Biotech Inventions in Latin America
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Biotech Inventions in Latin America Argentina. Ignacio Sánchez Echagüe Marval, O’Farrell & Mairal. AGENDA Importance of biotech in Argentina Plant variety protection Patents Registration of biotech products Data exclusivity and biotech products Summary. AGENDA

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Biotech inventions in latin america argentina

Biotech Inventions in Latin America

Argentina

Ignacio Sánchez Echagüe

Marval, O’Farrell & Mairal


Biotech inventions in latin america argentina

AGENDA

  • Importance of biotech in Argentina

  • Plant variety protection

  • Patents

  • Registration of biotech products

  • Data exclusivity and biotech products

  • Summary


Biotech inventions in latin america argentina

AGENDA

  • Importance of biotech in Argentina

  • Plant variety protection

  • Patents

  • Registration of biotech products

  • Data exclusivity and biotech products

  • Summary


Importance of biotech in argentina

Importance of biotech in Argentina

Pharma

Agribusiness


Importance of biotech in argentina pharma industry

Importance of biotech in ArgentinaPharma industry

  • Argentine pharmaceutical industry

    • Great importance in Argentina

    • Mainly devoted to small molecules – Moving to biotech field

    • Employing: 27,000 (directly) and 100,000 (indirectly)


Importance of biotech in argentina pharma industry1

Importance of biotech in ArgentinaPharma industry

  • Argentine pharmaceutical industry

    • 250 laboratories

    • Market:

      • 55% local – 45% international

      • 88% branded products

      • 90% (value) prescription drugs


Importance of biotech in argentina pharma industry2

Importance of biotech in ArgentinaPharma industry

  • Argentine pharmaceutical industry

    • $ 3,220 M (2008)

    • 7% of the Argentine industry

    • Imports

    • Exports

    • Negative trade balance: Government encouraging pharma exports


Importance of biotech in argentina pharma industry exports

Importance of biotech in ArgentinaPharma industry - Exports


Importance of biotech in argentina agribusiness industry

Importance of biotech in ArgentinaAgribusiness industry


Importance of biotech in argentina agribusiness industry1

Importance of biotech in ArgentinaAgribusiness industry

Agribusiness

  • 19% of GDP

  • 54% of Argentine exports

  • 36% of registered workers


Biotech inventions in latin america argentina

AGENDA

  • Importance of biotech in Argentina

  • Plant variety protection

  • Patents

  • Registration of biotech products

  • Data exclusivity and biotech products

  • Summary


Plant variety protection

Plant Variety Protection

  • Current Seeds and PVP Law: 40 years old

  • Extended use of farmer’s exemption

  • Widespread agreement on the need to amend the PVP Law

  • Bill drafted by the National Institute of Seeds –INASE- (enforcing agency of the current PVP law)


Plant variety protection1

Plant Variety Protection

  • INASE’s bill

    • Essentially derived variety

    • Farmer’s exemption

    • Provisional protection

    • Scope of PVP rights


Biotech inventions in latin america argentina

AGENDA

  • Importance of biotech in Argentina

  • Plant variety protection

  • Patents

  • Registration of biotech products

  • Data exclusivity and biotech products

  • Summary


Patents

Patents

  • Patentable subject matter

    • Restrictive approach compared to the US

      • Plants

      • Proteins, genes and/or DNA sequences

      • Methods for obtaining plants

      • Diagnostics and gene patenting


Patents patentable subject matter

Patents - Patentable subject matter

  • Plants

  • Not patentable:

  • Plants and animals (even if they are modified)

  • Plant parts and components that can derive in a complete individual, includingseeds

  • Plantcellscapable of regenerating a complete organism


  • Patents patentable subject matter1

    Patents - Patentable subject matter

    • Proteins

  • Not patentable:

  • Isolated proteins or their fragments, since they are considered to be natural substances

  • Recombinant proteins encoded by a sequence identical to the natural counterpart

  • Patentable:

  • Modified proteins

  • Compositions comprising an isolated protein (even when the sequence is not modified)


  • Patents patentable subject matter2

    Patents - Patentable subject matter

    • DNA sequences

  • Not patentable:

  • Isolated genes or their fragments: considered to be natural substances

  • Patentable:

  • Modified genes or promoters


  • Patents patentable subject matter3

    Patents - Patentable subject matter

    • Methods for obtaining plants

  • Not patentable:

  • Essentially biological processes (e.g. process for generating a plant by breeding and selection)

  • Patentable:

  • Biotechnological processes for producing a protein, gene or transgenic organism (eg. recombinant protein production, cloning, transforming methods)

  • Plant Breeding methods with a significant human intervention?


  • Patents patentable subject matter4

    Patents - Patentable subject matter

    • Diagnostics and gene patenting

  • Not patentable:

  • Medical treatment methods

  • Isolated and/or purified matter

  • Totipotential cells

  • Patentable:

  • In vitro (cultured) human-modified cells


  • Patents patentable subject matter5

    Patents - Patentable subject matter

    • In re: Pfizer (2013)

  • Pharma case related to selection inventions

  • Selection inventions: Patentable subject matter. A generic disclosure does not affect the novelty of a specific description

  • Support: Allows an obvious generalization of the originally disclosed subject matter. It is possible to amend and include obvious information and examples

  • Possible implications to the biotech industry:

    • Patentable subject matter: Selection of a specific product from a generic disclosure

    • Support: Identity percentages should be allowed


  • Patents enforcement

    Patents - Enforcement

    • Biotech patents can be enforced in Argentina

    • Judge – lacks technical background: Scientific evidence of greater importance – Independent expert appointed by the court

    • In re: Syngenta – GA21

      • Public acknowledgement of infringement

      • Damages

      • License agreement

      • Agreement


    Biotech inventions in latin america argentina

    AGENDA

    • Importance of biotech in Argentina

    • Plant variety protection

    • Patents

    • Registration of biotech products

    • Data exclusivity and biotech products

    • Summary


    Registration of biotech products

    Registration of biotech products

    • Newly issued regulations for approving biotech products

    • Biological products: Proteins, nucleic acids, sugars or complex combination of such substances, or living entities such as cells or tissues or are derivatives from them, that may be isolated from a variety of natural sources originated from humans, animals or microorganisms, or obtained by biotechnology methods or other technologies, thereby being more complex to characterize, requiring a more detailed description of structure and its manufacturing process

    • Approving a biotech product:

      • First worldwide approval in Argentina

      • Abbreviated approval in Argentina


    Registration of biotech products1

    Registration of biotech products

    • First worldwide approval in Argentina

    • Full dossier including:

      • Applicant and manufacturer general data,

      • Quality Information

      • Preclinical Information

        • Toxicity studies, toxicological evaluation of pollutants and impurities.

      • Clinical Information

        • Product’s pharmacological properties, pharmacological efficacy and safety.

        • Post-grant surveillance plan and duty of informing any adverse effect

        • Requirements in line with international standards


    Registration of biotech products2

    Registration of biotech products

    • Abbreviated approval in Argentina

    • The abbreviated procedure is available for products having an equivalent product, which has been commercialized in Argentina or abroad

    • Equivalent products: same qualitative and quantitative composition, therapeutic indication and way of administration

    • Only for products containing well characterized proteins and products manufactured under the same processes

    • General regulation: Product-specific guidelines to be issued


    Registration of biotech products3

    Registration of biotech products

    • Abbreviated approval in Argentina

    • Abbreviated dossier including:

      • Applicant and manufacturer general data,

      • Quality Information

        • No pre-clinical and clinical information required

        • Post-grant surveillance plan and duty of informing any adverse effect


    Biotech inventions in latin america argentina

    AGENDA

    • Importance of biotech in Argentina

    • Plant variety protection

    • Patents

    • Registration of biotech products

    • Data exclusivity and biotech products

    • Summary


    Data protection

    Data Protection

    Data Protection under the TRIPS Agreement

    Section 39.3 of the TRIPS Agreement provides: “Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use…”


    Data protection1

    Data Protection

    Data Protection under the Argentine Law

    Health approval system allows third parties to indirectly rely on confidential information produced by the originator of the product

    The third party obtains a free ride


    Data protection2

    Data Protection

    • Current state of data protection in Argentina

    • Lack of effective data protection

    • In re: Novartis (2011). The Federal Court of Appeals stated, obiter, in a data protection case that the Argentine approval system was not contrary to article 39.3 of the TRIPS Agreement

    • 4 cases still remaining


    Biotech inventions in latin america argentina

    AGENDA

    • Importance of biotech in Argentina

    • Plant variety protection

    • Patents

    • Registration of biotech products

    • Data exclusivity and biotech products

    • Summary


    Biotech inventions in latin america argentina

    Summary

    • Plant variety protection

      • Currently, inefficient law

      • Bill addressing and correcting some difficulties of the current law

    • Patents

      • Patentable subject matter: Currently, restrictive approach. May change in the future

      • Enforceable patents

    • Registration of Biotech products

      • Newly issued regulations. Allows third party’s free ride

    • Data exclusivity and biotech products

      • Lack of data exclusivity


    Thank you

    Thank you!


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