Biotechnology & Italian Patent

Biotechnology & Italian Patent

Biotechnology and Life science in general, are surely two of the most actual topics in the field of patents. Fortunately, although the difficult conditions of the world economy in general, biotechnology is evolving, and the technological progress therein correlated consequently continue to grow, leading to incredible results.

In Italy the regulation about biotechnological patents has been introduced only few years ago in particular, the 18 august 2012, was launched the regulation  of the patentability of the biotechnologies, clarifying the scope of previous Articles 81-bis to 81-quater. (In particular, in the Code of Industrial Property, have been introduced the articles 170 bis. And .2.3.4/170ter and correlated articles).

For example: Art. 81-bis defines the categories of biological materials and the allowed procedures; Art. 81-quater defines the patentability of the biological materials of Art. 81-bis. (Note that every type of biological material has different patentability criteria). Art. 170-bis defines and requires the origin of the biological material, and 170-ter requires for defined categories of biological materials,   the informed consent of the donors of the biological tissue, and if this condition is not satisfied, there are defined penalties to be paid for this. This last article in particular, caused some doubts and concerns in the ones who approached the field of the biotechnological patent in the last years. This because in Art. 170-ter it appears that for every sample of human tissue used during the reduction to practice of the invention has to be identified and certified from the point of view of origin, and that for every sample of human tissue used, it should have been signed an informed consent  by the specific donor. 

The too literal interpretation of this article seems to have led to the conviction that it is too difficult to file a patent application in Italy.

This is not correct, as it will be clear from the following data­; for what concerns the patents in Italy, in general, it is very interesting to underline that in Italy there are filed more than 9.000 patent applications every year. And this number is continuously growing in the last years.

Italy occupies the third place in the European ranking, for the number of patents field in one year, and is preceded only by Germany and France. This is surely a relevant and very positive signal.

Here we present the first statistical data on the result of the examination conducted by  UIBM (the Italian PTO) , on the basis of the Search Reports received from EPO.    

Number of applications
field in a year

Number of granted
patents

Number of rejected
applications (or not completely inventive or new)

Number of abandoned
applications

100%

58%

36%

6%

 36% is the number of applications with no completely positive search report, of those:

  •        The 50% is granted after having done some amendments
  •        The 45% is converted in a utility model
  •        The 5% is abandoned

Please note that the percentage of granted  biotechnological patent applications is in line with the data here presented. This could be surprising, but indeed, the patent applications regarding biotechnology don’t have worse fate than the other patent applications, even thought the regulation s seems to be very restrictive. This is a fact, which should lead to an important conclusion regarding the patentability of biotechnology in Italy, i.e. that it is not impossible, or even more difficult to obtain an Italian biotechnological patent, than other patents, or even not more difficult than in other European countries.

In fact, the described regulation, has articles referring to very precise objects in biotechnology, at least every category of objects has its own regulation, so not all biotechnological patent applications need to satisfy all the articles mentioned above, and for those which have to follow those article UIBM, gives clear explanations and indications of the best way to follow to satisfy the requests stated in the articles.

In particular, regarding Article 170bis and 170ter of The Code of Intellectual Property, the inventor who wants to file a patent application regarding biotechnology in Italy, must not be scared, because the mentioned more restrictive articles, are valid and applied only to very specific fields, and are detailed for every single patent application, and also in the most particular case, when following correctly the indications, it is still possible to achieve  to the allowance of the patent.