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    European Commission Fines Pharma Companies For Payments To Delay Generic Entry

    Published on 19 June 2013 @ 8:48 pm

    By for Intellectual Property Watch

    The European Commission (EC) has fined Danish pharmaceutical company Lundbeck as well as eight other generic manufacturers for delaying market entry of generic medicines by way of patent settlement agreements (also known as “pay-for-delay” agreements).

    According to a Commission press release, Lundbeck was fined € 93.8 million while other generic producers incurred fines totalling € 52.2 million. In 2002, Lundbeck and these generic firms agreed to delay the market entry of the generic versions of Lundbeck’s citalopram, a “blockbuster antidepressant.” The generic companies involved were Alpharma (now part of Zoetis), Merck KGaA/Generics UK (Generics UK is now part of Mylan), Arrow (now part of Actavis), and Ranbaxy.

    The EC decided that these agreements were anticompetitive and violated European Union antitrust rules (Article 101 of the Treaty on the Functioning of the European Union – TFEU). The reasoning was that these agreements guaranteed Lundbeck that potentially competing generics would stay off-market for the duration of the agreements but did not guarantee the generic firms market entry thereafter.

    The EC found that Lundbeck paid “significant lump sums, purchased generics’ stock for the sole purpose of destroying it, and offered guaranteed profits in a distribution agreement.” EC distinguished these agreements from other patent settlements “where generic companies are not simply paid off to stay out of the market.”

    “It is unacceptable that a company pays off its competitors to stay out of its market and delay the entry of cheaper medicines,” said Joaquín Almunia, European Commission vice-president and head of competition policy. “Agreements of this type directly harm patients and national health systems, which are already under tight budgetary constraints. The Commission will not tolerate such anticompetitive practices.”

    In a related development, earlier this week, the United States Supreme Court reached a decision that settlement agreements by branded pharmaceutical companies involving payments to generic companies to delay their cheaper drugs’ entry into the market may not be immune from antitrust scrutiny but are not “presumptively” unlawful (IPW, Public Health, 17 June 2013). That case also involved Actavis.

    Industry Reactions

    In response to the decision, Lundbeck released a statement claiming that the company “strongly believes in and advocates for a level-playing field, which includes that intellectual property rights should not be ignored and infringed by third parties, since this seriously damages innovators’ investments and reduce their incentives to innovate.” Lundbeck said it “strongly disagrees with the Commission’s decision” and intends to appeal the decision.

    The European Federation of Pharmaceutical Industries and Associations (EFPIA) has responded, saying that the EC decision will prolong patent litigation, weaken patent protection, and undermine confidence in the patent system itself, which will lead to less European innovation and growth.

    In its statement, EFPIA said that patent settlement agreements should not be presumed to be anti-competitive, and also that they involve payment should not undermine the validity or strength of the disputed patents. EFPIA claimed that patent settlement agreements are “efficiency enhancing and legitimate” where there are genuine grounds for dispute.

    EFPIA Director General Richard Bergström said, “The EU patent system is still a mess. It is no surprise that companies settle to save legal fees and uncertainty,” referring to Europe’s “fragmented and inefficient” IP enforcement regime.

    EFPIA believes the resulting reductions in innovation from this decision “will have knock-on effects for patient welfare and economic growth” and calls for a “full policy debate at the level of the College of Commissioners.”

    Brittany Ngo is currently completing her Master’s in Health Policy and Global Health at the Yale School of Public Health and previously obtained a Bachelor’s of Arts in Economics from Georgetown University. Through her studies she has developed an interest in health-related intellectual property issues. She is a summer intern at Intellectual Property Watch.

    Brittany Ngo may be reached at info@ip-watch.ch.

     

    Comments

    1. EU watchdog slaps fine on Ranbaxy for anti-competition deal over anti-depressant – Economic Times - Members of the European Union says:

      [...] antidepressant in the …European Commission slaps Rs.80 cr fine on RanbaxyThe HinduEuropean Commission Fines Pharma Companies For Payments To Delay …Intellectual Property WatchEU Fines Danish Pharma Company Lundbeck, Generic Drug Makers, Including [...]


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    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website. By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website.

    By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    1. You agree that you are fully responsible for the content that you post. You will not knowingly post content that violates the copyright, trademark, patent or other intellectual property right of any third party or which you know is under a confidentiality obligation preventing its publication and that you will request removal of the same should you discover that you have violated this provision. Likewise, you may not post content that is libelous, defamatory, obscene, abusive, that violates a third party's right to privacy, that otherwise violates any applicable local, state, national or international law, that amounts to spamming or that is otherwise inappropriate. You may not post content that degrades others on the basis of gender, race, class, ethnicity, national origin, religion, sexual preference, disability or other classification. Epithets and other language intended to intimidate or to incite violence are also prohibited. Furthermore, you may not impersonate others.

    2. You understand and agree that Intellectual Property Watch is not responsible for any content posted by you or third parties. You further understand that IP Watch does not monitor the content posted. Nevertheless, IP Watch may monitor the any user-generated content as it chooses and reserves the right to remove, edit or otherwise alter content that it deems inappropriate for any reason whatever without consent nor notice. We further reserve the right, in our sole discretion, to remove a user's privilege to post content on our site. IP Watch is not in any manner endorsing the content of the discussion forums and cannot and will not vouch for its reliability or otherwise accept liability for it.

    3. By submitting any contribution to IP Watch, you warrant that your contribution is your own original work and that you have the right to make it available to IP Watch for all purposes and you agree to indemnify IP Watch, its directors, employees and agents against all damages, legal fees and others expenses that may be incurred by IP Watch as a result of your breach of warranty or of these terms.

    4. You further agree not to publish any personal information about yourself or anyone else (for example telephone number or home address). If you add a comment to a blog, be aware that your email address will be apparent.

    5. IP Watch will not be liable for any loss including but not limited to the following (whether such losses are foreseen, known or otherwise): loss of data, loss of revenue or anticipated profit, loss of business, loss of opportunity, loss of goodwill or injury to reputation, losses suffered by third parties, any indirect, consequential or exemplary damages.

    6. You understand and agree that the discussion forums are to be used only for non-commercial purposes. You may not solicit funds, promote commercial entities or otherwise engage in commercial activity in our discussion forums.

    7. You acknowledge and agree that you use and/or rely on any information obtained through the discussion forums at your own risk.

    8. For any content that you post, you hereby grant to IP Watch the royalty-free, irrevocable, perpetual, exclusive and fully sub-licensable license to use, reproduce, modify, adapt, publish, translate, create derivative works from, distribute, perform and display such content in whole or in part, world-wide and to incorporate it in other works, in any form, media or technology now known or later developed.

    9. These terms and your posts and contributions shall be governed and interpreted in accordance with the laws of Switzerland (without giving effect to conflict of laws principles thereof) and any dispute exclusively settled by the Courts of the Canton of Geneva.

     

     
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