Chilean Law N° 20.560 published in the Official Gazette of 26 January 2007 has amended Industrial Property
Law N° 19.039 with several new provisions, some of them quite important.
The first part of the Law is devoted to clarify some aspects of the procedure for the granting of industrial
property rights, of the procedure for filing and prosecuting cancellation actions against industrial property
rights and a few referring to trademarks, including regulations when a trademark is registered in the name of
two or more owners.
Patents
Insofar as patents are concerned, the amendments are as follows:
New article 42: "The disclosures made within twelve months prior to the filing of the application will not be
considered for the purpose of determining the novelty of the invention nor the inventive level when said
disclosure:
- a) was made, authorized or derives from the applicant of the patent;
- b) has been made on account or deriving from abuses or disloyal practices affecting the applicant or
its heirs". (Comment: this is an improvement, especially concerning those applications filed abroad
which have to be published within a certain term and otherwise would affect the novelty or inventive
level of the Chilean application).
Article 49, that provides for the exclusive rights deriving from a granted patent, has been amended with the
addition of the following provision: ''The patent of invention does not confer the right to prevent that third
parties import, export, manufacture or produce the matter protected by a patent with the purpose of obtaining
registry or sanitary authorization of a pharmaceutical product. However, this does not allow that said products
be commercialized without the patent owner's authorization". (Comment: I fail to understand the logic of this
provision, which seems to favor the local pharmaceutical industry in that they could obtain sanitary
authorizations for pharmaceutical compounds or products that are patented, but unable to sell or
commercialized them without the authorization of the owner of the patent. In my opinion, this new provision
tends to enfeeble the patent rights on pharmaceutical products. This is indeed a "grey area", unless it refers
to original or authentic products that can be imported and sold by anybody in Chile. In a very recent seminar,
a suggestion was made to the effect that for preventing possible infringements by third parties, the application
for sanitary authorization be submitted simultaneously with the patent application).
Supplementary protection.
In new articles 53 bis 1 to bis 5 the Law has instituted a supplementary protection concerning the term of
patents when their prosecution is excessive or when the patented product cannot be commercialized due to
lack of official authorization. The provisions read as follows:
Article 53 bis 1.-Within the six months of the grant of a patent, the owner will have the rights to request for a
Supplementary Protection term, only if unjustified administrative delay has exist in the granting of the patent
and the term of grant has been over five years counted from the date of filing the application, or three years
counted from the request for examination, whichever is longer. The supplementary protection will be
extended only for the term considered as unjustified administrative delay.
Article 53 bis 2.- Within the six months of the grant of a sanitary registration of a pharmaceuticaJ product
protected by a patent, the owner will have the right to require a Supplementary Protection term tor the part of
the patent that contains the pharmaceutical product, only if unjustified administrative delay has existed in the
granting of the indicated registry. This supplementary protection can be applied tor by those owners whose
authorization or sanitary registry has been granted after one year counted from the date of the filing of the
request. The supplementary protection will be extended only for the term considered as unjustified
administrativa delay by the administrative organ in charge of granting that registry.
Article 53 bis 3. - The following do not constitute unjustified delay affecting the applications of patents or the
sanitary registry attributable to:
- a) the opposition or any remedy or judicial order action;
- b) the delay of reports or procedures of national or intemational agencies required for the registration
proceeding ot the patent.
- c) Actions or omissions by the applicant.
Article 53 bis 4.- The application of Supplementary Protection must be filed before the Industrial Property
Court, which must decide on the existence of unjustified delays and the extensions of these in single
instance, in conformity with the procedure established for appeals. The resolution issued in each case will
have as unique effect the extension of the term of protection and will not give origin to responsibilities of any
kind.
Previous to the hearing the Court will request from the respective organisms its opinion, which has to be
delivered within the term of sixty days.
Article 53 bis 5.- The term for Supplementary Protection must be recorded in the margin of the respective
registry with a prior payment of a tax of 1 Monthly Tax Unit for every year or traction of year of additional
protection. The payment must be made within the six months prior to the expiration date of the patent, without
which the protection established in this title will not be effective.
Articles 89 to 90 refer to the information disclosed to the authority to obtain health registrations or
authorizations, and article 91 numbers the cases in which said protection is not applicable. The recent Law
replaces paragraph e) by "the application for registration or sanitary authorization of the pharmaceutical or
agricultural chemical product filed in Chile after twelve months of the granting of the first registration or
sanitary authorization abroad".
We shall be glad to supply you with any additional information or explanation that you may require.
Santiago, February 2007. |
