IP basics in Life sciences
So far, we’ve explored the medicine classification and patents ( Vol. 1), and the reasons why Medicines and Patents are inseparable ( Vol. 2). In this volume, the spotlight falls on the patent itself.
Do you know how to obtain a patent? Many of you might say, “By submitting an invention with the Japan Patent Office.” Hmm, close—but not quite. It’s not entirely wrong but not entirely correct either. Submitting an invention is just the beginning, but this alone isn’t enough to secure a patent.
So, this time I’d like to explain how to obtain a patent (“a patent” here means “a patent right”).
Vol. 3: Shall we talk about how to obtain a patent?
-Process flow from patent application to obtaining a patent-
To obtain a patent in Japan, the first step is to file a patent application with the Japan Patent Office. You may have come across the term “patent submission,” but the correct official term is “patent application.” Furthermore, the person (whether an individual, company, or academic institution) who files the patent application is referred to as the “applicant,” and the date of filing is known as the “application date” or “filing date.”
The chart below illustrates the process flow. As you can see, there are several steps to obtain a patent. So, let’s take a closer look.
Patent Application
A patent application is submitted to the Japan Patent Office together with the official application form, specifications and claims, and drawings, if necessary, along with the application fee (¥ 14,000).
Publication: one year and six months from the patent application
When a patent application is filed, the application contents are published one year and six months after the application date as a “patent publication.” This publication is freely accessible to the public via the Japan Patent Office’s database, J-PlatPat. However, at this stage, a patent has not been obtained.
Request for Examination: within 3 years from the patent application
In Japan, if you want a patent, you must file a request for examination within three years from the application date . If you fail to file the request within the set period, the application will be deemed withdrawn, and you won’t be able to obtain patent rights after that. It is therefore essential not to overlook this step. The examination request fee is significantly higher than the filing fee, with a base fee of ¥138,000 plus an additional fee based on the number of claims included in the application. However, small and medium-sized enterprises (SMEs) and academic institutions may be eligible for fee reductions, which can lower the standard fee to between one-half and one-third of its original amount.
Examination
Once you have filed a request for examination, a patent examiner at the Japan Patent Office will assess whether the application satisfies the patentability requirements. In simple terms, these requirements determine whether the invention described in the application is eligible for patent protection or not. Representative criteria include novelty (not previously known) and inventive step (a significant advancement over previously known technology).
These requirements are stipulated under the Patent Act, and the terms “novelty” and “inventive step” carry specific legal meanings in the context of patent law. They differ significantly from how such terms may be used in other fields, such as pharmaceuticals, or from public understanding. If you are interested in the patentability requirements, please refer to relevant provisions of the Patent Act such as Art. 29, 29bis, 36, and 39.
If the patent application passes the examination…
If all patentability requirements are met and the application passes the examination, congratulations, the examiner issues a decision to grant a patent. Once you pay the patent fee, the patent is registered, and the patent right is officially established. Following registration, a patent gazette is published and made available for all to see on J-PlatPat.
If the patent application does not pass the examination…
If the application is deemed not to meet the patentability requirements, “an office action” is issued. In response, you, the applicant, may submit “an argument” stating, for example, that the examiner’s judgment is incorrect, or “a written amendment” to revise the content of the invention (such as the scope of claims). However, amendments to the invention are only permitted within the scope of the original disclosure at the time of filing; the addition of new details or items (so-called “new matters” in the Patent Act.) is strictly prohibited.
Once you submit a response, the examiner conducts a further examination. If the application meets the patentability requirements, “a Decision to Grant a Patent” is issued. If not, “a Decision of Refusal” is rendered. But this is not the end of the process! There is still hope for you to get a patent!
The applicant may file “a Request for Appeal Against the Decision of Refusal.” Then, if the application satisfies the patentability requirements, “a Decision to Grant a Patent” is issued, and the patent is registered upon payment of the patent fee. Conversely, if the application is still found not to meet the requirements, “an Appeal Decision of Refusal” is issued. In such cases, the applicant may further challenge the decision by filing “an Appeal” with the Intellectual Property High Court of Japan.
Post registration
After registration, a patent may remain valid for up to 20 years from the application date. Japanese patents are enforceable only within Japan. To secure protection in other jurisdictions, it is necessary to file a patent application in each country you plan to operate in. While the process to obtain a patent varies by country, the 20-year patent term is commonly adopted worldwide.
Whoops, I almost forgot; a pharmaceutical patent can be extended up to five years. Considering how long drug development takes, you can see how valuable the five years are, right?
I’ll be talking about patent term extension in the next volume. Stay tuned!
※1 Some countries, such as the United States, have a system in which all patent applications are automatically examined.
Author Profile
Yasuko Tanaka
President & CEO, S-Cube Corporation / Patent Attorney, S-Cube International Patent Firm
Outside Director, Strategic Capital Inc.; Part-time Lecturer, Tokyo University of Agriculture and Technology Graduate School; Technical Advisor for IP-related Litigation
Ms. Tanaka graduated from Chiba University (Biochemistry) in 1990. She has worked in the IP Dept. of Teijin, Pfizer Japan and 3M Japan dealing with global patent prosecution both in English and Japanese, IP strategy/consulting, transactions, and IP education. She resigned from her last company, 3M Japan, in March 2013 to start her own venture “S-Cube Corporation” (IP Business Consultancy) in April. In August, she expanded her firm establishing S-Cube International Patent Firm.
