News & Analysis as of

Product of Nature Doctrine Pharmaceutical Patents Patent-Eligible Subject Matter

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

Holland & Knight LLP

Section 101 Update: Pharmaceutical and Life Sciences March 2020

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This month, the U.S. Court of Appeals for the Federal Circuit has handed down a pair of opinions concerning Section 101 in the field of pharmaceuticals and life sciences. In both cases, the district courts held claims of the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. 2020)

The latest Federal Circuit decision on subject matter eligibility in the life sciences came down (by a divided court) in favor of eligibility, in Illumina, Inc. v. Ariosa Diagnostics, Inc.  The claims at issue fell into the...more

McDonnell Boehnen Hulbert & Berghoff LLP

CareDX, Inc. v. Natera, Inc. (D. Del. 2020)

Ever since the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories was handed down in 2012, diagnostic method claims have been routinely invalidated by the district courts and those decisions...more

Knobbe Martens

Federal Circuit Review - October 2019

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The PTAB Cannot Approve or Deny Certificates of Correction - In Honeywell International, Inc. v. Arkema Inc., Arkema France, Appeal Nos. 2018-1151, -1153, the Patent Trial and Appeal Board (“Board”) does not have the...more

Knobbe Martens

Federal Circuit Review - March 2019

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Federal Circuit Determines Time-Barred Petitioner Joined to an IPR Has Appellate Standing - In Mylan Pharmaceuticals Inc. v. Research Corporation Tech., Appeal Nos. 2017-2088, -2089, -2091, the Federal Circuit held that a...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

Stinson LLP

Federal Appeals Court Cautions Against Overapplication of Alice in Biotechnology

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In Natural Alternatives Intl. v. Creative Compounds, LLC, the U.S. Court of Appeals for the Federal Circuit reversed a decision by a lower court finding claims directed to dietary supplements containing beta-alanine...more

Knobbe Martens

Natural Alternatives Int'l, Inc. v. Creative Compounds, LLC

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Federal Circuit Summary - Before Moore, Reyna, and Wallach. Appeal from the Southern District of California. Summary: District court improperly held that claims were directed to a natural law where the claims recited a...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - March 2019 #3

PATENT CASE OF THE WEEK - Natural Alternatives Int’l v. Creative Compounds, LLC, Appeal No. 2018-1295 (Fed. Cir. Mar. 15, 2019) In an appeal from a judgment on the pleadings, the Federal Circuit reversed, issuing an...more

Knobbe Martens

Federal Circuit Review - November 2018

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Federal Circuit Finds Claims Directed to Tabbed Spreadsheets Patent Eligible and Claims Directed to Tracking Changes in Documents Ineligible Under Section 101 - In Data Engine Technologies LLC v. Google LLC, Appeal No....more

Knobbe Martens

Patent Law Update for Medical Device Companies 2018 (Presentation)

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Knobbe Martens Partners Paul Conover, Irfan Lateef, and Curtis Huffmire presented "Patent Law Update for Medical Device Companies 2018" at the MedTech Innovation Summit in San Francisco, CA on November 28, 2018. This session...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

Mintz

With its Vanda Pharma and Berkheimer Memos, USPTO Provides Increased Clarity and Predictability in the Patent Eligibility...

Mintz on

In the time since the Federal Circuit issued its Vanda Pharma decision in April, Vanda Pharm. Inc. v West-Ward Pharm. Intl. Ltd. 887 F.3d 1117 (Fed. Cir. 2018), we have had more good news for the patent eligibility of claims...more

Mintz - Intellectual Property Viewpoints

With its Vanda Pharma and Berkheimer memos, USPTO provides increased clarity around personalized medicine patent eligibility

In the time since the Federal Circuit issued its Vanda Pharma decision in April, Vanda Pharm. Inc. v West-Ward Pharm. Intl. Ltd. 887 F.3d 1117 (Fed. Cir. 2018) the US Patent and Trademark Office (USPTO) has issued two memos...more

Knobbe Martens

Federal Circuit Review - May 2018

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Priority Claims Cannot Be Incorporated by Reference - In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Limited, Appeal Nos. 2016-2707 and 2016-2708, the Federal Circuit held that when a patent for a...more

Foley & Lardner LLP

Medical Treatment Patent Claims Held Patentable Subject Matter Under the Alice/Mayo Section 101 Test

Foley & Lardner LLP on

In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd, Slip Op. (Nos. 2016-2707, 2016-2708, April 13, 2018) the U.S. Court of Appeals for the Federal Circuit provided useful guidance for patentees seeking to...more

Mintz

Personalized Medicine Gets a Boost from Federal Circuit’s Vanda Pharma Decision

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The Federal Circuit provided a welcome boost for stakeholders in the field of personalized medicine with its recent decision in Vanda Pharm. Inc. v West-Ward Pharm. Intl. Ltd. (2016-2702, 2016-2708 April 13, 2018). Vanda...more

Knobbe Martens

Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Limited

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Federal Circuit Summaries - Before Prost, Lourie and Hughes. Appeal from the United States District Court for the District of Delaware. Summary: When another patent for a drug issues after an ANDA is filed, there can...more

Foley & Lardner LLP

Federal Circuit Upholds Vanda Fanapt Personalized Method Claims Against Patent Eligibility Challenge

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In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd., a divided panel of the Federal Circuit upheld Vanda’s personalized method of treatment claims relating to its Fanapt® (iloperidone) product against a...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

Knobbe Martens

Recent Development on Patent Eligibility of Method of Treatment Claims

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The United States Patent and Trademark Office (USPTO) recently published a new revision to the Ninth Edition of the Manual of Patent Examining Procedure (MPEP) (Revision 08.2017). This revision added a number of chapters...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

Knobbe Martens

District Court Finds Mallinckrodt Patents Claim Unpatentable Natural Phenomena

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The recent district court ruling in INO Therapeutics LLC et al v. Praxair Distribution, Inc. et al employed the two-step analytical framework of Mayo/Alice to evaluate subject matter eligibility under 35 U.S.C. § 101, and the...more

Foley & Lardner LLP

District Court Invalidates Dietary Supplement Patents On Motion To Dismiss

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The U.S. District Court for the Southern District of California invalidated several dietary supplement product and method patents as being directed to ineligible subject matter, even though they claimed products providing a...more

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