The Law Today

First Report of the Supreme Court on the Bill amending the rules on non-voluntary medical leave during a health alert, epidemic or pandemic.

31 Jul 2020

Intoduction

On June 9, 2020, a draft law was introduced that relaxes the rules on access to non-voluntary medical licenses for patents and utility models, medicines, vaccines and medical technologies necessary for the prevention, diagnosis and treatment of diseases, and establishes a special procedure for this purpose, in a context of health alert, epidemic or pandemic.  In particular, the Project proposes, among other things, the following:

A. Replace the current procedure for the application for voluntary medical leave with a short and summary one.

B. Within the procedure, it is determined that notification of the application shall be made through the publication, in a newspaper with national circulation and in the Official Gazette, of an extract thereof authorized by the National Director of the National Institute of Industrial Property (INAPI).

C. Any appeals against the ruling on the origin of non-voluntary licenses, and any incidents, shall be granted only in the form of a refund.

D. A percentage of the royalties payable under non-voluntary licenses shall be set at 5% of the retail price of the licensed product or process.

E. Article 91 b) of the Industrial Property Law is expressly applied, in the sense that the protection indicated on test data or other undisclosed data will not apply, thus allowing the use of those already submitted to the Institute of Public Health (ISP).

F. In the event that the applicant for the non-voluntary license is a public service or other entity governed by public law, the latter may import, manufacture and distribute the subject matter of the application, as from the date on which the administrative act providing for it is issued.

G. The liability of applicants who, through ignorance of the existence of a patent concerned or by acting in good faith, commit an infringement of the Industrial Property Law shall be limited.

The bill is currently in its first constitutional stage in the Chamber of Deputies and has been submitted to the Supreme Court for analysis, which, by means of Official Letter No. 137/2020 of 23 July 2020, issued the corresponding report, setting out the following comments:

– It considers it necessary to specify the context of the health alert, pandemic or epidemic, i.e. what administrative acts may determine such states; and to set the parameters establishing their duration.

– It considers that complaints against the administrative decision of INAPI should be lodged with the Intellectual Property Court, given its technical and special nature. In this case, in order to keep the speed in its knowledge, it determines that certain characteristics of the claim must be kept, but with more limited times.

– Without prejudice to the above, it states that it is necessary to maintain the final control by means of an appeal in cassation of the decisions of the referred Court.

– On the other hand, it notices the omissions of essential elements of the proposed complaint procedure, stating that it should be similar to the complaint of municipal illegality of Law No. 18.695, Constitutional Organic Law of Municipalities, but with shorter periods of time.

– Finally, it states that the nature of the claim should be that of an action for nullity, and not of full jurisdiction, with express mention in the Project, in order to determine a procedure to rectify the defects detected.

Contact

In case you require additional information on this matter, you may contact Andrea Abascal (aabascal@jdf.cl), Manuel Bernet (mbernet@jdf.cl) and/or Rocío Vergara (rvergara@jdf.cl).

JDF