Life sciences in Colombia
Cavelier’s in-house patent and regulatory affairs practice includes 22 experts covering a very broad range of specialist areas - including biotechnology, microbiology, biomechanics, software and electronics - under the direction of Andrés Rincón and Adriana Durán. Offering integrated advice throughout the patent prosecution process, the boutique represents some of the most relevant companies in the pharma and biotech, agrochemical, cannabis, food and beverage industries, as well as research institutions, such as the Colombian Coffee Growers Federation and several Colombian universities. Leading lawyer Rincón has 20 years' experience and is the current Colombian representative before AIPPI's biotechnology committee; he focuses his practice on patent drafting, prosecution, litigation and freedom to operate in Colombia and the Andean region, mainly for the pharmaceutical industry. With over 15 years' experience, co-head Durán leads the regulatory affairs and healthcare compliance practice.
‘Communication is extremely clear, questions are answered with speed and consistency. Working with the Cavelier team gives us the assurance that we are doing the best in terms of regulatory strategy and time-to-market in Colombia‘.
‘Adriana Durán is an excellent professional, with great experience in medical devices regulation in Colombia, has objective and clear communication. she give us subsidies to make decisions with technical and strategic basis‘.
‘What characterises Cavelier’s practice is that it has a technical patent team with experts in many areas of practice. This is not so common in Latin America. The team is highly trained in patent and life sciences processing and provides very good support. With them we handle issues, particularly pharmaceuticals, biotechnology and mechanics for regional clients and Colombian clients interested in protecting their developments in Perú‘.
‘Andrés Rincón is the partner who heads the Cavelier patent team. What makes him stand out is that he is directly involved in the firm’s cases and coordinates them very skillfully with his work team, where professionals such as Carolina Vargas also stand out. Andrés is one of the few people highly trained and experienced in patent issues in Colombia and in the region. He is particularly involved in pharmaceutical and biotechnology issues‘.
‘We had the opportunity to work with the Cavelier patent department, which is managed by partner Andrés Rincón. In my opinion, the team led by Rincón is excellent and with it we handle our patent matters in Colombia. We always have excellent support, particularly on issues related to drug and biotechnology. Andrés has managed to create a truly interdisciplinary team, difficult to find in the region‘.
‘Andrés Rincón. Highly trained in the area‘.
Federación Nacional de Cafeteros de Colombia
Thermo Fisher Scientific
Allergan de Colombia
Applied Medical Technlogy
Boehringer Animal Health Unit
- Prosecuted the first pharmacological evaluation for a phytotherapeutic cannabis product before the National Institute for Food and Drug Surveillance (INVIMA), on behalf of Aphria.
- Obtained the registration of over 900 reagent items for Research Use Only (RUO) prior to the July 2019 introduction of new regulations, on behalf of Thermo Fisher Scientific.
- Represented Vetiplus in a legal action against the licences granted by the Environmental Licencing Authority (ANLA); the authority finally accepted the nature of the company’s products as disinfectants and stopped requiring the company to comply with and pay government fees applicable only to pesticides.
- Advised Federación Nacional de Cafeteros de Colombia on several matters, including redrafting and overcoming an objection of a patent application of a new biological pesticide.
- Managed Intercept Pharmaceutical’s patents portfolio for a client in Latin America and the Caribbean countries by implementing the patent prosecution highways provided by the USPTO and several Latin American Patent Offices.
A top tier IP firm, Lloreda Camacho & Co. brings comprehensive coverage to major global players of R&D pharmaceutical, biotechnology, medical devices, food, beverage and cosmetics with its impressively wide-ranging service offering. Commanding the recognition of the market, Ana María Castro has led the patent and regulatory and life science department since 2004. Focusing her practice on patents, utility models, industrial designs and plant variety protection, Castro has ample experience in litigation on patent infringement cases, civil and criminal, as well as in nullity actions before the Council of State, the country's highest court. The seven-strong team is supported by nine in-house technical advisors. Associate director Daniel Cardona advises on regulatory issues at every stage of the product life cycle, as well as supporting on data protection, investigations for alleged health regulation and labelling, among others. Co-head Enrique Álvarez leads the competition law practice and co-heads the corporate group.
Eli Lilly Interamerica
- Permanent legal representation of Gilead Sciences with regard to the company’s patent portfolio in 18 jurisdictions in Latin America; as welll as advising on obtaining protection for specific chemical compounds including the main active ingredients in blockbuster medicines for HIV and HCV in Perú, Chile, Colombia, Argentina, among others.
- Advised Productos Roche on all legal proceedings and strategy regarding marketing authorization submissions before the INVIMA in connection with new products and renewals, data exclusivity protection and different changes to the current portfolio; the advisory included biotechnology matters such as decree 1782 on the biologic products authorization process.
- Advised Gilead Pharmasset throughout the initiation of an administrative action seeking a declaration of public interest regarding its pharmaceutical product for treating hepatitis C, to thereby secure the issuance of a compulsory licence both in Chile and Colombia.
- Advised Janssen Cilag on all legal proceedings and strategy in matters related to biotech, patient advocacy, data exclusivity protection, clinical trials, commercial agreements and price regulation, as well as advising the client on the defence against a constitutional rights action filed by patients.
- Represented the Colombian Association of Pharmaceutical Research and Development Laboratories (AFIDRO) in various judicial actions – including a nullity action against biotechnology decree 1782 – before the Council of State; as well as in the defence and validity of decree 2085 regarding data exclusivity protection in Colombia within a nullity action filed by a third party.
Boutique OlarteMoure is recognised among peers as top notch in the patent field and is frequently active on regional matters, especially in the bio-pharmacy sector, where the highly-regarded Carlos Olarte has an impressive reputation. The specialist firm also renders advice on medical devices, food and beverages, and new materials manufacturing, as well as to R&D institutions and universities. Olarte - who has vast experience advising major global R&D pharma companies - heads the firm's patents, life sciences and plant breeder's rights (PBR) department, leading a sizeable team that touts dual-background professionals (law and science), including that of Alexander Agudelo who directs the patent department. The firm also has an infringement search and freedom to operate (FTO) practice and an Asian desk led - from Tokyo - by Carlos Parra, director of innovation, protection and technology transfer.
‘OlarteMoure is a large firm that is very good in its areas of expertise.’
- Led the regional prosecution in 18 Latin American countries of Novartis’ patent portfolio.
- Developed a worldwide patent and trade mark strategy for a multinational food and beverages company, maintaining and strengthening its IP portfolio, and providing IP counsel and litigation management in courts in the US, Panama, Europe, and others.
- Assisted a medical devices company with patent drafting, patent prosecution and IP strategy.
Baker McKenzie S.A.S.
Profusely recommended, Baker McKenzie S.A.S. handles all types of regulatory transactions related to any product registrations before the local regulatory authorities. Acting on behalf of major players in the pharmaceutical, medical devices, cosmetics, food, dietary supplements and agricultural industries, the group also delivers patent advisory and prosecution, clinical trials, price regulation, importations and storage activities of controlled substances. Combining the experience of practice head Juan Pablo Concha, focused for over 20 years on intellectual property enforcement through administrative, civil or criminal litigation, and that of associate Diana Bohórquez, with in-house experience in a biotech company and currently the leader of the regulatory healthcare team, the three-strong team is supported by three technical associates.
‘The technical support that the firm has structured is key: with a technical team with pharmaceutical chemists‘.
‘Juan Pablo Concha is a warm person and close to people’.
‘An organised firm with in-depth knowledge of intellectual property processes; their quality is comparable to lawyers of international stature‘.
‘A good platform to share confidential information‘.
‘Open for negotiation, availability and follow up‘.
‘Regulatory healthcare practice leader, Diana Bohórquez, has a broad scope of knowledge and experience in the regulatory agency that overseas the production of our products by local licensees’.
‘Again, practice leader, Diana Bohórquez has invaluable experience working under the applicable regulations and is well connected with the agency that we deal with on a constant basis. The associate working on our matters, Alejandrina Adrián, is very responsive and has been able to deal with the workload assigned on our matters, which at times can be very heavy’.
‘Diana Bohórquez and Juan Pablo Concha. They care about the customer, delivering prompt responses and with a high level of detail‘.
‘We work with are Diana Bohórquez and Alejandrina Adrián; their plus is their knowledge of the internal process of my company and the local laws of INVIMA‘.
- Advised a multinational medical devices company on all regulatory matters related to its portfolio of sanitary licenses.
- Advised a pharmaceutical multinational in legal modifications before INVIMA in order to begin the direct importation of products.
- Advised a multinational manufacturing company in relation to the use of substances that are subject to control by the Ministry of Justice.
- Advised a pharmaceutical multinational on the implementation of internal procedures in relation to the Value Transfers registry created by the health ministry.
Brigard Castro provides thorough, specialised advice addressing all legal and regulatory needs of the life sciences industry. Co-head María Fernanda Castellanos has ample experience in health matters, and previously led the restructuring of the regulatory and patent practice of the firm, to better provide integrated risk identification services, strategy and litigation to clients in the sector. Castellanos coordinates the regulatory area with four in-house chemical and technical directors under her direction. Her fellow area co-head, managing partner Juan Cadena, has 30 years' experience advising on IP litigation, patents, and sanitary and health registrations, among other matters. The group draws support from its sibling full-service firm Brigard Urrutia to offer an interdisciplinary approach, participating in several projects and M&A transactions involving regulated companies in the life sciences and food sectors.
Ingenio del Cauca (INCAUCA)
Chart Industries BioMedical Division
- Assisted Cofarma on its interaction with INVIMA and the Ministry of Health to clarify the processes and stages needed to encourage Colombian and Chinese government agencies to share information regarding their coordinated compliance requirements and allow Cofarma to obtain marketing permission for its pesticides.
- Assisted Ferrero LADM in relation to the filing of a technical response regarding an excipient that is part of the formula for many of its marketed products.
- Provided assistance to Ingenio del Cauca on the launch of a new product line named ‘Incauca zero’ which does not contain calories.
- Provided regulatory assistance to the client in order to deliver an accurate classification of different medical devices intended to be marketed within Colombian territory.
- Assisted an international pharmaceutical company with an application for the quotes of psychoactive cannabis plants to perform agricultural evaluation tests.
Gómez-Pinzón Abogados (GPA)'s regulatory affairs and patents practice receives praise in particular for its 'knowledge of health registration management, and its connection with state entities'. Part of the intellectual property department, the 17-strong team, supported by in-house patent engineers, pharmaceutical chemists and food engineers, has wide experience in drafting and prosecuting patent applications and sanitary applications for local and international clients across a range of industries including health, pharmaceuticals, cosmetics, medical devices and the food and beverages industries. Led by Mauricio Jaramillo, who has over 25 years' experience in the IP and competition fields, the practice group includes well regarded associate Andrea Pieschacón who leads the regulatory law sub-practice; she too has a 25-year legal trajectory, including senior in-house roles in related industry companies.
‘The practice is unique given their knowledge in health registration management, and their connection with state entities‘.
‘We’d highlight their willingness, generous listening and compliance with delivery times to meet the requirements of our company‘.
‘All the services provided are of a high level, the lawyers are very kind, professional and have mastery of the subject’.
‘Both Andrea Pieschacón, the lawyer responsible for our account, and the technician that helped us were always available, guiding our team with great precision and care. This made a big difference, since we manage our business remotely. There is a lot of confidence in the work they do‘.
Glenmark Pharmaceuticals Colombia
Drypers Andina (Softys)
- Provided regulatory advice to Glenmark Pharmaceuticals on the company’s health registration portfolio in Colombia, obtaining authorisations before the Health Authority for the commercialisation of pharmaceutical products and medical devices, as well as the certification of Good Manufacturing Practices.
- Prosecution of an international application (after successfully arguing against an opposition filed by a competitor), on behalf of Vegenics Pty.
- Acted as strategic advisor to Pricesmart on the introduction of new food product and cosmetics lines, obtaining new sanitary registrations and authorisations for amendments from the Health Authority; additionally providing general regulatory advice on health registration applications and labeling consultations.
- Acted for Inis Biotech, Consejo Nacional de Investigaciones Científicas y Técnicas, and Instituto Nacional de Tecnologia Agropecuaria on the prosecution of the national phase of the international application for a vaccine against babesiosis.
- Provided regulatory advice to Intersurgical on the company’s health registrations portfolio in Colombia, as well as the applications for obtaining health registrations for medical devices before the Health Authority so as to import the products (including authorisations of labels, certifications and petitions).
Showing 'deep commitment' and 'proven ability', Posse Herrera Ruiz assists clients across the key life science sectors such as pharmaceuticals, food and beverages, medical devices, and biotechnological innovation. The firm has developed a centralised structure and workflow to offer patent prosecution and regulatory consultancy in 23 Latin American countries, also facilitating multiple registrations. Helena Camargo has over 25 years' experience in negotiating regulatory and compliance aspects of the development, approval, manufacture and marketing of drugs and medical equipment, as well as in obtaining health registrations and handling complex investigations. Camargo co-leads a five-strong practice (that also includes an in-house patent agent with a chemical engineering background), with senior associate Mónica Bonnett, who holds 20 years' experience in patents, health registrations and plant varieties. Both lawyers have developed expertise in the emergent cannabis segment.
‘The entire team works with deep dedication, commitment, responsibility and a proven ability to manage and solve problems‘.
‘Posse Herrera Ruiz’ lawyers have the undeniable ability to work hard in the name of the best results; they are all versatile, focused, very fast, practical and objective‘.
Strataca Systems (through Ferrer IP)
Sennics (through Bird & Bird)
Munksjö Oyj (through Genip Patent Agency)
BioLoGA (through Botti & Ferrari)
Regeneron Pharmaceuticals and Zogenix International (through Bozicevic Field & Francis)
Fall Creek Farm and Nursery, CostaExchange and Berry Blue (through Diaz Wiechers)
CSP Technologies (through Eckert Seamans Cherin & Mellot)
- Advised Strataca Systems on designing the strategy to move into the PCT national phase as the existing international phase involved several claims which cumulatively increased government fees costs.
- Successfully acted for Munksjö Oyj filing a reconsideration appeal against a patent protection rejection issued by the Colombian Patent Office.
- Advised Regeneron Pharmaceuticals in a multi-jurisdictional national phase filing project of a group of patents relating to a pharmaceutical compound for the treatment of opioid addiction; the advisory included submitting PCT national phase patents in Colombia, Peru, Brazil, Mexico, and Chile.
- Advised Kannabee on its cannabis license application before the Ministry of Health and Ministry of Justice.
A recommended choice for regulatory law regarding pharma and medical devices, as well as for the food and drinks industry, CMS Rodríguez-Azuero handles health registration prosecution and modifications, market approval for innovative products, certifications and authorisations for production and storage facilities, and advertising and labelling evaluations. Head of practice Karl Mutter, who for eight years led his own firm specialising in the comprehensive management of sanitary regulatory law, leads both the life sciences, and healthcare and intellectual property areas. Associate director Luz Helena Vargas, who has over 14 years in sanitary regulatory and registration matters, and associate María Ximena Castellanos make up the three-strong team, which also handles functional claims, investigations and penalties for alleged breaches.
‘The team led by Karl Mutter is highly specialised and knows the food and beverage industry and regulation very well‘.
‘Karl Mutter’s strength is undoubtedly knowledge on regulation and his commercial vision regarding legal advice. He always delivers concepts adjusted to the reality of the company, the market and the regulation‘.
‘The CMS Rodriguez-Azuero team is always available even if the client is “small”. In teams from other offices you can see the difference in care when you are not one of the big pharma companies. The CMS Rodriguez-Azuero team always does it best to assist you in the best way and if they do not know the information they are in charge of finding out and informing you. The team is always ready to accelerate the processes when required and works together with the client to achieve the objectives. They have specialists in all matters and advise us on any legal matter that we need, not just regulatory‘.
‘Always available, friendly service and easy to get in contact. The partners and associates serve us directly, they do not delegate the attention to their assistants. Luz Helena Vargas and Karl Mutter stand out‘.
‘They have a great deal of technical knowledge‘.
‘Karl Mutter is very professional and quick in his answers‘.
Red Bull Gmbh
Lohmann & Rauscher
Lentesplus.Com (Locust Sas)
- Assisted Lohmann & Rauscher with complex risk product classification, as well as to manage the company’s market approvals portfolio and to update them in order to include new references and products.
- Assisted Lentesplus.Com (Locust Sas) on obtaining the first ever approval for a site that sells contact lenses online; the advisory -which began back in 2015 – had to argue in different stages before the Ministry of Health and the Health Regulatory Authority to gain approval for the business model.
- Assisted Ethypharm on obtaining market approval for innovative pharma products; the advisory included the design and prosecution of a market approval strategy.
- Assisted Khiron Lifesciences on legal burdens and misinterpretations as per their use of cannabis; the company had issues with different suppliers and other players (such as financial institutions) unaware of the legal implications of cannabis-based products, so advisory required actively explaining to suppliers and others that cannabis products trading is legal.
Dentons Cardenas & Cardenas
Amply recommended, Dentons Cardenas & Cardenas has a pre-eminent offering in the cannabis-for-medicinal-purposes segment, where experienced lawyers from across the firm's finance, regulatory and tax practices combine to provide multidisciplinary, integrated advice. Also acting for other industries, the team is very active in this new and highly regulated industry at a regional and global level through the firm's international network of offices. Advising local and foreign clients, the seven-strong team assists with matters related to cultivation, production licensing, products registration and commercialisation, among other matters. Experienced and well-regarded IP lawyer Luz Helena Adarve's expertise encompasses the full range of life sciences as well as cosmetics, nutraceuticals, food and beverages products; she co-leads the practice with Catalina Pinilla and Santiago González, who have expertise in the finance and natural resources sectors respectively.
‘We value their commitment, their ability to give an immediate response, and the ability to give practical and not theoretical answers‘.
‘Dentons Cárdenas & Cárdenas has done a great job with the chemicals and life sciences sector, and on the subject of medicinal cannabis. They have been a pioneer in holding events and the practice advises large companies and investors in the sector. They are connected to all public entities in the sector and actively participate in technical tables, which makes them have updated information‘.
‘I had the opportunity to collaborate with Luz Helena Adarve and Catalina Pinilla; both are fast, helpful and prepared lawyers‘.
‘Catalina Pinilla, lawyer in charge of the cannabis sector, has supported and advised various companies, therefore, she keeps in contact with the entities, which allows her to have updated information on the sector. And since the regulation is new, they have been updating, preparing important events within the industry and actively participating in the technical tables’.
‘Carmen Sanabria is recommended for her familiarity with the operations of our company, and her technical capacity on corporate and tax issues. Carmen is very practical and adapts well to our needs‘.
Khiron Life Sciences
- Acted as Colombian counsel to Avicanna on certain cannabis regulatory matters, as well as aspects concerning the company’s listing on the Toronto Stock Exchange.
- Acted as local counsel to Canopy Growth on the review of the regulatory aspects of the acquisition of Colombian Cannabis, a licensed medicinal-cannabis company.
- Obtained pharmacological evaluations and health registrations of biological products on behalf of Grifols Therapeutics, in order for the company to be able to commercialise products in Colombia.
- Acted for Biosidus to obtain health registrations of biological products for commercialisation in Colombia.
Philippi Prietocarrizosa Ferrero DU & Uría handles the full spread of patent prosecution processes for local and global companies in the life sciences sector, with the food and beverages and the cannabis industries also featuring strongly in the firm's client base. The practice has genuine region-wide capability, acting as a regional hub specifically for Andean countries, Central America, Chile, Uruguay and Paraguay. A notable strong suit is the firm's handling of sanctioning processes, investigations and advertising violations, as well as acting in wider IP dispute resolution and unfair competition matters. Mauricio Patiño leads the seven-strong intellectual property and life sciences department, with principal associates Gerardo Flórez (in charge of health registration matters, copyright and data protection) and Camilo Suárez (who leads the IP enforcement, unfair competition litigation and patent practice).
Alpina Productos Alimenticios
Econnabis / Plena Global Holdings
Alimentos Polar Colombia
- Strategically managed Mondelez Colombia’s foodstuffs portfolio (around 230 items), including modifications, renewals and new applications, promotional activities, consumer protection and advertising campaigns; the advisory included representing the client before the Consumer Protection Authority.
- Advised and represented Tierragrande on obtaining licences and permits required to operate, cultivate, store and produce cannabis in Colombia.
- Represented a multinational company in a sanctioning process before the INVIMA for the alleged violation of medical devices labelling, advertising and insert regulations.