Increasingly important to life sciences innovation, the repurposing of existing drugs is not patentable in some major developing markets. While the caselaw suggests that second medical uses can be protected in Brazil, Roberto Ribeiro of Daniel IP explains, there are significant hurdles for inventors to overcome.
The world is waiting anxiously for COVID-19 treatments. Given the significant time, expense, and difficulty involved in developing new drugs and vaccines, the repurposing of existing drugs is an attractive option for innovators seeking to help tackle the pandemic. Indeed, this approach has already produced the combination of the anti-malarial Hydroxychloroquine and the antibiotic Azithromycin, as well as the biological product Kevzara (Sarilumab from Sanofi) as candidate treatment for COVID-19.
As Latin America’s most populous country and major developing economy, Brazil is an important jurisdiction in which to protect repurposed drugs. But, not only is the patenting of new therapeutic uses controversial in the country – being perceived as unfairly extending monopolies – there is no provision in Brazilian legislation explicitly permitting second medical use patents.
The limited case law on this question suggests that such IP rights can be acquired. However, innovators must meet stringent novelty and inventive step criteria and must provide strong scientific evidence for the improvements achieved.
The possibility of obtaining patents for second uses was crystallized in the jurisprudence that resulted from a lawsuit filed by Eli Lilly against the Brazilian Patent Office (the INPI) in 2008. This related to a patent application for a new use of atomoxetine for the preparation of medications to treat Attention Deficit Hyperactivity Disorder. Atomoxetine was already known to treat urinary incontinence.
Lilly’s application was rejected during examination, because of prior art references relating to the drug’s being tested for the treatment of depression. On appeal, launched in 2008, it argued vague references to other treatments, such as for depression, would not prevent claims directed to ADHD from being novel or inventive.
Though this rejection was upheld on appeal, Chief Judge Abel Gomes in his October 2014 decision made important statements clarifying the concept of “second use patent” as well as recognizing the possibility of granting second use patents. And, while Brazilian law operates under Roman Law principles and decisions at the appeal level are non-binding, the judgment certainly sets an important milestone.
Judge Gomes stated: “Anyway, although neither the TRIPS Agreement nor Brazilian legislation have provisions that expressly authorize the granting of a new use patent or a new dosage formulation for known substances, as the winning vote, Law no. 9.279 / 96, establishes in art. 8, that inventions that meet the requirements of novelty, inventive step, and industrial application are patentable…”
However, he went on, second use patents must unequivocally fulfill ordinary novelty and inventiveness requirements; and these requirements “must even be measured in a more rigorous way, since it is a matter of starting from something already known (in this case the substance and process as a whole), both in the state of the art, so that another monopoly is extended to it.”
Among the rigorous standards, second medical use patents must meet are those which have been set out in Chapter 9 of the Guidelines for Aspects relating to the Examination of Patent Application in the Chemical Field. In particular, patent applicants should bear several points relating to the inventive step requirement in mind:
- The mechanism of action of the compound involved in the new use must not be understood from its mechanism of action for medical use already disclosed in the state of the art;
- The new use must refer to the treatment of a disease whose etiology is different from the etiology of the disease related to the use revealed in the prior art;
- The new use cannot be inferred from the structure-activity relationship of the drug in comparison with structurally related molecules, that is, from the structural analogy with other compounds that present the same activity now claimed, already revealed in the state of the art;
- The new use cannot be inferred from the disclosure of known adverse effects of the state of the art for the drug in question; and
- The new use cannot be inferred from the use of the compound for the treatment of a symptom of a disease already revealed in the state of the art, even though the claimed use refers to a different disease.
On the top of this, the patent application description should include strong evidence of the scientific improvement achieved, given that the starting point to what protection is sought is “something already known”.
Article published on IAM. Read it here.