(1) Decision of IP High Court made on November 28, 2019 (2018 [administrative litigation case, the first instance] No. 10115)

1. Outline of the Case
  The Plaintiff filed a request for an invalidation trial against Japanese Patent No. 5102928 titled “Novel antifolate combination therapies” (hereinafter, referred to as "Invention"). The JPO rendered a trial decision dismissing the invalidation trial (hereinafter, referred to as "Trial Decision"), and then the Plaintiff filed a litigation rescinding the Trial Decision (hereinafter, referred to as "Case"). In the Case, the Plaintiff alleged that the Trial Decision had an error in the recognition and determination on the novelty and inventive step, which constituted a reason for cancellation of the Trial Decision. The IP High Court, however, dismissed the Plaintiff’s request because there was no error in the recognition and determination of the Trial Decision.

2. Issues

  The Invention relates to an agent for maintaining antitumor efficacy of pemetrexed disodium (hereinafter, referred to as "MTA"), an antifolate antimetabolite pemetrexed disodium, the agent including MTA, folic acid, and vitamin B12 in combination. The issues in the Case are recognition on inventive step with respect to a combination of two or more pharmaceutical ingredients and recognition on novelty with respect to whether the Invention may be considered as "publicly known invention" or "publicly worked invention" based on a clinical trial performed in foreign countries before the priority date. Here, the outline of the latter issue, the recognition and determination on novelty, will be explained.

3. Plaintiff’s Arguments

  The Plaintiff alleged that the Invention was "publicly known" or "publicly worked" before the priority date of the Invention, because the dose, time of administration, and administration route of MTA, folic acid, and vitamin B12 included in the Invention had already been employed in a phase II clinical trial performed in Europe and in the United States before the priority date.

4. Court’s Judgment

  Regarding the Plaintiff’s argument, the Court judged as follows. The clinical trial cited in the Case was performed in accordance with a guideline established by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) (hereinafter, referred to as "ICH-GCP guideline"). The ICH-GCP guideline stipulates that a written informed consent form etc. should describe "the purpose of the trial," "the trial treatments," "the trial procedures to be followed," and "the reasonably expected benefits." According to the stipulation of the ICH-GCP guideline, however, no express rule is found with regard to what is specifically meant by and what level of information is required to be disclosed as "the purpose of the trial," "the trial treatments," "the trial procedures to be followed," and "the reasonably expected benefits," although it can be inferred that the participants of the clinical trial were provided with some information regarding that the anticancer agent to be administered was MTA in combination with folic acid and vitamin B12. Therefore, it cannot be recognized that written informed consent forms etc. included information such as specific dose, time of administration, and administration route of MTA, folic acid, and vitamin B12, or information that "toxicity associated with the administration of MTA is reduced and antitumor efficacy of MTA is maintained."

  Further, although the ICH-GCP guideline stipulates that a physician responsible for a clinical trial should answer questions to the satisfaction of the subject etc. for obtaining his/her consent, the wording is abstract and insufficient for recognizing that the circumstances allowed for provision of all information (e.g. that there was an established system where the physician responsible would provide the all information for the subjects in response to their requests), including specific dose, time of administration, and administration route of MTA, folic acid, and vitamin B12, or information that "toxicity associated with the administration of MTA is reduced and antitumor efficacy of MTA is maintained." It also cannot be recognized that the physician responsible for the clinical trial actually provided all such information for the subjects in response to their requests.

  Therefore, it is not recognized that the invention was "publicly known" or "publicly worked" based on the phase II clinical trial performed in foreign countries before the priority date.

5. Our Comments

  Pharmaceutical patent applications are generally filed before performing clinical trials, but in some cases it can be assumed that clinical trials are performed before filing of patent applications, if novel use or pharmaceutical formulation (e.g., novel combination pharmaceutical formulation as in the Case) is found. According to the judgment of the Court in the Case, it is not recognized that the Invention was "publicly known" or "publicly worked" based on the clinical trial in the Case, because "it cannot be recognized that the physician responsible for the clinical trial provided all information (including specific dose, time of administration, administration route, an effect, etc.) for the subjects in response to their requests." In addition, the Court does not recognize existence of any express duty of confidentiality for the clinical trial owed by the participants, unlike the physician. In view of this, together with the above judgment, if a written informed consent form etc. of a clinical trial includes all of the information explained above, we cannot deny the possibility that the invention is evaluated as "publicly known" or "publicly worked" based on the clinical trial.

(2) Decision of IP High Court made on November 14, 2019 (2018 [administrative litigation case, the first instance] Nos. 10110, 10112, and 10155)

1. Outline of the Case

  The Plaintiff filed a request for an invalidation trial against Japanese Patent No. 3563036 titled "Celecoxib compositions" (hereinafter, referred to as "Invention"). The JPO rendered a trial decision dismissing the invalidation trial with respect to the inventions of the claims other than the claim deleted by a request for correction (hereinafter, referred to as "Trial Decision"), and then the Plaintiff filed a litigation rescinding the Trial Decision (hereinafter, referred to as "Case"). In the Case, the Plaintiff alleged that the Trial Decision had errors in the recognition and determination on the novelty, inventive step, violation of the support requirement, and violation of the enablement requirement, which constituted reasons for cancellation of the Trial Decision. The IP High Court overturned the Trial Decision because there was an error in the recognition and determination of the Trial Decision with regard to the support requirement.

2. Issues

  The Invention relates to a pharmaceutical composition including particulate celecoxib having a distribution of particle sizes within a predetermined numerical value range. The issue in the Case is recognition on the support requirement with respect to patent right for an invention defined by a predetermined numerical value range, and the Court presented no judgment on other reasons for cancellation of the Trial Decision, including the error in recognition and determination on novelty. Here, the outline of the recognition and determination on the support requirement with respect to the invention of claim 1 (hereinafter, referred to as "Invention 1") will be explained.

3. Plaintiff’s Arguments

  The Invention 1 relates to "a pharmaceutical composition comprising one or more discrete solid orally deliverable dosage units, each comprising particulate celecoxib in an amount of 10 mg to 1000 mg in intimate mixture with one or more pharmaceutically acceptable excipients, and having a distribution of celecoxib particle sizes such that D₉₀ of the celecoxib particles is less than 200 μm in the longest dimension of said particles." The Plaintiff alleged that the Invention 1 failed to comply with the support requirement because those skilled in the art would not appreciate that the object of the Invention 1 could be achieved over the entire numerical value range "such that D₉₀ of the celecoxib particles is less than 200 μm in the longest dimension of said particles."

4. Court’s Judgment

  When a predetermined numerical value range is included in matters defining an invention, it is appropriately understood that whether or not recitation of claims comply with the support requirement should be determined by considering whether or not those skilled in the art would appreciate that the object of the invention could be achieved over the entire numerical value range encompassed by the invention based on detailed description of the invention in a specification and the common general technical knowledge as of the filing of the application.

  This is applied to the Invention 1. The Invention is characterized by "having a distribution of celecoxib particle sizes such that D₉₀ of the celecoxib particles is less than 200 μm in the longest dimension of said particles," and thus is considered as an invention defined by a predetermined numerical value range. According to the disclosure of the specification, it is recognized that the object of the Invention 1 is to provide a pharmaceutical composition including solid orally deliverable celecoxib particles and having improved bioavailability as compared to unformulated celecoxib.

  The specification includes no description indicating any specific method for obtaining the constitution "having a distribution of celecoxib particle sizes such that D₉₀ of the celecoxib particles is less than 200 μm," while it describes that celecoxib is unusually insoluble in aqueous media. As of the priority date of the Invention, it was well known or common general technical knowledge that: although grinding decreases a particle size of a drug to increase its specific surface area (effective surface area) and thereby improves its elution, a drug with low solubility and poor wettability by a solvent becomes more likely to aggregate and thus to have a smaller effective surface area, resulting in lower speed of solution, when it has a small particle size; and powder with refined particles may have poor fluidity and tend to aggregate.

  In view of this, it is impossible to immediately understand that bioavailability of celecoxib, a drug with low solubility, is improved by the constitution "such that D₉₀ of the celecoxib particles is less than 200 μm." Further, even in view of the entire description of the specification, no specific explication is found regarding technical significance of indicating the distribution of celecoxib particle sizes using a "D₉₀" value of the celecoxib particles in the longest dimension of the particles or the relationship between a "D₉₀" value and bioavailability. In addition, "D₉₀" merely represents a value of a particle size corresponding to 90% cumulative number of undersize particles, and it was common general technical knowledge as of the priority date of the Invention that bulk drugs with low solubility have different forms of distribution of particle sizes among various compounds. In view of these points, it is impossible to understand that bioavailability is improved by only limiting the ratio of particles with a particle size of 200 μm or more, regardless of the form of the distribution of particle sizes of the 90% of the particles.

  In short, the Invention 1 is not recognized to comply with the support requirement, because those skilled in the art cannot recognize that the Invention 1 can achieve the object of the Invention, that is, to provide a pharmaceutical composition including solid orally deliverable celecoxib particles and having an improved bioavailability as compared to unformulated celecoxib, over the entire numerical value range encompassed in the Invention 1, based on the detailed description of the invention in the specification and the common general technical knowledge as of the priority date of the Invention.

5. Our Comments

  In this Case, the Court judged that the Invention failed to comply with the support requirement because those skilled in the art could not recognize the object of the Invention could be achieved over the entire predetermined numerical value range. Particularly, although the defendant (the patentee of the Invention) alleged that the detailed description of the invention in the specification included evaluation of the effect of improving bioavailability of celecoxib achieved by refining celecoxib particles, the Court did not recognize such an evaluation as the grounds for the compliance with the support requirement, because the composition confirmed for the improving effect included sodium lauryl sulfate, a wetting agent, which would have influenced on the effect of improving bioavailability of celecoxib. Many chemical, including pharmaceutical, patent applications are filed for inventions including a predetermined numerical value limitation, but should be filed after careful consideration on whether or not one would recognize that an object of the invention can be achieved over the entire range of the numerical value limitation based on the detailed description of the invention in the specification or suggestions included therein, and the common general knowledge as of the filing of the application.