Announcements

Welcome to Mofo Life Sciences

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.

October 24, 2023 - Biotech
MoFo and Bayer Co.Lab Kick-Off Partnership to Advance Cell and Gene Therapy Innovation
By: Wolfgang Schönig and Matt Karlyn
Morrison Foerster and Bayer Co.Lab are partnering to offer legal programming and support to the next generation of cell and gene therapy (CGT) startups. Bayer Co.Lab is a growing global network of life science incubators that provides entrepreneurs and early-stage companies access to state-of-the-art
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October 23, 2023 - Intellectual Property, Regulatory
Top 10 Considerations in Licensing Cleantech Innovations
By: Matthew A. Ferry, Anita Choi and Emily Jane Roberts Ph.D.
Spurred by both planetary and economic needs, the industry commonly referred to as “cleantech”—short for “clean technology”—has been on the rise. Current estimates predict clean energy technologies could dominate oil and gas by as early as 2030 (Global cleantech market size by country 2030 |
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October 11, 2023 - FDA
FDA Issues New Draft Guidance on Demonstrating Substantial Evidence of Effectiveness with One Clinical Investigation and Confirmatory Evidence
By: Brigid DeCoursey Bondoc
On September 19, FDA released a highly anticipated new draft guidance for industry titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence. The draft guidance expands on Section 115 of the Food and Drug Administration Modernization
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October 11, 2023 - Intellectual Property
Retaining Your Patent Priority Date in Europe: Formal Priority Given a Rebuttable Presumption in Favor of Applicant/Patentee
By: Jeffrey W. Schmidt Ph.D. and Karen G Potter Ph.D.
On October 10, 2023, the Enlarged Board of Appeal of the European Patent Office (EPO) issued a groundbreaking decision that reflects a major change in how formal priority is assessed at the EPO during examination and in post-grant opposition proceedings, to the benefit of
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September 15, 2023 - Litigation, Intellectual Property, United States
Patent Term Adjustment Takes a Hit in Cellect Decision
By: Meghan McLean Poon Ph.D.
Recently, the Federal Circuit addressed a significant issue of first impression with respect to obviousness-type double patenting (ODP), holding that ODP applies to patent claims that claim priority to the same application and have different expiration dates due only to patent term adjustment (PTA).
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August 29, 2023 - Intellectual Property, Medical Devices + Diagnostics, United States
A Glimmer of Hope for Simplified Patenting of Medical Diagnostics in the United States
By: Michelle Celine Bradley Ph.D. and John D Chapman Ph.D.
Should the recent bill entitled the Patent Eligibility Restoration Act of 2023 (PERA) become law, it would override the existing jurisprudence and redefine which inventions are eligible for patenting under 35 U.S.C. § 101. By way of the Patent Act of 1952, the United
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August 14, 2023 - Intellectual Property, United States
Biden Executive Order Has Potential to Discourage U.S. Company Participation in Federal Research
By: Tina D. Reynolds
A new Biden administration Executive Order proposes to enforce more rigorously U.S. manufacturing requirements attendant to federally funded inventions. While the aim of the Executive Order is to support domestic manufacturing and jobs, the policy could have the unintended effect of discouraging U.S. company
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August 08, 2023 - FDA, Pharma, United States, Healthcare
Medicare Drug Price Negotiation Program Final Guidance
Elena Klonoski, a summer associate in our Boston office, and Lauren Limbach, a summer associate in our Washington, D.C. office, contributed to the drafting of this post. 1. Introduction On June 30, 2023, the Centers for Medicare and Medicaid Services (CMS) released its much-anticipated
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August 02, 2023 - FDA, Regulatory, AI + Robotics, Healthcare
5 Questions About Generative AI in Healthcare
By: Brigid DeCoursey Bondoc
Brigid Bondoc and Wendy Chow authored an article for HealthTech about what the recent growth of generative artificial intelligence (AI) tools means for providers and patients. “In the absence of a clear legal and ethical framework that promotes the complete scope of the benefits
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July 31, 2023 - Intellectual Property, United States
It Takes Two to Taco: Taco John’s Abandons “Taco Tuesday” Trademark Registration
By: Muzamil Huq, Joyce Liou and Morgan O'Neill Mitruka
On July 18, 2023, the phrase “Taco Tuesday” was returned to the public after Taco John’s submitted a notice of abandonment for its TACO TUESDAY trademark registration before the United States Patent & Trademark Office’s Trademark Trial and Appeal Board. Taco John’s, a popular
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Welcome to Mofo Life Sciences

MoFo and Bayer Co.Lab Kick-Off Partnership to Advance Cell and Gene Therapy Innovation

By: Wolfgang Schönig and Matt Karlyn

Top 10 Considerations in Licensing Cleantech Innovations

By: Matthew A. Ferry, Anita Choi and Emily Jane Roberts Ph.D.

FDA Issues New Draft Guidance on Demonstrating Substantial Evidence of Effectiveness with One Clinical Investigation and Confirmatory Evidence

By: Brigid DeCoursey Bondoc

Retaining Your Patent Priority Date in Europe: Formal Priority Given a Rebuttable Presumption in Favor of Applicant/Patentee

By: Jeffrey W. Schmidt Ph.D. and Karen G Potter Ph.D.

Patent Term Adjustment Takes a Hit in Cellect Decision

By: Meghan McLean Poon Ph.D.

A Glimmer of Hope for Simplified Patenting of Medical Diagnostics in the United States

By: Michelle Celine Bradley Ph.D. and John D Chapman Ph.D.

Biden Executive Order Has Potential to Discourage U.S. Company Participation in Federal Research

By: Tina D. Reynolds

Medicare Drug Price Negotiation Program Final Guidance

5 Questions About Generative AI in Healthcare

By: Brigid DeCoursey Bondoc

It Takes Two to Taco: Taco John’s Abandons “Taco Tuesday” Trademark Registration

By: Muzamil Huq, Joyce Liou and Morgan O'Neill Mitruka