In Europe, Directive 2004/27/EC (amending Directive 2001/83/EC) introduced into European Union legislation for the first time an exemption from patent infringement for conducting certain developmental work pre-patent expiry (the EU ‘Bolar’1 exemption). Member States of the European Union had until 30 October 2005 to implement the Directive into national law and it was hoped that the Directive would harmonise the approach in Europe to exempting such acts. Many EU Member States have implemented this ‘Bolar’ exemption. Many have not. This update looks at how the provisions have been adopted in certain key European jurisdictions and considers whether this harmonisation has in fact happened. This article will also explore what, if any, recourse parties will have if the Directive’s provisions were not implemented into national law by the due date and if, although implemented, the national legislation does not adhere to the strict wording of the Directive.

The Directive

Article 10(6) of the Directive states:

“Conducting the necessary studies and trials with a view to application of paragraphs 1, 2, 3 and 4 [of Art 10] and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products”.

Article 10(1) deals with generics of ‘reference medicinal products’. A generic manufacturer may, at the end of the data exclusivity period, rely on the innovator’s dossier to obtain marketing authorisation. The generic manufacturer may need to show bioequivalence with bioavailability studies and may also need additional data to support its marketing authorisation (for example, if the generic is a different salt of the reference medicinal product).

Article 10(2) sets out the definitions applicable to the Article, namely what ‘reference medicinal product’ and ‘generic medicinal product’ mean. Article 10(3) deals with products which are not generic medicinal products or not otherwise equivalent to the reference medicinal product. In such cases pre-clinical and clinical trial data will be required to get marketing authorisation. Finally, Article 10(4) deals with biosimilar products. Therefore, the object of the Bolar exemption was to exempt from patent infringement certain acts such as bioequivalence testing so that generic manufacturers could ‘piggy-back’ on the innovator dossier to obtain marketing authorisation for its generic, biosimilar or neargeneric product.

Implementation of the Bolar provision by Member States

The national legislation of many of the new entrants to the EU already legislated for a Bolar-type exemption. Among these countries were some of the principal generic manufacturers in Europe. What of the other Member States? Of the Member States that have already implemented the provisions, some have adhered closely to the wording in Article 10(6). However, others have not. Three of the key European jurisdictions for pharmaceutical product sales will be compared to demonstrate the differences in scope of the exemption following implementation of Article 10(6).

United Kingdom

In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) was responsible for implementing the Directive.

In the MHRA’s view, the Bolar exemption should cover the following types of activities:

1 The carrying out of chemical and biological synthetic processes suitable for the making, disposal or keeping of the active substance(s) including the manufacture or the import of batches in quantities sufficient to provide material for preparing investigative batches of the medicinal product and to validate the processes to the satisfaction of the competent authorities.

2 The development, testing and use of the associated analytical techniques for the above.

3 The development of the final pharmaceutical composition and the manufacturing processes for the medicinal product to be marketed including the making, disposal or keeping or import of product batches in quantities sufficient to conduct the necessary pre-clinical tests, clinical and bioavailability trials and stability studies of the medicinal product and to validate the processes to the satisfaction of the competent authorities.

4 The development, testing and use of the associated analytical techniques for the above.

5 The manufacture and supply to the competent authorities of samples of active substances, their precursors, intermediates or impurities and of finished product samples.

6 The compilation and submission of a marketing authorisation or variation application and application for marketing authorisation.

Further, the MHRA stated that, in its view the following would not fall within the ambit of the exemption: “The manufacture, packaging and testing of the active substance or finished product not required for conducting the tests and trials necessary for gaining authorisation or for providing small quantities as samples.”

Finally, the MHRA’s view was that the exempted activities will be exempt from the date of the proposed amendment to the patent legislation in the UK so long as those activities are for the purposes of submitting an application under the Directive. This is regardless of whether the reference products were submitted for authorisation before or after the date of implementation or whether the old or new data and market exclusivity periods protect it.

Following the MHRA consultation period the UK Patents Act 1977 was amended in October 2005 as follows. Section 60(5)(i):

(5) “An act which, apart from this subsection, would constitute an infringement of a patent for an invention shall not do so if:

(i) it consists of -

(i) an act done in conducting a study, test or trial which is necessary for and is conducted with a view to the application of paragraphs 1 to 5 of article 13 of Directive 2001/82/EC or paragraphs 1 to 4 of article 10 of Directive 2001/83/EC, or

(ii) any other act which is required for the purpose of the application of those paragraphs.”

This wording closely adheres to the wording of Article 10(6) of the Directive. However, it will be noted that this exemption does not limit itself to exemption from patent infringement of patents for medicinal products. However, this may be of little relevance as the exemption is limited to the regulatory framework within the Directive for the abridged application procedure for generics, near-generics or biosimilar products.

If an experimental act in the UK relates to a non-abridged application or pre-clinical or clinical trials related to such a non-abridged route, then the party seeking to rely on the exemption must (as before) seek to rely on the pre-existing statutory regime under Section 60(5)(b) of the Patents Act 1977:

(5) “An act which, apart from this subsection, would constitute an infringement of a patent for an invention shall not do so if:

(b) it is done for experimental purposes relating to the subject matter of the invention.”

The current thinking (although not tested in UK courts) is that such pre-clinical and clinical trials (even Phase III) will fall within Section 60(5)(b) if the experiment is seeking to find out something new about the subject matter of the patented invention. This may even encompass the situation where a competitor compound is synthesised for use in comparative studies.

Germany and France

In Germany, Section 11(2) of the German Patents Act was amended in September 2005 as follows to implement the Bolar provision:

“The effect of a patent shall not extend to:

(2b) Studies and trials and the consequential practical requirements which are necessary to obtain an authorisation according to the Medicines Act for the marketing in the European Union or an authorisation according to the Medicines Act for the marketing in the Member States of the European Union or in third countries.”

This is a very broad interpretation of Article 10(6). It exempts acts which are not related to obtaining approval through the abridged routes.

The exemption is so wide that any acts that are necessary for putting on the market a product under EU pharmaceutical law, or pharmaceutical laws elsewhere, will be exempt. Under this provision, any studies that need to be conducted for approval outside the EU can be conducted in Germany.

The French legislators implemented the Bolar exemption into national law in March this year (after the date of implementation). Article L.613-5 of the French Intellectual Property Code was amended to provide the following:

“The rights afforded by a patent shall not extend to:

(d) research and tests required in order to obtain a marketing approval for a medicinal product, as well as to steps necessary for their making and for granting of such approval.”

As with the German exemption, the proposed French wording is much broader than that contemplated by the Directive. Again there is no limitation to generic/biosimilar products, nor is there a restriction to approval of such products in the EU.

Recourse

Member States have a bad track record for meeting implementation deadlines. The Directive on legal protection of biotechnological inventions2 provides a good example of this. Not all the Member States have thus far implemented the Bolar provisions into national laws. Hungary, Poland and the Czech Republic, Malta, Slovenia and Slovakia, who joined the EU in May 2004, already had national provisions to cover the exemptions. What if a Member State has implemented the exemption late or is still to implement it? Could a generics company nonetheless rely on the Bolar exemption in the Directive in that Member State?

In that case, the generics company may have the following recourse:

1 The existing national law can be interpreted in the light of the Directive so as to include the EU Bolar exemption. This will only be possible if the provisions of the existing law allow such a wide interpretation without doing violence to the language of the existing law3.

2 The EU doctrine of “direct effect” may apply, to require the national court to give effect to the Bolar exemption in the Directive vis-à-vis the Member State. However, it may not operate so as to give rise to a cause of action for a private entity visà- vis another private entity. There is a large body of case law on this issue exploring when provisions of a Directive may be ‘apt’ for direct effect vis-à-vis the Member State.

This jurisprudence may be broadly summarised as considering whether the obligations imposed on a Member State by a Directive leave any discretion to a Member State, or whether they are sufficiently clear and precise such that an individual may rely on them against the State. In the current case, both arguments can be advanced. The Directive is sufficiently clear (as exemplified by the UK implementation), and some Member States appear to be applying a degree of discretion as to how it has been implemented (as exemplified by the French and German legislators).

3 In any event, the generics company may have grounds for an action for damages against the Member State for any failure to implement the Directive by the implementation date, thus depriving it of rights which would otherwise have accrued to it.

Given the breadth of some of the implemented Bolar provisions, patentees may feel that their rights in a particular jurisdiction have been eroded as a result of certain Member States implementing Article 10(6) too broadly. Do patentees have any recourse in such a case? Article 30 of the Agreement on Trade Related aspects of Intellectual Property Rights (TRIPS) states that Member States may provide limited exceptions to the exclusive rights conferred by a patent provided those exceptions do not unreasonably conflict with the normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking into account the legitimate interests of a third party. So, prima facie, patentees may consider that they have a right to challenge the implementation under TRIPS. However, challenging a Member State for contravention of TRIPS is not easy (see for example the challenge under TRIPS brought by the European Union against Canada).

Harmony

In the US, even after over 20 years of experience with their Bolar provision, there is still debate as to its scope. The Federal Supreme Court’s ruling in Integra v Merck4 demonstrates this.

In comparison, the Bolar exemption (or rather exemptions) are still at a nascent stage. The hoped-for harmonisation has not occurred. Instead, we are left with a bundle of different exemptions from patent infringement across the Member States. The implementation of the Directive into national legislation is certainly a step in the right direction. However, because of the disparate pattern of implementation adopted by the Member States, generic and innovator companies will not be able to assume that an act exempted in one European Member State will be exempted in another. A country by country analysis will need to be undertaken.