79075 - Legal Issues in Pharmaceutical Markets

Course Unit Page

Academic Year 2018/2019

Learning outcomes

At the end of the course the student is expected to reach a detailed knowledge of the enforcement of EU antitrust rules in the field of health care. In particular, he/she is aware of the main antitrust issues dealt with at the EU level in this field. The student especially becomes familiar with the case law developed by the EU jurisprudence in the field of pharmaceuticals, medical devices, hospital services, sickness funds and health insurance. This requires from him/her an interdisciplinary approach to legal issues that touches upon intellectual property law, trade law, commercial law, and competition policy. The course is based on a Law & Economics approach that should help student in fully understanding the impact of the rules of EU competition law on national health care policies and especially how EU institutions and Member States attempt to solve the trade-off between equity and efficiency in the provision of health care services.

Course contents

Lecture 1

Introduction to EU competition law

  • What is competition law about?
  • The notion of relevant market
  • Agreements restrictive of competition
  • Abuse of a dominant position

Lecture 2

The interaction between EU competition law and pharmaceutical regulation

  • Economic features of the pharmaceutical market
  • Forms of competition among pharmaceuticals

    o Intrabrand competition: parallel traded drugs

    • Interbrand competition: generic drugs and biosimilar drugs

      o Interbrand competition: off-label drugs

  • Mechanism of competition among pharmaceuticals: the therapeutic interchangeability
  • The definition of the relevant market in pharmaceutical antitrust cases

Lecture 3

Parallel trade of medicines

· A single market for pharmaceuticals: the free movement of drugs

· Parallel trade and trademark rights

· Parallel trade and patents rights

· Anticompetitive agreements hampering parallel imports of pharmaceuticals – the Glaxo case

  • Refusal to supply parallel traders as an abuse of dominant position – the Lélos case

Lecture 4

Generic and biosimilars’ competition

  • Regulatory obstacles to generics
    • Marketing authorisation procedures
    • Pricing and reimbursement policies
    • Patent laws and generic entry
      • Obstacles to therapeutic equivalence among biosimilars
    • Biosimilars and public procurement

Lecture 5

Firms’ obstacles to generic competition

  • Refusal to licence IPRs – the Merck and the Glaxo cases
  • Regulatory gaming – the Astrazeneca case
  • Abuse of patent filing – the Pfizer case

Lecture 6

Firms’ obstacles to generic competition

  • Other life-cycle management strategies: patent evergreening, patent thickets, product hopping
  • The US cases on patent evergreening - product hopping

Lecture 7

Firms’ obstacles to generic competition

  • “Pay-for-delay” agreements – the Lundbeck e and the Servier case
  • The US experience – the Actavis case

Lecture 8

Competition from off-label drugs

  • Competition between off-label and on-label drugs – the Avastin case

Lecture 9

Excessive pricing in the pharmaceutical market

  • The Aspen case
  • The Flynn case

Lecture 10

International experiences: the developing countries

  • Striking the balance between innovation and accessibility 1: drug compulsory licensing – the South Africa AIDS Controversy
  • Striking the balance between innovation and accessibility 2: the Indian legislation establishing therapeutic innovation as a requirement for the patentability of drugs – the Novartis case

Readings/Bibliography

·       Coscelli and Overd, Market Definition in the Pharmaceutical Sector, in European Competition Law Review, 2007, no. 25(3), p. 294-296 (Lecture 2).

·        Danzon, The Economics of Parallel Trade, in Pharmacoeconomics, 1998, no. 13(3), p. 293-304 (Lecture 3).

·        Desogus, Parallel Trade and Pharmaceutical R&D: The Pitfalls of the Rule of Reason, in European Competition Law Review, 2008, no. 29(11), p. 649-665 (Lecture 3).

·     Drexl, AstraZeneca and the EU sector inquiry: when do patent filings violate competition law?, in Pharmaceutical Innovation, Competition and Patent Law. A Trilateral Perspective, eds. Drexl, Lee, pp. 290-322 (Lecture 5).

·   Geradin, The Uncertainties Created by Relying on the Vague ‘Competition on the Merits’ Standard in the Pharmaceutical Sector: The Italian Pfizer/ Pharmacia Case, in Journal of Competition Law and Practice, 2014, n. 5(6), pp. 344-352 (Lecture 5).

·        Tuominen, Patenting Strategies of the EU Pharmaceutical Industry: Regular Business Practice or Abuse of Dominance, in World Competition Law and Economics Review, 2012, Vol. 35, Issue 1, pp. 27 - 54 (Lectures 5 and 6).

·     Hovenkamp, Antitrust Law and Patent Settlement Design, in Harvard Journal of Law & Technology, Forthcoming, available at https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3219954 (Lecture 7).

Arnaudo, The Strange Case of Dr. Lucentis and Mr. Avastin. The Italian Competition Authority Fines Roche and Novartis for Collusion, in European Competition Law Review, 2014, no. 35(7), p. 347-351  (Lecture 8).

·     Colangelo, Desogus, Antitrust Scrutiny of Excessive Prices in the Pharmaceutical Sector: A Comparative Study of the Italian and UK Experiences, in World Competition: Law and Economics Review, Vol. 41, no. 2, 2018 (Lecture 9).

·        Fisher-Rigamonti, The South Africa AIDS Controversy A Case Study in Patent Law and Policy, The Law and Business of Patents, 2005 (Lecture 10).

·     Banerjee, The Success of, and Response to, lndia's Law against Patent Layering, in Harvard lnternational Law Journal, 2013, n. 54, p. 204 ss. (Lecture 10).

          Other optional articles might be circulated during each lecture

Teaching methods

Teaching will be provided by the lecturer but significant time is also allocated for discussion of the case law.

Assessment methods

The assessment will be based on final written examinations lasting 1 hours and a half (2/3 of the final mark) and on the contribution to the solution of a case study assigned to a group of students (1/3 of the final mark).

Office hours

See the website of Claudia Desogus