European Bolar Provisions in Romania

Article 10(6) of Directive 2001/83/EC (as amended by Directive 2004/27/EC) was implemented into Romanian law in Article 708(6) of Law no. 95/2006 regarding the health reform (the Health Law):

• Article 708(6) reads as follows: “Conducting the necessary tests and studies with a view to the application of paragraphs (1) – (4) and the resulting practical requirements are not considered to be contrary to patent rights and supplemental protection certificates for medicinal products.”

Note, an additional exemption which may apply to tests and studies conducted in Romania is the so-called ‘experimental use exemption’. The ‘experimental use exemption’ is regulated by the Romanian Patent Law no. 64/1991 as further amended and complemented (the Patent Law), in Article 33(1)(e), and in Article 80(a) (Exceptions to infringement) of the 2008 Regulation for the implementation of the Patent Law (the 2008 Patent Regulation):

• Article 33(1)(e) states that “use for experimental purposes, exclusively of a non-commercial nature, of the subject-matter of the invention” does not represent an infringement of the patent owner’s rights.
• Article 80(a) states that, “in furtherance of Article 33(1)(e) of the law” (i.e. the Patent Law), the following actions are not considered infringements of the general patent rights: “a) conducting the necessary tests and studies with a view to obtaining a marketing authorization of a medicinal product, as well as the practical requirements resulting therefrom.”

The Bolar provision allows the use of patented products as necessary for conducting tests and studies, with a view to obtaining a regulatory approval for medicinal products. 

The Bolar provision under Article 708(6) of the Health Law only exempts tests and studies provided they are “necessary for” and “conducted with a view to” a medicinal product application under any of the Paragraphs 1-4 of Health Law (reproducing Art 10(1)-(4) of Directive 2001/83/EC as amended). Hence, the conclusion based on the cited legal provision would be that exemption is limited to activities relating to marketing approval of generic medicines.

On the other hand, Romania has the ‘experimental use exemption’ with the contents detailed in the above-cited Article 80(a) of the 2008 Patent Regulations. Essentially, this is a broader exemption than the (Bolar) exemption regulated under the Health Law, being widely accepted that Article 80(a) of the 2008 Patent Regulations exempts from infringement trials relating to innovative medicines too.

There is no relevant case law under Romanian law.

The wording of the Bolar exemption does not make it clear whether there is any relevance where the regulatory approval (MA) is intended to be obtained. As there seems to be no restriction placed in that regard, it would arguably not matter where the MA is intended to be obtained in order for a company to be able to rely on the Bolar exemption for acts conducted in Romania. 

However, please note that the issue has not been tested in the Romanian courts nor is there any readily available guidance on it.  

Note: We consider that upholding the case for the experimental use exemption should be even easier than for the Bolar exemption and this, considering the overall permissive intent behind the legal wording applicable in case of the experimental use exemption, which is geared to ensuring a clear path to regulatory approval for medicinal products.

There is nothing in the legislation to suggest that only the MAH may avail itself of the exemption. The same conclusion as to the query above applies, namely, even if the testing were conducted by a third party who assist the MAH in carrying out the activities, the Bolar exemption would still apply. Care should be given though to the fact that this issue neither has been tested in the Romanian courts and that there is no readily available guidance on it.  

Please see the Note at the question above that applies mutatis mutandis to the response to this question.