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Biotechnology had its beginning with fermentation, the use of which coincides with the very beginning of the Christian era, mingling with the history of humanity. The Sumerians and Babylonians had known about the production of alcohol by fermentation of cereal grains prior to the year 6,000BC.

Around the year 2,000BC the Egyptians, who had already used yeast to brew wine, also employed it to make bread. However, it was from the 1950s that biotechnology came into existence, with the discovery of the chemical synthesis of DNA and genetic manipulation techniques.

Biotechnology involves a number of ethical questions, in particular with respect to intellectual property protection, such as those involving the protection of living organisms, including human genes and chimeras. This mainly raises the discussion of the limits of patent protection and the direction in which biotechnology is heading.

The development of biotechnology largely depends on high-risk investments. Attracting such investments requires a safe business environment, and the protection of IP is key to the creation of such an environment. In view of this, patent protection must be effective, and grant should be swift. As such, it is imperative that the examination of a patent application in the area of biotechnology be as judicious as possible.

There are two documents that govern the examination of patent applications in the area of biotechnology in Brazil: 1) Instruction No. 17/2013, previously called Normative Act No. 127 of March 5, 1997; and 2) the Guidelines for Examination of Patent Applications in the areas of Biotechnology and Pharmaceuticals filed after December 31, 1994, published in the Industrial Property Journal No. 1648 of August 6, 2002.

The National Institute of Industrial Property (INPI), seeking greater uniformity and predictability in examination analysis, is in the process of preparing new guidelines for the examination of patent applications in the biotechnology field. The INPI recently released a draft of the proposed guidelines for public comment in relation to the text that will form the basis of the new guidelines.

New approach

The proposed guidelines reflect an innovative approach in that they refine some of the terms in biotechnology, such as “biological materials found in nature”, “natural biological process”, “therapy”, “surgery”, terms that neither Brazilian Patent Law (BPL) nor the current guidelines include, providing a better overall scope of interpretation when it comes to patent examination.

The proposed guidelines released by the INPI also clarify when an applicant is required to file a sequence listing attached to the application. Such clarification does not exist in the current guidelines. Thus, when the subject matter of the invention includes the sequence, or when the set of claims includes “protein”, “polypeptide”, “nucleic acid” or any other term designating a biological sequence, it will be considered an essential part of the invention, and the attachment of the sequence listing will be required.

On the other hand, when the molecule in question is only one example, a specific sequence would not be considered an essential part of the invention, and no sequence listing would need to be presented as part of the application.

Additionally, it is worth mentioning that the proposed guidelines include definitions of oligonucleotides (or primers): promoters; vectors; complementary DNA; expressed sequence tags (ESTs); and open reading frames (ORFs), where such definitions are not interpreted in, or are less embodied in, the current guidelines.

“ESPECIALLY NOTEWORTHY IN THE PROPOSED GUIDELINES IS THE SPECIFICATION THAT REACH-THROUGH CLAIMS ARE NOT PATENTABLE IN BRAZIL—THE CURRENT GUIDELINES HAVE BEEN SILENT ON THE ISSUE.”

Another positive aspect of the proposed guidelines is to establish norms regarding genetic heritage in patent applications. Examples of some of the references are “organisms” (plants, animals, fungi, bacteria, archaea, etc); parts of organisms (sheets, nails, skin, mucus, blood, roots, extracts, organs, oils, poisons, fangs, etc); and molecules isolated from organisms (DNA, RNA, proteins, sugars, lipids, etc), and their corresponding synthetics.

The proposed guidelines better define the following as being patentable, provided that the requirements of novelty, inventive step and industrial application are satisfied: hybridomas, monoclonal antibodies and chimeric/humanised antibodies, transgenic microorganisms, nucleotide and amino acid sequences that do not exist in nature, microbiological processes, methods of obtaining transgenic plants and the use of stem cells in the preparation of compositions.

With regard to the industrial application requirement, it is important to be aware that for the biologic sequence listing, this requirement is met if a utility or use is identified for such listing. Therefore, if the patent application identifies, through homology, a new sequence listing and this homologous sequence is part of the prior art and has a known function, the new biologic sequence listing will fulfil the industrial application as long as its function or utility has already been mentioned in the description of its patent application.

Regarding an amino acid sequence listing, its claims should be defined with clarity and precision. The set of claims should refer to the proteins in question by the corresponding “Seq ID No”. The proposed guidelines also bring attention to the use of the terms “consists of or comprises”, which results in differences in the scope of protection.

The terms “consist of” and “consisting of” and their derivatives are regarded as closed terms of defining the invention. For example, if a claim is a “composition characterised in that it consists of components A, B and C”, the presence of additional components is excluded, whereas the terms “comprise”, “contain”, “encompass” and “include” as well as derivatives thereof are considered open terms of defining the invention, which in the example above (the composition “comprising components A, B and C”) is not limited to these elements.

Especially noteworthy in the proposed guidelines is the specification that reach-through claims are not patentable in Brazil—the current guidelines have been silent on the issue. According to the proposed guidelines, the subject matter of reach-through claims typically does not exhibit sufficient disclosure, clarity and accuracy, as required under Articles 24 and 25 of the BPL.

The proposed guidelines seem to reflect an interpretation of legislation which, unfortunately, does not come with the dynamism of biotechnological inventions. For example, the proposed guidelines continue to exclude patent protection for synthetic products, and even recombinant products, based on a starting material naturally occurring, even in its isolated form, which runs contrary to the criteria adopted by examiners around the world.

In summary, although the proposed guidelines in question do not entirely correspond with the wishes of the biotech community, they do not cause any regression and so bring a better attempt to delimit the scope of interpretation for patent applications for biotechnological products and processes. It is expected that the proposed guidelines will attract new biological innovation to Brazil.

Alexandre Santos is a molecular biologist and patent agent at Di Blasi Parente & Associados. He can be contacted at alexandre.santos@diblasi.com.br

Gabriel Di Blasi is a managing partner at Di Blasi Parente & Associados. He can be contacted at gabriel.diblasi@diblasi.com.br

biotech guidelines, brazil ip, inpi

http://www.lifesciencesipreview.com/article/new-horizons-biotech-guidelines-in-brazil



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