In a major win for generic drugmakers, the U.S. Supreme Court upheld disputed language in a patent law that could make patents easier to cancel, STAT reports.
The issue centered on the America Invents Act, which made several changes to U.S. patent law in 2011 that prevent companies from patenting an invention if it was "on sale" for more than a year before filing a patent.
The initial case was brought by Swiss drugmaker Helsinn Healthcare over its drug Aloxi, which treats nausea caused by chemotherapy. In 2001, Helsinn entered into agreements with MGI Pharma, giving the Minnesota company the right to distribute, promote and market the drug in the U.S. Two years after that agreement, Helsinn filed a provisional patent application.
In 2011, the company began facing generic threat from Teva Pharmaceuticals. To prevent Teva from entering the market with a generic version, Helsinn filed a lawsuit for infringing its patent. Teva fought back, however, using the disputed language in patent law to argue Helsinn's patent was invalid because it was filed two years after the MGI agreement had been reached and that the deal constituted a publicly known sale.
The district court initially ruled that the "on sale" provision did not apply because an invention is not "on sale" unless it is made available to the public. This didn't happen with MGI Pharma deal, because the company agreed to keep the deal confidential. The federal court reversed this decision, saying that the details of the sale don't need to be publicly disclosed in order for it to be classified as "on sale" under the America Invents Act.
The Supreme Court, in a unanimous decision, ruled that an invention sold to a third party under a confidentiality agreement means that the invention was "on sale." This means any sale or offer, whether public or not, can lead to an invalidated patent.
Read the full report here.