Posts Tagged: orange book


The Updated PTAB Trial Practice Guide – Not Quite There Yet

While the changes to the Trial Practice Guide begin to move the rules in the right direction, more is needed before post-grant proceedings will be accepted as …
By Russell Slifer
28 days ago 2

Vanda v. West-Ward: This Time, Dosage Adjustment Claims are Patent Eligible Subject Matter

The Federal Circuit’s decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, No. 2016-2707, addresses the complicated topic of patent eligibility in the pharmaceutical space. Much of …
By Stephanie Sivinski
4 months ago 18

Hatch-Waxman Litigation: 60 Percent Increase in ANDA Lawsuits from 2016 to 2017

In 2017, U.S. district courts saw a total of 417 patent infringement suits related to ANDA filings made by drugmakers with the U.S. Food and Drug Administration (…
By Steve Brachmann
4 months ago 0

The Abuse of Orange Book Listings by Branded Pharmaceutical Companies

AbbVie’s maneuver worked like clockwork to induce regulatory gridlock, which prevented generic competition and kept the company’s profits high at public expense, for years. Fortunately, …
By Arie Michelsohn
6 months ago 20

St. Regis Mohawks, BIO send letters to Senate Judiciary slamming the unfair playing field of IPRs at PTAB

On Thursday, October 12th, a pair of letters addressed to the bipartisan leadership of the Senate Judiciary Committee were delivered in an attempt to inform Senators on …
By Steve Brachmann
11 months ago 22

Report shows drug patents fare better in IPR proceedings at PTAB

While the Patent Trial and Appeal Board (PTAB) has not been friendly to patent owners, to put it mildly, the PTAB has not been inhospitable to pharma …
By Steve Brachmann
1 year ago 36

PTAB institutes Mylan IPR challenges on Allergan patents for RESTASIS

Last week the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) instituted six separate inter partes reviews (IPRs) against patents …
By Gene Quinn
2 years ago 1

FDA rules updated on patent information, paragraph IV certifications for ANDAs and 505(b)(2) applications

On Thursday, October 6th, the U.S. Food and Drug Administration (FDA) published a 79-page notice in the Federal Register regarding new rules surrounding Abbreviated New Drug …
By Steve Brachmann
2 years ago 0

Reverse Payment Settlements and Holdup Under PTAB

One reason the PTAB is convenient for reaching reverse payment deals is that there is no direct antitrust oversight, since its judges are administrators with very narrow …
By Erik Hovenkamp & Jorge Lemus
2 years ago 8

Reexamination of Patents Listed in the FDA’s Orange Book: Surprising Facts For Brands and Generics

Did you know that while a total of 4,849 ex parte and inter partes patent reexamination requests were filed from 1999 to 2009, only 55 are reexaminations of patents associated with …
By Gaby Longsworth
9 years ago 1

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