biotech inventions in latin america argentina ignacio sánchez echagüe marval, o’farrell &...

Biotech Inventions in Latin AmericaArgentina

Ignacio Sánchez Echagüe

Marval, O’Farrell & Mairal

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AGENDA

1. Importance of biotech in Argentina

2. Plant variety protection

3. Patents

4. Registration of biotech products

5. Data exclusivity and biotech products

6. Summary

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AGENDA



3. Patents



6. Summary

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Importance of biotech in Argentina

Pharma

Agribusiness

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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)

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• 250 laboratories

• Market:

• 55% local – 45% international

• 88% branded products

• 90% (value) prescription drugs

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• $ 3,220 M (2008)

• 7% of the Argentine industry

• Imports

• Exports

• Negative trade balance: Government encouraging pharma exports

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Importance of biotech in ArgentinaPharma industry - Exports

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Importance of biotech in ArgentinaAgribusiness industry

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Argentine GDP

81%

19%

Agribusiness Other industries

Argentine Exports

54%

46%


Importance of biotech in ArgentinaAgribusiness industry

Agribusiness• 19% of GDP

• 54% of Argentine exports

• 36% of registered workersRegistered workers

36%

64%


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AGENDA



3. Patents



6. Summary

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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)

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Plant Variety Protection

• INASE’s bill

• Essentially derived variety

• Farmer’s exemption

• Provisional protection

• Scope of PVP rights

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AGENDA



3. Patents



6. Summary

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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

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Patents - Patentable subject matterPlants

Not patentable:

• Plants and animals (even if they are modified)

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

• Plant cells capable of regenerating a complete organism

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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)

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DNA sequences

Not patentable:

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

Patentable:

• Modified genes or promoters

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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?

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Diagnostics and gene patenting

Not patentable:

• Medical treatment methods • Isolated and/or purified matter• Totipotential cells

Patentable:

• In vitro (cultured) human-modified cells

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Patents - Patentable subject matterIn 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:

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

2. Support: Identity percentages should be allowed

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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

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AGENDA



3. Patents



6. Summary

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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:

1. First worldwide approval in Argentina2. Abbreviated approval in Argentina

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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

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AGENDA



3. Patents



6. Summary

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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…”

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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

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Data Protection

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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

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AGENDA



3. Patents



6. Summary

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Summary

1. Plant variety protection1. Currently, inefficient law2. Bill addressing and correcting some difficulties of the current law

2. Patents1. Patentable subject matter: Currently, restrictive approach. May

change in the future2. Enforceable patents

3. Registration of Biotech products1. Newly issued regulations. Allows third party’s free ride

4. Data exclusivity and biotech products1. Lack of data exclusivity

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Thank you!

biotech inventions in latin america argentina ignacio sánchez echagüe marval, o’farrell &...

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