عن الملكية الفكرية التدريب في مجال الملكية الفكرية إذكاء الاحترام للملكية الفكرية التوعية بالملكية الفكرية الملكية الفكرية لفائدة… الملكية الفكرية و… الملكية الفكرية في… معلومات البراءات والتكنولوجيا معلومات العلامات التجارية معلومات التصاميم الصناعية معلومات المؤشرات الجغرافية معلومات الأصناف النباتية (الأوبوف) القوانين والمعاهدات والأحكام القضائية المتعلقة بالملكية الفكرية مراجع الملكية الفكرية تقارير الملكية الفكرية حماية البراءات حماية العلامات التجارية حماية التصاميم الصناعية حماية المؤشرات الجغرافية حماية الأصناف النباتية (الأوبوف) تسوية المنازعات المتعلقة بالملكية الفكرية حلول الأعمال التجارية لمكاتب الملكية الفكرية دفع ثمن خدمات الملكية الفكرية هيئات صنع القرار والتفاوض التعاون التنموي دعم الابتكار الشراكات بين القطاعين العام والخاص أدوات وخدمات الذكاء الاصطناعي المنظمة العمل مع الويبو المساءلة البراءات العلامات التجارية التصاميم الصناعية المؤشرات الجغرافية حق المؤلف الأسرار التجارية أكاديمية الويبو الندوات وحلقات العمل إنفاذ الملكية الفكرية WIPO ALERT إذكاء الوعي اليوم العالمي للملكية الفكرية مجلة الويبو دراسات حالة وقصص ناجحة في مجال الملكية الفكرية أخبار الملكية الفكرية جوائز الويبو الأعمال الجامعات الشعوب الأصلية الأجهزة القضائية الموارد الوراثية والمعارف التقليدية وأشكال التعبير الثقافي التقليدي الاقتصاد التمويل الأصول غير الملموسة المساواة بين الجنسين الصحة العالمية تغير المناخ سياسة المنافسة أهداف التنمية المستدامة التكنولوجيات الحدودية التطبيقات المحمولة الرياضة السياحة ركن البراءات تحليلات البراءات التصنيف الدولي للبراءات أَردي – البحث لأغراض الابتكار أَردي – البحث لأغراض الابتكار قاعدة البيانات العالمية للعلامات مرصد مدريد قاعدة بيانات المادة 6(ثالثاً) تصنيف نيس تصنيف فيينا قاعدة البيانات العالمية للتصاميم نشرة التصاميم الدولية قاعدة بيانات Hague Express تصنيف لوكارنو قاعدة بيانات Lisbon Express قاعدة البيانات العالمية للعلامات الخاصة بالمؤشرات الجغرافية قاعدة بيانات الأصناف النباتية (PLUTO) قاعدة بيانات الأجناس والأنواع (GENIE) المعاهدات التي تديرها الويبو ويبو لكس - القوانين والمعاهدات والأحكام القضائية المتعلقة بالملكية الفكرية معايير الويبو إحصاءات الملكية الفكرية ويبو بورل (المصطلحات) منشورات الويبو البيانات القطرية الخاصة بالملكية الفكرية مركز الويبو للمعارف الاتجاهات التكنولوجية للويبو مؤشر الابتكار العالمي التقرير العالمي للملكية الفكرية معاهدة التعاون بشأن البراءات – نظام البراءات الدولي ePCT بودابست – نظام الإيداع الدولي للكائنات الدقيقة مدريد – النظام الدولي للعلامات التجارية eMadrid الحماية بموجب المادة 6(ثالثاً) (الشعارات الشرفية، الأعلام، شعارات الدول) لاهاي – النظام الدولي للتصاميم eHague لشبونة – النظام الدولي لتسميات المنشأ والمؤشرات الجغرافية eLisbon UPOV PRISMA UPOV e-PVP Administration UPOV e-PVP DUS Exchange الوساطة التحكيم قرارات الخبراء المنازعات المتعلقة بأسماء الحقول نظام النفاذ المركزي إلى نتائج البحث والفحص (CASE) خدمة النفاذ الرقمي (DAS) WIPO Pay الحساب الجاري لدى الويبو جمعيات الويبو اللجان الدائمة الجدول الزمني للاجتماعات WIPO Webcast وثائق الويبو الرسمية أجندة التنمية المساعدة التقنية مؤسسات التدريب في مجال الملكية الفكرية الدعم المتعلق بكوفيد-19 الاستراتيجيات الوطنية للملكية الفكرية المساعدة في مجالي السياسة والتشريع محور التعاون مراكز دعم التكنولوجيا والابتكار نقل التكنولوجيا برنامج مساعدة المخترعين WIPO GREEN WIPO's PAT-INFORMED اتحاد الكتب الميسّرة اتحاد الويبو للمبدعين WIPO Translate أداة تحويل الكلام إلى نص مساعد التصنيف الدول الأعضاء المراقبون المدير العام الأنشطة بحسب كل وحدة المكاتب الخارجية المناصب الشاغرة المشتريات النتائج والميزانية التقارير المالية الرقابة
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القوانين المعاهدات الأحكام التصفح بحسب الاختصاص القضائي

اليابان

JP010-j

عودة للخلف

2009 (Gyo-Hi) 326, Minshu Vol. 65, No. 3

Date of Judgment: April 28, 2011

 

Issuing Authority: Supreme Court

 

Level of the Issuing Authority: Final Instance

 

Type of Procedure: Judicial (Administrative)

 

Subject Matter: Patent (Inventions)

 

Main text of the judgment (decision):

 

1.The final appeal is dismissed.

 

2.The appellant of final appeal shall bear the cost of the final appeal.

 

Reasons:

 

Concerning the reasons for acceptance of final appeal argued by the agents appointed for final appeal, SUDO Noriaki, et al.

1. In this case, the appellee of final appeal, who holds a patent right for Patent No. 3134187 (this patent and patent right shall hereinafter be referred to as the "Patent" and "Patent Right," respectively), seeks revocation of the trial decision issued by the Japan Patent Office (JPO) dismissing the appellee's request for a trial against the examiner's decision to refuse the appellee's application for registration of extension of the duration of the Patent Right.

2. The outline of the facts legally determined by the court of prior instance is as follows.

(1) The Patent (containing 22 claims) was based on the patent application filed on March 6, 1997, for the invention entitled "controlled release composition," and was registered on December 1, 2000.

The invention claimed in the Patent relates to a controlled release composition wherein the core containing medicinal substances is coated by a coating agent that contains a water-insoluble substance, a certain hydrophilic substance, and a certain cross-linked acrylic polymer.

(2) On September 30, 2005, the appellee obtained approval for manufacturing and sale under Article 14, paragraph (1) of the Pharmaceutical Affairs Act (hereinafter referred to as the "Disposition") with regard to the pharmaceutical product called "Pacif Capsules 30mg" (hereinafter referred to as the "Pharmaceutical Product"). The Pharmaceutical Product contains morphine hydrochloride as its active ingredient, and has the effect and efficacy of a painkiller for various types of cancers that cause a medium to high level of pain.

(3) Prior to the Disposition, another approval for manufacturing and sale under Article 14, paragraph (1) of the Pharmaceutical Affairs Act had been issued to another pharmaceutical product called "OPSO (oral solution) 5mg/10mg" which has the same active ingredient as well as effect and efficacy as those of the Pharmaceutical Product (this approval and pharmaceutical product shall hereinafter be referred to as the "Earlier Disposition" and "Earlier Pharmaceutical Product," respectively). The Earlier Pharmaceutical Product is not included in the technical scope of the patented invention specified by any of the claims for the Patent Right.

(4) On December 16, 2005, the appellee filed an application for registration of extension of the duration of the Patent Right, on the grounds that the appellee had been unable to work the patented invention based on the Patent Right during a certain period of time due to the necessity to obtain the Disposition, but the JPO examiner issued a decision to refuse this application. Dissatisfied with this decision, the appellee filed a request for a trial against the examiner's decision of refusal.

(5) On October 21, 2008, the JPO issued a trial decision dismissing the appellee's request for a trial, holding that since the Earlier Disposition had been issued, prior to the Disposition, with regard to the Earlier Pharmaceutical Disposition which has the same active ingredient as well as effect and efficacy as those of the Pharmaceutical Product, it is not found that it was necessary to obtain the Disposition for the working of the patented invention based on the Patent Right (this trial decision by the JPO shall hereinafter be referred to as the "JPO Decision").

3. Even in the case where, prior to the approval for manufacturing and sale under Article 14, paragraph (1) of the Pharmaceutical Affairs Act, which gave rise to the necessity to file an application for registration of extension of the duration of a patent right (this approval shall hereinafter be referred to as the "later disposition"), another approval for manufacturing and sale under said paragraph (hereinafter referred to as the "earlier disposition") had been issued with regard to the pharmaceutical product which has the same active ingredient as well as effect and efficacy as those of the pharmaceutical product covered by the later disposition (the pharmaceutical product covered by the earlier disposition and that covered by the later disposition shall hereinafter be referred to as the "earlier pharmaceutical product" and "later pharmaceutical product," respectively), if the earlier pharmaceutical product is not included in the technical scope of the patented invention specified by any of the claims for the patent right pertaining to the application for registration of extension, it is unreasonable to deny that it was necessary to obtain the later disposition for the working of the patented invention based on said patent right, on the grounds of the existence of the earlier disposition. The purpose of the system of extension of the duration of a patent right is to reclaim the period of time during which the patentee has been unable to work the patented invention due to the necessity to obtain the disposition designated by Cabinet Order as set forth in Article 67, paragraph (2) of the Patent Act. Just because the earlier disposition had been issued with regard to the earlier pharmaceutical product which has the same active ingredient as well as effect and efficacy as those of the later pharmaceutical product, inasmuch as the earlier pharmaceutical product is not included in the technical scope of the patented invention specified by any of the claims for the patent right pertaining to the application for registration of extension, the existence of the earlier disposition does not mean that the patentee must have been able to work the patented invention based on the patent right pertaining to the application for registration of extension where the later pharmaceutical product constitutes the working of said patented invention, nor does it meant that the patentee must have been able to work the patented invention specified by any of the claims for said patent right. If the earlier pharmaceutical product is not included in the technical scope of the patented invention specified by any of the claims for the patent right pertaining to the application for registration of extension, this conclusion is not affected irrespective of how the scope of the effect of the patent right (Article 68-2 of the Patent Act) is defined in the case where the duration could have been extended because of the existence of the earlier disposition.

Since the Earlier Pharmaceutical Product is not included in the technical scope of the patented invention specified by any of the claims for the Patent Right, it is unreasonable to deny, in this case, that it was necessary to obtain the Disposition for the working of the patented invention, on the grounds of the existence of the Earlier Disposition.

4. For the reasons stated above, the ruling by the court of prior instance can be affirmed as justifiable in that the court found the JPO Decision to be illegal, holding that the existence of the Earlier Disposition cannot be the grounds for denying that it was necessary to obtain approval for manufacturing and sale under Article 14, paragraph (1) of the Pharmaceutical Affairs Act for the working of the patented invention based on the Patent Right. We cannot accept the arguments for the final appeal.

Therefore, the judgment has been rendered in the form of the main text by the unanimous consent of the Justices.

(This translation is provisional and subject to revision.)