Sanofi 2 – EN

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Third Party Opposition against Sanofi’s Patent Application no. BR 11 2017 004197-9 (Sanofi 2)

Sanofi seeks to perpetuate an undue protection in the field of vaccination against Dengue.


Prior Art Listing

Sanofi 2 (Patent Application no. BR 11 2017 004197-9)

Patent Application no. BR 11 2017 004197-9 does not merit being granted, as it is contrary to many of the legal requirements set forth on Public Law no. 9.729/96 (Industrial Property Statute – LPI)

Unpatentability of Therapeutic Methods

Art. 10, VIII, of the LPI

Insufficiency of Disclosure

Art. 24 of the LPI

Lack of Clarity and Support of the Claims

Art. 25 of the LPI

Lack of Novelty

Art. 8º and 11 of the LPI

Lack of an Inventive Step

Art. 8º and 13 of the LPI

Sanofi 2 – Unpatentability of Therapeutic Methods

The current claims of the Sanofi 2 application clearly attempt to protect therapeutic methods – which is in explicit violation of the Industrial Property Statute

Sanofi 2 – Insufficiency of Disclosure

The current claims of the Sanofi 2 application cover subject matter which is not supported by the specification. Thus, the Person of Ordinary Skill in the Art (POSITA) has no means of reproducing the technology without incurring in undue experimentation.

What is covered by the independent claims of Sanofi 2?

What is actually disclosed in the specification?

Example 1

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This Example only demonstrates the use of a tetravalent CYD vaccine produced and cultured according to a list of prior art documents which exclusively disclose the ChimeriVax concept. Therefore, it does not demonstrate any other “live attenuated dengue viruses” or “live attenuated chimeric viruses”

Example 2

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The vaccine composition prepared and administered in Example 2 is identical to that which was administered in Example 1 – using a CYD 1-4 vaccine which relies on the ChimeriVax concept.

Example 3

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This Example only provides an amalgamation of data collected from the clinical trials described in Examples 1 and 2. No change in the vaccine composition has been demonstrated to justify the broad scope of the claims.

Example 4

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Much in the same vein as Example 3, the information disclosed in Example 4 merely refers to a Long-Term Follow-Up (LTFU) of the clinical trials descibed in Examples 1 and 2. Hence, once again there is no justification provided as for the wide scope of the claims.

What is claimed yet not disclosed in the specification?

Anti-Dengue vials called Dengvaxia ready to be administered to the PNP personnel. Studies conducted by the University of the Philippines National Institute of Health, dengue cases in the country will expected to reduce by 25% in the span of five (5) years. Philippines is the first country to launched Dengvaxia vaccines and where will be made commercially available. (Photo by Herman Lumanog/Pacific Press/Sipa USA)(Sipa via AP Images)

The claim allows for the inclusion of all types of viruses

While the specification only discloses the ChimeriVax concept – a chimeric virus formed using a Yellow Fever backbone (YF17D) – the claims encompass several types of viruses which could be used in a vaccine for eventually eliciting an immune response against dengue (even those not yet produced or tested). This wide array of claimed subject matter is simply not supported in any way by the scope of the disclosure.

Sanofi 2 – Lack of Clarity and Support of the Claims


BRPTO’s Resolution no. 208/2017 – Guidelines for Patent Applications in the Field of Chemistry

Composition claims related to a therapeutic regimen cannot be accepted as they lack clarity

6. COMPOSITIONS, FORMULATIONS AND PHYSICAL FORMS OF COMPOSITIONS

6.1. CLARITY AND PRECISENESS OF CLAIMS

Example 11:

Claim 1: Pharmaceutical composition, characterized by comprising compound A and excipients B and C.

Claim 2: Pharmaceutical composition according to claim 1, characterized by the fact that the dosage of A varies from 45 to 90 mg per Kg of the patient.

Not acceptable for lacking clarity (Article 25 of the IPL) since the additional feature of the dependent claim refers to the method of administration of the pharmaceutical composition, which is part of the therapeutic regimen, and is not related to the product. The added characteristic does not add information regarding the product per se, thereby generating inconsistency as to the claimed subject matter.

Claim 3: Pharmaceutical composition according to claim 1, characterized by the fact of being administered 2 times a day.

Not acceptable for lacking clarity (Article 25 of the IPL), since the additional feature of the dependent claim refers to the method of administration of the pharmaceutical composition, which is part of the therapeutic regimen, and is not part of the product. The added characteristic does not add information regarding the product per se, thereby generating inconsistency as to the claimed subject matter.

“Use” claims with features related to a therapeutic regimen cannot be accepted for lack of clarity

9. NOVEL USES OF KNOWN COMPOUNDS

9.1.4. Groundings, clarity and preciseness of the claims

The claims of new use for preparing a medicament should specify the disease to be treated. […]

Fragments related to the therapeutic regimen contained within the new medical use claims and the group of patients neither define the use of the compound for preparing a medicament, and as such, they cannot be accepted for causing uncertainty as to the subject matter.

In this sense, it is clear that the claims of Sanofi 2 lack clarity, whereas:

Claim 1 is a composition claim linked to a therapeutic regimen

and, thus, is not patentable according to art. 25 of the LPI and item 6.1 of the BRPTO’s Resolution no. 208/2017

Claim 15 is an “use” claim linked to a therapeutic regimen

and, thus, is not patentable according to art. 25 of the LPI and item 9.1.4 of the BRPTO’s Resolution no. 208/2017

Claim 16 is a kit comprising the matter of Claim 1

and, thus, is not patentable according to art. 25 of the LPI and item 6.1 of the BRPTO’s Resolution no. 208/2017

Sanofi 2 – Patentability

Relevant Prior Art Documents


D1 – WO2014016362

Date of Publishing: 30/01/2014

Published as: WIPO International Patent Application

    Main Disclosures:

  • The disclosed invention relates to a dengue virus serotype 2 vaccine composition.
  • The patent application describes the results of a Phase IIb clinical Trial conducted by the Applicant, as disclosed in the application as Example 1.
  • Strains are selected to compose the prME component of the vaccine against the Dengue caused by serotype 2 Dengue virus based on a Global Consensus Sequence obtained in Example 2: LAV-2 (PDK53-16681); BID-V585; PR/DB023; and MD-1280.
  • Tetravalent vaccines are also foreseen in the application.
  • Tests with a tetravalent vaccine Chimerivax (CYD-TDV) compared to other Test Tetravalent Formulations in which component of Serotype 2 is varied, are reported.
  • Examples 4 and 5 describe comparative tests in Cynomolgus monkeys and naïve adults in Mexico to assess the immunogenicity against DEN-2 for the tested formulations compared to the Chimerivax (CYD-TDV), respectively.


D2 – WO2014016360

Date of Publishing: 30/01/2014

Published as: WIPO International Patent Application

    Main Disclosures:

  • The disclosed invention relates to a tetravalent vaccine composition against Dengue.
  • This a patent application describes the results of a Phase IIb clinical Trial conducted by the Applicant, as disclosed in the application as Example 1.
  • Due to an alleged lack of efficacy of the Chimerivax (CYD-TDV) vaccine against DEN-2, like in the WO2014/016362 (D1), a Global Consensus Sequence was developed, and DEN-2 Dengue virus strains have been selected (Example 2), namely: BID-V585; MD-1280; LAV-2 (PDK53-16681); and PR/DB023
  • In Example 3, construction of the cDNA clones corresponding to the optimized serotype 2 chimeric viruses selected in Example 2 is described. The virus used as backbone for the constructions is the Yellow Fever strain YF17D204, using Chimerivax technology. No tests with these chimeric strains are reported in this document.
  • Example 4 corresponds to the immunogenicity test of CYD 1, 2 and 4-VDV2 composition in Naïve adults in Mexico. This Example is identical to Example 5 from WO2014016362 (D1).


D3 – Bhamarapravati & Sutee

Date of Publishing: 28/03/2000; Date of Publishing (online): 01/09/2010

Published as: Scientific article in the “Vaccine” journal, v. 18, p. 44-47.

    Main Disclosures:

  • Bhamarapravati is a short communication reporting the developments of dengue vaccines, at the Mahidol University group based on live attenuated (non-chimeric) dengue viruses obtained by serial passages of the viruses in primary dog kidney cells or primary African green monkey kidney cells.
  • According to the authors, tetravalent vaccines described have been tested in Thai volunteers, and were found to be immunogenic in both adults and children.
  • This document is relevant with regard to the broad component “live attenuated dengue virus” from currently pending claim 1.


D4 – Guy et al.

Date of Publishing: 01/09/2010

Published as: Scientific Article in the “Human Vaccines” journal, v. 6, issue 9, p. 696-705.

    Main Disclosures:

  • The review is concerned about developments made in relation to Sanofi Pasteur tetravalent vaccine candidate composed of four recombinant live attenuated vaccines based on a yellow fever vaccine 17D (YFV 17D) backbone, each expressing the prM and envelope genes of one of the four dengue virus serotypes, also known as Chimerivax.
  • The paper discusses about the overall development of the CYD 1-4 viruses used in the relevant vaccine, i.e., the chimeric yellow fever/dengue (CYD) constructs (see Figure 1); and comments about the Pre-clinical evaluation and Clinical Development of the vaccine, at the occasion. The vaccine composition in this document is the same being tested in application BR112017004197-9 .
  • Phase I studies with monovalent CYD-2 and Tetravalent (TDV) vaccine have been discussed in this Review, with seroconversion of volunteers being shown, inclusive for all four serotypes with CYD-TDV (Chimerivax).
  • Phase IIb and Phase III clinical evaluations being conducted are mentioned in the paper, thus showing that efficacy tests were being carried out with the vaccine, at the occasion. The phase III trial in children and adolescents in Latin America (Example 1) and Asia (Example 2) are mentioned herein. The phase IIb study from Sanofi 1, and included in the Example 4 (LTFU) of the instant application are also reported.
  • The document, therefore, discloses the immunogenicity achieved with the TDV vaccine, the use of the vaccine in humans (children from endemic areas), and the dosage regimen of 0-6-12 months.


D5 – Osorio et al.

Date of Publishing: 21/07/2011

Published as: Scientific Article in the “Vaccine” journal, v. 29, issue 42, p. 7251-7260.

    Main Disclosures:

  • This document consists of a review article disclosing the results of a chimeric dengue-2 PDK-53-based tetravalent vaccine successfully protecting monkeys in challenge studies.
  • The paper describes the attenuated DEN-2 PDK-53 strain and chimeric viruses containing the prM and E genes from DEN-1, DEN-3 and DEN-4, in a DEN-2 PDK-53 backbone, known as DENVax.
  • The tetravalent vaccine candidate showed a safety profile and immunogenicity against the four Dengue serotypes, as shown in Phase I Clinical Trials.
  • This document is relevant with respect to the broad component “live attenuated chimeric dengue virus” from currently pending claim 1.


Sanofi 2 – Patentability

Lack of Novelty and an Inventive Step

Sanofi 1 lacks novelty when compared to D1

The standard Lorem Ipsum passage, used since the 1500s

Contrary to popular belief, Lorem Ipsum is not simply random text. It has roots in a piece of classical Latin literature from 45 BC, making it over 2000 years old. Richard McClintock, a Latin professor at Hampden-Sydney College in Virginia, looked up one of the more obscure Latin words, consectetur, from a Lorem Ipsum passage, and going through the cites of the word in classical literature, discovered the undoubtable source. Lorem Ipsum comes from sections 1.10.32 and 1.10.33 of “de Finibus Bonorum et Malorum” (The Extremes of Good and Evil) by Cicero, written in 45 BC. This book is a treatise on the theory of ethics, very popular during the Renaissance. The first line of Lorem Ipsum, “Lorem ipsum dolor sit amet..”, comes from a line in section 1.10.32.

Sanofi 1 lacks novelty when compared to D2

The standard Lorem Ipsum passage, used since the 1500s

Contrary to popular belief, Lorem Ipsum is not simply random text. It has roots in a piece of classical Latin literature from 45 BC, making it over 2000 years old. Richard McClintock, a Latin professor at Hampden-Sydney College in Virginia, looked up one of the more obscure Latin words, consectetur, from a Lorem Ipsum passage, and going through the cites of the word in classical literature, discovered the undoubtable source. Lorem Ipsum comes from sections 1.10.32 and 1.10.33 of “de Finibus Bonorum et Malorum” (The Extremes of Good and Evil) by Cicero, written in 45 BC. This book is a treatise on the theory of ethics, very popular during the Renaissance. The first line of Lorem Ipsum, “Lorem ipsum dolor sit amet..”, comes from a line in section 1.10.32.

Sanofi 2 – Opinions from Experts in the Field

Renowned experts from the field of immunology attest and reinforce that the Sanofi 2 application DOES NOT meet the requirements for patentability as set forth in the Industrial Property Statute (Public Law no. 9.279/96) and the BRPTO’s Guidelines for Patent Applications (specifically Resolutions no. 169/2016 and 208/2017).


Aliquam dignissim lacinia tristique nulla lobortis nunc ac eros scelerisque varius suspendisse sit amet urna vitae urna semper quis at ligula.
Dr.ª Alice RayolFarmacêutica, Imunóloga e Doutora em Propriedade Intelectual

Aliquam dignissim lacinia tristique nulla lobortis nunc ac eros scelerisque varius suspendisse sit amet urna vitae urna semper quis at ligula.
Dr.ª Ana Claudia Dias de OliveiraBióloga e Doutora em Biotecnologia e Propriedade Intelectual

Sanofi 2 – Takeaways

Due to its lack of conformity with the legal standards for patentability, the Sanofi 2 application should be rejected by the National Institute of Industrial Property (INPI – BRPTO).

Unpatentability of Therapeutic Methods

Art. 10, VIII, of the LPI

Insufficiency of Disclosure

Art. 24 of the LPI

Lack of Clarity and Support of the Claims​

Art. 25 of the LPI

Lack of Novelty

Art. 8º and 13 of the LPI

Lack of an Inventive Step

Art. 8º and 13 of the LPI

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