The Cancer Immunotherapy Pilot Program: An Update

In June 2017, we wrote about the United States Patent and Trademark Office (USPTO) extending the Cancer Immunotherapy Pilot Program (also known as “Patents 4 Patients”) until December 31, 2018.  (here).  Applications that qualify for the program are given “special” status with the USPTO and are fast tracked through prosecution free of charge.

On August 2, 2017, the USPTO held a Biotechnology, Chemical and Pharmaceutical (BCP) Customer Partnership Meeting providing some statistics that may shed some light on why the program was extended.  Some of the statistics from this meeting are highlighted below.

Increasing number of petitions to enter the Pilot Program

The statistics show that, between July 2016 and July 2017, 111 petitions were filed, i.e., an average about 8.5 petitions filed per month.  The majority of these petitions (73 out of 111) were granted and the rest were either undecided or dismissed.  Although the number of petitions filed per month fluctuated slightly throughout the year, May and June of 2017 saw a pick-up in the number of petitions filed with 15 and 24, respectively.  While a small sample size, the pick-up in May and June of 2017 may indicate that the program has gained popularity throughout institution.

Art Units that examined 10 or more of these applications include Art Unit 1643 (23 cases), Art Unit 1642 (14 cases), Art Unit 1644 (13 cases), and Art Unit 1645 (10 cases).  About 24% of the Pilot Program applications were examined by Art Unit 1643.

Majority of granted petitions received final dispositions within 12 months

The objective of the Pilot Program is to complete examination of an application within 12 months of special status being granted under the Pilot Program, i.e., within 12 months from the mailing date of the decision granting the petition to make special.
The statistics show that 40 out of 73 granted petitions (about 55%) have achieved one of the following final dispositions within 12 months from grant of special status under the Pilot Program: (1) mailing of a notice of allowance; (2) mailing of a final Office action; (3) filing of an RCE; (4) abandonment of the application; or (5) filing of a Notice of Appeal.  About 34% (25 total) of applications that have qualified for the program have been allowed.

As indicated by the statistics, the Cancer Immunotherapy Pilot Program appears to be a promising avenue to expedite qualifying applications.  The first-year statistics show steady, if not increasing, subscription to the program.  Additionally, examination appears to be fast-tracked with the goal of receiving a final disposition in 12 months.

As currently configured, to be eligible for the Pilot Program, the applications 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.  Expansion of the program to include additional claim types, such as composition, vaccine, peptide, protein, T-cell receptor (TCR), and antibody claims related to the cancer industry, would go a long way to fostering investment by expediting patent application examination while also advancing public policy goals by emphasizing the importance of cancer therapy treatments.

Going forward, the benefits of rapid issuance of patents under the Cancer Immunotherapy Pilot Program should continue to help applicants in the field of immunotherapy develop effective patent strategies while attracting investment for facilitating commercialization of needed cancer therapies.


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