Accelerated Patent ExaminationCancer Moonshot Expedited ExaminationExpedited ExaminationPatent LawPharmaPilot ProgramUSUSPTO
10 January 2023

Introducing the New USPTO Cancer Moonshot Expedited Examination Pilot Program

Starting from February 1, 2023, the USPTO will begin the new Cancer Moonshot Expedited Examination Pilot Program that advances out-of-turn applications that are directed to oncology or smoking cessation. This new program will replace the Cancer Immunotherapy Pilot Program that has been in place since 2016, and covers more technologies than only cancer immunotherapies.

Applications accepted into the new program will be accorded special status in Examiner’s docket and enjoy expedited examination until the first Office action is issued (including restriction requirements). The new program is available for a non-reissue (original), nonprovisional utility application filed under 35 U.S.C. 111(a), or an international application that has entered the national stage under 35 U.S.C. 371.

How to Qualify

To qualify for the new program, an application must claim an invention pertaining to one or more of the below eligible technologies:

  1. Cancer immunotherapies;
  2. Personalized medicine to treat a cancer by targeting specific genetic markers or mutations using a specific pharmaceutical composition;
  3. Cancer treatments for rare cancers, including all childhood cancers, using a specific pharmaceutical composition;
  4. Detecting or treating a cancer using a medical device specifically adapted to detect or treat the cancer;
  5. Treating a cancer by administering a specific pharmaceutical composition after diagnosing the cancer; and
  6. Treating a nicotine dependency and promoting smoking cessation by administering a specific pharmaceutical composition.

Applicants wishing to participate in the Cancer Moonshot Expedited Examination Pilot Program should contact an agent to help them file a petition to make special with the USPTO. Compared to regular accelerated examination, the new program has less stringent submission requirements. For example, it is free (no fees!) and it waives the requirement of a preexamination search report. More detailed information about the program’s exact requirements can be found here.

The program is set to run until either January 31, 2025, or the date the USPTO accepts a total of 1,000 grantable petitions, whichever is earlier.

If you would like to know whether your invention may benefit from the new program, or if you have any inquiries, please feel free to reach out to us at [email protected].

This article is for general informational purposes only and should not be considered legal advice or a legal opinion on a specific set of facts.

About the Authors

Bonnie Lau is a US Patent Agent at Eagle IP, a Boutique Patent Firm with offices in Hong Kong, Shenzhen, and Macau.

Jennifer Che, J.D. is Vice President, Principal, and a US Patent Attorney at Eagle IP, a Boutique Patent Firm with offices in Hong Kong, Shenzhen, and Macau.

Other Articles

How to Protect a Crystal Form (Polymorph) Patent in China

4 June 2025
Crystalline forms are critical to pharmaceutical patents, offering extended protection for improved stability, bioavailability, or manufacturability. However, securing such patents in China has grown increasingly difficult due to the China National Intellectual Property Administration (CNIPA)’s strict patentability criteria. Unlike the U.S. or Europe, where structural novelty or problem-solving utility may suffice, China demands quantifiable evidence of […]

China Announcing More Proposed Amendments to the Examination Guidelines in 2022

17 November 2022
It’s been a year and a half since the new Chinese Patent Law came into effect (1 June 2021). Although various versions of draft Examination Guidelines have been released, thus far no official finalized versions have been confirmed. On October 31, 2022, yet another new list of proposed amendments was published1, this time consolidating the […]

New Fee Standards Released for Chinese Patent Applications

6 September 2024
Recently, the Chinese government issued four official notices introducing new fee standards and deduction rules for Chinese patent applications.1 These updates address international applications (PCT applications) and the Chinese national phase applications thereof, as well as patent term adjustment/extension (PTA/PTE). Please find our summary below: PCT application fee deduction rules   Application fee & extra […]

China Top 50 Case of 2019: How a Functional Feature is Construed Greatly Impacts Protection Scope - Shimano KK v. SENSAH

20 July 2020
Every year in the spring The Supreme People’s Court of PRC announces its “Top 10 Intellectual Property (IP) cases” and “50 typical IP cases in Chinese courts” of the year. Although not having precedential weight, these cases serve as a reference and guide people's courts at all levels regarding their intellectual property trials. It’s always […]

Our Past Events

Top crossarrow-right