Medical radiation physics is an application field developed from atomic energy technology. Due to potential technology control regulations, the patenting of medical radiation physics-related inventions may be subject to additional procedures in some countries or regions.

 

35 U.S. Code § 181 sets forth as follows: "Whenever publication or disclosure by the grant of a patent on an invention in which the Government has a property interest might, in the opinion of the head of the interested Government agency, be detrimental to the national security, the Commissioner upon being so notified shall order that the invention be kept secret and shall withhold the grant of a patent therefor under the conditions set forth hereinafter." Section 181 further prescribes as follows: "Whenever the publication or disclosure of an invention by the publication of an application or by the granting of a patent, in which the Government does not have a property interest, might, in the opinion of the Commissioner of Patents, be detrimental to the national security, he shall make the application for patent in which such invention is disclosed available for inspection to the Atomic Energy Commission, the Secretary of Defense, and the chief officer of any other department or agency of the Government designated by the President as a defense agency of the United States."

 

The above provisions concerning confidentiality examination are associated with the Invention Secrecy Act of 1951. Under this Act, U.S. defense-related agencies—including the Army, Navy, Air Force, National Security Agency, NASA, Energy Information Administration, etc.—provide the United States Patent and Trademark Office (USPTO) with a Patent Security Category Review List (hereafter referred to as the “List.”) Security examination may be triggered if the technical contents of a patent application filed with the USPTO involve any keyword on the List. Once the security examination is triggered, the USPTO will review the patent application to determine whether to issue a secrecy order.

 

In principle, the List should be kept updated with technological developments and changes. However, reference to the Lists declassified by the U.S. government (e.g., the 1971 version) shows that many radiation-related technologies are within the scope of the List. Therefore, even though medical radiation physics-related patent applications should in essence have no connection with national security, they may still be reviewed during prosecution due to automatic identification of keywords by the filing system. According to practical experience, the USPTO will not include a Foreign Filing License in the Filing Receipt issued with respect to an invention that is “completed within the territory of the United States” and is first filed with the USPTO if there is a concern that a secrecy order could be issued after review. Unless an applicant is granted a Foreign Filing License by the USPTO, the applicant shall not file patent applications for the same invention in other countries within 6 months from the filing date of the U.S. application. For inventions “completed within the territory of the United States” that are not first filed in a foreign country, the applicant shall file with the USPTO a request for a Foreign Filing License before making the foreign filings. Any violation will render the future patents (if granted) invalid, and will subject the applicant to a fine of up to USD10,000 and/or a maximum of 2 years in prison. Applicants who are patenting radiation-related techniques in more than one country should be aware that inventions will be deemed as being “completed within the territory of the United States” if their research and development bases are set up in the United States or if their inventors frequently request entry into the United States. Therefore, applicants should pay special attention to related regulations if intending to file their first or non-first patent applications in a country other than the United States.   

 

Apart from the United States, China also sets forth regulations governing confidentiality examination. In accordance with Rule 8 of the Detailed Rules for the Implementation of the Patent Law, “An entity or individual who is to patent in a foreign country an invention or utility model completed within the territory of China shall file with the CNIPA a request for confidentiality examination following one of the methods below: (1) where a patent application is to be filed directly in a foreign country or an international patent application is to be filed with a relevant foreign institute, the request along with a detailed description of the technical solution to be claimed shall be submitted to the CNIPA in advance; and (2) where a patent application is to be filed in a foreign country or an international patent application is to be filed with a relevant foreign institute after patent filing in China, the request shall be submitted to the CNIPA before patent filing in that foreign country or with that relevant foreign institute.” With reference to specific practical experience, concerning an invention “completed within the territory of China” and to be first patented in China, if a request for confidentiality examination is submitted upon the patent filing and if there are doubts about secrecy after review, the CNIPA will issue a “Notification of Confidentiality Examination Regarding Patent Application to Be Filed in Foreign Countries” (hereinafter “Notification”), ordering the applicant to suspend patent filing in foreign countries. Where a further review finds no need for secrecy, the CNIPA will issue a “Decision on Confidentiality Examination Regarding Patent Application to Be Filed in Foreign Countries” (hereinafter “Decision”), notifying the applicant of permission to patent the reviewed invention or technical solution in foreign countries. Concerning an invention “completed within the territory of China” that is not first patented in a foreign country, a separate request for confidentiality examination shall be filed with the CNIPA, together with a full disclosure of the technical solution to be patented. Although it is set forth in relevant regulations that the CNIPA should serve the Notification (if any) and/or Decision to the applicant within 4 and 6 months respectively, in practice the applicant will receive the Notification within a week and the Decision within two to three weeks. Where research and development bases have been set up in China or inventors frequently request entry into China, associated inventions or utility models will be deemed as being “completed within the territory of China.” In such circumstances, applicants who intend to file patent applications in more than one country should take into consideration the required waiting times for the aforementioned confidentiality examination when devising their patent filing strategies.

 

In summary, medical radiation physics, especially BNCT technologies that have developed rapidly in recent years, offers a powerful new tool for tumor treatment. With advancements in technology, necessary patent filings from related industries are inevitable. However, given that some countries or regions impose limitations on the patenting of medical-related inventions, applicants should, during the process of developing global patent portfolios, be aware that therapeutic methods can be ineligible patent subject matters and should adapt their claim drafting accordingly, to ensure compliance with local regulations and coverage of the claimed technology to the broadest extent possible. In addition, as medical radiation physics involves technologies of nuclear transformation and radiation, special attention should be paid to local technology export control regulations to avoid any violation thereof.