Azurity Pharmaceuticals, Inc. — a pioneer drug company that markets its FDA-approved oral vancomycin hydrochloride solution, FIRVANQ® — has sued Edge Pharma, LLC, an outsourcing facility operating pursuant to section 503B of...more
2/26/2020
/ Drug Compounding ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Lanham Act ,
Manufacturers ,
Orange Book ,
Outsourcing ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Pharmacies ,
Prescription Drugs ,
Statutory Violations
We have all been there: An advertisement on television or a pop-up on Facebook beckons us to try the latest “visit-free,” “delivered to your door” treatment for a medical condition.
Originally published in Dermatology Times...more
1/22/2020
/ Direct to Consumer Sales ,
Drug Compounding ,
E-Commerce ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Off-Label Promotion ,
Online Distribution ,
Online Platforms ,
Pharmaceutical Industry ,
Pharmacies ,
Popular ,
Prescription Drugs ,
Telemedicine
Every year, the National Institutes of Health (NIH) spends billions of federal dollars on research and development of new drugs and therapies for treating and preventing serious illnesses....more
3/27/2018
/ Failure to Report ,
Federal Funding ,
Gilead Sciences ,
Inventions ,
Life Sciences ,
National Institute of Health (NIH) ,
Patent Ownership ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
R&D ,
Reporting Requirements ,
Research and Development ,
Scientific Research
Patent protection can be critical for health care products, including medical devices, prescription drugs, dietary supplements and software as a medical device (SaMD).
Originally published in Law360 - September 8, 2017....more
FDA recently awarded new chemical entity (NCE) exclusivity to Austedo™ (deutetrabenazine). The Austedo approval is notable for two reasons: One, it is the first deuterated drug (i.e., a drug containing the stable isotope —...more
In a recent ruling, the U.S. Supreme Court clarified what happens when biosimilar applicants do not follow the regulatory framework for disputes with reference product sponsors — a process known as the “patent dance.” Since...more
6/23/2017
/ Amgen ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen
The prior approval of a drug containing an active ingredient of the innovator drug is not necessarily a death knell for NCE exclusivity.
Originally published in the Intellectual Property and Life Sciences sections of...more
The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more
10/5/2015
/ Affordable Care Act ,
America Invents Act ,
Appeals ,
Biologics ,
Biosimilars ,
Declaratory Judgments ,
Generic Drugs ,
Hatch-Waxman ,
Innovator Liability ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Post-Grant Review ,
Standing ,
STRONG Patents Act ,
USPTO
The recently established inter partes review (IPR) and post-grant review (PGR) of the America Invents Act have been in the spotlight lately, especially now that the life sciences industry has begun to utilize these...more
5/13/2015
/ America Invents Act ,
Generic Drugs ,
Hedge Funds ,
Intellectual Property Litigation ,
Inter Partes Review (IPR) Proceeding ,
Jurisdiction ,
Life Sciences ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review ,
Stocks