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Reproduced with permission from PharmaceuticalLaw & Industry Report, 9 PLIR 945, 07/22/2011. Copy-right ஽ 2011 by The Bureau of National Affairs, Inc.
(800-372-1033) http://www.bna.com New Regulatory Actions Underscore Global Antitrust/CompetitionRisk of Altering Product Offerings in Light of Imminent Generic Competition BY RICHARD S. GOLDSTEIN, DOUGLAS LAHNBORG, the products coming off patent. The recent develop-ments have increased the likelihood of challenges to such actions going forward and, with that, potential dif- Recent EU regulatory actions and statements by ferencesastohowthekeylegalquestionsareanalyzed U.S. antitrust regulators have directed attention to on both sides of the Atlantic have taken on greater sig- practices employed by brand name drug manufac- turers whose key products are facing patent expiration.
The specific conduct in question—called ‘‘product hop- ping’’ or ‘‘product switching’’ by some—involves effortsto escape the financial consequences of generic entry In the EU, the UK Office of Fair Trading (‘‘OFT’’) an- by steering consumers to new and improved versions of nounced in October 2010 that global drug manufacturerReckitt Benckiser had agreed to pay a GBP 10.2 millionfine in connection with the withdrawal and de-listing of The authors are partners in the law firm Gaviscon Original Liquid from the National Health Ser- Orrick, Herrington & Sutcliffe LLP, resident in vice prescription channel in 2005.1 The patent for Ga- New York, London, and Washington, respec-tively, and are members of the firm’s phar- 1 See OFT Press release ‘‘Reckitt Benckiser agrees to pay £10.2 million penalty for abuse of dominance,’’ October 15,2010. The fine was later confirmed by the OFT in a formal de- COPYRIGHT ஽ 2011 BY THE BUREAU OF NATIONAL AFFAIRS, INC.
viscon Original Liquid had expired, and doctors were prompted to prescribe Gaviscon Advance Liquid, a In the United States, ‘‘product hopping’’ has been ad- newer version of the product that is patent protecteduntil 2016. The effect of de-listing the older product was dressed in a few court cases and enforcement actions, to deter the dispensing of the generic form of the de- and as recently as November 2010 was identified as a listed product to customers who brought in prescrip- subject of potential concern in a speech by a Federal tions for Gaviscon. The fine followed an allegation by Trade Commission member.3 The earlier of the leading the OFT that Reckitt Benckiser’s action was deliber- cases, Abbott Labs. v. Teva Pharmaceuticals U.S.A., ately timed to restrict competition from generic rivals.
Inc.,4 was decided in 2006 and reflected an unusually As part of its settlement, Reckitt Benckiser admitted determined and aggressive program by Abbott Labora- that its actions violated UK and EU competition law.
tories to avoid generic competition. On three separateoccasions, the court found, Abbott had sought approval Earlier in 2010, the EU’s General Court (‘‘General of slightly different dosage strengths and forms of Tri- Court’’) rejected an argument by AstraZeneca that the Cor (fenofibrate) so as to stay one step ahead of approv- withdrawal or de-registration of product registrations als of generic copies. Teva, which had challenged the for a patent protected product, Losec (omeprazole), a patent for TriCor, sued Abbott, claiming a violation of Proton Pump Inhibitor (‘‘PPI’’) (branded as ‘‘Prilosec’’ the U.S. antitrust laws. The court denied Abbott’s mo- in the United States), was a legitimate exercise of its tion to dismiss the complaint, presuming without dis- patent rights. The General Court found that AstraZen- cussion that Abbott was a monopolist in a market for fe- eca’s actions had the effect of preventing or delaying nofibrate, and concluding that Abbott’s removal of the for a period of between 6 and 10 years the launch of ge- older formulations of TriCor from the market blocked neric equivalents to Losec in Scandinavia, to the benefit the introduction of generic fenofibrate. Whether Abbott of AstraZeneca’s new formulation of Losec. The Gen- had a legitimate pro-competitive reason for its actions eral Court concluded that AstraZeneca’s actions were was left for trial; the company’s intent was not determi- intended to delay generic entry, and that there was no objective justification for the withdrawals other than tomake generic entry more difficult. In its judgment, the The outcome in the second leading case, Walgreen General Court noted that the fact AstraZeneca was not Co. v. AstraZeneca Pharmaceuticals L.P.,5 in 2008 was in a dominant position when the abusive behavior pro- different. There, the plaintiff drug store chain alleged duced its effects did not matter: When the acts were that AstraZeneca aggressively promoted Nexium, a suc- committed, AstraZeneca had a responsibility not to cessor product to Prilosec, and ceased to promote abuse its position and impair genuine competition on Prilosec as Prilosec’s patent was about to expire. The point, allegedly, was to shift Prilosec patients to The pharmaceutical industry has also come under re- Nexium, which had several more years of patent exclu- cent scrutiny in Italy. On October 26, 2010, at the insti- sivity, or to the then newly-approved Prilosec OTC. As- gation of a generic manufacturer, the Italian competi- traZeneca did not, however, take Prilosec off the mar- tion authority conducted a surprise inspection of Pfiz- ket. The court cited this fact in distinguishing the Ab- er’s offices and informed Pfizer that it had launched an bott Labs. decision, noting that ‘‘Courts and juries are investigation to establish whether the company had ar- not tasked with determining which product among sev- tificially extended the patent for latanoprost, the active eral is superior. Those determinations are left to the ingredient in Xalatan (used in the treatment of glau- marketplace.’’ As was the case in Abbott Labs., the coma) to prevent or delay generic competition. Accord- court did not consider AstraZeneca’s subjective intent ing to the authority, the purpose of Pfizer’s conduct was to obstruct or delay access to the market of a new ge- The U.S. Federal Trade Commission had similarly ad- neric drug. In May 2011, Pfizer offered undertakings to dressed charges of illegal ‘‘product hopping.’’ For ex- the authority in order to close the investigation. Pursu- ample, the agency declined to block a 1998 deal in ant to these undertakings, Pfizer will, inter alia: (i) of- which Eli Lilly & Co., which manufactures Prozac (flu- fer to all interested parties an irrevocable royalty free li- oxetine), licensed the rights to Sepracor’s subsequently cense on the divisional patent covering latanoprost in developed isomer of Prozac’s active ingredient. Six Italy; (ii) refrain from seeking further patent protection years later the FTC inserted terms in a consent decree in relation to the paediatric use of latanoprost; (iii) dis- with Warner Chilcott regarding Ovcon that Warner continue any legal proceedings against generics manu- Chilcott could not delist the product or, for three facturers in respect of their marketing of latanoprost; months, destroy any existing inventory.6 In November (iv) settle claims brought by the generics manufacturers 2010, FTC Commissioner J. Thomas Rosch noted in a that have sued Pfizer in the Italian courts; and (v) pub- speech before the World Generic Medicine Congress lish a press release on its website informing consumers that the practice of ‘‘product hopping’’ would continue of the availability of cheaper generic latanoprost.2 cision; see OFT Press release ‘‘OFT issues decision in Reckitt 3 Remarks of J. Thomas Rosch before the World Generic Benckiser case,’’ April 13, 2011.
Medicine Congress, Nov. 17, 2010, available at 2 See the full text submitted by Pfizer to the Italian compe- tition authority: ‘‘Documento Non Riservato, Formulario Per 4 434 F. Supp. 2d 408 (D. Del. 2006).
La Presentazione Degli Impegni Ai Sensi Dell’ Articolo 17-ter 5 534 F. Supp. 2d 146 (D.D.C. 2008).
6 FTC v. Warner Chilcott Holdings Co. III, 2006 WL COPYRIGHT ஽ 2011 BY THE BUREAU OF NATIONAL AFFAIRS, INC.
Lessons For Actions in The United States portant than an objective economic evaluation of the market and the likely consequences of the brand manu-facturer’s series of actions. And in this area differences Broadly, pharmaceutical companies are free to mar- in approaches among regulatory authorities persist de- ket branded products for the duration of the patent lifeand introduce new products at the end of the original spite efforts to ‘‘harmonize’’ enforcement. In the EU, product’s patent life in any way they see fit, without pharmaceutical markets are typically defined, as a running afoul of antitrust/competition law. This in- starting point, by reference to the therapeutic indication cludes launching new generation drugs, as well as of the drug found in ‘‘Anatomical Therapeutic Chemi- launching products with only incremental improvement cal’’ classification, with the Commission’s 2008 decision in efficacy or with similar formulation to the original in the Teva/Barr merger and the AstraZeneca decision product. Pharmaceutical companies, even when ‘‘domi- reflecting a willingness to consider additional market nant’’ (EU terminology) or possessing monopoly or the factors. U.S. market definition is more market-focused, lesser ‘‘market’’ power (U.S. terminology) are free to and among enforcement agencies for a decade has in- compete on the merits with generic products without cluded an emphasis on real-word economic evidence of violating competition law. Concerns will arise only pricing as distinct from what an economic analysis where the brand name manufacturer’s actions, taken might predict in the abstract would occur.
individually or collectively, could be seen as precluding A manufacturer’s decision how to proceed must thus effective competition by the generic.
take into consideration potential disparities in legal Differences between the European and American ap- rules, and to complicate matters, will likely be required proaches exist, and the extent to which those differ- years in advance as follow-on branded products are be- ences may alter the outcome of an investigation or acourt case will turn on the circumstances. The decisions ing set for development and modeled for likely success.
in AstraZeneca and Reckitt Benckiser demonstrate the In the EU, it is prudent to keep a close eye on market importance of intent in European investigations into developments across countries that affect historic mar- dominant companies’ protection against generic entry.
ket definitions, in particular in the years leading up to And, of course, the role of ‘‘dominance’’ status in the patent expiry. In the United States, evidence of compe- EU remains critical, triggering the ‘‘special responsibil- tition reflected in pricing decisions and bidding on man- ity’’ imposed by Article 102 of the Treaty for the Func- aged care rebate and discount contracts should be con- tioning of the European Union, which prohibits abuse sulted. In the United States and the EU, the actual with- drawal of products about to face generic competition, In the United States, in connection with evaluating (or measures with a similar effect), must be considered the lawfulness of ‘‘product hopping,’’ intent is less im- presumptively likely to attract scrutiny.

Source: http://www.orrick.com/Events-and-Publications/Documents/3844.pdf


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