Patent registration for Celltrion Regkirona only in 19 days with lightning speed
One published patent...jointly owned by Celltrion and the Korea Disease Control and Prevention Agency Call Center
The year 2021 is likely to be recorded as the year when the 31st and the 32nd new domestic drugs are born consecutively from the beginning of the year in the history of Korean drug development. The 31st new domestic drug approved on Jan. 18, 2021 is Yuhan Corporation’s Leclaza (lazertinib), which was discussed in the last editorial (Hit News, editorial “Lazertinib's meticulous patent strategy which only the patent attorneys can see” dated Feb. 02, 2021). And the 32nd new domestic drug approved on Feb. 5, 2021 is Celltrion's Regkirona (regdanvimab; CT-P59), which has a unique meaning in that it is the first new domestic antibody drug.
Both Leclaza (lazertinib) and Regkirona (regdanvimab) have in common that they were approved conditionally on the premise of phase 3 clinical trials, and different levels of response is observed in the industry. In general, there are praises for Leclaza, and a slightly skewed gaze towards Regkirona. As a patent attorney, I do not have the ability to evaluate this, so I have no intention of discussing it. I would like to state first that I just wanted to purely look at what kind of patent issues there are in Regkirona (regdanvimab), the 32nd new domestic drug and the first new domestic antibody drug.
There is still one patent published for Regkirona.
It is investigated that there is only one published patent related to regdanvimab so far (there may be hidden inventions which have not yet been published like formulation invention, etc.) The above patent is an antibody substance patent which was newly registered in early January this year, and Celltrion and the Korea Disease Control and Prevention Agency (KDCA, formerly the Center for Disease Control) jointly own the patent right (patent registration No. 10-2205028, Title of invention: Binding molecules with neutralizing activity in SARS-COVID-19 virus-2).
Looking at the specification of the above registered patent, a total of 290 recombinant monoclonal antibodies were synthesized based on the antibody genetic information obtained from the blood of a patient who was cured after being confirmed as infected with COVID-19, and the sequence list for such antibody information, experimental results of measuring the neutralizing ability against SARS-CoV-2 or mutant virus are described (approx. 900 pages including the sequence list based on public bulletin of registered patents). Celltrion and the KDCA have succeeded in obtaining rights for 105 antibodies out of the above 290 candidate antibody groups.
It is not directly mentioned which antibody is “regdanvimab” in the above patent specification. However, it seems clear that it is one of the 105 registered antibodies. Meanwhile, Celltrion has announced that it retains antibodies that can neutralize even UK and South African mutant viruses and that it is developing a customized cocktail treatment, so I hope that they are included in 105 antibody list above.
Celltrion's COVID-19 antibody treatment, 'Regkirona'
Registration which was made as fast as a flash of lightning
Looking at the registration process of the above patent, I could not keep my mouth shut at the promptness of the registration process.
The above patent application, which was filed with the Korean Intellectual Property Office (KIPO) around Nov. 2020 (based on a total of 7 provisional applications including the provisional application filed on March 22, 2020), was requested for expedited examination on Dec. 4 simultaneously with the request for examination. Only 11 days later, the examination result (OA; Office Action) was issued by the KIPO, which was a comprehensive refusal with grounds for rejection including 1) industrial applicability, 2) novelty, 3) inventive step, 4) lack of description. Celltrion and others submitted an amendment on the very next day as if they were waiting, and the examiners of the KIPO made a registration decision on Dec. 23, a week later. It took less than a month from the request for examination to the decision of registration (surprisingly only 19 calendar days and not working days).
It is unusually fast considering that it takes 4 to 6 months to register even using the expedited examination system, aside from the general patent registration process, which easily takes 1 to 2 years from request for examination to registration. This seems to be the result of a complex action of the specialty, etc. of a COVID-19 treatment which attracts attention not only from Korea but also from the world.
If you want to register quickly, consider the expedited examination system.
Let's take a brief look at the expedited examination system which made it possible to quickly register a patent for Regkirona (regdanvimab).
The KIPO does not examine all patent applications, but an examiner in charge examines only the applications requested for examination and decides whether to register a patent. Usually, it takes more than 12 months after the request for examination to be notified of the first examination result, but this period may vary depending on the personnel status of examiners at the KIPO and the number of applications.
In the case of patents in the pharmaceutical/bio fields, patent applications are mainly made in the basic research stage, so patent registration is usually completed before clinical trials are completed. However, if phase 1 clinical trials, phase 2 clinical trials, and conditional approval are completed within a short period of less than a year, like Celltrion's Regkirona (regdanvimab), there may occur problems that a patent may not be registered even after approval or product release with the normal patent examination period.
The KIPO is operating an expedited examination system which can significantly shorten the examination period to about two to three months for patent applications meeting certain conditions. Patent applications subject to expedited examination are stipulated in the Notice on Application for Expedited Examination for Patents and Utility Models, and the subjects for expedited examination are adjusted by policies. Recently, the subject of expedited examination has been expanded for patent applications designated as fields related to the 4th industrial revolution, including innovative new drugs and customized healthcare. In practical business, if a prior art search is requested after payment of prescribed fee to a specialized search institution, it is subject to expedited examination, so the applicant can proceed with the expedited examination if desired regardless of the field.
In the case of the Regkirona (regdanvimab) patent, it seems highly likely that the expedited examination system was used as an application in the process of preparing an invention (clinical trial on CT-P59). The examination results came out just 11 days after the application for expedited examination, which is extremely short even considering the expedited examination system currently in operation. It is presumed that the KIPO also moved swiftly in consideration of the urgent circumstances on development of the first COVID-19 antibody treatment in the country and the KDCA being included as co-applicants.
What are the other advantages of expedited examination system?
Usually, when 18 months have elapsed from the filing of a patent application, the contents of patent are published regardless of the intention of applicant (Regkirona patents are published in the form of registered patents because they were registered before). Using the expedited examination system, it is possible to determine whether a patent can be registered even before the patent is published. If the registration seems unlikely or any insufficiencies are found, it would be better to withdraw the existing application and consider re-application with the supplemented specification. In this case, the application withdrawn before publication remains unpublished forever.
In addition, when considering international application, it is necessary to decide whether to proceed within 12 months of initial filing date (the earliest date including a provisional application), (in the case of the Regkirona patent, the international application must be completed by March 22, 2021). International registration can be predicted with the expedited examination of Korea. In addition, if a patent is registered in Korea, search fees can be reduced when filing an application under the Patent Cooperation Treaty (PCT), and an international search report (ISR) favorable to the applicant can be prepared, creating a favorable environment for international registration in the future.
In the meantime, foreign countries, including the United States, are operating the expedited examination system as that of Korea. Although the system is not exactly the same as its Korean counterpart, many countries have adopted a common system called the patent prosecution highway (PPH). In this case, an applicant can go through expedited examination in foreign countries if a patent is first registered through expedited examination in the country, and then examined with a registered patent claim, so this is one of the regularly-used international application strategies.
Similarly, the patent for Regkirona (regdanvimab) has already been registered quickly in the country, it is expected that it will be able to be registered more easily and quickly in foreign countries as well.
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