In an effort to lend further support to the expedited development of COVID-19-related vaccines and therapeutics (see Covid-19 Prioritized Examination Pilot Program), the United States Patent and Trademark Office (USPTO) has implemented a deferred-fee provisional patent application pilot program whereby applicants filing under 35 U.S.C. 111(b) can elect to defer…
World affairs are currently clouded by the global COVID-19 pandemic. In a very short period of time, approximately 191 vaccine projects have been launched according to the World Health Organization (WHO). Among the countries with a particularly large number of projects, approximately twenty in total, is Germany. This already displays…
…the essential criterion for being classified as a medical device is the software’s medical objective… Background Relying on an unregulated app or piece of standalone software to provide a diagnosis or recommend treatment could have potentially life-threatening consequences. In June 2020, the UK’s medical devices regulator, the Medicines and Healthcare…
On December 1, 2020, Nasdaq filed a proposal with the SEC to adopt new listing rules relating to board diversity and heighted disclosure. Nasdaq’s position is clear – “diversity in the boardroom is good corporate governance.” Citing the recent social justice movement and a wide range of studies linking board…
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…
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…
Flexibility provides the greatest value in laboratory space design for both owners and users of life sciences real estate. Science and technology are evolving at such a rapid pace that it is difficult to predict future needs. Bespoke spaces can become obsolete before they are even occupied. Spaces that can…
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…
When submitting a new drug application (“NDA”) with the FDA, an applicant (or branded company) is required to file a list of patents that cover the drug product. These patents will be listed in the FDA’s Orange Book upon approval of the drug for commercial sale. Patents that are eligible…
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…