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
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
For drug innovators, particularly those focusing on repurposing drugs for new indications and developing drugs that are not considered new chemical entities, understanding the scope of the clinical investigation exclusivity...more
8/27/2019
/ Administrative Procedure Act ,
Arbitrary and Capricious ,
Chevron Deference ,
Clinical Trials ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Innovation ,
Life Sciences ,
Medical Research ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Exclusivity ,
Statutory Interpretation
The Federal Circuit recently issued a pair of decisions concerning the Gilead doctrine, which allowed later-issuing patents to be obviousness-type double patenting (ODP) references against earlier-issuing patents....more
12/11/2018
/ Double Patent ,
Gilead Sciences ,
Intellectual Property Protection ,
Obviousness ,
Patent Applications ,
Patent Expiration ,
Patent Litigation ,
Patent Term Adjustment ,
Patent Term Extensions ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
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
This is the final article in our five-part series on PTE.
Obtaining a patent term extension (PTE) is extremely valuable to an innovator. By design, PTE extends the patent term to recoup time lost to the rigorous...more
This is the fourth article in our five-part series on PTE.
When applying for a patent term extension (PTE), due diligence matters. If an applicant did not act with due diligence during the testing phase or the approval...more
This is the third article in our five-part series on PTE.
Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more
5/19/2017
/ Biologics ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Investigational New Drug Application (IND) ,
Medical Devices ,
Patent Term Extensions ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
USPTO
This is the second article in our five-part series on PTE.
Everywhere you look, patent term extension (PTE) is described using the “Rule of Ones:” one patent, one product, one PTE. However, the Rule of Ones does not...more
Patent term extension is a valuable tool that drug manufacturers should consider, even when their products are not new entities. Recent decisions from the U.S. Patent and Trademark Office, coupled with various court...more
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 court found that a different interpretation could result in marketing exclusivity for the original innovator drug in perpetuity.
In Otsuka Pharmaceutical Co. v. Burwell, the U.S. District Court for the District 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