French Autorité de la Concurrence Fines Sanofi €40.6 Million for Denigrating Competing Generics"

by Skadden, Arps, Slate, Meagher & Flom LLP
Contact

On May 14, 2013, the French Autorité de la Concurrence (Autorité) issued a decision imposing a fine of €40.6 million on French company Sanofi-Aventis France (Sanofi) for an abuse of dominance in the market for the cardiovascular drug clopidogrel. This is not the first time the French competition authority has addressed the issue of an originator’s defamation of competing generics companies’ products, and highlights that this is a key area for the Autorité to ensure and facilitate generic entry. For example, in December 2007, the Autorité ordered Schering Plough by way of an interim measures order to stop making denigrating comments to physicians and pharmacists and to publish a statement in two medical magazines confirming the bioequivalence of the relevant generic drugs that had been permitted on the market and the possible substitution by pharmacists as soon as they were listed as generic drugs. The decision also makes clear that the Autorité is willing to define markets narrowly to be limited to the pharmaceutical in question in relation to issues involving life cycle management and generic entry.

The Products Concerned

Plavix is a clopidogrel brand drug which prevents relapses in cardiovascular diseases and is very widely prescribed in cases of Acute Coronary Syndrome (ACS). It is the fourth best-selling drug in the world and, in 2008, was the number one reimbursed pharmaceutical in France based on total reimbursements made by the French social security agencies.

The Context: Opening to Competition From Generics in 2008

Sanofi’s patents for Plavix expired in 2008, opening the clopidogrel market to competition from generics. However, Sanofi obtained further patents on salts used in the composition of Plavix, which expired in 2013, leading competing generics manufacturers to use different salts in order to avoid patent infringement.

Moreover, a combination of Plavix and aspirin remains patent protected until 2017, and is specifically indicated for the treatment of ACS. Therefore, Sanofi is the only manufacturer authorized to sell this combination of Plavix and aspirin until 2017.

The French authorities had approved generics using different salts, finding them bioequivalent, and issued marketing authorizations for a number of generic versions at the beginning of 2009.

Finally, Sanofi also manufactures its own generic of Plavix (Clopidogrel Winthrop), which is thus the only generic version of clopidogrel using the same salts as Plavix.

The Commercial Practice Concerned

The Autorité found that Sanofi had set up a commercial strategy to counter the entry of generics of Plavix. According to the Autorité, the strategy consisted of systematically denigrating and discouraging the use of competing generics.

According to the decision, Sanofi implemented this strategy through its team of medical representatives who visited with physicians and with pharmacists:

  • At the prescription stage: Sanofi representatives denigrated competing generics to physicians, to ensure that they would insert a “nonsubstitutable” mention when prescribing Plavix or its Winthrop generic product;
  • At the substitution stage: Sanofi representatives denigrated competing generics to pharmacists, with the aim of avoiding substitution for Plavix, or at least only for its Winthrop generic.

In addition, the decision found that Sanofi representatives issued threats of legal liability vis-à-vis physicians and pharmacists if they prescribed the generics companies’ products.

Sanofi had tried to justify its communications to physicians and pharmacists by arguing the following:

  • The difference in the salts used by the generics raises issues regarding the generics’ efficacy and innocuousness. However, according to the decision, French public authorities had confirmed the inaccuracy of Sanofi’s insinuations in a letter to Sanofi and instead authorized the generics as bioequivalent, despite the use of different salts;
  • The generics companies did not have an authorization to market their products as a combination with aspirin for ACS treatment. Sanofi sought to raise doubts about the compatibility of the different salts used by generic products and aspirin. However, according to the decision, it was possible to prescribe the generics alongside aspirin, a treatment having the same efficacy in ACS treatment.

Sanofi Held a Dominant Position in a Market for Clopidogrel

The Autorité found that Sanofi enjoyed a dominant position in the French market for clopidogrel sold in pharmacies, in which Sanofi has a market share of about 60 percent through its brand-drug Plavix and its own Winthrop generic. The Autorité thoroughly investigated alternatives to Plavix within the relevant ATC 4 category, which is typically the relevant market definition, and which has been accepted by the Autorité in prior cases when assessing whether pharmaceutical companies hold a dominant position in the analysis of life cycle management strategies. However, based on the facts of this case, the Autorité defined a narrower market because it considered that there are no substitutes to clopidogrel and because the importance of the pharmaceutical’s brand meant that prescribers and patients would not consider any substitutes.

Denigrating a Competitor’s Product Can Constitute an Abuse of Dominant Position The Autorité, basing its decision on Article L.420-2 of the Commercial Code, as well as Article 102 TFEU, found that an originator’s statements concerning the quality of a generic competitor’s products vis-à-vis physicians and pharmacists can constitute an abuse of a dominant position if the statements are inaccurate and have the effect of maintaining or strengthening a dominant position. According to the decision, the denigrating statements created an illegitimate doubt on the efficacy and innocuousness of the competing generics and, along with threats of legal liability, were anticompetitive. The Autorité stated that the only acceptable commercial strategy for Sanofi in this case would have been to emphasize the difference in salts. Implying that this difference in salts could have consequences on health and legal liability when the French authorities had already granted marketing authorizations and had confirmed by letter to Sanofi the bioequivalence of these generic products constituted an abuse of dominant position.

The Effects Analysis

In assessing whether Sanofi’s statements had the effect of maintaining or strengthening a dominant position, the Autorité looked at the substitution rate (or “generification” rate) of Plavix with generics compared to trends of other molecules using projections of the French health care authorities.

The Autorité found that the substitution rate for Plavix was:

  • Lower than projected; and
  • Lower when compared to the substitution trend of other drugs in general.

This effect was key in the decision. In 2010, the Autorité had refused to grant interim measures in this case because the Securité Sociale studies showed normal substitution rates for Plavix. Updated studies on effects led the Autorité to find an anticompetitive effect because the entry of competing generics was significantly slowed.

Tackling Obstruction of Generic Entry Through Strategies of Misrepresentation

The Sanofi decision is in line with earlier cases of the Autorité, which focus on obstruction of generic entry through defamation of generic products and their bioequivalence. For example, in the case of Schering Plough the Autorité found that the direct interference with and obstruction of the launch of a competitor’s product based on inaccurate statements fell outside competition on the merits. In the Sanofi decision, the Autorité paid special attention to the fact that these statements were inaccurate and that Sanofi had full knowledge that they were inaccurate given the marketing authorizations and the letter received by Sanofi from the French authorities, which confirmed the efficacy of generic products with different salts, as well as the possibility to use them in conjunction with an aspirin treatment for ACS.

The full text of the decision is here.

Download PDF

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Skadden, Arps, Slate, Meagher & Flom LLP | Attorney Advertising

Written by:

Skadden, Arps, Slate, Meagher & Flom LLP
Contact
more
less

Skadden, Arps, Slate, Meagher & Flom LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.