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
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
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
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
Recently, the Federal Circuit has taken up issues relating to infringement under the doctrine of equivalents (DOE) and a related doctrine, prosecution history estoppel (PHE), that limits the scope of equivalents that can be...more
On November 20, 2019, the Federal Court (FC) issued its reconsideration decision on the quantum of damages owed by Apotex for its infringement of eight Eli Lilly process patents related to the antibiotic cefaclor: Eli Lilly...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
(Updated October 1, 2019) - On July 3, 2019, Eli Lilly was granted leave to amend its pleadings to introduce a new cause of action for direct infringement of claims relating to a new use without including an allegation of...more
Recent Federal Circuit decisions demonstrate that the doctrine of equivalents is alive and well, and not always barred by claim amendments. In both Ajinomoto Co. v. ITC and Eli Lilly and Co. v. Hospira, Inc., the Federal...more
In 2018 we reported on a number of developments in life sciences IP and regulatory law. Our most-read articles were: #1 a June update on biosimilars (authored by Urszula Wojtyra); #2 a “live” summary chart of Vanessa’s Law...more
On November 23, 2018, the Federal Court of Appeal (FCA) allowed in part Apotex’s appeal of a decision awarding Eli Lilly over $100 million for Apotex’s infringement of eight process patents related to the antibiotic cefaclor:...more
In This Issue: Ontario Court of Appeal allows Sanofi and Schering to plead that Federal Court ramipril patent invalidity decision was flawed due to “promise doctrine” - In an action by Apotex for compensation from...more
Teva succeeds in section 8 bortezomib action; infringement counterclaim dismissed - On July 18, 2018, Justice Locke of the Federal Court granted Teva’s claim for compensation under section 8 of the Patented Medicines...more
On July 13, 2018, the Federal Court dismissed Eli Lilly’s application for a prohibition order, finding that Apotex’s allegation of obviousness of Patent No. 2,432,644 (644 Patent) was justified: Eli Lilly Canada Inc v Apotex...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
Last week, Genentech Inc. filed a complaint against Eli Lilly and Company (Lilly) in the United States District Court for the Southern District of California alleging infringement of U.S. Patent No. 10,011,654 (’654 patent)...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
No Section 8 Liability for Valid and Infringed Patent in NEXIUM Proceeding - What happens when a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) (PMNOC)...more
On March 20, 2018, the Federal Court of Appeal (FCA) issued public reasons for judgment dismissing Eli Lilly Canada Inc. (Lilly)’s appeal of a Federal Court decision awarding more than $70 million to Teva Canada Limited...more