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Patent-Eligible Subject Matter › Food and Drug Administration (FDA)

Patent-Eligible Subject Matter refers to the types of inventions that can be legally patented. The criteria for patentability varies depending on the jurisdiction. In the United States, for instance, if a... more +
Patent-Eligible Subject Matter refers to the types of inventions that can be legally patented. The criteria for patentability varies depending on the jurisdiction. In the United States, for instance, if a researcher discovers a naturally occurring substance, the substance itself cannot be patented. This issue was examined in a United States Supreme Court case, AMP v. Myriad, in regard to the patentability of human genes.  less -
Knobbe Martens

Federal Circuit Review | August 2024

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Specify the Steps of Information Manipulation or Lose under § 101 - In Mobile Acuity Ltd. v. Blippar Ltd. Appeal No. 22-2216, the Federal Circuit held that patent claims that merely recite result-orientated, functional...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 6, July 2024

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Welcome to our seventh 2024 issue of Decoded - our technology law insights e-newsletter. We have a few events we want to pass along to those interested in technology, but also other areas of law and business....more

Goodwin

District Court Grants Summary Judgment and Invalidates Patent in REGENXBIO v. Sarepta Litigation

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On January 5, 2024, in litigation between REGENXBIO and Sarepta Therapeutics, Judge Richard Andrews of the U.S. District Court for the District of Delaware District Court granted summary judgment for Sarepta and ruled that...more

Goodwin

Top IP, FDA, and Compliance Issues for Medtech Companies Transitioning to Data-Enabled Product Solutions

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Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. ​​​​​​​ Companies that once only developed hardware-based solutions for...more

American Conference Institute (ACI)

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

American Conference Institute (ACI) on

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

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Master Symposium - September 21st - 22nd, Chicago, IL

American Conference Institute (ACI) on

ACI’s 8th Annual Paragraph IV Disputes Master Symposium returns in person to Chicago on September 21-22! Join leading pharmaceutical patent litigators for brand name and generic drug companies to receive up-to-the-minute...more

American Conference Institute (ACI)

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

American Conference Institute (ACI) on

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

Manatt, Phelps & Phillips, LLP

Invention Directed Solely to Printed Matter Held Not Patent Eligible

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C. R. Bard Inc. and Bard Peripheral Vascular, Inc. (collectively, Bard), and AngioDynamics, Inc., manufactured vascular access ports that were inserted under a patient’s skin to enable medical providers to insert fluid into...more

Harris Beach PLLC

Important 2020 Patent Law Decisions from the Court of Appeals for the Federal Circuit

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Whether you are pursuing patents on your new technology, thinking about bringing patent infringement litigation or defending patent infringement claims in court, knowing the important developments in patent law will help you...more

Robins Kaplan LLP

Horizon Medicines LLC v. Alkem Labs. Ltd.

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Duexis® (ibuprofen / famotidine) - Case Name: Horizon Medicines LLC v. Alkem Labs. Ltd., No. 18-1014-RGA, 2020 WL 7022591 (D. Del. Nov. 30, 2020) (Andrews, J.) ...more

Foley & Lardner LLP

USPTO Announces New Program To Promote Publication Of COVID-19 Innovation

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In an effort to both promote innovation against COVID-19 and promote dissemination of information about innovation against COVID-19, the USPTO is launching a new “deferred fee” pilot program for certain provisional patent...more

American Conference Institute (ACI)

[Virtual Event] 11th Summit on Biosimilars & Innovator Biologics - September 23rd - 24th, 7:45 am - 5:00 pm ET

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This year, the BPCIA turns 10! As we prepare to enter the next decade of this revolutionary law, we cordially invite you to join us for ACI’s 11th Annual Biosimilars & Innovator Biologics Summit, in a fully virtual,...more

Akin Gump Strauss Hauer & Feld LLP

MedTech Update 2020: Legal and Regulatory Issues to Watch For in the Medical Technology Industry in the New Year

Akin Gump Strauss Hauer & Feld LLP on

Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more

Morgan Lewis

Life Science International Review Q3 - Nov. 2019

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Welcome to the Q3 2019 issue of our Life Sciences International Review. This issue covers new developments within Europe, Asia, and the United States in intellectual property, regulatory, pricing, and international trade,...more

Robins Kaplan LLP

INO Therapeutics LLC v. Praxair Distribution Inc.

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BUT FOR A CLERICAL ERROR TO BE ADDRESSED ON REMAND, THE FEDERAL CIRCUIT AFFIRMS FINDINGS OF INELIGIBLE SUBJECT MATTER AND NON-INFRINGEMENT. Case Name: INO Therapeutics LLC v. Praxair Distribution Inc., 2019 U.S. App. LEXIS...more

Foley & Lardner LLP

The Senate Holds Hearings On The State Of Patent Eligibility In America

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Last week the Senate Judiciary Committee held two of three scheduled hearings on “The State of Patent Eligibility in America.” Many witnesses with prominent roles in the patent field testified in favor of legislative action...more

McDermott Will & Emery

Skepticism Does Not Need to Be Based on Impossibility

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Addressing secondary considerations of non-obviousness, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial and Appeal Board (PTAB) obviousness decision, finding that skepticism does not need to be...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit: Skepticism of FDA Supports Finding of Nonobviousness and Patent Eligibility Not Within Scope of Appeal of an IPR

Akin Gump Strauss Hauer & Feld LLP on

The Federal Circuit has affirmed a decision by the Patent Trial and Appeal Board finding nonobvious the claims of U.S. Patent No. 7,772,209 (the “’209 Patent”), which are directed to a method of treating cancer. The claims...more

Bradley Arant Boult Cummings LLP

Evidence of Industry Skepticism Supports Finding of Nonobviousness - Intellectual Property News

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In a precedential decision delivered recently, the Federal Circuit shot down arguments from Neptune Generics, LLC, Mylan Laboratories Ltd., and Fresenius Kabi USA, LLC that the Patent Trial and Appeals Board (PTAB) erred in...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

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In an ANDA applicant’s appeal from a bench trial judgment of validity and infringement, the Court affirmed the district court’s judgment on all counts. The case presented unusual procedural circumstances in a Hatch-Waxman...more

Patterson Belknap Webb & Tyler LLP

FDA Authorizes First Direct-to-Consumer Test for BRCA Gene Mutations

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On March 6, 2018, the U.S. Food and Drug Administration (“FDA”) authorized, with special controls, the first direct-to-consumer test to detect the presence of genetic mutations in the BRCA1 and BRCA2 genes (“BRCA genes”). ...more

Knobbe Martens

The Supreme Court’s Decisions Not to Hear Patent Cases Leaves Federal Circuit Decisions on Key Questions Intact

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The Supreme Court recently declined to hear several patent cases, thus leaving the decisions by the Federal Circuit intact. Issues that were not taken up by the Supreme Court include (1) whether performing patented methods...more

McDermott Will & Emery

“Providing . . . Information” to Medical Providers Is Not Given Patentable Weight

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Addressing the application of the “printed matter” doctrine, the Patent Trial and Appeal Board (PTAB or Board) determined that claim elements directed to “providing [certain] information” fell within the doctrine and...more

WilmerHale

Federal Circuit Patent Updates - July 2016

WilmerHale on

Amgen Inc. v. Apotex Inc. (No. 2016-1308, 7/5/16) (Wallach, Bryson, Taranto) - July 5, 2016 12:05 PM - Taranto, J. In a suit under the Biologics Price Competition and Innovation Act, affirming the grant of a...more

McDonnell Boehnen Hulbert & Berghoff LLP

The Tyranny of the Judiciary

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There has always been a tension between the need for a final arbiter of the law and the inherent power associated with such a role placed in the judicial branch. Jefferson himself was wary of this tendency, writing in a...more

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