Patents Contributing editor Richard T McCaulley Jr 2017

Patents Contributing editor Richard T McCaulley Jr

2017

© Law Business Research 2017

Patents 2017 Contributing editor Richard T McCaulley Jr Ropes & Gray LLP

Publisher Gideon Roberton [email protected] Subscriptions Sophie Pallier [email protected] Senior business development managers Alan Lee [email protected] Adam Sargent [email protected] Dan White [email protected]

Law Business Research Published by Law Business Research Ltd 87 Lancaster Road London, W11 1QQ, UK Tel: +44 20 3708 4199 Fax: +44 20 7229 6910 © Law Business Research Ltd 2017 No photocopying without a CLA licence. First published 2004 Fourteenth edition ISSN 1742-9862


The information provided in this publication is general and may not apply in a specific situation. Legal advice should always be sought before taking any legal action based on the information provided. This information is not intended to create, nor does receipt of it constitute, a lawyer–client relationship. The publishers and authors accept no responsibility for any acts or omissions contained herein. The information provided was verified between February and March 2017. Be advised that this is a developing area.

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CONTENTS Global overview

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Richard T McCaulley Jr Ropes & Gray LLP

Malaysia107 Bong Kwang Teo, Min Lee Boo and Yen Cheng Koo Wong Jin Nee & Teo 114

Austria8

Mexico

Peter Israiloff Barger, Piso & Partner

Eugenio Pérez and José Luis Ramos-Zurita Uhthoff, Gómez Vega & Uhthoff, SC

Brazil16

Nigeria120

Philippe Bhering, Jiuliano Maurer, Flavia Merola and Rafael Toegel Bhering Advogados

Florence Atuluku and Samira Usman Aliant Law Nigeria

Chile24 Andrés Grunewaldt and Sebastián Alvarado Silva China30 Matthew Murphy and Xia Yu MMLC Group

Krister Mangersnes Håmsø Patentbyrå Pakistan131

Colombia36 Carlos R Olarte, Alexander Agudelo and Liliana Galindo OlarteMoure Costa Rica

Norway125 Kyrre Tangen Andersen Kluge Advokatfirma

Ali Kabir Shah and Hanya Haroon Ali & Associates Peru138

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Luis Diego Castro and Simón A Valverde Castro & Pal Asociados Ltda

Maria del Carmen Arana Courrejolles Estudio Colmenares & Asociados Philippines148

Ecuador48 María Rosa Fabara Vera and Gerardo Naranjo Fabara & Compañía Abogados

Mila Federis and Caesar J Poblador Federis and Associates Law Offices Poland156

France55

Dorota Rzążewska, Piotr Godlewski and Mirosława Ważyńska JWP Patent & Trademark Attorneys

Benjamin May, Louis Jestaz and Mickaël Da Costa Aramis

Portugal163

Germany61

António Andrade VdA Vieira de Almeida

Henrik Holzapfel and Martin Königs McDermott Will & Emery

Russia168

Honduras67

Vladimir Biriulin and Nikolay Bogdanov Gorodissky & Partners

Ricardo A Mejía Bufete Mejía & Asociados

Saudi Arabia

India73

Mohammad Jomoa and Asif Iqbal Kadasa and Partners

Archana Shanker and Gitika Suri Anand and Anand

South Africa

Italy85

Russell Bagnall Adams & Adams

Stefania Bergia Vanzetti e Associati Japan93

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179

Switzerland186 Rudolf A Rentsch CMS

Masayuki Yamanouchi and Makoto Ono Anderson Mōri & Tomotsune

Andrea Carreira and Demian Stauber Rentsch Partner AG

Korea99

Taiwan192

Yoon Suk Shin, Eun-Young Park and Gon-Uk Huh Lee International IP & Law Group

Yulan Kuo, Frank Lu and Charles Chen Formosa Transnational, Attorneys at Law

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Getting the Deal Through – Patents 2017 © Law Business Research 2017

CONTENTS

Turkey199 Korcan Dericioğlu Dericioglu & Eren Law Office Ukraine205 Oleksandr Mamunya and Yulia Chyzhova Aequo United Kingdom

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Richard T McCaulley Jr Ropes & Gray LLP United States

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Richard T McCaulley Jr Ropes & Gray LLP Venezuela230 María Milagros Nebreda and Carlos Pacheco Hoet Peláez Castillo & Duque Vietnam236 Pham Vu Khanh Toan Pham & Associates

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Silva

CHILE

Chile Andrés Grunewaldt and Sebastián Alvarado Silva

Patent enforcement proceedings 1

Lawsuits and courts What legal or administrative proceedings are available for enforcing patent rights against an infringer? Are there specialised courts in which a patent infringement lawsuit can or must be brought?

There are civil and criminal proceedings available for patent holders to enforce their rights against an infringer. These proceedings are initiated before judicial courts specialised in civil and criminal matters. Nonetheless, there are no specialised IP courts where a patent infringement lawsuit can or must be brought. 2

Trial format and timing What is the format of a patent infringement trial?

In a civil trial, after the claim is filed and served, the parties have an opportunity for conciliation in a hearing before a judge, where the defendant should respond to the claim if no settlement is reached. An evidence term may be opened depending on the parties’ allegations and defences, and after such term is closed the judge must reach a decision. For a criminal trial, after the claim is filed (either directly before criminal courts or as a complaint before the General Prosecutor’s Office or the police), the prosecutor may initiate a formal investigation with the intervention of the police before a pretrial judge. After gathering enough evidence the prosecutor may file charges against the defendant. In this context, the judge will not only guarantee the defendant’s rights, but will also seek an alternative dispute resolution between the parties. Once the formal investigation is closed (which can extend up to two years), the prosecutor will have an opportunity to file accusation against the defendant. The latter can choose between accepting the facts presented by the prosecutor and a determined penalty, opting for a brief proceeding before the pretrial judge or denying the facts and continue in an oral criminal trial before a criminal judge. In both civil and criminal trials, judges rely heavily on experts’ opinions since they do not specialise in patent law or the technical matters within the claims of a patent. Judges may additionally rely on documents, affidavits or live testimony. Cross-examination of witnesses is allowed in both types of trial. A civil trial may typically last two years in the first instance and a criminal law trial may last up to three years. 3

Proof requirements What are the burdens of proof for establishing infringement, invalidity and unenforceability of a patent?

The plaintiff generally has the burden of proof in an infringement or invalidation proceeding. Such burden shifts to the defendant in infringement cases in regard to patented methods. The latter means that the judge can order the defendant to prove that he or she has employed a method other than the patented one, on the condition that the product obtained through the patented method is new. Moreover, the defendant must overcome a legal presumption that the patented method is deemed to be infringed if the infringer’s product is identical

to the product obtained by the patented method, unless proven otherwise (article 31 bis Law 19.039). There are no established standards of proof (eg, ‘clear and convincing evidence’), with the exception of the ‘beyond all reasonable doubt’ standard for infringement cases brought before criminal courts. Civil courts are allowed to examine and value evidence following their experience, rules of logic and scientific knowledge. 4 Standing to sue Who may sue for patent infringement? Under what conditions can an accused infringer bring a lawsuit to obtain a judicial ruling or declaration on the accusation? The rightholder or holders, acting jointly, have standing to sue for patent infringement and also anyone acting on their behalf under a special power of attorney for litigation purposes (eg, a licensee with power of attorney). Chilean civil procedure law allows an accused infringer to file a petition before the courts to force the accuser who has been boasting about a right that he or she does not have (ie, jactitation), to file a lawsuit within 10 days. If no lawsuit is filed, then the accuser will lose the opportunity to sue in court for that right. 5

Inducement, and contributory and multiple party infringement To what extent can someone be liable for inducing or contributing to patent infringement? Can multiple parties be jointly liable for infringement if each practises only some of the elements of a patent claim, but together they practise all the elements?

Inducement, contributory and multiple party infringement are liabilities not regulated in our patent law. Nevertheless, under general criminal law principles such as ‘accomplice liability’, multiple parties may be jointly liable for infringement. 6 Joinder of multiple defendants Can multiple parties be joined as defendants in the same lawsuit? If so, what are the requirements? Must all of the defendants be accused of infringing all of the same patents? Multiple parties can be joined in the same lawsuit as defendants, provided they are all accused of infringing the same patents, even if the infringing activities are different. 7

Infringement by foreign activities To what extent can activities that take place outside the jurisdiction support a charge of patent infringement?

Foreign activities outside the jurisdiction do not support a charge of patent infringement, because of territoriality principles in the patent system (eg, article 49 in4 of Law 19.039). Such activities may be used to persuade judges to demonstrate a defendant’s bad faith in the way it conducts business in order to obtain a favourable decision in a local infringement case, but these are not binding to judges.

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CHILE Silva There are no extraterritorial rules in our patent law for patent infringement (eg, importation of a product produced in a foreign country with a patented method in Chile). 8

Infringement by equivalents To what extent can ‘equivalents’ of the claimed subject matter be shown to infringe?

The law does not specifically set forth a doctrine of equivalents in our patent system. Nevertheless, one judicial decision (Milton Astudillo Capetillo v CODELCO, 2nd Court of Calama, C-50763-2009) recognises its existence by a broad interpretation of the Patent Law Regulations that define the term ‘technical equivalent’ as the ‘Element or medium with the same function to the one claimed in an invention, in the same form and producing the same effect or result described in the claims’ (article 2 of the Patent Law Regulations). This judicial decision applies the doctrine of equivalents under a triple identity rule. 9 Discovery of evidence What mechanisms are available for obtaining evidence from an opponent, from third parties or from outside the country for proving infringement, damages or invalidity? Civil court judges may issue an order to exhibit certain identified documents that is of interest to one of the parties, pre-litigation or during litigation. Other than that, there is no general discovery rule in Chilean civil procedure law. Criminal court judges may issue orders to the police in order to obtain relevant evidence from the defendant’s premises. 10 Litigation timetable What is the typical timetable for a patent infringement lawsuit in the trial and appellate courts? A typical timetable for a civil trial would be: • Once the claim is filed and served (a notification that may take two to three months), a hearing will be scheduled on the fifth day from the serving of the claim for conciliation of the parties or defendant’s response to the claim before a judge. • The judge may take two to three months to open an evidence term for eight days, if needed, based on the allegations of the parties. After the term is closed the judge must reach a decision within 10 days, but in practice the decision is usually reached and served to the parties in three months. • Once an appeal is filed, it usually takes six months for the Court of Appeals to schedule a hearing to review the appeal and up to two to three months to reach a second instance decision. The losing party may request that the Supreme Court review the second instance decision based on its legal merits, and may file a cassation action for this purpose, which may take up for a year for a final decision. A typical timetable for a criminal trial would be that after the claim is filed, the prosecutor will formalise the investigation in where he or she will have two years to gather evidence and eventually file charges against the defendant. The prosecutor will have the opportunity to file accusation against the defendant, this happens after the formal investigation is closed. The defendant can choose between accepting the facts presented by the prosecutor and a determined penalty, opting for a brief proceeding before the pretrial judge or denying the facts and continue in an oral criminal trial before a criminal judge. A final decision in both cases is usually immediately served after the hearing end (hearings can take up to five days depending on the complexity of the case). This timetable does not consider situations where the defendant may not show up to court hearings and a detention order has to be issued by the court, while court hearings are rescheduled.

11 Litigation costs What is the typical range of costs of a patent infringement lawsuit before trial, during trial and for an appeal? Are contingency fees permitted? In a civil trial: costs may typically range from US$20,000 to 80,000 for first instance. For appeal in the second instance it is US$20,000 to 40,000. For a cassation action before the Supreme Court, US$20,000 to 30,000. In a criminal trial, the range of costs before trial, including cease and desist letters, drafting and filing of a criminal action, investigations, potential hearings, meetings with the police and the prosecutor, and possible ADRs, range between US$10,000 and 50,000. During the trial, costs may range from US$10,000 to 40,000, depending on how many days the trial lasts, the complexity of the case, bulk of evidence to analysed and a decision to be rendered. 12 Court appeals What avenues of appeal are available following an adverse decision in a patent infringement lawsuit? Is new evidence allowed at the appellate stage? In civil proceedings, appeal is available before the Court of Appeals and new evidence is allowed at the appellate stage but only for submission before the hearing (which usually takes place between three and six months after the filing of the appeal). For criminal proceedings, no appeal is available, only an annulment of the decision before the Court of Appeals and the Supreme Court depending on the reason of the annulment. 13 Competition considerations To what extent can enforcement of a patent expose the patent owner to liability for a competition violation, unfair competition or a business-related tort? As regards competition violation or unfair competition, liability exists if there is an abuse of IP rights where there is an attempt to enforce the patent under a very broad interpretation of the claims or in a case in where the enforced patent was granted without fulfilling disclosure duties during the prosecution (found in article 44 of Law 19.039). A recent case involved an investigation and accusation of abuse of dominant position from the Competition Authority (FNE) and generic pharmaceutical companies against a brand-name company over the branded drug Celebra (Celecoxib), alleged by FNE to be granted without fulfilling patentability requirements and under an evergreening practice. The case was settled before a decision was reached by the Competition Tribunal, and as a result of the settlement, the patent owner granted a licence over the drug to all generic pharmaceutical companies in Chile. 14 Alternative dispute resolution To what extent are alternative dispute resolution techniques available to resolve patent disputes? In case of an ongoing dispute before a court of law If litigation is ongoing before a civil court, parties are allowed to settle the case and the purpose of the first hearing is for the conciliation of the parties, where the judge or clerk from the court will act as a conciliator. The prosecutor and defendant may agree on a suspension of the procedure while certain conditions are met (eg, paying of a compensation or community work) for a term of one to three years. If the defendant does not meet the conditions or infringes them again within that term, this ADR will fail and the procedure will continue. Also, the defendant and the victim, with the approval of the judge, may agree on damages that would also put an end to the criminal procedure. If parties are deciding on how to resolve future disputes ADR only applies in a breach of contract context and provided the parties have agreed to settle disputes before arbitrators or mediators. Infringement and invalidation cannot be resolved by ADR techniques since these are matters of exclusive jurisdiction to judicial courts and the Patent Office (INAPI), respectively. This does not mean

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that while litigation is going, parties may settle the case or opt for the ADRs mentioned in the paragraphs above. Scope and ownership of patents 15 Types of protectable inventions Can a patent be obtained to cover any type of invention, including software, business methods and medical procedures? Patents can be obtained for all inventions, whether products or methods, in all fields of technology, but with the exception of patentability subject matter exclusions set forth in article 37 of Law 19.039. Software, business methods and medical procedures are within the list of exclusions, among other things. Without prejudice to the foregoing, if software is included within a system then such system that includes the software and other technical elements can be patented. 16 Patent ownership Who owns the patent on an invention made by a company employee, an independent contractor, multiple inventors or a joint venture? How is patent ownership officially recorded and transferred? The company owns a patent made by an employee or an independent contractor, provided they were specifically hired for the purpose of executing an inventive or creative activity and that their contract does not establish otherwise (article 68 Law 19.039). In the case the employee or independent contractor was not specifically hired for said purpose, but benefitted in the creation of the invention from the knowledge acquired inside the company and its resources, then the patent shall be owned by the company, and the employee and contractor have the right to an additional retribution to be agreed by the parties (article 69 in2 Law 19.039). Multiple inventors will own the patent jointly if there is no employment or contractor relationship with a third party or an agreement that establishes otherwise. The parties in a joint venture will own the patent jointly unless established otherwise in the joint venture agreement. Patent ownership is officially recorded before the Patent Office. Such recordal officially discloses the transfer of the patent to the public. Defences

applications filed in Chile, as originally filed, published on or after the filing date in Chile or the claimed priority date (article 33 of the Law 19.039). This absolute novelty requirement has as an exception a 12 month ‘grace period’ for disclosure of the invention prior to the filing of an application (article 42 of Law 19.039). This exception has to be properly requested when filing the patent application, following the formal requirements set forth by the Patent Law Regulations (ie, article 37). 19 Obviousness or inventiveness test What is the legal standard for determining whether a patent is ‘obvious’ or ‘inventive’ in view of the prior art? The legal standard for determining whether a patent is ‘obvious’ or ‘inventive’ is that the invention cannot result as obviously or derived evidently from the prior art for a person normally skilled in the corresponding technical matter (article 35 of Law 19.039). The Patent Office guidelines set forth a ‘problem-solution’ methodology to determine whether a patent is ‘obvious’ or ‘inventive’ under patent law. This methodology establishes a series of steps that assists the examiner in discarding irrelevant prior art and avoiding any ex post facto analysis, while directing it to the objective relationship between the technical problem and the solution provided by the invention. 20 Patent unenforceability Are there any grounds on which an otherwise valid patent can be deemed unenforceable owing to misconduct by the inventors or the patent owner, or for some other reason? There are no legal grounds for a valid patent to be deemed unenforceable based on misconduct by the inventors or the patent owner. Chilean legislation includes a provision on international rights exhaustion in where the patent owner would not be able to enforce its patent rights over the further commercialisation of a patented product that was lawfully acquired from the rightholder in commerce of any country (article 49 in5 of Law 19.039). Additionally, the patent law sets forth a ‘Bolar exception’, in which a patent is deemed to be unenforceable against importation, exportation, use and production of a patented pharmaceutical product for the purpose of obtaining a sanitary authorisation (article 49 in6 of Law 19.039). Finally, compulsory licences obtained following the provisions of our patent law would consequently make the valid patent unenforceable. 21 Prior user defence

17 Patent invalidity How and on what grounds can the validity of a patent be challenged? Is there a special court or administrative tribunal in which to do this? Validity of a patent can be challenged on any of the following grounds (article 50 of Law 19.039): • when whoever has obtained the patent is not its inventor or assignee; • when the concession is based on erroneous expert reports or reports that are evidently deficient; and • when the registration has been conceded in contravention of patentability norms and related requirements, in accordance with that established under the law. The Patent Office has exclusive jurisdiction to solve validity issues on patents in an administrative procedure. The decision can be appealed before the Industrial Property Tribunal and it is further susceptible to a cassation action before the Supreme Court. 18 Absolute novelty requirement Is there an ‘absolute novelty’ requirement for patentability, and if so, are there any exceptions? There is an absolute novelty requirement for patentability, and therefore it includes everything that has be disclosed or made accessible to the public in any part of the world, as a publication, sale or commercialisation, use or any other form. The novelty requirement also includes, although not in an absolute manner, the content of the patent

Is it a defence if an accused infringer has been privately using the accused method or device prior to the filing date or publication date of the patent? If so, does the defence cover all types of inventions? Is the defence limited to commercial uses? No prior use defence is available under Chilean law. Remedies 22 Monetary remedies for infringement What monetary remedies are available against a patent infringer? When do damages start to accrue? Do damage awards tend to be nominal, provide fair compensation or be punitive in nature? How are royalties calculated? The monetary remedies available in case of a patent infringement brought in a civil venue are: • a compensation for damages according to the general rules of civil liability (eg, direct, moral and lost profit damages); or • one of the following alternatives for compensation set forth in our patent law (article 108 of Law 19.039): • lost profits from the patent holder as a result of the infringement; • profits earned by infringer as a result of the infringement; and • a licence fee, taking into account the commercial value of the infringed right and other licences previously granted by the patent holder.

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CHILE Silva These damages tend to include interests and readjustments. There are no punitive damages. 23 Injunctions against infringement To what extent is it possible to obtain a temporary injunction or a final injunction against future infringement? Is an injunction effective against the infringer’s suppliers or customers? Yes, it is possible to obtain both temporary and final injunctions against future infringement. Those seeking temporary injunctions must show qualified and serious reasons for the request, determination of the value of the products and a bond as guarantee for damage sustained by the defendant. Final injunctions are granted with the case decision, and a defendant would fall into contempt of court if he or she disobeyed the decision. An injunction is not effective (directly) against the infringer’s suppliers or customers unless they are also defendants in the infringement case. The injunction might be indirectly effective against the infringer’s suppliers or customers if it consists in prohibiting the defendant from drawing up a contract for or over the infringing products. 24 Banning importation of infringing products To what extent is it possible to block the importation of infringing products into the country? Is there a specific tribunal or proceeding available to accomplish this? The permanent injunction from a finding of infringement in a civil case would enable block importation of infringing products in regard to that specific infringer. Additionally, importation can be blocked by triggering a border measure procedure at Customs, when information of upcoming shipments with infringing products is available to the patent holder. Border measure procedures require a judicial order from the filing of a civil or criminal action within 10 days from the triggering of such procedure, to keep the delivery of the products to the importer under suspension. 25 Attorneys’ fees Under what conditions can a successful litigant recover costs and attorneys’ fees? A successful litigant can recover costs and attorneys’ fees when the defeated party did not have a justifiable reason to litigate, as determined by the court. The court will determine the costs and attorneys’ fees and the parties will have three days to file their objections, otherwise these will be considered approved. 26 Wilful infringement Are additional remedies available against a deliberate or wilful infringer? If so, what is the test or standard to determine whether the infringement is deliberate? Are opinions of counsel used as a defence to a charge of wilful infringement? No additional remedies are available against a deliberate or wilful infringer. Opinions of counsel may help as a defence against a charge of wilful infringement in a criminal case to rebut criminal intent of accused infringer. 27 Time limits for lawsuits What is the time limit for seeking a remedy for patent infringement? The time limit according to our statute of limitations is four years from the act of infringement for civil actions and five years from the act of infringement for criminal actions.

28 Patent marking Must a patent holder mark its patented products? If so, how must the marking be made? What are the consequences of failure to mark? What are the consequences of false patent marking? If a patent holder wants to be able to bring criminal actions for patent infringement, it must mark its patented product indicating the registration number and the expression ‘patent invention’ (PI, article 53 of Law 19.039). False patent marking is a misdemeanour punished with a monetary fine (article 52 of Law 19.039). Licensing 29 Voluntary licensing Are there any restrictions on the contractual terms by which a patent owner may license a patent? There are no restrictions in view of our patent law. Under general civil contract law there could be restrictions. For example, a licence with terms extending beyond the expiration of the patent registration would be null and void due to lack of cause. 30 Compulsory licences Are any mechanisms available to obtain a compulsory licence to a patent? How are the terms of such a licence determined? Yes, there are mechanisms (article 51 of Law 19.039) to obtain a compulsory licence when: • the patent holder has incurred in acts that are contrary to free competition, in direct relation to the use or exploitation of the patent, declared so by the Competition Tribunal; • for reasons of public health, national security, non-commercial public use or national emergency, or any other extreme urgency, declared by the competent authorities, that would justify the granting of such licence; and • for exploiting a subsequent patent that cannot be exploited without violating it (cross-licence situation). The terms of the compulsory licence are determined by the competent authority at its own discretion. Patent office proceedings 31 Patenting timetable and costs How long does it typically take, and how much does it typically cost, to obtain a patent? To obtain a patent in Chile usually takes an average of four to five years and it typically costs between US$44,000 and 6,000 in professional fees and US$1,800 in government fees. 32 Expedited patent prosecution Are there any procedures to expedite patent prosecution? Yes, to expedite patent prosecution Chile currently has PPH programmes with a certain number of American countries (Argentina, Brazil, Canada, Colombia, Peru, Mexico, Ecuador, Paraguay and Uruguay) based on PPH-Mottainai and PCT-PPH. The examiner’s report from one of the above-mentioned countries under the said programmes can be filed after publication and before the appointment of the examiner in a patent application for expediting prosecution. Additional requirements • The patent application from the Office of Earlier Examination (OEE, in this case the ISA/IPEA Office), the basis for the PPH petition and the patent application filed in Chile before the Chilean Patent Office acting as an Office of Later Examination, are applications that share the same priority or filing date; • that the patent application from the OEE has been examined and has at least one patentable claim according to the OEE.

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that all the claims filed before the Chilean Patent Office correspond sufficiently to the claim or claims found to be patentable by the OEE.

33 Patent application contents What must be disclosed or described about the invention in a patent application? Are there any particular guidelines that should be followed or pitfalls to avoid in deciding what to include in the application? A patent application must disclose the invention fully so as to allow the expert skilled in the art to reproduce the invention without the need of further information (article 43 bis of Law 19.039). This means the patent application must include the following (article 42 of Law 19.039): • an abstract of the invention; • specifications; • set of claims; and • drawings (schemes, diagrams and graphics), if needed to further understand the invention for its reproduction and interpretation of the claims. The specifications require the applicant to disclose prior art and one example of application of the invention (article 39 of the Patent Law Regulations). There is no obligation to disclose the best way of applying the invention. The Patent Office has prosecution and examination guidelines (‘Directrices de Examen y Procedimiento de Registro de Patentes’, 2013 Edition) that should be followed. 34 Prior art disclosure obligations Must an inventor disclose prior art to the patent office examiner? Yes, the specifications require the inventor to disclose prior art to the patent office examiner (article 39 of the Patent Law Regulations). Furthermore, the law mandates that the ‘declarations relating to novelty, property and utility of the invention, shall be incumbent on the interested party, who shall make them his or her own responsibility’ (article 44 Law 19.039).

Update and trends We have observed two emerging trends in Chile’s patent law: the involvement of Competition Authorities in the exercise by right holders of registered patents and the request of social organisations for compulsory licences over patented pharmaceutical products based on inaccessibility due to price considerations. The first trend emerged with a recent case involving an investigation and accusation by the Competition Authority and generic pharmaceutical companies of abuse of dominant position against a brand-name company over the branded drug Celebra (Celecoxib), as mentioned in question 13. The second trend emerged with Innovarte Corporation petition to the Ministry of Health for a declaration and initiation of procedures before the Patent Office for granting a compulsory licence over the patent applications and registrations protecting the Sofosbuvir and Enlazutamide drugs and their combinations for the treatment of Hepatitis C and prostate cancer. The grounds for such petition are public health reasons and barriers to the accessibility of an effective treatment for Hepatitis C and prostate cancer for the population in Chile, due to the drugs’ high non-competitive market value. Although the Ministry of Health has refused the Corporation’s petition, it has found support from politicians and it would not be surprising if it were a subject of debate in this year’s presidential elections.

Divisional patent applications can be filed when there is a lack of unity of invention, meaning that there are more than one invention in the same application. It is required that the content of a divisional patent application cannot extend the scope of the invention, otherwise it will not benefit from the priority date of the original patent application. A voluntary division of a patent application must be filed before the first Office Action is issued by examiner. Additionally, the examiner may require the division of a patent application at any stage of the prosecution if he or she notices there is lack of unity of invention (article 50 of the Patent Law Regulations). In this case, the applicant must file the divisional patent application while the original one is still undergoing prosecution (ie, not granted, rejected without pending appeals or abandoned), if not, it will not benefit from the priority date. 36 Patent office appeals

35 Pursuit of additional claims May a patent applicant file one or more later applications to pursue additional claims to an invention disclosed in its earlier filed application? If so, what are the applicable requirements or limitations? A patent applicant could try to pursue additional claims to an invention disclosed in its earlier filed application, but these will not benefit from its priority date and risk to be rejected for lack of inventive step, unless these are filed as divisional patent applications provided they do not extend the scope of the originally disclosed invention (article 49 of the Patent Law Regulations).

Is it possible to appeal an adverse decision by the patent office in a court of law? Yes, the adverse decision can be appealed before Industrial Property Tribunal that shall rule according to the law. This second instance decision can be reviewed on the application of the law by the Supreme Court, via a cassation action (article 17 bis b of Law 19.039).

Andrés Grunewaldt Sebastián Alvarado

[email protected] [email protected]

Hendaya 60, 4th Floor Las Condes, Santiago Chile

Tel: +56 22 438 7000 www.silva.cl

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CHILE Silva 37 Oppositions or protests to patents

39 Modification and re-examination of patents

Does the patent office provide any mechanism for opposing the grant of a patent? Yes, the law sets forth a mechanism of pre-grant oppositions to any interested third party (article 5 of Law 19.039). Oppositions must be filed within 45 days from publication of the patent application (publication usually occurs six months from filing date). There are no restrictions or limits on the content of the opposition brief. Once the opposition is filed, the Patent Office will allow the applicant to formally respond the opposition within 45 days. After such response or if no response is filed, the Patent Office will open, if needed based on the allegations of the parties, an evidence term of 45 days. This opposition mechanism allows the opponent to respond to the Office Actions within the same terms as the applicant (60 days and the possibility to require an additional 60 days one-time extension), to appeal to the first instance decision (within 15 days of its notification) and request the review of the second instance decision to the Supreme Court via cassation action (within 15 days from the notification of the second instance decision). 38 Priority of invention Does the patent office provide any mechanism for resolving priority disputes between different applicants for the same invention? What factors determine who has priority?

Does the patent office provide procedures for modifying, re-examining or revoking a patent? May a court amend the patent claims during a lawsuit? The law only provides a procedure for revoking a patent before the Patent Office. See question 17 in regards to patent validity. The Patent office may not amend the patent claims, but may entirely or partially cancel the claims that were declared to be invalid. 40 Patent duration How is the duration of patent protection determined? It is currently determined based on the filing date, and for patents filed before the 2005 amendment to the law, it was determined based on the registration date. This means that for patent applications filed before December 1, 2005, the duration of the patent protection is 15 years from the granting date. For patent applications filed from 1 December 2005, the duration of the patent protection is 20 years from filing date. Additionally, it is possible to request a patent extension term (known as ‘supplementary protection’, article 53 of Law 19.039) provided there has been an unjustified administrative delay in the granting of the patent and the term for the granting was of over five years from the filing date of the application or of three years from the request for examination, whichever occurs after. Such request is made before the Industrial Property Tribunal.

The only mechanism for priority dispute between different applicants for the same invention would be the opposition of the patent application or its invalidation within five years of the patent registration. It is not an effective mechanism since it would ultimately generate the rejection or invalidation of the patent application or registration. No other mechanism is available.

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Shareholder Activism & Engagement

Corporate Immigration

Labour & Employment

Ship Finance

Cybersecurity

Legal Privilege & Professional Secrecy

Shipbuilding

Data Protection & Privacy

Licensing

Shipping

Debt Capital Markets

Life Sciences

State Aid

Dispute Resolution

Loans & Secured Financing

Structured Finance & Securitisation

Distribution & Agency

Mediation

Tax Controversy

Domains & Domain Names

Merger Control

Tax on Inbound Investment

Dominance

Mergers & Acquisitions

Telecoms & Media

e-Commerce

Mining

Trade & Customs

Electricity Regulation

Oil Regulation

Trademarks

Energy Disputes

Outsourcing

Transfer Pricing

Enforcement of Foreign Judgments

Patents

Vertical Agreements

Environment & Climate Regulation

Pensions & Retirement Plans

Equity Derivatives

Pharmaceutical Antitrust

Also available digitally

Online www.gettingthedealthrough.com

Patents ISSN 1742-9862

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