Last night, several generic companies in Brazil filed lawsuits against patents held by pharmaceutical companies. Specifically, 46 identical lawsuits were filed 46 targeting 79 patents. The cases challenge the patent term awarded by the Brazilian Patent and Trademark Office (BRPTO) based on Article 40, sole paragraph, of the Intellectual Property Statute. As readers are aware, Article 40 was held unconstitutional by Brazil’s Supreme Court last week; however, as mentioned in our post of May 7, 2021, a decision on whether the ruling should apply retroactively to reach patents already granted by the BRPTO prior to the preliminary injunction granted by Justice Toffoli (see our post of April 8, 2021) was postponed until today, May 12, 2021.
The 11 Supreme Court Justices are scheduled to discuss and decide later this afternoon whether to apply Justice Toffoli’s proposal to retroactively apply the decision of unconstitutionality to reduce the terms of patents: (i) directed to pharmaceuticals (including products and medical devices); and/or (ii) that have been challenged based on the unconstitutionality of Article 40, sole paragraph, prior to the publication of the Supreme Court’s final decision (which would also include non-pharma patents).
Some of the impacted companies: Amgen (2 lawsuits); GlaxoSmithKline (2 lawsuits); Novartis (4 lawsuits); Eli Lilly and Boehringer Ingelheim (3 lawsuits each); Regeneron Pharmaceuticals (2 lawsuits); Astrazeneca (2 lawsuits); Cipla; Daiichi Sankyo; Incyte; Les Laboires Servier; Novo Nordisk (2 lawsuits); Onyx Therapeutics; Pfizer (3 lawsuits); Pharmacyclics; Takeda and Shire
Each lawsuit challenges patents from the portfolio of specific products, such as: Repatha® (evolocumab), Nucala® (mepolizumab), Entyvio® (vedolizumab), Xvega® (denosumab), Brilinta® (ticagrelor), Xarelto® (rivaroxaban), Vyvanse® (lisdexamfetamine), Xalkori® (crizotinib), Latuda® (lurasidone), Ibrance® (palbociclib)
Please continue to watch BRICS & Beyond for continued updates on the Supreme Court decision and the Brazilian landscape post-constitutional challenge.
This post was written by Lisa Mueller and by Rob Rodrigues and Brenno Telles from Licks Attorneys
This is an update to our posts on April 8, 2021, March 15, 2021 and March 10, 2021. As readers are aware, the Brazilian Supreme Court was scheduled to decide the constitutional challenge involving Article 40 of the Brazilian Intellectual Property (IP) Statute (ADI 5529), on April 7, 2021; however, the hearing was delayed due to a discussion in another case.
Yesterday, the Brazilian Supreme Court issued its decision, with a majority holding the 10-year patent term unconstitutional (Article 40, sole paragraph). Nine Justices issued opinions stating that 10-year patent term, even in view of the backlog of patent applications waiting to be examined at the Brazilian Patent and Trademark Office (BRPTO), violates the country’s Constitution. The Justices also decided that the general provision of 20 years from the date of filing provides a suitable and sufficient term of protection for patent owners.
The decision was based on 5 reasons that can be summarized as it follows. Specifically, according to the Court, the challenged provision:
Constitutes a “term extension” that affords disproportionate protection to patent owners;
Undermines the temporary nature of a patent as provided by the Brazilian Constitution;
Provides automatic compensation to an applicant without assessing the applicant’s responsibility in contributing to the delay in examination;
Finds no parallel in any other IP regimes abroad (namely, the fact that patents automatically receive a patent term of 10-years from the date of grant); and
Raises drug prices in the Brazilian market by creating monopolies thereby impacting society’s access to drugs and public health social policies.
Justice Barroso, followed by Chief Justice Fux, issued dissenting opinions, arguing that pending patent applications do not provide any type of protection for patent owners, therefore, there is no protection prior to grant. Only granted patents provide protection. In their view, if patent owners are not provided a 10-year patent term, they might not have sufficient term to protect their inventions. Additionally, Justice Barroso stated that if the BRPTO is examining applications at a faster rate as a result of the backlog combat plan, the 10-year patent term will soon be unnecessary and would not need to be declared unconstitutional or revoked. Therefore, in his opinion, Congress should focus on improving the BRPTO.
Chief Justice Fux also stated that it was necessary to observe the consequences of the decision and its impact in the economy.
Is the Decision Retroactive?
The Supreme Court will decide next week whether the decision applies retroactively.Justice Toffoli is proposing not to apply the decision retroactively to all patents issued before the publication of the final decision with two notable exceptions. Specifically, under Justice Toffoli’s proposal, the decision would be retroactive for: (i) patents directed to pharmaceuticals (including both products and medical devices); and (ii) in specific cases where the constitutionality of Article 40 was argued in lawsuits already in progress (which would include non-pharma patents). However, several of the Justices expressed concern that the decision should not be retroactive or should be tailored only to pandemic related products (versus all pharmaceutical products).
After some debate, the Justices decided to postpone a final decision on the retroactive effect of its decision until Wednesday, May 12th session.
Please continue to watch BRICS & Beyond for continued updates on the Supreme Court decision.
This post was written by Lisa Mueller and by Rob Rodrigues and Luisa Saraiva from Licks Attorneys
This is an update to our posts on March 15, 2021 and March 10, 2021. As readers are aware, the Brazilian Supreme Court was scheduled to decide the constitutional challenge involving Article 40 of the Brazilian Intellectual Property (IP) Statute (ADI 5529) yesterday, on April 7, 2021. Unfortunately, the patent term hearing did not take place because the agenda of the Supreme Court was delayed due to discussion in another case. A new hearing is scheduled for April 14, 2021.
After the Supreme Court announced the new hearing date, Justice Toffoli partially granted the preliminary injunction (PI) requested by the Federal Prosecutor’s Office (FPO) to suspend the effect of the 10-year patent term for pharmaceuticals effective immediately until the Supreme Court’s final ruling. Justice Toffoli’s decision does not mention TRIPS Article 27.1 (non-discrimination) or its impact on the case – which is a relevant omission, as the PI is restricted to one sector (pharmaceuticals). Justice Toffoli’s decision is heavily anti-patent and confusing regarding its impact. While the PI is not retroactive by law, the opinion does provide for the possibility of retroactive effect for pharmaceutical patents if there is a pending invalidity challenge based on constitutional grounds related to ADI 5529.
BRICS & Beyond is preparing a detailed analysis on Justice Toffoli’s decision and will post more information on this decision soon.
This post was written by Lisa Mueller and by Rob Rodrigues and Ana Luiza from Licks Attorneys
This is an update to our post on March 10, 2021. On Thursday, March 11th, Reporting Justice Dias Toffoli requested that the Brazilian Patent and Trademark Office (BRPTO) respond to 13 questions considered relevant by the Brazilian Supreme Court in deciding the constitutional challenge involving Article 40 of the Brazilian Intellectual Property (IP) Statute (ADI 5529). The 13 questions address the backlog and patent application pendency before the BRPTO. In our opinion, the fact that Justice Toffoli has asked for input from the BRPTO indicates that the Brazilian Supreme Court is struggling with how to decide this case.
The Brazilian Supreme Court is scheduled to hear ADI 5529 on April 7, 2021. Given that the hearing is less than a month away, Justice Toffoli’s request is quite unusual. Typically, requests such as this by the Supreme Court are made when a case is not yet ripe for a hearing.
The BRPTO has five working days (e.g., until March 18, 2021) to respond to Justice Toffoli’s questions. The question posed by Justice Toffoli are:
What is the current backlog of pending patent applications awaiting a grant or rejection decision based on Article 37 of the Brazilian IP Statute? The BRPTO should provide the total number and number by technical section (technological area).
How many of the backlog patent applications awaiting decision (Article 37 of the Brazilian IP Statute) have been pending for more than ten years? The BRPTO should provide the total number and number by technical section (technological area).
How many of the backlog patent applications awaiting decision (Article 37 of the Brazilian IP Statute) in the health sector (e.g., drugs, hospital equipment, etc.) have a potential indication related to COVID-19?
What was the average time elapsed between the filing of a patent application and the BRPTO’s decision to grant or reject an application (Article 37 of the Brazilian IP Statute) in the last ten, five and one year(s)? The BRPTO should publish the total number and number by technical section (technological area).
Which technical sections (technological area) have applications with the longest average time between the application’s filing date and the BRPTO’s decision to grant or reject (Article 37 of Brazilian IP Statute) the application?
By July 2021, is it expected that the BRPTO will be able to reduce the number of pending patent applications awaiting decision by 80% as estimated in the Plan to Combat Patent Backlog? So far, how much has this stock of patent applications have been reduced?
Among the patents currently in force, how many (in total and by percentage) have been in force for more than 20 years from their filing date, in the case of utility patents, and 15 years, in the case of utility model patents (Article 40 of the Brazilian IP Statute)? The BRPTO should publish the total number and number by technical section (technological area).
Among the patents currently in force for more than 20 years, in the case of utility patents, and 15 years, in the case of utility model patents, how many (in total and by percentage) are held by public entities (including universities)? The BRPTO should publish the total number and number by technical section (technological area).
Among the patents currently in force for more than 20 years, in the case of utility patents, and 15 years, in the case of utility model patents, how many have a potential indication related to COVID-19?
How many examiners conduct patent examination? What is the average number of applications awaiting analysis per examiner? Based on the statistics produced by the World Intellectual Property Organization (WIPO), are there any international comparative performance indicators/parameters in this regard?
Do the number of examiners correspond to the total number of vacancies for positions in the BRPTO? If there are open vacancies, how many are there? What are the reasons for those vacancies, and how long have they been open? When was the last public tender to fill vacancies at the BRPTO?
Considering the Federal Court of Accounts decision in the Audit Process TC #015.369 / 2019-6 recognized that at that time the BRPTO lacked a technological solution in its operations that allowed it to manage the entire flow of patent applications, has the BRPTO, since this decision, adopted any measures aimed to implement a technological solution? Are there any ongoing administrative actions to develop a tool in this regard?
Considering the Federal Court of Accounts decision in the Audit Process TC #015.369 / 2019-6, has the BRPTO provided, or is it providing, any standardization of patent examination procedures?
This post was written by Lisa Mueller and Rob Rodrigues from Licks Attorneys
The constitutional challenge before the Brazilian Supreme Court (ADI 5529) that seeks to invalidate any remaining patent term of approximately 40% of Brazil’s patents and pending applications is scheduled to be decided on April 7, 2021 instead of May 2021.
The lawsuit challenging Article 40 of the Brazilian IP Statute was filed by the Federal Prosecutor’s Office (FPO) in 2016. Article 40 establishes a minimum term for patents of 10 years from the date of grant. Due to the backlog in examination of patent applications at the Brazilian Patent and Trademark Office, Article 40 is critical for many patent owners investing in Brazil affected by the backlog.
The Supreme Court is deciding this case earlier due to a request filed on February 24, 2021 by the FPO seeking a preliminary injunction (PI) to immediately suspend the effect of 10-year patent term. The basis for the request was the impact of the 10-year patent term on pharmaceutical products and the supply of generic drugs to address the Covid-19 pandemic.
The FPO’s PI request was followed by several amici curiae filings. On March 4, 2021, without deciding the PI request, Reporting Justice Toffoli requested that Supreme Court Chief Justice Luiz Fux move the oral hearing to a date earlier than May 2021.
As alluded to above, ADI 5529 has the potential to impact about 40% of all patents currently in force in Brazil. Approximately 25,119 utility patents and 1,907 utility model patents could have their term reduced, of which about 2,279 and 456, respectively, would immediately expire. Almost 14,000 pending patent applications are at risk of having with no patent term left when granted (10,049 utility patent applications and 3,631 utility model patent applications).
If the ADI 5529 is successful, the strategic industrial sector of the Brazilian economy will be severely affected. For example, about 88.32% of telecommunications utility patents could have their patent term reduced or invalidated. A similar outcome might result for about 67.66% of biotech patents, about 66.67% of pharmaceutical patents, about 59.94% of electronic patents, etc.
Brazilian patentees will also these effects if ADI 5529 is successful. Specifically, about 36.52% of Brazilian owned utility and utility model patent currently in force may immediately become expired. Among the top 15 Brazilian patentees are important research institutions, universities, and public companies such as FAPESP, UNICAMP, EMBRAPA, UFRJ, USP and PETROBRAS. The impact on these institutions could undermine Brazil’s capability to foster innovation.
Licks Attorneys has prepared a special publication with information about the potential impact that ADI 5529 might have, if successful, on the Brazilian patent system, patent owners, investments, manufacturing, and value-added chains that rely on patents in Brazil. This material is available at Licks’ website.
Please continue to watch BRICS & Beyond for updates on ADI 5529.
This post was written by Lisa Mueller and by Rob Rodrigues, Otto Licks, Ana Calil, and Alysson Farias from Licks Attorneys
On December 1st, 2020, the Instituto Nacional da Propriedade Industrial (INPI; also known as the Brazilian Patent and Trademark Office (BRPTO)) published Normative Instruction #118 (November 12, 2020), revoking the previous guidelines (Rule #144/2015) and establishing new guidelines for the examination of biotechnology inventions.
Summary of Main Changes Between New Guidelines and Previous Guidelines
A summary of the main changes between the new guidelines and the previous ones are provided below:
Regarding enablement, the following will not constitute undue experimentation: (i) standard procedures for carrying out the claimed invention (e.g., obvious or routine experiments, such as standardized optimal conditions for conducting a polymerase chain reaction (PCR)), unless the standard procedures are specifically related to the technical problem that is solved by the claimed invention; and (ii) the determination of degenerate nucleotide sequences of preferred codons in species that were well studied at the time of the invention (e.g., filing date of the application).
Regarding non-statutory matter, medical or surgical techniques and methods of treatment or diagnosis involving human and animal embryos are now explicitly excluded from patentability (article 10 (VIII) of the Brazilian Patent Statute). However, inventions related to products and methods of obtaining and using human embryonic stem cells constitute statutory matter.
With respect to biological sequences (e.g., amino acid and/or polynucleotide sequences), any sequences not disclosed in the application at the time of filing cannot later be added to the application, even if such sequences can be inferred from the disclosure as filed. In fact, any amendments to the application to include such information will be rejected by the BRPTO as constituting new matter. However, if a biological sequence is known in the art and a specific reference (e.g., citation to a publication, database and/or patent) to the sequence is included in the specification, its later inclusion in the application will be allowed.
Claims directed to DNA or RNA must be defined by its sequences of nucleotides (SEQ ID NO), while a protein must be defined by its sequence of amino acids (SEQ ID NO) in order to clearly define the subject matter of protection, provided that such sequences are disclosed in the application as originally filed. According to the new guidelines, it is possible to redraft DNA, RNA and protein claims that were not defined as outlined above, provided that their corresponding SEQ ID NO is disclosed in the application as originally filed. For example, a claim to a DNA encoding a polypeptide having a certain sequence of amino acids (SEQ ID NO) can be redrafted to recite a DNA having a certain nucleotide sequence. Moreover, degenerated sequences of a DNA or RNA defined by a nucleotide sequence through their SEQ ID NO are acceptable provided they generate the same protein and the protein is precisely defined in the specification.
Clarification of the Criteria for Written Description and Unity of Invention for Claims Involving Markush Language
Additionally, the new guidelines clarify the criteria to be used for assessing written description support and unity of invention for claims reciting Markush language for polynucleotides and peptides, as summarized below:
Regarding written description support of alternatives in a claim containing Markush language for amino acid sequences, it is necessary to evaluate: (i) the physical and chemical characteristics of the amino acids claimed at each position in view of what was disclosed in the specification; and (ii) the region in which modifications occur, since in the critical areas involving the function of a polypeptide even conservative modifications can generate different results;
For written description support of claims containing Markush language for nucleotide sequences, it is necessary to evaluate whether the sequence encodes a protein. In the case of coding sequences, alternatives that generate the same protein are acceptable. If the claimed sequence is not a coding sequence, then the evaluation of alternatives must consider the information presented in the specification, i.e., only the sequences disclosed in the specification will be accepted; and
Claims containing Markush language should meet the unity of invention criteria specific to Markush groups as set forth in BRTPO´s Rule #124/2013 which establishes that: (i) all alternatives should have a common property or activity; and (ii) a common structure should be presented, i.e., a significant structural element should be shared by the alternatives.
Clarification of Several Issues Relating to Antibodies
The new guidelines also provide clarification on several issues relating to antibodies, such as:
A better definition of what is considered patentable in connection with antibodies and fragments thereof. For example, if an antibody is obtained from an organism that is naturally exposed to an antigen, the antibody will be considered to be naturally occurring and will not be patentable pursuant to article 10 (IX) of the Brazilian Patent Statute. However, if the antibody can only be obtained through human intervention, such as, for example, by an immunization protocol (e.g., immunization of a mouse), then the antibody will not be deemed to be naturally occurring and will be patentable;
Methods for obtaining polyclonal antibodies will be considered to be patentable, provided that all of the steps of the methods are sufficiently described in the specification and that the methods are neither of natural occurrence nor invasive. Therefore, methods of immunization/vaccination that comprises an invasive step are not eligible for patent protection;
Monoclonal antibodies can be claimed by their complementary determining regions (CDRs); however, the claims must recite the three CDR sequences of the light and heavy chains by their SEQ ID NO; and
Claims directed to chimeric, humanized and human antibodies and methods for obtaining the same must be defined by (i) their CDRs sequences; or (ii) biological sequences to specific regions (e.g., variable region) in order to ensure clarity, precision and support of the claimed subject matter. The new guidelines provide specific examples on how such antibodies can be claimed. Specifically, example 37 provides the following recommendation of how such claims can be worded: (a) A humanized antibody against α-actin characterized by comprising the variable murine region consisting of SEQ ID NO:X and constant regions in the human γ chain; and/or (b) A humanized antibody against α-actin characterized by comprising the complementarity determining murine regions (CDR1; CDR2; CDR3) that consist of SEQ ID NO: X, SEQ ID NO:Y, SEQ ID NO:Z in the light chain and SEQ ID NO:A, SEQ ID NO:B and SEQ ID NO:C in the heavy chain and constant regions in the human γ chain.
Patentability of Genetic Use Restriction Technology
Moreover, according to the new guidelines, the processes for the generation/multiplication of genetically modified plants that involve genetic use restriction technology (GURTs) are excluded from patentability, in particular, those directed to the production of sterile reproductive structures (e.g., those which encompass processes that involve the activation or inactivation of plant fertility genes with external chemical inductors), in compliance with the provisions of article 6th (VII) of the Biosafety Law (Law #11, 105/2005). However, methods for restoring the fertility of plants that do not involve the use of external chemical inductors are considered to be patentable.
Requirements for Patent Applications Resulting from Access to Brazilian National Genetic Heritage
Finally, under the new guidelines, if any subject matter claimed in a patent application is the result of access to any Brazilian national genetic heritage, it is mandatory that registration before the Genetic Heritage Management Council (CGEN) via the System for Genetic Heritage and Associated Traditional Knowledge Management occur prior to the filing of a patent application.
Please continue to watch BRICS & Beyond for updates on changes to patent examination guidelines in Brazil.
This post was written by Lisa Mueller and Roberto Rodrigues, Rafaella Oliveira, Luiza Cotia and Danielle Altomari from Licks Attorneys.
Brazil has become the first among the Latin American countries to approve the marketing of gene therapy products. Specifically, the Brazilian Health Regulatory Agency (ANVISA) recently granted marketing authorization for Novartis’ gene therapy products Luxturna® and Zolgensma®. As published in the Brazilian Federal Register, Luxturna® received its marketing authorization on August 6th and a few days later, on August 17th, Zolgensma® received its marketing authorization. Prior to ANVISA’s final decision, both products had been approved by the Brazilian Technical Commission of Biosafety (CTNBio), which is responsible for evaluating biosafety of Genetically Modified Organisms (GMOs) in Brazil.
Luxturna® (voretigene neparvovec) is indicated for the treatment of adult and pediatric (children over 12 months) patients with vision loss caused by bi-allelic retinal pigment epithelium (RPE) mutation-associated hereditary retinal dystrophies. In Brazil, no other therapeutic option available for the treatment of this rare disease until approval of Novartis’ gene therapy.
It took 232 business days from the submission of the marketing authorization application for ANVISA to provide its decision. As part of the administrative approval procedure, ANVISA and Novartis signed a Term of Commitment to ensure that the company will conduct additional trials with Brazilian patients to continue to monitor the safety and effectiveness of Luxturna® on a long-term basis.
Zolgensma® (onasemnogene abeparvovec) is indicated for the treatment of pediatric patients less than 2 years of age with type 1 spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron (SMN1) gene and with bi-allelic mutations in the SMN1 gene and up to 3 copies of the SMN2 gene.
After 149 business days of analysis, ANVISA concluded that the product’s benefits surpassed its risks and granted the marketing authorization. However, because it is a new gene therapy, the authorization was granted on a exceptional basis, meaning that Novartis is required to send data on Zolgensma’s® ongoing trials as agreed to in the signed Term of Commitment.
Novartis also commited to conduct additional studies with Brazilian patients to enable the evaluation of whether Zolgensma® maintains a positive benefit-risk balance. Additionally, Novartis also agreed to train (i) healthcare professionals who will perform infusions of the drug; and (ii) Brazilian hospitals in the appropriate storage and handling of Zolgensma®.
Regulatory framework and next steps
The Brazilian regulatory framework on advanced therapeutic products is very new. At the end of 2018, ANVISA’s Collegiate Board of Directors approved Rule #260/2018, which defines the technical standards for conducting clinical trials with experimental advanced therapy products. On February 26, 2020, ANVISA’s Rule #338/2020 was published which provides the requirements for obtaining a marketing authorization for advanced therapy products. The regulation classifies advanced therapy products into three different categories: (i) advanced cell therapy; (ii) gene therapy; and (iii) tissue engineering. Both Luxturna® and Zolgensma® fall into the second category, gene therapy.
The next step for Novartis to introduce Luxturna® and Zolgensma® into the Brazilian market involves receiving price approval from the Brazilian Drugs Market Regulation Chamber (CMED). This approval is expected by the end of 2020. There is much anticipation regarding the pricing of these drugs, particularly since Zolgensma® is currently considered to be the world’s most expensive drug (at USD $2.125 million).
The approval of the first gene therapy products in Brazil also brings up the issue of whether these drugs will become available in the Public Healthcare System (SUS). The analysis of whether a drug is incorporated into the SUS is conducted by the National Commission for Incorporation of Health Technologies (CONITEC), which issues a recommendation to the Ministry of Health. While Luxturna® and Zolgensma® are currently not in the SUS, the Brazilian population can obtain free access to these products through a court order.
Although there are still some a few steps to be taken until Luxturna® and Zolgensma® truly get into the hands of patients in Brazil, the approval itself and the consolidation of a regulatory framework on advanced therapeutic products is expected to promote the development of this pharmaceutical in Brazil.
This post was written by Lisa Mueller, Roberto Rodrigues, Ana Calil and Natalia Toledo of Licks Attorneys.
On August 10, 2020, a draft of the National Strategy of Intellectual Property (ENPI) was published in the Brazilian Official Gazette Public Consultation #46/2020. A copy of the ENPI can be found here: Eng_Annex-ii_enpi -public consultation. Publication of the draft of the ENPI set a 20-day period (which has now been extended) for the public to make comments and suggestions on the draft. The draft was produced by a working group that includes various public administration entities that are coordinated by the Intellectual Property Interministerial Group (GIPI), which is presided by the Ministry of Economy.
The objective of the ENPI is to set forth the grounds for a balanced and effective National System of Intellectual Property (SNPI), which will be broadly used to foster creativity, investments in innovation and access to knowledge with the aim of promoting competition and the social and economic development of Brazil. The ENPI is divided into seven structural axes : (i) Intellectual Property (IP) for Competitiveness and Development; (ii) Dissemination, Education, and Training in IP; (iii) Governance and Institutional Strengthening; (iv) Modernization of Legal and Infralegal Marks; (v) Legal Observance and Security; (vi) Intelligence and the Vision of the Future; and (vii) Inclusion of Brazil in the Global IP system.
As alluded to above, public comments and suggestions on the draft can be submitted until September 13, 2020 (extended deadline) and is completely voluntary. Specifically, any comments or suggestions should be submitted electronically and should use ENPI’s General Glossary of Terms.Specifically, comments and suggestions should be structured based on each of ENPI’s seven structural axes.
The draft proposes several actions to be implemented and follows the general guideline that intellectual IP is a general tool that is to be used to foster innovation and attract investments. Additionally, the draft proposes to establish new IP regulatory landmarks to prepare Brazil for a 4.0 Economy that will allow for digital transformation of Brazilian companies.
We would like to highlight several significant actions proposed by the draft:
In the section relating to “Governance and Institutional Strengthening” (Structural Axis 3), the draft proposes the development of an IP policy within the Ministry of Health. Development of such a policy would help to establish a connection and a continuation of strategic actions or actions that would be implemented (short-term, middle-term or long-term strategies) by stakeholders and public administration entities.
In the “Modernization of Legal and Infralegal Marks” (Structural Axis 4) section, several proposals are made which may impact the pharmaceutical area. For example, one proposal supports measures to adjust the patents granted on drugs that are considered strategic to the Brazilian Health System (SUS). Specifically, the proposal in the draft aims at (i) enabling changes to the minimum medication price, established by Law #10,742/2003, based on the remaining term of a patent; (ii) reviewing Resolution #02/2004 of the Drug Market Regulation Chamber – CMED – (Brazilian FDA Department) to include patent evaluation before allowing the commercialization of a first generic medicine; and (iii) reviewing Ordinance #2/GM/MS/2017, Chapter III, Annex XXVII, that institutes the National Policy of Medicine.
Also proposed is the creation of a technical group at GIPI to evaluate and (eventually) propose adjustments in several intellectual property legal “landmarks” that affect public health and innovation policy in the health sector. These adjustments will be directed at: (i) the sole paragraph of article 40 of Law #9.279/96, which states that a patent will have at least a ten year term from the date of grant; (ii) article 229C of #9.279/96 establishing ANVISA’s (the Brazilian FDA) prior consent for the granting of patents on pharmaceutical products and processes ; (iii) data protection for tests submitted to ANVISA for obtaining marketing authorization for drugs; and (iv) evaluating the repurposing/repositioning of medical uses (second medical use patents.)
“Brazil’s inclusion in the Global System of IP” (Structural Axis 7) is intended to empower its participation in IP international forums, stimulate the presence of Brazilian companies abroad and promote a local business environment beneficial for foreign investments. This section also seeks to set the groundwork for promoting Brazil’s inclusion in the Global Patent Prosecution Highway´s (GPPH) pilot program. Accordingly, this section intends to assess and stimulate Brazil’s participation in international agreements, such as: The Geneva Act of the Hague Agreement Concerning the International Registration of Industrial Designs; 1991 Act of the International Convention for the Protection of New Varieties of Plants); Patent Law Treaty – PLT; Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure; Singapore Treaty on the Law of Trademarks; WIPO Copyright Treaty – WCT; WIPO Performances and Phonograms Treaty – WPPT; Beijing Treaty on Audiovisual Performances; and Lisbon Agreement on Appellations of Origin and Geographical Indications.
After receiving comments and suggestions by September 13, 2020, the National Strategy of Intellectual Property will be finalized and implemented. The implementation should last about 10 years. Specifically, its execution will be divided into separate Action Plans having their own 2-year schedule which will be aligned with the government’s future actions for the IP sector. GIPI will be responsible for ENPI’s governance and implementation.
Please continue to watch BRICS & Beyond for updates on the National Strategy of Intellectual Property in Brazil.
This post was written by Lisa Mueller and Roberto Rodrigues Pinho and Ana Calil of Licks Attorneys.
On July 8, 2020, the Brazilian Chamber of the State Representatives unanimously voted on the Bill of Legislative Decree # 324/20 to approve the Nagoya Protocol. As a result, the text was sent for consideration to the Senate and, once approved, the President should enact a federal Decree allowing the treaty to take effect in the country.
The Nagoya Protocol (Protocol) is a multilateral agreement ancillary to the Convention on Biological Diversity (CBD) and aims to implement the CBD’s objective relating to the sharing of benefits arising from the utilization of genetic resources and/or associated traditional knowledge in a fair and equitable way. The Protocol entered in force on October 12, 2014. Currently, 124 countries are signatories to the agreement.
The Protocol takes into consideration the principle established by the CBD that countries have sovereign rights over the genetic resources within their territory and may demand compliance with the requirements and sharing of any benefits arising from their use by individuals, companies, or government entities whose countries are parties to the Protocol.
The country providing the genetic resources (i.e., provider country) has the right to establish (or not if it so chooses) specific requirements for access to its genetic resources and/or associated traditional knowledge as an exercise of its own sovereignty. The other parties to the Protocol (i.e., user countries) are required to take appropriate measures to comply with the requirements that have been established by the provider country. Accordingly, the parties to the Protocol, both as provider and/or user countries, must ensure that access to these genetic resources and/or associated traditional knowledge, as well as the sharing of the benefits arising from their use, comply with their own country’s legislation.
The impact arising from the ratification of the Protocol on the national industry in Brazil will mostly involve the general duty of individuals, companies, and government entities to know and comply with the obligations established by a provider country that supplies any foreign genetic resources and/or any associated traditional knowledge for the development and manufacture of products. This same duty will also apply to any user country (i.e., foreign individual, company or government entity) that accesses any genetic resources of Brazil’s biodiversity and/or associated traditional knowledge for the development and manufacture of products. Thus, the Protocol has the potential to eliminate any asymmetries that exist between national and international industries.
Since the enactment of the CBD, Brazil, as a “mega biodiverse” country, has taken a leadership role in several discussions relating to the access and benefit sharing of genetic resources. As a result, the delay in the approval of the Protocol may have been the result of internal (political) dissent regarding the positive or negative impact of the Protocol on the country’s economy. Despite Brazil’s huge biodiversity, the country relies heavily on foreign genetic resources, such as in the area of agriculture and livestock.
Nonetheless, despite the delay, both the agricultural and environmental caucuses agreed that accession to the Protocol would be important in order for Brazil to have a voting seat in on-going discussions relating to the implementation of the Protocol. Some of the matters currently under debate by the 124 parties include, for example, the scope of the Protocol (e.g., whether it will be applicable only to the species that entered into the user country after ratification of the Protocol or if new uses of species already in user countries would be encompassed), definition of checkpoints and information to be provided (e.g., would patent offices be included as one of the authorities to be used as a check point?), how to handle genetic resources of biomes in transborder areas, and the use of digital sequence information.
It is important to note that the Brazilian law on access to the biodiversity, Law #13123, establishes that the sharing of benefits provided for in the Protocol should not apply to the use of species introduced into Brazil as a result of human action relating to agriculture and livestock activities. In other words, Brazil has limited the Protocol’s scope in its national legislation in order to mitigate its impact in this area.
Please continue to watch BRICS & Beyond for updates on the Nagoya Protocol in Brazil.
This post was written by Lisa Mueller and Viviane Kunisawaat Licks Attorneys
The Guidelines for Examination (Guidelines) of the Brazilian Patent & Trademark Office (BRPTO), also known as the National Institute of Industrial Property, establish a three-step test for examining the non-obviousness of a claimed invention. This three-step test involves: (i) determining the closest prior art; (ii) identifying the distinguishing features of the invention and/or the technical problem actually solved by the invention; and (iii) determining, in view of the technical problem, and considering the closest prior art, whether an invention is obvious to a person skilled in the art (items 5.9 to 5.21 of the Guidelines).
However, a detailed review of recent decisions from the BRPTO indicates that different tests for non-obviousness are being applied by Examiners in the examining division (e.g., first instance) when compared to Examiners handling appeals (e.g., Board of Appeals). This conclusion was obtained based on a review of cases being handled by Examiners in the pharmaceutical unit art divisions. The results demonstrate that Applicants must be strategic when dealing with an Examiner. In other words, a one-size-fits all type of approach during patent prosecution may lead to higher denials at first instance. Nonetheless, understanding the experience and background of the Examiner may result in a better result (e.g., allowance) for an Applicant.
The cases considered in this analysis had an appeal decision issued in 2020 and were examined (at the first instance) after the issuance of BRPTO’s Rule #169/2016 (i.e., the current Guidelines). The results show that the BRPTO conducts a much more detailed analysis (based on its Guidelines) during appeals (i.e. appeal stage) than during examination at first instance. Specifically, while 83% of the analysis carried out by the Examiner during the appeal stage applied the non-obviousness test as defined according to the Guidelines (e.g., BRPTO’s Rule #169/2016), only 20% of the analysis performed by Examiners during first instance applied the test.
In general, we observed that at first instance Examiners failed to: (1) identify the closest prior art; and (2) determine a starting point for a person skilled in the art. In most of the analysis examined it was not clear whether the closest prior art consisted of a combination of documents. Moreover, general allegations stating that an invention “would be obvious” over the prior art, without explaining how one skilled in the art would have arrived at such a conclusion, were commonly found to form the basis for rejection. Some examples of such allegations include:
“Upon analyzing the present application in view of documents D2 to D4, we noted that it is obvious. The methods claimed in claims 1 to 58 have the same goal and the same steps encompassed in the teachings of D2 to D4. The chromatographic techniques employed are non-inventive variations of those presented in said documents”. (PI0709726-3)
“Hence, a person skilled in the art that knew the state of the art at the time [previously described by means of 8 prior art documents] would have been motivated to carry out a similar process for the preparation of 2-oxoindoline products comprised in the state of the art to arrive at the 2-oxoindoline compounds claimed in the present patent application with reasonable expectation of success and obtain the additional beneficial compounds useful in the treatment of rheumatoid arthritis or cancer, for instance”. (BR 11 2015 022431 8)
“Claims 16 to 23, which refer to the lentiviral recombinant vector, are not inventive in view of any of the teachings of D1 or D2. Considering the vectors disclosed therein and that Flavivirus proteins are known from the state of the art, the construction of Ptrip lentiviral recombinant vectors expressing Flavivirus proteins derives in an obvious way for a person skilled in the art”. (PI0510016-0)
“(…) document D4 already disclosed Fe compounds close to the claimed compounds for the same function claims, namely, fighting tuberculosis. Thus, the claimed matter is not inventive”. (PI0300770-7)
“Even though the document cited in table 4 refers to serotoninergic receptor modulators, D1 does not motivate a person skilled in the art to carry out the structural modifications to obtain the compounds of the present application”. (PI0312176-3)
With respect to second medical use claims, we reviewed 37 second medical use inventions examined by the BRPTO during the appeal stage after issuance of BRPTO’s Rule #169/2016. Surprisingly, we found that the three-part test for obviousness was applied in only 53% of the second medical use inventions examined by the BRPTO (during the appeal stage) compared to 83% overall as discussed above. Moreover, examination at first instance only applied the three-part test in 23% of the cases.
In fact, with respect to the patentability of second medical use inventions, the BRPTO relies most frequently on Rule #208/2017, which establishes examination guidelines for chemistry-related applications (Chemistry Guidelines). Unfortunately, the Chemistry Guidelines take a very strict view regarding the patentability of second medical use inventions. Specifically, general standards have been established for determining the novelty and non-obviousness of these inventions. For example, if an invention claims a particular dosing regimen or the treatment of a specific patient population, these types of claims are automatically deemed to lack novelty and be obvious. In other words, in most instances, the three-part test defined in the Guidelines is simply not even applied to these types of inventions.
Because Applicants must submit counter arguments to the BRPTO’s obviousness objections raised in an Office Action, the methodology by which the non-obviousness of a claimed invention is assessed by an Examiner can have a huge impact on the outcome of the examination. Therefore, as illustrated by the above, replying to Office Actions at the BRPTO represents an extra challenge, which can be even greater in the case of second medical use inventions. Thus, when defending the patentability of a claimed invention, Applicants must come up with an argument regarding the non-obviousness of the claimed invention which can often be challenging in view of the harsh conditions pre-defined in the Guidelines. As illustrated by the above, Applicants for pharmaceutical inventions in Brazil need to have a good understanding of the experience and background of the Examiner handling their case at first instance, and if need, be, at the appeal stage, as well.