Biotech Inventions in Latin America Argentina

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

Importance of biotech in Argentina Pharma Agribusiness

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 ArgentinaPharma industry • Argentine pharmaceutical industry • 250 laboratories • Market: • 55% local – 45% international • 88% branded products • 90% (value) prescription drugs

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 ArgentinaPharma industry - Exports

Importance of biotech in ArgentinaAgribusiness industry

Importance of biotech in ArgentinaAgribusiness industry Agribusiness • 19% of GDP • 54% of Argentine exports • 36% of registered workers

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 Protection • INASE’s bill • Essentially derived variety • Farmer’s exemption • Provisional protection • Scope of PVP rights

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 • 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 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 matter • DNA sequences • Not patentable: • Isolated genes or their fragments: considered to be natural substances • Patentable: • Modified genes or promoters

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 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 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 • 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

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 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 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 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

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 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 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

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!

Biotech Inventions in Latin America Argentina