What the current rules give

Article 10(1) of Directive 2001/83/EC is the baseline. A generic applicant may rely on the reference product's data once it has been authorised "for not less than eight years", and the generic cannot be placed on the market until ten years have passed from the initial authorisation. The ten years can be extended to a maximum of eleven where, within the first eight, the holder obtains authorisation for a new indication with significant clinical benefit. That is the familiar 8+2+1 shape. The text of Article 10 of the Directive is the place to read the conditions.

What the deal says

According to the Parliament's press release on the deal, the new model has 8 years of regulatory data protection, during which other companies cannot access the product data, followed by 1 year of market protection, during which generics and biosimilars cannot be sold. Three conditions each add a further 12 months of market protection: the product addresses an unmet medical need; the product contains a new active substance and meets a combination of conditions (comparative clinical trials, trials in several member states, and an EU marketing authorisation application within 90 days of the first application outside the Union); or the holder obtains one or more new indications bringing significant clinical benefit. The combined regulatory protection period is capped at 11 years.

The same release gives breakthrough orphan medicinal products up to 11 years of market exclusivity, and a transferable 12-month data exclusivity voucher for priority antimicrobials.

Source: the European Parliament press release of December 11, 2025, and Directive 2001/83/EC, Article 10, both linked above.

What this changes in practice

The ceiling did not move. The baseline did: a product with no add-on now reaches the market-protection end at year 9 where it used to reach it at year 10, and holders have to qualify for each extra year rather than receive two of the three years automatically. Reaching the 11-year ceiling now takes two of the three add-ons (8 + 1 + 1 + 1), where it used to take one qualifying indication, and a third add-on would add nothing under the cap.

For generic and biosimilar developers the useful reading is the other way round: a product that meets none of the conditions has one year less of market protection than before, and the qualification questions (unmet need, comparative trials, timing of the EU filing) become facts to establish in the dossier. The press release does not say how the conditions will be assessed, who decides, or at what point in the life of the product. That detail is in the legal text, which this note does not reproduce.

What is still open

The Parliament's legislative tracker records Coreper's endorsement of the compromise on March 6, 2026 and the health committee's approval on March 18, 2026, with Council adoption expected after the summer and a plenary vote indicatively in October 2026. It gives no entry-into-force date and no transition period, and neither does the press release. Dates for application, and the treatment of products already authorised or in development, are therefore not available from these sources.

For a reader watching several markets, the practical point is that the headline "11 years" is unchanged, so a comparison with the Russian rules on data and marketing exclusivity or the change in the United Arab Emirates should be made on the baseline and on what must be proved for each extra year.

The base rule

In the United States the term "ending 20 years from the date on which the application for the patent was filed in the United States" comes from 35 U.S.C. 154(a)(2). If the application claims the benefit of an earlier one under sections 120, 121, 365(c) or 386(c), the 20 years run from the earliest such filing. A continuation or divisional therefore does not buy a fresh 20 years.

Article 63(1) of the European Patent Convention is shorter still: "The term of the European patent shall be 20 years from the date of filing of the application." Section 53(1) of the Indian Patents Act, 1970 says the same, and adds that for an international application designating India under the Patent Cooperation Treaty the 20 years are counted from the international filing date. In China, Article 42 of the Patent Law gives invention patents 20 years, utility models 10 and designs 15, all from the filing date. Section 53 of the Indian Act is the cleanest of the group: a 20-year rule, a renewal-fee rule, and nothing on adjustment or extension.

Compensation for office delay

Only two of the five systems compensate for slow examination.

The United States does it by statute. Under 35 U.S.C. 154(b)(1) the term is extended one day for each day of delay in three situations: the Office misses the 14-month deadline for a first action (the A delay), the patent has not issued within three years of filing (the B delay, with time spent on requests for continued examination and some appeals excluded), and certain proceedings such as derivation proceedings, secrecy orders and successful appeals take place (the C delay). Section 154(b)(2) then trims the total. Overlapping days are counted once, the adjustment cannot exceed the actual days the issuance was delayed, and time the applicant spent without reasonable efforts to conclude prosecution is deducted. A patent that was subject to a terminal disclaimer cannot be adjusted past the disclaimed date.

China introduced a comparable mechanism in the 2020 amendment of Article 42. Where an invention patent is granted more than four years after filing and more than three years after the request for substantive examination, the patent administration extends the term on the patentee's request to compensate for unreasonable delay, except delay caused by the applicant. It applies to invention patents only.

Europe, India and Brazil have no such mechanism in the provisions quoted above. The Brazilian position on adjustment is taken up again below.

Extensions for medicines awaiting approval

Three systems extend the term for the time a medicine spends in regulatory review.

In the US, 35 U.S.C. 156 caps the extension based on the review period at five years, and also caps the combined result: if the patent term left after approval, plus the extension, would exceed 14 years, the extension is cut back so the total does not exceed 14. As a hypothetical, a patent with 12 years left on the day of approval can gain at most two. Only one patent can be extended for the same product review period.

In the European Union the vehicle is the supplementary protection certificate under Regulation (EC) No 469/2009, granted nationally rather than by the EPO. Article 13 sets its duration as the period between the filing date and the first marketing authorisation in the Union, minus five years, with a ceiling of five years.

China's Article 42 provides that the compensation for a new drug "may not be more than five years" and that the total effective term after marketing approval may not exceed 14 years. The request is the patentee's to make; nothing is automatic.

India and Brazil have no equivalent in the texts above. Russia is outside this note.

The Brazilian floor that was struck down

Article 40 of Law 9,279/1996 gives invention patents 20 years and utility models 15, from filing. Its sole paragraph added a floor: no less than 10 years for inventions and seven for utility models, counted from grant. Where examination at the national office took many years, the floor decided the real end date, so the practical term could reach well past 20 years from filing.

In May 2021 the Supreme Federal Court (STF) declared the sole paragraph unconstitutional in ADI 5529, by a majority, and modulated the effects; see the STF report on the judgment. Applications still pending then take the caput term of 20 or 15 years from filing, whatever the examination time.

Patents already granted and in force with an extension were generally left alone, because the ruling looks forward from the publication of the judgment record. The exception is health: for granted patents on pharmaceutical products and processes and on health equipment and materials, the extension falls with retroactive effect, as the STF report on the modulation records. The judgment text should be checked for the exact scope in a given case.

The blog followed the decision as it happened, and its first report on the ruling records the initial reaction.

The terms side by side

Where the counts differ in practice

Two traps sit under the table. First, "20 years from filing" ignores what is actually claimed as the start date: in the US and the PCT route the earliest relevant filing, not the grant, is the anchor, so a long-pending family loses term to its own history. Second, the Brazilian row describes the law after the 2021 judgment, not the terms of patents granted before it, and the exceptions for pharmaceutical and health patents show how a single court order can produce different end dates for neighbouring patents.

How this part differs from earlier series

Part 14 of the divisional series on the United States and Part 15 on Europe cover divisionals and continuations, which do not restart the 20-year clock described here.

As of October 2026 these are the texts in force as quoted from the sources above. Rules on adjustment and extension are the ones most likely to be revised, so the sources, not this table, are what to check before relying on a date.

What the Office has published

The Office's news page carries a public notice for each draft: Draft Guidelines for Examination of Pharmaceutical Applications for Patent and Draft Guidelines for Examination of Biotechnology Applications for Patent. Both asked stakeholders to comment within 15 days of publication of the notice, so the comment window has closed by now. The news listing shows October 2026 dates (07-10-2026 and 08-10-2026), which do not match the 4 September date of the documents, and which date governs is not clear from the Office's pages.

The trade press reports that the pharmaceutical draft aims at better "quality, consistency and uniformity of scrutiny" among examiners. Its PDF could not be read as text at the time of writing, so nothing below describes its provisions.

The biotechnology draft in numbers

Published commentary on the biotechnology draft describes a 49-page document with 21 headings, 18 Indian court decisions and 36 illustrative examples. It covers the same ground as the March 2013 biotechnology guidelines and names newer technologies such as antibody-drug conjugates, CRISPR-based therapeutics and synthetic biology.

Per the commentary, two procedural points are new: the examiner's report must disclose the search string or query used, which the 2013 guidelines did not require, and sequence listings are to be filed electronically in WIPO Standard ST.26.

Point by point against the 2013 text

According to the commentary, the draft differs from the 2013 guidelines unevenly. On novelty it identifies no difference. On inventive step the draft restates the statutory test and adds that a claim can be obvious over a single document or a mosaic of documents, with six examples (four refused, two allowed). On sufficiency under Section 10 the draft carries over the 2013 doctrine on laundry-list and reach-through claims, and adds that the source and geographical origin of biological material must be disclosed to meet enablement. Two new refused examples sit here: an antigen-binding molecule defined by an 80 per cent CDR3 identity range, and a biomarker method built on unspecified machine learning models. This comparison rests on the commentary, not on a reading of the draft itself.

Section 3(d) and the other exclusions

Per the commentary, Section 3(d) is handled through four decisions: Novartis in the Supreme Court (efficacy means therapeutic efficacy for medicines), Natco v Novartis (Delhi High Court Division Bench, 2024: bioavailability is not a direct measure of therapeutic efficacy), Novozymes (Madras High Court, 2023: enzyme variants must pass the efficacy filter, with no fixed numerical threshold) and DS Biopharma (Delhi High Court, 2022: the Office must identify the one known substance it relies on).

On Section 3(i), the commentary says the draft draws on the Delhi High Court decision of 9 October 2025 in Sequenom, EMD Millipore and Natera: physical diagnostic kits fall outside the exclusion, while software-only diagnostic tools are examined under the computer programme exclusion.

On divisionals, the commentary reports that the draft relies on Syngenta (Delhi High Court Division Bench) for the view that a divisional is maintainable where a plurality of inventions is disclosed in the specification. Earlier posts on this blog set out how divisionals work in the country: Filing a Divisional Application in India - Part 4.

Who is affected

Applicants and patent owners with antibody, gene-editing, cell and tissue, or bioinformatics claims are the main audience. Generic and biosimilar manufacturers are affected from the other side, because, per the commentary, the draft addresses how Section 3(d) applies to new forms and variants of known substances. The pharmaceutical draft concerns the same groups, but only its stated purpose is reported above.

What changes in practice

The draft is not law and changes nothing for pending applications today. The items below are what the commentary reports as new, and they would matter only if the draft is adopted in this shape; this note has not read the draft itself and draws no further conclusions.

1. The examination report would disclose the search string or query used.
2. Sequence listings would be filed electronically in WIPO Standard ST.26.
3. Examples and court decisions listed in the draft would serve as reference points for examiners, according to the commentary.

What stays open

Sections 3(b) and 3(k) get new refused examples, including a germline-editing claim and two bioinformatics claims, but no decisions are quoted for either, which makes them the least predictable part of the text. A readable copy of the pharmaceutical draft is needed for a point-by-point reading. Examination reform has been a recurring theme here since the 2019 proposal to amend the Rules (see Indian Government's Proposal to Amend Patent Rules 2003), and the full run of earlier posts sits in the India category. What matters next is the final text, and whether the search-string disclosure survives it.

ANVISA’s Collegiate Board (DICOL) submitted for public consultation a proposal to change RDC Rule #47 of 2009, which regulates the marketing authorization for generics, specifically, their package inserts.  The proposal recommended amending a portion of this rule to read: “[…] the package leaflets of generic and similar medicines may differ from their respective Standard Package Leaflets with respect to patented therapeutic indications or indications claimed in published patent applications”. 

During a vote on the proposal on December 6, 2023, the director president of ANVISA, Mr. André Barra Torres, stated that the new wording of Rule #47 was in line with the “real” objective of Brazil’s national generics public policy, namely, to guarantee access to healthcare. Mr. Torres stated that the removal of a patent protected indication from a label, accompanied by the reason why the indication was removed, made it clear that the removal was not related to the interchangeability of a drug but was the result of the indication being patent protected.  According to Mr. Torres, allowing removal of a patented indication would solidify the patent owner’s rights, as it would reinforce the patentee’s right to exclude others from using the patented invention.

A copy of the regulation approved by ANVISA is provided below.

BRAZILIAN FOOD AN DRUGS AGENCY

DRAFT RESOLUTON OF THE COLLEGIATE BOARD OF DIRECTORS

RESOLUTON OF THE COLLEGIATE BOARD OF DIRECTORS –

RDC N^o, [^o], of [Month], [Day], [Year]

Amends Collegiate Board Resolution (RDC) N^o 47, September 8^th, 2009, which establishes rules for preparation, harmonization, updating, publication, and availability of drug labels for patients and health professionals

The Collegiate Board of Directors of the Brazilian Food and Drug Agency (BFDA), exercising the powers conferred by articles 7, item III, and 15, items III and IV, of Law Nº 9,782, of January 26th , 1999, and considering the provisions of article 187, item VI and paragraph 1º, of the Internal Regiment, approved by Resolution of the Collegiate Board of Directors (RDC) Nº. 581, of December 10th, 2021, resolves to adopt the following Resolution of the Collegiate Board of Directors. 187, item VI and paragraph 1º, of the Internal Regulations, approved by Resolution of the Collegiate Board of Directors – RDC Nº 585, of December 10th, 2021, resolves to adopt the following Resolution of the Collegiate Board of Directors, as deliberated at a meeting held on XX, XXXX, 2023, and I, the Director-President, order its publication:

Art. 1. Art. 14 of Collegiate Board Resolution – RDC No. 47, of September 8, 2009, is hereby amended as follows:

“Art. 14. ……………………………..

§1 The labels of generic and similar drugs may differ from their respective Standard Package Labels in the specific information for each product, which must be in accordance with the pharmacotechnical characteristics approved in the registration, as contained in the parts:

…………………………………………..

§3 In addition to the provisions of Paragraphs 1 and 2 of this article, labels of generics and branded generics may differ from their Standard Label with respect to patented therapeutic indications or indications claimed in published patent applications.

§4 In the package labels of generic and similar drugs that differ from their respective Standard Package Label in relation to patent-protected therapeutic indications or indications claimed in published patent applications, the sentence “The information referring to the patent-protected indications of the drug has been suppressed.”, in bold, must be inserted in the section “1. WHAT IS THIS MEDICINE FOR?” in the patient’s package label and “1. INDICATIONS” in the healthcare professional’s package label.”

§5 If the patent application is denied or the validity period of the patent letter expires, the package leaflets of generic and similar drugs must: I – include the indications referred to in §3; and II – remove the sentence referred to in §4.

§6 In the case of §5 of this article, the new labels texts must be notified electronically within 90 (ninety) days of the publication of the denial of the patent application or at the term of the patent and the deadline for starting the manufacture of the drug with the new label text material will be up to 180 (one hundred and eighty) days from the date of the notification request, which must be implemented regardless of prior manifestation by BFDA and this being the time foreseen for the stock of obsolete label text material to be exhausted.” (NR)

Art. 2. Art. 16 of Collegiate Board Resolution – RDC No. 47, of September 8, 2009, is hereby amended as follows:

“Art. 16. ……………………………………….

VI – to the Legal Sayings, regarding the corporate name of international companies;

VII – to the Legal Sayings, regarding the corporate name of national companies, after BFDA’s approval of the change of corporate name, and;

VIII – indications protected by patent or claimed in published patent applications, regarding the application of the provisions of §4º of art. 14 of this Resolution.

………………………………………………..” (NR)

Art. 3 This Resolution comes into force on mmmm dd of yyyy. [in accordance with Decree 10.139/19, art. 4º, items I and II]

This post was written by Corinne Haldane and Rod Almeida and Thiago Barros of Licks Attorneys.

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 Corinne Haldane and Laura Dantas and Rod Almeida of Licks Attorneys.

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 2^nd 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 Corinne Haldane and Rod Almeida and Laura Dantas from Licks Attorneys.

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 Corinne Haldane and Chiara Benedetti of Modiano & Partners.

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 Corinne Haldane and Rod Almeida and Laura Beatriz Dantas of Licks Attorneys.

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:   

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 Corinne Haldane and Chiara Benedetti of Modiano & Partners

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 Corinne Haldane and  Andrés Morales Vega of Pi360 Legal