biotech inventions in latin america argentina
DESCRIPTION
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 - PowerPoint PPT PresentationTRANSCRIPT
Biotech Inventions in Latin AmericaArgentina
Ignacio Sánchez Echagüe
Marval, O’Farrell & Mairal
MAR
VAL,
O'F
ARRE
LL &
MAI
RAL
2
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
MAR
VAL,
O'F
ARRE
LL &
MAI
RAL
3
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
MAR
VAL,
O'F
ARRE
LL &
MAI
RAL
4
Importance of biotech in Argentina
Pharma
Agribusiness
MAR
VAL,
O'F
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LL &
MAI
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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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Importance of biotech in ArgentinaPharma industry
Argentine pharmaceutical industry
• 250 laboratories
• Market:
• 55% local – 45% international
• 88% branded products
• 90% (value) prescription drugs
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LL &
MAI
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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
MAR
VAL,
O'F
ARRE
LL &
MAI
RAL
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Importance of biotech in ArgentinaPharma industry - Exports
MAR
VAL,
O'F
ARRE
LL &
MAI
RAL
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Importance of biotech in ArgentinaAgribusiness industry
MAR
VAL,
O'F
ARRE
LL &
MAI
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Argentine GDP
81%
19%
Agribusiness Other industries
Argentine Exports
54%
46%
Agribusiness Other industries
Importance of biotech in ArgentinaAgribusiness industry
Agribusiness• 19% of GDP
• 54% of Argentine exports
• 36% of registered workersRegistered workers
36%
64%
Agribusiness Other industries
MAR
VAL,
O'F
ARRE
LL &
MAI
RAL
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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
MAR
VAL,
O'F
ARRE
LL &
MAI
RAL
12
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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VAL,
O'F
ARRE
LL &
MAI
RAL
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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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VAL,
O'F
ARRE
LL &
MAI
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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
MAR
VAL,
O'F
ARRE
LL &
MAI
RAL
15
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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O'F
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LL &
MAI
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Patents - Patentable subject matter
DNA sequences
Not patentable:
• Isolated genes or their fragments: considered to be natural substances
Patentable:
• Modified genes or promoters
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VAL,
O'F
ARRE
LL &
MAI
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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?
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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
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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
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
MAR
VAL,
O'F
ARRE
LL &
MAI
RAL
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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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Registration of biotech products
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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
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Registration of biotech products
MAR
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LL &
MAI
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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
MAR
VAL,
O'F
ARRE
LL &
MAI
RAL
29
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
MAR
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O'F
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MAI
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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
MAR
VAL,
O'F
ARRE
LL &
MAI
RAL
33
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
MAR
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Thank you!