News & Analysis as of

Patent-Eligible Subject Matter Patents 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 -
DLA Piper

Astellas Case Highlights Patent Eligibility Under Section 101 and the Party Presentation Principle

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In Astellas Pharma Inc. v. Sandoz Inc., the US Court of Appeals for the Federal Circuit vacated a sua sponte district court ruling that found Astellas’s asserted patent ineligible under Title 35 of the US Code, Section 101....more

MoFo Life Sciences

Patent Vs. Trade Secret Considerations For Cell And Gene Therapies

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Understanding what to patent versus what to keep as a trade secret is an increasingly important and challenging decision facing companies developing biologics products, such as cell and gene therapies, where technologies are...more

Knobbe Martens

Federal Circuit Review | August 2024

Knobbe Martens on

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

Goodwin

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

Goodwin on

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

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

American Conference Institute (ACI)

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

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

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

Harris Beach Murtha PLLC

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

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.

Robins Kaplan LLP on

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

American Conference Institute (ACI)

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

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

Morgan Lewis

Life Science International Review Q3 - Nov. 2019

Morgan Lewis on

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.

Robins Kaplan LLP on

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

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

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

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

Knobbe Martens

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

Knobbe Martens on

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

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

McDonnell Boehnen Hulbert & Berghoff LLP

The Tyranny of the Judiciary

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

Bradley Arant Boult Cummings LLP

The Patent Office Clarifies the Ban on Patenting Naturally-Derived Drugs and Other Products

Since the very beginning of America’s revolutionary patent system, inventors in the life sciences have been granted patents for discovering and purifying natural products. It was taken as a given that a purified natural...more

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