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.

 

Compulsory Patent Licensing in Response to COVID-19: Recent International Developments

Can a government authorize the production of a COVID-19 vaccine without the consent of the patent holder? The answer is likely yes, depending on which country you are in. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provides a mechanism for member states to authorize themselves or third…

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Territorial Licensing in Collaboration Agreements

Life sciences companies often turn to geographical licensing to realise the maximum value from their assets, and to ensure their products reach markets worldwide, particularly where they do not have a global footprint. In the context of a collaboration agreement, the owner of certain intellectual property rights may collaborate with…

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Are Pre-Approval and Pre-Licensure Inspections Limiting Approvals During COVID-19?

In this post, we discuss FDA’s conduct of inspections of manufacturing facilities for new drugs and biologics during the COVID-19 pandemic. These inspections, known as pre-approval and pre-licensure inspections (PAIs/PLIs, respectively), are performed to give FDA assurance that a manufacturing site named in a new drug or biologics license application…

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Underwriting Life Sciences Companies: What Owners and Developers of Real Estate Should Think About When Entering the Life Sciences Market

The process of underwriting tenants can be complex at the best of times, even more so when you add the particular requirements of early stage and/or fast growing life sciences companies and a global pandemic into the equation. With that in mind, we have summarized a few of the key…

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