PTO Offers Fast Action on Cancer Immunotherapy Patent Apps

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By Tony Dutra

June 28 — The Patent and Trademark Office announced June 28 a pilot program to move applications for cancer immunotherapy treatment patents up in the examination queue.

The program supports the Obama administration's “National Cancer Moonshot” initiative designed to accelerate cancer research.

Patent applications featuring any method of treating or preventing a malignancy by boosting the immune system are eligible. An applicant will get an answer on patentability within 12 months of its petition for accelerated processing being accepted. No additional fee is required.

The program is described in a notice to be published the following day in the Federal Register. The procedure generally follows a current mechanism at the PTO known as a “petition to make special.” Patent applications are normally taken up for examination in the order they are filed, but applications accorded special status are placed in a separate docket and taken up out of turn.

Because the pilot program runs for one year, petitions to make special must be filed before June 29, 2017.

An application must contain no more than 20 claims in total, with no more than three independent claims and no multiple dependent claims. It can be a new or pending application, so long as no office actions are outstanding. The petition to make special must be filed electronically.

The claimed immunotherapy invention must be the subject of an active Investigational New Drug (IND) application currently on record with the Food and Drug Administration that has entered a phase II or III clinical trial.

Examples listed in the notice include patent claims drawn to:

  •   “the administration of cells, antibodies, proteins, or nucleic acids that invoke an active (or achieve a passive) immune response to destroy cancerous cells;”
  •   “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;”
  •  “administering any vaccine that works by activating the immune system to prevent or destroy cancer cell growth;” and
  •  “ in vivo, ex vivo, and adoptive immunotherapies, including those using autologous and/or heterologous cells or immortalized cell lines.”

One potential drawback is that applicants must also agree to have a patent application published earlier than the normal 18 months after an initial filing. Applicants can expect publication 14 weeks after a petition to make special.

To contact the reporter on this story: Tony Dutra in Washington at

To contact the editor responsible for this story: Mike Wilczek in Washington at

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