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Eli Lilly

Goodwin

Eli Lilly Files Suit Challenging the FDA’s Drug Classification of Retatrutide

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​​​​​​​On September 3, 2024, Eli Lilly filed a complaint against the FDA in the District Court for the Southern District of Indiana pursuing the latest challenge to the FDA’s application of its “biological product”...more

Goodwin

Antitrust and Competition Life Sciences Quarterly Update Q2 2024

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To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more

Goodwin

Insulin Updates: March 2023

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On March 1, Eli Lilly was the first to announce U.S. list price reductions of 70% for its most commonly prescribed insulins and an expansion of its Insulin Value Program that caps patient out-of-pocket costs at $35 or less...more

Smart & Biggar

Ontario Court of Appeal affirms dismissal of Apotex’s Statutes of Monopolies and Trademarks Act claims regarding olanzapine

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On March 8, 2021, the Ontario Superior Court of Justice dismissed Apotex’s claims against Eli Lilly (Lilly) under the Statute of Monopolies, Trademarks Act, and common law conspiracy relating to Canadian Patent No. 2,041,113...more

Goodwin

China NMPA Approves TYVYT (sintilimab) in Combination with Chemotherapy for Gastric Cancer

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On June 24, 2022, Innovent Biologics, Inc. and Eli Lilly and Company announced that the National Medical Products Administration (NMPA) of China approved the supplemental New Drug Application (sNDA) for TYVYT (sintilimab) - a...more

Knobbe Martens

Federal Circuit Review - August 2021

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It’s No Secret That a Related Company’s Physical Presence in a Jurisdiction May Not Be Enough For Proper Venue - In Andra Group, LP v. Victoria’s Secret Stores, LLC, Appeal No. 20-2009, The Federal Circuit held that an...more

Kilpatrick

Federal Circuit Decides Teva-Lilly Spat for Antibody Compositions and Methods

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On August 16, 2021, the Federal Circuit handed down two rulings related to patents issued to Teva, which involve therapeutic antibodies targeting a calcitonin gene-related peptide (“CGRP”). In both cases, the Federal Circuit...more

Knobbe Martens

The Obviousness of Preamble Limitations Can Be a Real Headache for Patent Challengers

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ELI LILLY AND COMPANY v. TEVA PHARMACEUTICALS  - Before Lourie, Bryson and O’Malley.  Appeal from the Patent Trial and Appeal Board. Summary: In claims for methods of using apparatuses or compositions, statements of...more

Knobbe Martens

Presumption of Nexus Between Claims and Commercial Products May Not Apply When Unclaimed Features Are Critical

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TEVA PHARMACEUTICALS v. ELI LILLY AND COMPANY - Before LOURIE, BRYSON, and O’MALLEY. Appeal from the Patent Trial and Appeal Board. Summary: The presumption of nexus analysis requires the fact finder to consider the...more

Smart & Biggar

FCA upholds reconsideration decision maintaining $100M+ award against Apotex for cefaclor patent infringement

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Update: On September 28, 2021, Apotex applied to the Supreme Court of Canada for leave to appeal (Docket No. 39851).  On July 23, 2021, the Federal Court of Appeal (FCA) dismissed Apotex’s appeal of the Federal Court’s (FC)...more

Bricker Graydon LLP

Federal court sides with Eli Lilly challenge to HHS expansion of 340B discounts

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On March 16, 2021, the United States District Court in Indiana granted plaintiff Eli Lilly’s request for a preliminary injunction to halt implementation of a Department of Health and Human Services (HHS) rule published in...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, March 2021 # 8

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In Washington: The House on Wednesday passed a sweeping $1.9 trillion COVID-19 relief package in a 220-211 vote. No Republican lawmakers backed the legislation. Just one Democrat, Rep. Jared Golden (ME), opposed it. The White...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, February 2021 # 8

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In Washington: The Senate resumed former President Trump’s impeachment trial Wednesday. House impeachment managers presented a step-by-step timeline of the January 6 assault on the Capitol aided by new evidence. Senators saw...more

Robins Kaplan LLP

Financial Daily Dose 2.10.2021 | Top Story: U.S. Drops Plans to Force TikTok Sale to Oracle and Walmart

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After months of drama that we dutifully catalogued right here, the U.S. plan to “force the sale of TikTok’s American operations” to Oracle and Walmart “has been shelved indefinitely.” The forced sale has “languished since...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, January 2021 # 15

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In Washington: House Democrats are altering the House calendar to speed up passing a COVID-19 relief through a reconciliation package by mid-March. House Majority Leader Steny Hoyer (D-MD) announced that the House will not...more

Robins Kaplan LLP

Eli Lilly & Co. v. Apotex, Inc.

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Alimta® (pemetrexed disodium) - Case Name: Eli Lilly & Co. v. Apotex, Inc., No. 2020-1328, 2020 WL 7490251 (Fed. Cir. Dec. 21, 2020) (Circuit Judges Prost, Bryson, and Stoll presiding; Opinion by Stoll, J.) (Appeal from...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

Hogan Lovells

Coronavirus: The Hill and the Headlines, November 2020 # 6

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In Washington: The Senate Appropriations Committee on Tuesday released drafts of all 12 annual spending bills for 2021, setting up negotiations for a deal ahead of the Dec. 11 deadline to keep the government-funded. Bogged...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, October 2020 # 18

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In Washington: The Trump administration will pay Eli Lilly $375 million to supply 300,000 doses of its experimental antibody drug to treat COVID-19, the Department of Health and Human Services said Wednesday. If the Food and...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, October 2020 # 17

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In Washington: White House communications director Alyssa Farah said Tuesday that the White House still hopes for a coronavirus relief package, probably post-election. Speaking on Fox & Friends, Farah said President Trump...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, October 2020 # 7

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In Washington: Hopes for a quick resolution to the stimulus talks continue to fade though House Speaker Nancy Pelosi (D-CA) and Treasury Secretary Steven Mnuchin continue talking this week to try and bridge the gap between...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, October 2020 # 5

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In Washington: After halting coronavirus stimulus negotiations on Tuesday afternoon, President Donald Trump hours later signaled he would support specific coronavirus relief measures on stimulus checks, help for the...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

McDonnell Boehnen Hulbert & Berghoff LLP

Why Method of Treatment Patents for Repurposed Drugs Are Worth the Investment

Scientists, clinicians, and other investigators are discovering new uses for drugs previously known for different medical indications. Such “drug repurposing” (also called drug repositioning, profiling, or re-tasking) has...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – September 2020 # 6

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In Washington - The House of Representatives returns from recess this week to join the Senate colleagues for the final work period before they adjourn in mid-October for the November elections. The likelihood of a deal on...more

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