AI and Inventorship
Artificial intelligence (AI) is a cutting-edge technology that has been generating substantial attention worldwide recently, including in the patent community. Balancing the rapid development in AI and adapting the patent...Read more
Anagha Tendulkar
In-house Patent Counsel, Cipla, India
REMS Patents: Listability and Other Issues
Abstract: Are Risk Evaluation and Mitigation Strategy (REMS) patents Orange Book listable (or even should be)? A straightforward question with a lot of disagreement. This paper discusses recent litigation on...Read more
Joanna Brougher
Owner & Principal, BioPharma Law Group PLLC, USA
Tom Irving
Partner, Marbury Law Group, USA
Stacy Lewis
Law Clerk, Finnegan, USA
Mark Feldstein
Partner, Finnegan, USA
Adriana Burgy
Finnegan, USA
Needs, Challenges, and Obstacles in the Implementation of the EU Medical Device Regulation
The Medical Device Regulation (MDR) 2017/745 is a novel piece of legislation intended to govern the high-tech commercial domain of medical devices in the European Union to the highest possible...Read more
Tancredi Vergani
Consultant, Obelis Group, Belgium
Carlos Francisco Marin Barrios
Consultant, Obelis Group, Belgium
Creative Claiming Strategies
Innovator companies in the biopharmaceutical space are looking to their patent counsel for creative patent claiming strategies to protect their assets. In this article, using the Federal Circuit opinions in...Read more
Angela Sebor
Director Intellectual Property, Tolmar, Inc., USA
Xiaoguang Michelle Gao
Associate VP - Assistant General Patent Counsel , Eli Lilly and Company, USA
Stacy Lewis
Law Clerk, Finnegan, USA
Implementing a Robust Compliance Program in a Remote Environment
Implementing an effective Compliance program can be complicated and challenging in the best of times, especially when you operate globally in a rapidly changing environment. These challenges and complexities have...Read more
Fabiana Lacerca-Allen
Chief Compliance Officer, Cipla, USA
Tatiyana Akers
Associate Director, Compliance, Aimmune Therapeutics, USA
Laura Hamm
Sr. Director, Corporate Compliance, Aimmune Therapeutics, USA
Brenda Crabtree
Director, Compliance Auditing and Monitoring, Aimmune Therapeutics, USA
Brazilian Data Protection Law and its first Impacts
Following the global movement of countries to protect the personal data of national people, Brazil has definitely plunged into this theme by making the Brazilian data protection law applicable in...Read more
Mariana Bueno
Legal Manager & DPO, Mindray do Brasil, Brazil
Covid19 and the new Role of Legal and Compliance
Lawyers and compliance officer are, basically professionals of the “status quo”. They seek assurance that everyone is performing in accordance with existing laws, regulations, and policies. So, “follow the rules...Read more
Fabio Cunha
General Counsel, Legal and Compliance Director, Dasa, Brazil
What Makes a Great Compliance Leader?
Great leaders exercise emotional intelligence, and they are very adept at understanding their strengths and weaknesses as well as those around them and can assess a situation pretty accurately and...Read more
Fabiana Lacerca-Allen
Chief Compliance Officer, Cipla, USA
Laura Hamm
Sr. Director, Corporate Compliance, Aimmune Therapeutics, USA
Brenda Crabtree
Director, Compliance Auditing and Monitoring, Aimmune Therapeutics, USA
Lisa Mares
Executive Assistant, Compliance, Aimmune Therapeutics, Inc., USA
Smart Contracts – Self-Executing Contracts of the Future?
The first thing many people think of when they hear the term ‘smart contract’ is a contract that is somehow transposed into computer code and runs without any human intervention....Read more
Jelena Madir
General Counsel, Gavi, the Vaccine Alliance, Switzerland
Amazon v. Donald J. Trump: A Massive Defense Contract Award Tainted by the Appearance of Impropriety
An unconventional U.S. president personally attacking the CEO of Amazon, one of the country’s largest and most impactful companies, is salacious news. Important public policy considerations are implicated when those...Read more
Rodney Sweetland
Vice President and General Counsel, Camris International Inc., USA