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. …
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, …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
