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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 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FDA Issues New Draft Guidance on Demonstrating Substantial Evidence of Effectiveness with One Clinical Investigation and Confirmatory Evidence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On September 19, FDA released a highly anticipated new draft guidance for industry titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory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 The draft guidance expands on Section 115 of the Food and Drug Administration Modernization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
By: Elena Catherine Klonoski
1. Introduction On June 30, 2023, the Centers for Medicare and Medicaid Services (CMS) released its much-anticipated final guidance (“Final Guidance”) for the Medicare Drug Price Negotiation Program (“Negotiation Program”) through the Inflation Reduction Act (IRA).[1] The Negotiation Program is an unprecedented program intended
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August 02, 2023 - FDA, Regulatory, AI, 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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July 24, 2023 - FDA, Healthcare, Litigation, Pharma, United States
Legal Battles Continue Over Inflation Reduction Act’s Drug Price Negotiation Measures
By: Joseph R. Palmore
In recent months, six different lawsuits have been filed challenging the Inflation Reduction Act (IRA)’s Drug Price Negotiation Program (the “Program”), with a flurry of activity likely in the coming months before the Program’s first deadlines. Below we analyze the latest developments in the
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July 20, 2023 - Intellectual Property, Litigation, Pharma, Biotech, United States
Obviousness in Drug Combinations – Unexpected Results Vs. Unexpected Mechanisms of Action
By: Mark D. McBriar Ph.D.
Ascertaining the differences between prior art and claims at issue requires interpreting the claim language and considering both the invention and the prior art references as a whole. [1] The Supreme Court emphasized “the need for caution in granting a patent based on the
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Welcome to Mofo Life Sciences

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

By: Elena Catherine Klonoski

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

Legal Battles Continue Over Inflation Reduction Act’s Drug Price Negotiation Measures

By: Joseph R. Palmore

Obviousness in Drug Combinations – Unexpected Results Vs. Unexpected Mechanisms of Action

By: Mark D. McBriar Ph.D.