Could Secret Sales Bar Your Ability to Patent a Medical Device?

A recent Supreme Court decision could have a significant impact on medical device manufacturers. These companies must continue to exercise caution in engaging in confidential sales and offers with outside partners—such as in contracts for device prototype development or stockpiling of products—before filing patent applications. Medical device manufacturers should ideally file patent applications before entering into such agreements or, if not feasible, structure the agreements to reduce the risk of triggering the on-sale bar. These guidelines are based on the Helsinn Healthcare v. Teva Pharmaceuticals decision in which the Supreme Court confirmed that an inventor’s “secret sales”—that is, sales or offers for sale in which invention details are not made available to the public—can still act as a bar to patentability under the America Invents Act of 2011 (“AIA”), which applies to U.S. patents and patent applications filed after March 15, 2013, as they had under pre-AIA law. 1 Though there had been hope that medical device manufacturers would have more leeway under the AIA to engage in confidential sales without jeopardizing patent rights, in line with other worldwide patent systems, that possibility has been laid to rest as a result of the decision. Like the U.S. Patent and Trademark Office did in its own guidelines, 2...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news