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Enablement Inquiries Patent Infringement

Akin Gump Strauss Hauer & Feld LLP

In the Aftermath of Amgen v. Sanofi, Federal Circuit Finds Functional Antibody Claims Invalid for Lack of Enablement

Applying the Supreme Court’s Amgen v. Sanofi decision for the first time, the Federal Circuit recently affirmed a district court decision finding claims to antibodies characterized by their ability to bind a particular...more

Knobbe Martens

Federal Circuit Revisits Standard for Enablement of Antibody Claims

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In Baxalta Incorporated v. Genentech, Inc., 2022-1461, the Federal Circuit affirmed the district court’s decision granting Genentech’s motion for summary judgment that claims 1-4, 9, and 20 of U.S. Patent No. 7,033,590 (“the...more

McDermott Will & Emery

Holy Pulmonary Hypertension, Batman: Method of Treatment Not Constrained by Safety and Efficacy

The US Court of Appeals for the Federal Circuit affirmed a district court’s holding that the asserted method of treatment patent was valid and infringed because safety and efficacy are not patent concerns. The Federal Circuit...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

Vinson & Elkins LLP

The Supreme Court Invalidates Functional Genus Claims

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In a unanimous opinion in Amgen Inc. v. Sanofi, the Supreme Court held that two functional genus patent claims were not enabled under 35 U.S.C. § 112(a).1 In doing so, it affirmed both the Federal Circuit’s previous decision...more

Axinn, Veltrop & Harkrider LLP

The Supreme Court Hears Arguments About the Enablement Standard in Amgen v. Sanofi

The Supreme Court heard arguments this week in Amgen v. Sanofi, the closely-watched case involving the enablement standard for patent claims, particularly as applied to functionally-defined genus claims. The question raised...more

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

Amgen Inc. v. Sanofi Live Coverage

On Monday, March 27, 2023, at 10:00 a.m. EDT, the Supreme Court of the United States will hear oral arguments in Amgen Inc. v. Sanofi, No. 21-757. William H. Milliken, a director in Sterne Kessler’s Trial & Appellate Practice...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Grants Certiorari in Amgen v. Sanofi

High Court Will Tackle Proper Enablement Standard - Constituting something of a surprise, the Supreme Court on Friday, November 3rd granted Amgen's petition for certiorari on the second of the Questions Presented in its...more

American Conference Institute (ACI)

[Event] 20th Advanced Summit on Life Sciences Patents - June 2nd - 3rd, New York, NY

ACI’s Advanced Summit on Life Sciences Patents is back in person on June 2–3 in New York City. Our reimagined 2022 conference will provide practical insights on how to implement bullet-proof patent prosecution tactics,...more

Jones Day

Didn’t Cut the Mustard: PTAB Finds Claims Lacked Written Description and Enablement

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A recent post-grant review decision once again reminds patentees of the increasing scrutiny that claims are facing under the written description and enablement requirements under 35 U.S.C. § 112 (a).  In this case,...more

Manatt, Phelps & Phillips, LLP

Broad Functional Claims Have a Higher Bar for Enablement; Genus of Antibodies Fails Requirement

In Amgen Inc. v. Sanofi, the Federal Circuit held that the use of broad functional claim language raises the bar for enablement. Specifically, the court held that defining an antibody based on binding to a certain protein...more

Knobbe Martens

“Some” Enablement Isn’t Enough for PacBio

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PACIFIC BIOSCIENCES OF CALIFORNIA v. OXFORD NANOPORE TECHNOLOGIES - Before Lourie, Taranto, and Stoll. Appeal from the United States District Court for the District of Delaware. Summary: Enablement is required for...more

Haug Partners LLP

Are Biopharma Genus Patent Claims Dead?

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A recent Supreme Court petition for certiorari alleges that genus claims are no longer viable under the Federal Circuit’s recent application of enablement and written description law.The petition has huge ramifications not...more

Dunlap Bennett & Ludwig PLLC

The Transgenic Mice of Regeneron

At a recent campaign stop, President Trump informed supporters that he “felt like Superman” after his experimental COVID-19 treatment with a Regeneron Pharmaceuticals Inc. antiviral drug. The antiviral drug may have resulted...more

Smart & Biggar

Federal Court finds Eli Lilly’s tadalafil dosage form and process patents invalid

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UPDATE: On September 30, 2020, Eli Lilly appealed both decisions by Justice St-Louis: Eli Lilly v Apotex (A-234-20 and A-239-20); Eli Lilly v Pharmascience and Riva (A-236-20); Eli Lilly v Mylan (A-237-20); and Eli Lilly v...more

McDermott Will & Emery

Broad Genus of HCV Compounds Wasn’t Enabled or Described

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In a case relating to compounds for the treatment of the Hepatitis C virus (HCV), the US Court of Appeals for the Federal Circuit upheld a district court’s grant of judgment as a matter of law (JMOL) for lack of enablement...more

Knobbe Martens

Federal Circuit Review - October 2019

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The PTAB Cannot Approve or Deny Certificates of Correction - In Honeywell International, Inc. v. Arkema Inc., Arkema France, Appeal Nos. 2018-1151, -1153, the Patent Trial and Appeal Board (“Board”) does not have the...more

Knobbe Martens

Large Quantity of Routine Experimentation Can Be “Undue Experimentation”

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IDENIX PHARMACEUTICALS LLC v. GILEAD SCIENCES INC. Before Prost, Newman, and Wallach. Appeal from the United States District Court for the District of Delaware. Summary: Synthesizing and screening tens of thousands of...more

WilmerHale

Federal Circuit Patent Updates - August 2018

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Ericsson Inc. v. Intellectual Ventures I LLC (No. 2017-1521, 8/27/18) (Reyna, Taranto, Chen) Reyna, J. - Vacating and remanding the PTAB’s IPR decision because the PTAB erred in not considering portions of the petitioner’s...more

McDermott Will & Emery

Specification Must Enable Full Scope of Claims as Construed

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In an opinion addressing enablement under 35 USC 112, the US Court of Appeals for the Federal Circuit concluded that an asserted claim was invalid because the specification failed to enable its full scope, even though...more

Knobbe Martens

Trustees Of Boston University v. Everlight Electronics Co.

Knobbe Martens on

Federal Circuit Summary - Before Prost, Moore, and Reyna. Appeal from the United States District Court for the District of Massachusetts Summary: A patent claim having multiple permutations is only enabled if each and...more

Patterson Belknap Webb & Tyler LLP

Hepatitis C Patent Falls for Non-Enablement, Wiping Out $2.5 Billion Infringement Verdict

In a hard-fought patent battle involving “groundbreaking” work by both parties, Chief Judge Stark of the U.S. District Court for the District of Delaware ruled that plaintiff Idenix’s patent for treating Hepatitis C virus...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

One-E-Way, Inc. v. ITC, Fed. Cir. Case 2016-2105 (June 12, 2017) - A divided panel reverses a determination of indefiniteness by the ITC, ruling that under Nautilus, the claim language, in combination with the...more

Goodwin

UPDATE Amgen v. Apotex: Amgen argues they have met their burden to prove infringement

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As we previously reported, on July 20, the Southern District of Florida granted Amgen’s motion for judgment on partial findings that the ’138 patent was not proven invalid on grounds of anticipation, lack of written...more

Goodwin

Amgen v. Apotex: District Court Decides that the ’138 Patent is Not Invalid on Some Grounds; Enablement is Still an Open Issue

Goodwin on

As we previously reported, on July 5, the Federal Circuit affirmed the district court’s grant of a preliminary injunction enjoining Apotex from launching its biosimilar version of Amgen’s Neulasta (pegfilgrastim) until it...more

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