MASTERCLASS PATENT FORMALITIES IN LATIN AMERICA. Platform formalities Officers Unilever Center, Vlaardingen NL. 29 th September 2016

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1 MASTERCLASS PATENT FORMALITIES IN LATIN AMERICA Platform formalities Officers Unilever Center, Vlaardingen NL 29 th September 2016

2 2 01 ARGENTINA 02 BRAZIL CHILE MEXICO ANDEAN COMMUNITY (COLOMBIA, PERU), URUGUAY & VENEZUELA TIPS, TRICKS AND RECOMMENDATIONS

3 3 LATIN AMERICA MAP Central American Common Market Mexico Caribbean Countries (new entrants) Venezuela (since 2012) Colombia Ecuador Southern Common Market The Andean Community Peru Bolivia Chile Brazil Paraguay Uruguay Argentina

4 4 PATENT INDEX LATIN AMERICA (FORMALITIES) Tier Tier 1 Country Patent Index Brazil Mexico Tier 2 Colombia, Peru & Chile Tier 3 Argentina, Uruguay Ecuador, Bolivia Venezuela Tier 1 Low formalities required Tier 2 There are few barriers in granting pharmaceutical and chemical patents No acceptance of Use related claims Medium formalities requirement Tier 3 Very restrictive countries in granting pharma and chemical patents High Official Fees Non-PCT countries

5 ARGENTINA

6 6 FILING REQUIREMENTS Patent application process in Argentina Paris Convention only DIRECT (not PCT member) DOCUMENTS FORMAL REQUIREMENTS DUE DATE Power of attorney General Information Yes, Notarized/Legalized by Consul or Apostille Title of the invention, Applicant name and address; inventors name, citizenship and address; and a fully identification of the priority (s) claimed 40-working days from the filing date. Not extensible term. At the date of the filing; one formal Office Action 180 days to comply or the application will be abandoned. Priority (s) claimed Certified copy. It must be accompanied by a local Sworn Spanish translation Within the 90 days following the filing date

7 7 PROSECUTION Language of filing Argentina: allows the filing in a foreign language. The Certified Spanish translation must be filed within the ten working days following the filing date. Grace Period YES: If the disclosure of an invention occurs 1 year before the filing or priority date. Pre- Filing Amendments Yes. Opposition System OBSERVATIONS: Any person may offer grounded observations in relation to a patent application and add documentary evidence within a period of sixty (60) working days after it has been published. Third-party observations cannot be filed anonymously.

8 8 PROSECUTION Average time from filing to grant: 8 years average, depends on the type of technology. Substantive examination must be requested by the applicant YES, within 36 months from filing date.. Term of protection for patents: 20 years from the filing date. Link to Patent Office:

9 9 ANNUITIES WHEN? Yearly. Accumulated annuities must be paid from the granting date

10 10 DIVISIONAL APPLICATIONS In Argentina, divisional applications may be filed at any time during prosecution. No provision allows the filing of Continuation or Continuation in Part applications. The Patent Office will request the division of applications comprising more than one invention, while applicants may voluntarily decide to divide their applications for the same or other reasons. There are neither limitations for filing divisional applications derived from previously filed divisional applications nor restrictions as to what may be included in a divisional application, but for new matter.

11 11 PROSECUTION HIGHLIGHTS Biologic Material Certificate At the moment of filing. Sequence Listing At the moment of the filing Genetic Resources Convention on Biological Diversity, no mandatory disclosure nor it is monitored.

12 12 PATENT PROSECUTION PRIORITY FILING 12 months 18 months (speed up publication can be requested) up to 36 months PRELIMINARY EXAMINATION PUBLICATION REQUEST FOR EXAMINATION WITHIN 60 WORKING DAYS Third parties may present information for aiding examination EXAMINATION

13 13 TECHNICAL EXAMINATION Office Action (3) 90 days; with 3 time extension of 30 days Response Allowance Rejection Patent Issued Accepted 30 working days Appeal before PTO Denied Appeal before Federal Court 90 working days Rejection Maintained

14 14 REJECTION AND ADMINISTRATIVE NULLITY 1 REJECTION To appeal before the PTO ( Industrial Property National Institute, PTO ) within the 30 working days period from the date of the notification of the resolution refusing the application. Once the appeal is filed the PTO will determine if the claims are correctly refused or not. If the PTO accept the arguments the patent will be granted with the same claims, if not the applicant may decide to appeal before the Civil and Commercial Courts. It is possible to appeal directly before the Civil and Commercial Federal Courts within the 90 working days period from the date of the notification of the resolution refusing the application 2 ADMINISTRATIVE NULLITY Anyone having a legitimate interest may file a nullity or lapsing action at any time after granting. The administrative decision declaring the lapsing of a patent may be appealed in court.

15 15 THINGS TO WATCH OUT Internal PPH in force from October 15, Voluntary amendments, complementary data, etc., may be submitted up until 90 working days after application filing. After said period is up to the Examiner whether to accept any submission other than those directed to correct deficiencies pointed out in Office Actions. Assignment of priority rights : It must be filed within the 90 days following to the application date. NO extensions nor grace period is available. Simple Spanish translation and no legalization needed. Filing patent application in another language would mean submitting the sworn full translation within 10 working days, avoid excess translation fees with assistance from your strategic partner.

16 BRAZIL

17 17 FILING REQUIREMENTS Patent application process in Brazil DOCUMENTS FORMAL REQUIREMENTS DUE DATE Specification/drawings/ claims General Information Direct applications could be filed in the original priority Language. PCT national phase, translation of at least the claim set, abstract and tittle. Title of the invention, Applicant s name and address; inventors names, citizenship, qualification-profession (s) and address; and a full identification and description of the priority(s) claimed 12 months direct applications 30 months PCT We recommend at the date of the filing. Can be requested, by a non-substantive Office Action and 30 days to comply Priority Document Simple copy of the completed Priority Document Not required if was filed before the IB during the international PCT phase Direct entry within the 180 days following the filing date, PCT entry 60 days from the national phase entry. Power of Attorney The Power of Attorney does not require any formalities but would be signed by the legal representative of the owner stating the qualification Within the sixty (60) days following the filing date. The original document is required, a strategy to preserve the lapse a copy of the document could be filed and the original will be required by Office Action.

18 18 PROSECUTION Language of filing Brazil: allows the filing in a foreign language : Direct applications, the translation has to be filed 30 months from a formal request from the Patent Office; PCT national phase (at least claims set, abstract and title have to be translated) the translation has to be filed 30 months from a formal request from the Patent Office. Grace Period YES: If the disclosure of an invention occurs 1 year before the filing or priority date. Pre- Filing Amendments NO. Opposition System OBSERVATIONS. *Requirement to provide Inventor s Profession

19 19 PROSECUTION Average time from filing to grant: 14 years average, depends on the type of technology. Substantive examination must be requested by the applicant YES, within 36 months from filing date. Term of protection for patents: 20 years from the filing date or 10 years from granting date, whichever is longer Link to Patent Office:

20 20 PROSECUTION HIGHLIGHTS Biologic Material Certificate At the moment of the filing, before requesting examination at the latest. Sequence Listing At the moment of the filing, before requesting examination at the latest. Genetic Resources Convention on Biological Diversity, mandatory disclosure.

21 21 PROSECUTION HIGHLIGHTS Request of Substantive Examination Up to 36 months since the filing of the application Access to Genetic Resources Explicit compliance according to the IP Law. We recommend authorizing the Preferred Agent (Clarke Modet) the no access to Genetic Resources to avoid unnecessary Formal Office Action. Adhesion to Hague Treaty Apostille Documents, enforced from August

22 22 ANNUITIES WHEN? Direct applications.- Yearly from the third year of filing date. PCT applications.- Yearly from the third year of the filing date of the International Application.

23 23 DIVISIONAL APPLICATIONS No provisions for filing continuation or continuation in part applications. Divisional applications can be filed prior to the FINAL RESOLUTION of the parent patent application. Cascades of Divisionals are prohibited by law. Normative Instruction 30/2013 "the parent application and their divisional applications should be decided simultaneously". The payment of examination fees at the moment of filing of divisional applications is the best practice; nevertheless it can be analyze on case by case scenario. NO ADDITIONAL MATTER CAN BE ADDED AFTER REQUESTING SUBSTANTIVE EXAMINATION

24 24 PATENT PROSECUTION PRIORITY FILING 12 months 18 months up to 36 months PUBLICATION REQUEST FOR SUBSTANTIVE EXAMINATION EXAMINATION Third parties may present Observations (information for aiding Examination) at any time of prosecution

25 25 TECHNICAL EXAMINATION OFFICE ACTION OR UNFAVORABLE OPINION 90 days (no extension) RESPONSE 60 days (no extension) REJECTION ALLOWANCE Accepted APPEAL Denied PATENT ISSUED REJECTION MAINTAINED

26 26 THIRD PARTY OBSERVATIONS - TIMING (i) Filing evidence and/or prior art references and/or arguments to be considered during the technical examination; Up to the end of examination (ii) Administrative nullity request after grant of the application; 6 months from the grant date (iii) Nullity Court Action Any time within the term of protection in Brazil

27 PATENT PROSECUTION ADMINISTRATIVE NULLITY 27 ISSUANCE OF THE LETTERS PATENT 6 months ADMINISTRATIVE NULLITY 60 days PATENTEE S RESPONSE 60 days PTO S OPINION 60 days PATENTEE S AND OPPONENT S RESPONSES PTO S DECISION

28 NEW PROSECUTION FLOW FOR PHARMA RELATED INVENTIONS 28

29 29 FAST TRACK EXAMINATION

30 CHILE

31 31 FILING REQUIREMENTS Patent application process in Chile DOCUMENTS FORMAL REQUIREMENTS DUE DATE Specification/drawings/ claims Full and complete specification, drawings and claims. Copy of the International publication, International Search Report, Written Opinion and its answer, International Preliminary Examination Report with amendments. Even in the case that the amendments are not included in the IPER 12 months direct applications 30 months PCT. General Information Power of Attorney Inventor /s Assignment Title of the invention, Applicant s name and address; inventors names, citizenship and address; and a full identification of priority(ies) claimed. Simple *Simple *Not required if it was filed during the International PCT phase At the date of the filing Can be requested, by a non-substantive Office Action and 60 days to comply (1) 60 days as from a CL PTO Office Action notification. Priority Document Certified copy of the complete Priority Document Not required if was filed before the IB during the international PCT phase. Certified copy of priority application within 90 working-days from filing

32 32 PROSECUTION Language of filing Chile: allows the filing in a foreign language. The Spanish translation must be filed in one month after the filing date. Grace Period YES: If the disclosure of an invention occurs 1 year before the filing or priority date, it will not affect its novelty. Pre- Filing Amendments NO. Opposition System YES, within 45-working days from publication.

33 33 PROSECUTION Average time from filing to grant: 5 years average, depends on the type of technology. Substantive examination must be requested by the applicant YES, within 60-working days as from the end of the opposition term. Term of protection for patents: 20 years from the filing, patent restoration term may be request due to unjustified Administrative delays. Link to Patent Office:

34 34 PROSECUTION HIGHLIGHTS Duty of Disclosure It is mandatory. The international search report including any documents cited therein must be provided. If any of the documents is not published in Spanish or English, the corresponding Spanish translation must be submitted. Biologic Material Certificate At the moment of the filing. Adhesion to Hague Treaty Apostille Documents, enforced in August

35 35 PROSECUTION HIGHLIGHTS Biologic Material Certificate At the moment of the filing, can be requested during technical examination. Sequence Listing At the moment of the filing, can be requested during technical examination Genetic Resources Convention on Biological Diversity, no mandatory disclosure.

36 36 ANNUITIES WHEN? Direct applications.- Ten-year period (only for applications filed from 2006) from granted PCT applications.- Ten-year period from granted.

37 37 DIVISIONAL APPLICATIONS If the unity of the invention is not present within a specific application, then a divisional patent can be filed to cover the part of the former application which lacks unity of invention. Once the substantive examination has begun, no voluntary Divisional applications could be file ; only Divisional applications can be file due to a lack of unity objection.

38 38 PATENT PROSECUTION PRIORITY Filing 12 months Up to 24 months 60-working days Formal office action Formal response Publication Request for patentability examination Patentability examination 60 days + 60 days (time extension *ONLY 1 through out the whole prosecution) Third parties may file an Opposition up to 45-working days after publication Optional response 60 working days + 60 working days (time extension)

39 39 TECHNICAL EXAMINATION OFFICE ACTION (2) RESPONSE 60 days FINAL REJECTION ALLOWANCE APPEAL PATENT ISSUED

40 MEXICO

41 41 FILING REQUIREMENTS Patent application process in Mexico DOCUMENTS FORMAL REQUIREMENTS DUE DATE Specification/drawings/ claims Copy of the International publication, International Search Report, Written Opinion and its answer, International Preliminary Examination Report with amendments. 12 months direct applications 30 months PCT. The Spanish translation and drawings could be filed through an Office Action. General Information Title of the invention, Applicant s name and address; inventors names, citizenship and address; identification and description of the claimed priority(ies) claimed and if requested grace period the document that divulged the technology. At the date of filing. Two Office Actions to comply with the examination. preliminary Power of Attorney Priority Document Simple just signed before two witnesses Or Notarized and legalized by Apostille. For litigation cases is mandatary to be Notarized and legalized by Apostille. Certified copy of the completed Priority Document Not required if was filed before the IB during the international PCT phase. If not presented within filing it can be filed as a Late filing document (required by Office Action). Before the 90 days following the filing date.

42 42 PROSECUTION Language of filing México: If the Spanish translation is not available by the time of filing, the application can be filed in a foreign language, and the Spanish translation will be required through an Office Action requiring the same, usually issued within the sixty (60) days following the filing date. Grace Period YES: If the disclosure of an invention occurs 1 year before the filing or priority date. This grace period does not cover patent-related documents. Pre- Filing Amendments YES. Opposition System OBSERVATIONS: filed by a 3 rd party within a period of 6 months counted from the publication in the official gazette. They do not slow down prosecution.

43 43 PROSECUTION Average time from filing to grant: 3 or 5 years average, depends on the type of technology. Substantive examination must be requested by the applicant NO, it is automatic. Term of protection for patents: 20 years from the filing date, internacional filing date (PCT) Link to Patent Office:

44 44 PROSECUTION Biologic Material Certificate Not unified, although by Law required at the moment of filing. Sequence Listing At the moment of filing, can be requested at the substantive examination Genetic Resources Nagoya Protocol, not unified.

45 45 ANNUITIES WHEN? Direct applications.- Five-year period from the granting date, Accumulated annuities must be paid from the granting date PCT applications.- Same

46 46 DIVISIONAL APPLICATIONS In Mexico, divisional applications may be filed at any time during prosecution up to the a final Resolution, if it is a granting Resolution up to the payment of the granting fees. No provision allows the filing of Continuation or Continuation in Part applications. Divisional Applications can be voluntary filed or by request of the Patent Office. Cascades of Divisional Applications are allowed and no initial restrictions for subject matter included in a divisional application. Divisional application can be filed up to the payment of the granting fees and it is recommendable to file Divisional applications in a response to a 4th outstanding Office Action, to maintain alive the application if a Rejection resolution is foreseen to a response to the 4th Office Action.

47 47 PATENT PROSECUTION 30 months for PCT cases, 12 months for Paris convention (6 months for designs) PRIORITY FILING 18 months From 3 to 6 months FORMAL EXAMINATION From 24 to 48 months Depending on the Technical field PUBLICATION TECHNICAL EXAMINATION After Publication Third parties may present information for aiding examination within 6 months of the publication

48 48 TECHNICAL EXAMINATION Office Action (4) Response 4 months Allowance Rejection 15 working days Patent Issued Accepted Appeal Denied 45 days Rejection Maintained

49 49 THINGS TO WATCH OUT Patent Prosecution Highway (PPH) available through specific agreements with different foreign Patent Offices (US, EP, PT, CA, CN, ES, JP, KR, SG). Similar criteria as in US/EP (closer to EP). Request for Examination automatic for all applications at filing. 3 rd party observations do not slow down prosecution. Utility Models accepted. Design/Utility Model applications published only if granted.

50 50 DO S AND DONT S / RECOMMENDED STRATEGY If acceptable, conform to the granted Subject-Matter, if any, of the US/EP parallel case, as it usually results in granting in MX. 1 2 Since the US/EP criteria is close to the criteria in Mexico, is highly likely that the documents cited in US/EP will be cited on Mexico; as such, similar arguments/amendments in US/EP can be used during prosecution in Mexico. Follow closely the US/EP parallel cases in order to anticipate rejections/prior art documents in Mexico Do not file divisional applications as a tool to extend the substantive examination, as they will be rejected.

51 COLOMBIA

52 52 FILING REQUIREMENTS Patent application process in Colombia DOCUMENTS FORMAL REQUIREMENTS DUE DATE Specification/drawings/ claims Full and complete specification, drawings and claims. Copy of the International publication, International Search Report, Written Opinion and its answer, International Preliminary Examination Report with amendments Direct entry 12 months PCT 31 months as of the oldest priority or as from the PCT application initially filed General Information Power of Attorney Inventor /s Assignment Title of the invention, Applicant s name and address; inventors names, citizenship and address; and a full identification and description of the priority(ies) claimed Simple Simple At the date of the filing Can be requested, by a non-substantive Office Action, two months to comply (1) 2 months as from CO PTO notification (2) 2 months as from CO PTO notification Priority Document Certified copy of the completed Priority Document, along with its Spanish translation Not required if was filed before the IB during the international PCT phase

53 53 PROSECUTION Language of filing Colombia: the Spanish translation of the specification and claims is compulsory at the filing date. Grace Period YES: If the disclosure of an invention occurs 1 year before the filing or priority date, it will not affect its novelty. Pre- Filing Amendments NO. Opposition System YES.

54 54 PROSECUTION Average time from filing to grant: 3 or 5 years average, depends on the type of technology. Substantive examination must be requested by the applicant YES, up to 6 months from publication. Term of protection for patents: 20 years from the filing, patent restoration term may be request due to unjustified Administrative delays. Link to Patent Office:

55 55 PROSECUTION Biologic Material Certificate At the moment of filing. Genetic Resources Cartagena Protocol, only mandatory if application relates to Andean genetic resources. Sequence Listing At the moment of the filing

56 56 ANNUITIES WHEN? Direct applications.- Yearly from the granting date PCT applications.- Yearly from the filing date of the International PCT application but until the patent has been granted.

57 57 DIVISIONAL APPLICATIONS In Colombia, divisional applications may be filed at any time during prosecution, but continuation-in-part applications are not available. Each individual divisional application has a limited scope with respect to the original application. Cascades of divisional application are prohibited by law. If subject matter from the Original application is rejected by the Patent Office, it is not possible to include said matter again within a new Divisional Application.

58 58 PATENT PROSECUTION PRIORITY Filing 12 months Up to 24 months 6 months Formal office action Formal response Publication Request for patentability examination Patentability examination 2 months + 2 months (time extension) Third parties may file an Opposition up to 2 months after publication of the application Optional response 60 working days + 60 working days (time extension)

59 59 TECHNICAL EXAMINATION Substantive Office action (3) Technical response 60 working days + 30 working days (time extension) NON-FINAL RESOLUTION: granted DENIAL DECISION denied About 6 weeks (no time extension) Reconsideration Petition NON-FINAL RESOLUTION: GRANTING DECISION LETTERS PATENT about 6 months FINAL RESOLUTION denied Nullity Action 4 months (no time extension)

60 60 THINGS TO WATCH OUT Colombian examiners are very strict in connection with drafting of claims. Products are to be characterized only by components and structure (results, effects, uses or functions are not considered technical characteristics) and methods are to be defined in terms of a sequence of steps and conditions. Colombian examiners are reluctant to grant patents related to polymorphs, because in their opinion, they constitute an essential routine task for a formulator. However, according to the Colombian Handbook for the Examination of Patent Applications, polymorphs are patentable as long as they are novel and inventive. Transgenic biological material is not considered patentable, even when there is no specific exception established in the legislation. What may be patented are genetic modifications. Methods which really refer to the use of a product are not considered patentable (uses are not patentable in Colombia).

61 61 THINGS TO WATCH OUT Appointments may be requested with examiners but only for clarity purposes or to seek advice. Examiners are not allowed to determine possible decisions on how will they act based on the filed responses. Applications which refer to a treatment method and do not contain any example or specific information in the description related to the manufacture of a composition or a kit, may not be subject of amendments in the claims in order to refer to such elements. This is considered as broadening the matter initially claimed. Products defined by non-tangible characteristics or by the function of their components are objected. Modified microorganisms require the deposit in any depositary authority in compliance with the Budapest Treaty for the purpose of a Patent Procedure.

62 62 RECOMMENDED STRATEGY Please remember that uses, second uses, treatment methods, software as such, biological material existing in nature, are not considered patentable matter in Colombia. Applications related to these exceptions have low chances of success. The Colombian Patent Office carries out a first formal examination (during the weeks following the filing of the application) wherein the claim set is examined as to clarity, conciseness, unity of invention and exception to patentability. It is thus recommendable waiting for the results of such formal official action in order to introduce any amendments of interest, thereby avoiding costs for a voluntary amendment. Please bear in mind that claims in Colombia must enter into National Phase based on the claims of the International Phase. The response to the formal requirement allows preparing the claim set for the substantive stage. Accordingly, it is 4 highly advisable following the expert s recommendation in order to avoid the repetition of objections during said substantive stage.

63 63 RECOMMENDED STRATEGY 4 It is advisable filing a Patent Prosecution Highway (PPH) request when the patent has been granted in countries that have signed a PPH program with Colombia (USA, South Korea, Japan, Europe, Spain). PPH should be requested along with the substantive examination request, that is, during the six months following the publication of the application in the Official Gazette. 2 The Patent Office currently issues up to three substantive official actions within the 18 months following the 5 publication of the application in the Official Gazette, if it is considered pertinent to do so. Please note that for the Patent Office to issue a new official action, an official fee must be paid. It is recommended paying such official fee, when possible, in order to have additional opportunities in case objections persist. 6 In case of rejection, it is possible filing a reconsideration petition along with a voluntary amendment for the claims. It is highly advisable submitting as much technical evidence as possible at this stage. 4

64 64 PROSECUTION HIGHLIGHTS HOW TO ACCELERATE Patent Prosecution Highway Pilot Programs (PPH) signed and enforceable with: Spain, Japan, USA, Europe and South Korea PPH programs signed: Pacific Alliance (Chile, Mexico, Peru)

65 PERÚ

66 66 FILING REQUIREMENTS Patent application process in Peru DOCUMENTS FORMAL REQUIREMENTS DUE DATE Specification/drawings/ claims General Information Full and complete specification, drawings and claims. Copy of the International publication, International Search Report, Written Opinion and its answer, International Preliminary Examination Report with amendments. Even in the case that the amendments are not included in the IPER Title of the invention, Applicant s name and address; inventors names, citizenship and address; and a full identification of the priority(ies) claimed. Direct applications 12 months from the priority claimed. PCT national phase 30 months from the priority claimed. At the date of the filing -Power of Attorney -Inventor /s Assignment -Simple -Simple -Within a period of two months following the date of notification. -Within a period of two months following the date of notification Priority Document Certified copy of the completed Priority Document Not required if was filed before the IB during the international PCT phase.

67 67 PROSECUTION Language of filing The Spanish translation of the specification is compulsory at the filing date. Grace Period YES: If the disclosure of an invention by the inventor, occurs 1 year before the filing or priority date, it will not affect its novelty. Pre- Filing Amendments NO Opposition System YES 60 working days from publication.

68 68 PROSECUTION Average time from filing to grant: 4 or 5 years average, depends on the type of technology. Substantive examination must be requested by the applicant YES, up to 6 months from publication. Term of protection for patents: 20 years from the filing, patent restoration term may be request due to unjustified Administrative delays. Link to Patent Office:

69 69 PROSECUTION Biologic Material Certificate At the moment of filing. Genetic Resources Cartagena Protocol, only mandatory if application relates to Andean genetic resources. Sequence Listing At the moment of the filing

70 70 ANNUITIES WHEN? Direct applications.- Yearly from the granting date PCT applications.- Yearly from the filing date of the International PCT application but when the patent will be granted.

71 71 DIVISIONAL APPLICATIONS In Peru, divisional applications may be filed at any time during prosecution; but continuation-in-part applications are not available. Each individual divisional application has a limited scope with respect to the original application. Divisionals may be filed only from the parent application and only while the parent application is pending. Cascades of divisional application are prohibited by law. No double-patenting is permitted, the subject matter sought in the divisional application must be deleted from the parent application. Divisonals should be filed when different subject matters are found.

72 72 PATENT PROSECUTION FILING FORMAL EXAMINATION RESPONSE Yes PTO REQUIREMENT No No Abandonment Yes PUBLICATION Third parties may file an Opposition up to 60 working days after publication of the application SUBSTANTIVE EXAMINATION Optional response 60 working days + 60 working days (time extension)

73 73 TECHNICAL EXAMINATION SUBSTANTIVE EXAMINATION OFFICE ACTION (1) RESPONSE The PTO is only required to issue One Office Action; no maximum number of possible Office Action, nevertheless response to subsequent may have to be submitted within 5 working days UNFAVOURABLE OPINION (Optional) FAVOURABLE OPINION DENIAL ALLOWANCE

74 74 PROSECUTION HIGHLIGHTS HOW TO ACCELERATE PERU HAS SIGNED TWO PPH AGREEMENTS (SPAIN AND THE PACIFIC ALLIANCE COUNTRIES MEXICO, CHILE AND COLOMBIA) IN ORDER TO ACCELERATE THE PROSECUTION

75 75 ANDEAN COMMUNITY (CAN) A trade bloc of four countries: Bolivia, Peru, Ecuador and Colombia. CAN s headquarters are in Lima, Peru.

76 76 ANDEAN COMMUNITY MAIN PRACTICAL EFFECT Same law in all member countries, but separate registrations or applications of trademarks and patents in each country. Judicial decisions on IP matters in each country may require Andean Tribunal opinion. A patent/trademark application first filed in an Andean Pact country gives the right to claim priority. The use of a patent/trademark in any of the Andean countries is allowed to evidence proper use of the same. In spite of some of the over boarding characteristics of the territoriality principle, the protection applied for in connection with patents and trademarks is granted only within the national territory of the country in which the letters patent is issued.

77 77 ANDEAN COMMUNITY NULLITY ACTIONS Objective: revoking the final decision issued by the PTO. There are no specialized courts in IP within Andean Member countries. According to the Andean Community Treaty, in all proceedings in which the verdict is not susceptible to appeal, the process shall be suspended and directly request the Court's interpretation, so that the judge (whom is not specialized in this field) adopts this binding interpretation in the sentencing. (Applicable in all Andean Countries). Nullity actions take several years due to lack of specialized courts and judges.

78 78 ANDEAN COMMUNITY ENFORCEMENT

79 URUGUAY

80 80 FILING REQUIREMENTS Patent application process in Uruguay Paris Convention DOCUMENTS FORMAL REQUIREMENTS DUE DATE Specification/drawings/ claims General Information Priority(s) claimed Full and complete specifications, drawings and claims Title of the invention, Applicant s name and address; inventors names, citizenship and address; and a full identification and description of the priority(s) claimed Certified copy. It must be accompanied by a local Sworn Spanish translation. 12 months as of the priority claimed At the date of the filing Within the 180 days following the filing date. Power of Attorney Declaration of Inventorship POA-Simple Declaration of inventor - must be Notarized and legalized up to the Uruguayan Consulate, or by Apostille. Within the 30 days following the filing date. Within the 180 days following the filing date.

81 81 PROSECUTION Language of filing Uruguay : allows the filing in a foreign language (just required to translate the claims, abstract and title). The Spanish translation for Uruguay must be filed within one month following the filing date. Grace Period YES: If the disclosure of an invention occurs 1 year before the filing or priority date, it will not affect its novelty. Pre- Filing Amendments Yes, within 60 days of publication. Opposition System OBSERVATIONS.

82 82 PROSECUTION Average time from filing to grant: 10 years average, depends on the type of technology. Substantive examination must be requested by the applicant YES, within 120 days from publication. Term of protection for patents: 20 years from the filing date. Link to Patent Office:

83 83 PROSECUTION Biologic Material Certificate At the moment of filing. Sequence Listing At the moment of the filing Genetic Resources Nagoya Protocol, not unified.

84 84 ANNUITIES WHEN? Direct applications.- Yearly from the granting date.

85 85 DIVISIONAL APPLICATIONS In Uruguay, divisional applications may be filed at any time during prosecution. No provision allows the filing of Continuation or Continuation in Part applications. The Patent Office will request the division of applications comprising more than one invention, while applicants may voluntarily decide to divide their applications for the same or other reasons. There are neither limitations for filing divisional applications derived from previously filed divisional applications nor restrictions as to what may be included in a divisional application, but for new matter.

86 VENEZUELA

87 87 FILING REQUIREMENTS Patent application process in Venezuela Paris Convention DOCUMENTS FORMAL REQUIREMENTS DUE DATE Specification/drawings/ claims General Information Priority(ies) claimed Power of Attorney/ Declaration of Inventorship Full and complete specifications, drawings and claims Title of the invention, Applicant s name and address; inventors names, citizenship and address; and a full identification and description of the priority(ies) claimed Documents must be Notarized and legalized up to the Venezuelan Consulate or by Apostille. Documents must be Notarized and legalized up to the Venezuelan Consulate or by Apostille. 12 months as of the priority claimed At the date of the filing At the date of filing. Not Official: the VE PTO is accepting late filing of documents, but it is not according to the current Law. At the date of filing. Not Official: the VE PTO is accepting late filing of documents, but it is not according to the current Law.

88 88 PROSECUTION Language of filing Venezuela: the Spanish translation of the specification and claims is compulsory at the filing date. Grace Period NO. Pre- Filing Amendments Yes. Official Fees At the time of filing: Mandatory Publication in two Local Newspaper First annuity to be paid at time of filing Once granted, we should pay the registration official fees and the second annuity

89 89 PROSECUTION Average time from filing to grant: Not yet available. Substantive examination must be requested by the applicant No. Term of protection for patents: 10 years from grant date. Link to Patent Office:

90 90 ANNUITIES WHEN? Direct applications.- Yearly. First annuity must be paid at the filing date and the others, from the granting date

91 91 DIVISIONAL APPLICATIONS In Venezuela, there are no legal basis for divisional applications in local patent law, but it is ruled under the Paris Convention.

92 92 PATENT PROSECUTION

93 93 Industrial Designs are granted in Venezuela for the first time First designs granted since 2006 Bulletin No. 563, May 2, 2016 included Resolution No designs granted (filed from ) Does not mention legal basis of granting/period of protection/annuities.

94 TIPS, TRICKS AND RECOMMENDATIONS

95 95 GLOBAL GENERAL POWER OF ATTORNEY 1 ONE General Power of Attorney for all countries in the name of the Applicant 2 3 This Power of Attorney will be made in the name of Latin American Hub Agent for all Latin American Countries, to represent the Applicant in all countries This will need to be signed ONCE before a Notary Public and legalized. In this case, the Hub Agent will be responsible in each country to give relevant PoA s to the local offices. ADVANTAGES 1 Time saving by not having to control PoA deadlines in each country 2 Remove unnecessary internal multiple signatures 3 Less administrative work for the Applicant

96 96 PCT COUNTRIES COMPLETE ASSIGMENT OF INVENTION This enables the applicant not to file the original assignment. If the PCT assignment form is in another language other than English, a simple Spanish translation must be filed. 1 2 Remove unnecessary internal multiple signatures Less administrative work for the Applicant

97 97 FAST EXAMINATION PROCEDURES 1 2 ALIANZA DEL PACÍFICO PPH between Mexico, Colombia, Chile & Peru 1 2 Remove unnecessary internal multiple signatures Less administrative work for the Applicant

98 ARGENTINA 98 Time until examination depends on when the request for examination is filed. The sooner the request is filed, the sooner the application will be examined. If possible, request examination along with the filing of the application. Even though there is no accelerated examination procedure, adapting the claims to those corresponding to a granted equivalent foreign patent might expedite the prosecution (examination will not start sooner, but may take less time once it starts). Independent claims other than claim 1 tend to be objected. Avoid filing several independent claims if possible.

99 BRAZIL 99 Confirm no access to Genetic resources at time of filing to avoid Office Actions Voluntary amendments can only be requested prior to Examination Request Divisional applications cannot add additional claims after the Examination Request, and it is highly recommendable to file a Divisional Application prior to respond the Final Office Action.

100 CHILE 100 Add International Search Report with Prior Art documents translation into English or Spanish (if not the original language) at the time of filing to avoid formal Office Action

101 PPH MÉXICO 101 Simple Power of Attorney for Patent Prosecution No deadline to submit translation and Power of Attorney. This will be required ex-officio by IMPI, when not submitted at time of filing. Only TWO Formal Office Actions, if not complied with formal requirements, the Office will reject the Application

102 102 ANDEAN COMMUNUTY (CO, PE, BO, EC) Full Spanish translation at the time of filing. No extensions permitted For Colombia, 31 months still apply for PCT filings Second Medical Uses not allowed, recommended to amend claims to avoid unnecessary Office Actions Patent Term Extension Provision not available for pharmaceutical patents

103 103 TRANSLATION SPANISH SPEAKING COUNTRIES Recommended strategy: ONE SINGLE Translation PCT COUNTRIES (MX, CO, CL, PE, CU, DO, SV, GT, HN, CR, EC, NI, PA): One Spanish translation will be valid for all countries NOT PCT COUNTRIES (AR, VE, UY, PY, BO): Official Sworn translation required. Recommendation: One Spanish Translation in One Member country, and only review by Local Sworn translator in the others. SAME SPANISH TRANSLATION WILL BE VALID FOR PCT countries and (with review) EP VALIDATION IN SPAIN AR UY-PY VE Whole text Translation Priority Document(s) Translation Review by official Sworn Translator -- (Priority ) Claims Review by official Sworn Translator

104 104 THANK YOU Ms. Clara Pombo Corporate Director, Attorney-at-law Mr. Mario Vázquez Patent Attorney

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