**Update: The USPTO has extended the Cancer Immunotherapy Pilot Program, which was set to expire on June 23, 2017, to a new expiration date of December 31, 2018. To date, the USPTO says that over 80 petitions to make special under the program have been made and 9 patents granted.**
The Patent Office has implemented the Patents 4 Patients program (a.k.a. the Cancer Immunotherapy Pilot Program) as part of the National Cancer Moonshot announced by President Obama in his 2016 State of the Union address. Normally, patent applications are taken up for examination based on their filing date. The program’s mission is expediting patent prosecution for applications pertaining to cancer immunotherapy by advancing them out of turn. The pilot program is effective for 12 months starting from June 29, 2016, although it may be extended at the Office’s discretion. As time is running out to take advantage of this program, here are ten points to consider when figuring out if the Cancer Immunotherapy Pilot Program is right for your invention as well as points differentiating this pilot program from existing fast track programs.
How to apply
Interested Applicants fill out the appropriate petition to make special (Petition Form PTO/SB/443) certifying that their application satisfies the requirements of the pilot program and submit the form via EFS-Web (the Patent Office’s online filing system). Applicants must not choose Accelerated Exam or Track 1 if they intend to participate in the pilot program, and the application cannot have been made special under any other Patent Office procedure. No fee is required.
Eligible applications must contain one or more claims to a method of treating cancer using immunotherapy. The eligible topic area includes methods 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. This can include the administration of cells, antibodies, proteins, or nucleic acids that invoke an active (or achieve a passive) immune response to destroy cancerous cells. The topic area further includes the co-administration of biological adjuvants (e.g., interleukins, cytokines, Bacillus Comette-Guerin, monophosphoryl lipid A, etc.) in combination with conventional therapies for treating cancer such as chemotherapy, radiation, or surgery, as well as in vivo, ex vivo, and adoptive immunotherapies, including those using autologous and/or heterologous cells or immortalized cell lines.
Eligible applications must contain 1-3 independent claims, no more than 20 total claims, and no multiple dependent claims. Both new and pending non-provisional utility applications are eligible, as well as international applications entering via 35 U.S.C. 371 (the national stage of a PCT application). The petition must be filed (i) at least one day prior to the date that notice of a first Office action (including a restriction requirement) appears in PAIR; or (ii) with a proper request for RCE. However, an applicant may file the petition after a first office action if they can certify that the claimed cancer immunotherapy is the subject of an active Investigational New Drug (IND) application at the FDA that has entered phase II or III clinical trials. While continuing applications are eligible for the pilot program, a petition must be filed for each application (the participation of the parent application does not automatically enroll the child application).
The goal is completing examination in 12 months
The purpose of this program is to complete examination of an application within 12 months of special status being granted. The Patent Office considers this to be met if an application receives a notice of allowance, a final Office action, files an RCE, goes abandoned, or files a notice of appeal within the 12-month time period.
The petition requires the Applicant to commit to several restrictions to expedite prosecution as part of the pilot program. Should a Restriction Requirement be issued, the Applicant agrees to make an election without traverse by telephonic interview, and must elect an invention directed to a method of treating cancer using immunotherapy. If the Applicant does not respond by telephone and make an election within two days, the Examiner will treat the first group of claims directed to a method of treating cancer using immunotherapy that meet the requirement as elected without traverse. Furthermore, if the Applicant takes any extensions of time in responding to the Patent Office, the application will be removed from the pilot program and examined under standard procedures.
Alternative: Accelerated Examination
The Accelerated Examination (AE) program has been available for non-reissue non-provisional utility or design applications since August 25, 2006. The purpose of AE is similar to that of the pilot program: provide a pathway for applications that satisfy particular requirements to be examined out of turn and resolve examination within 12 months. The Patent Office considers the same examination completion conditions (notice of allowance, final Office action, etc.) as the pilot program. Some similar restrictions to the application also apply (e.g., the application must contain 1-3 independent claims and 20 or fewer total claims).
Key Differences with Accelerated Examination
There are a number of important differences between AE and the cancer immunotherapy pilot program. AE is not available for national stage applications of PCT applications or RCEs (unless the application receiving an RCE was previously granted AE). At the time of filing, an application for AE must: pay all its fees (in addition to a fee for AE); provide a statement that a preexamination search has been conducted that covers all features of the claims or features that will be claimed and includes US patent publications, foreign patent documents, and non-patent literature; and provide an AE support document comprising an IDS which identifies the features of the claims recited by each reference, support for each claim feature in the specification, and explanations for why the claims are patentable over the references. These documents can represent significant investments in resources. The Applicant’s AE statement also must agree to not separately argue the patentability of dependent claims during any appeal that might arise from the AE application.
Alternative: Prioritized Examination (Track 1)
Track 1 examination, available since September 2011, is another vehicle to expedite examination of utility and plant patent applications. Similar to the cancer immunotherapy pilot program, the goal is to provide a final disposition (e.g., notice of allowance, final Office action, etc.) within 12 months of prioritized status being granted. Similar restrictions apply, for example, a Track 1 application must contain no more than 4 independent claims and 30 total claims, and a request to participate in the program can be filed prior to notice of a first Office action or in conjunction with a request for continued examination.
Key Differences with Track 1 Examination
Track 1 examination comes with a prioritized examination fee of $4,000 for a large entity (reduced to $2,000 for a small entity and $1,000 for a micro entity) in addition to the normal filing, searching, examination, and publication fees. In contrast, the cancer immunotherapy pilot program does not require any additional fee for participation, and the Accelerated Examination program only requires a $140 petition fee ($70 small entity fee and $35 micro entity fee). In addition, the number of Track 1 requests allowed is capped at 10,000 per fiscal year whereas there is no limit on the number of applications admitted to the other two programs.
The Decision to Enter the Pilot Program
When deciding whether to enter the cancer immunotherapy pilot program or any fast track program, applicants are advised to consider the pros and cons of pursuing expedited examination. Obtaining granted patents swiftly may prove valuable or even critical when seeking partners/licensees or deferring/challenging potential infringers. However, fast tracking examination may eliminate the possibility of obtaining patent term adjustment (PTA). Indeed, dragging out patent prosecution appropriately is a common strategy to maximize PTA, which extends the life of a patent beyond the standard 20-year term. PTA is especially important for applicants in the pharmaceutical industry as patents are often most valuable towards the end of their life after a drug is approved.
After balancing all the considerations, if it is desirable to expedite patent examination, an applicant may choose from applicable programs based on their benefits and limitations. Despite the cost difference, Track 1 examination has been a preferred choice over the Accelerated Examination program by applicants. As discussed above, in the Accelerated Examination program, applicants are required to conduct their own prior art searches and submit an examination support document to identify the limitations in each claim and explain why each claim is patentable over prior art reference. This self-examination is not only costly and time-consuming but may also create a written record that makes the later-granted patents more vulnerable for attack. Not surprisingly, the number of Accelerated Examination requests has been low and in January 2017, the USPTO requested public comments on whether the Accelerated Examination program should be retained given its unpopularity. In contrast, Track 1 examination and the cancer immunotherapy pilot program do not bear such a burden. Given the hefty request fee associated with the Track 1 examination, the cancer immunotherapy pilot program is a good choice for applications relating to cancer immunotherapies.