Experimental Data: A Key Element of Brazilian Medical Use Claims

There is no doubt that it is a challenge to design a patent protection strategy for a new medical use (for example, a new disease to be treated or prevented by a known composition, active ingredient or biological). The proper format for claiming such subject matter may vary significantly between patent jurisdictions. In Brazil, besides the accepted format, there are other points that deserve attention in terms of increasing the chances of success in obtaining a patent, such as the need to present experimental data in medical use patent applications in order to meet the sufficiency of disclosure requirements.

Although therapeutic, surgical and diagnostic methods practiced on the human or animal body are excluded from patentability under Article 10 (VIII) of the Brazilian IP Law # 9,279/96, it is possible to obtain protection for medical use inventions through the so-called Swiss-type format, namely, “use of a compound X in the manufacture of a medicament/composition for the treatment of a disease Y”, provided that said use is novel and inventive.

According to Brazilian Patent and Trademark Office (BPTO) examination guidelines, the medical use claim should also specify the therapeutic condition for which the invention is intended, that is, the name of the disease(s) to be treated must be defined in the claim, and the specification as filed should clearly and sufficiently describe the claimed new use, by in vitro tests and/or in vivo assays.

The Claimed Subject Matter Must Be Fully Carried Out by the Person Skilled in the Art

In May 2021, the BPTO published a compilation of decisions taken at second instance by the Office’s boards of appeal, providing a more in-depth basis for understanding the position of Brazilian examiners on experimental data to support medical use claims.

The substantive question addressed by the BPTO in the analysis of appeals related to new medical use claims was the bargaining system in granting a patent – disclosure of an invention in exchange for a secured exclusive right over the invention. Thus, it is essential that a patent application discloses the invention clearly and sufficiently to allow a person skilled in the art to carry it out.

According to the BPTO, the traditional product and/or process claims can usually be reproduced by a skilled person following the instructions provided in the specification. However, in the case of medical use inventions, the skilled person already knows how to obtain the prior art product, the differential of the invention being the new use for which the product must be manufactured. The application must establish the feasibility of the claimed compounds to treat the diseases.

In view of this, the sufficiency of disclosure of a medical use claim cannot be limited to the already known compound and its use for treating a specific therapeutic condition, but rather the applicant must disclose some experimental data to consider the claimed use as plausible, in order to overcome the speculative nature of the subject matter.

Evidence of New Therapeutic Use: Need for In Vivo Tests?

Although in vitro tests may indicate a therapeutic effect of the subject matter, the BPTO understands that in vitro tests often are not confirmed in vivo, due to pharmacokinetic aspects, among others related to the behavior of the product within the organism. In this sense, in vitro tests would be acceptable, provided that supplementary information proving equivalence of product effect within the organism is submitted. In the case of animal studies, the models adopted should present the possibility of extrapolation for humans.

In the absence of such evidence of new therapeutic use, the BPTO will consider that the essential technical feature of the claim is not supported by the specification of the patent application and the subject matter will be challenged for lacking sufficiency of disclosure.

As the addition of new matter in the application is not allowed by the BPTO at any time during prosecution, post-filing data to strengthen arguments in favor of sufficiency of disclosure may be rejected by the BPTO.

Therefore, when seeking protection for second use claims in Brazil and evaluating the best patent strategy to follow, foreign applicants must consider filing the patent application along with pharmacological test data or the equivalent, preferably, in vivo tests showing any medical effect when the compounds are administered to humans/animals.

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Author: jpgon
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