News & Analysis as of

Inventions Pharmaceutical Patents Patent Litigation

McDermott Will & Schulte

Motivation, expectation of success negate obviousness presumption in overlapping range case

The US Court of Appeals for the Federal Circuit affirmed (on its second review) a district court’s ruling upholding the validity of patent claims related to a long-acting injectable dosing regimen, finding that the...more

Mintz - Intellectual Property Viewpoints

Is Your Enantiomer Possessed? Patenting of Enantiomers – Does Written Description Require More Than Actual Possession?

It is well established that an enantiomerically pure compound exhibiting advantageous properties not present in its isomer or its corresponding racemic mixture, can be patented even if its corresponding racemic mixtures are...more

White & Case LLP

Federal Circuit Clarifies Standard for Patent Conception in Ongoing CRISPR Dispute

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On May 12, 2025, the U.S. Court of Appeals for the Federal Circuit issued a long-awaited decision in Regents of the University of California v. Broad Institute (Nos. 22-1594, 22-1653) addressing priority for disputed...more

Wilson Sonsini Goodrich & Rosati

Federal Circuit Revives CRISPR-Cas9 Patent Priority Dispute

The CRISPR-Cas9 patent landscape remains complex and unsettled. The Federal Circuit’s latest decision in University of California v. Broad Institute1 revived the high-stakes dispute between UC2 and Broad3 over foundational...more

A&O Shearman

Dutch District Court rules on the plausibility standard on the merits (apixaban)

A&O Shearman on

In this note, we will discuss the latest decisions on the merits from the Dutch patent court on the matter of plausibility and inventive step. These were handed down in two cases (BMS v Sandoz and BMS v Teva) on 30 October...more

McDonnell Boehnen Hulbert & Berghoff LLP

Vascular Solutions LLC v. Medtronic, Inc. (Fed. Cir. 2024)

The metes and bounds of how courts should consider indefiniteness under 35 U.S.C. § 112(b) were addressed most recently by the Supreme Court in Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014).  Regardless,...more

Baker Donelson

Patent Cases to Watch for in the Second Half of 2024

Baker Donelson on

As we move into the second half of the year, we are alerting you to 11 patent cases that you should look out for during the second half of 2024. This judicial mix touches on a range of industries and interests, such as...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - August 2024 #3

Allergan USA, Inc. v. MSN Laboratories Private Ltd., Appeal No. 2024-1061 (Fed. Cir. August 13, 2024) In this week’s Case of the Week, the Federal Circuit clarifies rules relating to when an applicant’s patent can be...more

Bradley Arant Boult Cummings LLP

Spring Has Sprung Obviousness Trends from the Federal Circuit

There have been only a few precedential decisions from the Federal Circuit related to obviousness since spring sprung. While these decisions have produced mixed results for the lower courts, clinical study protocols have held...more

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

Federal Circuit IP Appeals: Summaries of Key 2023 Decisions (8th Edition): Amgen Inc. v. Sanofi, 598 U.S. 594 (2023)

The Supreme Court’s lone patent case from last term does not break new ground on enablement law. The Court’s core holdings—that a patent specification must enable the full scope of the claimed invention and therefore that...more

Knobbe Martens

USPTO Says Wands Still Controls Enablement Analysis Post-Amgen

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On January 9, 2024, the USPTO published guidelines for its patent examiners when evaluating compliance with the enablement requirement in light of the U.S. Supreme Court’s recent decision in Amgen Inc. et al. v. Sanofi et...more

McDonnell Boehnen Hulbert & Berghoff LLP

Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2023)

Proper construction of claim limitations reciting the chemical property of pH (which denotes the concentration of hydrogen ions in a solution as an indication of acidity) has arisen several times in district court and Federal...more

Bradley Arant Boult Cummings LLP

More Antibody Claims Falling Under Post-Amgen Scrutiny

With only two precedential IP decisions coming down from the Federal Circuit in the second half of September, pickings were a little slim for blogging. That said, the opinion in Baxalta v. Genentech (2022-1461) — drafted by...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - September 2023 #3

Baxalta Inc. v. Genentech, Inc., Appeal No. 22-1461 (Fed. Cir. Sept. 20, 2023) Our Case of the Week focuses on the enablement requirement. It’s the first case to come before the Federal Circuit following the Supreme...more

Axinn, Veltrop & Harkrider LLP

Axinn IP Update: Federal Circuit Applies Lead Compound Analysis and Confirms Obviousness of Deuterated Derivatives of Ruxolitinib

On August 22, 2023, the Federal Circuit affirmed an IPR Final Written Decision holding claims to deuterated derivatives of ruxolitinib unpatentable as obvious and rejected the patentee’s argument that a skilled artisan would...more

Hudnell Law Group

Supreme Court Uses Enablement To Curb Broad Patents

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On May 18, 2023, the Supreme Court held claims of two patents owned by Amgen, Inc. to be invalid for failing to enable persons skilled in the art to practice the invention as required by 35 U.S.C. §112.  Amgen, Inc., et al....more

Sheppard Mullin Richter & Hampton LLP

In re Couvaras, No. 2022-1489 (Fed. Cir. June 14, 2023)

This case addresses obviousness under 35 U.S.C. § 103 in relation to a method of increasing prostacyclin release to reduce hypertension in a patient. In particular, this case discusses issues relating to motivation to...more

Buckingham, Doolittle & Burroughs, LLC

Amgen is Not the End of Chemical Innovation

Some chemical innovators have found the recent Supreme Court decision in Amgen v. Sanofi to suggest that chemical inventions will be subject to new and draconian disclosure standards going forward. A few have even suggested...more

Buckingham, Doolittle & Burroughs, LLC

Amgen Ratifies CAFC’s Requirement to Enable a Claim’s Full Scope

The Court’s reasoning in Amgen v. Sanofi upholds the Federal Circuit’s long-standing requirement to enable the full scope of a claimed invention. Since the Patent Act of 1790, patent law has required describing inventions...more

Womble Bond Dickinson

Unpredictability In The Art: Amgen v. Sanofi In View Of “Simultaneous Conception And Reduction To Practice”

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After reading the Supreme Court’s decision in Amgen v. Sanofi, I thought of the doctrine of simultaneous conception and reduction to practice, given both the decision’s and the doctrine’s focus on unpredictability in the art....more

Levenfeld Pearlstein, LLC

Enablement Unchanged: Amgen v. Sanofi and the Future of Software Patents

In a unanimous ruling, the Supreme Court of the United States (SCOTUS) addressed the enablement requirement under Section 112 of the Patent Act, placing this into sharper focus with the Amgen v. Sanofi case. This landmark...more

Dorsey & Whitney LLP

Supreme Court Upholds Patent Law Precedent

Dorsey & Whitney LLP on

The case of Amgen Inc. v. Sanofi, U.S., No. 21-757 dealt with patent law’s “enablement” requirement. Essentially, the Court affirmed 150 years of precedent requiring the invention to be described “‘in such full, clear,...more

Procopio, Cory, Hargreaves & Savitch LLP

5 Takeaways from the U.S. Supreme Court Decision in Amgen v. Sanofi

The U.S. Supreme Court’s unanimous decision in Amgen Inc. v. Sanofi (referred to as the Amgen decision) likely makes it more difficult for life sciences companies to obtain broad patents claiming an entire genus of antibodies...more

Schwabe, Williamson & Wyatt PC

SUPREME COURT RULING: Amgen Inc. et al. v. Sanofi et al, May 18, 2023

Amgen Inc. et al. v. Sanofi et al, No. 21-757 (S. Ct. May 18, 2023) The Supreme Court issued a long-awaited decision today concerning the enablement requirement found in Section 112 of the Patent Act. Specifically, the...more

Bradley Arant Boult Cummings LLP

Supreme Court Delivers the Final Blow to Amgen

The questions from the high court during oral argument at the end of March 2023 were fairly telling of the 9-0 ruling that came down yesterday in Amgen, Inc. v. Sanofi (No. 21-757). In fact, it did not come as much of a...more

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