Klinische Proeven en Volksgezondheid: Naar een Herijking van het Algemeen Belang in het Octrooirecht (Clincial Trials and Public Health: Reassessing the Notion of Public Interest in Patent Law)
Tijdschrift voor Privaatrecht (Journal for Private Law), pp. 899-968, 2000
36 Pages Posted: 4 Dec 2010 Last revised: 13 May 2018
Date Written: 2000
Dutch Abstract: Een medisch-farmaceutisch bedrijf voert klinische proeven uit met een kandidaat-geneesmiddel ter voorbereiding van het op de markt brengen ervan. De producent van het oorspronkelijk, geoctrooieerd geneesmiddel daagt het bedrijf voor de rechter wegens octrooiinbreuk. Terecht? Een onderzoek van de wetgeving, rechtspraak en rechtsleer leert dat bij de beoordeling van de vraag of klinische proeven toelaatbaar zijn verschillende criteria op de voorgrond treden. Eén van de doorslaggevende parameters blijkt uiteindelijk de bijdrage van de proeven aan het algemeen belang te zijn. Traditioneel geeft het octrooirecht een economische invulling aan het begrip algemeen belang. In deze bijdrage wordt gepleit voor een herziening van de klassieke octrooirechtelijke benadering en een verbreding van het algemeen belang tot volksgezondheid. Dit voert ons tot het besluit dat klinische proeven die het op de markt brengen van generieke geneesmiddelen voorbereiden, zogeheten bio-equivalentieproeven, wegens hun geringe bijdrage aan de volksgezondheid, en dus aan het algemeen belang, niet onder de onderzoeksexceptie vallen en een inbreuk uitmaken op nog lopende octrooien
English Abstract: A pharmaceutical firm performs clinical trials on a “candidate” drug, in order to prepare the latter for marketing. The producer of the original drug sues this firm for breach of patent.
The present paper examines the manner in which Belgian law deals with the thorny question of whether clinical trials are lawful. Belgian law provides relatively few criteria by which this question can be answered. From a comparative overview of the rules applying in the Netherlands and Germany, it would appear that, on the one hand, there is no unanimity to be found on the question whether experimental acts, carried out in the context of clinical trials, constitute an infringement of an existing patent but that, on the other hand, a number of criteria or “parameters” can be discerned which can be of considerable relevance to the debate surrounding this issue. An examination of these parameters shows that, in doubtful cases, the contribution made by clinical trials to the public interest is one of the decisive criteria for deciding whether or not the practice in question is lawful.
However, exactly how is the term “public interest” to be defined? The public interest is a concept which is well-known to the lawyer, yet remains at the same time both enigmatic and multi-faceted. In an attempt to identify the essential components of the public interest, the author examines the various circumstances in which this term arises in Belgian and in European law. This analysis reveals an extremely wide range of interests, which can be brought under three categories located between two extremes. At the one end we find the notion of the public interest which is subsumed under such concepts as “the public interest” or “public benefit”. At the opposite end we encounter the concepts of “individual interest” and “private interest”. In between these two extremes we find the notions of “collective interest” and “common interest”. The latter terms embody the transition from the individual to the collective, and refer to situations whereby certain interests converge.
The author’s analysis also makes the notion of the public interest appear to be a kind of mosaic. The following become identified as essential components of the public interest: not only concepts such as public order, morality and public safety, but also the protection of the consumer, of health and public health, of the life of persons, animals or plants.
These considerations first of all prompt the conclusion that the traditional dichotomy between the individual and the public, or between the private and the public, is no longer tenable. In addition, they lend support to the frequently expressed view that the “public interest” concept is not subject to an unambiguously consistent and invariable meaning. They also prompt the conclusion that the notion of public interest is not coterminous with that of public order and morality, given that the notion of public interest is broader than the twin concepts public order/morality. Finally, they lead to the conclusion that public health is a component of the public interest. The tendency to subsume public health under the public interest seems to find unambiguous support in legislative practice and case law.
It being firmly established that, under Belgian and European law, public health is an indelible component of the notion of public interest, the author advocates the reassessment of the public interest criterion in patent law. The substance which has been attributed to the concept of public interest by patent law, of which a contribution towards economic progress is an essential element, needs to be expanded in such a way as to enable the public health dimension to be taken into account.
This interpretation makes it possible to assess the lawfulness of clinical trials not only in the light of their contribution towards economic prosperity, but also from the point of view of the advance which they represent for public health. From this assessment, it appears that the contribution made by certain clinical trials towards public health, and therefore also towards the public interest, is of doubtful value. This leads one to conclude that, because of their paltry contribution towards public health – and therefore towards the public interest – clinical trials which lead to the marketing of generic drugs – i.e. the so-called bio equivalency trials -, do not fall within the research exemption and constitute an infringement of existing patents.
The debate surrounding clinical trials also has the incidental effect of reviving an old controversy, namely the debate concerning patents covering medical drugs. Patent law purports to strike a balance between two conflicting interests: the individual interest of the inventor/investor, which seeks moral and financial recognition, and the promotion of the public interest, which benefits from economic prosperity. It is the author’s view that the balance inherent in the patent law has currently been distorted as far as medical drugs are concerned, and that too much weight is being accorded to the individual interest of the inventor/investor – i.e. the drug producer.
The author recommends a reappraisal of the issues concerning drug patents, the tensions to which they give rise between the individual and the public interest and between the inventor/investor and public health, in the light of the conclusions reached by this paper regarding the public interest, public health and the rather modest contribution of curative medicine towards public health.
Note: Downloadable document is in Dutch.
Keywords: Patents, Drugs, Generics, Clinical trials, Bio equivalency trials, Public health, Economic progress, Public interest, Public benefit, Private interest, Collective interest, Common interest, Odre public, Morality, Curative medicine
JEL Classification: I18, K11, O32, O34, H51
Suggested Citation: Suggested Citation