Many researchers will probably have heard of the so-called Bolar Clause when conducting research in a patent environment. It is usually defined as an exception to the rights attached to a patent, according to which the use of patented products for experimental purposes in studies or trials necessary to obtain the corresponding generic authorisation is not considered to be infringement.
However, this is not the only exception for possible infringement. According to the current Spanish Patent Law 24/2015 of 24 July 2015, there are cases in which the rights conferred by the patent are not applicable. Thus, we have Article 61 in which the following exceptions are indicated:
(a) To acts done in a private sphere and for non-commercial purposes.
b) Acts carried out for experimental purposes relating to the subject matter of the patented invention.
(c) To the execution of the studies and trials necessary to obtain marketing authorisation for medicinal products in Spain or outside Spain, and the consequent practical requirements, including the preparation, procurement and use of the active ingredient for these purposes.
(d) The preparation of medicinal products in pharmacies extemporaneously and per unit in execution of a medical prescription and the acts relating to the medicinal products thus prepared.
(e) The use of the subject matter of the patented invention on board ships of countries of the Paris Union for the Protection of Industrial Property, in the body of the ship, in the machinery, gear, apparatus and other accessories, where such ships temporarily or accidentally enter Spanish waters, provided that the subject matter of the invention is used exclusively for the needs of the ship.
(f) The use of the subject matter of the patented invention in the construction or operation of means of locomotion, whether by air or land, belonging to countries that are members of the Paris Union for the Protection of Industrial Property or accessories thereto, where such means of locomotion temporarily or accidentally enter Spanish territory.
g) To the acts provided for in Article 27 of the Convention on International Civil Aviation, done at Chicago on 7 December 1944, when such acts relate to aircraft of a State to which the provisions of the aforementioned Article are applicable.
Another point of the same article states that the rights conferred by the patent do not extend to acts relating to a product protected by the patent after that product has been put on the market in the European Economic Area by the holder of the patent or with his consent, unless there are legitimate grounds for the holder of the patent to oppose further commercialisation of the product.
Finally, the rights conferred by the patent shall not extend to acts relating to biological material obtained by reproduction or multiplication of a protected biological material covered by the patent, after it has been placed on the market in the European Economic Area by the proprietor of the patent or with his consent, where the reproduction or multiplication is the necessary result of the use for which the biological material was placed on the market, and provided that the material obtained is not subsequently used for further reproduction or multiplication. This limitation shall not apply where there are legitimate reasons for the patent owner to oppose further commercialisation of the biological material.
Article by Rafael Moreno.