Posts in Hatch-Waxman


Reflections on Drug Patents and the High Cost of Healthcare

The Hatch-Waxman Act and the Biologic Price Competition and Innovation Act are both forged from a noble ideal, grounded in a commitment to a robust and earnest …
By Arie Michelsohn
5 days ago 1

Why should we encourage generics to challenge pharma patents?

What was the federal government thinking when Hatch-Waxman originally passed. Why would Congress incentivize generic manufacturers to challenge the patents of pharmaceutical companies? It is the same …
By Gene Quinn
1 month ago 1

Senator Hatch files Amendment to Fix IPRs for Pharma, Save Hatch-Waxman

Late yesterday, Senator Orrin Hatch (R-UT), co-author of the Hatch-Waxman Act, filed an amendment in the Senate Judiciary Committee to address what many characterize as abusive inter …
By Gene Quinn
1 month ago 21

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
2 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
2 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
3 months 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
8 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 …

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
11 months ago 2

Horizon Pharma patents covering Vimovo arthritis pain relief treatment have validity upheld at district court and PTAB

Irish biopharmaceutical firm Horizon Pharma announced that two of its patents covering Vimovo, a pain relief treatment for arthritis patients, had their validity upheld in a patent …
By Steve Brachmann
1 year ago 0

Supreme Court of Canada rules on Promise Doctrine in favor of Pharma Patent Owners

The Supreme Court of Canada issued a ruling in AstraZeneca Canada Inc. v. Apotex Inc., which gives patent owners a far greater ability to protect their intellectual …
By Steve Brachmann
1 year ago 1

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
1 year ago 0

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

The FDA process, patents and market exclusivity

A patent is not the only path to exclusivity. In fact, the FDA characterizes patents and "exclusivity" separately. "Exclusivity" refers to exclusive marketing rights granted by the …

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

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