On January 12, 2016, President Barack Obama announced his goal of a nationwide “Cancer Moonshot,” with the ultimate goal of accelerating cancer research “to end cancer as we know it” during his State of the Union Address As a part of the response, the U.S. Patent and Trademark Office (“the Office”) established a program for accelerated review of patent applications directed toward one particular promising area of cancer research. This program is called the Cancer Immunotherapy Pilot Program, also referred to as “Patents 4 Patients,” and is meant to provide a final disposition within 12 months for patent applications with one or more claims drawn to a method of treating or preventing cancer using immunotherapies. Though this program is still too new to have developed a clear track record, we consider here the basic framework of the program, and some of the reasons why innovators in the immuno-oncology space may or may not want to participate in this new program.
The Cancer Immunotherapy Pilot Program provides applicants with the opportunity to obtain “special” status, providing expedited review of a patent application, with the goal being to obtain either a final rejection or a notice of allowance within 12 months of the initial filing. In this way, the program is similar to existing pathways for granting an application special status, such as the Prioritized Examination (Track I) program, the Accelerated Examination, the Patent Prosecution Highway, and petitions to grant special status due to the age or health of the applicant. The Cancer Immunotherapy Pilot Program began accepting petitions on June 29, 2016, and is expected to run for twelve months.
Eligible applications are non-reissue, non-provisional utility applications filed under 35 U.S.C. 111(a) and international applications that have entered the national stage under 35 U.S.C. 371, that contain at least one claim drawn to a method of treating cancer using immunotherapy. A petition to make special under the Cancer Immunotherapy Pilot Program needs to be filed; however, in contrast to the popular Prioritized Examination (Track I) program, no fee is required. The Office provides several examples of eligible claims including, “the administration of cells, antibodies, proteins, or nucleic acids that invoke an active (or achieve a passive) immune response to kill cancer cells,” and also indicates that therapies for treating cancer using vaccines, adjuvants, autologous or heterologous cell lines, and cytokine therapies, as well as the combination of any immunological or immunology-adjacent technology with established means of cancer therapy will also be considered.
In keeping with its goal of streamlined prosecution, applications to the Cancer Immunotherapy Pilot Program must contain no more than three independent claims and twenty total claims, with no multiple dependent claims. Similar to the Prioritized Examination (Track I) program, time periods for reply to office actions must be rigidly adhered to, and any request for extensions of time will result in the application being withdrawn from the program. In the event a restriction requirement is issued, the applicant must agree to make an election without traverse within three days, and ideally by telephone at the time the requirement is issued. In contrast to the Prioritized Examination (Track I) program, the first action interview pilot program is not available to Cancer Immunotherapy Pilot Program applications, however standard interview practice is allowed. While there are certainly other procedural details, the program is geared toward speed, though the office admits that its goal of twelve-month disposition of any given application is aspirational, and is not binding.
The “fast track” nature of the Cancer Immunotherapy Pilot Program makes the program appealing to cancer immunotherapy innovators. However, the question of when and why to participate in this pilot program is worth considering. Sometimes, a fast path to allowance may not be in the best interest of companies that develop cancer immunotherapies, as rapid allowance eliminates much if not all of potential Patent Term Adjustment (“PTA”) caused by USPTO delay. Because pharmaceutical products tend to be most valuable toward the end of their patent term, the loss of potential PTA can be a significant concern for companies seeking to protect products that are close to market.
Closer to the beginning of the R&D path for an immunotherapy however, in some cases rapid issuance of a patent can be desirable. In the case of an early-stage start-up company or a university developing methods and compositions for early proof-of-concept studies, for example, the added value of an issued patent over a less-certain pending application can be significant both as a bedrock IP asset, and as a lure to potential investors.
The ability to exclude competitors can also be of significant strategic value in earlier R&D phases. Especially in a rapidly-moving field like immunotherapy where new approaches and new competitors rise and fall quickly, having the relative certainty of an issued patent can help establish boundaries around a group of product leads early on, helping to mitigate potential conflicts with competing technologies that might come a little too close to one’s own. While patents more specifically geared toward a product may be better positioned to make use of any potential PTA, and thus may not be good candidates for accelerated review, the chance to rapidly obtain broad coverage over what is, in essence, a core research space, can provide some valuable breathing room leading up to proof-of-concept studies. The use of a rapidly granted patent to “stake a claim” to a therapeutic approach early in development can thus be an important part of a broader IP strategy covering the full lifecycle of a therapy.
No process is perfect, and for developers of cancer immunotherapies, “Patents 4 Patients” will not always be the ideal approach to growing an IP portfolio. However, by carefully weighing the benefits of rapid issuance vs. the drawbacks of fast prosecution, this pilot program, at least for the coming year, provides innovators in the immuno-oncology space with another tool to develop effective patent strategies and attract investment dollars needed to move their innovation into the clinic.