answersLogoWhite

0

An at-risk launch, in the context of pharmaceuticals, is when a generic manufacturer challenges the validity of an existing patent.

If the company were to launch the drug before this first round of litigation and lose (ie. the patent is upheld), they would owe the patent-holder treble damages. This would be roughly three times the sales loss incurred to the patent-holder, and no small change to even a large company.

If, however, the court rules that the patent is invalid then the newcomer might choose to launch the product "at risk": while the erstwhile patent-holder appeals the initial court decision not to uphold the patent.

Ultimately the court will stand by its decision and the newcomer will have successfully launched at-risk, or it will revert back and support the appeal. In this situation, the newcomer only owes 1x damages. This is a considerably less prohibitive sum, one that theoretically begot the original risk-reward question of launching the product despite the appeal.

For examples, see Sanofi's Plavix, Eisai's Aricept, AstraZeneca's Nexium, and Wyeth's Protonix.

Mel

www.mpglobal.com

User Avatar

Wiki User

17y ago

What else can I help you with?

Related Questions

What is the last step in the risk management process?

Launch ReferenceQuestion 19What is the last step in the composite risk management (CRM) process?Supervise and evaluate.


What is the last step in the risk management (crm) process?

Launch ReferenceQuestion 19What is the last step in the composite risk management (CRM) process?Supervise and evaluate.


Why do you have to stand far away from a shuttle launch?

You need to stand far away from a shuttle launch to ensure safety in case of an explosion or malfunction. The intense heat and pressure generated by the launch can be dangerous, and standing at a distance minimizes the risk of harm from any debris.


Is launch an adverb?

"Launch" is not an adverb, no.The word "launch" is a verb ("we will launch it into the air") and sometimes a noun ("the launch pad is broken").


What difficulties or challenges Dr.A P J Abdul Kalamhe has faced?

He was being opposed at the time of his nuclear missile launch..But still he took risk and now he is praised for such.


What is the word 'launch' when translated from English to Japanese?

launch = chakushu to launch = orosu


Why cant nuclear waste be deposited into deep space?

It could be, if the right rocket vehicles were built, but would the risk of it falling back to Earth in the event of a launch failure be acceptable?


What happens to the launch pad after launch?

It is a little burnt but the launch pad is designed to take extreme heat and pressure created by the space shuttle. If it wasn't, they would have to make a new launch pad every launch and those things are worth a pretty penny...


Where is the Chinese rocket launch facility?

It is at Jiuquan Satellite Launch Center, Taiyuan Satellite Launch Center, Xichang Satellite Launch Center, and Jingyu.


What was Peter Dolan's role with cancer?

Bristol-Myers Squibb and Armstrong teamed up to launch the Cycle of Hope, a national educational campaign for people with cancer or at risk of developing the disease.


How do you launch rabbot on Poptropica?

In Poptropica you launch the rabbot when you type in fuzzy bunny and the mission is launch rabbot


What is the past tense of launch?

launchedThe past tense of launch is launched.