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BRAZILIAN HIGH-TECH LITIGATION:

Law, Business & Policy

Thursday, May 12 – Washington, DC

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BRAZILIAN HIGH-TECH LITIGATION: Law, Business & Policy The George Washington University Law School

Pharma and Biotech ch Patents s Prose secu cutio ion: Examin inin ing guideli lines s and fast-track ck examin inatio ion

Luiza Cotia Pharmacist and Patent Specialist

Pharma and Biotech Patents Prosecution

Examining guidelines and fast-track examination

Luiza Cotia, Pharmacist and Patent Specialist

Thursday, May 12 – Washington, DC

Fast-track examination

5

• The Brazilian Patent Office (BRPTO)
• Strong influence of the EPO
• Training by the WIPO in the 1980’s
• Examiners will often study the examination of the EPO patent family
• Major problems of the BRPTO
• Infrastructure
• Budget
• Inefficiency
• Huge backlog (average 10 years for starting to examine a patent application)

The Brazilian Patent Office

6

• BRPTO prioritized examination programs applicable to pharma and biotech patent

applications

• GENERAL (Rule #151/2015): fast-track examination of applications covering:

1. Technology being used by unauthorized third parties (ongoing or potential infringement activity) (requested by the applicant); 2. Technology of public interest (requested by the Government);

• PHARMA (Rule #80/2013): fast-track examination of applications related to

the diagnosis, prevention or treatment of HIV, cancer or neglected diseases;

Overcoming the backlog: pharma fast-track

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• The Ministry of Health and Rule #80/2013
• Rule #80/2013 also provides the possibility of prioritized examination of patent

applications covering products, process and medical devices considered strategic to SUS (art. 3 of the Rule).

• The patent applications are not related only to the diagnosis, prevention or treatment of

HIV, cancer or neglected diseases.

• The Ministry of Health has never used this fast-track possibility.
• On April 16 2015 a cooperation program between the BRFDA and the Fiocruz was

approved (Proceeding #25351.538402/2014-3)

• The Cooperation program has the goal of identifying pending patent applications that

should be requested by the Ministry of Health to be placed under priority examination by the BRPTO.

Overcoming the backlog: pharma fast-track

8

• 1,832 priority examination requests in total.
• 95 are patent applications covering pharma inventions.
• 69 priority examinations granted for pharma applications.
• Only 26 applications using Rule #80/2013 -> 10 applications (39%) are being

handled by Licks.

• The decision granting the priority examination request is published within 35 to 50

days.

• After granting the priority examination, the BRPTO takes between 3 to 5 months

to forward the application to BRFDA for prior approval.

Overcoming the backlog: Our strategic counseling

Claiming biotech and pharma inventions

10

• The whole or part of natural living beings and biological materials found in nature

represent non-statutory subject matter (art. 10, line IX of Statute #9,279/96):

• Synthetic molecules vs. natural counterparts;
• Composition comprising natural molecules or synthetic molecules identical to the

natural molecules and water and saline as excipients are not patentable (art. 10, IX);

• Latter published documents may be used to show that the molecule is of natural
• ccurrence.
• Living beings, in whole or in part, except transgenic microorganisms meeting the

three patentability requirements, also represent non-statutory subject matter (art. 18, line III of Statute #9,279/96):

• Microorganims are bacteria, archaea, fungus, single-cell algae not classified in the Plant

Kingdom and protozoaria.

Claiming biological molecules

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• DNA must be defined through its nucleotide sequence:
• A DNA sequence cannot be described by its hybridization process.
• Protein must be defined through its amino acid sequence;
• Biologic molecules cannot be claimed by its function;
• Derivatives are permitted as long as the amino acid substitution, deletion,

addition or insertion are defined by the amino acid sequence. This can be used to avoid application of art. 10, line IX;

Claiming biological molecules

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• Polyclonal antibodies are biological products isolated from nature and, thus,

represent non-statutory subject matter (art. 10, IX of Statute #9,279/96);

• Monoclonal antibodies are considered as statutory subject matter:
• Monoclonal antibodies must be claimed by its sequence identification number or by its

hybridoma;

• The hybridoma must be clearly defined in the specification, or the deposit number of

the hybridoma must otherwise be informed. The hybridoma must be filed until the filing or priority date of the application;

• The BRPTO recognizes only depository authorities indicated under the Budapest Treaty.

Claiming biological molecules

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• Patent examination guidelines of 2015 (item 3.79 – block I) => the acceptable

format for claiming a medical use invention is the Swiss-type.

• Swiss-type: “use of compound X in the manufacture of a medicine/composition for

treating condition Y”

• The BRPTO will probably follow the EPO rules.
• Suggestion: Including both Swiss-type claims and “EPC 2000” claims.
• EPC2000: “Compound X for use in the treatment of condition Y”

Claiming pharma inventions

Claim amendments

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• BRPTO strict position when the applicant perform amendments after the

examination request

• BRPTO issued Rule #93/2013 regarding articles 26 and 32 of the Statute

#9,279 on claim amendments;

• Before the request of substantive examination, any amendment on the

specification, abstract, drawings or claims is acceptable if it is limited to the subject matter disclosed in the originally filed application;

• After the request of substantive examination only amendments intended to

restrict the claimed matter or to correct clerical and translation mistakes are acceptable.

• Suggestion: Including an omnibus claim.
• “Invention of product, process, system or use characterized by all their elements

disclosed in the application.”

Claim amendments

Thanks!

luiza.cotia@lickslegal.com T +55 21 3550-3792 M +55 21 99457-3549