Brazilian Appellate Court Clarifies Legality of Redrafting Therapeutic Method Claims to Swiss-Type Format
Introduction
Therapeutic methods, those involving the direct treatment, cure, prevention, or diagnosis of diseases in the human or animal body, are expressly excluded from patent protection in Brazil. This exclusion is rooted in Article 10(VIII) of Brazil’s Industrial Property Law (Law No. 9,279/96), which states that “operating or surgical techniques and therapeutic or diagnostic methods for use on the human or animal body” are not considered inventions and, therefore, are not eligible for patent protection. The rationale behind this exclusion is to ensure unrestricted access to medical and therapeutic procedures, safeguarding the public’s health and the ethical practice of medicine. As a result, any claim directed to a method of treatment, such as administering a drug or performing a surgical step on a patient, will be rejected by the Brazilian Patent and Trademark Office (BRPTO).
However, this prohibition does not extend to substances, compositions, or devices used in medical practice, nor to claims drafted in alternative formats. For example, Brazil allows so-called “Swiss-type” claims, which protect the use of a substance or composition in the manufacture of a medicament for a specified therapeutic application, provided the claim does not encompass the therapeutic method itself. This approach enables innovators to secure meaningful patent protection for new uses of known compounds while maintaining the statutory prohibition on patenting methods of medical treatment.
Appellate Court Decision
In a recent decision (Appeal case #0225909-95.2017.4.02.5101), the Federal Court of Appeals for the Second Region (TRF-2) addressed the legality of a denial by the BRPTO’s of a divisional patent application (PI 9917687-4), containing a set of claims that had been reformulated from reciting a therapeutic method to “use in the preparation of a medicament” under the “Swiss-type” format.
The BRPTO argued that the applicant’s reformulation modified the scope of protection and violated Article 32 of the statute, which prohibits amendments after the request for examination. However, a report provided by a court-appointed expert stated that the content of the divisional application did not exceed the subject matter as originally disclosed. Specifically, the expert clarified that the Swiss-type claim format restricts, rather than expands, the scope of protection, since it does not involve the therapeutic application itself but rather the use of substances for the preparation of a medicament.
Relying on this expert opinion, the Court of Appeals held that the redrafting of the claim set into the Swiss-type format did not violate Article 32 when no expansion of the original scope of protection occurred. As a result, the Court nullified the BRPTO’s administrative decision and ordered the continuation of the examination of the divisional application.
This important decision provides greater certainty for applicants seeking to protect second medical use inventions in Brazil, provided claim amendments do not expand the original disclosure.
Final thoughts
This decision from Brazil's Federal Court of Appeals is a welcome development for pharmaceutical and biotech applicants seeking to navigate the country’s restrictive approach to therapeutic method claims. By allowing the redrafting of such claims into the Swiss-type format—provided the scope is not expanded and the subject matter remains within the original disclosure—the Court has provided much-needed clarity and flexibility. This ruling aligns Brazil more closely with international practices, supporting innovators in securing meaningful protection for second medical use inventions. Practitioners should, however, remain vigilant to ensure that any amendments do not impermissibly broaden the scope of the original application, as this remains a key limitation under Article 32.
This post was written by Lisa Mueller, Rob Rodrigues, and Daniela Fernandes of RNA Law.