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26 September 2011
The European Commission has brought an infraction procedure against Italy over the rule in Article 68.1(2) of the Code of Industrial Property whereby "the process for obtaining a marketing authorisation for a generic drug may start one year before the expiry of the supplementary patent protection related to the active pharmaceutical raw material". The literal wording of the rule has been held to be contrary to Article 10 of the EU Medicinal Products Directive (2001/83/EC) (as amended by EU Directive 2004/27/EC) which transposed into EU law the so-called 'Bolar clause'. In its response to the infraction procedure, the government has indicated that it is prepared to repeal the problematic rule.
The rule at issue pre-dates the implementation of EU Directive 2004/27. It was introduced by Law 112/2002 in an attempt to mitigate the negative effect of the long duration - up to 18 years - of Italian supplementary protection certificates.(1) These certificates were granted in Italy before EU Regulation 1768/92 (now replaced by EU Regulation 469/2009) came into force.
In 2005 Italy's industrial property rights legislation was consolidated in the Code of Industrial Property. The rule at issue was inserted into Article 61.5. However, at the same time a general rule, which complied fully with Article 10 of the EU Medicinal Products Directive, was introduced as Article 68.1 of the code. In 2011, as part of the reform implemented by Legislative Decree 131/2010, the text of Article 61.5 became a subsection of Article 68.1. Moreover, it was expressly stated to apply not only to Italian supplementary protection certificates, but also to patents and supplementary protection certificates granted under EU rules.
The correct interpretation of the rule has been debated by academics and in case law. It is not universally accepted that Article 68.1(2) prevents a producer of generics from commencing the procedure for obtaining a marketing authorisation before the final year of the patent on the active element in question (assuming that the patent is valid and that the future generic would be infringe on it). However, no interpretation of the paragraph should disregard its context. Article 68 is entitled "Limitations on patent right" and comprises a series of exceptions which limit the two preceding provisions (ie, Articles 66 and 67, which define the scope of patent protection). Thus, it is clearly wrong to consider that such scope may be extended - rather than limited - on the basis of Article 68, as it may be on the basis of Articles 66 and 67.(2)
The interpretation of Article 68.1(2) as an exception to the Bolar clause totally disregards its connection with the provisions of the first paragraph of the article. Under subheading (b), the article sets out the general principle that:
"Whatever the subject matter of the invention, the exclusive right granted by the patent does not extend… to studies and trials aimed at obtaining, even in foreign countries, a marketing authorisation of a medical product or to the subsequent practical fulfilment, including... the preparation and use of pharmacologically active raw materials strictly necessary for that purpose."
This provision was introduced into Italian law with express reference to Article 10 of the directive. Therefore, under the general principle that national laws must be construed according to EU law, Article 68.1 of the code prevails over Article 68.1(2). This precedence is also guaranteed as a point of Italian constitutional principle, since a non-compliant interpretation would render the provisions unconstitutional.
It cannot be argued that the new provision might circumscribe the scope of the general principle on the grounds that, as far as a marketing authorisation is concerned, it would operate only in the year preceeding the expiry of patent cover. There is nothing in the relevant provision of the directive which allows for the assumption that national legislatures may carve out a more limited scope for it. This view is supported by the fact that before the introduction of the directive, the European Court of Justice (ECJ) was called upon to rule on a question raised by the Dutch Supreme Court, which turned on whether the ban on submitting samples of a product covered by another party's patent to the competent authorities upon issuance of a marketing authorisation could be defined as a measure whose effect was equivalent to 'a quantitative restriction which could not be justified by the aim of protecting IP rights' under Articles 30 to 36 of the EC Treaty.(3)
The ECJ held that:
"the application of a rule of national law which gives the proprietor of a patent in respect of a manufacturing process for a medicinal product the right to oppose the submission by another person of samples of medicinal products manufactured in accordance with that process to the authority competent for issuing marketing authorizations constitutes a measure having equivalent effect to a quantitative restriction within the meaning of Article 30 of the EC Treaty."
Furthermore, the ECJ held that the ban was justified in light of Article 36 of the treaty only if the samples were "manufactured in accordance with [the patented process] by a person other than the patentee".(4) It thus made clear that only the production and use of the samples could theoretically interfere with the scope of protection of the patent. Such production and use are now considered lawful, without time limits, under the directive.
The prevailing nature of Article 68.1 of the code is made clear by the start of the following paragraph, which begins with the words "without prejudice to the provision of Paragraph 1". Thus, Article 68.1(2) may not be interpreted in a way which sets it in opposition to the relevant provision of EU law.
The Court of Milan has considered the only possible interpretation of the Italian provisions which complies with the EU law from which they derive, and has stated that:
"The mere filing of an marketing authorisation application for a drug does not constitute proof of infringement, even of a preparatory nature, given the absence of current production and sale and the possibility that the relative commercial activity has not actually been carried out."
In relation to the two provisions in question, the court held that:
"Article 68.1 [of the code], by stating that the exclusive right given by a patent right does not extend to acts carried out in an experimental manner - even where such acts are aimed at obtaining, [whether in Italy or]... abroad, a marketing authorisation for a drug and the consequent practical formalities - raises a principle which goes beyond the annual limit."(5)
Therefore, the court held that there is no prohibition against producers of generics commencing the procedure for obtaining an marketing authorisation before the final year of patent cover.
On February 14 2011 the Court of Turin reached the opposite conclusion. It issued an order concerning a marketing authorisation which had been granted to a manufacturer of generics that had commenced the procedure more than a year before the expiry of the supplementary protection certificate. The certificate related to the magnesium salt of the (-)-omeprazole with an enantiomeric excess of at least 99.8%. However, a panel of judges of the same court later revoked the order, primarily because the enantiomeric excess of the active element of the generic drug was no greater than 99.78%. Therefore did not fall within the scope of protection of the supplementary protection certificate and patent. The court held that the equivalence doctrine cannot be invoked with regard to specific ranges of expressly claimed values.
However, there is potential for ambiguity in the new classification of the rule within the code and in the fact that the correct interpretation of the general rule in Paragraph 1 would make the provision in Paragraph 1(2) tautologous.(6) At least one commentator has claimed that the preparation and use of pharmacologically active raw materials are lawful under the general provision, as are studies and trials aimed at obtaining a marketing authorisation, whereas the application and grant of such an authorisation are lawful only in the last year of the validity of the relevant patent or supplementary protection certificate.(7)
From this perspective, the commission's infraction procedure is to be welcomed, since it may lead either to the repeal of this ambiguous rule or to its clarification at EU level.
(1) See Galli, "Certificato protettivo complementare: tra legge interna e disciplina comunitaria", in Dir Prat Soc, 1999, and "L'uso sperimentale dell'altrui invenzione brevettata", in Riv Dir Ind, 1998, I.
(6) See Galli and Bianchetti, "La disciplina del certificato complementare e gli usi leciti dell'invenzione", in Codice della Proprietà Industriale: la riforma 2010, Galli (Ed), Milan, 2010, page 101.
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