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Trends and Developments - Life Sciences & Pharma IP Litigation 2025

January 28, 2025

The 1ª Specialized Panel of the Federal Court of Appeals for the Second Circuit (TRF-2) in Brazil issued a relevant precedent regarding the interpretation of Article 32 of the Brazilian Patent Statute (BPS – Law # 9.279/96), especially for the life sciences and pharmaceutical research and development industries. For the first time in an invalidity lawsuit, the court confirmed the legality of making restrictive amendments to a patent application claim chart, whether voluntarily or in response to a BPTO (Brazilian Patent and Trademark Office) order, even after a request for examination has been submitted to the BPTO – provided these amendments are included in the patent application as filed. The court has also confirmed that BPTO Ordinance # 93/2003, which regulates this matter, is legal and does not violate any prior legal precedent (namely, Case # 0513584-06.2003.4.02.5101). This precedent is still subject to appeals to the superior courts, but it is relevant, since generic industry often mentions the judgment of Case # 0513584-06.2003.4.02.5101 to argue against the possibility of restrictive amendments after the request for examination. This decision provides greater legal certainty, aligns with what the BPTO has already established on the matter, confirms the provisions of the TRIPS Agreement, and sets the standard for how such cases will be analysed going forward.

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Licks Attorneys Compliance’s Blog provides regular and insightful updates about Ethic and Compliance. The posts are authored by Alexandre Dalmasso, our partner. Licks Attorneys is a top tier Brazilian law firm, specialized in Intellectual Property and recognized for its success handling large and strategic projects in the country.

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Licks Attorneys' COMPLIANCE Blog

LACK OF REGULATION FOR DATA PROTECTION OFFICERS GIVES RISE TO UNCERTAINTIES ON THEIR ROLE

The Brazilian General Data Protection Act (LGPD) entered into force in September 2020, introducing the role of Data Protection Officer (DPO). In the Act, the role is described as the person appointed by the controller and processor to act as a communication channel between the controller, the data subjects and the National Data Protection Authority (ANPD).

LACK OF REGULATION FOR DATA PROTECTION OFFICERS GIVES RISE TO UNCERTAINTIES ON THEIR ROLE Read Full Article

ESG for laymen!

In the corporate world of finance, ESG is “in”. Indeed, ESG is an acronym of three words in English, meaning environmental, social, and governance.

ESG for laymen! Read Full Article

DISCOUNT ON MEDICATION - A SOURCE OF CONCERN FOR THE PHARMACEUTICAL SECTOR

In May 2021, the State of Arkansas in the United States published the HB1709 bill prohibiting manufacturers from offering discount on any product containing insulin, with the exception of the discount provided directly to the end user in the form of a pharmaceutical manufacturer discount coupon and which can be obtained through the National Council for Prescription Drug Programs e-prescribing service.

DISCOUNT ON MEDICATION - A SOURCE OF CONCERN FOR THE PHARMACEUTICAL SECTORRead Full Article

THE LACK OF PROPORTIONALITY IN THE GENERAL DATA PROTECTION LAW

The General Data Protection Law (LGPD) established 10 (ten) principles that must be observed in the activities of processing personal data.

THE LACK OF PROPORTIONALITY IN THE GENERAL DATA PROTECTION LAWRead Full Article

THE COMPLIANCE POLICY FOR FINANCIAL INSTITUTIONS ACCORDING TO THE NATIONAL MONETARY COUNCIL

The National Monetary Council (CMN) has regulated – through the CMN Resolution 4,595, of August 28, 2017 - the compliance policy applicable to financial institutions authorized to operate in Brazil by the Central Bank, but not applicable to consortium administrators and payment institutions.

THE COMPLIANCE POLICY FOR FINANCIAL INSTITUTIONS ACCORDING TO THE NATIONAL MONETARY COUNCILRead Full Article

EUROPEAN BODIES APPROVE JOINT PROPOSAL TO PROHIBIT THE USE OF AI FOR AUTOMATED RECOGNITION

The European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) announced on June 21st, 2021 that they have approved a joint opinion on the European Commission's Proposal for a Regulation laying down harmonised rules on artificial intelligence (AI).

EUROPEAN BODIES APPROVE JOINT PROPOSAL TO PROHIBIT THE USE OF AI FOR AUTOMATED RECOGNITIONRead Full Article

THE NATIONAL REGISTRY OF INELIGIBLE AND SUSPENDED COMPANIES (CEIS) AND THE NATIONAL REGISTRY OF PUNISHED COMPANIES (CNEP)

Brazil published its Anti-Corruption Law - Law 12. 846, on August 1, 2013, whereby companies were committed to administrative and civil liability, with regard specifically to acts related to corruption, fraud in tenders and creating impeding circumstances for investigation or inspection. Unfortunately, the Brazilian legislator missed a great opportunity to criminalize companies’ operation and conduct, as is already the case in some countries.

THE NATIONAL REGISTRY OF INELIGIBLE AND SUSPENDED COMPANIES (CEIS) AND THE NATIONAL REGISTRY OF PUNISHED COMPANIES (CNEP) Read Full Article

COOKIES, UNDERSTAND IT ONCE AND FOR ALL!

There are many definitions out there for cookies, but the one I like the most is found on the Positivo website, as well as some other websites, which clarifies that cookies are simple text files sent by the website to the browser the first time you visit it. A simple and effective definition. It’s there so that when the user visits the website again, their browser sends the data collected by the cookie, depending on its goal.

COOKIES, UNDERSTAND IT ONCE AND FOR ALL!Read Full Article

Webinar LGPD – Data Leaks and first decisions

On the afternoon of April 22, the webinar ‘Data Leaks and first decisions’ was presented by partner Douglas Leite and Attorneys at Law and data protection specialists Flávio Buzanovsky and Angela Fonseca.

Webinar LGPD – Data Leaks and first decisionsRead Full Article

Webinar ‘FCPA Review 2020 – Hot Cases’

On the afternoon of April 8th, the webinar ‘FCPA Review 2020 – Hot Cases’ was presented by partner Alexandre Dalmasso.

Webinar ‘FCPA Review 2020 – Hot Cases’Read Full Article

NEW GOVERNMENT PROCUREMENT RULES ARE ENACTED IN BRAZIL

President Jair Messias Bolsonaro just signed the new Government Procurement Act into law, converting the Bill (PL) 4.253 / 2020 into Law 14.133 of April 1, 2021.

NEW GOVERNMENT PROCUREMENT RULES ARE ENACTED IN BRAZILRead Full Article

THE DISPOSAL OF PERSONAL DATA

Recently, the Federal Supreme Court (STF) positioned itself against the right to be forgotten versus the media's right to report certain facts. In this specific case, the STF ended up endorsing the thesis recognizing a right to be forgotten would be an act of censorship, given the media's right to report news for society's knowledge accurately.

THE DISPOSAL OF PERSONAL DATARead Full Article

CNIL INTRODUCED NEW RULES FOR THE USE OF COOKIES IN FRANCE IN 2020

In October 2020, the Commission Nationale de l’Informatique et des Libertés (CNIL), the French body that regulates the protection of personal data in that country, published two documents, one designated “guidelines” and the other called “recommendations,” establishing rules and good practices, concerning the use of cookies on the internet.

CNIL INTRODUCED NEW RULES FOR THE USE OF COOKIES IN FRANCE IN 2020Read Full Article