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
Telehealth companies selling compounded drugs are making modest inroads into the market for popular weight loss drugs that Big Pharma spent decades and billions of dollars to develop and bring to market. The compounded...more
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
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 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
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 this episode, Richard Church, Andrew Ruskin, and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent actions by drug manufacturers to limit contract pharmacy access to 340B...more
This week, the FDA approved LYUMJEV (insulin lispro-aabc), a new insulin lispro product by Lilly. LYUMJEV is a formulation of insulin lispro, developed to speed the absorption of insulin into the blood stream and reduce A1C...more
WHILE THE DISTRICT COURT’S FINDING OF LITERAL INFRINGEMENT WAS REVERSED, THE FEDERAL CIRCUIT AFFIRMED THE DISTRICT COURT’S FINDING OF INFRINGEMENT UNDER THE DOCTRINE OF EQUIVALENT BECAUSE THE NARROWING AMENDMENT WAS...more
On March 4, 2019, Eli Lilly announced that they will begin selling a lower-priced version of Humalog® (isulin lispro injection 100 units/mL) in the United States with a list price 50% lower than the current Humalog® list...more
Case Name: Eli Lilly & Co. v. Hospira, Inc., Civ. No. 12-3460-TWP-MPB, 2018 U.S. Dist. LEXIS 100550 (S.D. Ind. June 15, 2018) (Pratt, J.)....more
Case Name: Eli Lilly & Co. v. Dr. Reddy’s Labs., Ltd., Civ. No. 16-0308-TWP-MPB, 2018 U.S. Dist. LEXIS 104653 (S.D. Ind. June 22, 2018) (Pratt, J.). Drug Product and Patent(s)-in-Suit: Alimta® (pemetrexed disodium); U.S....more
An Update on Vanessa’s Law - This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act...more
In its decision of July 12, 2017 in Actavis v. Eli Lilly, the Supreme Court of the United Kingdom for the first time formally adopted the concept of a doctrine of equivalents when considering what constituted an infringement...more
Case Name: Eli Lilly & Co. v. Dr. Reddy’s Labs., Ltd., Civ. No. 1:16-cv-00308-TWP-MPB, 2017 U.S. Dist. LEXIS 205578 (S.D. Ind. Dec. 14, 2017) (Pratt, J.)....more
Case Name: Eli Lilly and Co. v. Perrigo Co., No. 2016-2555, -2614, 2017 U.S. App. LEXIS 23624 (Fed. Cir. Nov. 22, 2017) (Circuit judges Chen, Plager, and Hughes presiding; Opinion by Chen, J.) (Appeal from S.D. Ind., Barker,...more
Following last Friday’s (7 July 2017) unusual move of advance publication of the outcome of the case, the UK Supreme Court now published the reasons for its decision in the long-running Actavis v Eli Lilly case. The reasons...more
Case Name: Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., No. 2015-2067, 2017 U.S. App. LEXIS 555 (Fed. Cir. Jan. 12, 2017) (Circuit Judges Prost, Newman, and Dyk presiding; Opinion by Prost, C.J.) (Appeal from S.D....more
Federal Court of Appeal opines on the framework for analyzing obviousness-type double-patenting - On November 4, 2016, the Federal Court of Appeal dismissed Apotex’s appeal in Apotex Inc v Eli Lilly Canada Inc, 2016 FCA...more
Case Name: Eli Lilly & Co. v. Perrigo Co., Case No. 1:13-cv-00851-SEB-DKL (S.D. Ind. Aug. 22, 2016) - Drug Product and Patent(s)-in-Suit: Axiron® (testosterone metered transdermal solution); U.S. Patents Nos. 8,071,075...more
Case Name: Eli Lilly & Co. v. Nang Kuang Pharm.Co., Ltd., 1:14-cv-1647-TWP-DKL, 2015 U.S. Dist. LEXIS 11510 (S.D. Ind. Aug. 24, 2015) - Drug Product and Patent-in-Suit: Alimta® (pemetrexed disodium); U.S. Patents Nos....more
Case Name: Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., Civ. No. 10-cv-1376-TWP, 2015 U.S. Dist. LEXIS 112221 (S.D. Ind. Aug. 25, 2015) (Pratt, J.) - Drug Product and Patents-in-Suit: Alimta® (pemetrexed...more