Patents and Trademarks
The legal framework for patents and trademarks in Japanese Pharma. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for USD 99.
1. What are the basic requirements to obtain patent and trademark protection?
The Patent Act stipulates that an invention must be novel, non-obvious and have industrial applicability. The Trademark Act allows any trademark unless the mark is the same or similar to another registered mark or otherwise prohibited under the Act. On top of the Trademark Act restriction, there is a special restriction for the medicine to avoid confusion among medicines.
2. What agencies or bodies regulate patents and trademarks?
The Japan Patent Office (JPO) regulates both patents and trademarks.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
For patents, basically any novel, non-obvious and industrial applicable substances and processes can be protected. However, under the Japanese Patent Act, medical treatment and related practices are not approved as a patent. So those cannot be patented even as a process patent.
For trademarks, a name of a medicine that is confusing with another medicine is not approved, even if it is granted under The Trademark Act.
4. How can patents and trademarks be revoked?
An interested party may claim for invalidation request to JPO. JPO will decide whether or not a patent or a trademarks be revoked as the first instance. The second instance for the invalidation request is the Intellectual Property High Court. There are two in Japan, one is in Tokyo High Court and another is in Osaka High Court. The final instance is the Supreme Court.
5. Are foreign patents and trademarks recognized and under what circumstances?
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
There is a re-examination System under the PMD Act, and a certain Re-examination Period is provided when a new medicine is approved or in other cases stipulated in the list below. The re-examination period is extended for a certain duration not exceeding 10 years. The purpose of the re-examination period is to obtain safety and efficacy evidence in the real healthcare market. The MA holder must conduct researches and trials as agreed with MHLW at the time of approval, including Post Marketing Surveillance and gathering Drug Safety Information Data during the Re-examination Period. Then, after such period, MHLW will re-examine and approve the efficacy and safety of the medicine. Until the medicine is re-examined and approved, generic medicines cannot come into the market. Accordingly, the Re-examination Period works similar to Data Exclusivity in other jurisdictions.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?