Hitting the Ground Running: The Brazilian Patent Office Publishes New Guidelines Relating to the Examination of Chemical Inventions

On January 2, 2018, things got off to a fast start in Brazil with the publication of new guidelines (Guidelines) by the Instituto Nacional da Propriedade Industrial (INPI; also known as the Brazilian Patent and Trademark Office (BRPTO)) relating to patent applications involving chemical inventions. The Guidelines complement several other guidelines issued over the last few years, such as block I (BRPTO Rule #124/2013) and block II (BRPTO Rule #169/2016).

The issued Guidelines add substantive text when compared to the draft published for public comment in March 2017.  Specifically, some highlights of the Guidelines include:

  1. Definition of a chemical compound:  A chemical compound should be defined by its chemical structure or chemical name.  Compounds defined only by their physical, physicochemical or biological properties or by its use or application (functional claiming), will not be accepted.  An example of a type of claim that will not be accepted is:  “A compound characterized by having property Y”.
  2. Examination requirements for N-oxides: According to item 2.4 of Guidelines, a simple description of a N-oxide/salt/ester/ether of a known compound will be considered to be obvious unless the compound is associated with a non-obvious property or an “unexpected technical effect” over the prior art.  INPI uses very specific language in this section of the Guidelines thus giving particularly strong emphasis and meaning to the phrase “unexpected technical effects”.  It is important for applicants to keep this phrase in mind when drafting their applications for filing in Brazil.
  3. Esters, ethers, pro-drugs, solvates, hydrates, clathrates, and co-crystals: These terms alone, in the absence of any specific content (namely, a definition), will be interpreted as generic expressions, and as such, run the risk of receiving an “indefiniteness” type rejection during examination.  Applicants should consider defining these terms in the specification to reduce the risk of receiving such a rejection.
  4. Selection patents:  Comparative data between selected compound(s) claimed in an application and those of close structural similarity known in prior art should be provided for the purpose of demonstrating how the selected compounds are non-obvious over the prior art.  Specifically, applicants should demonstrate how the selected compounds exhibit an unexpected technical effect over the prior art compounds.
  5. Written description of polymorph inventions:  Advanced techniques used to characterize crystalline solid substances that were not foreseen in the Guidelines will be considered, in addition to x-ray diffraction data, by examiners in light of their relevance in the identification of the claimed crystalline solid.  Additionally, a lack of data characterizing a crystalline solid will result in the specification being considered to not clearly and sufficiently describe the claimed subject matter.  Moreover, INPI will consider the submission of further data on the characterization of crystalline solids after the filing date to be added subject matter (or new matter) which will not be accepted (however, such a decision could form the basis of a challenge in the Brazilian court system).
  6. Combination claims:  As discussed in the draft of the guidelines, when assessing the obviousness of a combination claim, the combination should not have been disclosed in the prior art in connection with compounds belonging to the same chemical class.
  7. New medical use claims: The specification should provide evidence supporting a new medical use as of the filing date of the application.  Failure to do so may result in the application being considered to lack an essential technical feature thereby resulting in the invention being considered to be insufficiently disclosed.  According to the Guidelines, extrapolation of “in vitro” tests to support an in vivo effect will only be possible when complementary information  proving equivalence is provided (such as through the use of a scientific publication stating that an in vitro-in vivo correlation exists).  Additionally, studies carried out in animal models must be capable of being extrapolated to humans or the animals being treated.
  8. Submission of additional data during prosecution:  Item 9.1.3 of the Guidelines states that an applicant can submit additional data during examination exclusively to complement the information already contained in the specification as originally filed.  If no experimental data is provided in the specification at the time of filing, there is a risk that INPI may reject the submission of such new data.

This post was written by Lisa Mueller and Roberto Rodrigues Pinho.

After Years of Waiting, Your or Your Competitor’s Patent Application May Quickly Issue in Brazil. Are You Ready?

The Instituto Nacional da Propriedade Industrial (INPI), also known as the Brazilian Patent and Trademark Office (BRPTO), may soon automatically grant approximately 231,000 currently pending patent applications in an effort to reduce the backlog of unexamined patent applications that have plagued the office for years.  As many of our readers know, the backlog of unexamined applications has resulted in pendency periods on average of at least ten (10) years.  Although expedited examination is available for green technologies, oil and gas technologies (under the patent prosecution highway (PPH), limited pharmaceutical applications, and when an Applicant can demonstrate clear infringement, these measures have failed to put a significant dent in the existing backlog.

In July 2017, the Brazilian government stated that it was considering an emergency measure authorizing INPI to automatically grant approximately 231,000 pending patent applications by 2020.  More information on this measure can be found at the following links:  here, here and here.  Although the announcement of this “automatic” grant has been highly controversial, INPI has implied that it has few, if any other options for dealing with the current backlog. Interestingly, some examiners are threatening to go on strike against the measure.

The emergency measure involves a simplified examination procedure in which INPI would automatically grant any unexamined applications that do not have any outstanding annuity payments due and do not have pre-grant submissions filed by parties against the granting of the patent.  Pharmaceutical applications or divisional applications where the parent application has not yet been examined, are excluded from the measure.

Proposed rules for implementing the new measure were available for public comment until August 31, 2017.  Interestingly, during recent meetings, INPI has suggested that proposals made by local associations that add complexity to the process, such as the possibility of amending claims prior to grant or requesting substantive examination after grant, will likely be disregarded.

While the exact details and the timing of implementation of the measure are unknown, now is the time for Applicants with pending non-pharmaceutical or (certain) divisional applications to be developing a strategy to take advantage of the measure while minimizing any potential risks.  For example, Applicants with products having a short product life span should consider taking full advantage of this emergency measure.

The measure as currently drafted contains an “opt-out” clause in which an Applicant may, within 90 days, request that an application not be automatically granted but instead be subject to regular, substantive examination.  Applicants should strongly consider using the “opt-out” option for applications covering very important inventions and/or if the claims as originally filed do not provide the desired coverage (especially since INPI is likely to disregard any amendments made after the application was filed).  Moreover, Applicants should examine applications of competitors since the measure provides the opportunity for third parties to prevent the automatic granting of an application by the submission of pre-grant submissions with briefs and accompanying prior art.  These pre-grant submissions must be filed before the emergency measure comes into effect.  Moreover, there is no cost for filing the brief before INPI.  .

Please continue to watch the BRIC Wall Blog for updates on the emergency measure for eliminating the backlog of patent applications in INPI.

This post was written by Lisa Mueller and Roberto Rodrigues of Licks Attorneys

Two Important Decisions Addressing ANVISA’s Prior Approval of Pharmaceutical Patents in Brazil

In the second half of 2016, two very interesting decisions were issued by the federal courts in Brazil against the Brazilian Food and Drug Agency (ANVISA) involving the prior approval of patent applications claiming pharmaceutical products.  These decisions bring some very good news to pharmaceutical patent owners who have struggled for years with ANVISA while trying to protect their pharmaceutical patents in this country. 

In the decisions, Genentech and Novartis each obtained preliminary injunctions against ANVISA in cases of prior approval of their patent applications under Article 229-C of the Brazilian Patent Statute (Additional information about each of the decisions can be found here:  novartisdecision genentechdecision).  Specifically, Novartis’ patent application claims fingolimod (Gilenya) and Genentech’s application claims bevacizumab (Avastin). 

Two different trial judges affirmed that ANVISA did not have the authority to examine patentability requirements under Article 229-C of the Patent Statute.  In the decision involving Genentech’s application, the judge, the Honorable Diana Silva, limited ANVISA’s role during the prior approval process to only aspects involving public health. The decision also stated that the Brazilian Patent and Trademark Office, namely, the Instituto Nacional da Propriedade Industrial (INPI) is the sole legitimate agency to examine the patentability requirements of patent applications directed to pharmaceutical products. 

The decision involving Novartis’ application is an important case for pharmaceutical companies facing the issues of backlog and pendency of their patent applications in Brazil.  Specifically, in this case, Novartis sought a preliminary injunction against ANVISA, claiming that the agency was taking an unreasonable amount of time to issue a decision regarding prior approval.  Additionally, Novartis also requested preventive measures against the agency to prevent it from examining the application for compliance with patentability requirements under the Brazilian Patent Statute (which is the function of INPI).   The judge, the Honorable Iolete Oliveira, accepted  Novartis’ arguments and granted a preliminary injunction ordering ANVISA to:  (1) analyze the prior approval of the patent application within 15 days; and (2) abstain from examining the application for compliance with any patentability requirements but focus instead only on aspects of public health. 

Both of these decisions highlight that the Brazilian federal courts are willing to limit ANVISA’s role under the prior approval analysis.  The Novartis case establishes important precedent that can be used by other companies currently waiting ANVISA’s decision on prior approval analysis. 

Please continue to watch the BRIC Wall Blog for continuing updates on Brazil’s prior approval of pharmaceutical patent applications.

This post was written by Lisa Mueller and Roberto Rodrigues Pinho, LLM candidate at Stanford University.

A New Beginning? The Brazilian Patent and Trademark Office has a New President.

Mr. Luiz Otávio Pimentel has been appointed as the new president of INPI (the Brazilian Patent and Trademark Office – BRPTO). The official notice for the nomination was published yesterday, July 28, 2015, in the Federal Register. On April 10, 2015, President Dilma published an official notice dismissing the former president, Otávio Brandelli, who had been in charge of the office for less than one and a half years. Since then, vice-president, Ademir Tardelli, acted as interim head of the BRPTO. There is strong speculation on the reasons for Mr. Brandellis’ departure. Mr. Brandelli had a strong background in Intellectual Property and, while in office, took a series of measures to expedite prosecution and to reduce the BRPTO’s backlog.

What do we know about Mr. Pimentel? He is a professor with expertise on International Law and Intellectual Property. He holds a Masters in Law from the Federal University of Santa Catarina (UFSC) and a Ph.D. in Legal Sciences from the National University of Asunción – Paraguay. He is also an arbitrator at the Ad Hoc Arbitration Court of Mercosur.

Mr. Pimentel faces numerous challenges in his new position as the BRPTO requires strong leadership by an intellectual property expert with the ability to take drastic measures to restore a high-quality management at the office. In addition to having the fortitude needed to fight the battle against the huge backlog, Mr. Pimentel will need to lead the BRPTO with transparency, allowing applicants to have advance knowledge of which guidelines and rules the examiners will adopt during prosecution.

Other important goals that need to be achieved are the acceleration of the examination process and signature of the main international agreements to simplify prosecution, such as the Patent Prosecution Highway.

The next few months will be crucial for the BRPTO’s future and for the development of Intellectual Property in Brazil.

This post was written by Lisa Mueller and Licks Attorneys law firm.