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Netherlands

European Bolar Provisions in Netherlands

Table of contents
  1.  How is Bolar implemented?
  2.  How does the Bolar provision work?
  3.  Is Bolar restricted to exempting studies for generic marketing authorisations?
  4.  Has Bolar been litigated in your jurisdiction?
  5.  Are exempted activities covered by a local exemption regardless of where regulatory approval is ultimately sought? 
  6.  Does Bolar extend to a third party who assists the MAH in carrying out the activities? 
Netherlands
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1. How is Bolar implemented?

The Bolar provision as stipulated in Article 10 Paragraph 6 of Directive 2001/83/EC (relating to medicinal products for human use, as amended) and Article 13 Paragraph 6 of Directive 2001/82/EC (relating to veterinary medicinal products, as amended) has been implemented in Article 53 Paragraph 4 of the Dutch Patent Act 1995 (“DPA”). The provision has been implemented in Dutch law almost literally and reads as follows:

“Conducting the necessary studies, tests and trials with a view to the application of Article 10, first to fourth paragraph, of Directive 2001/83 / EC establishing a Community code relating to medicinal products for human use (PbEG L 311) or Article 13, paragraphs 1 to 5 of Directive 2001/82 / EC establishing a Community code relating to veterinary medicinal products (PbEG L 311) and the consequential practical requirements are not regarded as an infringement of patents with regard to medicinal products for human use or medicinal products for veterinary use. “

This Article came into force on 1 February 2007.

The Netherlands has adopted a narrow scope of the Bolar exemption. It only covers abridged applications and only applies to marketing authorisation procedures in the European Economic Area (“EEA”).  

2. How does the Bolar provision work?

The Bolar provision states that, under certain conditions, studies, tests and examinations which are necessary to determine that a medicine is a generic version of an (IP) protected medicine (“reference medicinal product”), do not infringe any existing patent right or protection certificate for medicinal products.

It is a policy that allows generic manufacturers to prepare production and regulatory procedures before patents expire, so that products can be ready for sale as soon as the patent lapses, rather than having to go through the lengthy preparatory process only after the patent period is over. It gives generic manufacturers earlier access to patented information.

The Bolar exemption states that research activities that are necessary to obtain a marketing authorisation for a generic, hybrid or biosimilar medicine are not regarded as an infringement on the exclusive rights of the patent holder. This includes (clinical) studies, tests and trials, for example to demonstrate that a product is bioequivalent to a reference medicinal product, so that the shortened procedure for applying for a marketing authorisation will suffice.

3. Is Bolar restricted to exempting studies for generic marketing authorisations?

Because of its narrow implementation in the Netherlands, the Bolar exemption specifically covers the conducting of the necessary studies, tests, and trials within the context of obtaining a market authorization for generic medicinal products.

4. Has Bolar been litigated in your jurisdiction?

There is no known court case about the Bolar exemption in the Netherlands.

5. Are exempted activities covered by a local exemption regardless of where regulatory approval is ultimately sought? 

The Bolar exemption covers marketing authorisation procedures in the EEA.  Due to the narrow scope adopted in the Netherlands of the Bolar exemption, carrying out the necessary activities in the Netherlands is allowed as long as regulatory approval is being sought within the EEA. 

6. Does Bolar extend to a third party who assists the MAH in carrying out the activities? 

There is uncertainty as to whether subcontractors carrying out acts on behalf of the ultimate marketing authorisation applicant qualify for protection under this exemption also holds for the Netherlands. This point has not been tested in Dutch case law.