Dunlap Codding Director Jordan Sigale Quoted in Law360 re On-Sale Bar Threat to Pharma Patents
On May 4, 2016, Law360 published an article by Ryan Davis, “Fed. Circ. Could Ease On-Sale Bar Threat to Pharma Patents.” The article noted that the Federal Circuit will hear arguments Thursday in a patent case regarding the blood-thinning drug Angiomax. “The on-sale bar holds that an invention cannot be patented if it has been on sale for a year prior to the patent filing. The court decided last year to reconsider when the bar applies after a panel used it to invalidate two of The Medicines Co.’s patents on Angiomax in a dispute with generics maker Hospira Inc. The Medicines Co. did not sell Angiomax to the public before filing for a patent, but instead paid a supplier to make experimental batches while the drug was being developed.”
The article notes that Dunlap Codding Director Jordan Sigale opined that in recent years, companies have become less integrated and more have begun outsourcing aspects of the production process to third parties. This case will have widespread importance. The panel’s holding that an outsourcing arrangement can render patents invalid under the on-sale bar, “makes it really super tough for companies that can’t make large quantities of things themselves, and there are a lot of companies like that….[if the ruling stands] it’s going to stunt the further development of outsourcing culture….It bothers me because the whole idea of the on-sale bar as I understood it was that we don’t want companies to exploit their invention for a year of sales before they get a patent. But that’s not what’s going on here….There’s a distinction in my mind between working with a third party to make sure the product meets FDA requirements and going out and selling to the public.”