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Articles

Comparing Supplementary Protection Regimes Between Canada (CSPs) and The EU (SPCs)

By Nancy P. Pei, Partner, Smart & Biggar LLP, and Daniel Wise, Carpmaels & Ransford LLP

Amendments to the Canadian Patent Act and enactment of the Certificate of Supplementary Protection Regulations flowing from the Canada-European Union (EU) Comprehensive Economic and Trade Agreement introduced a new framework in Canada for the issuance of Certificates of Supplementary Protection (CSPs).

This chart compare key aspects of the two regimes, Canada's and the EU's.

Articles

Growing Scrutiny of Private Equity in Health Care

By Lori A. Rubin, Michelle A. Freeman, Samantha Robbins Jamali

The presence of private equity (PE) investment has exploded in recent years in all areas of the health care sector. PE in health care is a good thing when done right: It can pave the way for much needed innovation, efficiency, and nontraditional care delivery models. However, government regulators, media journalists, some health care practitioners, and private parties are watching PE investment with growing suspicion that profit-driven goals may conflict with the quality of care for patients.

Articles

Considerations When Conducting Decentralized Clinical Trials

By Kyle Y. Faget

Although use of telehealth in clinical trials is not new, the modality was not popularized until social distancing efforts brought about by COVID-19 forced the issue. Companies interested in providing clinical trial services via telehealth have to deal with whether the carrying out the clinical aspects of a clinical trial is part of the practice of medicine.

Articles

Building Biotech with Brains: Strategies for Maximizing Value of AI-Driven Biotechnology Inventions

By Aashish R. Karkhanis, Jeffrey Simon

The rapid rise of artificial intelligence (AI) and machine learning (ML) in biotechnology products and services is becoming a driver of the personalized medicine and health care sectors. While this integration can require special consideration during development of a patent portfolio, stakeholders across engineering, legal, and executive teams in both established companies and start-ups can leverage it to create valuable intellectual property (IP) assets in the marketplace.

Articles

2023 Telemedicine & Digital Health Trends

By Thomas B. Ferrante, Rachel B. Goodman, Jennifer J. Hennessy, Jacqueline N. Acosta, Sunny J. Levine, Aaron T. Maguregui, Sarah J. Iacomini, Kristen A. Murphy

Medicare telehealth post-Public Health Emergency (PHE): With the COVID-19 PHE concluding on May 11, 2023, many of the telehealth flexibilities the Centers for Medicare & Medicaid Services (CMS) implemented during the PHE will sunset at varying times.

Articles

The BioPharma Patent Cliff: 2023 and Beyond

By Jason N. Mock

Between now and 2030, the biopharma sector is expected to be rocked by a number of high-profile patent cliffs that are likely to reshape the market in potentially unpredictable ways. A “patent cliff” refers to the end of IP protection for a drug that has enjoyed market exclusivity since its launch.

Articles

New Data Privacy Laws Now Playing at a Theatre New You. Are you Ready?

By Tara Cho, Ted Claypoole

2023 is shaping up to be a landmark year for data privacy, as comprehensive consumer privacy laws take effect in four states and a fifth state expands its already robust privacy compliance requirements. Womble Bond Dickinson assembled a panel of privacy, technology and data security attorneys to discuss these upcoming changes and the regulatory compliance steps companies need to take. This article is taken from that conversation. 

Articles

Today's Remote Workplace

By John Pueschel, Mark Henriques

This resource from Womble Bond Dickinson discusses how remote and hybrid work bring new legal and compliance challenges for in-house counsel.

Articles

How the Music Industry Can Fight Back Against Generative AI

Several generative AI models now provide the ability to simulate your favorite artist’s voice and lyrical tempo to create a track that sounds indistinguishable from the real thing. Several artists have voiced their displeasure for these impersonations and music giants are now pushing streaming services to ban music created by AI models with some success. This article from Seyfarth and Shaw discusses how artists can legally fight back.