The Trials That Lie Ahead: EDPB Opines on Interplay Between EU Clinical Trials Regulation and GDPR
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MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.
- There has been a lot of confusion in the past months on applying the General Data Protection Regulation (GDPR) to clinical trials. For example, the GDPR requires honoring specific individual rights such as notice, access and deletion. However, that seems to be at odds... ›
Transforming the U.S. Healthcare Industry with Blockchain Technology
By: Spencer D. Klein, Julie O'Neill and Mary RacePatients accumulate vast quantities of healthcare data over the course of their lives. Those data are generally housed in centralized servers operated by various unrelated industry participants, including government regulators and payors, insurance carriers, hospitals, doctors, pharmacies and pharmaceutical companies. Unfortunately, those repositories rely... ›
Morrison & Foerster Opens Boston Office, Further Expanding Premier Technology and Life Sciences CapabilitiesMorrison & Foerster, a leading global law firm, is pleased to announce that it has opened an office in Boston to further extend its market-leading technology and life sciences capabilities. The move also expands the firm’s premier Finance and Emerging Companies and Venture Capital (ECVC) practices. Additionally, the... ›
Federal Circuit Corrects USPTO on Reasonable Efforts When Calculating Patent Term AdjustmentThe Federal Circuit ruled on January 23, 2019, that the United States Patent and Trademark Office (“PTO”) erred in reducing the term of a patent owned by Supernus Pharmaceuticals by 546 days, during which time the company could not have furthered prosecution of the... ›
A Structured Guide to Recent Case Law of the Court of Justice of the European Union on Supplementary Protection Certificates in Europe
By: Wolfgang SchönigIn principle, patents confer protection for a maximum of 20 years. In Europe, however, the patent terms for pharmaceutical products that meet the conditions necessary for supplementary protection certificates (“SPC”) can be extended for up to five years. Once a patent has been filed,... ›
The EU General Court’s Ruling on Pay for Delay
By: Wolfgang Schönig, Andreas Grünwald, Jens Hackl, Theresa Oehm and Robert GrohmannThe EU General Court (“Court”) reduced the fines imposed on Servier SAS and its subsidiaries (“Servier”) from a total of €428 million to €315 million (see press release no. 194/18), thereby partially annulling a European Commission (“Commission”) decision. The Court confirmed the Commission’s finding that... ›
A New Year's Gift for Patent Applicants?
By: Jonathan Bockman, Sejin Ahn, Shouvik Biswas, Christopher E. Gloria and Karen G PotterThe USPTO rang in the new year by releasing new Examiner Guidance that could potentially benefit patent applicants who have previously encountered difficulty acquiring patents under the Office’s procedures for determining patent subject matter eligibility under 35 U.S.C. § 101. Supreme Court decisions regarding § 101... ›
IP Protection Post-Brexit: A Right-by-Right Analysis
By: Alistair Maughan, Wolfgang Schönig, Sana Ashcroft and Robert GrohmannThe United Kingdom is set to leave the European Union on 29 March 2019 (“Exit Date”). With Brexit fast approaching, on 25 November 2018 the EU and the UK announced their consensus on a withdrawal agreement that sets out the terms of the UK's... ›
Planting the Seeds of Change
By: Michael R. Ward, Liz Freeman Rosenzweig and Liz NewmanMorrison & Foerster partner Michael R. Ward explained the specialized versions of IP law that have been developed for new plants in his article for Intellectual Property Magazine , “ Planting the seeds of change .” “…plants are unlike other inventions in that they... ›
Are Employee Non-Solicitation Clauses Still Legal In California?
By: Lloyd W. Aubry, Jr.The Fourth District Court of Appeals in San Diego on November 1, 2018, issued AMN Healthcare Inc. v. Aya Healthcare Services Inc. , in which it called into question the continuing viability in California of employee non-solicitation clauses found in many employment contracts and... ›