Support and enablement requirements tend to be controversial particularly in the biotechnology and pharmaceutical fields. In this article, we will introduce a case in which the court judged that a claimed feature of “having storage stability for at least 24 months” fails to satisfy support and enablement requirements because “it cannot be deemed that it is stated with concrete supporting evidence that the specific pharmaceutical formulations have storage stability for at least 24 months” in the specification.

 

 

 

Patent Act Article 36(6)(i) provides that the claimed invention shall not exceed the extent of disclosure in the Detailed Description of the invention. Determination of the support requirement is made based on an examination on whether or not the claimed invention exceeds “the extent of disclosure in the description to which a person skilled in the art would recognize that a problem to be solved by the invention would be actually solved”. When it is determined that the claimed invention exceeds “the extent of disclosure in the description,” the statement in the claims does not satisfy the support requirement

 

 

 

Patent Act Article 36(4)(i) provides that the Detailed Description of the invention shall be stated clearly and sufficiently as to enable a person skilled in the art to carry out a claimed invention. The statement in the description does not satisfy the enablement requirement when a person skilled in the art cannot understand how to carry out the claimed invention based on the statements in the description and drawings as well as the common general technical knowledge at the time of filing. Furthermore, in a case when a person skilled in the art who intends to carry out the invention would have to make trials and errors and/or complicated and sophisticated experimentation beyond the reasonably expected extent, the statement in the description fails to comply with the enablement requirement.

 

 

 

This case is a lawsuit against a trial decision made by the JPO for a trial for invalidation of a patent concerning an invention of “Liquid Pharmaceutical Formulations of Palonosetron” (Patent No. 5551658). In the trial decision, it is determined that the patent should be invalidated because the invention fails to fulfill the support and enablement requirements. In response to this, the plaintiff (patentee) filed a lawsuit against the trial decision.

 

Claim 1 is shown below.

1. A solution for preventing or reducing emesis having storage stability for at least 24 months, comprising;

a) 0.01 to 0.2 mg/mL palonosetron or a pharmaceutically acceptable salt thereof; and

b) a pharmaceutically acceptable carrier,

wherein the pharmaceutically acceptable carrier comprises mannitol.

 

The main issue in the lawsuit is whether the above-described underlined recitation of claim 1 satisfies the support and enablement requirements. It should be noted that the plaintiff made an amendment to add the underlined requirement to claim 1 to involve inventive step against cited references at the time of responding to a notice of reasons for rejection during the examination stage.

 

 

 

With regard to the underlined recitation in the above-described claim 1 (hereinafter referred to as “24-months requirement”), the court judged as follows. “The description of the present patent states… that an effective and versatile formulation using palonosetron is storage-stable for a period exceeding 24 months at room temperature, and thus can be stored without refrigeration. Further, the specification states… by a method of storing a container containing a solution of palonosetron or a salt thereof in which a product can be stored for a prolonged period at room temperature, the container can be stored for 24 months or more. However, none of the paragraphs includes any concrete statements as to how it was confirmed that the formulation or the container could be stored for 24 months or more”.

 

Although Examples 1 to 6 are described in the specification, these Examples do not contain data proving that the pharmaceutical formulation of the invention has storage stability of 24 months. Thus, the court determined that “it cannot be deemed that it is stated with concrete supporting evidence that the specific pharmaceutical formulations have storage stability for at least 24 months”. Excerpts here are taken from the court’s findings regarding the Examples described in the specification.

 

“The specification states that the stability of the solution containing palonosetron or a pharmaceutically acceptable salt thereof is increased by adjusting the pH and/or excipient concentrations and by adding mannitol and a chelating agent at appropriate concentrations. In Examples 1 to 3, the pH value at which the formulation is most stable, the preferred concentration ranges of citrate buffer and EDTA, and the optimal level of mannitol are shown. In Examples 4 and 5, representative pharmaceutical formulations are shown. However, in Examples 4 and 5, no stability studies were actually conducted, and therefore, it cannot be deemed that the pharmaceutical formulation described therein has storage stability for at least 24 months. In other portions of the description, factors which contribute to stabilization are listed. However, there are no direct statements that these factors achieve storage stability for 24 months. Furthermore, there is no concrete indication to provide grounds for inferring what factors would make it possible to achieve what level of storage stability. After all, it cannot be deemed that it is stated with concrete supporting evidence that the specific pharmaceutical formulations have storage stability for at least 24 months.”

“Since Examples 6 and 7 lack statements on the presence or absence and the concentrations of ingredients (excipients, isotonic agents, etc.) other than palonosetron hydrochloride as well as the pH values, it cannot be deemed that these are working examples on the formulations corresponding to each of the present inventions. In Examples 6 and 7, the stability was confirmed for only 16 days at the longest. Therefore, even in light of the common general technical knowledge in (2)B above, Examples 6 and 7 cannot be grounds for solving the problem of each of the present inventions ((1)A above) such as providing a palonosetron formulation with the 24-months requirement.”

 

The plaintiffs submitted experimental data on storage stability for 24 months and argued that the support and enablement requirements were satisfied. However, the court determined that “compliance with the support requirement should be acknowledged on the basis of the matters stated in the description and the common general technical knowledge at the time of filing the application. Thus, … even though the present description and the common general technical knowledge do not enable us to recognize that a formulation with the 24-months requirement is stated, it should be deemed that it is not permissible to compensate for the above deficiency in the description by submitting experimental data (Exhibits Ko 36 and Ko 33) after filing of the present application.”

 

For these reasons, the court judged that the support requirement was not satisfied. For the same reasons, it was also judged that the enablement requirement was not satisfied.

 

 

 

As in this case, if a claim recites a configuration related to an effect that is not supported by examples, it is highly likely to be deemed as a violation of the support requirement. According to this judgement, in order to satisfy the support requirement, it is not enough that the effects of the invention are literally disclosed in the specification, but there has to be a statement to the extent that a person ordinarily skilled in the art can obtain a reasonable expectation that the problem could be solved, i.e., there has to be concrete support such as experimental results. In Japan, unlike in the U.S. and other countries, it is highly likely that late submission of experimental data proving an effect that is not recognized from the description in the specification and common general technical knowledge at the time of application will not be accepted. Thus, care should be taken, for example, when making amendments in response to a rejection.

In addition, referring to the text of this judgement, if there was “concrete indication to provide grounds for inferring what factors would make it possible to achieve what level of storage stability”, the support requirement could have been deemed to be satisfied, or the arguments based on the late submission of experimental data could have been accepted. Although it is often difficult to prepare sufficient experimental data at the time of filing an application in consideration of later amendments, it may be effective to include inferences that are considered to have a certain degree of validity as described above.

We believe that understanding the boundary between whether or not the late submission of experimental data is acceptable and how such experimental data should be described (e.g., tense, etc.) would be important issues in filing applications and obtaining rights for pharmaceuticals as this case. With such challenges in mind, we will continue to closely monitor related judicial cases.