Posts Tagged: hatch-waxman


USPTO Director Andrei Iancu Discusses Patentability of Algorithms, PTAB Proceedings at Senate Judiciary Committee

Sen. Harris followed up by asking whether algorithms were mathematical representations of laws of nature. “You’re getting right to the heart of the issue,” Iancu said. …
By Steve Brachmann
3 days ago 19

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
18 days ago 20

Celgene’s New Revlimid® Lawsuits Shows Shifting Tactics From Earlier Natco Case

Celgene faces a new gang of generics moving in on its blockbuster Revlimid®.  Over the past year, a number of generics have filed ANDAs against Revlimid®, including …
By Zachary Silbersher
5 months ago 3

Merck Process for Stabilizing Antibiotic Compound Invalid as Obvious

The District of Delaware found that one of two patents asserted by Merck was not invalid and infringed, and the other patent, while infringed, was invalid as …

Double jeopardy at the PTAB forces Allergan and others to seek sovereign immunity defenses

The PTAB subjects all patent owners to double jeopardy, but the situation is particularly bad for pharmaceutical companies which already have to face a Congressionally-mandated validity review …
By Steve Brachmann
6 months ago 0

Allergan’s RESTASIS® patents declared invalid by Eastern District of Texas

Judge William C. Bryson of the United States Federal District Court for the Eastern District of Texas found that Allergan's RESTASIS® patents were infringed by Teva Pharmaceuticals …
By Gene Quinn
6 months ago 17

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
6 months ago 22

Inherent obviousness necessitates specific motivation to modify lead compound in pharma process due to surprising, unexpected results

Inherent obviousness cannot be based on what the inventor thought, and, in addition, the results in a particular case may not be inherently obvious depending on what …
By Jay S. Pattumudi
8 months ago 2

Lex Machina ANDA litigation report shows recent decline in case filings and top parties in filings

Lex Machina recently released a Hatch-Waxman/ANDA litigation report detailing trends and key findings from pharmaceutical cases filed in U.S. district courts between January 1st, 2009, and …
By Steve Brachmann
12 months ago 0

Make Ohlhausen the FTC Chairman

One of the most straightforward steps President Trump can take to steer the ship of state on its new course is to put good people in place …
By James Edwards
12 months ago 0

Mylan’s proposed ANDA drug does not infringe MedCo patents

A claim term can be limited to an embodiment described in the specification, if the claim would otherwise be found invalid and the embodiment was not disclaimed. …

Bristol-Myers Squibb, Pfizer file ANDA lawsuits against makers of generic Eliquis

American drugmakers Bristol Myers Squibb Co. (NYSE:BMY) and Pfizer, Inc. (NYSE:PFE) fired off a series of nine lawsuits to prevent generic versions of Eliquis, a …
By Steve Brachmann
1 year ago 0

Understanding the BPCIA Litigation Pathway to Avoid Expensive, Incurable Mistakes

Modeled after the Hatch-Waxman Act, the BPCIA seeks not only to encourage competition in the field of biologics but also to promote innovation by, among other things, …

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

Horizon Pharma sues Actavis, Lupin for Paragraph IV certifications on generic Pennsaid

Horizon Pharma filed an action for patent infringement against Actavis and Lupin Pharmaceuticals in response to the filing of Abbreviated New Drug Applications (ANDAs) by both defendants …
By Steve Brachmann
2 years ago 0