© 2011 dannemann siemsen. todos os direitos reservados. biotech ip issues in brazil gustavo morais...

© 2011 Dannemann Siemsen. Todos os direitos reservados.

Biotech IP issues in Brazil

Gustavo Morais

May 2011

Gustavo Morais

May 2011


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Brazil - Patents Changing scenario

Brazil - Patents Changing scenario

No pharmaceutical and agrochemical patents (products) as of 1945 (processes excluded as of 1969)

No provisions concerning living matter

TRIPS - Jan 1, 1995

IP Law Nº 9,279 of May 14, 1996 (IPL)

No pharmaceutical and agrochemical patents (products) as of 1945 (processes excluded as of 1969)

No provisions concerning living matter

TRIPS - Jan 1, 1995

IP Law Nº 9,279 of May 14, 1996 (IPL)


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Agrochemical patents

Patentability of GM microorganisms and of several inventions involving living matter

Waive of transition periods

Pipeline patents

Criteria for damage calculation

Agrochemical patents

Patentability of GM microorganisms and of several inventions involving living matter

Waive of transition periods

Pipeline patents

Criteria for damage calculation


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Preliminary injunctions

Civil and criminal penalties against infringers

Infringement by equivalency

Patent term: 20 years as of filing or 10 years from grant, whichever expires later

Problem: ANVISA’s intervention – pharmaceutical products and processes

Preliminary injunctions

Civil and criminal penalties against infringers

Infringement by equivalency

Patent term: 20 years as of filing or 10 years from grant, whichever expires later

Problem: ANVISA’s intervention – pharmaceutical products and processes


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Patentability criteria Novelty Inventive step Industrial applicability

Enablement Brazil not a member of Budapest Treaty Biological material may be filed in any IDA

Patentability criteria Novelty Inventive step Industrial applicability

Enablement Brazil not a member of Budapest Treaty Biological material may be filed in any IDA

Patent basicsPatent basics


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PatentsSubject matter

PatentsSubject matter

Not patentable:

Living beings and parts thereof, including cells even if modified TRIPS 27.3(b) allows exclusion of patentability only “plants

and animals”

Naturally occurring biological material (even if isolated, purified or synthesized) and natural biologic processes

Not patentable:

Living beings and parts thereof, including cells even if modified TRIPS 27.3(b) allows exclusion of patentability only “plants

and animals”

Naturally occurring biological material (even if isolated, purified or synthesized) and natural biologic processes


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Not patentable:

Therapeutic, surgical and diagnostic methods applied to human or animal bodies

Discoveries as opposed to inventions

Genetic Use Restriction Technologies (GURTs) Crime to use, sell, register, patent and license

Not patentable:

Therapeutic, surgical and diagnostic methods applied to human or animal bodies

Discoveries as opposed to inventions

Genetic Use Restriction Technologies (GURTs) Crime to use, sell, register, patent and license


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Patentable:

Microorganisms genetically modified through human intervention

Modified DNA/RNA sequences and genes Considered as chemical compounds

Any process of genome modification

Patentable:

Microorganisms genetically modified through human intervention

Modified DNA/RNA sequences and genes Considered as chemical compounds

Any process of genome modification


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Patentable:

Chemical compositions characterized by its intrinsic features, even if including naturally occurring biological material

Processes for obtaining, isolating, modifying, manufacturing and using biological materials and living beings Except humans (biosafety law)

Patentable:

Chemical compositions characterized by its intrinsic features, even if including naturally occurring biological material

Processes for obtaining, isolating, modifying, manufacturing and using biological materials and living beings Except humans (biosafety law)


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Polynucleotides epolypeptides


Allowable claims:

DNA sequence characterized by presenting ... Sequence DNA sequence characterized by being Seq. ID nº Recombinant protein characterized by being Seq. ID nº

Not allowable claims:

DNA sequence characterized by codifying protein X Protein characterized by presenting activity Y

Allowable claims:

DNA sequence characterized by presenting ... Sequence DNA sequence characterized by being Seq. ID nº Recombinant protein characterized by being Seq. ID nº

Not allowable claims:

DNA sequence characterized by codifying protein X Protein characterized by presenting activity Y


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Naturally occuring biological material – not patentable

A composition including such material may be if its only distinctive feature is not the presence of of the material

Purifying and isolation methods - patentable

Naturally occuring biological material – not patentable

A composition including such material may be if its only distinctive feature is not the presence of of the material

Purifying and isolation methods - patentable


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AntibodiesAntibodies

Patentable

Monoclonal antibody characterized by its hybridoma

Not patentable

Polyclonal antibodies since they considered a by-product of natural biological processes

Patentable

Monoclonal antibody characterized by its hybridoma

Not patentable

Polyclonal antibodies since they considered a by-product of natural biological processes


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Methods of treatment and diagnosisMethods of treatment and diagnosis

Not patentable per se Swiss type claims

Patentable - methods of obtaining data outside the human or animal body such as measuring blood pressure, X-ray examination, hemograms, etc.

Not patentable - methods of diagnosis performed in the human or animal body (e.g, to determine an allergy)

Not patentable per se Swiss type claims

Patentable - methods of obtaining data outside the human or animal body such as measuring blood pressure, X-ray examination, hemograms, etc.

Not patentable - methods of diagnosis performed in the human or animal body (e.g, to determine an allergy)


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Stem cellsStem cells

Not patentable per se

Patentable - methods of obtaining stem cells and using them, except if method of treatment or diagnosis

Not patentable per se

Patentable - methods of obtaining stem cells and using them, except if method of treatment or diagnosis


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IP in agricultureIP in agriculture

Plants not patentable, even if GM Only the genes Plant variety protection

Examples of allowable claims:

Method of pest or weed control using certain agrochemicals and/or plants

Process to confer to plants resistance to XYZ pesticide

Plants not patentable, even if GM Only the genes Plant variety protection

Examples of allowable claims:

Method of pest or weed control using certain agrochemicals and/or plants

Process to confer to plants resistance to XYZ pesticide


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Access to Brazilian biodiversityAccess to Brazilian biodiversity

Authorization to access GRs and associated TK

Indication of source in patent applications filed as of 2007

Components of genetic heritage x biological resources

Recent PTO office actions and fines imposed on companies

Authorization to access GRs and associated TK

Indication of source in patent applications filed as of 2007

Components of genetic heritage x biological resources

Recent PTO office actions and fines imposed on companies


Thank you!

Obrigado!

[email protected]

© 2011 dannemann siemsen. todos os direitos reservados. biotech ip issues in brazil gustavo morais...

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