MoFo Life Sciences

July 02, 2019 - Medical Devices + Diagnostics, Product Liability + Class Action, Regulatory
Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR
By: Erin M. Bosman and Julie Y. Park
On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.”[1] This report describes updates to FDA’s Medical Device Reporting (MDR) Program, namely the conclusion of the Alternative Summary Reporting (ASR) Program. In
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June 25, 2019 - United States, FDA, Regulatory, Privacy + Data Security
Nationally Recognized FDA Partner Bethany J. Hills Joins Morrison & Foerster in New York
Ms. Hills brings a full-service FDA practice to the firm rounding out its market-leading Life Sciences Group Morrison & Foerster, a leading global law firm, is pleased to announce that Bethany J. Hills has joined the firm in the New York office as a
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May 30, 2019 - United States, Medical Devices + Diagnostics, Regulatory, Intellectual Property
The Diagnostics Dilemma: Securing and Protecting Diagnostic-Based Claims
By: Karen G Potter Ph.D.
While many life sciences companies are built on platforms involving the development of diagnostic products and methods that underlie personalized medicine allowing treatment that is customized to a patient’s unique biology, the U.S. Supreme Court dealt a blow to the industry with its decision
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May 24, 2019 - United States, Biotech, Pharma, Regulatory, Intellectual Property
Congress releases bipartisan draft bill to repair the law on patent eligibility
By: Karen G Potter Ph.D. and Jeffrey W. Schmidt Ph.D.
On May 22, 2019, members of Congress made available for public comment a one-page draft of a bill that aims to rewrite the patent eligibility provisions of the Patent Act to address the muddled jurisprudence spawned by the Supreme Court cases of Mayo Collaborative
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May 22, 2019 - Biotech, European Union, Pharma, Regulatory, Intellectual Property
Manufacturing Waiver Weakens SPC Protection in Europe
By: Wolfgang Schönig
On May 14, 2019, the Council of the European Union adopted the amending Regulation (EC) No. 469/2009 , effectively exempting certain manufacturing activities in the EU from the scope of Supplementary Protection Certificates that have not yet been granted (“New SPC Regulation”). The New SPC Regulation will enter
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March 12, 2019 - United States, Product Liability + Class Action, Agtech, Regulatory
Cannabidiol: Is CBD Legal in the United States in 2019?
By: William F. Tarantino
Cannabis-derived extracts are one of the hottest trends in the consumer products industry. Sales of consumer products containing cannabidiol (CBD) are reported to exceed $510 million in 2018. Experts predict that the market for CBD products could grow to $22 billion by 2022. Hemp oil can now be found
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February 26, 2019 - European Union, Pharma, Regulatory, Privacy + Data Security
The Trials That Lie Ahead: EDPB Opines on Interplay Between EU Clinical Trials Regulation and GDPR
By: Miriam H. Wugmeister
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
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January 26, 2019 - United States, Biotech, Pharma, Regulatory, Intellectual Property
Federal Circuit Corrects USPTO on Reasonable Efforts When Calculating Patent Term Adjustment
The 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
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January 25, 2019 - European Union, Pharma, Regulatory, Intellectual Property
A Structured Guide to Recent Case Law of the Court of Justice of the European Union on Supplementary Protection Certificates in Europe
By: Wolfgang Schönig
In 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,
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January 11, 2019 - Litigation, European Union, Pharma, Regulatory, Intellectual Property
The EU General Court’s Ruling on Pay for Delay
By: Wolfgang Schönig, Andreas Grünwald, Jens Hackl, Theresa Oehm and Robert Grohmann
The 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
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