Plant Extracts and Their Patent Protection in Brazil

Since the earliest days of medicine, plant extracts have been used to treat a wide range of diseases. Drugs of plant origin have grown increasingly valuable to society. In addition, the commercial appeal of these drugs is particularly important, since they are commonly associated with health and with the absence of side effects.

Article 10 (IX) of Industrial Property Law No. 9,279/96 (IPL) does not consider that the whole or part of natural living beings or biological material found in nature or isolated from it1 to be inventions, but rather to be merely discoveries. In other words, plant extracts per se would not be considered patentable in Brazil.

However, although the patent system presents legal impediments for protecting extracts obtained from plants, there are other alternatives for protecting this type of invention.

For example, the extract in question may be claimed in the form of a pharmaceutical or cosmetic composition, including pharmaceutically or cosmetically acceptable excipients. Naturally such a composition, provided it is novel and inventive, would be considered patentable under Article 10 (IX) of the Industrial Property Law. It must only be advised that the Brazilian Patent and Trademark Office (BPTO), the federal entit y responsible for granting patents in Brazil, does not consider the extraction media to be a composition’s excipient. That is to say, the BPTO considers, for example, water or alcohol not to be excipients of a pharmaceutical composition as concerns its patentability, but to be mere diluents, and the pharmaceutical composition would be considered a mere dilution of a natural product2 . Likewise, if the pharmaceutical composition includes only the plant extract, the BPTO does not consider that protection is being claimed for a composition, but rather for the extract per se, which is not patentable. Thus, when claiming a pharmaceutical composition that includes a natural extract, it is best to specify the adjuvants it contains.

Notwithstanding the foregoing, IPL Article 42 ensures process patent owners protection against others using, offering to sell, selling or importing the process or product obtained directly by the patented process3.

Therefore, another option for securing patent protection indirectly, for an extract or even a molecule obtained from a plant or through a synthetic process, would be to claim a process by which they were obtained. Naturally, this extraction or isolation process must meet the basic patentability requirements established in the IPL’s Article 8: it must be novel, inventive and have industrial application.

A third avenue for seeking protection in the patent system for natural extracts is by claiming therapeutic use. However, it is recommended that these claims be written in the format known as "Swiss Formula" (use of product X characterized by its use in preparing a drug to treat disease Y). This sidesteps the legal prohibitions of the IPL’s Article 10 (VIII)4, which denies the patentability of treatment methods.

Thus, even with the legal impediments imposed by the IPL, there are alternatives for indirect patent protection for products directly extracted from nature.

[1] Article 10. "The following are not considered to be inventions or utility models: (…)