Posts Tagged: generic Drug


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
2 years ago 1

Patent settlement between AbbVie and Amgen delays Humira generic until 2023

On Thursday, September 28th, a judge in the District of Delaware entered an order stipulating dismissal in a patent infringement case brought by North Chicago-based pharmaceutical firm …
By Steve Brachmann
3 years ago 0

Big Pharma, Generics and Trade Related Aspects of Intellectual Property Rights (TRIPS)

Generic drug manufacturers can pose major financial threats to those companies that invent and develop the copied drugs both domestically and internationally... Before TRIPS, most of the …
By Angélique McCall
3 years ago 0

Winning the Drug Development Debate

We create two new companies around academic inventions every day of the year. The critical role such companies play in drug development is clear. The successful integration …
By Joseph Allen
4 years ago 0

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 Gene Quinn & Steve Brachmann
4 years ago 0

95 percent of WHO’s essential medicines are off-patent

The vast majority of medicines found on WHO’s model list of essential medicines are off-patent according to information published by the World International Property Organization (WIPO). …
By Steve Brachmann & Gene Quinn
4 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
4 years ago 8

A Simple Way to Lower Drug Prices

Consumers suffer the scourge of high drug prices. Brand-name drug companies reap monopoly profits. But generic drugs, which promise lower prices, are often nowhere to be found. …
By Michael Carrier
4 years ago 4

Eli Lilly prevails in divided infringement Alimta® patent case

The United States District Court for the Southern District of Indiana ruled in favor of Eli Lilly (NASDAQ: LLY), issuing a final judgment in the Hatch-Waxman infringement …
By Gene Quinn
5 years ago 1

The Sticking Point that Shouldn’t Be: The Role of Pharmaceutical Patents in the TPP Negotiations

The controversy swirling around the Trans-Pacific Partnership (TPP) Trade Agreement sheds light on two critically important but divisive issues: international trade and intellectual property protection for pharmaceuticals. …

BIO, PhRMA lobby for IPR fix to insulate their patents from challenge

Greenwood and Castellani will have two major problems as they seek relief. First, the IPR provisions do not include a standing requirement, which means that anyone can …
By Gene Quinn
5 years ago 7

Uncle Sam the Patent Troll Sues to Stop Generic HIV Drug

HHS is suing a defendant that merely wants to market a generic version of a drug that is used to treat patients with human immunodeficiency virus (HIV). …
By Gene Quinn
5 years ago 12

Patents, Drugs and the Moral High Ground

There are millions and millions of people dying each year from all kinds of illnesses that are easily preventable using simple technologies and drugs that are off …
By Gene Quinn
6 years ago 9

Pharma Update July 2013: FDA, Preemption & SCOTUS

The FDA is following through on plans to issue a proposed rule to revise regulations to allow generic drugmakers to update labeling. The rule would update current …
By Ed Silverman
7 years ago 0

Reverse Payments: Into the Belly Of The Hatch-Waxman Beast Part 3

“Reverse payment” cases are an outgrowth of a key feature I noted in my first article on the basics of Paragraph IV Certifications: the filing of an …
By Eric Guttag
7 years ago 0