December, 2020｜News Letter

How Much Certainty should be Required as Support in Specification for Acknowledging Support Requirement?

Helsinn Healthcare S.A. v. Nipro Corporation; Case No. 2019 (Gyo-Ke) 10136 (Decision rendered on December 2, 2020)

The Patentee, Helsinn Healthcare (Helsinn), obtained a patent relating to a liquid pharmaceutical formulation of palonosetron in 2014. Against the Helsinn’s patent, Nipro filed an invalidation trial with the JPO in 2018. The JPO rendered a decision of invalidation in 2019. Helsinn filed an appeal against the JPO's decision with the IPHC in 2019.

The granted Claim 1 of the Helsinn’s patent at issue claims as follows:
A solution for preventing or reducing emesis having a storage stability for at least 24 months, comprising:
a) from 0.01 mg/mL to 0.2 mg/mL of palonosetron or a pharmaceutically acceptable salt thereof; and
b) a pharmaceutically acceptable carrier;
wherein the pharmaceutically acceptable carrier comprises mannitol.

The main issue in this case related to how much certainty should be required as a support in the specification for acknowledging support requirement. The IPHC answered to the issue as follows:

First, having reviewed the disclosures of the specification of the patent at issue in detail, the IPHC found that the specification only states that "[t]hese formulations are storage-stable for a period exceeding 24 months at room temperature" in "Summary of the Invention", and "storing the containers (containing the formulations) ... for 24 months or more" in the explanation of the embodiment, and that the specification discloses no experimental data relating to “having a storage stability for at least 24 months” (hereinafter referred to as the “24 month requirement”).

On the basis of the above finding, the IPHC decided as below:

According to the experimental results demonstrated in the working examples of the specification of the patent at issue, the stability test was not actually conducted. Thus, it cannot be said that there is a description ensuring that the pharmaceutical formulations have storage stability for at least 24 months. In addition, there are no direct references that factors which contribute to storage stabilization achieve storage stability for 24 months although these factors are listed in other portions of the specification. Further, there is no specific indication to provide grounds for inferring what factors would make it possible to achieve what level of storage stability. After all, it cannot be said that there is a description ensuring with grounds that a specific pharmaceutical formulation has storage stability for at least 24 months.
Therefore, it cannot be said that the specification discloses a palonosetron formulation with the “24 month requirement”. Furthermore, even in light of the common technical knowledge at the time of filing the patent at issue, it cannot be said that the invention of the patent at issue is within the scope of the invention which those skilled in the art could have recognized that the problem to be solved by the invention could in fact be solved; i.e., the problem of providing a palonosetron formulation with improved pharmaceutical stability to allow storage for 24 months or more, and of providing an acceptable range of concentrations which stabilize the palonosetron formulation.

In this connection, during the court proceedings, Helsinn asserted as below:

It is construed (i) that, in order to acknowledge the support requirement, it is sufficient that there is a disclosure to the extent that those skilled in the art could have obtained a reasonable expectation that the problem could be solved in view of the common technical knowledge, and (ii) that, with regard to the solution to the problem, it is sufficient that there is a disclosure to the extent that those skilled in the art could have obtained a reasonable expectation that the problem could be solved in view of the common technical knowledge, and it is not necessary to disclose the extent to which the disclosure reaches a rigorous scientific proof.
This is because (i) the support requirement is derived from the principle of the patent system which grants an exclusive right as a reward for laying an invention open to the public, and thus, the purpose of imposing the support requirement can be achieved to some extent if those skilled in the art having regard to the specification could have contributed to the further development of the art by conducting a replication study and an analysis of the invention, and (ii) taking into consideration that the description is prepared within a time constraint under the first-to-file system, it is not reasonable to require that the content of the specification be demonstrated to the same degree of rigor as required in a scientific paper.

However, the IPHC rejected the Helsinn's assertion by pointing out as below:

It cannot be acknowledged that there is a disclosure to the extent that those skilled in the art having regard to the specification of the patent at issue could have obtained a reasonable expectation that the problem (i.e., achieving a storage stability for 24 months or more) could be solved, since the specification lacks any specific disclosure according to the “24 month requirement”. In addition, even if there is a time constraint under the first-to-file system, the support requirement cannot be acknowledged by disclosures which do not even reach the extent that "a reasonable expectation" can be obtained. With regard to this, it cannot be acknowledged that there is a disclosure to the extent that "a reasonable expectation" can be obtained in the specification.

Conclusively, the IPHC dismissed the Helsinn’s appeal and upheld the JPO’s decision.

An appeal to the Supreme Court was NOT filed against this decision, and thus the decision is made final and binding.

K&P’s Comments In a preceding IPHC decision handed down in July 2020 <Case No. 2018 (Gyo-Ke) 10158>, the IPHC first decided as a general rule on that how much certainty should be required as a support in the specification for acknowledging support requirement. Specifically, the ruling of the IPHC is the same as the above assertion by Helsinn during the court proceedings. From now on, this general ruling will be an important guideline for considering support requirement.

(by Katsumasa OSAKI, Patent Attorney)

In December, 2020, the IPHC handed down 9 decisions including the above case on patent, and overturned the previous decision in 1 case.

In November, 2020, the IPHC handed down 6 decisions on trademark, and maintained all the previous decisions.

In November, 2020, the IPHC handed down no decision on industrial design.