On February 1, 2023, the United States Patent & Trademark Office (USPTO) will begin accepting petitions to accelerate examination under the Cancer Moonshot Expedited Examination Pilot Program (the “Moonshot Program”). The Moonshot Program replaces and expands the current “Cancer Immunotherapy Pilot Program” (also called “Patents for Patients” or “P4P”). The Moonshot Program is scheduled to continue until the earlier of January 31, 2025 or until the USPTO has accepted 1,000 grantable petitions.
The Moonshot Program offers expedited examination of patent applications in the fields of oncology or smoking cessation that have an eligible method claim selected from:
- Methods of treating cancer using an immunotherapy (as in the current P4P program).
- Methods of treating cancer by targeting specific markers or mutations (“personalized medicine”) using a specific pharmaceutical composition.
- Methods of treating rare or childhood cancers using a specific pharmaceutical composition. Qualifying cancers are those classified as rare by the National Institutes of Health.
- Methods of detecting or treating a cancer using a medical device specifically adapted to detect or treat the cancer.
- Methods of diagnosing and treating a cancer using a specific pharmaceutical composition.
- Methods of treating a nicotine dependency and promoting smoking cessation by administering a specific pharmaceutical composition.
Under the Moonshot Program, claim sets can focus on compounds, compositions, and devices. Importantly, for applications with an independent claim to a compound, composition, or device, the application must also include a method claim that (1) is directed to one of the enumerated categories of eligible claims above and (2) incorporates all the requirements of the broadest compound/composition/device claim. Also noteworthy, for applications focused on methods of diagnosing and treating cancer, the claimed diagnostic step must be a specific diagnostic protocol.
Applicants considering the Moonshot Program should work with their patent counsel to ensure that the patent application is drafted with the Moonshot Program in mind. For immunotherapeutic methods/compositions applications, the specification must contain evidence that the claimed compound/composition is immunotherapeutic. Likewise, for personalized medicine applications, the specification must contain evidence that the claimed compound/composition targets the specifically identified genetic markers/mutations to treat the cancer.1 For medical devices, the Moonshot Program requires that “the only use disclosed in the specification for the medical device is to treat or detect a cancer.”
Petitions to make special under the Moonshot Program do not need to be filed with the application; they must only be filed prior to the receipt of a first office action (including a restriction requirement). Various additional technical formalities must be met and can be found on the Federal Register Notice and on USPTO.gov.
In both cases, a petition must be filed with the request to make special that identifies the specific page(s) of the specification containing the evidence.
Michael H. BrodowskiPartner
Maria C. Smith Ph.D.Associate
Stephanie Dusaban Gonzales Ph.D.Associate