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 insidious thought process underlying Hatch-Waxman seen underlying the justification for post grant challenges of all patents at the USPTO. How absurd is it that those who question the need for incentive to innovate are so eager to provide incentive to challenge patents?

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 AbbVie (NYSE:ABBV) against Thousand Oaks, CA-based drugmaker Amgen (NASDAQ:AMGN). According to reports, the settlement follows an agreement between the two companies to delay a generic version of the anti-inflammatory drug Humira from the U.S. market until 2023… Of AbbVie’s total $6.94 billion in net revenues from U.S. and international sales during the quarter, Humira contributed $4.71 billion in revenues.

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 world’s developing countries had very weak patent protections, especially for pharmaceuticals. These weaknesses included — but were not limited to — shorter patent terms ranging from 4 to 7 years, narrowly defined patents which allowed for imitations, and greatly reduced monopoly rights of the patent owner by the permissive use of compulsory licenses. This divergence demonstrates a disconnect between the above mentioned weaknesses and the strong protections of industrial countries with their 20-year patent terms and almost unlimited monopoly rights… For pharmaceutical patent owners, these TRIPS amendments try to harmonize the worldwide rights afforded to them by balancing the interests of the rights holder and those of consumers.

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 of public research institutions into the economy is based on the Bayh-Dole Act, which inserted the incentives of patent ownership into the government R&D system. Not a single new drug had been developed from NIH funded research under the patent destroying policies preceding Bayh-Dole. No one is going to spend billions of dollars and more than a decade of effort turning early stage inventions into new drugs or fund a life science startup company without strong patent protection. Yet the patent system and Bayh-Dole are precisely what the critics seek to undermine.

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 Applications (ANDAs) and 505(b)(2) new drug applications. Many provisions of the new rules affect information that must be submitted by applicants regarding patents which could affect the outcome of applications for new generic versions of drug treatments.