3.5.2 Defenses
A third party may claim that they did not violate patent law. However, in this case, when it comes to the infringement of a process patent, the burden of proof is reversed (Article 42(2) of the LPI).
3.5.2.1 Absence of liability
For an accused infringer to avoid being held liable, it is possible to claim the provisions of Articles 43 and 45 of the LPI, which, by express legal definition, stipulate circumstances in which a patent is not infringed. Patent nullity may also be claimed, at any time, as a defense.
Article 43 of the LPI provides for cases in which a patent is not infringed. For example, acts committed privately and without commercial purposes by unauthorized third parties do not infringe a patent as long as they do not harm the patent holder’s economic interests (Article 43(I) of the LPI).
A person who exploited, in good faith, the subject matter of a patent in Brazil before the filing or priority date of a patent application is ensured the right to continue with such exploitation, without burden, as before (Article 45 of the LPI). This right is not ensured to a person who became aware of the patent’s subject matter by the disclosure made pursuant to Article 12 of the LPI, as long as the application has been filed within one year of the disclosure (Article 45(2) of the LPI). The right granted pursuant to this article may be assigned only to the business or company, or a company representative directly related to the exploitation of the patented object, by disposal or lease (Article 45(1) of the LPI).
3.5.2.2 Consent or license
Third parties may claim to have a license authorizing their use of the patent. This would exempt them from liability for alleged infringement.
3.5.2.3 First-sale (exhaustion) doctrine
The principle of the exhaustion of patent rights is provided for in Article 43(IV) of the LPI. Under this provision, a third party may also claim to have a product that has been manufactured according to a process or product patent and that has been placed on the domestic market directly by the patent holder or with their consent. Consent or placement on the market by the patent holder are conditions for the exhaustion of the patent holder’s right. Exhaustion refers to the product sold, not to the patent as a whole. However even if primary exploitation is not carried out by the patent holder, the acts of the secondary exploitation may still constitute an infringement.70
If there is more than one holder of the patent, it is necessary to check whether any of them had the right to place the product on the market or to grant a license. If so, this right is exhausted in relation to the others. Otherwise, there may be no exhaustion.
For patents relating to living matter, patent law is also not infringed if third parties use, circulate or sell a patented product that has been lawfully introduced into the market by the patent holder or license holder, provided that the patented product is not used to multiply or propagate the living matter for commercial purposes (Article 43(VI) of the LPI). Additionally, patent law is not infringed if third parties use the patented product as an initial source of variation or propagation to obtain other products without commercial purposes. Finally, there is no infringement for acts performed by unauthorized third parties, related to the protected invention and intended exclusively for the production of information, data and test results aimed at obtaining a trade license – in Brazil or in any other country – for the exploitation and sale of the patented product after expiration of the time limits set forth in Article 40 (Article 43(VII) of the LPI).
Article 43(IV) of the LPI provides for exhaustion only for products placed on the domestic market by the patent holder or with their consent. Therefore, holders may exercise their right to prevent the parallel importation if they import their product, even if the product is placed on the foreign market by the patent holder or with their consent.71