Patent Strategy in Latin America: Enforcement in Latin America. Speaker: Ms. Clara Pombo, LL.M Attorney-at-law Corporate Director, IP Strategy

Transcription

1 Patent Strategy in Latin America: Enforcement in Latin America Speaker: Ms. Clara Pombo, LL.M Attorney-at-law Corporate Director, IP Strategy

2 2 01 Patent Enforcement Index Latin America 02 General Trends Country Spotlight: Argentina, Brazil, Colombia and Mexico Key Developments comparison with US and EP

3 LATIN AMERICAN MAP 3 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 ENFORCEMENT INDEX IN LATIN AMERICA 4 Tier Country Patent Index Tier 1 Brazil, Chile, Colombia Tier 2 Argentina, Mexico and Peru Tier 3 Venezuela Tier 1 Civil and procedural remedies in legislation IP Courts Preliminary measures and damages available Time Tier 2 Judicial procedure slow and court decisions unpredictable. Insufficient action by customs officials Difficulty in achieving high damages Tier 3 Very weak patent framework

5 IP SPECIALIZED COURTS 5 Tier Tier 1 Country Patent Index Andean Court, Brazil, Colombia, Mexico, & Peru Tier 2 Argentina, *Chile, Uruguay, & Venezuela Tier 1 Specialized IP courts Tier 2 Do NOT have Specialized IP Courts *Chile has a stand-alone IP Court for Invalidity proceedings.

6 PATENTS RECORDED AT CUSTOMS 6 Tier Tier 1 Country Patent Index *Brazil, Chile Tier 2 Argentina, Colombia, Mexico, Peru, Uruguay, & Venezuela Tier 1 Can be recorded *No formal procedure established for patents but specific seizure request can be made by interested parties. Tier 2 Cannot be recorded

7 CRIMINAL PROCEEDINGS FOR PATENT INFRINGEMENT 7 Tier Tier 1 Country Patent Index Brazil, Chile Argentina, Colombia, Mexico, Peru, Uruguay, & Venezuela Tier 2 Mexico* Tier 1 Available Tier 2 Not available *not available ab initio but if the infringer is a repeat ofender criminal actions are available

8 CRIMINAL PROCEEDINGS FOR PATENT INFRINGEMENT 8 Tier Tier 1 Country Patent Index Brazil, Chile Argentina, Colombia, Mexico, Peru, Uruguay, & Venezuela Tier 2 Mexico* Tier 1 Available Tier 2 Not available *not available ab initio but if the infringer is a repeat ofender criminal actions are available

9 DOCTRINE OF EQUIVALENTS 9 Tier Tier 1 Country Patent Index Argentina, Brazil, Mexico, Chile, Uruguay & Andean Community Tier 1 Applicable *It isn t recognized under any Patent Law, but it is applicable under the interpretation of claims, specifically provided within each Latin American country patent Law

10 BOLAR EXEMPTION 10 Tier Tier 1 Country Patent Index Argentina, Brazil, Chile & Andean Community Tier 2 Mexico*, Uruguay Tier 1 Explicit Tier 2 General exceptions provision *It isn t recognized under the Mexican Industrial Property Law, but under article 167bis and 177bis 2 of the Regulations on Health-Related Consumable Goods

11 PUNITIVE DAMAGES IN CIVIL PROCEEDINGS 11 Tier Tier 1 Country Patent Index United States of America, Canada, & Australia Tier 2 Argentina, Brazil, Colombia, Chile, Mexico, Peru, Uruguay, & Venezuela Tier 1 Available Tier 2 Not Available

12 ARGENTINA

13 PROSECUTION OF A PATENT INFRINGEMENT 13 CSJN (National Supreme Court of Justice) CFA (Federal Court of Appeals) 2-3 years First Instance Federal Court 4-6 years Mediation Proceeding

14 PROSECUTION OF A PATENT INFRINGEMENT 14 1) Mediation hearing is mandatory. 2) Filing a complaint at Court containing all the arguments of infringement along with all the evidence to prove it. 3) Defendant has 15 working days to answer in writing the lawsuit along with all the proofs that support it s defense. 4) The Technical Expert is appointed by the judge and his report must be performed within 15 working days from the date he accepts the task. 5) The parties can offer their owns experts

15 PROSECUTION OF A PATENT INFRINGEMENT 15 6) Parties have a common period of 10 working days to submit allegations. 7) First instance verdict. 8) Chambers of Appeal resolution. Important: As a general rule, infringement claims must be filed in the State Court of the city where the infringer is located. Although some plaintiffs try to file the claim in the jurisdiction where the infringement has taken place. It is up to the judge to analyze the jurisdiction issue but the parties, in general, try to attract jurisdiction to whatever city would be more convenient for them. Technical experts opinion are decisive since the Judges do not have sufficient technical knowledge and they leverage on the technical opinion in order to decide on infringements and validity.

16 ENFORCEMENT OF FIRST INSTANCE JUDGEMENT 16 Competent Court: Civil and Commercial Federal Court: Recommended Action Courts are not specialized in patent infringement issues and the judges usually seek expert advice. First instance judgement usually takes 4-6 years. Second instance judgment could take 1-2 years.

17 PRELIMINARY MEASURES: INJUNCTIONS 17 Judges may order injunctions to: 1) Prevent the patent infringement and in particular, to prevent goods are commercialized, including imported goods, immediately after customs clearance; 2) Preserve relevant evidence in regards to the alleged infringement, provided that in either case the following conditions are verified: a.- There is a reasonable probability that the patent, if considered null by the defendant, be declared valid; b.- It is summarily proved that any delay in granting such measures will cause irreparable damage to the holder; c-.- The damage that can be caused to the owner exceeds the damage that the alleged infringer will suffer if the measure is erroneously granted, and d.- There is a reasonable probability that the patent is infringed.

18 PRELIMINARY MEASURES: INJUNCTIONS 18 Timing: The Court notifies the Defendant 2-3 months Technical Expert Report is necessary to request the Preliminary Measures Preliminary Measures are awarded after the Oral Proceedings A Bond is requested and can be very high

19 REGULAR PROCEDURES 19 Complaint and Proposal of evidence. Reply by Defendant. Production of evidence: each party presents its evidence. Pleas: Once the evidence period has been completed, each party makes its argument about the merit of the evidence. Sentence: the Judge makes a ruling in the form of a sentence. The First Instance decision is subject to appeal before a higher Court. The final decision will be made by the Civil and Commercial Federal Court of Appeal.

20 DAMAGES Our law does not state the content or limits of the compensation. 20 Damages are defined by application of the Civil Code as to civil liability. Punitive damages are not admitted. Low (difficult to calculate) Damages claims should be initiated within 3 years as from the time of infringement. Before a final decision is issued, the Judge having jurisdiction on the case will demand from the Plaintiff to pay a bond equivalent to 3 % of the amount requested as compensation for damages. Losing party will have to pay Attorney s fees of the counterparty, and the amount will be set by the Judge in a range between 11% to 20% of the amount of the damages Important: Sometimes, the proof of the damage suffered is impossible to submit. As a consequence, the possibility of being indemnified turns low.

21 PROSECUTION NULLITY ACTION 21 COMPETENT COURT Estimated timeframe CIVIL and COMMERCIAL FEDERAL COURT Between 4-6 years The defendant dealing with infringement actions must offer the evidence to prove that the invention lacks of novelty, inventive step or industrial application. Highly recommended to chose Buenos Aires (domicile of the infringer or where the infringement took place) Mediation proceeding is mandatory and previous to legal action Ordinary proceeding VERY IMPORTANT: The Argentinean Courts deal with infringement and validity issues in one trail (unified system) unless the defendant files a nullity action when the infringement case is already well advanced

22 DO S AND DONT S / RECOMMEND STRATEGY 22 Before initiating legal claims Review the validity of the rights and record the changes in the ownership to the current owner to enforce rights. Carry out investigations on the infringer s activities and rights in order to avoid adverse surprises and for designing the best strategy for each specific case. Pre-constitute proof by notary certification if possible- and reports on experts or specialized agencies. Develop together with the owner an approach strategy in case of patent infringement.

23 DO S AND DONT S / RECOMMEND STRATEGY 23 Legal measures Send the infringer a cease and desist letter to try to stop the infringement or negotiate a license. Promptly file a precautionary measure petition to prevent exploitation of the invention. Request the inventory or seizure of counterfeit objects and /or machines for the manufacture of the products or practicing the patented process. Take very seriously the appointment of the technical expert since Judges support their decisions mainly on the technical experts reports.

24 CASE LAW 24 All Graphic SRC vs Cartocor S.A. on Injuction AG filed an injunction against CSA regarding cease of use of patent. First instance Court: Appointed an expert. After his report, the Court approved the injunction. Court of Appeal: Stated that in order to guarantee the right to legal defense it is necessary to comply with the bilaterality principle. Rejected the first instance judgment and ordered the notification of the expert s report to the defendant. Important: In Argentina, patent related injunctions inaudita altera parte are exceptional.

25 KEY DEVELOPMENTS COMPARISON WITH US 25 The Argentine and US patent systems are similar in regards to patent procurement. However differences arises regarding the award of damages, while in the US damages tend to be high and more easily enforceable, in AR the entity of damages are usually not very high particularly because punitive damages are not granted. Also, the damages are difficult to enforce. While the laws in Argentina afford patent owners significant protection and relief against infringement, patent case law and doctrine are still evolving. Argentine intellectual property doctrine recognizes the policy that intellectual property rights must be protected even to the extent of imposing criminal liability for infringement. However, Argentine courts have yet to issue landmark rulings awarding patent owners significant damages to remedy infringement.

26 BRAZIL

27 PROCEDURE 27 In Brazil, there are federal specialized courts in IP (Patent Annulment Lawsuits) and state courts specialized in IP (Patent Infringement Lawsuits São Paulo). There are three possible actions to enforce patent rights: Criminal action and civil infringement action (State Courts) and Nullity Action (Federal Court) The Federal Courts have competence to judge all lawsuits involving government entities (such as the BPTO) while State Courts have competence to judge all lawsuits involving private companies or individuals. In both cases the actions can be used when a patent has been validly granted. Brazil has a bifurcated system. Validity actions are brought before the Federal Courts and the infringement actions before State Courts

28 TIME LINE (INFRINGEMENT) 28 Patent Infringement Actions in Brazil 3) STJ (Superior Tribunal of Justice) 1-2 year OR 3) STF (Federal Supreme Court) 1-2 year 2) State Tribunals 1 year 1) State Courts 3-4 years Summons Infringer

29 TIME LINE (NULLITY) 29 Patent Nullity Actions in Brazil 3) STJ (Superior Tribunal of Justice) 1-2 year Subject Matter Jurisdiction -STJ (Superior Court of Justice) -Federal Law Violation -Different construction in comparison with another Brazilian Court OR 2) TRF (Regional Federal Tribunal) of the 2nd REGION 1 year 3) STF (Federal Supreme Court) 1-2 year STF (Federal Supreme Court) - - Violation of Constitutional Norms 1) Designated Federal Court in Rio de Janeiro 3-4 years Summons Summons Brazilian PTO/ANVISA Patent Owner

30 TECHNICAL EXPERT 27 Court Expert: During the development of the lawsuit, and upon requesting from the parties, the Judge will appoint an independent expert trusted by the Court, who will analyze the issues raised by the parties and the judge regarding the patentability requirements, and then present an expert report. The judge usually chooses an expert who has technical expertise in the field which is the subject of lawsuit. Parties Expert: Each party can appoint one or more further experts to assist the expert of the Court in dealing with the technical issues. Then, the expert of the Court will render his/her opinion by analyzing all the technical issues, answering written questions from the parties and stating whether or not invention meets patentability requirements. It is important to choose an expert with extensive experience in accordance with the subject matter of the patent.

31 TECHNICAL EXPERT 28 The importance in choosing a Technical Expert In the scope of most patent refusal cases, the expert's opinion is taken by the Judges as the main evidence to rule on the merits of the lawsuit.

32 REMEDIES AND ACTIONS 32 A. Criminal Remedies: Search and seizure of the infringing products; Criminal complaint; Imprisonment of the infringers; Fines. B. Civil Remedies: Search and seizure of the infringing products; Preliminary injunctions; Cessation of use; Recovery of damages; Destruction of seized products; Recovery of attorney fees and judicial costs.

33 REMEDIES AND ACTIONS 33 C. Types of injunctions available.. Preliminary ex parte injunctions are widely available and sometimes obtained within 24hrs after the infringement action is filed Seizure of infringing product. Orders to stop commercialization Border measures Orders to withdraw from circulation: Infringing products Articles, packing, wrappings, stationery, advertising material Ads, signs, posters, stationery Utensil or instruments destined for or used in the manufacture, production or obtention of the infringing product

34 DAMAGES 34 Article 944 of the Brazilian Civil Code provides full compensation to the victim which suffered the damages. Damages Valid Patent Existence of damages has to be shown in cognitive stage of proceedings

35 DAMAGES 35 The Plaintiff may request compensation for material and moral damages in the lawsuit. Material damages are divided into actual damages deriving from the violation of trade secret rights as well as loss of profit. The compensation for actual damages, according to article 208 of the BIPL, shall be determined according to the benefits that the injured party would have gained had the infringement not occurred. The compensation for loss of profits may be calculated by the most favorable and adequate of the following standards set forth by article 210 of the BIPL: I. the benefits that the injured party would have gained had the infringement not occurred; or II. the benefits that were gained by the infringer of the right; or III. the remuneration that the infringer would have paid to the holder of the infringed right for the grant of a license which would have enabled lawful use of the trade secret.

36 DO S AND DONT S / RECOMMENDED STRATEGY 36 Definition of a good strategy to solve the problem or to prevent infringement activity is VERY IMPORTANT and will vary in a case by case basis. The specific approach to take and the strategy to adopt depend on the patent owner s short and longterm goals, budget limitations, time constraints and nature of the infringer s operations. For instance, some forms of legal action may bring about financial costs that are out of proportion to the desired results, whilst the size and nature of the business operations of certain infringers may justify the adoption of both civil and criminal actions. There are more and more court actions being filed involving Patent Law in Brazil, but most of them are filed against the Brazilian PTO or ANVISA, aiming at reversing rejection decisions.

37 DO S AND DONT S / RECOMMENDED STRATEGY TO AVOID DELAYS Before proceeding with an action, and with the objective of enforcing patent rights over an invention, we suggest: Demostrate the existence of the granted and allegedly infringed patent, and comparing the granted claims with the supposedly infringing product or process. The above, taking into consideration that local authorities are very strict, requiring the product or process, that is allegedly infringing, to literally reproduce or develop the protected patent. Secondly, fully identifying the infringer, producers and distributers. Determining the scope of the issue, namely, give value to the loss of income, sales, benefits, and/or reputation of the company, in front of the expenses involved in the action to defend the protected rights. Evaluating the possibility of obtaining a favorable decision if an action is performed, and the possibility that the infringer has the financial means to pay for the damages, as well as the possibility of a refund of fees. Prior to initiating an action, sending a cease and desist letter to the possible infringer, could be an alternative to avoid a long judicial procedure. According to the current case law, invalidity cannot be raised as a defense in an infringement action, and must be decided in a separate lawsuit filed in federal courts 37

38 DO S AND DONT S / RECOMMENDED STRATEGY 38 Chances of success will depend on: Strong Claims Evidence of Infringement Where to litigate (RJ SP) Judges are impartial. However, depending on the concrete case, they can be mildly pro local companies

39 RECENT CASE LAW ANVISA PRIOR APPROVAL 39 Pharma companies have been filing lawsuits against ANVISA attempting to obtain an order to ANVISA to render prior approvals on patent applications. Most of the lawsuits have been filed against ANVISA with the Federal Courts of Brasilia, where ANVISA is headquartered. Pharma companies have been requesting preliminary injunctions in the initial motions, but Judges are not granting such injunctions, as the matters are not considered as urgent in Brazil; on the merits, though, some judges have been ruling that ANVISA is not competent to render opinions on patentability requirements, but only in connection with health matters; Bearing in mind the timeframe of the lawsuits (2-6 years), pharma companies have been filing writs of mandamus against ANVISA, instead of lawsuits. Writ of Mandamus are faster than lawsuits and the merits discussed/goals therein are the same: ordering ANVISA to render prior approvals and send the files back to the Brazilian PTO.

40 RECENT CASE LAW BRPTO ANALYSIS AND ANVISA PRIOR APPROVAL : NEWRON PHARMACEUTICALS v. PATENT DIRECTOR OF BRPTO: The case refers to the Patent Application PI that had the prior approval issued by ANVISA and was returned to BRPTO to be examined under the new flow. However, BRPTO delayed the starting of the examination which lead the Company to file the indicated Writ of Mandamus, requesting that the Judge orders the examination of the Patent Application by BRPTO within 90 (ninety) days. After analyzing the initial motion, the Judge granted the order and accepted the Applicant s claim. After the granting of the order, BRPTO started the examination of the Patent Application and the rejection decision was issued last January 31 st. The applicant has until April 1 st to file and appeal against such decision. However, at the same day (January 31 st ), it was published in Brazilian Official Bulletin a Court order stating that any further administrative report must be issued by BRPTO in a 60- day term.

41 RECENT CASE LAW ANVISA PRIOR APPROVAL : ABBVIE INC. v. ANVISA: ABBVIE filed a Lawsuit claiming the annulment of the decisions rendered by ANVISA which denied prior approval regarding patent applications since Anvisa s decisions were grounded in patentability requirements. After the legal proceedings of the lawsuit, the Judge rendered the court decision, recognizing Anvisa s technical competence in examining patentability requirements. ABBVIE filed an appeal against the court decision and, at the present time, the records of the lawsuit are pending to be transferred to Federal Court of Appeals to analyze and judge the appeal. It is important to highlight that during the procedures of this case, the Federal Court of Appeals granted an injunction in reply of the Company s interlocutory appeal in order to transfer of the records to BRPTO for examination, but the final decision of the Federal Court of Appeal rejected the Interlocutory Appeal filed by ABBVIE. However, in the meantime, BRPTO started the examination and rejected the Patent Application that, at the present time is under administrative appeal.

42 BRAZIL: ANVISA UPDATES ANVISA s examiners do not consider patentable: Selection inventions Polimorph inventions and Second use inventions

43 BRAZIL: ANVISA UPDATES

44 COLOMBIA

45 MAIN LEGISLATION ON ENFORCEMENT IN COLOMBIA 45 Decision 486 of the Andean Community It establishes the general guidelines for the enforcement of I.P. rights in the Andean Community Countries. Colombian Criminal Code: The usurpation of Intellectual Property rights is typified as a crime. It also includes a specific chapter concerning copyright. Law 1648 of Intellectual Property Enforcement Law Establishes specific procedures for Colombia in the protection of IP right holders.

46 PRE-JUDICIAL ACTIONS - INITIAL PROCEDURE FOR INFRINGEMENTS 46 Obtain evidence of infringement and identify the offender. Infringement Infringement investigation It is detected through our surveillance or customer's notice. C&D LETTER IS SENT Infringer accepts and signs a transaction agreement Infringer does not accept A conciliation hearing is requested before the Chamber of Commerce. No agreement is reached, the procedural requirement is exhausted and judicial proceedings can be initiated Se concilia y se firma acta

47 KEY CONSIDERATIONS 47 ADRM Conciliation before Chambers of Commerce. Description It is important to take advantage of alternative dispute resolution methods to end the dispute before litigation. Requesting conciliation hearings before local Chambers of Commerce puts pressure on offenders who normally prefer to reach agreements before assuming legal actions.

48 JUDICIAL ACTIONS 48 Judicial Actions I.P. Infringement Civil Action (PTO or Civil Circuit Judge) Can be carried out in both jurisdictions Criminal Action (District Attorney s Office) Preliminary injunctions measures may be requested Compensation can be requested (Decree 2664 or ordinary rules on damages) It seeks to stop the infringement and compensates the owner of the rights of P.I. The prosecutor in charge can be requested to order the seizure of the infringing material. Compensation can be requested but in a mini-process attached to the initial process once there is a conviction. Not only does it seek to stop the infringement, it also punishes the responsible individuals

49 CONSIDERATIONS 49 Description Specialized Judges Reduced Times Injunctions The Patent and Trademark Office has jurisdictional powers. By having specialized judges, the times in which the sentences are issued are reduced. Decisions are of a higher legal quality. Preliminary injunctions may be requested. These are decided before the defendant receives service of process.

50 DAMAGES: 50 The plaintiff can choose to use the general rules on proving and claiming damages or choose to adhere to the Schedule of pre-established compensations. Decree 2264 of 2014 Are aimed specifically for Trademark Infringements The plaintiff does not have to prove the amount claimed. The plaintiff will be subject to the appraisal of damages set by the Judge in accordance with the schedule set in the decree. General rules on damages Can be used for any type of IP infringement. The plaintiff has to concretely prove damages exist and they rise up to the amount that is claimed. This is done following the general rules on evidence.

51 51 1) Filing a written claim containing all the arguments of infringement along with all the evidence to support it can be filed before a Civil Judge or before the Colombian PTO under its jurisdictional powers. 2) The Judge has 30 days to admit the claim and service the defendant.. This is done through an official writ in which the deadline to file the correspondent claim reply is also set. 3) The process is carried out by hearings. There is an initial hearing in which the litigious matter is set and procedural defects are mended. Afterwards there is the evidence stage hearing in which all evidence is reviewed, if there are expert witnesses they are presented at this hearing. 4) In the final hearing the parties will present their closing arguments. 5) Judge issues his ruling. PATENT INFRINGEMENT (CIVIL ACTION) 6) Civil Courts has very little technical knowledge in IP, on the contrary CPTO Judicial Division has a lot more knowledge in IP and is more effective in enforcement. Hence the CPTO has become the main forum for litigate in Patent related matters.

52 PROSECUTION OF A PATENT INFRINGEMENT (CRIMINAL ACTION) 52 1) Filing a written claim containing all the arguments of infringement along with all the evidence to support it. This is filed before the District Attorney s Office. 2) The claim is assigned to a Prosecutor who will initiate the investigation stage. 3) If there is enough evidence the Prosecutor will formally initiate the indictment of the defendant. 4) The Prosecution will move to trial in which there will be a full discovery of evidence based on which the Judge will issue his ruling.

53 PROSECUTION OF A NULLITY ACTION 53 1) Filing a written claim containing all the arguments pertaining as to why the PTO s decisions should be nullified. All evidence to support the arguments should be filed as well. This action is filed before The Council of State which is the highest court responsible for reviewing the legality of administrative acts. 2) The claim is admitted into process and the judge sets a date for the initial hearing. 3) Judge requests pre-judicial interpretation form the Andean Community Court of Justice. Date for the evidence stage 4) Closing arguments and final decision from the judge. 5) Colombia also has a bifurcated system, hence, nullity actions can not be used as a defense within an infringement process,

54 TIME LINE (INFRINGEMENT) 54 IMPORTANT: between 2015 and 2016, 76 decisions have been issued. It is important to keep in mind that patent infringement disputes are not the most common in Colombia and the ones that arise are solved mostly in prejudicial scenarios

55 TIME LINE (NULLITY) 55 Objective: to obtain the revoking of the decision issued by the PTO (granting or denying a patent registration). There are no uniform times for each stage. In general a Nullity Action Procedure may take approximately 5 to 6 years to have a final decision issued by the Judge. There are no further remedies or proceedings after this action. Actions before the Council of State: between 2015 and 2016, 136 decisions have been issued on nullity actions against PTO decisions, 12 decisions were on patent related matters

56 REMEDIES AND ACTIONS 56 A. Preliminary and permanent injunctions. Before filing an infringement action in the Civil Jurisdiction. In a Criminal action, the Procreator will decide to move forward with injunctions. Requirements: File a written petition. Post a bond (By Law:20% of the estimated total value of the claims requested) Show prima facie proof of infringement.

57 REMEDIES AND ACTIONS 57 B. Types of injunctions available.. Seizure of infringing product. Orders to stop commercialization. Border measures. Orders to withdraw from circulation: - Infringing products. - Articles, packing, wrappings, stationery, advertising material - Ads, signs, posters, stationery - Utensil or instruments destined for or used in the manufacture, production or obtention of the infringing product.

58 DAMAGES 58 i. Consequential damages and loss of profits can be requested during the Civil procedures. However, the defendant must request a defined amount and must concretely provide evidence to show that those damages were the direct consequence of the infringement that the defendant was carrying out. ii. In the Criminal procedure, damages can also be requested but this is done through a mini procedure carried out after the Judge has convicted the plaintiff. The criteria for granting damages is similar to the one applied in civil actions. However, in a Criminal procedure the plaintiff could face up to 8 years in prison and even if damages are not awarded to the plaintiff, the Judge can still punish the defendant with court issued fines.

59 DO S AND DONT S / RECOMMENDED STRATEGY 59 File infringement actions before the specialized entity (Colombian PTO) 1 2 Use litigations as the last resort. Make full use of Alternative Dispute Resolution Methods. Preliminary injunctions Request damages by proving the value of a patent license to a third party. That would be the amount the infringer would have had to pay to the patent owner for the use of his patent.

60 RECENT LAW AND THE REVELANCE OF THE ANDEAN COURT DECISIONS 60 - Patent infringement cases are very technical and expensive to carry out in judicial scenarios; therefore up to date most patent infringement cases are settled though ADR in which the parties reach settlements agreements to avoid further litigation. - In litigation, specifically in the Council of State, the role of the Court is to provide a pre-judicial interpretation in which it takes the specific Andean Community legislation that is being discussed and interprets it according to the facts of the case. The court then gives the judge a set of guidelines on how to apply that specific legislation to the case. It is important to keep in mind that Andean Court s interpretation is not binding and the Colombian PTO as well was the Judges have always stated that each decision is independent and strictly motivated on the law applied to the case facts. However, more and more cases regarding IP law are presented before the PTO and the Council of State, previous decisions and pre-judicial interpretations are becoming relevant and it is the litigators who have to use this "Common IP Law" to set up their strategy and cite this law before the different legal entities to leave precedents.

61 MEXICO

62 TIME LINE (INFRINGEMENT) 62

63 TIME LINE (NULLITY) 63 IMPORTANT: As a general rule Mexico follows the unified system unless the infringer decides to start a separate procedure regarding the validity of the Patent in such a case the case is decided by a different Judge

64 PROSECUTION OF A PATENT INFRINGEMENT 64 Under the Mexican Law, legal patent enforcement are always to be initiated before the MPTO 1) Filing a written claim containing all the arguments of infringement along with all the evidence to prove it. 2) Defendant has 10 working days to respond in writing the claim along with the all proofs to support its defenses. 3) If expert witness testimonies are offered by the parties, IMPI grants a discretional time to be rendered (documental only, witness deposition are not allowed before the IMPI). 4) Official file is sent to the Patent Division of IMPI for the Infringement technical analysis. 5) Parties have a common period of 10 working days to submit allegations (closing arguments) 6) Resolution.

65 PROSECUTION OF A NULLITY ACTION 65 1) Filing a written claim containing all the arguments of the nullity along with all the evidence to prove it, before IMPI. 2) Defendant has one month to respond in writing the claim along with the all proofs to support its defenses. 3) Plaintiff will be allowed a 3 day period for challenging defendant s arguments and evidence. 4) Official file is sent to the Patent Division of IMPI for the nullity technical analysis. 5) Parties have a common period of 10 working days to submit allegations (closing arguments) 6) Resolution.

66 REMEDIES AND ACTIONS 66 A. Preliminary and permanent injunctions. Before filing an infringement action, or at any time during the litigation. Requirements: File a written petition. Prima facie proof of infringement. Show marking. Post a bond. A counter-bond equal to the bond + 40% could be placed in order to lift the preliminary injunction

67 REMEDIES AND ACTIONS 67 B. Types of injunctions available.. Seizure of infringing product. Orders to stop commercialization. Border measures. Orders to withdraw from circulation: - Infringing products. - Articles, packing, wrappings, stationery, advertising material - Ads, signs, posters, stationery - Utensil or instruments destined for or used in the manufacture, production or obtention of the infringing product. Injunctions to third parties.

68 PUNISHMENT 29 i. Fine up to 20,000 days of minimum wage ($70,000 USD, approximately) ii. Additional fine, 500 days of minimum wage iii. Temporary closure (never applied) iv.definitive closure (never applied) v. Administrative arrest (never applied) Damages and lost profits shall not be less than 40% of the total amount of sales of the infringing goods.

69 DO S AND DONT S / RECOMMENDED STRATEGY 29 INDIRECT INFRINGMENT 1 2 LOCAL RELEVANT TOPICS e.g. Mexico LINKAGE System. Compulsory Arbitration. Damages through a separate Civil procedure. DOCTRINE OF EQUIVALENTS. As in many LATAM countries there is no explicit legal provision, however, the doctrine is de facto applied through judicial ruling Relevant Aspects Preliminary injunctions

70 GENERAL EXCEPTIONS TO PATENT ASSERTION 70 According to the Mexican IP law (art. 22), the right conferred by a patent shall not have any effect, amongst others, against: i. scientific or technological research activities for purely experimental (non-commercial purposes) [Bolar exemption, in accordance also with article 167 bis of the HLR]; ii. iii. iv. Any person who commercializes a legally-introduced patented product or process; Good faith users (prior use); The use of patented living matter as an initial source of variation to obtain other products, except where such use is made repeatedly; etc.

71 BOLAR EXEMPTION 71 Mexico contemplates a Bolar clause which exempts a person from infringing a patent when performing clinical tests or scientific studies with the purpose of commercializing a medicament. Such provision is found in Articles 167 Bis and 177 Bis of the Regulations on Health-Related Consumable Goods. Generic products: 3 years Biosimilar products: 8 years

72 DOCTRINE OF EQUIVALENTS 72 According to the Mexican IP law (art. 21), the right conferred by the patent shall be determined by the claims as approved. In light of the above, the Doctrine of Equivalents is not recognized by our law and there are no court precedents thereof; however, on a case-by-case basis, it may be possible to bring Authority s interpretation of the claims into the subjectivity realm.

73 SUMMARY 74 Compulsory Arbitration in Argentina Linkage System in Mexico (ONLY) No punitive damages (all countries) and unlike in the US and EU in LATAM the amount of damages are not high and are difficult to enforce Alleged infringers are becoming more proactive Damages are to be requested in a separate civil action (except Brazil) Low degree of specialization of the Courts even the trend is to constitute new ones.

74 THANK YOU VERY MUCH Ms. Clara Pombo, LL.M. Attorney-at-law Corporate Director, IP Strategy