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Patent Invalidity Enablement Inquiries

Rothwell, Figg, Ernst & Manbeck, P.C.

Threading the Needle: Navigating the Matrix Created by the U.S. Supreme Court and Unified Patent Court   

As a firm responsible for managing global portfolios for pharmaceutical companies, we closely follow and seek to stay abreast of developments regarding patentability in various jurisdictions. We recently reviewed the Unified...more

Goodwin

Issue 44: PTAB Trial Tracker

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The availability of post-grant proceedings at the Patent Trial and Appeal Board (PTAB) has changed the face of patent litigation. This periodic digest is designed to keep you up-to-date by highlighting interesting PTAB,...more

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

Fish & Richardson

Federal Circuit Evaluates Enablement for Antibody Claims for the First Time Since Amgen v. Sanofi in Baxalta Inc. et al. v....

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On May 18, 2023, the Supreme Court in Amgen Inc. v. Sanofi unanimously affirmed the Federal Circuit’s holding that U.S. Patent Nos. 8,829,165 and 8,859,741 did not enable certain functional genus claims describing a class of...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

Burns & Levinson LLP

Amgen v. Sanofi and Points Beyond

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A week ago Thursday, the Supreme Court issued its decision in the Amgen v. Sanofi case, affirming the judgment of the Court of Appeals for the Federal Circuit, that the claims of the two patents Amgen asserted against Sanofi...more

Goodwin

Supreme Court Affirms Amgen Patents’ Invalidity in Closely Watched Enablement Case

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The U.S. Supreme Court has decided a closely watched case regarding patent law’s enablement requirement, Amgen Inc. v. Sanofi. The Supreme Court affirmed the Federal Circuit’s decision that Amgen’s patent claims were invalid,...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

Haug Partners LLP

Federal Circuit Affirms Invalidity of Nanopore Sequencing Patents for Failing to Enable, and Affirms Denial of New Trial on the...

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On May 11, 2021, the Federal Circuit affirmed the District Court of Delaware’s judgment that patents belonging to Pacific Biosciences of California (“PacBio”) were invalid for lack of enablement under 35 U.S.C. § 112. A...more

Knobbe Martens

A Standalone Obviousness Reference Must Be Enabling to Invalidate

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RAYTHEON TECHNOLOGIES V GENERAL ELECTRIC - Before Lourie, Chen, and Hughes. Summary: Unrebutted evidence of non-enablement is sufficient to overcome an invalidity challenge based on a standalone §103 reference....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

Knobbe Martens on

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

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

Goodwin

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

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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

Foley & Lardner LLP

The Value Of Prophetic Examples

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In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit affirmed the district court decision that upheld the validity of the Allergan patents relating to Lumigan® 0.01% glaucoma eye drops against obviousness, written...more

Foley & Lardner LLP

Lumigan Patents Upheld by Unexpected Results

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In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit affirmed the district court decision that upheld the validity of the Allergan patents relating to Lumigan® 0.01% glaucoma eye drops. This decision shows that it is still...more

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