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Healthcare Sector in Latin America 1. The Healthcare sector in Latin America The Latin American Healthcare market is growing in the pharmaceutical industry as well as in medical equipment, devices and consumables. For the year 2018, healthcare spending in Latin America is estimated at 7.20% of GDP. (The Economist, Intelligence Unit) This region’s emerging market is due to the growth of the middle class, positive demographic trends and the self-payed nature of primary healthcare. The fact that a large part of the po- pulation lives in rural areas prompted the expansion of mobile internet access with demands for telemedicine, a mobile health service which has experienced high growth at a value of €1 billion in 2017 and €2 billion expected by 2021 (Global Health Intelligence). Brazil and Mexico are leaders in the market of telemedicine. Generally, the region is also experiencing increasing urbanization and subsequent access to modern retail, as well as slowly improving regulatory environments. The government and private hospital budgets are increasing, e.g. Argentina invested €40.64 million in healthcare infrastructure; legislative changes in Colombia entailed that medical services have now be- come a fundamental right and their coverage has been extended; and Chile has expanded healthcare coverage. Subsequently, a recent report places Brazil, Colombia and Chile in the top 20 Global Access to Healthcare Index. Another important market is the one regarding over the counter (OTC) medicines (i.e. drugs you can buy without a prescription). This type of medicine continues to overtake that of patented prescription medicines. For instance, while in the US and Europe OTC represents 9% of total pharma sales, in Brazil it amounts to 27%. In the same vein, generic medicines represent a third of pharma sales volume in Brazil, and 40% in Mexico in 2018 (Global Health Intelligence 2017). Taking into account that 75% of generic medicines consumed in Europe are produced in Europe; emerging markets outside Europe provide EU businesses with major export opportunities (Medicines for Europe). The generic prescription drug segment is the fastest growing pharmaceutical category in Latin America. 1. The Healthcare sector in Latin America 2. Why is IP important in the Healthcare sector? 3. Benefiting from IPRs in the Healthcare sector A. Patents and Utility models: Securing your technical innovations • Data protection and data exclusivity • Bolar exemption • Second medical use • Supplementary protection • Using your Patent B. Industrial Designs: Pro- tecting the appearance of your products C. Trademarks: Boosting your business identity D. Trade secrets: Sheltering your business information 4. Manage your IP: R&D and Technology Transfer con- tracts • Main Technology and Trans- fer contracts: Assignments and Licences 5. Glossary 6. Related links and additional information FACTSHEET

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Page 1: FACTSHEET Healthcare Sector in Latin Americalatinamerica-ipr-helpdesk.eu/sites/default/files/... · new devices that provide an improvement, or technical effect in the function of

Healthcare Sectorin Latin America

1. The Healthcare sector in Latin America

The Latin American Healthcare market is growing in the pharmaceutical industry as well as in medical equipment, devices and consumables. For the year 2018, healthcare spending in Latin America is estimated at 7.20% of GDP. (The Economist, Intelligence Unit)

This region’s emerging market is due to the growth of the middle class, positive demographic trends and the self-payed nature of primary healthcare. The fact that a large part of the po-pulation lives in rural areas prompted the expansion of mobile internet access with demands for telemedicine, a mobile health service which has experienced high growth at a value of €1 billion in 2017 and €2 billion expected by 2021 (Global Health Intelligence). Brazil and Mexico are leaders in the market of telemedicine.

Generally, the region is also experiencing increasing urbanization and subsequent access to modern retail, as well as slowly improving regulatory environments. The government and private hospital budgets are increasing, e.g. Argentina invested €40.64 million in healthcare infrastructure; legislative changes in Colombia entailed that medical services have now be-come a fundamental right and their coverage has been extended; and Chile has expanded healthcare coverage. Subsequently, a recent report places Brazil, Colombia and Chile in the top 20 Global Access to Healthcare Index.

Another important market is the one regarding over the counter (OTC) medicines (i.e. drugs you can buy without a prescription). This type of medicine continues to overtake that of patented prescription medicines. For instance, while in the US and Europe OTC represents 9% of total pharma sales, in Brazil it amounts to 27%. In the same vein, generic medicines represent a third of pharma sales volume in Brazil, and 40% in Mexico in 2018 (Global Health Intelligence 2017). Taking into account that 75% of generic medicines consumed in Europe are produced in Europe; emerging markets outside Europe provide EU businesses with major export opportunities (Medicines for Europe). The generic prescription drug segment is the fastest growing pharmaceutical category in Latin America.

1. The Healthcare sector in Latin America

2. Why is IP important in the Healthcare sector?

3. BenefitingfromIPRsintheHealthcare sectorA. Patents and Utility models:

Securing your technical innovations• Data protection and data exclusivity• Bolar exemption• Second medical use• Supplementary protection• Using your Patent

B. Industrial Designs: Pro-tecting the appearance of your products

C. Trademarks: Boosting your business identity

D. Trade secrets: Sheltering your business information

4. ManageyourIP:R&DandTechnologyTransfercon-tracts • Main Technology and Trans-fer contracts: Assignments and Licences

5. Glossary

6. Relatedlinksandadditionalinformation

FACTSHEET

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Finally, infectious diseases are decreasing and thus the challenges presented by non-communicable diseases are growing and are shif-ting the priorities of healthcare systems in the region. Cancer is La-tin America’s second-biggest killer; there are 1.1 million new cases diagnosed each year (Global Health Intelligence 2018). The size of the market and life expectancy are increasing (The Economist, Inte-lligence Unit)). Obesity rates are the highest in this part of the world, affecting a large portion of children and by 2030 it will affect more that 50% of men and 60% of women (Global Health Intelligence 2018). In order to make the most out of the business opportunities in the region, foreign entrepreneurs need to identify and look into the unmet needs of the region, creating products and services that will provide an added value to the healthcare market.

2. Why is IP important in the Healthcare sector?

The Healthcare sector is a highly innovative and challenging indus-try where ground-breaking products and technologies are needed to stay ahead of the competition. Research and development efforts on pharmaceutical products, medical technologies, equipment and devices are protected from unlawful copy, misappropriation or even loss of the right by different IP rights or mechanisms, such as Pa-tents, Trade Secrets or Industrial Designs. In addition, the reputation and distinctiveness achieved by your company through sustained product innovation, product quality standards and original commer-cial approaches can be protected against imitation or copy by Tra-demarks, Copyright or Design Rights.

According to a recent report published by the Organisation for Eco-nomic Cooperation and Development, Latin America suffers from sales of counterfeit products, the most common being contact len-ses, microscopes, veterinary instruments and medical supplies. In terms of volume of trade of counterfeited products, optical, pho-tographic and medical equipment came in 4th place (estimated in €23.57 billion); and pharma products in 5th place (estimated at €3.25billion) in 2013. However, this data only refers to trademark infringements and does not cover patent infringements regarding pharma products (for example, pharma products with incorrect quantities of active or wrong ingredients). Main transit points for counterfeits are Belize, Panama and Paraguay, and the main produ-cer of counterfeits in the region is Mexico.

Therefore, it is crucial in this sector to register your IP on a coun-try-by-country basis and to have a proactive enforcement strategy in place. Do not forget that IPRs provide you with exclusive rights granting you with the most secure way to recoup your investments, exploit your inventions and creations while excluding third parties from unauthorised uses.

3.BenefitingfromIPRsintheHealthcaresector

As the Healthcare sector market has a vast range of products and services e.g. disposable gloves, contact lenses, surgical implants, drugs or pharma products, insurers, medical devices, spas, among others, there are many relevant IPRs. EU SMEs in this sector could take advantage of the opportunities offered by Patents, Utility Mo-dels, Industrial Designs, Copyright, Trademarks and Trade Secrets.

Be aware that regulatory frameworks and application for IPRs differ, sometimes only slightly, between the countries of the region. To secure your healthcare related IPR there is a need to register be-fore the competent National Intellectual Property Office, and while for some IPRs it is not a pre-requisite (e.g. Copyright), we strongly recommend you register your rights in the region in order to avoid any potential risks.

Moreover, EU SMEs must take into account that aside from securing their technologies through IPRs, in all five countries analysed in this guide, there are also National Medicines and Healthcare Product Regulatory Agencies in charge of granting marketing and sanitary approvals. The Agencies of the most relevant markets of this region are:

Country Healthauthority

Argentina The National Administration for Drugs, Food and Medical Technology (ANMAT)

Argentina The National Health Surveillance Office (ANVISA)

Chile The Institute of Public Health (ISP)

Colombia The Ministry of Health and Social Protection (INVIMA)

Mexico The Medicines Regulatory Agency (COFEPRIS)

Healthcare Sector in Latin America1

BenefitsofmanagingyourIP:EUSMErealcasestudies

The European Patent Office (EPO) has published a series of cases on EU SMEs from different countries, operating in di-fferent industries and technology sectors. These SMEs were interviewed about their IP strategies and underlying busi-ness models. The resulting case studies illustrate how new and established SMEs have developed the IP management capabilities they need and how they are using IP to their advantage.

For Medical Technology, do not miss the Italian SME case “At the cutting edge of cardiopulmonary diagnostics”

HEALTHCAREANDPHARMACEUTICALSECTORINMEXICO

For specific commercial data and information on the poten-tial of this sector in Mexico, IP statistics and best practices to protect your innovations in these fields, do not miss our Infographic Healthcare and Pharmaceutical innovation in Mexico.

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A.PatentsandUtilityModels:Securingyourtechnicalinno-vations

The highly competitive Healthcare industry requires to continuous-ly look for ways to differentiate companies’ products and services from the ones of their competitors by improving quality and tech-nical characteristics, reducing production, distribution and manage-ment costs and offering greater value to consumers.

In this context, Patents, Utility Models and Industrial Designs also contribute to build your reputation and strengthen your market posi-tion. Combining a diversified IP portfolio with an efficient marketing strategy will provide you with a good basis to acquire customer’s loyalty, brand name and reputation, which will result in an increase of the company’s value and improve future profitability.

Patents and Utility Models protect inventions offering new techni-cal solutions to a problem, and are particularly relevant in research related sectors, such as the medical field. According to EPO’s sta-tistics, during 2017, European Patent applications filed within the EPO in the medical technology field grew by 6,2%, reaching 13.090 applications and becoming the most patented field of that year.

In Latin America, a Patent is usually granted if the invention fulfils the following requirements:

• Novelty: Inventions are considered new if they are not included in the state of the art (see Glossary).

Many Latin American countries establish a 12 months grace pe-riod by law. This means that certain disclosures of the invention will not be taken into account when evaluating the novelty and inventiveness of your application. Should you need further infor-mation on grace periods and their requirements please contact our Helpline: it is free, fast and confidential.

• Inventivestep: An invention shall be regarded as involving an inventive step when it is not obviously derived from the state of the art for a person skilled in the field.

• Industrialapplicability: An invention shall be regarded as indus-trially applicable when its subject matter may be produced or used in any type of industry. Industry is usually broadly unders-tood - any productive activity, including services.

Utility Models are known as ‘petty patents’ or ‘minor patents’ e.g. new devices that provide an improvement, or technical effect in the function of an object. Be aware that this type of protection can only be obtained for products, not for processes. All five countries provide this type of protection. Requirements are the same as for Patents. However, criteria are less strict and the substantive examination is simpler and faster. In Argentina, it is irrelevant that the invention lacks inventive activity, or is known, or has been disclosed abroad. Chile, Colombia and Mexico only require novelty and industrial appli-cation.

As regards the term of protection, as a rule of thumb, the maximum period a Patent can be maintained in force is 20 years counted from the date of the application - they need to be renewed usually on a yearly basis. On the other hand, as regards Utility Models, the monopoly is granted for a shorter period. In Brazil 15 years, and in

the other four countries, the term is 10 years counted from the filing date. This term is not renewable. For more detailed information on Patents, check our guides on How to conduct a Patent search: the basics, Patent Acceleration in Brazil, and our Country IP Factsheets in Argentina, Brazil, Chile, Colombia and Mexico.

Because innovations in the Healthcare sector require years of inten-se research and development, strong investments, numerous trials and tests before starting its patenting and commercialization pro-cess and implies high risks, offering proper protection to the results is a must. For these reasons, patent protection in this industry has certain particularities:

Dataprotectionanddataexclusivity

In the pharma sector, National Health Regulators are required to protect the originator’s company’s test data against unfair use. However, there is no obligation to provide periods of data exclusi-vity (see Glossary). Yet, your exclusivity is protected by the patent. Data exclusivity acts independently from the patent once patent protection has expired. Its purpose is to guarantee the exclusivity of the data, studies and tests a company has invested time and money in to produce for the marketing authorisation. It can also delay the entry of generic companies to the market.

Argentina, Brazil (except for veterinary and agrochemical use) and Chile do not provide data exclusivity. Mexico provides a five-year pe-riod. In Colombia while the regional legislation (CAN Decision 486) provides 3-5 years for the protection of registered data, national legislation remains silent.

Bolar exemption

The Bolar exemption facilitates generic drug manufacturing allowing, without infringing, companies that produce generic medi-cines to apply for marketing authorisations and use patented mate-rials. Thanks to this exemption, generic medicines can quickly enter the market once the originator’s patent has expired. The generic medicine has the same active substance as the originator’s medi-cine and is required to comply with the same standards of safety, quality and efficacy. The name of the medicine and its appearance may be different from the originator’s one because they may be protected by other IPRs such as Trademarks and Copyright.

Brazil, Chile and Colombia contemplate this exception in their na-tional legislation. However, while Argentina provides a Bolar-like exemption, its actual application remains to be tested in courts. Fi-nally, Mexico allows for this exemption to be applied but only when the patent is 8 years away from expiration for a biologic product, or 3 years for a small molecule.

Healthcare Sector in Latin America 2

RestrictivepatentabilitycriteriainArgentinaandBrazil

Concerning Patent applications, in Argentina and Brazil there are new guidelines for the examination of chemical-phar-maceutical patent applications. These severely restrict the patentability of a number of categories or inventions in the pharmaceutical field. In Brazil, the granting of patents for pharmaceutical products and processes depends on the pre-vious approval of ANVISA.

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Secondmedicaluse

Where a substance or composition is already known and has been used for a ‘first medical use’, it may still be patentable for any se-cond or further uses if said use is new and inventive. This second (or further) medical use of known pharmaceutical products is per-mitted in Brazil and Mexico, but not allowed in Argentina, Chile and Colombia.

SupplementaryProtection

A Supplementary Protection Certificate (SPC) is the right to request the extension of the duration of the Patent protection due to an unjustified administrative delay as a consequence of the time taken to receive marketing authorisation for such a product. It is a unique right that can give up to 5 additional years of protection after the expiration of the patent term. Chilean legislation foresees this su-pplementary protection. This is also the case for Colombia, but the legislation excludes pharma-products. There are no provisions for SPC in the Argentinian and Mexican law. Brazil does not set up an SPC, but Brazilian law establishes that the period of validity shall not be less than 10 years for a patent as of the date of grant.

UsingyourPatent

In Argentina, Brazil, Colombia and Mexico, you need to use your Pa-tent, otherwise if after 3 years of non-use, any person may request the authorization to use the invention without your permission - un-less there are justified reasons for the non-use. This is known as a compulsory license. In Chile there is no time specification, but if you have a non-working patent, compulsory licenses will be granted if there is a monopoly abuse.

IPRSINLATINAMERICA

If your company aims to do business in Latin American countries, it is highly recommended to seek professional IP advice prior to any commercialization of your valuable in-tangible assets. Be aware that you might deal with issues and situations in this region that may represent a critical factor for your business success.

When it comes to protection and enforcement (see Glossary) of IPRs in Latin America, EU SMEs may take into considera-tion the following aspects:

• Low level of regional harmonization

• Whether or not these countries are part to the Madrid Sys-tem, PCT or The Hague agreement

• Longer registration procedures

• Cost of filings

Knowing in advance these, and any other barriers can help your company develop an effective protection strategy and prevent you from incurring unnecessary costs.

B.IndustrialDesigns:Protectingtheappearanceofyourproducts

Aside from the technology itself, in some fields (e.g. medical de-vices), protection of the shape of the product is essential. In this case, the appearance is the essence of protection, not the technical features. For example, you can protect the entire look of a medical device or parts of its design such as blood sampling devices, diag-nostic devices, inhalers and stents and thus stop competitors from making or selling similar looking devices.

Requirements and their assessment differ slightly from country to country. In general, Industrial Designs are only required to be of new appearance (novelty is evaluated on a worldwide basis), capa-ble of being original, resulting in a distinctive visual configuration in comparison to others already known; and capable of industrial manufacturing by being able to be reproduced industrially. Designs cannot be offensive, go against public order or morality. You cannot register designs if the appearance is dictated entirely for considera-tions of a technical or functional nature.

While it is common to submit photographs with your application, we strongly recommend to submit line drawings clearly showing the distinctive features. Remember, to protect your design you need to register locally. Unlike Europe, this region does not provide anything similar to the European ‘unregistered design right’.

INTERNATIONALCLASSIFICATIONUSEDFORINDUSTRIALDESIGNS

Argentina and Mexico use the Locarno Classification, which is an international classification used for the purposes of the registration of Industrial Designs. Medical devices are usua-lly classified in class 24 and class 28. Note that e-cigarettes may be considered as medical devices and so, in class 27.

The maximum duration of the registered Industrial Design is usua-lly around 10 years (Colombia and Chile) or 15 years (Mexico and Argentina). These are non-renewable terms. In Brazil, however, pro-tection can be obtained for up to 25 years from the application date (an initial period of 10 years with three subsequent renewals of 5 years each one).

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C.Trademarks:Boostingyourbusinessidentity

In pioneering sectors, more and more companies build their repu-tation on their ability and willingness to innovate, mainly relying on Patents and Industrial Designs. However, take into account that other IPRs such as Trademarks and Domain Names will allow cus-tomers to link product’s quality to the reputation of your company.

Note that in Argentina, physicians are required, by law, to use ge-neric names for active principal ingredients but it does not forbid to include the brand name of a drug in the patient prescriptions. Data from 2010 indicates that only 20% of the prescription includes a non-brand name. National pharma companies invest heavily in creating brand loyalties in order to differentiate their products from their competitors. (Coalitions and Compliance. The Political Eco-nomy of Pharmaceutical Patents in Latin America. Oxford. 2017).

This competitive environment, together with the fact that medical services are also increasingly being offered by large private carriers, an effective brand strategy is necessary.

Most trademark rights derive from registration. In Brazil, a trade-mark is awarded to the first party that applies for the registration. However, any person who, in good faith, at the date of priority or the date of application, has been using in Brazil an identical or si-milar trademark for at least six months to distinguish or certify an identical, similar or related product/service, shall have a preferential right to registration.

Do not forget that trademark protection covers distinctive signs such as trade names, logos, symbols, slogans or even shape and packaging. Protection lasts 10 years but, since it can be renewed for an indefinite number of 10-year periods, protection can potentially be indefinite.

The application for a trademark’s registration, and any documents attached, must be presented in Portuguese in Brazil and Spanish in the other countries. Before applying, it is recommended to do a tra-demark clearance to ensure that your trademark does not infringe third-party’s rights. A proper trademark search should reveal all the pre-existing registered trademarks which are similar or identical to your proposed mark.

If you want to know more about how to protect your brand, read our guides on Trademark registration in Argentina, Trademark re-gistration in Chile, Trademark registration in Brazil, How to conduct a Trademark search in Chile, the Country IP Factsheets of Argentina, Brazil, Chile, Colombia and Mexico, or contact our Helpline. It is free, fast and confidential and it is available in English, Spanish, German, French and Portuguese.

INTERNATIONALCLASSIFICATIONUSEDFORTRADEMARKS

The five national offices use the Nice International Classi-fication System in order to classify trademarks. Regarding medical device manufacturers, several classes of trademar-ks are commonly used, for example an in vitro diagnostic (IVD) blood composition analyser can be filed in: class 5 (IVD for medical purposes), class 9 (computer software and com-puter hardware for medical purposes), class 10 (surgical and medical instruments, equipment and apparatus), class 41 (providing of training, education and tuition for medical purposes). However, if you apply for trademark protection across a very broad range of goods and or services you in-crease the risk that your trademark application will be oppo-sed by a third party.

D.TradeSecrets:Shelteringyourbusinessinformation

The best way to keep a Trade Secret protected is not disclosing it. However, to achieve your commercial goal you may need to relea-se such information. Technical solutions, client lists, know-how and marketing strategies, among others, can be protected as Trade Se-crets. This is done through ‘confidentiality agreements’, also known as non-disclosure agreements, which are contracts that establish conditions under which the disclosing party releases info in confi-dence to another, binding it not to reveal the info given and to keep confidential the sensitive information contained within.

This type of agreement must be done before entering into business relationships, that is, before disclosing the information. Protection through Trade Secrets is granted without any formal or registration requirements being needed and the term of protection is unlimited. It is important to insert clauses calculating damages for breaches of confidentiality and make clear that the confidentiality obligations extend beyond the lifetime of the contract.

In order to claim protection, three requirements must be met:

• Information should be secret

• It cannot be generally known or easily accessible

• Information must have commercial value (excluding Brazil)

• The holder should take reasonable measures to keep the secrecy of the information.

These agreements are common in pre-clinical stages when a drug or a medical device is in the study phase, if not patented. It is re-commended to introduce clauses that set an economic penalty if any party violates the confidentiality duty. Best practices on Trade Secrets can be found in our guides Trade Secrets in Chile and Trade Secrets in Argentina.

Healthcare Sector in Latin America 4

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4.ManageyourIP:R&DandTechnologyTransfercontracts

IPRs offer a wider range of options when it comes to usage. Besides the manufacture and commercialization of the product or services, owners may choose other means to profit from their creations, by for instance selling the IPRs, licensing all or part of their rights, or deciding on any other type of arrangement, such as cross-licensing technology (see Glossary).

EU SMEs can find in this region an opportunity to continue develo-ping a product by joining efforts and abilities with Latin American partners, such as companies or public research institutions.

In the latter, it is interesting to note that there are research opportu-nities offered by some Latin American countries due to their pro-in-novation provisions or ecosystem. In Mexico 52% of the national patent applications are filed by research centres and universities. Chile’s incentives promote R&D projects of universities and public research institutes in conjunction with private companies. In ad-dition, there is a Chilean Tax Incentive Act for R&D. In Colombia, foreign investors can participate without discrimination in govern-ment-subsidized research programs and R&D incentives include Tax exemptions for imported equipment or materials used in scientific, technology, or innovation projects.

MainTechnologyTransfercontracts:AssignmentsandLicences

There are two main types of contracts when exchanging technology and IPRs: assignments and licences. Recording an assignment/licen-ce is not mandatory and the agreement is enforceable between the parties regardless of whether or not it is registered. However, it is highly recommended that the assignment/licence be in writing and registered before the national IP office to be effective against any third party and ensure the title holder has the right to use the IPRs.

By licensing, the IPR holder (licensor) grants permission to a third party (licensee) to undertake an act(s) which would otherwise in-fringe his/her right. Full ownership is not transferred as it the case with assignments.

European business licensing in Latin America will allow you to ob-tain higher profits due to lower production costs in the region. Howe-ver, other costs such as strong contract negotiations, and high fees payable to the licensee to discourage imitation are needed (United Nations Industrial Development Organization).

The agreement should contain the type of licence (exclusive, sole - see Glossary-, or non-exclusive); enforcement rights, limitations, payment (lump sum or royalties), term of contract, territory, liabili-ty, and improvements (and ownership of said improvements) if the collaboration results in an invention.

The national IP offices are the competent authorities for the analy-sis and registration of IP licensing, technology transfer (TT) and franchising agreements. In Brazil, the assessment and approval of TT and IP licensing agreements are mandatory in order to authorize remittance of royalties to a foreign licensor, grantor of IPRs recog-nized in Brazil; to trigger tax deductibility by the Brazilian party of amounts paid in connection with an IP license, acquisition and to entitle the Brazilian party to enforce licensed, granted IP rights.

Licence and/or assignment agreements submitted to the Brazilian IP office must be notarised. If they were signed outside Brazil, then they must also be legalised. In Chile, such agreements must also be notarized and registered before the national IP office. There is also a need to submit a ‘‘Recording Form’ which is a specified set-up form available online, indicating the transfer of IPRs that will be analysed by the IP office. If the agreement originates abroad, you must lega-lize it before the consul of Chile in the foreign country and then in the Chilean Ministry of Foreign Affairs.

In many developing countries, the inflow of technology is subject to a variety of controls (ensuring that contracts are consistent with the economic aims of the government). These controls are part of a more comprehensive system of laws dealing with foreign invest-ment in the country. In Brazil, for example, after registering the li-cence, the agreements must also be registered before the Central Bank of Brazil. Make sure that, before licensing or transferring your technology to Latin America, you seek the professional advice of an expert on the subject that will provide you with accurate information on all the legal provisions that need to be complied with.

Healthcare Sector in Latin America5

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5. Glossary

DataExclusivity:Determines the length of time during which data submitted to the regulators remain undisclosed to third parties. The latter, do not have direct access to the pre-clinical and clinical data submitted by originator companies but after the expiry of exclusi-vity. This is completely independent of IP laws and it is administra-tively regulated.

Stateoftheart: The state of the art includes everything that has been disclosed or made publicly available before anywhere in the world. That disclosure can be made by means of an oral or written description, exploitation, sale or commercialisation, or through any other media or information services, that allow a skilled person to carry out the invention.

Cross-licenses: are agreements whereby the parties grant licenses in exchange for other licenses. These types of contracts are com-mon in technological sectors with a high level of litigation, such as ICTs, to avoid litigation or even to settle an infringement dispute. Sometimes, they constitute a great basis for R&D partnerships and joint ventures.

Solelicence: It is an exclusive license which has the peculiarity that the licensor reserves full rights to exploit the intellectual property itself. The licensor does not have the right to grant any other sub-li-cences.

IPR enforcement: The use of legal actions, remedies, measures and procedures against the infringement of any IPR. This includes, among others, stopping unauthorized use, deterring future infrin-gements or obtaining recovery for damages resulting from the in-fringing act.

6.Relatedlinksandadditionalinformation

LatinAmericaIPRSMEHelpdeskmaterials

IPCountryFactsheets:

Argentina: http://www.latinamerica-ipr-helpdesk.eu/content/argentina-ip-country-factsheet

Brazil: http://www.latinamerica-ipr-helpdesk.eu/content/brazil-ip-country-factsheet

Chile: http://www.latinamerica-ipr-helpdesk.eu/content/chile-ip-country-factsheet

Colombia: http://www.latinamerica-ipr-helpdesk.eu/content/colombia-ip-country-factsheet

Mexico: http://www.latinamerica-ipr-helpdesk.eu/content/mexico-ip-factsheet

Infographic:

Protect it before you get there: Healthcare and Pharmaceutical innovation in Mexico: http://latinamerica-ipr-helpdesk.eu/content/protect-it-you-get-there-healthcare-and-pharmaceutical-innovation-mexico

IPRsguides:

How to conduct a Patent search: the basics: http://www.latinamerica-ipr-helpdesk.eu/content/how-conduct-patent-search-basics

Patent Acceleration in Brazil: http://latinamerica-ipr-helpdesk.eu/content/patent-acceleration-brazil

Guide to Trademark registration in Argentina: http://www.lat inamerica- ipr-helpdesk .eu/content/guide-trademark-registration-argentina Guide to Trademark registration in Chile: http://www.latinamerica-ipr-helpdesk.eu/content/guide-trademark-registration-chile

Guide to Trademark registration in Brazil: http://latinamerica-ipr-helpdesk.eu/content/guide-trademark-registration-brazil

How to conduct a Trademark search in Chile: http://www.latinamerica-ipr-helpdesk.eu/content/how-conduct-trademark-search-chile

Trade Secrets in Chile: http://www.latinamerica-ipr-helpdesk.eu/content/trade-secrets-chile

Trade Secrets in Argentina: http://www.latinamerica-ipr-helpdesk.eu/content/trade-secrets-argentina

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Healthcare Sector in Latin AmericaDownload Guide

©European Union, 2019

Reuse is authorised provided the source is acknowledged.

The reuse policy of European Commission documents is regulated by Decision 2011/833/EU (OJ L 330, 14.12.2011, p.39).

The Latin America IPR SME Helpdesk is a free service for SMEs which provides practical, objective and factual information about Intellectual Property Rights in Latin America. The services are not of a legal or advisory nature and no responsibility is accepted for the results of any actions made on the basis of its services. The content and opinions expressed are those of the authors and do not necessarily represent the views of the European Commission and/or the Executive Agency for Small and Medium-sized Enterprises or any other body of the European Union.

Before taking specific actions in relation to IPR protection or enforcement all customers are advised to seek independent advice. Neither the European Commission nor the Agency may be held responsible for the use which may be made of the information contained herein.EA-01-19-652-EN-C - ISBN 978-92-9202-578-6 - DOI 10.2826/133692EA-01-19-652-EN-N - ISBN 978-92-9202-577-9 - DOI 10.2826/407111

Last update February 2019

The Latin America IPR SME Helpdesk offers multilingual services (English, French, German, Spanish and Portuguese1), with free information and first-line legal advice on IP related subjects, as well as training, webinars and publications, especially designed for EU SMEs.

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HELPLINE First-line advisory service on IP protection and enforcement for EU SMEs working or planning to operate in Latin America.

TRAINING Targeted trainings and webinars on IPR protection and enforcement for EU SMEs (including sector- specific approaches).

IP CONTENT State-of-the-art publications (factsheets, learning modules, videos, IP glossary, info graphics, case studies and newsletters) on the protection and enforcement of IPR in Latin America – specifically addressing IP matters from the SME business needs point of view.

AWARENESSRAISINGEVENTS Participation in events attended by EU SMEs to increase the awareness of IP and of the visibility of the services provided by the Helpdesk.

IP ANALYSIS Analysis of IP challenges faced by EU SMEs in the target markets.

IP DIAGNOSTIC TOOLKIT Toolkit for self-evaluation of the IP-status of the user in terms of IP knowledge and management.

IP COST TOOL Online tool that allows the user to pre evaluate the costs related to IP management in every Latin American country covered by the Helpdesk.

1The language offer will depend on the specific service and experts’ availability.

www.latinamerica-ipr-helpdesk.eu

If you have any queries on how to protect your Intellectual Property in Latinamerica contact our Helpdesk service:

If you want more information on additional free services offered by the Helpdesk contact the coordination team:

Follow us on Social Media and stay tuned on new releases of factsheets and other IP content: @latinamericaipr

[email protected]+34 96 590 9684Working Hours: Monday - Friday 9:00 -16:30 (CEST)

[email protected] of Alicante, Campus San Vicente del Raspeig, Edificio Torre de Control, 03690 Alicante, Spain+34 96 590 9684