MoFo Life Sciences

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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October 30, 2018 - United States, Biotech, CFIUS, Pharma, Regulatory
New CFIUS Pilot Program: What Life Sciences Companies and Investors Need to Know
By: Robert S. Litt and Joseph A. Benkert
As many life sciences companies and investors are aware, the U.S. Department of the Treasury (“Treasury”) recently announced a new “pilot program” for the Committee on Foreign Investment in the United States (“CFIUS”) effective November 10, 2018. The pilot program implements certain provisions of
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March 01, 2018 - United States, Litigation, Pharma, Intellectual Property
PTAB Rejects Tribal Immunity Proceedings
By: Matthew I. Kreeger
On February 23rd, 2018, a panel of the Patent Trial and Appeal Board (PTAB or “Board”) decided that: (1) Indian tribal sovereignty did not apply to post-grant proceedings established under the America Invents Act (AIA) and (2) licensing agreements between a tribe and a
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January 24, 2018 - United States, Startup, Biotech, Pharma, Regulatory, Intellectual Property
Life Sciences Startups: Patent, FDA Considerations
By: Lisa N. Silverman Ph.D.
Innovator companies at all stages seek patent protection in order to limit market competition. Many early-stage companies seek patent protection with the additional goal of attracting investment. However, even if patent filings are accelerated in order to raise funds, it is important that early-stage
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June 24, 2017 - United States, Pharma, Regulatory, Intellectual Property
Cancer Moonshot: USPTO Extends Cancer Immunotherapy Pilot Program Initiative
By: Karen G Potter Ph.D.
The United States Patent and Trademark Office (PTO) issued a Notice today extending the Cancer Immunotherapy Pilot Program (Pilot Program), also known as “Patents 4 Patients.” The Pilot Program, which accelerates the examination of patent applications directed to cancer immunotherapy methods, will now expire
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Topic Archives: Pharma

The Trials That Lie Ahead: EDPB Opines on Interplay Between EU Clinical Trials Regulation and GDPR

By: Miriam H. Wugmeister

Federal Circuit Corrects USPTO on Reasonable Efforts When Calculating Patent Term Adjustment

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

The EU General Court’s Ruling on Pay for Delay

By: Wolfgang Schönig, Andreas Grünwald, Jens Hackl, Theresa Oehm and Robert Grohmann

New CFIUS Pilot Program: What Life Sciences Companies and Investors Need to Know

By: Robert S. Litt and Joseph A. Benkert

PTAB Rejects Tribal Immunity Proceedings

By: Matthew I. Kreeger

Life Sciences Startups: Patent, FDA Considerations

By: Lisa N. Silverman Ph.D.

Cancer Moonshot: USPTO Extends Cancer Immunotherapy Pilot Program Initiative

By: Karen G Potter Ph.D.