Patent protection in Latin America: Main provisions and recommended strategy

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1 Patent protection in Latin America: Main provisions and recommended strategy Speaker: Mr. Rafael Freire Technical & Legal Services Manager Clarke, Modet & Cº Brazil

2 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 examination 02 Patentability issues related to: - pharmaceutical inventions - electronic/software inventions and Industrial Designs in Brazil 03

3 Patent Prosecution Latin America 3 Tier Country Patent Index Tier 1 Mexico Chile Tier 2 Colombia, Ecuador, *Bolivia & Peru Tier 3 *Argentina, Brazil Tier 1 - Easy prosecution - Less strict examiners: rely mainly on foreign prosecution - Reduced backlog Tier 2 - Strict examiners (difficulties for proving inventiveness) - Reduced to Mid backlog * Bolivia is a Non-PCT country Tier 3 - Strict examiners (difficulties for proving inventiveness) - High Official Fees for exceeding claims, specially BR - Restrictions for protection of pharmaceutical inventions - Substantial Backlog * Argentina is a Non-PCT country

4 SPOTLIGHT: NON-ELIGIBLE PATENT SUBJECT MATTER 4

5 SPOTLIGHT: DIVISIONALS 5 Argentina Brasil Chile Up to the conclusion of the examination. In case of rejection, at the filing of the reply to the previous action. 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. 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.

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

7 SPOTLIGHT: AVERAGE TIME FOR GRANTING DECISION 7

8 AGENDA Summary - Patent Prosecution and Noneligible patent subject matter 01 Key Developments in Argentina, Brazil, Chile, Mexico, and Andean Community countries including Mechanisms to expedite examination 02 Patentability issues related to: - pharmaceutical inventions - electronic/software inventions and Industrial Designs in Brazil 03

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10 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.

11 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

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13 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).

14 Case 1 Divisional application filed after the issuance of the Rejection On July 30 th, 2015, the BRPTO issued the Rejection Decision for PI 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 02 nd, 2015, the divisional application BR was filed. On October 06 th, 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 7 th, 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.

15 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.

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

17 Backlog in Brazil 17 WHAT TO EXPECT? Aiming to reduce the backlog: 100 new examiners hired in 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.

18 Best practices for Expediting Examination in Brazil 18 a) Infringement of the invention When a 3 rd party is reproducing the object of the patent application without applicant s authorization, the applicant may submit a request for expediting examination. The following documents must be presented at the Brazilian PTO: - Proof that a 3 rd 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.

19 Case 2 Potential Infringement made by a 3 RD Party 19 The applicant of the MU 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 23 th, 2016, and allowed on August 16, The first Office Action was issued on October 11 th, 2016 and the response was filed on January 9 th, 2017.

20 Case 3 Potential Infringement of a 3 RD Party application 20 One of our clients was notified by the applicant of application BR , 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 16 th, 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 16 th, 2016, and the first Office Action was already issued.

21 Best practices for Expediting Examination in Brazil 21 b) Green Patents Brazilian PTO relaunched Green Patent Resolution in Dec. 6, 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).

22 Case 4 Green Patent Invention 22 that, The application BR , which is directed to a Method of treatment of emissions from coal processing and related devices and systems, was filed on December 5 th, On December 10 th, 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 23 th, The patent was granted on December 24 th, 2013 around one year from the filing date.

23 Best practices for Expediting Examination in Brazil 23 c) Pilot Project PPH with USPTO for Oil and Gas:

24 Case 5 PPH USPTO-BRPTO 24 Application BR 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.

25 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)

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27 Best practices for Expediting Examination in Argentina Best practices for prosecution 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.

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29 Best practices for Expediting Examination in Argentina Best practices for prosecution and expediting 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.

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31 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.

32 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.

33 AGENDA Summary - Patent Prosecution and Noneligible patent subject matter 01 Key Developments in Argentina, Brazil, Chile Mexico, and Andean Community countries including Mechanisms to expedite examination 02 Patentability issues related to: - pharmaceutical inventions - electronic/software inventions and Industrial Designs in Brazil 03

34 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).

35 Spotlight: Pharma protection in Latin America 35 SUBJECT MATTER ARGENTINA BRAZIL COLOMBIA CHILE MEXICO PERU ECUADOR BOLIVIA PRODUCT PROCESS APPARATUS PRODUCT OBTAINED FROM A PROCESS (product by process claims) only when it is not possible to define the product by its chemical structure? only when it is not possible to define the product by its chemical structure only when it is not possible to define such product by its chemical structure USE SECOND MEDICAL USE? POLYMORPHS? characterized by its complete pattern values powder diffraction spectrum of X rays however, it contradicts Andean Resolution 486 and can be argued at Courts SALTS? however, it contradicts Andean Resolution 486 and can be argued at Courts

36 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.

37 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 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 byanvisa 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.

38 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 PTO s 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.

39 Spotlight: Electronic/Software protection in Latin America 39 Argentina Brasil Can be indirectly protected if the invention involves hardware (devices) and software and both component work together and it is impossible to separate them. The software per se is not patentable. BRPTO usually accepts: 1) method claims (usually from a flowchart) Chile Mexico Andean Community Can be indirectly protected if the invention involves hardware (devices) and software and both component work together and it is impossible to separate them. 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. Can be indirectly protected if the invention involves hardware (devices) and software and both component work together and it is impossible to separate them.

40 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

41 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 Community 10 years of validity.

42 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.

43 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

44 Industrial Designs in Brazil 44 2D Designs: colors may limit the scope of protection.

45 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.

46 THANK YOU VERY MUCH Mr. Rafael Freire Technical & Legal Services Manager Clarke, Modet & Cº Brazil