The long and arduous path of prosecution begins with the filing of a parent patent application. Several years later, the applicant files a first continuation application. A few more years pass after which the applicant files...more
National emergencies, like the one COVID-19 has triggered in the United States, spur technological development, as concerned researchers look for ways to repurpose existing technology or develop new technology to help. ...more
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
In this follow up to last month’s topic on intellectual property and technology transfer, we will extend our discussion on ownership to patents.
Originally published in DermatologyTimes....more
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 prevalence of inter partes reviews (and post-grant reviews to come) forces practitioners to consider the strong likelihood that patents covering commercial products will face post-grant challenges.
Originally...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