Posts Tagged: drugs
Drug Product Pipelines: Potential Blockbusters?
Drug manufactures spend billions of dollars in R&D and it takes years to get FDA approvals and patent protection. It is vital that these companies keep …
Focus on Stronger IP Incentives: Price Setting is Not the Cure for Healthcare Spending
The WHO is gathering governments, academics and activists in Amsterdam next month to discuss price setting options for medicines. But the so-called Fair Pricing Forum ignores the …
Regeneron, Sanofi-Aventis sue for declaration that dermatitis treatment Dupixent doesn’t infringe Amgen patent
Although Dupixent hasn’t been granted FDA approval as of yet, the drug has made it further than Amgen’s AMG-317, the code name for Amgen’s …
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 …
Will President Trump directly negotiate Medicare prescription drug pricing?
The savings impact of directly negotiated drug costs is considered negligible, but intrusion into biomedical pricing will destabilize life science commercialization... Any way you slice it, added …
Amgen v. Regeneron: Will the permanent injunction against Regeneron’s new PCSK9-inhibitor hold up on appeal?
On January 5, 2017, the District of Delaware issued its long-awaited decision in the patent dispute pending between Amgen and Regeneron wherein the Court granted Amgen’s request for …
Patent issued on vaccine for one of the most common causes of bronchiolitis and pneumonia
Respiratory syncytial virus, commonly referred to simply as RSV, is a highly contagious viral disease and is one of the most common causes of bronchiolitis and pneumonia. …
Passage of the 21st Century Cures Act and its Potential Implications on Biodefense
With the Cures Act now signed into law, the incoming Trump administration has an opportunity to advance the broad-spectrum medical countermeasure goal set forth by the U.…
How Can You Protect Cannabis-based Intellectual Property Under Federal Prohibition?
What started as a curiosity in Colorado and Washington state in 2012 could have gained the momentum of a juggernaut: marijuana legalization. Now with California and other states …
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 …
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). …
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 …
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 …
