The U.S. Patent and Trademark Office (PTO) is seeking feedback on artificial intelligence (AI), posing questions on whether the regulations or even the statute will have to be amended to allow the agency to issue patents for items invented in part or in whole by AI. The Federal Register notice for the PTO announcement states that the agency's examiners have been evaluating AI patents "for decades," but notes that the term "AI inventions" has been used to describe both inventions that use AI and inventions that have been developed by AI. The agency said that one question on which it seeks feedback is whether the current laws and regulations need revision to take into account the role of non-persons in the conception of an invention.
The FDA issued a draft guidance encouraging the inclusion of male patients in breast cancer clinical trials. The draft provides clarity on how additional data to support efficacy and safety for male patients can be generated through a variety of trial designs using different data sources, including studies that use real-world data. It includes clinical development recommendations – when males haven't been included in the trials or their inclusion is limited – for when no difference in efficacy or safety is anticipated between males and females based on the drug's mechanism of action and for when there is a concern for differences in efficacy or safety between males and females. With less than 1% of all breast cancers occurring in men, they are more likely to be diagnosed at an older age and have a more advanced stage of disease, said Richard Pazdur, director of the FDA's Oncology Center of Excellence. Comments on the draft are due by Oct. 26.