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Pharmaceutical Patents Patent-Eligible Subject Matter United States Patent and Trademark Office

MoFo Life Sciences

Subject Matter Eligibility of AI Medical Treatments

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Artificial intelligence (AI) has quickly become a springboard for breakthroughs in personalized medicine, enhanced medical imaging, and predictive modeling for drug development. And given the role it played in two recent...more

Baker Donelson

Patent Cases to Watch for in the Second Half of 2024

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As we move into the second half of the year, we are alerting you to 11 patent cases that you should look out for during the second half of 2024. This judicial mix touches on a range of industries and interests, such as...more

Baker Donelson

A Baker's Dozen of Patent Law Developments for 2024

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The world of intellectual property law is always changing, and it can be difficult to keep up. Here are 13 developments in patent law so far in 2024 to help you stay in the know....more

McDonnell Boehnen Hulbert & Berghoff LLP

USPTO Publishes Updated Subject Matter Eligibility Guidance Focusing on AI

As required by President Biden's Executive Order 14110 ("Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence"), the U.S. Patent and Trademark Office has published an update to its subject matter...more

Sheppard Mullin Richter & Hampton LLP

2023 Federal Circuit Case Summaries - Intellectual Property: Year End Report

We are pleased to share Sheppard Mullin’s inaugural “Year in Review” report that collects and reports on most key patent law-related Federal Circuit decisions for 2023. This is a follow up to the quarterly report we...more

McDonnell Boehnen Hulbert & Berghoff LLP

RegenxBio Inc. v. Sarepta Therapeutics, Inc. (D. Del. 2024)

A consequence (predominantly negative) of the Supreme Court's recent foray into defining (however inadequately) the contours of patent-eligible subject matter is to give the district courts (and to a somewhat lesser extent,...more

McDonnell Boehnen Hulbert & Berghoff LLP

Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2023)

In those (in retrospect) halcyon days more than a decade ago (before Mayo, Myriad, Alice, and the subject matter eligibility quagmire arose), perhaps the most significant Supreme Court decision was KSR Int'l Co. v. Teleflex...more

American Conference Institute (ACI)

[Event] 18th Annual Paragraph IV Disputes - April 19th - 20th, New York, NY

Hosted by ACI, 18th Annual Paragraph IV Disputes Conference returns to New York City for another exciting year with curated programming that not only addresses the hot topics, but also puts them within the context of pre-suit...more

Foley & Lardner LLP

USPTO Launches Cancer Moonshot Expedited Examination Pilot Program

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To support the National Cancer Moonshot initiative, the USPTO launched the Cancer Moonshot Expedited Examination Pilot Program on February 1, 2023. The new program replaces the Cancer Immunotherapy Pilot Program, which...more

McDonnell Boehnen Hulbert & Berghoff LLP

Senator Tillis' Patent Eligibility Reform Proposal: A Biopharma Perspective

Senator Thom Tillis (R-NC) introduced S. 4734, entitled "A Bill to amend Title 35, U.S. Code, to address matters relating to patent subject matter eligibility, and for other purposes" last night, as was discussed in an...more

Foley & Lardner LLP

Impact of Current 101 Jurisprudence on Precision Medicine Innovation

Foley & Lardner LLP on

The USPTO recently released a Report to Congress (“Report”) detailing the results of its call for public comments regarding the impact of U.S. jurisprudence on patent subject matter eligibility. The Report is responsive to...more

McDonnell Boehnen Hulbert & Berghoff LLP

Top Stories of 2021: #4 to #6

After reflecting upon the events of the past twelve months, Patent Docs presents its 15th annual list of top patent stories. For 2021, we identified nine stories that were covered on Patent Docs last year that we believe had...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Conference - November 9th - 10th, New York, NY

Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more

Bradley Arant Boult Cummings LLP

Court Decision Means that Antibody Patenting Is Not Getting Easier

Patenting antibodies has long been challenging. Although most inventions can be patented based on their functionality, assuming the functionality is new and non-obvious, for antibodies and other biomolecules there is a higher...more

Fenwick & West LLP

Intellectual Property Bulletin - Winter 2021

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Written Description of Therapeutic Efficacy - In two 2019 rulings, the Federal Circuit invoked the “written description requirement” of 35 U.S.C. § 112 to require evidentiary support for therapeutic efficacy. Now that the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Top Four Stories of 2020

After reflecting upon the events of the past twelve months, Patent Docs presents its 14th annual list of top patent stories.  For 2020, we identified eight stories that were covered on Patent Docs last year that we believe...more

Holland & Knight LLP

Top Section 101 Patent Eligibility Stories of 2020

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Light a fire, pour yourself some glogg (21+) and find a comfy corner to read about the biggest Section 101 stories of 2020 because we're gonna have the hap-hap-happiest time since Bing Crosby tap-danced with . . . Well, you...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Patent Prosecution Tool Kit: Summary of Subject Matter Eligibility: Biotech/Pharma Inventions

It has nearly been ten years since the Supreme Court’s landmark Mayo v. Prometheus (132 S.Ct. 1289 (2012)) decision, in which the Court established a two-prong test for determining patentable subject matter under 35 U.S.C. §...more

Foley & Lardner LLP

Utilization of Natural Phenomenon Found Patent Eligible

Foley & Lardner LLP on

In Illumina, Inc. v. Ariosa Diagnositcs, Inc., (Fed. Cir. Slip Op. 2019-1419, March 17, 2020) the Federal Circuit held that process claims that exploit the discovered size differences between fetal and maternal DNA in serum...more

Knobbe Martens

Trends and Changes in View of the USPTO’s Updated Revised Guidance (Presentation)

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Partner Mauricio Uribe hosted a webinar presenting, "Trends and Changes in View of the USPTO's Updated Revised Guidance." Topics Include: • Summary of the October 2019 Update to the Revised Guidance •...more

Foley & Lardner LLP

USPTO October 2019 Patent Eligibility Guidance Update Includes New Example for Products of Nature

Foley & Lardner LLP on

We previously discussed the new personalized medicine example in the USPTO’s October 2019 Patent Eligibility Guidance Update. Here, we look at the new nature-based product example, and consider how it may impact...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - August 2019

PATENT CASE OF THE WEEK - Celgene Corporation v. Laura A. Peter, Appeal Nos. 2018-1167, -1168, -1169, -1171 (Fed. Cir. July 30, 2019) - In this week’s Case of the Week, the Federal Circuit held that the retroactive...more

Knobbe Martens

Cleveland Clinic II: Has the Federal Circuit Undermined Patent Office Guidance and Eliminated an Important Tool for Patenting...

Knobbe Martens on

On April 1, 2019, the Federal Circuit issued a non-precedential decision in Cleveland Clinic Foundation, Cleveland HeartLab, Inc. v. True Health Diagnostics LLC (“Cleveland Clinic II”), affirming the district court’s holding...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit Upholds Invalidity of Cleveland Clinic’s Claims Directed to Methods for Detecting an Elevated MPO Concentration

In Cleveland Clinic Foundation, Cleveland Heartlab, Inc. v. True Health Diagnostics LLC, (Cleveland Clinic II)[1], a unanimous panel of the Federal Circuit provided yet another guidepost illustrating what is not...more

Foley & Lardner LLP

Federal Circuit Finds Endo Method Of Treatment Claims Satisfy 35 USC 101

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In Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit distinguished method of treatment claims that involve personalized dosing from the claims invalidated in Mayo v. Prometheus, and found them...more

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