2019-00202. Extension of the Cancer Immunotherapy Pilot Program

AGENCY:

United States Patent and Trademark Office, Commerce.

ACTION:

Notice.

SUMMARY:

On June 29, 2016, the United States Patent and Trademark Office (USPTO) implemented the Cancer Immunotherapy Pilot Program, which permits patent applications pertaining to cancer immunotherapy to be advanced out of turn for examination and reviewed earlier (accorded special status). To date, over 300 petitions requesting participation in the pilot program have been filed, and over 100 patents have been granted under the pilot program. In view of the continued interest in the pilot program, the USPTO has extended the pilot program until June 30, 2020. All pilot parameters remain the same as the original pilot.

DATES:

Duration: The Cancer Immunotherapy Pilot Program will continue to run until June 30, 2020. Therefore, petitions to make special under the Cancer Immunotherapy Pilot Program must be filed on or before June 30, 2020. In addition, any petition to make special under the Cancer Immunotherapy Pilot Program filed between December 31, 2018, and the publication date of this notice will be considered timely. The USPTO may further extend the pilot program (with or without modifications) or terminate it depending on feedback received, continued interest and the effectiveness of the pilot program.

FOR FURTHER INFORMATION CONTACT:

Pinchus M. Laufer, Patent Attorney (telephone [phone]; electronic mail at [e-mail]) or Susy Tsang-Foster, Senior Legal Advisor (telephone [phone]; electronic mail at [e-mail]), of the Office of Patent Legal Administration, Office of the Deputy Commissioner for Patent Examination Policy.

For questions relating to a specific petition, please contact Gary B. Nickol, Supervisory Patent Examiner (telephone [phone]; electronic mail at [e-mail]) or Brandon J. Fetterolf, Supervisory Patent Examiner (telephone [phone]; electronic mail at [e-mail]), of Technology Center 1600.

SUPPLEMENTARY INFORMATION:

The USPTO published a notice for the implementation of the Cancer Immunotherapy Pilot Program on June 29, 2016. See Cancer Immunotherapy Pilot Program, 81 FR 42328 (June 29, 2016), 1428 Off. Gaz. Pat. Office 253 (July 26, 2016) (Cancer Immunotherapy Notice). The pilot program was designed to support the global fight against cancer. The Cancer Immunotherapy Notice indicated that an applicant may have an application advanced out of turn (accorded special status) for examination without meeting all of the current requirements of the accelerated examination program set forth in item VIII of MPEP section 708.02(a), if the application contained at least one claim to a method of treating cancer using immunotherapy and met other requirements specified in the Cancer Immunotherapy Notice.

The Cancer Immunotherapy Notice established that the pilot program would run for twelve months from June 29, 2016. The USPTO extended the pilot program to December 31, 2018, through a notice published in the Federal Register. See Extension of the Cancer Immunotherapy Pilot Program, 82 FR 28645 (June 23, 2017), 1440 Off. Gaz. Pat. Office 256 (July 25, 2017). In view of the continued interest in the pilot program, the USPTO has extended the pilot program through June 30, 2020. The extension also will allow the USPTO to continue its evaluation of the pilot program. The requirements of the pilot program have not been modified.

Various stakeholders from around the world have filed petitions to participate in the pilot program—they are independent inventors, universities, research institutions, hospitals, medical centers, government agencies, and large and small companies. To date, over 300 petitions requesting participation in the pilot program have been filed, and over 100 patents have been granted under the pilot program. The USPTO may again extend the pilot program (with or without modifications) depending on the feedback from the participants, continued interest, and the effectiveness of the pilot program.

Dated: January 18, 2019.

Andrei Iancu,

Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office.