Mar 202012

A lawsuit was filed to force the FDA to make a decision on the petition PIMR filed earlier. The FDA's decision was to reject our petition.

In response, the PIMR amended its complaint to force the FDA to revoke its approval of Alair®. The FDA then filed motion to dismiss for lack of standing. PFMIR made counter arguments asking that in case the court favors dismissal, to give permission to PIMR to amend the complaint one more time.

The judge dismissed the first amended complaint saying that the complaint did not allege any specific injury to the plaintiff. The judge also gave PIMR permission to file a revised (amended) complaint.

 Posted by at 6:57 am
Mar 202012

Bayer, the German pharmaceutical giant, priced its new cancer drug at $69,000 per patient per year in India. Adjusted for the per capita income that amounts to $1.6 million dollars in the USA. An Indian company, Natco Pharmaceuticals, produced the same drug but priced it at $177. The Indian company is still making money on it! Natco filed a lawsuit in the Indian Patent Court to force Bayer to give a license to Natco to produce and sell the drug.

Bayer was not happy and tried to enforce its patent. The case was finally decided in favor of the Indian company. The court ruled that it was an essential drug that was beyond the reach of patients in India and therefore the Indian company could make a generic version of the drug after paying a royalty to Bayer.

For the full story click on the link below.

 Posted by at 6:45 am