News & Analysis as of

Section 101 Pharmaceutical Patents United States Patent and Trademark Office

American Conference Institute (ACI)

[Event] 23rd Advanced Summit on Life Sciences Patents - May 19th - 20th, New York, NY

At ACI’s 23rd Advanced Summit on Life Sciences Patents, you can expect informational overviews and thorough discussion of every facet of the industry. In a time of major legislative, regulatory, and judicial change, you can't...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

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

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

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

Fenwick & West LLP

Written Description of Therapeutic Efficacy

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Inventors are generally counseled to file a patent application as soon as they have a patentable invention to avoid potential forfeiture of important rights in today’s first inventor-to-file system. However,...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

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

American Conference Institute (ACI)

[Virtual Event] 18th Advanced Summit on Life Sciences Patents - August 5th - 6th, 9:00 am EDT

Perfect Your Patent Prosecution Strategies and Master the Patent Application Process in the U.S and Around the World. ACI’s 18th Global Summit on Life Sciences Patents virtual conference this August will provide practical...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

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...

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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

Knobbe Martens

Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC: Claims Reciting Conventional Method Steps found Patent Ineligible

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On February 6, 2019, the Federal Circuit decided Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, affirming a District Court for the District of Massachusetts decision that the claims at issue were patent...more

Foley & Lardner LLP

Federal Circuit Finds Detection Claims Invalid Under 101

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In Roche Molecular Systems, Inc. v. Cepheid, the Federal Circuit affirmed the summary judgment decision of the U.S. District Court for the Northern District of California that held nucleotide primer claims and detection...more

Sunstein LLP

July 2018 IP Update: New Guidance for Patenting Method-of-Treatment Inventions

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The U.S. Patent and Trademark Office (USPTO) issued a memorandum on June 7 (the “Memorandum”), providing much-needed guidance to patent examiners as to whether method of treatment claims are to be considered patent-eligible...more

Husch Blackwell LLP

Patent Office Guidance Improves Personalized Medicine’s Long-Term Prognosis

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On June 7, 2018 the United States Patent and Trademark Office (USPTO) issued a new Memorandum that clarifies its view of Subject Matter Eligibility, under 35 U.S.C. § 101, regarding the patentability of Personalized Medicine...more

BakerHostetler

USPTO Memo Addresses Eligibility of Method-of-Treatment Claims in View of Federal Circuit Decision

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In a memorandum dated June 7, 2018 (Memo), the U.S. Patent and Trademark Office (USPTO) set out new guidance concerning method-of-treatment claims, which should be welcome news for patentees. The memo addressed the decision...more

Foley & Lardner LLP

Federal Circuit Finds Composition of Matter Ineligble For Patenting

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In a non-precedential decision issued in In re Bhagat, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that claims directed to certain lipid compositions were ineligible for...more

Foley & Lardner LLP

USPTO Finds SureGene Personalized Medicine Treatment Unpatentable Under Mayo

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In Ex Parte Timothy, the USPTO Patent Trial and Appeal Board (PTAB) affirmed the Examiner’s rejection of personalized medicine treatment claims. This decision highlights the PTAB’s willingness to invalidate claims that it...more

Foley & Lardner LLP

USPTO Patent Eligibility Guidance In View Of CellzDirect And Sequenom

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On July 14, 2016, the USPTO issued a Memorandum to the Patent Examining Corps on patent eligibility in view of recent court decisions. The July 2016 Memorandum extracts more guidance for assessing patent eligibility from the...more

Foley & Lardner LLP

Supreme Court Deals Blow To Diagnostic Method Patents, Denies Cert In Sequenom

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“If you can’t say something nice, don’t say anything at all” can be good words to live by, but in the context of the Supreme Court’s denial of certiorari in Sequenom, the silence is deafening–and could have a chilling impact...more

Foley & Lardner LLP

Will the Supreme Court Clarify Patent-Eligibility?

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The United States Supreme Court is set to render its decision on the grant or denial of Sequenom, Inc.’s (“Sequenom’s”) petition for writ of certiorari that posed the issue: ..Whether a novel method is patent-eligible...more

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