Olivares

Address:
Pedro Luis Ogazón 17
Col. San Ángel
01000
México
D.F

Contact:
(5255) 53 22 30 00

Telephone:

Email:

Website:
www.olivares.com.mx

Our Life Sciences Industry Group’s mission is clear – we are changing the regulatory landscape for companies doing business in Mexico.

We represent many of the world’s leading innovators in research, development and manufacture of pharmaceuticals, biotech products, agricultural goods, chemicals, medical devices as well as various types of food and beverages.

The origins of the group were primarily in IP and litigation but today we have a legal-technical team of professionals that focus on regulatory matters litigation, marketing authorizations, M&A, corporate and licesing structuring, financial and transactional support, privacy, FCPA and anti-bribery compliance, medical device, environmental, among other services.

The Life Sciences Industry Group has been using a multi-disciplinary approach to solving our clients’ legal needs for years; even before it was formally structures and given a name.

Multi-national companies managing legal risk in such heavily regulated industries, so far away from home face an extreme challenge. Especially in such a growing, dynamic and transforming market, such as Mexico. Therefore, it makes sense to have a team of lawyers and other professionals that manage client work cohesively so everyone has a 360 degree view of client matters industry wide.

We have devloped an unrivalled base of legal knowledge mixed with hands-on experience. We have enabled clients to reduce legal risk in various areas of their business and help them maintain a competitive advantage in a Mexican market that has recently seen much regulatory change and market consolidation. This pace of change is set to continue, and we are excited, because we are heavily involved in shaping it.

RECENT HIGHLIGHTS

Data Package Exclusivity (DPE): OLIVARES devised and executed pioneering new administrative court actions to seek recognition of DPE rights, which are not specifically contemplated by Mexican laws. Our active participation in the Mexican market led directly to our participation in drafting the proposal of new law for DPE.

Pharmaceutical pipepline patent term corrections: OLIVARES has successfully litigated several term corrections to obtain additional terms of patent exclusivity for pharmaceutical compound patents.
Linkage: OLIVARES has successfully argued several Jurisprudence setting cases before the Supreme Court in matters related to interpreting the scope of the Linkage regulation. Specifically, this is related to actions to obtain the publication of pharmaceutical formulation, use patents in the linkage gazette, and observance of patents. Enforcement of patent rights against the granting of marketing authorizations. Cancelling of marketing authorizations based on the violation of the patent Linkage regulation.

Regulatory proceedings advisory before the Mexican Agency in charge og granting marketing authorizations –COFEPRIS: OLIVARES has advised clients on issues ranging from the elimination of the “plan requisite”, to renewals and registration of medical devices.

Filing amicus briefs on Biologic drugs regulation: OLIVARES has advised the industry Chambers and specific clients on public policy and specific regulatory issues.

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