Life sciences in Colombia

Cavelier

IP powerhouse Cavelier stands out in the life sciences field due to its team of professionals who have backgrounds in a broad range of specialist areas - including biotechnology, microbiology, biomechanics, software and electronics. With an enviable client roster of global companies, the team is well versed in providing advice on approval processes for marketing authorisations, consulting and representation in sanction processes before administrative authorities, and consulting on test data protection for pharmaceuticals and agrochemicals. Practice head Andrés Rincón focuses his practice on patent drafting, prosecution, and litigation, while partner Adriana Durán leads on all health and regulatory matters. Associate Carolina Vargas, who holds an MA in both chemistry and IP law, also plays a key role in the practice.

Practice head(s):

Andrés Rincón

Key clients

Federación Nacional de Cafeteros de Colombia

Thermo Fisher Scientific

Institut Straumann

Neodent

Hoyu

Bimbo

Allergan de Colombia

Applied Medical Technlogy

Boehringer Animal Health Unit

Asili Global

Kolmar BNH

Atomy

Aphria

Pfizer

Bayer

Work highlights

  • 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.
  • 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.

Lloreda Camacho & Co.

Boasting an enviable client roster of prominent international biotechnology, medical devices and pharmaceutical companies, the ‘always available‘ team at Lloreda Camacho & Co. offers integrated advice throughout the full range of regulatory, patent, contracts, data privacy and competition life science’s related issues. With an in-house team of nine technical advisors making up the 17-strong patent and regulatory and life science department, the group has been lauded for its recent involvement in regulatory and IP issues related to vaccines and treatments for Covid-19. The practice is led by patent expert Ana María Castro, who previously worked at the Superintendence of Industry and Commerce, together with Enrique Álvarez who also heads up the firm’s competition law and labour and employment departments. The highly recommended Daniel Cardona also plays a pivotal role in the practice and, since publication, has been raised to the partnership (effective, December 2021).

Practice head(s):

Ana Maria Castro; Enrique Alvarez

Other key lawyers:

Daniel Cardona

Testimonials

Ana Maria Castro and Daniel Cardona are very knowledgeable about the industry and its regulation. They have contacts in the authorities so as to  always be up-to-date and facilitate the management of their clients’ affairs.

Ana Maria also knows the regulations and practices in other countries of the region and is very active in academic forums, so she can complement her opinions and recommendations with her knowledge and international experience, enriching the discussions and the identification of alternatives for solution to conflicts.’

Ana Maria Castro and Daniel Cardona are always available and with the best disposition. They go beyond the tasks entrusted, presenting you with alternatives, options and relevant current information for our professional practice and for our business.’

The firm has undertaken a very interesting strengthening of its digital alternatives. They are clear, timely, practical and concrete. Their involvement in regulatory and IP issues related to vaccines and treatments for Covid-19 have further increased their knowledge and experience of new regulatory and marketing modalities for innovative products, sometimes still in clinical studies and in exceptional states such as the one we have been living.

Super specialised in regulatory issues which they handle very well. It is a diverse firm with gender equity practices. Ana Maria Castro is specialised in life sciences issues and an international speaker on such topics.

Key clients

Gilead Sciences

F Hoffman La Roche

Astellas

Janssen Pharmaceutical

Boehringer Ingelheim

Eli Lilly Interamerica

Afidro

Biomarin

Sanofi

Biogen (BIIB Colombia)

Work highlights

  • Assisting Gilead Sciences – Gilead Pharmasset with the management of their patent portfolio in 18 jurisdictions in Latin America and issues related to data exclusivity protection in Central America, and Colombia.
  • From January 2020 to January 2021, the group achieved the granting of 21 invention patents for F Hoffmann-La Roche, representing an important precedent in the region.
  • Advising Boehringer Ingelheim on submissions of marketing authorisations before the Colombian Health Agency – INVIMA regarding issues related to legal considerations such as new products, and different changes on the marketing authorisations.

OlarteMoure

Recognised as experts in patent law, OlarteMoure are one of the go-to firms in the pharmaceuticals sector, advising some of the major players in this field on a wide variety of complex cases. Consisting of a multitude of professionals with backgrounds in both law and science, the group also works closely with the firm’s IP department to provide clients with a multidisciplinary approach. Founding partner Carlos Olarte who leads the life sciences team has more than 25 years of experience in patent drafting, prosecution, litigation, valuation, and portfolio management. With a focus on the biopharmaceutical sector, he has represented various Global 100 R&D pharma companies. Partner and patent director Alexander Agudelo combines his background in pharmaceuticals with expertise in patent prosecution and technical assistance in litigation.

Practice head(s):

Carlos Olarte

Key clients

Novartis

Merck

Astellas

Panacea-Velvack

Pfizer

AGP

Grupo Nutresa

Bristol-Myers Squibb

Productos Familia

Work highlights

  • Representing a broad array of leading pharma clients in prosecuting portfolios of patent applications in Latin America.
  • Handling Merck, Intervet, Organon’s trademark portfolios in eight Central American and Caribbean countries.
  • Assisting Panacea-Velvack with patent drafting, patent prosecution and IP strategy in regard to developing medical devices and green technology for human necessities.

Baker McKenzie S.A.S.

The regulatory and life sciences team at Baker McKenzie S.A.S. assists with health registration prosecution and modifications, market approvals, certifications and authorisations for production and good manufacturing practices on behalf of major players in the pharmaceutical, medical devices, food and beverages, and cosmetics industries. Combining the IP expertise of practice head Juan Pablo Concha Delgado and principal associates Sara Merizalde and Maria Ximena Guavita, the group's specialist knowledge in patents sees it handle a wide variety of work encompassing drafting, prosecution and litigation, especially in regulatory and sanitary transactions related to product registrations before the local regulatory authorities (INVIMA). The highly recommended team has been further strengthened by the arrival of Andres Hidalgo who joined as an associate in early 2021.

Practice head(s):

Juan Pablo Concha

Key clients

Biogen

FedEx

Work highlights

  • Advise Biogen on various topics including: compliance with regulatory guidelines that must be met by an IIT; the possibility of launching an Expanded Access Program (EAP) in Colombia of a drug that was not yet approved in the world; and regulations that have an impact on Patient Support Programs.
  • Advise FedEX regarding transportation of Covid-19 Vaccine Readiness, specifically to address the question whether the transportation service will turn into a pharmaceutical distributorship or other regulated business under the sanitary regulations.

Brigard Castro

Top tier IP firm Brigard Castro assists clients across all stages of the life sciences industry, ranging from initial R&D, through the IP-protection stage, trial, approval, marketing and authorisation to any post-approval issues. Drawing on support from its full-service sister firm Brigard Urrutia, the team has participated in several projects and M&A transactions involving regulated companies across the life sciences and food and beverage sectors, in areas such as regulatory due diligence, transactional matters, structuring of the transaction, and operational matters, among others. As head of the life sciences practice, María Fernanda Castellanos has significant experience in health and regulatory issues. She has been involved in the restructuring of the regulatory and patent practice of the firm in order to provide an integrated offering to clients, alongside managing partner and fellow co-head Juan Pablo Cadena, who also leads the IP litigation practice and trademark prosecution practice.

Practice head(s):

María Fernanda Castellanos; Juan Pablo Cadena

Testimonials

Brigard can be characterised as carrying out contracted legal management with exceptional professionalism, and demonstrating timeliness in the legal matters entrusted to them. The firm has highly-qualified and aligned teams to resolve highly-complex matters; which they carry out with exceptional performance and listening attentively to their clients.

We’d also highlight the virtual communication channels implemented to meet the needs of its customers in the absence of the possibility to do so in person. Likewise, the availability in its management and collaboration.

Key clients

Ferrero

Teleflex

Caire, Inc

Dentaid

Cruz Verde

Clever Leaves

Viña Tabali

Sanrai

Work highlights

  • Advised the local subsidiary of a major international food company in connection with a number of requirements from the Colombian regulatory authority, involving a detailed analysis of the situation in Colombia, with the purpose of integrating Colombia into the company’s global strategy, and being able to respond in due term to the local requirements, without affecting the validity of commercialisation licenses, or imposing further requirements on the manufacturing processes occurring abroad.
  • Assists a European company devoted to manufacturing of medical dental devices and cosmetics with all matters related to the applications to obtain commercialisation licenses to enable the sale of such products in Colombia.
  • Assisted Huber Corporation, which manufactures additives and manufacturing aids for the food industry, with analysis under Colombian Law of the internal classification of a particular product, that was to be imported into Colombia for sale to local companies in the food sector.

Gómez-Pinzón Abogados (GPA)

The ‘very professional’ team at Gómez-Pinzón Abogados (GPA) consists of a multidisciplinary team of specialised lawyers and technical associates. Partner Mauricio Jaramillo, who has more than 25 years’ experience advising on biotechnological and pharmaceuticals matters, co-leads the practice alongside Andrea Pieschacón who heads up the regulatory law sub-practice, and chemical and environmental engineer Germán Cortés who plays a key role in overseeing the firm’s patent prosecution practice. Drawing on this broad range of expertise, the firm’s regulatory affairs’ team is well versed in providing advice to clients from a wide range of industries. Playing a pivotal role in matters related to the Covid-19 pandemic, the group have advised several clients in connection with products declared as non-available vitals by the National Health Authority, the implementation of biosafety protocols and guidelines, and performed patentability assessments on Covid-19 related technologies for clients such as Universidad de Medellín.

Practice head(s):

Mauricio Jaramillo; Andrea Pieschacón; Germán Cortés

Testimonials

Very professional team full of experienced experts with deep knowledge of IP.’

Well-managed patent cases, ensure timely attendance to client’s instruction and efficient and accurate billing system.

Closeness, cordial treatment, always ready to resolve and collaborate.

‘We’d highlight their: responsibility / response times; closeness to the client; and service levels, with an assigned agent.

Key clients

Glenmark Pharmaceuticals Colombia

Congelados Agricolas

Intersurgical

Pricesmart

Silimed Industria De Implantes

Drypers Andina (Softys)

Glaxosmithkline Colombia

Northwestern University

Vyripharm Enterprises

H.Lee Moffit Cancer And Research Institue

Intas Pharmaceuticals

Continental Industries Group

Hanmi Pharm Co

Epizime

Botanical Extraction Solvent Free

Rigel Pharmaceuticals

The Clorox Company

Congelados Agrícolas – McCain

KL-Pong Oleomas

Work highlights

  • Provides regulatory advice to Glenmark Pharmaceuticals Colombia on matters relating to the company’s Health Registrations portfolio in Colombia, obtaining success in the authorisations before the Health Authority for the commercialisation of pharmaceutical products and medical devices and regarding the certification of good manufacturing practices.
  • Providing regulatory advice to Intersurgical on matters relating to the company’s Health Registrations portfolio in Colombia and the amendment applications to include new references in the health registrations for medical devices before the Health Authority to import new  products for Covid-19 treatment.
  • Provide regulatory advice to Drypers Andina (Softys) on matters relating to the company’s entire portfolio in Colombia, specifically to obtain from the Health Authority the necessary authorisations to market hygiene products and cleaning for domestic use and cosmetics declared vital and not available during the health emergency.

Posse Herrera Ruiz

With a full-service offering across all aspects of life sciences, including assisting with transactional, intellectual property and regulatory matters, Posse Herrera Ruiz works with leading healthcare and life sciences clients to handle complete patent prosecution and regulatory consultancy in not only Colombia but across the wider Latin America region. Specialised in the pharmaceutical industry, the firm works with leading pharma companies such as Regeneron and Zogenix International, alongside an increasing number of clients in the cannabis industry through the practice's investment into this growing sector. Helena Camargo specialises in working with both regional and international clients to obtain health registrations and permits, alongside senior associate and practice co-head Mónica Bonnett who provides expertise in the handling filings of patents and health registrations.

Practice head(s):

Helena Camargo; Monica Bonnett

Testimonials

In my case, they helped us obtain licenses for the manufacture of derivatives and the cultivation of cannabis. Lawyers need to know the regulations on the matter in order to obtain licenses, as well as a provision for teamwork due to having to work with professionals from other fields (i.e chemist, agronomist).

Monica Bonnett and Andrés Monroy have a wide and permanent disposition to help to carry the project forward. They are very clear in their concepts and attentive to the expiration of terms. They also provide valuable post-initial counseling assistance.

Key clients

Bozicevic, Field & Francis

Kannabee

Mattos Filho

Solla

Exactech

Schultze Asset Management

Ferrer IP Services

Universidad Simón Bolivar

Regeneron Pharmaceuticals

Zogeniz International

Work highlights

  • Advised Regeneron, through Bozicevic, Field & Francis, in requesting a patent for an antibody to be used in the treatment of eye diseases like glaucoma.
  • Advised Lorna Kennedy and Joseph Benson, through Bozicevic, Field and Francis, in requesting a patent for some compositions to treat neurological diseases in Brazil and Mexico, making sure that they comply with all local requirements.
  • Advised Regeneron, through Bozicevic, Field & Francis, in requesting a patent for a method to treat diabetes induced retinopathy in Brazil and Mexico.
  • Advising Zogenix International, through Bozicevic, Field and Francis, in protecting a method to reduce convulsions by the use of a medicinal component.

Aristizabal Abogados Consultores

Providing a ‘personalized and agile service’, the life sciences team at boutique firm Aristizabal Abogados Consultores has extensive experience in regulatory matters and sanitary registrations for the food and beverage, pharmaceutical, healthcare and technology industries. Focusing his practice on patent prosecution and life sciences registrations and protection, founding partner of the firm Ricardo Aristizabal leads the growing department and has built up an impressive client roster, including global companies such as Mars, Ocean Spray and Grupo Peroni. Associate support comes in the form of the ‘very valuable’ Julieth Gutierrez, who specialises in regulatory and health law and has extensive experience advising retail companies on procedures before public regulatory entities.

Practice head(s):

Ricardo Aristizabal

Testimonials

Their experience, degree of compliance and involvement with the business, achieves legal solutions that support the business.

In the pandemic they immediately adjusted to virtuality, they are always present when required, we did not feel any impact on the service.

Ricardo’s experience, his sense of business and vision of practice allows him to propose solutions according to the type of business; the involvement of the partner is very good, it is close to the needs of the business. The support of Dr Gutierrez is very valuable; she is always informed regarding the latest regulatory events and the positions of the authority, and her constant updating allows one to have peace of mind in the opinions.

The Aristizabal Abogados’ team provides us with consulting in a fast and accurate way.

Aristizabal Abogados provides a personalised and agile service.

Ricardo Aristizabal demonstrates great knowledge in the field of nutritional supplements and provides us with excellent advice; he is very professional, agile and courteous.

Knowledge of processes, agility and the monitoring of cases in order to achieve timely results.

They have an excellent relationship with the relevant authorities and provide their full collaboration to face situations, which makes the processes very reliable.

Julieth Gutierrez is an outstanding person in terms of her disposition and knowledge; Ricardo Ariztizabal is a great leader who projects his team along the best paths.

Strengths and abilities: the knowledge they have regarding regulations and the authorities, the recommendations that they make to us for the correct analysis of risks, the recommendations and / or even comparisons that they can make with other countries.

I can compare with other firms in other regions and in general with Aristizabal I have good service.

The collaboration is 1:1 despite being a firm with all the confidence we can discuss the issues with them in a transparent way, something that characterizes Aristizabal is that I feel comfortable working with them since I feel they are allies and not the allies of the authorities as has happened to me with other firms.

What I mentioned about collaboration, the attitude of service, always giving the best answer to help the business work, giving the best alternatives.

This practice is very strong on the whole subject of life sciences because it specialises in the subject – both in food for humans and the entire part of food for pets – and has great knowledge and an extensive network of contacts in Colombia.

Something that the Aristizabal lawyers’ team does well compared to other law firms is, before starting a process, to understand the different paths that the context offers and which of them best suits the strategies of the company.

I think the main novelty of the office has to do with the technology where we can access the different databases of records and processes that we have. Second would be in the collaboration between the different members of their team, and that which they achieve with our teams.

Key clients

Mars

Master Foods Brazil

Dian Pet Food (Symrise Group)

Ocean Spray

Grupo Peroni

Mahou

Campbell Soup Company

Wrigley

Natures Bounty

HINODE

ANDI (Asociación Nacional de Empresarios de Colombia)

Asahi Premium Brands

Altipal

Work highlights

  • Led the approval of the sanitary protocol between the authorities of Mexico and Colombia that allowed multinational company Mars to introduce to the Colombian market its Pedigree products.
  • Legal advisors to Ocean Spray, most recently with regard to updating the company’s portfolio, with its cranberry drinks, and its “Craisins” dehydrated.
  • Advising Grupo Peroni on updating its beer portfolio  in Colombia.
  • Assisting Lindt & Sprungli. on updating the records and labelling of the packaging of its products.

Buriticá Abogados

Buriticá Abogados has experience managing a wide portfolio of clients that cover various fields of the life sciences industry, including cosmetics, pharmaceuticals, medical devices, and medicinal cannabis. The firm currently acts as an advisor to one of the world’s leading biological drug companies. The ‘outstandingRaúl Buriticá heads up the team alongside partner Jenny Guerrero who leads on the regulatory side. The practice also stands out for its interdisciplinary team of experienced chemists and agronomists that provide a comprehensive service to clients in the licensing and registration application process.

Practice head(s):

Raúl Buriticá

Testimonials

Buritica Abogados diversified its life sciences practice entering the field of health authorisations for the use of medicinal cannabis for therapeutic purposes, a market that has been subject to exhaustive regulation in various countries in the region. Likewise, said firm has diversified its practice by focusing on advising on the commercialisation and export to countries of the Andean Community of products that have been classified by various governments as essential to combat Covid-19 (for example Ivermectin).

The plus that makes this firm stand out is definitely its well-experienced and well-established team in matters of health authorisations, as well as its ability to adapt to the needs and opportunities of the life sciences market. Partners Raúl Buriticá and Juan Carlos Torres Ibarra are outstanding.

Their specialised knowledge of local and foreign health legislation, the strategic vision with which it proposes solutions, its agility in terms of attention and the clarity and timeliness of execution. It compares very favourably with other firms.

They correctly attend to innovation issues, it is possible to hold meetings with them in a collaborative way from a distance with great efficiency. The billing system is adequate and also -in the physical visit to their offices- their openness was very noticeable in the face of a situation in which I had to unexpectedly take my children to a work meeting with them at their facilities; they were completely open to holding the meeting and collaborated in ensuring it was efficient, which speaks of their tolerance towards this type of situation.

Raul Buriticá and his experts are outstanding in their depth of knowledge of the life sciences area and they stand out from their competitors by their assertiveness in the approach to strategies and their effectiveness in solving the problems on which they are consulted.

It is an excellent team that responds immediately with smart solutions. They’re an excellent group of professionals, committed and creative in their solutions, providing pristine attention to detail in all matters and always with personalised service from its members. The best correspondent we have had in that country in years. It is a pleasure to collaborate with them and a peace of mind having them in “our corner”.

Key clients

Laboratorios Sophia México

Productos Familia

Alkem Labs

CannPharm Perú

Aurobindo

AVIDA Global

ADIN Implants

Novili

Mylan

CMS Rodríguez-Azuero

With a stronghold in the regulatory aspect of the life sciences sector, CMS Rodríguez-Azuero is well versed advising local and foreign companies in the manufacturing and distribution fields across the food and beverages, medical devices and pharmaceutical industries. Practice head Karl Mutter has over a decade of experience in everything related to market approvals, issues related to labelling, functional claims, and product advertising. Associate director Luz Helena Vargas focuses her practice on sanitary regulatory and leads the procedures and management of portfolios of health registrations at both national and international levels. Associate support comes from María Ximena Castellanos to complete the group.

Practice head(s):

Karl Mutter

Key clients

Red Bull

Lohmann & Rauscher

La Trocha Brewery

SDI

Livanova

Lentesplus.com (Locust)

Nobel Biocare

Pisa Farmaceutica

Nordic Naturals

New Earth Company

Work highlights

  • Advised Riopaila Castilla, one of the biggest producers of sugar in Colombia, with regard to producing disinfectant alcohol.
  • Assisting New Earth Company, a US-based dietary and nutritional supplements company specialising in innovative products with a difficult market approval for an algae based supplement.
  • Supported the Colombian branch of major Mexican pharma group, Pisa Farmaceutica, with new lines of products unfamiliar to them, such as cosmeceuticals.

Dentons Cardenas & Cardenas

A recommended choice for companies across a broad variety of industries including food and beverages, cosmetics, and technology, the team at Dentons Cardenas & Cardenas‘ expertise encompasses the full range of regulatory matters in the life sciences industry. The practice is also known as an expert in the emergent cannabis segment, advising international clients and foreign investors in Colombia on matters such as cultivation and production licensing. Practice co-head Santiago González has been involved in conducting several due diligence and rendering regulatory cannabis advice for clients such as Khiron Life Sciences Corp, Cannabco Pharmaceutical Corp, and MedReleaf Corp. He co-leads the nine-strong practice alongside well-regarded IP lawyer, Luz Helena Adarve whose expertise encompasses the full range of life sciences and cosmetics, nutraceuticals, food, and beverages products; and Catalina Pinilla who is also a partner in the firm’s banking and finance practice and advises on cross-border transactions and incorporation and licensing matters.

Practice head(s):

Luz Helena Adarve; Catalina Pinilla; Santiago González

Key clients

Blueberries Medical Corp. – Blueberries

Avicanna

Analizar Laboratorio Clínico Automatizado

La Santa

Griffols

Biosidus

Lundbeck

Xebra Brands

Cannopy

Baxter

Zambon

Vivy

Work highlights

  • Advising on legal and regulatory matters relevant to Blueberries Medical Corp. – Blueberries’ day-to-day operations in Colombia under its cannabis licenses and permits (seeds), including drafting and negotiation of a joint venture agreement for the development of a cannabis cosmetics business line, registration of IP rights and cannabis trademarks in Colombia and Latam, negotiation of an agreement for the purchase of land for its cultivation, among others.
  • Advised the client on preparing legal opinions regarding the existence, incorporation, and legality of the operations conducted by some of Avicanna’s subsidiaries located in Colombia (including export of the clients’ cannabis by-products and cannabis-based products).
  • Advised the shareholders of one of the leading Colombian sample laboratories on the sale of 100% of their shares and in the sale of the building in which the headquarters of the laboratory are located; the deal’s complexity was to establish a framework for transferring the shares and the building simultaneously, as the ownership structure of the company and the building were different, and the interests of both parties were not aligned.

Philippi Prietocarrizosa Ferrero DU & Uría

Acting as a regional hub (specifically for Andean countries, Central America, Chile, Uruguay and Paraguay), Philippi Prietocarrizosa Ferrero DU & Uría assists local and foreign clients across the key life science sectors such as pharmaceuticals, food and beverages, and consumer product manufacturing. Alongside this, the practice has further developed its expertise in the cannabis sector, most notably, assisting and representing Econnabis in the day-to-day operation of its cannabis business in Colombia which includes obtaining licenses and permits before ICA, INVIMA and Ministries of Health and Justice. Mauricio Patiño provides representation in trademark and patent litigation, alongside associates Gerardo Flórez and Camilo Suárez who assist with wider IP litigation.

Practice head(s):

Mauricio Patiño; Gerardo Flórez; Camilo Suárez

Key clients

Mondelez Colombia

Laboratorio Ballerina

Tropical Foods

Alpina Productos Alimenticios

Cochlear Colombia

Chocolates Garoto

Econnabis / Plena Global Holdings

Florian 123

Alimentos Polar Colombia

Sabormex

Work highlights

  • 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 Terragrande on local regulations, authorizations and permits with regard to conducting a cannabis business in Colombia.
  • Advises Skeletal Dynamics Inc. on all aspects required to obtain the health registration of a new line of medical devices including high risk products with INVIMA and consumer protection authorities as to labelling and advertising.