Patent protection in Latin America: Main provisions and

recommended strategy

Speaker:
Mr. Rafael Freire
Technical & Legal Services Manager
Clarke, Modet & C Brazil

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AGENDA
Summary - Patent Prosecution and
Non-eligible patent subject matter 01
Key Developments in Argentina, Brazil, Chile
Mexico, and Andean Community countries
including Mechanisms to expedite 02
examination

Patentability issues related to:

- pharmaceutical inventions 03
- electronic/software inventions
and Industrial Designs in Brazil

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Patent Prosecution Latin America
3

Tier Country Patent Index

Mexico
Tier 1
Chile

Tier 2 Colombia, Ecuador, *Bolivia & Peru

Tier 3 *Argentina, Brazil

Tier 1 Tier 2 Tier 3

- Easy prosecution - Strict examiners (difficulties - Strict examiners (difficulties for
- Less strict examiners: rely for proving inventiveness) proving inventiveness)
mainly on foreign prosecution - Reduced to Mid backlog - High Official Fees for exceeding
- Reduced backlog * Bolivia is a Non-PCT claims, specially BR
country - Restrictions for protection of
pharmaceutical inventions
- Substantial Backlog
* Argentina is a Non-PCT country
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SPOTLIGHT: NON-ELIGIBLE PATENT SUBJECT MATTER 4

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SPOTLIGHT: DIVISIONALS 5

Argentina Up to the conclusion of the examination.

In case of rejection, at the filing of the reply to the previous action.

Brasil Up to the conclusion of examination.

In case of rejection, at the filing of the reply to the previous action.
- amendments are restricted in case the examination is already
requested for the parent case.
Chile
Up to the conclusion of examination.

Mexico Up to the payment of the granting fees. In case of rejection, up to the

conclusion of examination.

Andean
Community Up to the conclusion of examination.
In case of rejection, at the filing of the appeal.

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SPOTLIGHT: IS GRACE PERIOD APPLICABLE FOR PREVIOUS DISCLOSURES?
6
Argentina Yes: 12 months backward from the filing date in Argentina or backward
from the respective priority date.

Brasil Yes: 12 months backward from the filing date in Brazil (PCT International
filing date for national phase application) or backward from the respective
priority date.

Chile Yes: 12 months backward from the filing date in Chile (PCT International
filing date for national phase application)

Mexico Yes: 12 months backward from the filing date in Mexico (PCT International
filing date for national phase application)

Andean Yes:
Community 12 months backward from the filing date in Colombia (PCT International
filing date for national phase application)
12 months backward from the filing date in Bolivia, Ecuador and Peru (PCT
International filing date for national phase application) or backward from
the respective priority date.
SPOTLIGHT: AVERAGE TIME FOR GRANTING DECISION 7

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AGENDA
Summary - Patent Prosecution and Non-
eligible patent subject matter 01
Key Developments in Argentina, Brazil,
Chile, Mexico, and Andean Community
countries including Mechanisms to 02
expedite examination

Patentability issues related to:

- pharmaceutical inventions 03
- electronic/software inventions
and Industrial Designs in Brazil

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Best practices for prosecution in Argentina 10

RECOMMENDED STRATEGY
If a counterpart application has been granted in the US or EP, it is recommended to adapt the set of claims to that of the
granted patent, since it might expedite the prosecution. Claims should comply with the formal requirements of the
Argentinean PTO and the subject matter should be limited to the subject matter patentable under the Argentine Patent Law.
Delay for as long as possible the reply to any outstanding Office Action in the Pharmaceutical and Biotechnology
fields, making use of the available deadline extensions, so as to gain time regarding a potential change or derogation of the
current guidelines.
Evaluate the possibility of filing divisional applications.

WHAT TO EXPECT?
Currently, we have seen a shift towards a more patent friendly environment, where patents have been granted by adapting the
local set of claims into the correspondent European granted claims.
 Best practices for Expediting Examination in Argentina 11

Request Examination when filing the Application.

PPH - New Resolution 56/2016 (in force since October 15, 2016):
- PPH may be required when any patent related to the same invention has been granted in any other country, but:

a) the patent must have been granted by a foreign Office that adopts similar patentability standards and provided that the granted claims complies with the
Argentine Law.

- the basic conditions in order to be eligible are:

a) the scope of the claims in Argentina should be identical to or narrower than that of the selected foreign patent, and
b) such foreign patent may not be eligible as prior art to the Argentinean application.

- After applying for the PPH, the first patentability report is expected to be received within 60 days.

Resolution PPH P56/16 is NOT recommendable for pharmaceutical applications

Best practices for prosecution in Brazil
13

RECOMMENDED STRATEGY
. Have as much examples as possible in the specification. Have a good description to comply with sufficiency of
disclosure (insert comments related to closest prior art references in the specification).
. Have as much claim categories as possible before requesting the examination.
. Amendments to the set of claims should preferable be filed prior to the examination request (strict position of Brazilian
PTO that is also applied for divisionals): scope can not be broadened after the examination request.
Strategy: include as many claim categories as possible and proceed with the filing of divisionals prior to the
examination request of the parent case.

Pay attention to the deadline for filing divisional applications after the rejection decision, divisionals are no
longer accepted (although the rejection may be reverted through the filing of an appeal).

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 Case 1 Divisional application filed after the issuance of the Rejection

On July 30th, 2015, the BRPTO issued the Rejection Decision for PI 0414085-0.
When appealing to this Decision, the Applicant, decided to file a divisional application, in order to seek protection for the claims removed
during the appeal stage.
On September 02nd, 2015, the divisional application BR 1220150214050 was filed.
On October 06th, 2015, the BRPTO issued the shelving of the application, without even performing a substantive examination, based on
Article 26 of the BR IP Law and Article 32 of the Normative Instruction 30/2013.
On December 7th, 2015, the appeal against the shelving decision was filed but subsequently, the BRPTO issued its final decision,
sustaining the shelving of the application.

End of examination in Brazil according to Normative Instruction 30/2013:

(I) the date stated in the conclusive opinion report (allowance, rejection or definitive shelving decision); or
(II) the thirtieth day that precedes the issuance thereof, whichever of these is the last to occur.

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Best practices for prosecution in Brazil 15

GENERAL ADVICES IN ORDER TO AVOID BASIC OFFICE ACTIONS

Avoid broad terminology, such as about and approximately in the claims.
Insert the expression characterized in that in all the claims.
Insert the reference numbers that appear in the drawings in the claims.
Avoid more than one independent claim of the same category.
The title must reflect the object of the invention as stated in the preamble of the independent claims.

STRATEGY
Adapting the Brazilian claims into the counterpart EP granted claims may be a good strategy.

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Backlog in Brazil
16
BRPTOs backlog is known all over the world, especially in patents division.

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Backlog in Brazil 17

WHAT TO EXPECT?
Aiming to reduce the backlog: 100 new examiners hired in 2016.
We have been hearing that the Patent Division of BRPTO is willing to use searches conducted by ISA/IPEA authorities and to
skip such stage. However, no Official resolution was issued so far.
More PPH agreements are expected for 2017: pilot PPH programs with JPO and EPO.

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Best practices for Expediting Examination in Brazil
18

a) Infringement of the invention

When a 3rd party is reproducing the object of the patent application without applicants authorization, the applicant may
submit a request for expediting examination.

The following documents must be presented at the Brazilian PTO:

- Proof that a 3rd party is reproducing the object of the invention without authorization.
- A copy of the cease and desist letter sent to the potential infringer specifying the number of the patent application.

It is important to notice that, since in Brazil, the term of validity shall not be less than 10 (ten) years for a patent of invention and 7 (seven) years for
a utility model counted from the granting decision, sometimes the applicant should consider if requesting the expedite examination would be a
good strategy, especially for products with long shelf life.
 Case 2 Potential Infringement made by a 3RD Party 19

The applicant of the MU 9101531-6 became aware that

its utility model was being reproduced by a third party
without its authorization.

A cease and desist letter was sent to the potential

infringer. However, the potential infringer did not cease
the marketing of the product.

Based on that, the applicant submitted a request for

expediting examination, which was filed on June 23th,
2016, and allowed on August 16, 2016.

The first Office Action was issued on October 11th, 2016

and the response was filed on January 9th, 2017.
Case 3 Potential Infringement of a 3RD Party application
20

One of our clients was notified by the applicant of application BR

2020120014268, alleging that said application was being reproduced
without its authorization.

Based on the arguments of the cease and desist letter, we

ascertained that the product of our client was not infringing said
application.

Further, during this process, we performed a search and found 3 prior

art documents which would be impeditive for the granting of this
patent.

On September 16th, 2016, a third party observation was filed, along

with the request for expediting examination, submitting said
documents and further arguments regarding the lack of novelty and
inventive act of this application.

The request for expediting examination was allowed on November

16th, 2016, and the first Office Action was already issued.
Best practices for Expediting Examination in Brazil 21

b) Green Patents
Brazilian PTO relaunched Green Patent Resolution in Dec. 6, 2016.
During pilot phase from the 480 applications, 325 were considered eligible.
Average decision-making time was about two years.

"green technology" encompasses methods, materials and techniques of product generation that cause less environmental impact in
the following areas: alternative energy sources, transport, conservation of energy, waste management and agriculture.
Requirements: applications should have been published or have the requirement for early publication filed, the technical examination
should not have started and should have a maximum of 15 claims (only three of them being independent).

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 Case 4 Green Patent Invention
22

that,

The application BR 1020120310384, which is directed to a

Method of treatment of emissions from coal processing and
related devices and systems, was filed on December 5th,
2012.
On December 10th, 2012, the applicant requested the entry
of the application in the Green Patent Program.
The BRPTO published the acceptance of the application in
said program on July 23th, 2013.
The patent was granted on December 24th, 2013 around
one year from the filing date.

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Best practices for Expediting Examination in Brazil
23

c) Pilot Project PPH with USPTO for Oil and Gas:

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Case 5 PPH USPTO-BRPTO 24

Application BR1020160008360 was filed on January 14,

2016 for a technology related to a Diesel engine and
additives for treating internal elements of fuel injectors
On April 25, 2016, the applicant requested the
participation in the PPH program
The BRPTO approved it on September 27, 2016
The granting of the patent was issued on December 20,
2016 without any intermediary opinion.

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 Best practices for Expediting Examination in Brazil 25

d) Pilot Project BR Priority: Interesting if the company is willing to start prosecution from Brazil

e) Age (applicant is 60 years old or older)

 Bestfor
Best practices practices for Expediting
prosecution Examination in Argentina
in Chile 27

RECOMMENDED STRATEGY:

Patent term extention (supplementary protection):

The Chilean PTO offers the possibility to apply for patent extension term under certain conditions:

(1) The term of prosecution of the application exceeds 5 years from the filing date until granting; or
(2) three years from the request for examination until granting, whichever of these is the last to occur.
(3) The time window to apply for the extension is up to 6 month from the granting date and it is applicable as long as there has
been an unjustified administrative delay for the granting of the patent.
- The supplementary protection will only correspond to the period which is proved as a delay in prosecution that could not be justified.
 Bestfor
Best practices practices for Expediting
prosecution andExamination
expeditingin Argentina
examination in Mexico 29

RECOMMENDED STRATEGY:
Conform the claim set to the corresponding granted claim set from a substantive examination done by a major Patent Office, e.g.
USPTO, EPO THIS MAY ALSO SPEED UP PROSECUTION

PPH Programs with US, EP, JP, SP, KR, CN, SG, CA and PT.
Requirements:
1) Formal examination completed;
2) Application must be published;
3) 6-month term for observation must be expired;
4) Substantive examination has not started.
The first examination report is expected within 30 working days.
 Best practices for prosecution in Andean Community 31

Economic block formed by Bolivia, Colombia, Ecuador and Peru.

RECOMMENDED STRATEGY
The Andean Community has a total population over 100 million with a combined GDP (Gross Domestic Product) of US$ 580
billion.

In spite of the Andean Regimen, the protection applied for the patents will be granted only within the national territory of each country in which the
protection is applied for. So, it is necessary to file the patent application in each country separately.
- Strict Examiners (specially in Colombia): clarity, sufficiency of description, support for the claims.
- Avoid Use and Second Use Claims they are considered as non-patentable subject matter.
- Probably adapting to EP granted claims will have even better results.

Patent term extension (Colombia and Peru):

- The term of prosecution of the application exceeds 5 years from the filing date until granting; or three years from the request for examination until
granting, whichever of these is the last to occur.
- The time window to apply for the extension is 2 months (Colombia) / 30 working days (Peru) from the granting date and it is applicable as long as
there has been an unjustified administrative delay for the granting of the patent.
- Exception: inventions related to pharmaceutical products or procedures.

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Best practices for Expediting Examination in Chile, Colombia, Mexico & Peru 32

Pacific Alliance PPH

- Expedite Examination: Recognition or utilization of search and examination results of each country.
- No additional official fee.
- Both local and foreign applicants may apply.
- In case the PPH is not accepted, the case returns to regular flow.
AGENDA
Summary - Patent Prosecution and Non-
eligible patent subject matter 01
Key Developments in Argentina, Brazil, Chile
Mexico, and Andean Community countries
including Mechanisms to expedite 02
examination

Patentability issues related to:

- pharmaceutical inventions 03
- electronic/software inventions
and Industrial Designs in Brazil

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Best practices for Pharma/Biotech in Latin America 34

- Have as much examples as possible to avoid objections based on lack of sufficiency of disclosure, specially for Markush Formulas.

- Product by process claims are usually accepted when they are the only possible manner of claiming a specific invention.

- AVOID undefined terms such as: approximately, about, % of homology.

- Remove medical use claims in the Andean countries and Maintain medical use claims in BR, CL and MX using Swiss-type format
(also in AR as restrictive guidelines may change in the future).

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Spotlight: Pharma protection in Latin America
35

SUBJECT MATTER ARGENTINA BRAZIL COLOMBIA CHILE MEXICO PERU ECUADOR BOLIVIA

PRODUCT

PROCESS

APPARATUS

PRODUCT ?
OBTAINED FROM A only when it is not only when it is not
only when it is not
PROCESS (product possible to define possible to define
possible to define
the product by its such product by its
by process the product by its
chemical structure chemical structure
chemical structure
claims)

USE

SECOND MEDICAL ?
USE
POLYMORPHS ?
characterized by its however, it
complete pattern contradicts Andean
values powder Resolution 486 and
diffraction can be argued at
spectrum of X rays Courts

SALTS ?
however, it contradicts
Andean Resolution 486
and can be argued at
Courts
 Spotlight: Pharma protection in Argentina 36

According to the new Joint Ministerial Resolutions MI 118/2012, MS 546/2012, and ARPTO 107/2012 published on May 8, 2012, patentability criteria
for pharmaceutical inventions have been strengthen in AR still in force.

The Resolution issued by the Argentinean PTO contains very restrictive criteria concerning the allowable scope of claims in the chemical and
pharmaceutical fields. However, the Argentinean PTO is going through a transition phase due to the recent change of government, and therefore the
currently restrictive examination criteria may change in the near future.

Some flexibility* in the Office Actions (for Chemical and Life Science patent applications) have been observed in the reports issued by the
Argentinean Patent Office.

The PPH is not reccomendable for pharma products, since the restrictive resolution may change in the near future.

Flexibility Example: Markush formula may be accepted if the application in AR has an equivalent granted patent in another Office, e.g. the European Office,
composition claims may be accepted if they are supported by tests and examples.
Spotlight: Pharma protection in Brazil 37

Brazil is in the top 10 of the bigger pharma markets. According to the IMS Health, BR market will reach
more than US$ 40 bi in sells in 2017. The government distributes (with no cost) to the population many
important drugs, including biological products.

the criteria for approving patents under ANVISA is not clear to the applicants since there are no
guidelines to be followed by ANVISA available to the public.

according to RDC 21/2013, ANVISA will not give prior approval to:
- applications disclosing a pharmaceutical product/process which involves a health risk, i.e. the
corresponding drug is prohibited in Brazil;
- applications disclosing a pharmaceutical product/process of interest to the policies of the Brazilian
Public Health Care System called the SUS, and that does not meet with the patentability requirements
and other criteria established by Brazilian IP Law 9.279/96.

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Spotlight: Pharma protection in Brazil 38

LAST NEWS
The Brazilian PTO and ANVISA are finally reaching into an agreement about the rules for analyzing
patent applications that must be followed by each institution.
On March 14, 2017, after a closed meeting at the headquarters of ANVISA between the board of
directors of ANVISA and representatives of the Brazilian PTO, a new workflow has apparently been
approved and will result in the publication of a new ordinance.
This document will be published in the next few days and will define the responsibilities of each entity
in the evaluation of pharmaceutical patent applications. As announced, the new workflow approved
by the board of directors of ANVISA would determine that ANVISA will firstly analyze aspects related
to public health and then the Brazilian PTO would evaluate the patentability criteria. If Brazilian
PTOs decision is different from the one of ANVISA, the Brazilian PTO will have the possibility of
accepting it or not, being necessary to justify its contrary decision. As for complex themes, the rules
will be defined through an specific group, with representatives of both Agencies.
We are closely accompanying the publication of this new ordinance.

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Spotlight: Electronic/Software protection in Latin America 39

Argentina Can be indirectly protected if the invention involves hardware (devices)

and software and both component work together and it is impossible to
separate them.
Brasil The software per se is not patentable. BRPTO usually accepts: 1) method
claims (usually from a flowchart)

Chile Can be indirectly protected if the invention involves hardware (devices)

and software and both component work together and it is impossible to
separate them.

Mexico Can be indirectly protected if the invention involves hardware (devices)

and software and both component work together and it is impossible to
separate them, in which case, the software embodiment must be related
with the particular method to be implemented by the device.

Andean Can be indirectly protected if the invention involves hardware (devices)

Community and software and both component work together and it is impossible to
separate them.

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Best practices for Electronic/Software in Latin America 40

Software per se is not patentable.

The industrial creation implemented by a computer program aiming to solve a technical problem
may be patentable.

Patent claim drafting:

- Method claims defined by the steps that describe the achieved functionality:

Example: Method of controlling the temperature of a room, characterized in that such

method contains the folowing steps:
- measuring the initial temperature;
- if the initial temperature is over the reference value, a signal is emitted from a controler circuit to
start an air conditioning machine; and
- once the reference value is detected by the sensor, the microcontroler emits a second signal to stop
the air conditioning machine.

It is important to avoid terminologies such as software, computer readable media, means for.

Software Registration:

Most of Latin American countries have a specific registration for Softwares

(related to Copyright) - protection of the source code

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Spotlight: Utility Model protection in Latin America 41

Argentina 10 years of validity.

Brasil 15 years of validity (*cannot be less than 7 years after granting)

Chile 10 years of validity.

Mexico 10 years of validity.

Andean 10 years of validity.

Community

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Industrial Designs in Brazil
42

- The protection is applied only to the external shape of the objects that gives to the final
product a special and ornamental appearance.

- Functionality is not considered for protection.

- the Industrial Design must have ornamental aim, that gives to the product a peculiar and own
aspect, being NOVEL, ORIGINAL and possible to be reproduced INDUSTRIALLY.

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Industrial Designs in Brazil
43

The Industrial Design is valid for 10 (ten) years counted from the filling date, and can be
extended for 3 (three) consecutive terms of 5 (five) years.

Up to 20 variations per application.

Only formal examination is performed before granting (exception is for shape determined
essentially by technical or functional considerations).

Option to request the examination on the merits after granting.

Main reasons for Office Actions:

- Dashed Lines (3D designs)
- Missing Views
- Irregular traces

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Industrial Designs in Brazil
44

2D Designs: colors may limit the scope of protection.

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Summary 45

Follow closely course of parallel Patent

Prosecution at EPO and USPTO to pro-actively
amend claims when necessary.

Consider patent extension term in Chile,

Colombia and Peru.

Consider fast-track programs such as

PPH.

Consider the term for amending the claims,

for filing divisional applications and the
particularities involving Designs in Brazil

Work closely with Preferred Agent to design an

optimal strategy for each country.

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THANK YOU VERY MUCH

Mr. Rafael Freire

Technical & Legal Services Manager
Clarke, Modet & C Brazil
rfreire@clarkemodet.com.br

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