Welcome to the Goodwin’s Life Sciences Perspectives Blog, a resource specifically aimed at addressing your most frequent and pressing issues and providing insights on current developments.

The challenges across the life sciences industry are as abundant as the opportunities. From tightening federal regulations and market forces to revolutionary innovations, the headwinds are stiff and shifting but they are navigable. We will be tracking emerging issues and developments on private and public company matters, licensing deals and collaborations, patent and IP matters, FDA and healthcare regulatory compliance, and European and Asian developments for life sciences companies. Sign up to receive postings from Goodwin’s Life Sciences Perspectives blog by clicking here.

 

Whistleblower Lawyers Use False Claims Act to Target Private Equity Firms Invested In Healthcare and Life Sciences

Recent developments demonstrate that the health care industry – including life sciences companies – continues to be subject to heightened regulatory scrutiny and enforcement risk. This alert addresses the U.S. Department of Justice (“DOJ”) use of the False Claims Act (“FCA”) to pursue private equity investors and their portfolio companies,…

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Potential AI/ML Learnings to Come from FDA Public Advisory Committee Meeting on Skin Lesion Analyzer Technology in Late July

On July 28, 2022, the U.S. Food and Drug Administration (FDA) will hold a public advisory committee meeting to discuss skin lesion analyzer (SLA) technology and its application to detecting skin cancers in various patient care settings. This meeting of the General and Plastic Surgery Devices Panel of the Medical…

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Canadian Patent Examination Will Soon Be More Expensive, Less Flexible and Require Additional Care in Prosecution to Avoid Loss of Rights

Canadian Patent Examination Significant fee increases will be effective at the Canadian Intellectual Property Office (“CIPO”) on October 3, 2022 related to excess claims (claims over 20) and the number of examination reports it issues during prosecution. These changes may negatively impact the breadth of patent protection an applicant could…

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California Law Requiring Female Directors on Public Company Boards Held Unconstitutional

A California court has held that California Senate Bill 826, which required that “publicly held” corporations that listed a California address for their principal executive offices on the cover page of their Form 10-K reports must have specified numbers of female directors by certain dates, violates the California constitution and has enjoined the…

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Brian Burgess to Speak on Emerging Legal Issues and Trends for Interchangeable Biosimilars at FDLI Annual Conference

The annual Food & Drug Law (FDLI) conference will be held on June 14-15, bringing together experts from the federal government, industry, the private bar, non-profit, patient and consumer advocates, consulting organizations, and academia to address complex legal, regulatory, compliance, and policy issues facing the FDA-regulated industry.  Goodwin is a…

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Clinical Trial Diversity Planning for Sponsors: What to Know About FDA's Recent Draft Guidance

On April 13, 2022, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance providing specific recommendations to the industry on how to improve diversity in clinical trials. The FDA’s focus on increasing racial and ethnic diversity in clinical trials is not new, with the agency issuing several guidances since 2016…

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