Tokyo District Court, 2024 (Yo) 30029 — Age-Related Macular Degeneration (Nakashima, Civil Division 40)
Updated: 3 hours ago
Article information
Article type: Case note
Categories: Patents, Unfair competition law
Topics: Claim interpretation, Novelty, Patent linkage, False allegations, Injunctions
First published on this website: 2026-10-16
Display and classification checked: 2026-10-17
Case information: 2024 (Yo) 30029
Tokyo District Court, 2024 (Yo) 30029 — Age-Related Macular Degeneration (Nakashima, Civil Division 40)
★ Application for a provisional injunction based on violation of the Unfair Competition Prevention Act: a case denying patent infringement by finding that the medical-use invention was not worked under an “exclusively” standard and that, on the patentee’s argument that a certain proportion sufficed, novelty would be lacking.
* However, the word “exclusively” does not mean 100%.
1. The court’s reasoning ①: infringement of a use invention
As set out below, the court denied patent infringement. It found non-satisfaction under an “exclusively” standard for working a medical-use invention: “working” under Article 2(3) of the Patent Act satisfies the use limitation when production, use, transfer, or similar acts are performed exclusively for the medical use specified in the claims (in this invention, for administration to the specified patient group). It also held that, on the patentee’s argument that a certain proportion sufficed, the invention lacked novelty.
“A use invention is technically characterized by discovering an unknown property of a known substance and, on the basis of that property, creating a novel use with a remarkable effect. Accordingly, ‘working’ under Article 2(3) of the Patent Act in relation to a use invention should be construed as producing, using, transferring, or otherwise dealing with a known substance exclusively for use in the novel use. Applying this to the invention at issue, the claims and the specification ([0005], [0006], and [0018]) show that anti-VEGF agents, which are known substances, were conventionally recognized as effective for wAMD patients having predominantly classic active subfoveal CNV regions occupying at least 50% of the total lesion size (pCNVwAMD patients). The invention at issue is characterized by creating a novel use with a remarkable effect through administration to wAMD patients who meet certain inclusion and exclusion criteria and have an active CNV lesion size of less than 50% of the total lesion size (sCNVwAMD patients; also referred to below as ‘the specified patient group’), based on the discovery of the unknown property of anti-VEGF agents that they exhibit a superior therapeutic effect in those patients compared with pCNVwAMD patients. Accordingly, ‘working’ under Article 2(3) of the Patent Act for this invention should be construed as producing, using, transferring, or otherwise dealing with an anti-VEGF agent exclusively for administration to the specified patient group. …
Turning to the creditor’s product in this case, according to the underlying facts, the creditor’s product is a biosimilar of the debtor’s product. The proposed package insert for the creditor’s product submitted with the approval application at issue merely states ‘age-related macular degeneration with subfoveal choroidal neovascularization’ as the indication. Neither the ‘Indications or Effects’ section nor the ‘Dosage and Administration’ section contains any reference to the specified patient group, and no statement can be found to the effect that administration to that group produces a remarkable effect. On these findings, the approval application for the creditor’s product cannot be said to be an application for administration to the patient group defined by Claim Limitations A2, B, and C of the invention (the specified patient group). Unless there are special circumstances establishing a likelihood that the creditor will deliberately sell or otherwise deal with its product for a use different from that in the approval application, the result is otherwise; even all of the prima facie evidentiary materials in this case are insufficient to clearly establish such special circumstances. In these circumstances, manufacture and sale or similar acts concerning the creditor’s product cannot be regarded as producing, using, transferring, or otherwise dealing with an anti-VEGF agent exclusively for administration to the specified patient group, and are insufficient to establish infringement of the patent right at issue.
Moreover, even if one were to adopt the debtor’s view that manufacture and sale or similar acts concerning the creditor’s product infringe the patent because the product may ultimately be administered to a certain proportion of the specified patient group, the underlying facts show that the creditor’s product is a biosimilar of the debtor’s product, has equivalence and similarity in quality to it, and that the debtor’s product had been manufactured and sold before the priority date at issue. Therefore, like the creditor’s product, the debtor’s product must also be found to have been administered to a certain proportion of the specified patient group. It is thus self-evident that manufacture and sale of the debtor’s product constitutes public working under Article 29(1)(ii) of the Patent Act and that the patent at issue should be invalidated.”
2. The court’s reasoning ②: the Unfair Competition Prevention Act / communication of false facts
The court found that the patentee’s act of responding to the Ministry of Health, Labour and Welfare and others that “manufacturing and selling a biosimilar of the debtor’s product would infringe this patent” (the communication at issue) constituted communication of false facts. However, as set out below, it held that this violates the Unfair Competition Prevention Act only “where there are special circumstances in which the act is found to be markedly inappropriate in light of the purpose and objectives of patent linkage.” It did not find a violation in this case.
“If, under patent linkage, a response by the aforementioned patentees or others stating that there is a patent conflict between a patent relating to an originator drug and a generic drug were immediately unlawful as communication of false facts whenever it differed from a subsequently final court determination, those patentees or others would be unable to fully state their own views on the existence of a patent conflict in the pharmaceutical patent information reporting form. The Ministry of Health, Labour and Welfare and others would consequently be unable to accurately determine whether a stable supply of the generic drug could be ensured, potentially undermining the purpose and objectives of patent linkage. However, patent linkage is intended, from the perspective of ensuring a stable supply of generic drugs, to confirm during approval review whether there is a patent conflict between a patent relating to an originator drug and a generic drug. It is therefore clear that it does not permit patentees or others relating to originator drugs to provide arbitrary information or grant them broad immunity. Accordingly, where a false response under patent linkage by a patentee or other person relating to an originator drug, stating that there is such a patent conflict, outwardly takes the form of information provision under patent linkage but in substance seeks to place the applicant for manufacturing and marketing approval of the generic drug at a disadvantage and to secure a competitive advantage for the respondent, it is appropriate, in light of the above purpose and objectives of Article 2(1)(xxi) of the Unfair Competition Prevention Act, to regard that act as a category of unfair competition obstructing fair competition among businesses. From this perspective, a false response by a patentee or other person relating to an originator drug under patent linkage, stating that there is a patent conflict between the patent relating to the originator drug and a generic drug, should be regarded as unfair competition under Article 2(1)(xxi) where special circumstances establish that it is markedly inappropriate in light of the purpose and objectives of patent linkage, because it communicates false facts damaging the business reputation of a competing applicant for manufacturing and marketing approval of the generic drug.”
3. Some observations
(1) Definition of a “use invention”
First, a “use invention” must be defined as the basis for discussion. Having comprehensively examined Japanese patent judgments, I consider that inventions for which there is no infringement unless manufacture and sale expressly present the relevant “use” are cases where the structural features of the product alone, excluding the “for …” use limitation, lack novelty or inventive step, and novelty or inventive step is recognized only through specification of the “for …” use.
This decision states: “A use invention is technically characterized by discovering an unknown property of a known substance and, on the basis of that property, creating a novel use with a remarkable effect.” It thus defines a “use invention” as an invention whose product features alone, excluding the use limitation, lack novelty. This is a case in which novelty or inventive step is recognized only through specification of the use, and falls within the above category in which manufacture and sale do not infringe unless the “use” is expressly presented.
(2) Technical scope of a “(medical) use invention” specifying the recipients of administration
For a medical-use invention limiting the recipients of administration, under this decision’s “exclusively” standard, the use limitation would apparently not be satisfied unless the product is manufactured and sold with labeling, promotion, or similar representations indicating that the recipients are persons “aged 60 or older,” persons “who have not had a recurrence of breast cancer,” or persons “who have not developed allergic asthma.”
Moreover, Patent No. 5705483, whose novelty was recognized in IP High Court, 2018 (Gyo-Ke) 10036, concerns an invention specifying a newly discovered mechanism as an invention-defining feature, a recent hot topic. Its claim reads: “A composition comprising an antagonist of interleukin-23 (IL-23), for use in an in vivo treatment method for inhibiting interleukin-17 (IL-17) production by T cells.” Since this too appears to be a use invention, the analysis would be that the limitation is satisfied when it is sold or otherwise dealt with “to inhibit IL-17 production”; in other words, it would not be satisfied unless the product is manufactured and sold with labeling or promotion indicating that the recipients are “patients showing elevated IL-17 levels.”
(3) Comparison with the “knowing” requirement for indirect infringement involving multifunctional products (the 25% rule)
The “knowing” requirement for indirect infringement involving multifunctional products (Article 101(ii) and (v) of the Patent Act) concerns manufacture and sale or similar acts involving an indirectly infringing product while “knowing” that it will be used to produce a directly infringing product. As in the cases reproduced below, it is held to be satisfied where the indirect infringer knows that persons within a “range that cannot be regarded as exceptional” use it to produce directly infringing products. (This appears to draw on the standard adopted in the Supreme Court decision of December 19, 2011, Keishū Vol. 65, No. 9, p. 1380, the Winny case.) Three decisions have treated approximately “25%” as satisfying a “range that cannot be regarded as exceptional.” (The Supreme Court’s Winny decision, however, denied intent and acquitted the defendant, holding that “it cannot be found that the defendant recognized and accepted that the proportion of users using it for copyright infringement had … extended to a range that could not be regarded as exceptional, such as approximately 40%.” In civil proceedings, the defendant will have knowledge by the close of oral argument, so at least an injunction claim cannot be avoided.)
For use inventions, there is also a view that working of the invention is not limited to sales expressly presenting the use through labeling or promotion, but can arise from “the possibility that the product will ultimately be administered to a certain proportion of the specified patient group.” The patentee advanced that argument in this case as well. If that view is assumed, an unresolved issue was what percentage of the products sold the seller must know will be used for the patented use before infringement arises: 100%, 99%, or a “range that cannot be regarded as exceptional” (approximately 25%?).
By contrast, this decision established an “exclusively” standard. Formally speaking, therefore, if even 1% is used for a use other than that of the use invention, the use limitation would not be satisfied. So-called off-label use—use of a drug for an indication or in a manner different from those approved, that is, use not stated in the labeling (package insert)—would thus appear not to infringe a use invention, unless there are circumstances such as promotion of that off-label use. (Nevertheless, “exclusively” does not mean 100%, so the proportion or amount “used for a use other than that of the use invention” that leads to non-satisfaction remains an unresolved issue.)
As to whether such a conclusion is appropriate, this decision holds that a ground for invalidity based on lack of novelty would exist if one “adopted the debtor’s view that manufacture and sale or similar acts concerning the creditor’s product infringe the patent because the product may ultimately be administered to a certain proportion of the specified patient group.”
However, on this approach, not only medical-use inventions but also selection inventions limiting the range of products to those with particularly high effects may face denial of novelty where the selected range had already been worked before filing, because they are not use inventions. Such an approach is not unreasonable, but it does not necessarily align with past practice in every respect. Further examination is therefore needed to seek a consistent understanding.
Furthermore, where inventive step is recognized because of an unpredictable remarkable effect, a question has been raised: does infringement arise only where the product is sold or otherwise dealt with while expressly presenting that effect, as with a so-called use invention, or does infringement arise irrespective of whether that effect is expressly presented? (Misao Shimizu, Hyakusen of Patent Cases, 5th ed., Case 69, “Inventive Step (5)—The Independent-Requirement Theory of Remarkable Effects [Shoe Press Belt Case].”)
093519_hanrei.pdf
Originally published: 2025-03-12
Original Japanese post: https://ameblo.jp/hideki-takaishi/entry-12889616530.html
English translations of the Japanese source figures
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This history records actual publication, display, and classification changes made on this website.
2026-10-16: The AMEBLO source was first published on this website.
2026-10-17: Added classification, topic tags, article information, translation navigation, related articles, consultation guidance, and SEO. The original article text was not changed.
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