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
Reasonably Continuous Diligence Is Not Negated If an Inventor Works On Improvements or Evaluates Alternatives to the Claimed Invention - In ATI Technologies ULC v. IANCU, Appeal Nos. 2016-2222, -2406, -2608, the Federal...more
The Federal Circuit held that a rat study in a provisional application and a conversion method in an uncited reference did not support the claimed human dosage form in Los Angeles Biomed. Research Inst. v. Eli Lilly & Co.,...more
Upon initiation of a patent infringement action between branded and generic pharmaceutical companies, the Hatch-Waxman Act (21 U.S.C. § 355(j)) provides for an automatic 30-month stay of Food and Drug Administration approval...more
In an inter partes review (IPR) proceeding, the Patent Trial and Appeal Board (Board) found all of Los Angeles Biomedical Research Institute’s (LA-Bio Med) patent claims unpatentable on the basis of obviousness in view of a...more
On December 11, 2015, the United States District Court for the Southern District of Indiana granted a motion to stay a Hatch-Waxman litigation pending the outcome of inter partes reviews (IPRs) on two of the patents-in-suit...more
Although Inter Partes Review (IPR) is limited to grounds of unpatentability based upon prior art references, it is nevertheless possible to raise issues of written description or enablement by applying intervening prior art...more