The Brazilian Patent & Trademark Office (PTO) has recently opened a new Public Consultation, this time on the draft guidelines for the examination of patent applications in the biotechnology field. The Public Consultation was published in the Federal Official Gazette on December 5, 2012 and any interested party may make their submissions within a 60-day-term counted as from that publication date.
The new draft provides more definitions and illustrations on biotech subject matter not expressly mentioned in Law # 9,279/96 (ESTs, primers, SNPs, cDNAs, ORFs, fusion proteins, etc.), indicating whether they would patentable or not in view of the main statutory prohibitions found in articles 10, (IX) and 18, (I) and (III) of that Law.
Hybridomas, monoclonal and chimeric/humanized antibodies, transgenic microorganisms, nucleotide and amino acid sequences that are not naturally occurring, microbiological processes, methods of obtaining transgenic plants, the use of stem cells in the manufacture of medicaments and the use of natural products in a variety of applications are among the patentable subject matter, as long as they meet the requirements of novelty, inventive activity and industrial application.
Nonetheless, our evaluation is that little progress has been made to the existing restrictive scenario and to overcome the difficult administrative hurdles patent applicants often have to navigate. Indeed, for those following administrative decisions on appeals and office actions closely, much of what is stated in the guidelines has been adopted by examiners over the last decade. In that way, the draft guidelines appear to be a mere institutionalization of what has already been in practice.
Unfortunately, with the proposed text, the Patent Office has failed in many ways to provide incentives for a fertile environment for biotech inventions in Brazil. In fact, most of the claims that are rejected by the Brazilian PTO are the basis for a large amount of innovative biotech products.
In this connection, the Patent Office has maintained the position that any product of nature, even in an isolated form, is not patentable. Claims to...