A new chapter for plant-based foods in Brazil – the Ministry of Agriculture’s request for public comment

July 14, 2023

The plant-based market continues to grow worldwide. According to a report from Bloomberg Intelligence, the global market for alternative plant-based proteins is expected grow to $166 billion by 2030. In Brazil, the survey “The Brazilian Consumer and the Plant-Based Market 2022”, carried out by The Good Food Institute Brazil (GFI Brazil), reports that 67% of respondents reduced their consumption of animal-derived ingredients over the past year. This is a growing market, with strong investment in research and development and expansion opportunities.  Given this growth, even traditional companies in the animal protein business are investing in plant-based proteins.   

New trends bring new discussions on the sufficiency of the regulations in force regarding these trends. On July 3, 2023, the Ordinance #831/2023 was officially published by the Office of Agricultural Defense of the Ministry of Agriculture (SDA/MAPA), launching a public comment period on a regulatory proposal for plant-based foods in Brazil.

The proposed regulation aims to establish the minimum requirements of identity and quality for similar plant-based products, as well as the visual identity and labeling rules for these products. It intends to define the parameters for this type of product, which includes the so-called “vegetarian meat”.

This is not the first time a social engagement procedure was conducted by the SDA/MAPA on this matter. In 2021, it published the Call for Subsidies # 05/2021, which set a period between June and September 2021, for the receipt of documents, information, and other contributions relating to the discussion on the regulation of processed products of vegetal origin. Generally, this procedure has been used to promote the evolution and maturation of the discussions on a given topic in a regulatory body for the purpose of preparing a normative proposal.

One of the debates that has arisen over the last few years is whether these products would continue to be called “meat”, and if so, whether this would create confusion for consumers. The proposed regulation from SDA/MAPA sets the minimum information that must appear on a label, including: (i) the name of the product for purposes of sale; (ii) the inclusion, on the main panel, of the phrase “vegetable equivalent to”, followed by the name of the corresponding product of animal origin; and (iii) a notice that the product does not replace its analogue of animal origin in nutritional or functional terms.

In addition, the use of derogatory terms for products of animal origin as well as misleading information and unauthorized nutrition claims have been expressly prohibited in Brazil. However, the use of the name of the product of animal origin with the word “vegetable” is permitted (e.g., vegetable sausage). The intention behind the regulation is to avoid providing misleading information to the consumer.

The proposal also sets forth the minimum quality requirements for plant-based food products, considering the characteristics and composition of each product. There are four main requirements: (i) the use of ingredients as authorized by specific legislation; (ii) the product be free of substances harmful to health and meet the microbiological standards provided for in specific legislation; (iii) the product be produced in accordance with good manufacturing practices; and (iv) the product be free of foreign odors.   Given these requirements, this potential new rule will likely refer to other regulations in force, especially regarding authorized ingredients. It is important to note that the regulations of Brazil’s FDA (ANVISA) are also relevant to plant-based foods.

The period for public comment is open until September 15, 2023.

This post was written by Lisa Mueller and Ana Calil and Rob Rodrigues of Licks Attorneys.

An update on patent term adjustment for life science inventions in Brazil

June 11, 2023

In 2021, the Brazilian Supreme Court ruled that the country’s patent term adjustment (PTA) provision that guaranteed a minimum patent term of ten (10) years was unconstitutional.  Since that time, there has been uncertainty whether patent owners of life science inventions can obtain an extension of term when there has been a significant delay by the Brazilian Patent and Trademark Office (BRPTO) in examining and granting their patents.  Because the Supreme Court’s decision threatens to shorten the term of thousands of pharmaceutical and medical device patents, 48 lawsuits have been filed in which patent owners have asserted their right to an extension of their patent term.  The outcome of this litigation will have significant ramifications in Brazil, which has the largest economy in Latin America.

To date, two different legal theories have been advanced in these lawsuits to support a patent owner’s right to an extended patent term.  The first legal theory is based on Article 4 of the Introductory Statute to the Norms of Brazilian Law (LINDB).  The LINDB states that when the legal order is silent regarding a matter, the judge “shall decide” the case according to analogy, customs, and general principles of law (e.g., normative gap).  The parties pursuing this theory argue that there is a normative gap in Brazilian law regarding PTA.  According to their argument, foreign law should be applied along with customary rules used by courts and that PTA should be calculated based on a generalist perspective.

The second legal theory is based on Administrative Law.  The parties pursuing this theory argue that since the granting of patents is governed by Administrative Law, federal procedural rules apply.  According to Brazilian Federal Administrative Procedure, the use of the efficiency principle is the basic rule for any procedure.  Additionally, Article 27 of the LINDB provides a right of compensation for any abnormal or unfair losses that result from an administrative procedure, meaning that hypothetically, if an administrative delay occurs, the delay constitutes “…a behavior capable of giving rise in theory, to indemnifying liability”.  This hypothesis is confirmed in Brazil’s Constitution (Art. 37, §6) and Article 27 of the LINDB.

In a lawsuit filed by Celgene involving patent PI 0315315-0 (Celgene Corp v. BRPTO and Brazilian FDA) on April 11, 2023 asserting the second legal theory, a Federal Judge found that the Brazilian Regulatory Agency (ANVISA) unjustifiably delayed the examination and granting of Celgene’s patent (an administrative procedure) by 358 days.  As a result of this delay, the judge issued a preliminary injunction suspending the BRPTO’s order reducing the term of Celgene’s patent.  Specifically, the judge held that the injunction was appropriate because Celgene was not seeking automatic patent term extension which would be in conflict with the Supreme Court’s decision.  Rather, the relief requested by Celgene was a determination of what, in terms of liability, would be the best protection to be provided by the judiciary to protect Celgene’s rights.  According to the judge’s decision, it was customary for the Judicial Branch in Brazil to deal with cases involving public administration delays and that the inefficiency (by the BRPTO) in performing an administrative procedure created a loss for a private party (e.g., Celgene).  This decision aligned with the understanding that Brazilian public law provides a proper recourse for the BRPTO’s delay in examination and, ultimately, its liability.   As a result, Celgene’s patent remains in force until April 5, 2024.  The lawsuit is not over, as ANVISA challenged the decision through an interlocutory appeal.

In contrast to the cases asserting the first legal theory which argued that the calculation for term adjustment should be based on a generalist perspective, the calculation for term adjustment under the second legal theory is based on consideration of each step in the prosecution process and the legal deadlines for administrative response (by the BRPTO).  Under this theory, a delay by the BRPTO was identified if: (1) the BRPTO did not comply with a response deadline set by law; (ii) there was no possible action required to be taken by the applicant; and (iii) ANVISA failed to comply with the response deadline set under the law for applications subject to a prior approval requirement. 

Additionally, a decision by the Supreme Court on the related pending Constitutional Complaints is also pending.  These complaints challenge the decisions issued by the Federal Court of Appeals in decision ADI #5529.  The 2nd Panel of the Supreme Court has not yet ruled on this matter. 

Given the complex legal issues being discussed, a full en banc hearing on this matter by the Supreme Court might be required.  The outcome of this litigation is extremely important for the life science industry in Brazil given that currently, the average pendency for the BRPTO to examine and grant a patent is about six years and three months.  However, the pendency is even longer, specifically, eight years plus in technologies such as molecular biology, pharmacy, food and plants, and telecommunications.  Given this, the discussion around compensation rights and PTA are critical given that delays in examination and granting of patents remain in Brazil.

Please continue to which BRICS & Beyond for updates on patent term adjustment in Brazil.

This post was written by Lisa Mueller and Rob Rodrigues and Ana Calil from Licks Attorneys.

Can evidence created after the filing date be used to show inventive step? Questions referred to the European Patent Office’s authority of highest instance

November 8, 2021

The European Patent Office (EPO) is a first-to-file system. Often times, this means that applicants have to file their European patent applications with little or no experimental data to support the inventive property of the invention. This is particularly true in the biotech, pharmaceutical and agrochemical fields.  In these fields and in the chemical field in more general, the well-known ‘publish-or-perish’ drive causes some applicants to rush to file their patent applications; for others, the time it takes to put together the experimental data for filing in the first place cannot always be reconciled with the need to file the patent application as soon as possible. Indeed, there are certain inventions, e.g., the new use of a known active ingredient to treat or prevent a certain condition, or an unexpectedly synergistic combination of active compounds, that may require some experimental data to support the inventive property.

In these situations, applicants may try to use experimental evidence created after the filing date of the European patent application or European patent (e.g., such as in an opposition) to show the inventive property, and/or to complete the data relating to the inventive property that is already contained in the European patent application as filed. The evidence may be in the form of scientific articles or research papers published by the inventors or their research teams, which contain the results of tests performed on the invention and show that the invention has a certain property, as long as that property is unexpected in view of the prior art but is already at least hinted at in the European patent application as filed.

The EPO’s authority of highest instance, i.e. the Enlarged Board of Appeal, has now received a referral on precisely this issue – whether and when evidence created after the filing date of a European patent application or European patent can be used to show inventive step.  

The case that generated the referral relates to an opposition filed against EP2484209B1 relating to a synergistic insecticidal combination. In that case, the patent owner (Sumitomo Chemical Company Ltd.) submitted experimental evidence generated after the patent’s filing date to show that the asserted synergy did arise from the claimed combinations. The opponent (Syngenta Ltd.) argued that that particular synergy had not been made plausible in the European application as filed, and thus the experimental evidence could not be taken into consideration. 

The EPO Board of Appeal observed that at present there seem to be three lines of case law at the EPO tying the concept of “plausibility” to inventive step (i.e. non-obviousness):

  • A first line of case law, on ab initio plausibility, whereby evidence created after the filing date can only be used to show inventive step if the property conferring inventive step to the claimed subject-matter was already plausible from the content of the European patent application as filed and/or from common general knowledge at the filing date;
  • A second line of case law, on ab initio implausibility, whereby evidence created after the filing date can always be used to show inventive step unless the property conferring inventive step to the claimed subject-matter is implausible based on the content of the European patent application as filed and/or on common general knowledge at the filing date;
  • A third line of case law, on no plausibility, whereby evidence created after the filing date can be used to show inventive step irrespective of whether the property conferring inventive step to the claimed subject-matter was already plausible from the content of the European patent application as filed and/or from common general knowledge at the filing date.

The Board of Appeal noted that each of these lines of case law leads to different and even opposing results, and it is therefore essential for the EPO’s authority of highest instance, i.e. the Enlarged Board of Appeal, to provide guidance. The Board of Appeal also noted that there has been some discussion, in the EPO and UK case law and in certain scholarly writings, on whether a requirement of plausibility is actually enshrined in the European Patent Convention or whether it is instead “court-invented”.

Therefore, the Board of Appeal referred the following questions to the EPO Enlarged Board of Appeal:

“If for acknowledgement of inventive step the patent proprietor relies on a technical effect and has submitted evidence, such as experimental data, to prove such an effect, this evidence not having been public before the filing date of the patent in suit and having been filed after that date (post-published evidence):

1. Should an exception to the principle of free evaluation of evidence … be accepted in that post-published evidence must be disregarded on the ground that the proof of the effect rests exclusively on the post-published evidence?

2. If the answer is yes (the post-published evidence must be disregarded if the proof of the effect rests exclusively on this evidence), can the post-published evidence be taken into consideration if, based on the information in the patent application in suit or the common general knowledge, the skilled person at the filing date of the patent application in suit would have considered the effect plausible (ab initio plausibility)?

3. If the answer to the first question is yes (the post-published evidence must be disregarded if the proof of the effect rests exclusively on this evidence), can the post-published evidence be taken into consideration if, based on the information in the patent application in suit or the common general knowledge, the skilled person at the filing date of the patent application in suit would have seen no reason to consider the effect implausible (ab initio implausibility)?”

The Enlarged Board of Appeal will now have to decide whether the referral is admissible in the first place. If it is, we should expect a multitude of amicus curiae briefs trying to persuade the Enlarged Board of Appeal one way or another, as the referred questions clearly relate to a high-stakes issue in many fields of technology. If the referral is admissible, a decision may take anywhere from about 6 months to two years or more.

Please continue to watch BRICS & Beyond for updates on this important case.

This post was written by Lisa Mueller and Micaela Modiano of Modiano & Partners.

Compulsory Licensing in Brazil: Updates and Perspectives

August 17, 2021

On August 11, 2021, the Brazilian Senate approved a Compulsory Licensing Bill (#12/2021). Bill #12/21 amends the Brazilian Patent Statute (Law #9,279/96) and authorizes the Federal Government to grant compulsory licenses for products or processes in the event of a declaration of national or international emergency of public interest or a declaration of state of nationwide public calamity.

On August 13, 2021, the Bill approved by the Senate was sent to the President for approval or veto. The President may either (i) enact the Bill into law without changes; (ii) partially enact the Bill and veto one or more other portions of the Bill; or (iii) veto the entire Bill. The deadline for the President to enact or veto the bill is September 2, 2021. If the Bill is vetoed, State Representatives and Senators can override the presidential veto with a majority vote.

The final version indicates that the Senate brought back into the Bill provisions specifically regarding the COVID-19 pandemic and the obligation of the patent holder to provide information to the public authorities regarding its patents and patent applications. Specifically, Paragraph 8 states that the authorities must be provided “necessary and sufficient information for the effective reproduction of the subject matter protected by the patent or patent application and the other technical aspects applicable to the specific case, as well as the results of tests and other data necessary for the granting of its registration by the competent authorities”.

Additionally, readers should also be aware of the provisions in Paragraphs 9 and 10 of the Bill, which were also brought back by the Senate. Specifically, Paragraph 9 provides that in situations where there is biological material related to the production of a patent or patent application’s object (e.g., product), the owner “has the obligation to supply such material to the licensee”. Further, Paragraph 10 establishes that if there is a refusal to provide the information or biological material, “article 24 and Title I, Chapter VI, of this Statute shall apply”.

Article 24 of the Brazilian Patent Statute states:

Article 24. The specification must describe the subject matter clearly and sufficiently so as to enable a person skilled in the art to carry it out and to indicate, when applicable, the best mode of execution.

Sole Paragraph. In the case of biological material essential for the practical execution of the subject matter of the application, which cannot be described in the form of this article and which has not been accessible to the public, the specification will be supplemented by a deposit of the material in an institution authorized by the BRPTO or indicated in an international agreement.

Title I, Chapter VI provides the General Provisions for the nullification of a patent. Articles 46 to 49 of this chapter do not provide any specific procedure or situation in which compulsory licensing applies. Specifically, Articles 46 to 49 recite:

Article 46. A patent is null when granted contrary to the provisions of this statute.

Article 47. Nullity may not be applicable to all of the claims, a condition for partial nullity being that the subsisting claims constitute subject matter that is patentable per se.

Article 48. Nullity of a patent will produce effects as from the filing date of the application.

Article 49. In the case of the provisions of article 6 not having been observed, the inventor may alternatively claim, in a court action, the adjudication of the patent.

In the previous versions of the Bill, there was an excerpt in Paragraph 8 that a nullity action could be invoked in situations where the patent holder did not provide the biological material requested by the public entity. However, in the final version of the Bill, the wording was modified to exclude this excerpt, because it was determined to potentially contradict the Brazilian Patent Statute. Thus, the reference to the nullification of a patent remains only indirectly in the Bill’s text in the provision of Paragraph 10, by quoting Title I, Chapter VI of the Patent Statute. 

Below is a summary of the Bill: 

  • The Brazilian Executive Branch must publish, within 30 days after the declaration date of a state of emergency or public calamity, a list of patents or patent applications involving technologies which may be useful to manage the emergency or calamity.  There is an exception for patents or patent applications that are subject to a technology transfer agreement or voluntary licensing agreement that are capable of ensuring that internal demand is satisfied;
  • The Brazilian Executive Branch will perform, within 30 days (which is extendable for an equal period of time), an individualized evaluation of the listed technologies and will grant compulsory licenses only to those manufacturers having the requisite ability to meet production capacity;
  • The patent or patent application holder must provide information regarding the reproduction of the protected subject matter and other applicable technical aspects, as well as tests results and other necessary data (this could include trade secret data);
  • The Brazilian Congress may declare a nationwide public calamity that authorizes the Executive Branch to conduct a compulsory licensing procedure. In such instances, any compulsory license will be valid for a term that is limited to the period in which the nationwide public calamity lasts;
  • The owner of a patent or patent application subject to a compulsory license will receive 1.5% of the net sales price of the product associated until the compensation due to the patent holder is effectively established. Compensation will only be payable on granted patents (and not pending applications);
  • The Brazilian Patent and Trademark Office will prioritize the examination of patent applications that are subject to compulsory licensing;
  • Products subject to the sanitary surveillance regime may only be marketed after authorization has been granted by Brazilian Food and Drug Administration, whether for an emergency basis or permanent basis;
  • Regardless of the granting of a compulsory license grant, the government will prioritize the execution of technical cooperation agreements and contracts with the patent owner for the acquisition of the productive technology as well as any processes for transferring the technology; and
  • For humanitarian reasons, compulsory licensing may be granted for patents on products intended to be exported to countries with little to no manufacturing capacity in the pharmaceutical sector.

The next few days will be critical in the development of the final text of the Bill.  Ultimately, the final text of the Bill will depend on the President’s analysis.


BRICS & Beyond will continue to provide updates on the status of the Bill as they become available.


This post was written by Lisa Mueller and Rob Rodrigues and Ana Luiza Calil of Licks Attorneys.

The European Patent Office issues a landmark decision on double patenting

July 20, 2021

The European Patent Convention (EPC) does not contain any specific provisions regarding the possibility of the same applicant obtaining two European patents for the same invention. As a result, and in the past, the Boards of Appeal of the European Patent Office (EPO) have issued decisions taking varying and sometimes conflicting positions regarding the issue of double patenting.

These conflicting positions culminated in a decision by the EPO’s Enlarged Board of Appeal (the EPO’s authority of highest instance) on June 22, 2021, holding that the EPC must be interpreted as precluding the possibility for the same applicant to obtain two European patents for the same invention in the same EPC states. A copy of the decision can be found here:   

DecisionDownload

In the decision, the Enlarged Board of Appeal (EBA) had to answer the following main question:

“Can a European patent application be refused … if it claims the same subject-matter as a European patent which was granted to the same applicant and does not form part of the state of the art [for the European patent application]?”

The EBA reviewed the EPC, as well as the preparatory works that had resulted in the creation of the EPC following a diplomatic conference of the EPC “founding” states, and concluded that even though the EPC does not contain an explicit provision regarding double patenting, the preparatory works demonstrated that the majority of the EPC “founding” states supported the notion that no two (or more) European patents should be granted to the same applicant for the same invention for the same EPC states, if those European patents claim the same filing or priority date.

Thus, the EBA found that “[a] European patent application can be refused [in examination] if it claims the same subject-matter as a European patent which has been granted to the same applicant and does not form part of the state of the art [for the European patent application].”

In its decision, the EBA clarified that the above finding applies to:

  1. Parent and divisional applications filed at the EPO; 
  2. European patent applications claiming the same priority (e.g., from a national patent application); 
  3. European patent applications claiming priority from an earlier European patent application; and
  4. European patent applications having the same filing date.

The EBA further clarified that the above finding means that the EPO can raise an objection against a European patent application that falls within one of the above categories during examination.  However, the EBA did not address the question of whether this objection could be raised in an opposition proceeding (this question went beyond the scope of the questions referred to the EBA in this case).

The EBA further clarified that the prohibition against double patenting applies only to European patent applications designating the same EPC states. Thus, if an already-granted European patent designates only certain EPC states and the still-pending European application designates other EPC states, then the double patenting prohibition does not apply.

Finally, the EBA did not expressly address or review the definition of “same invention” for the simple reason that the claims in the granted European patent that resulted in the referral to the EBA and the claims of the pending European application were completely (i.e., 100%) identical. It is worth noting that previous case law of the EPO Boards of Appeal established that claims with overlapping scope, but not identical scope, were not considered to be directed at the “same invention”.

The EBA’s decision finally clarifies a point of law that had remained open and was highly debated for several decades. As a result, Applicants should consider this important decision when filing and prosecuting divisional applications in the EPO.

This post was written by Lisa Mueller and Micaela Modiano of Modiano & Partners

Venezuelan Patent and Trademark Office issues the first notice of allowances in pharmaceutical patent applications since 2004

May 21, 2021

The Venezuelan Patent and Trademark Office (VPTO) has issued the first notice of allowances (NOA) in pending patent applications directed to pharmaceutical inventions since 2004.  At least two patent applications have received NOAs pursuant to Article 27.1 of the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).  Specifically, Article 27.1 of TRIPS recites:

  1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.

In November 2020, the VPTO announced that they would immediately begin to recognize the direct and preferred applicability of the TRIPS agreement and Paris Convention for the Protection of Industrial Property over Venezuelan national legislation.

The two patent applications for which NOAs have issued are owned by Sanofi Aventis (Sanofi).  Both applications claim the use of a certain compound to produce a medicament for the treatment of a certain disease and claim priority to French patent applications filed in 2007.  Assuming Sanofi pays the final registration fees before August 18, 2021, the patents will have a term of 10 years from the grant date of May 24, 2021.  It is important to emphasize that neither of the allowed applications contain product claims but only medical use claims.

Invalidation actions can be initiated during the two years following the issue date of the NOAs. Patent owners are required to provide evidence of practicing their patent (e.g., working) within two years following the date of grant, otherwise the patent can be declared to have lapsed.   

Currently, Venezuela’s patent law does not contain mechanisms such as patent term extension or Supplementary Protection Certificates (SPCs).

This post was written by Lisa Mueller and  Sebastian Gonzalez Yanes of Pi360 Legal                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   

Brazilian generic companies file a “tsunami” of lawsuits against several pharmaceutical companies in the wake of the Supreme Court’s ruling on the 10-year patent term

May 12, 2021

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 

Brazilian Supreme Court holds that the 10-Year Patent Term in Brazil is Unconstitutional

May 7, 2021

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: 

  1. Constitutes a “term extension” that affords disproportionate protection to patent owners;
  2. Undermines the temporary nature of a patent as provided by the Brazilian Constitution;
  3. Provides automatic compensation to an applicant without assessing the applicant’s responsibility in contributing to the delay in examination;
  4. 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
  5. 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 

Patent Examination Finally Begins in the Kuwaiti Patent Office

April 15, 2021

In a long awaited development, the Kuwaiti Patent Office (KPO) has finally initiated substantive examination of patent applications and is issuing search and examination reports on pending applications.  Nonetheless, given that substantive examination is new in Kuwait, the process has started out rather slowly but is expected to increase as the KPO becomes more accustomed to conducting formal examination.  Moreover, in the January 2021 Official Gazette, the KPO published two granted patents, which were the first two patents granted in Kuwait.  Finally, laws and regulations are in place in Kuwait for the complete prosecution of patent applications from filing to grant.

This news regarding the start of substantive examination is welcomed, particularly given the concern raised by many innovators on the ability to seek patent protection in Kuwait after the regional GCC Patent Office issued a notification to stop accepting new patent applications as of January 6, 2021. 

By way of background, in April 2016, the KPO adopted the GCC Patent Law and regulations as its current law and regulations. However, in July 2016, Kuwait acceded to the Patent Cooperation Treaty (PCT), which entered into force in September of the same year.

Currently, the KPO is working through an existing backlog of pending applications.  Applicants should expect that their pending Kuwaiti patent applications will be examined and final decisions issued thereafter in due course.  Under the local regulations, Applicants will have a non-extendable period three months from the date of any notification from the KPO to correct any formal defects in their applications. 

It is expected that the KPO’s efforts to develop the national system and streamline the registration process of patent applications will help promote local innovation and attract foreign patent applicants to protect their inventions in Kuwait.

This post was written by Lisa Mueller and Namir Sioufi of Saba IP.

Update on the Constitutional Challenges to the 10-Year Patent Term in Brazil

April 8, 2021

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