trade Commission (FTC) has generic manufacturer can give this assurance by certifying that: undertaken investigations and launched enforcement actions the brand-name manufacturer has not listed any relevant against pharmaceutical companies on the basis that reverse payment settlements are anticompetitive. [See Endnote 3.] Since the implementation of the Medicare Prescription Drug, marketing of the generic drug will not take place until any Improvement, and Modernization Act of 2003, pharmaceutical patents that are still in force expire; or companies in the US have been required to file certain agreements, the patent held by the brand-name manufacturer is “invalid including patent litigation settlement agreements, with the FTC and or will not be infringed by the manufacture, use or sale” of Department of Justice (DOJ) within ten days of their execution, the generic (the “paragraph IV” route).
enabling the terms and effects of such agreements to be scrutinised.
Certification by way of the paragraph IV route automatically [See Endnote 4.] As a result of these studies, the FTC has found constitutes a patent infringement and therefore opens the gate to that agreements with compensation from the brand-name to the litigation by the brand-name manufacturer. If the brand-name generic prohibit generic entry for nearly 17 months longer than manufacturer brings a suit within 45 days, the FDA must withhold agreements without payments. [See Endnote 5.] As the FTC points approval to market the generic drug for 30 months or until out, if one takes the example of a hypothetical consumer paying determination of the validity of the patent. [See Endnote 8.] $300 per month for a brand-name drug, instead of a generic price as The Hatch-Waxman Act provides a special incentive for a generic low as $30 per month, there is an additional cost of $270 per month to be first to file an ANDA, namely 180 days’ exclusivity from first to the consumer. A 17-month delay in a generic drug entering the commercial marketing of the generic drug. [See Endnote 9.] Any market can therefore cost the hypothetical consumer $4,590.
subsequent filer does not qualify for exclusivity and therefore takes Factoring in consumer savings that result from generic competition the risk of multiple contemporaneous entrants to the market. In in any given month, the likelihood of settlement between a brand- addition, a subsequent filer would have to wait at least 30 months name and generic manufacturer, the length of entry delay resulting for FDA approval if the brand-name manufacturer decided to from such settlement and the combined sales volumes of drugs for which settlements are likely, the FTC estimated in 2010 that the Solvay and Besins filed patent infringement suits against Watsonand Paddock, triggering a stay of the FDA approval process until In Federal Trade Commission v Actavis, [see Endnote 10] the early 2006. In order to minimise the costs risks associated with the Supreme Court acknowledged in a majority judgment that the patent litigation, Paddock entered into an agreement with Par conditions engendered by the Hatch-Waxman Act create a situation Pharmaceutical Companies Inc (Par) which would see Par share in whereby a settlement with the first filer “removes from the resultant profits associated with Paddock’s generic.
consideration the most motivated challenger, and the one closest to When the FDA stay was lifted, Watson received approval to market introducing competition”. [See Endnote 11.] As a result of this and its generic, meaning that the drug was as safe and effective as other factors, the Supreme Court found that such settlements have AndroGel. Watson immediately started planning the launch of the the potential for genuine adverse effects on competition and may, drug, anticipating a launch date in January 2007 regardless of therefore, constitute an unlawful restraint of trade.
whether the patent litigation had concluded. Notwithstanding, it was accepted by the majority in Actavis that On 13 September 2006, Solvay, Besins, Watson and Paddock/Par reverse payment settlements were not per se illegal and, in order to entered into agreements to settle the litigation. This was establish whether a particular agreement was anticompetitive, the notwithstanding that Watson and Paddock/Par had both taken “rule of reason” should be applied. In reaching this decision, the concrete steps to prepare for a generic launch, spending significant Supreme Court refused to adopt the “quick look” approach sums on commercial manufacturing equipment. Of course, it is implied by the FDA that such expenditure (which for Paddock The “quick look” approach is based on the economic realities of an amounted to three-quarters of its annual budget for equipment) agreement and proceeds on the basis that the very existence of a suggested that both were confident that they would succeed in the payment from a brand-name to a generic company which agrees to litigation. This position is supported by evidence cited by the FTC, delay market entry is prima facie evidence of an unreasonable including an email from Paddock’s CEO stating that it had been restraint of trade. The defendant companies are then required to “providing [testosterone] gel formulations to customers over 10 rebut the presumption by showing that the payment was for a years ago, so the patent simply cannot be valid”.
purpose other than delayed entry or that it offers some pro-competitive benefit. In contrast, the rule of reason analysis advocated by the Supreme Court involves three steps. First, theplaintiff bears the initial burden of showing that the defendant’s Financial analyses conducted by all parties to the settlement conduct had an actual adverse effect of competition as a whole in agreements predicted rapid market entry of a generic version of the relevant market. If the plaintiff satisfies this burden, it shifts to AndroGel. Par’s forecast showed that in the first year of sales, up the defendant to offer evidence that its conduct had pro-competitive to 90 per cent of prescriptions for AndroGel would be generic and effects. If the defendant can offer such proof, the burden shifts back the price of the generic would fall to 15 per cent of the branded. It to the plaintiff, who must prove that any legitimate competitive may therefore be inferred that by entering into a settlement effects could have been achieved through less restrictive agreement which saw the deferment of the anticipated launch of a generic AndroGel, competition in the market had been adversely Justice Breyer, writing on behalf of the majority in Actavis, was keen to emphasise that patent validity would not necessarily have to Of course, Solvay would argue that in permitting generic entry five be litigated – something a genuine settlement would have sought to years before the patent for AndoGel expired, the terms of its avoid. Instead, he focused on the rationale for the size of the settlement agreements with Watson and Paddock/Par were in fact reverse payment, which might or might not be supported by pro-competitive and the terms of the agreements reflected traditional settlement considerations or represent fair compensation traditional settlement considerations. Features of the settlement for other services rendered by the recipient of the payment.
agreements which militate against such an argument being While the judgment in Actavis answers a question of law and does not determine whether the agreements concerned are anticompetitive, Only months before Solvay entered into a co-promotion deal consideration of the underlying facts of the case, as outlined in the with Watson as part of their agreement to settle, a consulting FTC’s Complaint (the Complaint), [see Endnote 13] is enlightening, in firm employed by Solvay had concluded that co-promotion that it shows how a fact-finding tribunal, applying the rule of reason, was unlikely to make sense and in any event, Watson did not and particularly the question of whether a settlement was supported by meet the suggested criteria for co-promotion partners.
traditional considerations, could go about deciding the case without Nevertheless, under the co-promotion agreement between determining the validity of the relevant patent.
Solvay and Watson, Solvay projected a payment ofapproximately $19 million to Watson in the first year, risingto over $30 million annually.
Watson agreed not to market its generic until 2015 even thoughit knew of Solvay’s plan to introduce a “line extension” product The Complaint concerns the market for a testosterone replacement (a product related to, but different, from AndroGel) that the drug, AndroGel, which was distributed and sold in the US by FTC claimed would eliminate or substantially reduce potential Solvay Pharmaceuticals Inc (Solvay) under an exclusive licence from the patent holder, Besins Healthcare SA (Besins). In 2000, A co-promotion agreement was entered into between Solvay Solvay and Besins applied for a patent relating to AndroGel, which and Par under which Par had to perform at least 30,800 sales was granted in 2003 to subsist until 2020. A matter of months later, calls a year, with Solvay paying Par over $300 per call. In a Watson Pharmaceuticals Inc (Watson) and Paddock Laboratories previous co-promotion agreement for AndroGel, Solvay had Inc (Paddock) each filed ANDAs adopting the paragraph IV route.
agreed to payments of between $30 and $45 per sales call. AWatson executive is described as having deemed a rate of As the first filer, had its ANDA been approved, Watson would have $150 a call as “ridiculous”.
been eligible for the 180 days of exclusivity under the Hatch-Waxman Act.
Neither co-promotion agreement allowed for earlytermination if co-promotion was unsuccessful.
A back-up manufacturing deal entered into between Solvay which requires settlement agreements to be submitted to the FTC and Paddock guaranteed Paddock $2 million a year for six and DOJ for consideration, brand-name and generic companies in years regardless of whether Paddock ever manufactured the EU volunteered and continue voluntarily to provide information AndroGel and regardless of whether the FDA qualified them on concluded settlement agreements in response to requests from the European Commission pursuant to the Inquiry and the The Supreme Court’s decision must now be applied and a decision monitoring exercises following the Inquiry.
made as to whether the agreements outlined in the Complaint were, The Final Report on the Inquiry mentioned that during its currency, in fact, anticompetitive. In a recent statement to the US Senate but outside of the Inquiry, an enforcement action was already under Committee on the Judiciary Subcommittee on Antitrust, way in relation to suspected anticompetitive pay-for-delay Competition Policy and Consumer Rights, Edith Ramirez, agreements and that surprise inspections had been carried out.
Chairwoman of the FTC, confirmed that the FTC would pursue Formal proceedings, alleging violations of the European Union’s Actavis on its return to the Federal District Court and that it would rules on restrictive business practices (Article 101 of the Treaty on seek to resolve its other pending matter on pay-for-delay the Functioning of the European Union (TFEU)) and on abuse of agreements as quickly as possible. [See Endnote 14.] dominant market position (Article 102 TFEU), were subsequentlyopened against Les Laboratoires Servier (Servier) and others on 8 July 2009, [see Endnote 20] Lundbeck on 7 January 2010 [seeEndnote 21] and Johnson & Johnson and Novartis on 21 October2011. [See Endnote 22.] A Statement of Objections, in which the European Commission informs the parties concerned of theobjections against them and affords those parties the opportunity to In the European Union (EU) a drug must receive marketing consider the evidence against them and respond to it, has now been authorisation before it is placed on the market of an EU Member sent to each company under investigation [see Endnote 23] and in State and, like the US, the EU permits an abbreviated application to Lundbeck, the European Commission has taken one step further, be filed by potential generic entrants, in that the applicant does not fining the brand-name company and those companies with which it have to provide the results of pre-clinical tests and of clinical trials settled actual or potential claims, Alpharma (now part of Zoetis), if it can demonstrate that the drug is a generic of a reference Merck KGaA/Generics UK (Generics UK is now part of Mylan), medicinal product which is, or has been, authorised for not less than Arrow (now part of Actavis), and Ranbaxy. [See Endnote 24.] eight years. [See Endnote 15.] However, unlike the US, the firstapplicant to file an abbreviated application does not receive the special incentive of an exclusivity period.
This lack of special incentive has the effect that any brand-name The European Commission levied fines of €93.8 million on Danish company in the EU which seeks to prevent a bioequivalent drug Pharmaceutical company Lundbeck and fines totalling €52.2 from reaching the market, by way of settling potential or actual million on generic producers Alpharma, Merck KGaA/Generics litigation relating to the validity of its patent, may have to enter into UK, Arrow and Ranbaxy for infringements of Article 101 TFEU. In settlement agreements with a number of generic companies.
its press release announcing the levels of fines imposed (theCommission Press Release), [see Endnote 25] the EuropeanCommission stated that the companies had entered into agreements with the purpose of delaying market entry of generic versions ofCitalopram, Lundbeck’s blockbuster anti-depressant.
The European Commission has been somewhat slower than itstransatlantic counterpart in monitoring, investigating and The decision of the European Commission has yet to be published.
commencing enforcement procedures relating to pay-for-delay In announcing the fines imposed on Lundbeck and others, Joaquín agreements. On 15 January 2008 the Commission launched an Almunia, Vice President of the European Commission responsible inquiry into the pharmaceutical sector (the Inquiry). [See Endnote for Competition Policy, referred to the US Supreme Court’s decision 16.] On 8 July the following year, the European Commission in Actavis, but did not indicate what considerations had been applied adopted the Final Report on the Inquiry, [see Endnote 17] which by the Commission to determine whether a patent settlement found inter alia that between 2000 and June 2008, more than 200 agreement falls foul of competition laws. [See Endnote 26.] settlement agreements were concluded between brand-name and It is unlikely that a rule of reason-type approach will be applied generic companies. Of the 207 agreements that the Commission following the judgment of the Court of First Instance (CFI) in examined, 99 (48 per cent) restricted the generic company’s ability Métropole télévision (M6) and others v European Commission, [see to market its drug and of these, 45 (22 per cent) contained a value Endnote 27] which dealt with a potential infringement of Article 85 transfer in the form of a direct payment or a licence, distribution of the Treaty Establishing the European Community (Article 85 agreement or “side-deal”. [See endnote 18.] This compares with EC), the predecessor to Article 101 TFEU. In Métropole the CFI 629 final settlement agreements examined by the FTC for the fiscal refused to confirm the existence of the rule of reason in Community years (1 October to 30 September) 2004 to 2012 inclusive, of which competition law as it would be difficult to reconcile with the 165 (26 per cent) combined compensation to the generic provisions of Article 85 EC. In coming to this view, the CFI pointed manufacturer with a restriction on the generic manufacturer’s to the express provision in Article 85 EC, which subsists in Article ability to market its product. [See Endnote 19.] 101 TFEU, for the possibility of exempting agreements that restrict The European Commission concluded the section of its Inquiry competition where they satisfy a number of conditions, in particular dealing with settlement agreements between brand-name and where they are indispensable to the attainment of certain objectives generic companies by saying that agreements, which limited and do not afford undertakings the possibility of eliminating generic entry and included a value transfer, were potentially competition in respect of a substantial part of the products in anticompetitive and should be monitored. Unlike the Medicare question. It is only in this framework that the CFI accepted the pro Prescription Drug, Improvement, and Modernization Act of 2003, and anti-competitive aspects of a restriction may be weighed.
Having regard to the terms of Vice President Almunia’s speech, it strength of the underlying patent in order to assess whether the seems more likely that the European Commission will adopt a relevant compromise agreement reflected traditional settlement position more consistent with the “quick look” approach advocated concerns and whether it was, in fact, a true compromise. by the FTC. Vice President Almunia’s emphasis that the“overwhelming majority of [patent settlement agreements] are entirely legitimate as they do not involve any payments byoriginators to exclude generic companies” tends to suggest that an agreement involving a value transfer and delayed generic entry will Bingham LJ, Foreword to the Fourth Edition of D Foskett be prima facie evidence of an unlawful restraint of trade. [See QC, The Law and Practice of Compromise (6th edn., Sweet Endnote 28.] This is compounded by the terms of the Commission press release, [see Endnote 29] which refers to internal documents Federal Trade Commission (FTC), ‘Pay-for-Delay: How showing a “club” having been formed and a “pile of $$$” to be Drug Company Pay-Offs Cost Consumers Billions’ (January shared among participants. Evidence such as this may, of course, 2010). Available at: make it harder for a defendant to argue that the reverse payment 100112payfordelayrpt.pdf (accessed 18 August 2013).
settlements were in fact pro-competitive or achieved as a result of Medicare Prescription Drug, Improvement, and the application of traditional settlement considerations, although interestingly Lundbeck has indicated its intention to challenge the Commission’s decision, pointing to the fact that not only were the agreements it entered into scrutinised by antitrust experts, but thatthey were reviewed in 2004 by both the European Commission and the Danish Competition Authorities, “who publicly stated that it could not be rendered probable that the agreements were restricting FTC v Actavis et al. 570 US 756 (2013).
C Hemphill, ‘Paying for Delay: Pharmaceutical Patent Settlement as a Regulatory Design Problem’, (2006) 81NYUL Rev. 1553 at 1586, cited with approval in Actavis Reverse payment settlements have been the subject of both regulatory and private actions in the UK. On 19 April 2013, the Arkansas Carpenters Health and Welfare Fund & Ors v Office of Fair Trading issued a Statement of Objections alleging Bayer AG & Ors (re: Ciprofloxacin Hydrochloride Antitrust that GlaxoSmithKline (GSK) had concluded agreements which Litigation) 604 F.3d 98 (2d Cir. 2010).
infringed competition law with each of Alpharma Limited, Generics Second Amended Complaint for Injunctive and other (UK) Limited and Norton Healthcare Limited over the supply of a Equitable Relief, filed on 28 May 2009. Available at: generic version of GSK’s branded paroxetine product, Seroxat in (accessed 18 August 2013).
the UK. [See Endnote 31.] It is anticipated that a final decision willbe reached on this case in late 2014.
Edith Ramirez, ‘Pay-for-Delay Deals: Limiting Competitionand Costing Consumers’ (Statement to the United States In the meantime, the Secretary of State for Health for England and Senate Committee on the Judiciary Subcommittee on others are pursuing a claim in the Chancery Division of the High Antitrust, Competition Policy and Consumer Rights on 23 Court against Servier Laboratories Limited, Servier Research and July 2013). Available at: Development Limited, Les Laboratoires Servier and Servier SAS.
113hearings/130723payfordelay.pdf (accessed 18 August [See Endnote 32.] The claim, which is running in parallel to the European Commission investigation outlined above, alleges that, contrary to Articles 101 and 102 TFEU and section 18 of the Antitrust: Commission launches sector inquiry into Competition Act 1998, Servier formed and implemented a strategy pharmaceuticals with unannounced inspections, Europa to delay the entry of a generic version of its perindopril product, press release IP/08/49 (16 January 2008). Available at: Coversyl, by: (1) applying for a patent in circumstances where it h t t p : / / e u r o p a . e u / r a p i d / p r e s s - r e l e a s e _ I P - 0 8 - knew or had no honest belief that the patent was valid; (2) 49_en.htm?locale=en (accessed 18 August 2013).
attempting to enforce the patent through actual or threatened European Commission, Executive Summary of the proceedings against competitors in the market; and (3) entering into Pharmaceutical Sector Inquiry Report, 8 July 2009, unlawful reverse payment settlements with competitors. Similar COM(2009) 351 Final. Available at: http://eur- claims have also been brought by the health authorities for 351:FIN:EN:PDF (accessed 18 August 2013).
European Commission, Technical annex to the ExecutiveSummary of the Pharmaceutical Sector Inquiry Report, 8 July 2009, COM(2009) 351 Final. Available at: The decision in Actavis has opened the door for reverse payment uiry/staff_working_paper_part1.pdf (p.270, accessed 18 agreements to be found unlawful and it seems unlikely that the European courts will come to a contrary view given the tide of FTC, ‘Agreements Filed with the Federal Trade Commission negative sentiment existing in relation to these types of agreements.
under the Medicare Prescription Drug, Improvement, and However the outstanding question is whether any agreements will Modernization Act of 2003. Overview of Agreements Filed in actually be found to be anticompetitive and why. Whilst the FY 2012. A Report by the Bureau of Competition’. Available Supreme Court in Actavis was keen to stress that patent validity at: need not be re-litigated in a reverse payment agreement case, it seems inevitable that the courts will have to come to a view on the Antitrust: Commission opens formal proceedings against Les Antitrust: Commission fines Lundbeck and other pharma Laboratoires Servier and a number of generic pharmaceutical companies for delaying market entry of generic medicines, companies, Europa press release MEMO/09/322 (8 July 2009).
Europa press release IP/13/563 (19 June 2013). Available at: Available at: 322_en.htm (accessed 18 August 2013).
Antitrust: Commission opens formal proceedings against pharmaceutical company Lundbeck, Europa press release Commission fines Lundbeck and other pharma companies for delaying market entry of generic medicines: statement by (accessed SPEECH/13/553 (19 June 2013). Available at: Antitrust: Commission opens proceedings against Johnson & h t t p : / / e u r o p a . e u / r a p i d / p r e s s - r e l e a s e _ S P E E C H - 1 3 - Johnson and Novartis, Europa press release IP/11/1228 (21 553_en.htm (accessed 18 August 2013).
October 2011). Available at: release_IP-11-1228_en.htm (accessed 18 August 2013).
Antitrust: Commission sends Statement of Objections on perindopril to Servier and others, Europa press releaseIP/12/835 (30 July 2012). Available at: Lundbeck intends to appeal the decision from the European Commission, Lundbeck press release (19 June 2013).
(accessed 18 August 2013). Antitrust: Commission sends Available at: Statement of Objections to Lundbeck and others for ReleaseID=772307 (accessed 18 August 2013).
preventing market entry of generic antidepressant medicine, OFT issues statement of objections to certain Europa press release IP/12/834 (25 July 2012). Available at: pharmaceutical companies, OFT press release 36/13 (19 April 2013). Available at: (accessed 18 August 2013). Antitrust: Commission sends updates/press/2013/36-13 (accessed 18 August 2013).
Statement of Objections to J&J and Novartis on delayed entry of generic pain-killer, Europa press release IP/13/81 (31 January 2013). Available at: (accessed 18 August 2013).
Jonathan Tickner is a Partner at Peters & Peters Solicitors LLP Emma Ruane is an Associate in the commercial litigation specialising in commercial litigation, commercial fraud and department at Peters & Peters Solicitors LLP. Emma trained at competition law damages claims. Jonathan’s work ranges from Peters & Peters, before becoming an Associate in 2010. Emma large complex commercial disputes, the conduct of internal has extensive experience in dealing with competition law investigations and the diversion of business opportunities.
damages claims, and is part of the team assisting Jonathan Jonathan enjoys a long-standing relationship with the Department Tickner in cases brought by the Secretary of State for Health of Health and NHS Protect having acted for the NHS over the past against Les Laboratoires Servier and Reckitt Benckiser plc.
14 years in the largest pharmaceutical competition law cases in Emma’s practice includes competition, civil fraud and high-value the UK. He is currently acting on behalf of the Secretary of State commercial litigation cases. In addition to being a practising for Health and others in cases alleging anti-competitive conduct solicitor, Emma was also called to the New York Bar in 2012.
against Les Laboratoires Servier and Reckitt Benckiser plc in theHigh Court. Jonathan is recommended in The Legal 500, whichdescribed him as “a first-class lawyer”, Chambers & Partners UK,the UK Super Lawyers and in The International Who’s Who ofAsset Recovery Lawyers. He is co-author of Getting the DealThrough: Asset Recovery 2013.
Peters & Peters is one of the UK’s leading firms in civil fraud, commercial litigation, business crime and compliance. Our extensiveexperience includes pharmaceutical competition law damages claims and we are currently instructed on the highest value privatedamages competition claims on-going before the English Courts. Other areas of expertise include corruption, criminal cartels,extradition and government sanctions. Our clients include governments, corporates and individuals, both in the UK andinternationally. We often act on behalf of corporate clients under global investigation, individuals sought by foreign lawenforcement authorities and executives being prosecuted in the UK. Our lawyers are recognised experts, with unrivalledexperience and we have a reputation for client service, creativity and excellence. Previous winner of Niche Firm of The Year atthe Lawyer Awards, we are consistently ranked as amongst the leading firms in our practice areas by Chambers and Partners andThe Legal 500. ‘The Lawyers UK 200 Annual Report 2012’ said that Peters & Peters was an example of “how a litigation boutiqueshould be run” and referred to our “stellar reputation” being the reason that we pick up “some of the standout international casesbeing litigated in London”.



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