Posts Tagged: Pharmaceutical


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 months ago 0

Are Patents the Reason Poor Countries Lack Healthcare?

A consistent charge against the patent system is that it denies the poor access to critical medicines. This belief led the UN Secretary General to launch his …
By Joseph Allen
4 months ago 3

Property Rights Key to Bayh-Dole Act’s Success

The focus of the political advocates pushing march-in may be lower drug costs. But the long-term costs of ripping apart IP rights are far higher and more …
By James Edwards
4 months ago 5

Public Health and Bioscientific War on Superbugs is Hobbled by IP Uncertainties

How will our patent system treat this wonderful new discovery? How long will it take before its curative benefits can be deployed ? We can only hope that …
By Chris Gallagher
4 months ago 5

The superbugs are here, but where are we?

Superbugs have powerful friends in high places. SCOTUS’s patent eligibility criteria emanating from Mayo/Alice’s mysterious “laws of nature” and credible reports of unremitting turndowns …
By Chris Gallagher
5 months ago 6

Counterfeit Medicines and the Role of IP in Patient Safety

Given the devastating impact of counterfeit medicines on patients and the importance of intellectual property protection in combating pharmaceutical counterfeiting, it is troubling that the UN High …
By Dr. Kristina Lybecker
5 months ago 0

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
5 months ago 4

$1.5 billion Celator purchase buoys the financial future of Jazz Pharmaceuticals’ oncology division

Of particular interest in this deal is a drug in Celator’s pipeline is Vyxeos (cytarabine:daunorubicin), an injectable liposomal treatment for blood cancers, especially acute myeloid …
By Steve Brachmann
6 months ago 0

IP Protection Critical for BioPharma Given Number, Cost and Complexity of Clinical Trials

Biopharmaceutical innovation is difficult, expensive, time-consuming, and risky. More so now than ever. A 2014 study by Tufts University’s Center for the Study of Drug Development calculated …
By Dr. Kristina Lybecker
6 months ago 9

USPTO Provides Updates to Patent Subject Matter Eligibility Guidance

On its face, the new guidance seems to urge examiners to develop well-reasoned, substantive rejections rather than conclusory rejections which provide little basis for applicants to advance …

Clinical Trials and Tribulations: Why IP Protection is Critical to the Future of Biologic Medicine

Given the importance of intellectual property rights to economic growth and technological development, as well as the wider benefits of biopharmaceutical research, the provisions found in the …
By Dr. Kristina Lybecker
7 months ago 3

When Government Tried March In Rights To Control Health Care Costs

As we await the decision from the National Institutes of Health (NIH) on the petition backed by Senator Bernie Sanders and others urging that the march in …
By Joseph Allen
7 months ago 10

Injectable migraine treatment being developed by Alder, Eli Lilly, Amgen and others

Migraines are the result of a hereditary neurological disorder which causes certain areas of the brain to become over-excited, creating the throbbing pain and increased sensitivity to …
By Steve Brachmann
8 months ago 0

UN Panel on Access to Medicines Should Ensure Innovation by Preserving Market Incentives

The dilemma for developing countries is primarily a function of two things: lack of access to existing medicines and absence of innovation on the treatments and cures …
By Dr. Kristina Lybecker
10 months ago 0

Free Drugs: Bernie Sanders and the end of drug patent exclusivity

The Medical Innovation Prize Act of 2007, submitted by Senator Bernie Sanders (D-VT), would have effectively done away with patent rights for pharmaceutical drugs approved by the Food …
By Gene Quinn
10 months ago 41