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Supreme Court of the United States Medical Devices

The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary... more +
The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary with only a limited number of cases granted review each term.  The Court is comprised of one chief justice and eight associate justices, who are nominated by the President and confirmed by the Senate to hold lifetime positions. less -
King & Spalding

Transitional Coverage for Emerging Technologies: CMS’s Latest, But Not Necessarily Greatest, Coverage with Evidence Approach

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On August 7, 2024, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) issued a final procedural notice (“Notice”) outlining a new Medicare coverage pathway, aimed at achieving timelier and predictable access...more

Proskauer - Minding Your Business

The Broad Impact of Edwards v. Meril on the Safe Harbor Provision

The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. §...more

Foley & Lardner LLP

Acetaminophen MDL: Judge Excludes All of Plaintiffs’ Causation Experts Pursuant to Newly-Amended FRE Rule 702

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On December 1, 2023, amendments to Federal Rule of Evidence (FRE) 702 geared toward emphasizing and explaining the responsibility of the judge as a “gatekeeper” for expert testimony took effect. On December 18, 2023, one of...more

Dechert LLP

Dechert Re:Torts - Key Developments in Product Liability and Mass Torts - Issue 10

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Senators Focus Attention on Litigation Funding’s Opacity - Building on the momentum we previously noted related to litigation funding, on September 14, Senator John Kennedy introduced the Protecting Our Courts from Foreign...more

McGuireWoods LLP

Medical Device Legal News with Sam Bernstein: Episode 9

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The US Supreme Court rules that, under the Federal False Claims Act (FCA), the knowledge and subjective beliefs of a defendant at the time a false claim was submitted are determinative, and post hoc objectively reasonable...more

Butler Snow LLP

Can What the Supreme Court Said About Device Clearance in Lohr, a “Derelict on the Waters of the Law,” Finally Be Sunk?[1]

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Even though they are still quoted, statements in Medtronic v. Lohr, which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device’s safety, no longer accurately describe what...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

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US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Morrison & Foerster LLP - Federal Circuitry

Last Week In The Federal Circuit (August 8 – August 12): Taking A Round Trip On The Assignor Estoppel Express

For most of us, we’re stuck in the August heat, on delayed European vacations, or hopefully just hanging out at the beach. But for the Court it still was work as usual, including a return trip to the Federal Circuit for the...more

Amundsen Davis LLC

For Sale or Not for Sale? Consider a Patent Application First

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For sale, or not for sale- That is the question in Larry G. Junker v. Medical Components Inc. et al., case that started in the U.S. District Court for the Eastern District of Pennsylvania and which has now been appealed to...more

Knobbe Martens

Medical Device Patentee Petitions Supreme Court Regarding On-Sale Bar and Price Quotes

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A medical device patentee has asked the U.S. Supreme Court to save his design patent, related to an introducer sheath handle, from invalidity based on application of the “on-sale” bar, which prohibits patenting an invention...more

Knobbe Martens

Supreme Court Upholds, but Limits, Patent Infringement Defense of “Assignor Estoppel”

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The U.S. Supreme Court recently decided a case resolving a patent dispute between two medical device companies, Hologic, Inc. and Minerva Surgical.  The opinion was closely watched because it raised the question of whether an...more

Blank Rome LLP

Supreme Court Sets Limits for Assignor Estoppel

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The Supreme Court’s recent decision in Minerva Surgical Inc. v. Hologic, Inc. has drastically limited the doctrine of assignor estoppel, requiring patent practitioners to reconsider assignment and other contractual provisions...more

McCarter & English, LLP

“You Can’t Challenge This (Unless)”—SCOTUS Upholds But Limits 140-Year-Old Doctrine Of Assignor Estoppel

The doctrine of assignor estoppel bars an inventor who assigns a patent to a third party from later arguing that the assigned patent is invalid. The Supreme Court has now upheld this doctrine but has limited its scope,...more

Buckingham, Doolittle & Burroughs, LLC

Assignor Estoppel is Alive and Well after Minerva v. Hologic

The Supreme Court clarified the doctrine of assignor estoppel in its June 29th Minerva v. Hologic opinion. In doing so, the Court vacated the Federal Circuit’s opinion estopping Minerva from arguing that Hologic’s patent is...more

Williams Mullen

Supreme Court Upholds but Narrows Assignor Estoppel: What This Means For Your Company and its Employees

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On June 29, 2021, the Supreme Court published its divisive opinion in Minerva Surgical, Inc. v. Hologic, Inc., Et. Al. The 5-4 decision penned by Justice Kagan upheld the centuries-old doctrine of Assignor Estoppel, while...more

Fitch, Even, Tabin & Flannery LLP

Supreme Court Sets Boundaries for Assignor Estoppel in Minerva Surgical v. Hologic

The U.S. Supreme Court’s June 29 decision in Minerva Surgical, Inc. v. Hologic, Inc. has important implications for inventors who assign patent rights, employers to whom employees assign patent rights, other assignees, and...more

Proskauer Rose LLP

Supreme Court Rules that Inventors Can Contest the Validity of Patents After Assigning Them

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In a decision reaching all corners of the technology sector, the U.S. Supreme Court on June 29, 2021 held that, when fairness requires, a patent inventor can contest a patent's validity after assigning it to a third party....more

Shutts & Bowen LLP

Minerva Surgical, Inc. v. Hologic Inc.: The Supreme Court Limits the Scope of Assignor Estoppel

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Rooted in the principle of fairness, the doctrine of assignor estoppel generally prevents an inventor, who had previously assigned their patent rights to another for value, from later contesting the validity of the assigned...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Retains Doctrine of Assignor Estoppel, But With Limits

The Supreme Court, speaking through a five-justice majority, has reaffirmed the equitable principle of assignor estoppel while at the same time limiting its application in Minerva Surgical, Inc. v. Hologic, Inc. Assignor...more

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

PTAB Strategies and Insights Newsletter - June 2021

[co-authors: Patrick Murray, Risa Rahman, and Jae Bandeh] The PTAB Strategies and Insights newsletter provides timely updates and insights into how best to handle proceedings at the USPTO. It is designed to increase return...more

Vinson & Elkins LLP

No Foul In Fair Play: Supreme Court Clarifies The Boundaries Of Assignor Estoppel

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On June 29, 2021, the Supreme Court clarified the “boundaries” of the patent-law doctrine of assignor estoppel in Minerva Surgical, Inc. v. Hologic, Inc., 594 U.S. (2021). The Court, in Westinghouse Elec. & Mfg. Co. v....more

Burr & Forman

Supreme Court Upholds, But Limits, Assignor Estoppel Doctrine

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On June 29, 2021, the Supreme Court limited the doctrine of assignor estoppel that has long prevented inventors from challenging the validity of patents they have assigned to a third party. ...more

Troutman Pepper

US Supreme Court Narrows Assignor Estoppel Doctrine in Continuation Patent Case

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On June 29, the Supreme Court issued a 5-4 decision in Minerva Surgical, Inc. v. Hologic, Inc., No. 20-440 (June 29, 2021) (slip opinion). Minerva involves a challenge to the “assignor estoppel” doctrine, which is an...more

Snell & Wilmer

Supreme Court Determines New Limitations to Assignor Estoppel Doctrine

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The Supreme Court upheld assignor estoppel in Minerva Surgical, Inc. v. Hologic, Inc., et al. but held that the Federal Circuit “failed to recognize the doctrine’s proper limits.” In doing so, the Court imposed new...more

Knobbe Martens

Assignors Can Challenge Validity so Long as They Do Not Contradict Assignment Representations

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MINERVA SURGICAL, INC. v. HOLOGIC, INC., et al. - Supreme Court of the United States.  Opinion of the Court written by Justice Kagan.  Justice Alito filed a dissenting opinion.  Justice Barrett filed a dissenting opinion,...more

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