79075 - Legal Issues in Pharmaceutical Markets

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
• The 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

  Intrabrand competition: parallel traded drugs

  Interbrand competition: generic drugs and biosimilar drugs

  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

• International experiences: drug compulsory licensing – the South Africa AIDS Controversy

Lecture 4

Firms’ obstacles to generic competition

• Generics’ competition
• Refusal to license IPRs – the Merck and the Glaxo cases
• Regulatory gaming – the Astrazeneca case
• Abuse of patent filing – the Pfizer case and the Copaxone case

Lecture 5

Firms’ obstacles to generic competition

• Life-cycle management strategies: patent evergreening, patent thickets, product hopping
• The US cases on product hopping
• An attempt to limit patent evergreening strategies – the Indian Novartis case

Lecture 6

Firms’ obstacles to generic competition

• “Pay-for-delay” agreements – Lundbeck, Cephalon, Paroxetine and Servier cases
• The US experience – the Actavis case

Lecture 7

Firms’ obstacles to generic competition

• Disparagement cases: the Italian Avastin case
  • The French Plavix case and the EU Vifor case

Lecture 8

Firms’ obstacles to generic competition

• Predatory pricing: the French Glaxo case
• Abusive rebates
• Other practices hindering market entry

Lecture 9

Excessive pricing in the pharmaceutical market

• The Aspen case and the Flynn case
• The Leadiant case
• Other excessive prices cases

Lecture 10

Mergers and Acquisitions in the pharmaceutical market

• The Illumina/Grail case

Readings/Bibliography

Main book of reference:

• Sauter, Canoy, Milder, Rijcken, EU Competition law and pharmaceuticals, Edward Elgar, 2022 (Part I, ch. 2 (optional), 3, 4; Part II, ch. 5 (optional), 6, 7, 8 (optional), 10, 11 (optional), 12, 13, 14, 15 (optional), 17 (optional))

Selected literature:

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

• ●Siotis, Ornaghi, Castanheira, Market Definition and Competition Policy Enforcement in the Pharmaceutical Industry, 10 September 2021, available at https://www.uab.cat/ca/economia-aplicada/doc/papersiotisgeorge2021.pdf (Lecture 2). OPTIONAL
• ●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).
• ●Blockx, Durand, Ex post Assessment of European Competition Policy: The Pharmaceutical Parallel Trade Cases, Global Competition Law, 2021, available at https://www.coleurope.eu/sites/default/files/uploads/page/gclc_report_draft_-_the_pharmaceutical_parallel_trade_cases_0.pdf (Lecture 3). OPTIONAL

• 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 4).
• 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 (Lecture 4). OPTIONAL
• 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 4). OPTIONAL
• Foss-Solbrekk, The Divisional Game: Using Procedural Rights to Impede Generic/Biosimilar Market Entry, in International Review of Intellectual Property and Competition Law, 2022, vol 53, pp. 1007-1037.

• Carrier, Pharmaceutical Antitrust Complexity, in CPI Antitrust Chronicle (Nov. 2014), available at SSRN: https://ssrn.com/abstract=2530169

• 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 5). OPTIONAL
• Iyengar, Should Pharmaceutical Product Hopping Be Subject to Antitrust Scrutiny?, in Journal of the Patent and Trademark Office Society 97:4 (2015), p. 663, available at https://assets.fenwick.com/legacy/FenwickDocuments/Pharmaceutical-Product-Hopping.pdf (Lecture 5).
• Hovenkamp, Antitrust Law and Patent Settlement Design, in Harvard Journal of Law & Technology, in Harvard Journal of Law & Technology, 2019, Volume 32, No. 2 (Lecture 6). OPTIONAL
• Athanasiou, Lundbeck v. Commission, in Jusletter, 2016.
• 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 7).
• 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 8).
• Lanza, [https://heinonline-org.ezproxy.unibo.it/HOL/Page?public=true&handle=hein.journals/comptnlj22&div=4&start_page=11&collection=journals&set_as_cursor=0&men_tab=srchresults] in Journal of European Competition Law & Practice, 2024, 1-9 (Lecture 10).
• Report from the Commission to the Council and the EU Parliament. Update on competition enforcement in the pharmaceutical sector (2018-2022). Brussels, 26.1.2024 COM(2024) 36 final.

Other optional articles might be circulated during each lecture

C-501/06 P - GlaxoSmithKline Services and Others v Commission and Others

C-468/06 - Sot. Lélos kai Sia

Case C‑457/10 P - AstraZeneca AB and AstraZeneca plc v European Commission

AT.40588 - Teva Copaxone

C‑591/16 P - H. Lundbeck A/S, established in Valby (Denmark), Lundbeck Ltd, established in Milton Keynes (United Kingdom) v European Commission

Case C-176/19 P - European Commission v Servier SAS, Servier Laboratories Ltd, Les Laboratoires Servier, European Federation of Pharmaceutical Industries and Associations (EFPIA)

M.10188 – Illumina/Grail

The Leadiant case available at https://en.agcm.it/dotcmsdoc/pressrelease/A524%20chiusura%20EN.pdf (ENG)

The Avastin case available at https://www.agcm.it/dotcmsDOC/allegati-news/I760_provvedimento_5_mar_2014.pdf (ITA)

Teaching methods

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

Assessment methods

Students are required to attend at least 50% of the classes.

Students who cannot fulfill this requirement shall communicate it by email at the beginning of the course. The communication shall be sent to the Professor and the tutor.

The exam is written. Differences in the methods of examination for attending and non-attending students will be communicated during the lectures and/or by email.

Office hours

See the website of Claudia Desogus