Les accords de report d’entrée. Contribution à l’étude de la relation du droit de la concurrence et du droit des brevets, Walid CHAIEHLOUDJ

Walid Chaiehloudj

This section selects books on themes related to competition laws and economics. This compilation does not attempt to be exhaustive but rather a survey of themes important in the area. The survey usually covers publication over the last three months after publication of the latest issue of Concurrences. Publishers, authors and editors are welcome to send books to stephane.rodrigues-domingues@univ-paris1.fr for review in this section.

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Mr Walid Chaiehloudj’s thesis was awarded the Concurrences2018 thesis prize. and was published in December 2018 in the Thesis Concurrencescollection directed by Professor Laurence Idot.

The thesis of Mr. Walid Chaiehloudj was defended on December 7, 2017 at the University of Aix-Marseille, under the supervision of Professor David Bosco. Mr Chaiehloudj is now a lecturer at the University of Grenoble.

The acquisition of a monopoly under competition law may be the result of an intellectual property right, which gives the holder a dominant position on the market in question. However, there may be obstacles to the maintenance of such a position. This is particularly the case where the patent - then an instrument of monopoly - is liable to fall into the public domain, following a challenge action.

To offset this risk, economic operators have developed a contractual practice which has the effect of maintaining and/or prolonging the effects of these intellectual property rights vis-à-vis competing or potentially competing undertakings. These practices have developed mainly in the pharmaceutical field, where the so-called "originator companies" will pay the "generics" in order to guarantee their monopoly on the market in question. Thus, in return for a fee, the laboratories ensure their monopoly position, while sometimes knowing that their patent does not meet the conditions laid down by law.

This brief presentation of the subject of Mr Chaiehloudj’s study reveals, on the one hand, the importance of these issues and, on the other hand, the timeliness of the meeting of competition law and intellectual property law in order to ensure a legal treatment of this category of agreement.

The first part (P1) of this study focuses first of all on the emergence of deferred entry agreements. Through a comparative law analysis, the first title (T1) is devoted to the genesis of these agreements. Initially, these pay-for-delay agreements sont agreements appeared in the United States through the instrumentalisation of the Hatch-Waxman Act, the aim of which was to encourage generic companies to challenge fragile pharmaceutical patents. Secondly, the author analyses the reasons for the proliferation of these agreements in the European area, which, on the other hand, result from the exploitation by pharmaceutical companies of the weaknesses of European patent law.

In a second title (T2), the author proposes a taxonomy of deferral arrangements. If the desired effect is the same, the diversity is revealed by studying their respective nature. Thus, some are of a commercial nature while others put an end to a patent dispute. The latter are the main instrument of deferred entry, and the practice of laboratories has moreover shown an evolution. The author identifies in this respect the "first generation" agreements, which are transactional agreements in return for a financial consideration, and the "second generation" agreements, where payment is made in kind.

In the second part (P2), Mr Chaiehloudj examines the legal treatment of these agreements under antitrust law. In a forward-looking approach, the author first presents (T1) the control system in American and European law, then draws the consequences of his observations by formulating in a second part (T2) a number of proposals intended to remedy what he considers to be the shortcomings of European law.

Therefore, Chapter 1 of Title 1 first of all presents the US control system, which it demonstrates is, in its view, much more balanced than that implemented by the European Union. Indeed, while the Supreme Court imposes the application of a rule of reason, which obliges the supervisory authorities to balance the pro- and anti-competitive effects of agreements, the Commission takes a firmer stance in dealing with these agreements by implementing the restriction by object. According to the author, this method is not the most appropriate, given the European Commission’s limited experience on the subject. He then calls for the substitution of the current method by the method of restriction by effects, allowing the potential pro-competitive effects of these agreements to be taken into account.

Once this examination is established, in the final title, the author proposes various solutions, both in competition law and patent law. On the antitrust law side, the author suggests the implementation of a procedure known as "bifurcation" towards the patent judge in order to verify the validity of the intellectual property title. On the patent law side, a strengthening of the examination procedure by the European Patent Office is prescribed, as well as the adoption of a European exclusivity premium which would encourage generic companies to challenge patents that do not meet the conditions of patent law.

In the end, while the author does not dispute that deferral agreements may have anti-competitive effects, he also considers that EU law should take a more measured stance, leaving the way open for the potential pro-competitive effects of such agreements to be taken into account. Indeed, they may promote innovation and make it possible to maintain a satisfactory level of research in the pharmaceutical industry, in the general interest. Mr Chaiehloudj therefore calls for a legal treatment of deferred entry agreements marked by a balance of interests.

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  • University of Aix-Marseille

Quotation

Perrine Perez, Les accords de report d’entrée. Contribution à l’étude de la relation du droit de la concurrence et du droit des brevets, Walid CHAIEHLOUDJ, September 2018, Concurrences N° 3-2018, Art. N° 87439, p. 216

Publisher Concurrences

Date 9 January 2019

Number of pages 568

ISBN 979-10-94201-17-6

Visites 778

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