{"id":23003,"date":"2020-12-22T13:23:33","date_gmt":"2020-12-22T13:23:33","guid":{"rendered":"https:\/\/w21.olivares.mx\/?page_id=23003"},"modified":"2023-03-02T19:01:34","modified_gmt":"2023-03-02T19:01:34","slug":"life-science-pharmaceutical-law-group","status":"publish","type":"page","link":"https:\/\/www.olivares.mx\/es\/life-science-pharmaceutical-law-group\/","title":{"rendered":"Life Sciences"},"content":{"rendered":"
\n\t
\n\t\t\n\t\t
\n\t\t\t
\"\"<\/div>\n\t\t<\/figure>\n\t<\/div>\n<\/div><\/div><\/div><\/div>
<\/div>
\n\t
\n\t\t
\n\t\t\t

Life Sciences<\/h2>\n\n\t\t<\/div>\n\t<\/div>\n\n\t
\n\t\t
\n\t\t\t

The\u202fLife Sciences Industry Group\u2019s <\/em>mission is clear \u2013 OLIVARES is changing\u00a0and facilitating\u00a0the regulatory landscape for companies doing business in Mexico. The firm represents many of the world\u2019s leading innovators involved in research, development, and manufacture of pharmaceuticals, biotech products, agricultural goods, chemicals, medical devices, as well as food and beverages.<\/p>\n\n\t\t<\/div>\n\t<\/div>\n\n\t

\n\t\t
\n\t\t\t

OLIVARES advises on a variety of\u00a0regulatory\u00a0issues for R&D Life Sciences clients and is widely considered the top influencer in changing the regulatory landscape in Mexico\u00a0in pharmaceuticals. The firm has been the driving force setting new precedents in the following areas:<\/p>\n\n\t\t<\/div>\n\t<\/div>\n\n\t

\n\t\t
\n\t\t\t

The legal framework of health authorizations and approvals<\/p>\n\n\t\t<\/div>\n\t<\/div>\n\n\t

\n\t\t
\n\t\t\t

Sanitary, marketing authorizations and approvals advice, legal analysis, and actions when processes are not observed by the regulatory agencies.<\/p>\n

\n
<\/div>\n<\/div>\n\n\t\t<\/div>\n\t<\/div>\n\n\t
\n\t\t
\n\t\t\t

Regulatory\u00a0Data Exclusivity<\/strong>: \u202fEarned recognition of\u00a0Regulatory\u00a0Data Exclusivity for R&D pharma companies\u00a0in\u00a0Mexico in line with international trade agreements and\u00a0treaties.<\/p>\n\n\t\t<\/div>\n\t<\/div>\n\n\t

\n\t\t
\n\t\t\t

Pharmaceutical pipeline\u00a0pharmaceutical\u00a0patent term corrections\u00a0based on a transitory article of the derogated IP Law.<\/p>\n\n\t\t<\/div>\n\t<\/div>\n\n\t

\n\t\t
\n\t\t\t

Patent\u00a0Linkage:<\/strong>\u202fShape the criteria for\u00a0the inclusion of formulation\u00a0and use\u00a0patents in the linkage gazette. No other firm in Mexico has had more influence on\u00a0 the patent linkage system.<\/p>\n\n\t\t<\/div>\n\t<\/div>\n\n\t

\n\t\t
\n\t\t\t

First actions to obtain authorizations for the medical use of cannabis pre-the new law and regulation for products containing cannabis.<\/p>\n\n\t\t<\/div>\n\t<\/div>\n\n\t

\n\t\t
\n\t\t\t

Taking a lead role in the\u00a0CPTPP\u00a0and USMCA\u00a0negotiations\u202fon behalf of the R&D pharma\u00a0associations doing business\u00a0in Mexico<\/p>\n\n\t\t<\/div>\n\t<\/div>\n\n\t

\n\t\t
\n\t\t\t

Filing amicus briefs on biologic drug regulations<\/strong><\/p>\n\n\t\t<\/div>\n\t<\/div>\n\n\t

\n\t\t
\n\t\t\t

Created a proprietary\u00a0database\u00a0system\u00a0of the Mexican Trademark Office and the regulatory agency COFEPRIS \u202fthat predicts whether a drug will gain\u00a0the\u00a0authorization\u00a0of the commercial name\u00a0by COFEPRIS.<\/p>\n\n\t\t<\/div>\n\t<\/div>\n\n\t

\n\t\t
\n\t\t\t

Enforcement of exclusive rights in public acquisitions for pharmaceuticals, including before UNOPS.<\/p>\n\n\t\t<\/div>\n\t<\/div>\n\n\t

\n\t\t
\n\t\t\t

Preparation and drafting of agreements in the life science sector.<\/p>\n\n\t\t<\/div>\n\t<\/div>\n\n\t

\n\t\t
\n\t\t\t

Transfer of marketing authorizations and assets in the life science sector.<\/p>\n\n\t\t<\/div>\n\t<\/div>\n\n\t

\n\t\t
\n\t\t\t

Labeling requirements\u00a0for clearance of regulated products.<\/p>\n\n\t\t<\/div>\n\t<\/div>\n\n\t

\n\t\t
\n\t\t\t

Administrative Compliance. The pharmaceutical, biotechnology, clinical laboratories and medical device sectors must always be prepared to respond to the emergence of actions and reviews as a part of regulatory compliance. In many cases, non-compliance carries serious consequences that include fines, along with civil and criminal penalties.<\/p>\n\n\t\t<\/div>\n\t<\/div>\n\n\t

\n\t\t
\n\t\t\t

OLIVARES helps clients assess business practices and proactively monitor compliance programs in matters related to privacy, antitrust, anti-corruption and other related laws. The Firm is called upon from time to time to conduct corporate investigations that serve as tools for managing risks of non-compliance or alleged non-compliance behaviors. This can be valuable in all phases of the cycle of compliance within the legal framework in Mexico, from supporting the development of a robust compliance program, to further investigations, training, and remediation of illegal behavior or non-compliance.<\/p>\n\n\t\t<\/div>\n\t<\/div>\n\n\t

\n\t\t
\n\t\t\t

Transactional. Another facet of comprehensive services for this industry includes transactional support for the various operations of clients involved in the development, consolidation, and expansion of their respective businesses in Mexico. The group of experts in transactional matters helps foreign clients to structure their businesses in Mexico and to carry out various inherent transactions. OLIVARES frequently participates in the advisory and strategy of mergers and acquisitions and sale of assets, which often includes intellectual property portfolios, authorizations and sanitary records, databases, inventories, licensing, joint marketing agreements, distribution, supply, and marketing, where the firm maintains sight of all the relevant elements of these sophisticated transactions: intellectual property, regulatory issues, economic competition, and other issues related to the legal framework in Mexico.<\/p>\n\n\t\t<\/div>\n\t<\/div>\n\n\t

\n\t\t
\n\t\t\t

OLIVARES has built solid experience in advising and providing corporate structures for companies in the life sciences sector, based on extensive knowledge of the industry and the market.<\/p>\n\n\t\t<\/div>\n\t<\/div>\n<\/div><\/div><\/div>

\n\t
\n\t\t
\n\t\t\t

WE KNOW LIFE SCIENCES<\/h4>\n
<\/div>\n
\n
\n
<\/div>\n
\n

Gustavo Alcocer<\/h3>\n

Partner<\/span><\/p>\n<\/div>\n<\/div>\n

Gustavo Alcocer manages the Corporate and Commercial Law Group at OLIVARES, advising domestic and foreign businesses and the owners of those businesses on Mexican and cross-border corporate and commercial transactions.<\/div>\n
\n