It may be useful, in order to understand the present situation and to make a long story short, to briefly summarise the developments occured in the subject matter.
First, it is worth noting that it was not until 1978 that patent protection became available to pharmaceutical products in Italy, when the Constitutional Court pronounced, with its judgment of 20th March 1978, no. 20, the unconstitutionality of art. 14 of r.d. 29th June 1939, no. 1127 (the law on industrial inventions) which prohibited the granting of patents to pharmaceutical inventions, on the ground of some dubious "moral" justifications.
However, despite this important amendment to the law, the pharmaceutical industry found that such reform was inadequate and insufficient. As a matter of fact, while normal patent protection runs for twenty years from the date when the request for patent protection is filed, its manufacturer is immediately able to exploit his product commercially; not so for the producers of pharmaceutical products, who must first obtain authorisation to market their products from the health authorities by means of registration by the Ministry for the Interior in accordance with art. 162 of the unified text of the health laws, no. 1265/1934 as amended by art. 4 of the law no. 422/1941.
Unfortunately, the scientific and technical effort involved in obtaining such authorisation, which is often out of all proportion to the importance of the innovation, leads to long delays before commercialisation is possible. Typically, this leads to delays of up to twelve years from the date of filing the request for patent protection until authorisation is granted so that the actual period which remains for commercial exploitation of the patented product is reduced to eight years.
Thus, with the entering into force of the law of 19th October 1991, no. 349, and the advent of the Supplementary Protection Certificate, a new system of supplementary patent protection was introduced for pharmaceutical products and compounds which are capable of being the object of protection.
It is hardly necessary to say that the idea of the Supplemental Protection Certificate was not an Italian innovation, but one inspired by other legal systems such as those of France, the United States and Japan. The United States and Japan both chose to deal with the problem by introducing the extension of the original period of patent protection.
This approach, however, was not open to Italy or to the other signatories of the Munich and Luxembourg Conventions relating to European and Community patents which established that the twenty year duration of the patent could not be varied by national legislation. It is worth noting here that the European Community also deemed it necessary to introduce Supplementary Protection Certificates for European Patents relating to pharmaceuticals with its Regulation no. 1768/92.
The system of Supplementary Protection Certificates is, however, compatible with the Munich Convention on the European Patent since the Convention does not prevent the signatories from extending patent protection by introducing additional means of protection.
Given the importance of the patent as a method for protecting and nurturing scientific innovation, it is not surprising that the Supplementary Protection Certificates have the same effect (and the same limitations) as the original "base" patent grant.
In Italy, it is possible to request a Supplementary Protection Certificate for Italian patents or for patents having effect in Italy and which relate to pharmaceuticals, use of products as medication and processes for their manufacture.
Turning to the provisions of the Law of no. 349/91, the most significant of the transitional measures are found in article 4 and in accordance with which:
Otherwise, a Certificate may be requested by the owner of the patent within 180 days of the grant of the first ministerial authorisation and, in any event, at least 180 days before the expiry of the patent. In the event that the first authorisation is given before the grant of the patent, a Certificate can be requested within six months of the date of the grant of the patent.
- requests for grants of patent filed before 18th May 1972 are excluded;
- owners of pharmaceutical patents who obtained the first ministerial authorisation to market the product before 19th November 1991 and who filed the request for the patent between 18th May 1972 and 13th November 1972 can request a Certificate up to 180 days before the expiry of the patent.
The effect of the Certificate is to extend the duration of the protection for a period equal to the length of time which passes between the date of filing the request for the patent and the date of first authorisation but, in any case, for a maximum period of 18 years.
A Certificate will only be granted on the basis of one patent. In the event that a product is protected by more than one patent, for example, one for the product itself and one for the production process, it is up to the owner of such patents to choose which is to be the "base" patent on which the application for a Certificate will be made. This is particularly important as the protection afforded by the Certificate will be limited to that given by the original patent.
It should also be noted that one product often receives a number of successive authorisations for its commercialisation when, for example, a change is made to its form, to the dosage, to its composition etc. In this case it is the first authorisation that is relevant for the purposes of calculating the time that has passed since the request for the patent was made.
It goes without saying that the "base" patent should be valid and current, as should the authorisation, failing which the Certificate will be void. Care should be taken, since, in the pharmaceutical field, one patent may protect a number of products which conform to the same formula. Of those products, only some will be developed and, eventually, only one will be put on the market. In this case, the Certificate will only protect the product covered by the ministerial authorisation and not the rest of the products covered by the one patent.
In the same way, the protection given by a Certificate to a product which has been authorised will be limited to the subject matter of the "base" patent. Therefore, if an authorised product is made up of more than one active compound, only the compound that is protected by the patent will be protected by the Certificate.
In the event that a party wishes to challenge the validity of the Supplementary Protection Certificate, a request to have a Certificate declared void may be made to the body which first granted it, i.e. to l'Ufficio Italiano Brevetti e Marchi. A Certificate may be declared void for one of the three following reasons:
In conclusion, the purpose of the Law no. 349/91 is to extend the length of patent protection actually available to pharmaceutical products, not so that such products enjoy a privileged position, but so that they may enjoy the same length of protection as non-pharmaceutical products and, thus, put an end to the penalising effect that this has had on the Italian pharmaceutical industry with regard to its foreign competitors.
- if the conditions for obtaining the Certificate in accordance with art. 4bis of the Law are not fulfilled and, in particular, if the ministerial authorisation is void or was not the first to have been made with respect to that product, or if the "base" patent was no longer valid at the time of requesting a Certificate; or
- if the "base" patent is void at the date of its legal expiry, or is subsequently declared void. Thus, it is possible to obtain the annulment of the "base" patent after the date for its legal expiry but only in order to obtain annulment of the Certificate; or
- If the product which is protected by the Certificate is not protected by the "base" patent.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.