Innovation and Rights - Developing Biomedical Devices: Design, Innovation and Protection - page 36

The registration of a design is done by submitting an application at the Italian
Patent and Trademark Office (UIMB); registration is granted if the design meets
the requirements of Novelty and Individual character.
Since design has “peculiar features”, some amendments have been introduced
so that disclosure is not considered as destructive of novelty if the already existing
earlier design could not be reasonably be known (pre-use right) by circles special-
ized in the field and operating within the European Community.
The pre-use right protects anyone who has used in their own company and kept
secret an invention which is later patented by others.
Should an inventor keep secrecy and should another inventor achieve and patent
the same invention, the law envisages the right of pre-use, which allows the former
inventor to keep on exploiting the invention within the already existing limits of use.
The right of pre-use is granted only if the invention has been used during the
12 months preceding the patent application.
The second fundamental rule establishes that any disclosure of the design
before the application filing date or before the priority date prevents the valid reg-
istration thereof. Also in this case an amendment was envisaged: a “grace period”
has been introduced so that the disclosure made by the author in the 12 months
preceding the application filing date is not considered to be prior disclosure.
The grace period is a period of 12 months (6 months for the U.S. and Japan) in
which the company can test the product and see if there is feedback from the mar-
ket. The advantage is that it saves new inventions from “destruction” while giving
the company a “little time” to verify the validity of the product on the market. The
disadvantage is that if you disclose a model or design in Italy and then apply for
protection in other countries outside Europe, where there is a principle of absolute
novelty, pre-disclosure prevents from the registration in those countries.
The duration of protection is 5 years, renewable for four additional times, for a
total of 25 years. The renewal must be made within 6 months before expiration or
after 6 months by applying a surcharge for the additional period.
One single registration can contain several designs, if the products belong to
the same class of the International Classification for Industrial Designs. The same
registration can protect a set of products with the same characteristics normally
sold together, or that have been designed to be used together. In the same applica-
tion, products considered as variants of two designs can be filed too, but it is nec-
essary that they refer to the same product and are not substantially different from
each other.
The registration of a design and industrial model allows for adding the protec-
tion of the project with other forms of industrial property. If a new form or a new
variant of a shape makes the product/system more comfortable or allows for using
the same product in a more effective way, it is possible to apply for a patent or a
utility model.
A design is invalid when:
• it does not fullill the requirements of novelty and individual character;
• it is contrary to public policy or accepted principles of morality;