The Cancer Immunotherapy Pilot Program (also known as “Patents 4 Patients”) provides accelerated review without requiring a petition fee for US patent applications pertaining to cancer immunotherapy. Final decisions on these applications are to be issued in one year or less after the applications are received.
To be eligible, an application must be in the field of oncology and must contain at least one claim encompassing a method of ameliorating, treating or preventing a malignancy in a human subject wherein the steps of the method assist or boost the immune system in eradicating cancerous cells.
The applicant must file a grantable petition using the requested Office form PTO/SB/443, form which must be filed using the patent Electronic Filing System (EFS-Web).
Application Type. To qualify, the application must be a non-reissue, non-provisional utility application, or an international application that has entered the national stage. It does not benefit from a special status previously granted under any program.
Claims. The application must contain at least one claim, but no more than three independent claims and no more than twenty total claims. The application must also not contain any multiple dependent claims. At least one claim must be directed to a method of treating cancer using immunotherapy. Additionally, the petition must include statements that the application complies with these requirements.
Statement Regarding Multiple Inventions. Moreover, the petition must include a statement that, if the USPTO determines that the claims are directed to multiple inventions, the applicant agrees to make an election without traverse in a telephone interview, and further agrees to elect an invention directed to a method of treating a cancer using immunotherapy that meets the eligibility requirements.
Timing. A petition must be filed at least one day prior to the date that notice of first Office Action appears in the Patent Application Information Retrieval (PAIR) system, or with a proper request for continued examination (RCE). If the application is both eligible and has an active IND application at the United States Food and Drug Administration that has entered Phase II or Phase III clinical trials, the petition can be filed any time prior to an appeal or a final rejection. Petitions must be filed before June 29, 2017. However, the USPTO may extend the Pilot Program, or terminate it earlier.
Publication. If a nonpublication request has been filed in connection with an application, the applicant must file a rescission of the nonpublication request on or before the date the petition is filed. For unpublished patent applications, the petition must be accompanied by a request for early publication.
Any applicant seeking protection for cancer immunotherapy methods should strongly consider participating in this pilot program. This pilot program offers applicants the opportunity to receive final decisions considerably faster than they would otherwise. As this program is designed to facilitate cancer research in an effort to eliminate cancer, it does not discriminate between applicants based on size or money. Applicants of all sizes can benefit from this program, ranging from independent inventors to small biotech startups to large, international pharmaceutical firms. Furthermore, even already-pending applications can opt into the pilot program.
However, applicants should be mindful of the requirements for this program (particularly the requirements pertaining to claims and multiple inventions) when drafting applications or deciding whether to opt into the program. This program is limited in scope as it applies only to method claims and further requires that such method claims be elected in response to any restriction requirements. Consequently, composition claims, for example, do not receive the same preferential treatment.