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Patent-Eligible Subject Matter › Pharmaceutical Industry › Section 101

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 -
MoFo Life Sciences

Federal Circuit addresses subject matter eligibility for compositions of matter in US Synthetic v. ITC

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Earlier this month, the Federal Circuit decided a subject matter eligibility case closely watched in the pharmaceutical industry. The case involved composition-of-matter claims reciting measured results. Reversing the...more

WilmerHale

Recent Decision Raises Patent Eligibility Concerns Regarding Certain Gene Therapy-Related Inventions

WilmerHale on

This past Friday, a federal district court held that the mere fact of combining certain natural products – such as isolated, naturally occurring AAV sequences and a heterologous non-AAV sequence – and putting them into a...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

McDonnell Boehnen Hulbert & Berghoff LLP

Top Stories of 2022: #8 to #10

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After reflecting upon the events of the past twelve months, Patent Docs presents its 16th annual list of top patent stories.  For 2022, we identified ten stories that were covered on Patent Docs last year that we believe had...more

Proskauer - The Patent Playbook

Federal Circuit Invalidates Device Patent As Directed to an Abstract Idea

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Nearly seven years after the landmark Supreme Court decision in Alice Corp. v. CLS Bank Int’l, subject matter eligibility for patent claims under 35 U.S.C § 101 remains a moving target. In Alice, the Court found claims for a...more

Fish & Richardson

[Webinar] Life Sciences | 2020 Year in Review - January 27th, 1:30 pm - 2:30 pm ET

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2020 has been referred to as an unprecedented year for the world in so many ways—the pandemic, the California and Washington fires, the racial justice protests and calls to action—but that didn’t stop the Federal Circuit from...more

American Conference Institute (ACI)

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

American Conference Institute (ACI) on

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

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

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

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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

Robins Kaplan LLP

Section 101 Love in the Time of COVID-19, with Apologies to Gabriel García Márquez

Robins Kaplan LLP on

It is a good bet that everyone has a heightened appreciation for diagnostic technology right now. The countries that have fared reasonably well during the ongoing pandemic are those with meticulous testing regimens. After...more

Troutman Pepper Locke

Supreme Court Denies Review In Three Section 101 Cases

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On January 13, 2020, the U.S. Supreme Court denied certiorari in the following cases...more

Foley & Lardner LLP

Unpacking The Solicitor General’s Brief In Vanda

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Responding to the invitation from the Supreme Court, the Solicitor General for the United States has filed an amicus brief for the United States in Hikma Pharmaceuticals USC Inc. v. Vanda Pharmaceuticals Inc. Stakeholders...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

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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

Foley & Lardner LLP

Federal Circuit Finds Method Withholding Treatment Ineligible For Patenting

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In its non-precedential decision in INO Therapeutics LLC v. Praxair Distribution Inc., the Federal Circuit agreed with the district court that method of treatment claims reciting “excluding” specific patients from treatment...more

Sheppard Mullin Richter & Hampton LLP

Yes, UCANN!

Sheppard Mullin Richter & Hampton LLP on

Patentees and inventors of cannabis compounds may be happy to learn a district court in Colorado recently held that, based on the record before it, U.S. Patent No. 9,730,911, entitled “Cannabis extracts and methods of...more

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

Foley & Lardner LLP

Federal Circuit, USPTO Clarify Subject Matter Eligibility for Methods of Treatment

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On June 7, 2018, the USPTO issued new guidance in the form of a memorandum regarding the patentability of methods of treatment. This memorandum, issued in response to the Federal Circuit’s holding in Vanda Pharmaceuticals...more

Foley & Lardner LLP

USPTO Vanda Memo Emphasizes Patent Eligibility Of Method Of Treatment Claims

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On June 7, 2018, the USPTO issued a memorandum to the Examining Corps providing patent eligibility examination guidance based on the recent Federal Circuit decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals....more

Foley & Lardner LLP

Federal Circuit Finds ANDA Jurisdiction Before PIV Certification

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Our first article on Vanda Pharmaceuticals, Inc. v. Aventisub, LLC focused on the subject matter eligibility of the personalized method of treatment claims under 35 USC § 101. Next, we considered how the Fanapt® label was...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

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Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more

Akin Gump Strauss Hauer & Feld LLP

IP Newsflash - August 2015 #4

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SUPREME COURT CASES - The Supreme Court Upholds Prohibition on Charging Royalties After Patent Expiration - In Kimble v. Marvel Entertainment LLC, 576 U.S. ---- (2015), the Supreme Court declined to overrule its 1964...more

McDonnell Boehnen Hulbert & Berghoff LLP

Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)

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Disaster survivors, and even people who just hear about a disaster, are often first overwhelmed by it; they can only rationally process its significance after some time. During that time they overcome the initial visceral...more

McDonnell Boehnen Hulbert & Berghoff LLP

Examination of Myriad-Mayo Guidance Comments -- ACLU

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On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

Foley & Lardner LLP

The New USPTO Patent Eligibility Rejections Under Section 101

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Well, it’s happening. Office Actions with new patent eligibility rejections based on the USPTO’s March 4, 2014 Guidance are being mailed out to patent practitioners across the nation. While some new rejections under §101 were...more

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