MoFo Life Sciences

July 10, 2023 - Cell + Gene Therapy, Biotech, Intellectual Property, Litigation, Pharma
Mitigating Patent Risk in Gene Therapy Development
By: Daralyn Durie, Janet Xiao Ph.D. and Katherine E. McNutt
This article was first published by IAM on June 2, 2023 in its Special Report 2023 Q2: New Frontiers of Pharma and Biotech IP Strategy. Daralyn Durie, Janet Xiao and Katherine McNutt of Morrison Foerster explore strategies to reduce the threat of infringement liability
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June 20, 2023 - Biotech, Pharma, Intellectual Property, Litigation, Cell + Gene Therapy
Practical Strategies for Protecting Innovations Under the Doctrine of Equivalents
By: Kelsey J. Roberts Kingman Ph.D. and Bu Yin Ph.D.
Recent case law highlights enablement and written description challenges for genus claims.[1] Given the challenges of enforcing genus claims, the doctrine of equivalents (DOE) may become a more important tool for patentees when literal infringement is unavailable. As discussed below, the outlook for successful
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May 12, 2022 - United States, Biotech, Healthcare, Intellectual Property, Cell + Gene Therapy
The “Big Bang” for Sequence Listings: New Requirements in Place July 1, 2022
By: Liz Newman Ph.D. and Karen G Potter Ph.D.
Life sciences patent applications often contain DNA, RNA, and amino acid sequences in the specification, claims, or figures that are required to be provided in the form of a sequence listing. The inclusion of sequences in patent applications are compulsory to satisfy patent office
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April 07, 2022 - United States, FDA, Healthcare, Regulatory, Cell + Gene Therapy
FDA Issues Draft Guidance on Human Gene Therapy Products Incorporating Human Genome Editing
By: Brigid DeCoursey Bondoc
On March 14, 2022, U.S. Food and Drug Administration (FDA) issued two draft guidances: “ Human Gene Therapy Products Incorporating Human Genome Editing (GE)” and a draft guidance on Chimeric Antigen Receptor (CAR) T cell product development. These draft guidance documents were issued on
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February 15, 2022 - United States, FDA, Healthcare, Pharma, Intellectual Property, Cell + Gene Therapy
PATENT TERM EXTENSION FOR BIOLOGICS
By: Meghan McLean Poon Ph.D. and Yuying (Kate) You Ph.D.
Patent term extension (PTE) provides additional patent term for patents related to U.S. pharmaceutical products to compensate for the effective loss of patent term caused by delay during the drug approval process by the U.S. Food and Drug Administration (FDA). To be eligible for
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January 20, 2022 - FDA, Biotech, Healthcare, Pharma, Regulatory, Cell + Gene Therapy
FDA Releases Draft Guidance on Use of Real-World Evidence for Drug & Biological Products
Bethany Hills and Dan Rubin authored an article for Life Science Connect outlining the U.S. Food and Drug Administration’s (FDA) new draft guidance in its latest effort to clarify its expectations regarding the integration of real-world data and real-world evidence into clinical research, product
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January 05, 2022 - Litigation, Biotech, Healthcare, Pharma, Intellectual Property, Cell + Gene Therapy
Life Sciences Patent Trends in 2022 – Doctrine of Equivalents
By: Meghan McLean Poon Ph.D.
The Federal Circuit continues to tighten the standards for written description of functional claims, particularly in the biologics realm, which is putting patent applicants in the position of having to pursue narrow claims directed to specific sequences. At the same time, reliance on the
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October 25, 2021 - United States, FDA, Rare Disease, Pharma, Regulatory, Cell + Gene Therapy
FDA Finalizes Guidance on Interpretation of Orphan Drug “Sameness” for Gene Therapy Products
By: Brigid DeCoursey Bondoc
On September 30, 2021, the U.S. Food and Drug Administration (FDA) announced final guidance titled “ Interpreting Sameness of Gene Therapy Products under the Orphan Drug Regulations .” The guidance finalizes the January 2020 draft guidance and provides FDA’s current perspective on certain criteria
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September 09, 2020 - United States, FDA, Biotech, Healthcare, Pharma, Intellectual Property, Cell + Gene Therapy
Pediatric Exclusivity for Biologics
The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with certain distinctions), which may become a valuable life cycle management strategy for biopharmaceutical companies (hereinafter “Sponsors”) in addition to patent exclusionary rights. At
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January 23, 2020 - United States, FDA, Biotech, Healthcare, Pharma, Regulatory, Cell + Gene Therapy
FDA and Real-World Evidence in 2019
Around the end of 2018, FDA published the “Framework for FDA’s Real-World Evidence Program” (the “Framework”).[1] The Framework is to provide a basis for the agency in evaluating the potential use of real-world evidence (RWE) in regulatory decisions involving drug and biological products.[2] The
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Topic Archives: Cell + Gene Therapy

Mitigating Patent Risk in Gene Therapy Development

By: Daralyn Durie, Janet Xiao Ph.D. and Katherine E. McNutt

Practical Strategies for Protecting Innovations Under the Doctrine of Equivalents

By: Kelsey J. Roberts Kingman Ph.D. and Bu Yin Ph.D.

The “Big Bang” for Sequence Listings: New Requirements in Place July 1, 2022

By: Liz Newman Ph.D. and Karen G Potter Ph.D.

FDA Issues Draft Guidance on Human Gene Therapy Products Incorporating Human Genome Editing

By: Brigid DeCoursey Bondoc

PATENT TERM EXTENSION FOR BIOLOGICS

By: Meghan McLean Poon Ph.D. and Yuying (Kate) You Ph.D.

FDA Releases Draft Guidance on Use of Real-World Evidence for Drug & Biological Products

Life Sciences Patent Trends in 2022 – Doctrine of Equivalents

By: Meghan McLean Poon Ph.D.

FDA Finalizes Guidance on Interpretation of Orphan Drug “Sameness” for Gene Therapy Products

By: Brigid DeCoursey Bondoc

Pediatric Exclusivity for Biologics

FDA and Real-World Evidence in 2019