Posts Tagged: orange book


Key Insights from the PTAB’s Updated Orange Book and Biologic Patent Study

The U.S. Patent and Trademark Office Patent Trial and Appeal Board (PTAB) recently released an update to its Orange Book patent and biologic patent study, examining …

New Dance Moves? Purple Book Amendments Require Public Disclosure of ‘Patent Dance’ Patent Lists

Innovator (or “reference”) biologic drug makers and small-molecule drug makers face differing legal obligations with respect to public patent disclosures. Under the Hatch-Waxman Act, reference small-molecule drug …
By Christopher Loh
3 months ago 0

Holiday Gifts for IP Owners: Several Significant IP Bills Passed Last Minute by Congress

Late Monday evening, Congress passed a massive omnibus budget bill to avert a federal government shutdown and provide critical COVID-19 relief.  But that is not all – much …

FDA Issues Request for Comments on Modernizing Patent Listings in the Orange Book

On June 1, the Food and Drug Administration (FDA) published a notice in the Federal Register announcing that the agency was establishing a public docket for the receipt …
By Steve Brachmann
1 year ago 0

Examining the Truvada #BreakThePatent Debate: Gilead Responds

In July 2012, the U.S. Food and Drug Administration (FDA) first approved Truvada, an acquired immunodeficiency syndrome (AIDS) treatment manufactured by Gilead Sciences as a daily pre-exposure …
By Steve Brachmann
3 years ago 3

Freedom to Operate and the Interplay of Patent and Regulatory Exclusivity for Life Sciences

While part one of this two-part series on intellectual property (IP) due diligence focused on a life science company’s own IP portfolio, part two will address …

PTAB Trends: More Orange Book Patents Are Surviving the ‘Death Squad’

Since its inception, the Patent Trial and Appeal Board (PTAB) has been a frequent venue for patent challenges in the pharmaceutical and biotechnology industries. By the end …

IPR Outcomes of Orange Book Patents and its Effect on Hatch-Waxman Litigation

Out of the 230 Orange Book patents challenged in IPR proceedings, 90.4% (208) of these patents were also challenged in Hatch-Waxman litigation perhaps due to the lucrative 180-day exclusivity incentive …
By Tulip Mahaseth
3 years ago 3

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
3 years 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
3 years 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
3 years 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
4 years 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
4 years 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
4 years 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
5 years ago 1