New draft guidelines for patent examination
Part of this process involved holding public hearings with stakeholders and inviting comments on the draft guidelines disclosed.
The INPI’s plan is to have a set of guidelines divided in five parts: (i) software patents; (ii) utility models; (iii) formal aspects for filing applications (patentability block one, covering title, written specifications, claim language, drawings and summary); (iv) biotechnology patents; and (v) patentable subject matter and patentability requirements on substantive examination (patentability block two).
INPI resolutions 298/2012 on utility models, 124/2013 on formal aspects for filing applications (patentability block one), and 144/2015 on biotech patents were already enacted. Public hearings were also held on the draft software patent examination guidelines, but its official enactment has been due for a long time.
On March 16, 2015, the INPI published in the Official Gazette the draft guidelines for patentable subject matter and patentability requirements for substantive examination (patentability block two), opening a 60-day window for public comments and suggestions.
Block two focuses on patentable subject matter, patentability requirements and their examination by the INPI per se, with specific chapters on (i) novelty; (ii) inventive activity (non-obviousness); (iii) industrial application (utility); as well as chapters for (iv) definition of prior art and the person skilled in the art (POSA); (v) non-patentable subject matter; (vi) Markush formulas; and (vii) compositions of matters.
The previous guidelines, from December 2002, were outdated and were not able to establish clear rules for the assessment and analysis of the patentability requirements. For example, the 2002 guidelines cover the non-obviousness requirement on one page only, with a six-line paragraph for definition, secondary considerations and examples, which were interpreted as evidence of an obvious invention. The same happened with utility models, for which there is now a specific guideline too.
"The predictability that is now expected from the INPI’s examinations is higher and patentees should feel more confident about the outcome of their applications if they follow the guidelines."
The non-obviousness requirement now takes up 16 pages of the new draft, covering (i) the definition of the POSA; (ii) the rules for combination of two or more prior art documents; (iii) secondary considerations; and (iv) the steps to assess inventive activity (determining the state of the art, determining the distinctive characteristics of the invention and/or the technical problem solved by the invention and determining if the invention is obvious or not for a POSA).
Markush formulas and compositions of matter were not even mentioned in the previous guidelines. Now, they have their own chapters, with definitions and specific rules on how to assess novelty, inventive activity and enablement.
The INPI has been examining and granting patents for biotech inventions, inventions claiming Markush formulas and compositions of matter for years, but only now has a draft guideline been disclosed. The INPI’s examiners have been examining patentability based on internal regulations not disclosed to the public to this date. In this regard, the draft guidelines represent a positive step towards democracy, the rule of law and government transparency.
In fact, these are not ‘new’ draft guidelines, but in fact just the publication of the internal regulations the examiners have been using for quite some time. It is true that society will have a chance to comment on and suggest changes to the draft guidelines, but in reality these rules on examination of patentability have been in use for many years.
The advantage now is the opportunity for patent owners and applicants to achieve legal certainty. Having established guidelines with clear rules on what has been considered a grey area until now, assists in avoiding arbitrary and illegal use of government power to deny patents for political reasons.
The predictability that is now expected from the INPI’s examinations is higher and patentees should feel more confident about the outcome of their applications if they follow the guidelines. The probability of success in legal action will also increase since judges will be able to match exactly what happened in an actual case with the expected behaviour of the INPI’s examiner, and will depend less on the analysis of a court-appointed expert.
It is not the best-case scenario yet, but it certainly is a step in the right direction, with clear advantages to patent owners and applicants.
Felipe Mesquita is an attorney at Licks Attorneys. He can be contacted at: felipe.mesquita@lickslegal.com
Luiza Cotia is a pharmacist at Licks Attorneys. She can be contacted at: luiza.cotia@lickslegal.com
