Wednesday, 27 May 2015

Last Monday was the final day of the public consultation concerning the draft amendments of the Dutch national patent law. Quite a number of articles are amended or introduced to accommodate the unitary patent. Of we course we have also been looking at the proposal in the past weeks. On the whole the proposal looks solid and will make the Netherlands ready for adoption of the unitary patent.

Some of the interesting articles include the following:

Reestablishment


A new article 23a1 will allow reestablishment in case of the request for registration of unitary effect is denied. The deadline for filing this request is one month after publication of the mention of grant. The deadline for classic national validation is 3 months. So if your request for registration of unitary effect is denied, you may not have the opportunity for national validation anymore. This article allows you to get a Dutch patent in case your request for registration of unitary effect is denied and you missed the normal validation deadline.

One problem that I see with this article is that the delayed validation is not applicable while in Court. So if you challenge the denial in Court, you need to wait until the Court made its decision. Should that decision be negative, i.e., your request for registration is still denied, you can then apply for validation according to the new article. It is not possible to withdraw the Court case and validate earlier.


Protection in Curaçao and Sint-Maarten

A Dutch patent or a European patent validated in the Netherlands are also valid in Curaçao and Sint-Maarten. However, the unitary patent only applies to the European parts of the Netherlands. There is thus a loss of protection if one chooses for a unitary patent instead of a nationally validated patent. This has been implemented in a new article 50a which says that once the request for unitary effect has been registered, the patent is no longer in force in the European part of the Netherlands.

This has the interesting (and intentional) side-effect that even if unitary effect has been registered, one can still validate the European patent in the Netherlands. However, this Dutch validated patent will only be valid in the non-European part of the Netherlands, i.e., Curaçao and Sint-Maarten.

This means that if the loss of protection for these regions is a problem one can still validate for them, and obtain protection. Unfortunately the cost for this protection on top of the unitary patent is the same as a Dutch validation currently costs, i.e., the same renewal fees.

Pharmacy exception 

The agreement on a unified patent court includes the so-called pharmacy exception; the extemporaneous preparation by a pharmacy, for individual cases, of a medicine in accordance with a medical prescription is excepted from patent protection (Article 27(e) of the Agreement). This exception has been included in the Dutch patent law, and will thus also apply to non-unitary patents in the Netherlands. Interesting the phrase 'extemporaneous' has been translated as 'voor direct gebruik' (for immediate use). I'm not sure those two mean exactly the same thing. Then again, I'm not sure what extemporaneous really means either.

According to the official notes to the proposal (my translation):
The exemption applies, however, only if the preparation is for immediate use and is carried out in individual cases. This exception does not apply to producing for stock. In view of this the exemption will only apply in exceptional cases. The Dutch law is therefore in line with the Judiciary Treaty and the laws in the surrounding countries.
I have no idea about the law in the surrounding countries with respect to the pharmacy exception. I only found this Italian case. Apparently Italy also has an exception for the extemporaneous preparation by a pharmacy. The Italian court ruled that this allowed the preparation of a patented drug with a different dosage in view of a patient’s special needs. The preparation of a patented drug by the Italian pharmacists however did infringe. It will be interesting to see how the Dutch Court and/or the Unified Patent court will apply this exception.

The final proposal for amendments of the Dutch national patent law should be available before summer. 




2 comments:

  1. Similar rule in French patent law: Article L-613-5 c)

    ReplyDelete
    Replies
    1. Interesting. Do you know if the French law amendments for unitary patent are available?

      Delete