Transcript Patent protection of biotechnology inventions in Brazil

Patent protection of biotechnology
inventions in Brazil
Leonor Galvão de Botton, Ph.D.
AIPLA Webinar
June 27, 2013
Agenda
I.
Introduction
II.
Patentability Requirements of Biotechnology Inventions
•
•
•
•
Natural substances
Genes, biological pharmaceuticals and biosimilars
Cells and living organisms
Diagnostic methods and methods of treatment
III. Access to genetic resources and the disclosure of origin requirement
IV. ANVISA´s role in pharmaceutical patent review
V.
Patent Prosecution at the BPTO
VI. Patent enforcement
VII. Conclusions
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Agenda
I.
Introduction
II.
Patentability Requirements of Biotechnology Inventions
•
•
•
•
Natural substances
Genes, biological pharmaceuticals and biosimilars
Cells and living organisms
Diagnostic methods and methods of treatment
III. Access to genetic resources and the disclosure of origin requirement
IV. ANVISA´s role in pharmaceutical patent review
V.
Patent Prosecution at the BPTO
VI. Patent enforcement
VII. Conclusions
3
I. Introduction
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I. Introduction
International Treaties
• UPOV Convention (1978)
• Paris Convention - 1883
• Patent Cooperation Treaty - 1978
• TRIPS Agreement
Brazilian IP Laws & Regulations
•Plant Variety Protection Law No. 9.456/1997
•Industrial Property Law 9.279/1996
•Law 10.196/2001, Regulas ANVISA´s role in pharmaceutical patent
review
•Provisional Act 2.186/2001, Regulates the Convention on Biological
Diversity
•BPTO
Normative Act 127
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Agenda
I.
Introduction
II.
Patentability Requirements of Biotechnology Inventions
•
•
•
•
Natural substances
Genes, biological pharmaceuticals and biosimilars
Cells and living organisms
Diagnostic methods and methods of treatment
III. Access to genetic resources and the disclosure of origin requirement
IV. ANVISA´s role in pharmaceutical patent review
V.
Patent Prosecution at the BPTO
VI. Patent enforcement
VII. Conclusions
6
II. Patent Protection of Biotechnology Inventions:
Patentability Requirements
Natural substances
Article 10 of the Brazilian Industrial Property Law:
•“The following are not considered to be inventions or utility models: (…)
IX - natural living beings, in whole or in part, and biological material,
including the genome or germ plasm of any natural living being,
when found in nature or isolated therefrom, and natural
biological processes”.
•New bill (4,961/05) by House of Representatives to allow the patenting
of natural substances isolated from nature -> File now!
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II. Patent Protection of Biotechnology Inventions:
Patentability Requirements
Genes, biological pharmaceuticals and biosimilars
•
Natural substances even if purified and isolated: not allowed.
•
Synthetic polynucleotides, polypeptides and antibodies: allowed.
• If structure is not known, the compound may be defined in terms
of its physical, chemical or biological properties.
• % homology and ability to hybridize under certain conditions:
objected due to insufficient disclosure/lack of enablement
•
Recombinant DNA structures and vectors: allowed.
•
Compositions comprising natural substances: allowed.
•
Need to define components of the vector/composition: limiting
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II. Patent Protection of Biotechnology Inventions:
Patentability Requirements
Cells and living organisms
•“Art. 10 of the Brazilian Industrial Property Law – The following are not
considered to be inventions or utility models: (…)
IX - natural living beings, in whole or in part, and biological material,
including the genome or germ plasm of any natural living being, when
found in nature or isolated therefrom, and natural biological processes”.
•“Article 18 of the Brazilian Industrial Property Law - The following are not
patentable (…):
III - living beings, in whole or in part, except transgenic
microorganisms meeting the three patentability requirements - novelty,
inventive activity and industrial application – provided for in article 8 and
which are not mere discoveries”.
“Sole Paragraph – For the purposes of this law, transgenic
microorganisms are organisms, except the whole or part of plants or
animals, that exhibit, due to direct human intervention in their genetic
composition, a characteristic that can not normally be attained by the
species under natural conditions”.
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II. Patent Protection of Biotechnology Inventions:
Patentability Requirements
Cells and living organisms
• Modified microorganisms/ microorganism cells: allowed.
• Plant/animal cells: are not considered microorganisms and are not
allowed.
• Modified animals /plants: not allowed.
• Processes of modifying and producing microorganisms, plants and
animals and their cells are allowed (not human cells or embryos).
• Host cells: the same considerations used for microorganisms,
excluding plant/animal cells from patentability.
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II. Patent Protection of Biotechnology Inventions:
Patentability Requirements
Diagnostic methods, methods of treatment and medical uses
•
Methods of surgical, therapeutic or diagnostic treatment applicable to
the human body or to animals : not allowed.
•
Products destined to put methods into practice: allowed.
•
Methods outside the body and/or non-therapeutic: allowed.
•
1st and 2nd medical uses allowed as Swiss-type if inserted into the
claim set prior to the request for examination.
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II. Patent Protection of Biotechnology Inventions:
Patentability Requirements
Patentability of Biotechnology Inventions
Compound X isolated from nature (gene, protein, antibody etc).
Modified DNA, RNA, gene, protein, antibody, vector, etc.
Vaccines, medicaments, formulations comprising natural compounds
Natural biological processes
Processes to isolate, modify and synthesize natural substances
Use of gene, protein or compound X isolated from nature (non-therapeutic)
Modified microorganisms/ microorganism cells
Modified animals/plants or their cells
Processes of modifying and producing microorganisms
Processes of modifying and producing plants and animals
Surgical, therapeutic, diagnostic methods applic. to the human body or animals
First and second medical use – Swiss-type claim
Allowed
Allowed with restrictions
Not allowed
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Agenda
I.
Introduction
II.
Patentability Requirements of Biotechnology Inventions
•
•
•
•
Natural substances
Genes, biological pharmaceuticals and biosimilars
Cells and living organisms
Diagnostic methods and methods of treatment
III. Access to genetic resources and the disclosure of origin requirement
IV. ANVISA´s role in pharmaceutical patent review
V.
Patent Prosecution at the BPTO
VI. Patent enforcement
VII. Conclusions
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III. Access to Genetic Resources and the Disclosure
of Origin Requirement
Provisional Act No. 2,186/2001 - Regulates the CBD.
• Determines the need for Access Authorization & benefit sharing.
• If access was contrary to the PA patent rights may be null.
BPTO´s resolution 207 /2009
• Retroactive for applications filed after June 30, 2000. No BPTO fee.
• Office actions issued for all applications in relevant classes
• Must inform origin of the genetic material and associated traditional
knowledge and corresponding Access Authorization number issued by
CGEN.
• Information provided preferably in the start of examination.
Legal uncertainty:
• Brazilian mango bought at Walmart?
• New bill being proposed – less sanctions = more benefit sharing.
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Agenda
I.
Introduction
II.
Patentability Requirements of Biotechnology Inventions
•
•
•
•
Natural substances
Genes, biological pharmaceuticals and biosimilars
Cells and living organisms
Diagnostic methods and methods of treatment
III. Access to genetic resources and the disclosure of origin requirement
IV. ANVISA´s role in pharmaceutical patent review
V.
Patent Prosecution at the BPTO
VI. Patent enforcement
VII. Conclusions
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IV. ANVISA’s role in pharmaceutical patent review
Art. 229-C of IP Law 9.279/96 states that:
“The grant of patents to pharmaceutical products and processes will
depend on the previous approval of the National Health Surveillance
Agency (ANVISA).”
Interministerial Working Group Decision (May/2012):
“Prior allowance should occur even before the BPTO examination.
Procedure BPTO/ANVISA
1. BPTO will exam the formal aspects.
2. Files go to ANVISA for the technical examination.
3. Files return to the BPO for patenteabilty examination.
4. If the ANVISA does not allow the granting of the application, the
BPTO will not exam it, and will publish its shelving.
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IV. ANVISA’s role in pharmaceutical patent review
Federal Attorney General’s legal opinion (Jan/2011):
“ANVISA’s responsibility is to proceed with the analysis of the sanitary
risks of the patented drug to the health.”
Resolution – RDC nº 21 of April 10, 2013
"The patent application is deemed contrary to public health in 2 cases:
• If the claimed pharmaceutical product or process presents a
health risk;
• If the pharmaceutical product or process refer to substances
included in the Brazilian National List of Essential Medicines
(RENAME) or are declared of interest for the medicine policies
within the Unified Health System (SUS) through an Ordinance
of the Ministry of Health."
• Controversies in the public hearing of March 20, 2013.
• Legal uncertainty.
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Agenda
I.
Introduction
II.
Patentability Requirements of Biotechnology Inventions
•
•
•
•
Natural substances
Genes, biological pharmaceuticals and biosimilars
Cells and living organisms
Diagnostic methods and methods of treatment
III. Access to genetic resources and the disclosure of origin requirement
IV. ANVISA´s role in pharmaceutical patent review
V.
Patent Prosecution at the BPTO
VI. Patent enforcement
VII. Conclusions
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V. Patent Prosecution at the BPTO
Year
Examiners
Applications
filed
Patents
Granted
Examination time
2005
112
21,847
2,819
10
2010
253
28,141
3,617
8,1
2011
253
31,765
3,801
-
2012
320
33,780
3,137
-
2015
600
-
-
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•
More & better qualified examiners and prosecutors – stronger patents
•
Increased productivity (approx. 12-18 months once examination begins)
•
Implementation of the e-Patents system (2011-2013)
•
Examination time down to 4 yrs by 2016.
•
Higher BPTO fees.
•
Consistent exams - NEW GUIDELINES UNDER PUBLIC CONSULTATION
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Agenda
I.
Introduction
II.
Patentability Requirements of Biotechnology Inventions
•
•
•
•
Natural substances
Genes, biological pharmaceuticals and biosimilars
Cells and living organisms
Diagnostic methods and methods of treatment
III. Access to genetic resources and the disclosure of origin requirement
IV. ANVISA´s role in pharmaceutical patent review
V.
Patent Prosecution at the BPTO
VI. Patent enforcement
VII. Conclusions
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VI. Patent enforcement
• Legal proceedings are regulated by the Brazilian Civil Procedure
Code.
• No distinction as to the procedure of lawsuits involving patents or
other IP rights.
• IP Law is recent and there is a limited number of granted
patents, comparing to the United States or Europe.
• Brazil is a civil law country, i.e. Court precedents are not binding.
Any patent litigation precedents are more a directive and/or
interpretation concept than an actual source of law.
• Patent infringment lawsuits are filed before the State Court.
• Patent nullitylawsuits are filed before the Federal Court.
• Infringement and Nullity actions may not be litigated together.
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IV. Patent enforcement
Specialised IP Courts
• Better qualified judges and technical experts.
• Federal and State IP courts in Rio de Janeiro.
Increase in Patent Nullity Actions
• Patents that are granted without meeting all legal and formal
requirements;
• Nullity of the patent may be partial (i.e. only certain claims are null).
• Claim may not be re-written.
Increase in Patent Infringement Actions
• Infringement acts (literal and by equivalence);
• Indirect infringement acts.
Effective remedies
• Injunctions
• Cessation of the infringement (daily penalty);
• Destruction of the products;
• Loss and damages compensation, ex: loss of profits.
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Agenda
I.
Introduction
II.
Patentability Requirements of Biotechnology Inventions
•
•
•
•
Natural substances
Genes, biological pharmaceuticals and biosimilars
Cells and living organisms
Diagnostic methods and methods of treatment
III. Access to genetic resources and the disclosure of origin requirement
IV. ANVISA´s role in pharmaceutical patent review
V.
Patent Prosecution at the BPTO
VI. Patent enforcement
VII. Conclusions
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VII. Conclusions
Growing IP awareness & efficiency
•
•
•
562 PCT applications filed in 2012.
Improved prosecution, backlog etc.
Improved IP enforcement.
Less conservative legislative trends
• Bill (4,961/05) – Patentability of natural substances.
• Reduction ANVISA’s role in pharmaceutical patent review.
Brazil’s boom is driving the need for an improved IP system
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Thank you.
Obrigada.
Leonor Galvão de Botton, Ph.D.
[email protected]
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