31 Days to a More Effective Compliance Program - Charitable Donation Enforcement Actions
Transaction Monitoring Under the FCPA
Seventh Circuit Jumps Ahead of SCOTUS, Rules Pharmaceutical Sales Reps Exempt from Overtime—Jackson Lewis’ Noel Tripp
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
In Washington - Senate Majority Leader Mitch McConnell (R-KY) is planning to hold floor votes on unemployment benefits forcing Democrats to go on the record as coronavirus relief bill talks stall. Floor votes are a...more