The FTC is focusing its attention on the listing of pharmaceutical patents in the FDA’s Orange Book.
Patent listing may be the subject of FTC inquiry even absent infringement litigation enforcing the relevant patents....more
Although legal fees spent preparing Paragraph IV notice letters must be capitalized (and thus amortized over 15 years), legal fees spent defending ANDA suits launched in response to those letters may be taken as deductions in...more
8/2/2023
/ Abbreviated New Drug Application (ANDA) ,
Certifications ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
IRS ,
Legal Fees ,
Manufacturers ,
Patent Infringement ,
Patents ,
Tax Court
President Biden, in July 2021, issued an Executive Order (“E.O.”) observing that “too often, patent and other laws have been misused to inhibit or delay — for years and even decades — competition from generic drugs and...more
3/7/2023
/ Abbreviated New Drug Application (ANDA) ,
Biden Administration ,
Executive Orders ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
FOIA ,
Food and Drug Administration (FDA) ,
Patent Applications ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
PHRMA ,
Public Disclosure ,
Trade Secrets ,
USPTO
As we sensed when we last wrote about the Federal Circuit’s handling of the infringement dispute over GlaxoSmithKline’s ("GSK") Coreg® product in GlaxoSmithKline LLC, v. Teva Pharm. USA, Inc., the Judges have dug into their...more
The Chief Judge of the U.S. Court of Appeals for the Federal Circuit Sharon Prost, has quipped that, with her experience in both the legislative and judicial branches of government, she is a “walking separation of powers.”...more
In an important decision impacting life sciences patentees, a divided panel of the Federal Circuit in Barry v. Medtronic, Inc., Appeal No. 2017-2463 (Fed. Cir. January 24, 2019), affirmed a jury’s finding that a doctor was...more
2/2/2019
/ Appeals ,
Experimental Use Exception ,
Inventors ,
Jury Trial ,
Life Sciences ,
Medical Devices ,
On-Sale Bar ,
Patent Applications ,
Patents ,
Physicians ,
Section 102