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
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 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
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
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
Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazodone drug submission - On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that...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
On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of Compliance) Regulations (“PMNOC Regulations”) regarding pregabalin (Pfizer’s LYRICA)...more
Teva awarded section 8 damages regarding pregabalin and olanzapine - On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of...more
Do physicians ‘‘condition participation’’ of drug therapy based on patients’ compliance with drug manufacturer instructions regarding how to take drugs? Do physicians withhold medically necessary drug therapy from patients...more
Can a patient’s action in taking a generic drug be attributable to a physician such that it can support a finding of the physician’s direct patent infringement? According to a recent precedential opinion of the Court of...more
In Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., the Federal Circuit affirmed the district court decision finding infringement under Akamai of a two-step method of treatment when the prescribing information for the...more
The following are highlights of developments in Canadian life sciences intellectual property and regulatory law in 2016, updating our 2016 mid-year highlights. 1. Substantive patent law developments - Utility and...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Senju Pharmaceutical Co. et al. v. Watson Laboratories, Inc. et al. 1:15-cv-05591; filed July 16, 2015 in the District...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Eli Lilly and Company et al. v. Amneal Pharmaceuticals LLC 1:14-cv-01474 filed December 11, 2014 in the District Court...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Tris Pharma Inc. v. Actavis Laboratories FL Inc. et al. 1:14-cv-01309; filed October 15, 2014 in the District Court of...more