In a key development for companies working to treat cancer, the U.S. Patent and Trademark Office (USPTO) has launched a potentially beneficial pilot program. This is the latest Biden Administration initiative stemming from the reboot of the Cancer Moonshot Initiative in February 2022. Here are some key details of the USPTO’s new Cancer Moonshot Expedited Examination Pilot Program, which replaces a program established in 2016:

1. The Moonshot Program covers a wide range of applicable cancer-related technologies. While the original Pilot Program was limited to method claims for treating cancer using immunotherapies, the Moonshot Program includes a much more expansive list of eligible subject matter including: use of medical devices and pharmaceutical (i.e., non-immunotherapeutic) compositions. Further, the Moonshot Program includes eligible subject matter focused on treating nicotine dependence and smoking cessation.
2. The Moonshot Program can be applied for post-filing. The Moonshot Program permits a patent applicant to prepare a petition to enter this expedited prosecution program post-filing – i.e., not necessarily at the time of filing (as is the case for many other expedited prosecution programs) – so long as a first Office Action has not issued from the USPTO. Given this time-frame, the filing of a preliminary amendment to modify the patent claims may be a good option to put the application in the best possible position for an expedient prosecution under the Moonshot Program.
3. There are a limited number of spots available under the Moonshot Program. The Federal Register notice provides that the Moonshot Program will begin on February 1, 2023 and will end on the earlier of either January 31, 2025, or the date upon which the USPTO accepts a total of 1,000 grantable petitions under the Moonshot Program. Many commentators – including this author – expect that the Moonshot Program will end upon the 1,000 grantable petitions. As such, interested parties would be well advised to apply much sooner than later.

This new pilot program is a replacement of one implemented in 2016 under the Obama Administration’s Cancer Moonshot Program guided by then-Vice President Biden. Under that USPTO Pilot Program, a U.S. patent application that included at least one claim to a method of treating a cancer using immunotherapy and otherwise complied with certain formality requirements, could be expedited for prosecution without further payment. For patent applicants, this program was beneficial as it resulted in patent applications for these important therapies being prosecuted far faster than the typical processing time (e.g., 1-year from filing to allowance versus 3-4 years from filing to allowance). While the original program was set for a 12-month period, it has been extended year-after-year and, by nearly all accounts, has been a success.

It can be reasonably anticipated that the Moonshot Program will be used quickly by sophisticated patent applicants in the cancer/oncology arena. Patent applicants and inventors are well advised to work with their trusted patent counsel to determine whether pending filings or new inventions could appropriately be filed under the Moonshot Program.