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
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 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