1 / 18

Manuel Campolini mc@janson-baugniet.be

Janson Baugniet. IPRs vs. ANTI-TRUST RULES: IS THERE A SENSIBLE MIDDLE GROUND? - The case of the Pharmaceutical sector 27 June 2006 - Hôtel Amigo (Brussels). STOCKHOLM NETWORK. Manuel Campolini mc@janson-baugniet.be. PHARMA : EU IPRs / COMPETITION . KEY FEATURES

nituna
Télécharger la présentation

Manuel Campolini mc@janson-baugniet.be

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Janson Baugniet IPRs vs. ANTI-TRUST RULES: IS THERE A SENSIBLE MIDDLE GROUND?- The case of the Pharmaceutical sector27 June 2006 - Hôtel Amigo (Brussels) STOCKHOLM NETWORK Manuel Campolini mc@janson-baugniet.be

  2. PHARMA : EU IPRs / COMPETITION KEY FEATURES • a) R&D investment (800 millions $ = average per product) • b) Price control • c) IPRs • d) Patients want the best product • Janson Baugniet

  3. PHARMA : EU IPRs / COMPETITION KEY ISSUES • a) Strong product competition through innovation • b) Parallel trade • c) Generic competition • Janson Baugniet

  4. PHARMA : EU IPRs / COMPETITION PARALLEL TRADE • a) CONCERTED PRACTICES (Art. 81 EC) • - Bayer Adalat – off-patented product (i) i.Parallel trade of ADALAT from Spain/France (low price countries) into the UK (high price country). • ii. Controlled supply in France and in Spain • iii. Commission => breach of Art. 81 • Janson Baugniet

  5. PHARMA : EU IPRs / COMPETITION PARALLEL TRADE • a) CONCERTED PRACTICES (Art. 81 EC) • - Bayer Adalat – off-patented product (ii) • CFI => the Commission has failed to demonstrate • the existence of an agreement. • => Commission’s conviction that parallel imports • will bring about harmonization of the medici- • nal product price is devoid of all foundation. • IPR is not decisive • Janson Baugniet

  6. PHARMA : EU IPRs / COMPETITION PARALLEL TRADE • b)ABUSE OF A DOMINANT POSITION (Art. 82 EC) • - Syfait v. GSK – patented products (i) • GSK refuses to meet wholesaler’s orders in full, to • limit parallel trade. • GSK is in a dominant position • Breach of Art. 82 ? . • Janson Baugniet

  7. PHARMA : EU IPRs / COMPETITION PARALLEL TRADE • b)ABUSE OF A DOMINANT POSITION (Art. 82 EC) • - Syfait v. GSK - patented products (ii) Advocate General: unique characteristics of the pharmaceutical industry, i.e. => States’ intervention in the pricing of products, => Consequences for innovation, • => Absence of benefit for the consumers, etc. • Role of IPR? • Outcome and recent development. . • Janson Baugniet

  8. PHARMA : EU IPRs /COMPETITION COMMISSION v. ASTRA ZENECA (Losec) ABUSE OF A DOMINANT POSITION (Article 82 EC) • AstraZeneca wasfined for 1. “giving misleading information to several national patent offices … resulting in AstraZenecagaining extended patent protection for Losec through so-called … SPCs” 2.“misusing rules and procedures applied by national medicines agencies … by selectively deregistering the market authorisations for for Losec capsules in Denmark, Norway and Sweden with the intent of blocking or delaying entry by generic firms and parallel traders.” • The issue relates to IPRs, i.e. SPC & Data Exclusivity. Janson Baugniet

  9. PHARMA : EU IPRs / COMPETITION COMMISSION v. ASTRA ZENECA (Losec) a) THE PRODUCT - LOSEC (omeprazole) • - First PPI (1987) + others PPIs launched years later. • -One of the 90s’ most ‘successful’ product. • - Superior therapeutic effectiveness. • - In 2000, Nexium (esomeprazole) • Janson Baugniet

  10. PHARMA : EU IPRs / COMPETITION COMMISSION v. ASTRA ZENECA (Losec) • b) DEREGISTRATION – PARALLEL IMPORT - Capsule v/ Tablet - The capsule form was withdrawn (deregistration) from several high priced countries (e.g. Sweden and Denmark) • - On 1rst September 1998 the Swedish authority decided • that Paranova’s parallel import licence for Losec capsules • was no longer valid. • - On 8 May 2003, ECJ decision. • Janson Baugniet

  11. PHARMA : EU IPRs / COMPETITION COMMISSION v. ASTRA ZENECA (Losec) • b) DEREGISTRATION – GENERIC ENTRY • - Expiry of Data Exclusivity for Losec capsule and • Generics UK submitted an abridged application. • - 30 November 1998 : approval granted but challenged • - 16 October 2003 : ECJ judgment • Janson Baugniet

  12. PHARMA : EU IPRs / COMPETITION COMMISSION v. ASTRA ZENECA (Losec) • c) SPC - GENERIC ENTRY (i) • - SPC = IPR, which starts when patent expires. • - How does it work? • => max 5 years from patent expiry. • => max 15 years from first authorisation to • place the product in an EU country. • - Transitional measures, e.g. • => Germany – SPC limited to products • authorised after 01/01/88 • Janson Baugniet

  13. PHARMA : EU IPRs / COMPETITION COMMISSION v. ASTRA ZENECA (Losec) • c) SPC - GENERIC ENTRY (ii) • - 1987: first approval on the basis of a scientific dossier • - 1988: first publication of the price/reimbursement • - SPC granted by the German patent office (1988) • =>4 years extension up toMarch 2003 • - In the late 90s: German SPC challenged. • - 11th December 2003 : ECJ judgment. • Janson Baugniet

  14. PHARMA : EU IPRs / COMPETITION DOMINANCE • Does IPR lead to dominance and special responsibility? • Commission= Losec is dominant • - Other products did not exercise a significant competitive • constraint. • AZ= Losec is not dominant • - Just one of the treatments available. • - The Commission’s interpretation => any innovative product • may be considered dominant retrospectively. It could have • adverse effects on industry competitiveness, contrary to the • express aspirations of the Commission in relation to the • ‘Lisbon’ agenda. • Janson Baugniet

  15. PHARMA : EU IPRs / COMPETITION ABUSE (i) - Commission => AZ conduct was abusive • a) Internal documentation • b) The sequence of actions • c) Behaviour towards patent offices and Courts, etc. • Janson Baugniet

  16. PHARMA : EU IPRs / COMPETITION ABUSE (ii) - AZ => No abuse • a) Good faith. b) Alternative solution existed for the registration of the generic product. c) Freedom for an operator to withdraw its product. • d) Patient benefits. • Janson Baugniet

  17. PHARMA : EU IPRs / COMPETITION ABUSE (iii) Competition Commissioner Neelie Kroes: • “I fully support the need for innovative products to enjoy strong • IP protection so that companies can recoup their R&D • expenditure and be rewarded for their innovative efforts. • However, it is not for a dominant company but for the legislator • to decide which period of protection is adequate. Misleading • regulators to gain longer protection acts as a disincentive to • innovate and is a serious infringement of EU competition rules. • Health care systems throughout Europe rely on generic drugs • to keep costs down. Patients benefit from lower prices. • By preventing generic competition AZ kept Losec prices artifi- • cially high. Moreover, competition from generic products after • a patent has expired itself encourages innovation in pharma- • ceuticals. » • Janson Baugniet

  18. PHARMA : EU IPRs / COMPETITION FINAL REMARKS • CONFLICT OR COEXISTENCE (+ societal benefit) ? • IS THE SUBJECT MATTER OF IPRs AT STAKE ? • COULD THE SOLUTION BE FOUND IN IP LAW ? • WHAT IMPACT ON LIFE-CYCLE MANAGEMENT STRATEGY ? • WHAT IMPACT ON PRODUCT DEVELOPMENT AND INNOVATION ? • Janson Baugniet

More Related