The U.S. Patent and Trademark Office (USPTO) launched a deferred-fee provisional patent application pilot program Sept. 17 for drugs and devices intended to combat COVID-19.

Under the pilot program, applicants may defer payment of the provisional application filing fee until they file a corresponding, nonprovisional patent application.

However, they must agree to have the technical subject matter disclosed in their provisional applications made publicly available on the USPTO’s website. That way, they “can contribute to the public in the fight against COVID-19 while protecting their patent rights,” the USPTO said.

The pilot is open to products or processes that will require FDA approval. Certifications and requests to participate will be accepted through the next 12 months. Depending on public feedback, the effectiveness of the program, and the workload and resources needed to administer the pilot, the USPTO may extend it beyond a year. It also may expand the program’s scope beyond COVID-19 to other areas that are the focus of pioneering or rapid innovation.

Bladder cancer therapies evaluated

The Institute for Clinical and Economic Review (ICER) released a draft evidence report Sept. 17 assessing treatments for BCG-unresponsive, nonmuscle invasive bladder cancer.

The report evaluated Ferring Pharmaceutical SA’s nadofaragene firadenovec, which uses a nonreplicating recombinant adenovirus vector encoding the human interferon alfa-2b gene, and Sesen Bio Inc.’s Vicineum (oportuzumab monatox), an antibody-drug conjugate that combines a monoclonal antibody specific for the epithelial cell adhesion molecule on the surface of tumor cells with an agent that can kill the cells.

Comments on the draft should be submitted to publiccomments@icer-review.org by Oct. 15. ICER plans to hold a virtual public meeting on the evidence report Nov. 20.

No Comments