Posts Tagged: drug patents
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 …
State Department, Universities Blast UN Attack on Patents
If the UN Secretary General and the members of his "High Level Panel on Access to Medicines" thought the State Department was bluffing when it warned against …
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). …
Is Nome, Alaska ready for Paragraph 4 ANDA litigation? How about San Juan, Puerto Rico?
Nome, Alaska and San Juan, Puerto Rico are both home to a federal courthouse where, ostensibly, under the recent Acorda Therapeutics holding and subsequent court decisions, a …
The EpiPen Episode’s Silver Lining
EpiPen's eruptive timing was important. Had Congress been in town, lawmakers would have filled the front pages with populist blather. Had Mylan been less forthcoming about the …
Government is to blame for the skyrocketing price of EpiPens, not patents
The problem is that the government is standing in the way of these competitive autoinjectors getting into the hands of the patients who need them. For example, …
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 …
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 …
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 …
Legal Threats to Strong Returns on Pharmaceutical Patents Grow, Threatening Innovation
Pharmaceuticals is the industry sector where a strong patent system, promising substantial returns to successful innovation, is of paramount importance. Regrettably, the weakening of pharmaceutical patent rights …
PTAB to determine whether to sanction Kyle Bass for filing IPRs
According to Celgene, the Kyle Bass strategy of shorting a stock and filing an inter partes review challenge is an abuse of the process and not what …
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. …
The looming patent nightmare facing the pharmaceutical industry
During the last hearing of the House Judiciary Committee there was an attempt to insert language via amendment that would make it impossible for Kyle Bass and …
Bristol-Myers, AstraZeneca and AmGen maintain strong new drug pipelines
There’s been a lot of positive activity in recent months for Bristol-Myers Squibb of New York City. In early March, the U.S. Food and Drug …
