The United States Patent Office (USPTO) is implementing a new program that provides prioritized examination of patent applications relating to cancer immunotherapy (Cancer Immunotherapy Pilot Program or Program). The new patent examination program, which will run June 29, 2016-2017, reinforces the White House’s $1 billion “National Cancer Moonshot” initiative and follows on the heels of recent significant advances in cancer treatment with a new class of drugs known as immune check point inhibitors, such as Keytruda® and Opdivo®.
A patent application with at least one claim to a method of treating a cancer using immunotherapy may be eligible for fast track review under the Cancer Immunotherapy Pilot Program, provided that the application meets a number of additional criteria. The patent applicant must file a petition with the USPTO. If the petition is granted, the application will be reviewed in 12 months, which is significantly shorter than the 2-3 year pendency typical for many new applications. Moreover, the Program does not require a fee, unlike the USPTO’s similar, existing “Prioritized Examination” that generally requires a $2,000-4,000 fee.
Additional information regarding the Cancer Immunotherapy Pilot Program, including the requirements for petition, can be found in the Federal Register Notice (here) and the USPTO website (here and here). For other options to expedite examination, see the recent publication in Intellectual Property Magazine by Rory P. Pheiffer “Five readily available programmes to expedite US patent prosecution.”
Konstantin Linnik is a partner in Nutter’s Intellectual Property Department. He works with biotechnology and pharmaceutical companies on various matters involving intellectual property, such as IP strategy, building and ...
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