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
Arabic English Spanish French Russian Chinese
القوانين المعاهدات الأحكام التصفح بحسب الاختصاص القضائي

اللائحة رقم 1011/2006 بشأن التراخيص الإجبارية المتعلقة بتصدير المنتجات الصيدلانية للبلدان النامية والبلدان التي تعاني من مشاكل حادة للصحة العامة، إيسلندا

عودة للخلف
أحدث إصدار في ويبو لِكس
التفاصيل التفاصيل سنة الإصدار 2006 تواريخ بدء النفاذ : 23 نوفمبر 2006 الاعتماد : 23 نوفمبر 2006 نوع النص اللوائح التنفيذية الموضوع البراءات

المواد المتاحة

النصوص الرئيسية النصوص ذات الصلة
النصوص الرئيسية النصوص الرئيسية بالإنكليزية Regulation No. 1011/2006 on Compulsory Licenses Relating to the Export of Pharmaceutical Products to Developing Countries and to Countries Struggling with Severe Public Health Problems         بالإيسلندية Reglugerð nr 1011/2006 um skylduskil leyfi fyrir útflutningi á Pharmaceutical Products þróunarlöndum og til landa erfiðleikum með alvarlega Public Health Problems        

REGULATION
No. 1011/2006
on Compulsory Licenses Relating to the Export of Pharmaceutical Products to
Developing Countries and to Countries Struggling with Severe Public Health
Problems

Article 1

Scope, etc.

This Regulation applies to compulsory licenses under paragraph 5 of Article 49 of the Patents Act No. 17 of 1991, as amended, for the export of pharmaceutical products to developing countries and to countries struggling with severe public health problems, in accordance with the Decision of the World Trade Organization’s General Council of 30 August 2003 on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and Public Health.

The Reykjavik District Court grants compulsory licenses under this Regulation.

A compulsory license shall only be granted upon fulfilment of the conditions specified in the provisions of this Regulation.

Article 2

Definitions

For the purposes of this Regulation, the following definitions of terms and abbreviations shall apply:

(a)
“compulsory license” is defined as a compulsory license under paragraph 5 of Article 49 of the Patents Act No. 17 of 1991, as amended, for the export of pharmaceutical products to developing countries and to countries struggling with severe public health problems, in accordance with the Decision of the World Trade Organization’s General Council of 30 August 2003 on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and Public Health;
(b)
“patent holder” is defined as the proprietor of a patent or the holder of a supplementary protection certificate for pharmaceutical products under Article 65 (a) of the Patents Act No. 17 of 1991, as amended;
(c)
“pharmaceutical products” are defined as pharmaceutical products protected by a patent or a supplementary protection certificate under Article 65 (a) of the Patents Act No. 17 of 1991, as amended, or pharmaceutical products produced in accordance with a patented manufacturing process, or active substances necessary for that production, or equipment necessary for medical diagnosis;
(d)
“TRIPS” is defined as the Agreement on Trade-Related Aspects of Intellectual Property Rights, which is an annex to the Agreement on the Establishment of the World Trade Organization signed at Marrakesh on 15 April 1994;
(e)
the “TRIPS Council” is defined as the council supervising the implementation of the Agreement on Trade-Related Aspects of Intellectual Property Rights operating under the overall supervision of the World Trade Organization’s General Council.

Article 3

Importing countries

The following countries are eligible to import pharmaceutical products manufactured under a compulsory license:

(a)
any least-developed country that appears as such on the United Nations’ list;
(b)
any member of the World Trade Organization, other than members referred to in sub-paragraph (a), that has notified the TRIPS Council in accordance with subparagraph (b) of Article 1 and sub-paragraph (a) of Article 2 of the Decision of the World Trade Organization’s General Council of 30 August 2003 on the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health.

Article 4

Application for a compulsory license

Private individuals and legal bodies may submit an application for a compulsory license under this Regulation. The application must be signed by the applicant or his/her/its agent and must include the following:

(a)
the name, ID number and address of the applicant and his/her/its agent, if applicable;
(b)
the number and name of the patent, or the supplementary protection certificate under Article 65 (a) of the Patents Act, subject to the application for a compulsory license, including the name and address of its patent’s proprietor;
(c)
the names of the pharmaceutical products that the applicant intends to manufacture and sell for export under the compulsory license, including, if possible, international non-proprietary names approved by the World Health Organization.
(d)
the quantity of pharmaceutical products that the applicant seeks to produce under the compulsory license;
(e)
the countries to which the applicant intends to export the pharmaceutical products;
(f)
evidence of the applicant’s unsuccessful efforts to obtain a production license from the patent holder for 30 days before submitting the application for a compulsory license, or evidence of a national emergency or other circumstances of extreme urgency, cf. paragraph 5 of Article 49 of the Patents Act No. 17 of 1991, as amended;
(g)
evidence that countries intending to import the pharmaceutical products have notified the TRIPS Council in accordance with sub-paragraph (b) of Article 3, specifying the name and quantity of the pharmaceutical products required;
(h)
evidence that the pharmaceutical products are neither protected by patents nor by a supplementary protection certificate for the protection of pharmaceutical products in the importing country, or evidence that the importing country has granted a compulsory license, or evidence that the importing country has notified the TRIPS Council that it intends to grant a compulsory license in accordance with sub-paragraph (a) of Article 2 of the Decision of the World Trade Organization’s General Council of 30 August 2003 on the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health;
(i)
other matters as needed in accordance with the Decision of the World Trade Organization’s General Council of 30 August 2003.

Article 5

Notification to the patent holder

The District Court shall notify the patent holder as soon as possible of the application for a compulsory license and shall give him/her/it an opportunity to comment upon the application prior to granting the compulsory license.

Article 6

Verification of conditions, the granting of a compulsory license and its substance

The District Court shall verify whether the application fulfils the conditions set forth in this Regulation. The District Court may request the opinion of the Icelandic Patent Office during the procedure. In the event that the information provided for in Article 4 is insufficient, the District Court judge shall grant the applicant an extension of two weeks to provide the information. In the event that the conditions outlined in Article 4 are not met, or if the information is not provided within the two-week extension period, the District Court shall refuse the application for a compulsory license.

If the District Court judge determines that the application should be approved, the judge shall grant a compulsory license. The information provided in the compulsory license shall include:

(a)
the names of the pharmaceutical products that the compulsory license holder is authorized to manufacture and export;
(b)
the countries to which the pharmaceutical products may be exported;
(c)
the quantity of the pharmaceutical products that [the compulsory license holder] is authorized to produce and export, which may not exceed the needs of the importing countries;
(d)
a statement that the pharmaceutical products must be packaged and labelled in accordance with Article 8;
(e)
a provision that the compulsory license holder shall, before export, post information on his/her/its website in accordance with Article 9;
(f)
the duration of the compulsory license.

Concurrently with a decision to grant a compulsory license, the District Court judge shall determine the amount of remuneration to be paid to the patent holder.

Copies of the District Court’s decision shall be sent to the patent holder as well as to the Icelandic Patent Office, the latter of which shall record information concerning compulsory licenses in the patent register and post an announcement to that effect in the Icelandic Patent Gazette.

Article 7

The scope of a compulsory license

The compulsory license holder is authorized to manufacture only the pharmaceutical products specified in the compulsory license and only in the quantities therein cited. The holder does not have permission to market, sell or export the pharmaceutical products to countries other than those specified in the compulsory license.

Article 8

Labelling and packaging

Pharmaceutical products manufactured under the compulsory license shall be distinguishable from pharmaceutical products manufactured by the patent holder. The pharmaceutical products shall be distinguished from those manufactured by the patent holder through the use of special packaging, colouring or shape, provided that such distinctions are feasible and do not have a significant impact on price. The pharmaceutical products must be labelled in a way indicating that the product was manufactured in accordance with a compulsory license under paragraph 5 of Article 49 of the Patents Act No. 17 of 1991, as amended, and under this Regulation.

Article 9

Information posted on the website of the compulsory license holder

Prior to the export of the pharmaceutical products, the compulsory license holder shall post information in Icelandic and English on his/her/its website regarding the quantities being supplied under the license and the countries to which the pharmaceutical products are to be supplied. Furthermore, information must be posted there specifying how pharmaceutical products manufactured under the compulsory license may be distinguished from the pharmaceutical products of the patent holder. This information must remain on the website of the compulsory license holder for the duration of the compulsory license.

If the compulsory license holder does not host a website in his/her/its own name, the information referred to in paragraph 1 shall be sent to the World Trade Organization, which will post the information on a website that relates to the Decision of the General Council of 30 August 2003.

The compulsory license holder shall notify the Icelandic Patent Office and the patent holder that the information referred to in paragraph 1 has been posted on his/her/its website or the website of the World Trade Organization, along with the web address.

Article 10

Notification to the TRIPS Council

The Icelandic Patent Office shall notify the TRIPS Council that a compulsory license has been granted. The notification shall include the following information:

(a)
the name and address of the compulsory license holder;
(b)
the pharmaceutical products covered by the compulsory license;
(c)
the quantities of pharmaceutical products to be exported;
(d)
the countries to which the pharmaceutical products are to be exported;
(e)
the duration of the compulsory license;
(f)
the web address of the compulsory license holder that displays the information outlined in paragraph 1 of Article 9.

Article 11

Extension of the duration of a compulsory license

The compulsory license holder may request that the District Court extend the duration of a compulsory license if the licensee has been unable to export the permitted quantities of pharmaceutical products cited in the compulsory license. The patent holder shall be informed as soon as possible of a request by the compulsory license holder for an extension and must be given an opportunity to comment upon the application. The District Court shall only approve such a request if it finds that the compulsory license holder has in other respects fulfilled the conditions outlined in the compulsory license.

Article 12

Revocation of a compulsory license

The patent holder may submit a request that the District Court revoke a compulsory license. The District Court judge may comply with such a request if the court finds that the compulsory license holder has not fulfilled the conditions outlined in the compulsory license. Both the compulsory license holder and the patent holder shall be notified of the decision of revocation.

A copy of a decision to revoke a compulsory license must be sent to the Icelandic Patent Office, which must notify the TRIPS Council of the contents of the revocation as soon as possible.

In the event of a revocation of a compulsory license, the compulsory license holder must as soon as possible see to it that any excess stock of pharmaceutical products manufactured under the provisions of this Regulation be distributed to the countries designated as importing countries in the compulsory license, or see to it that the pharmaceutical products shall otherwise be disposed of.

Article 13

Entry into force

This Regulation, which has been issued pursuant to authorization provided in paragraph 5 of Article 49 of the Patents Act No. 17 of 1991, as amended, enters into force immediately.

The Ministry of Industry, 23 November 2006

Jon Sigurdsson

Kristjan Skarphedinsson

 REGLUGERÐ Nei 1011/2006 um skyldutryggingu leyfi varðandi útflutning lyfja til

Nr. 1011 23. nóvember 2006

REGLUGERÐ um nauðungarleyfi vegna útflutnings lyfja til þróunarríkja og ríkja

sem stríða við alvarlegan heilbrigðisvanda.

1. gr. Gildissvið o.fl.

Reglugerð þessi gildir um nauðungarleyfi skv. 5. mgr. 49. gr. laga nr. 17/1991 um einkaleyfi, með síðari breytingum, vegna útflutnings lyfja til þróunarríkja og ríkja, sem stríða við alvarlegan heilbrigðisvanda, í samræmi við ákvörðun aðalráðs Alþjóðaviðskiptastofnunar- innar frá 30. ágúst 2003 um samninginn um hugverkarétt í viðskiptum og heilbrigði almenn- ings.

Héraðsdómur Reykjavíkur veitir nauðungarleyfi samkvæmt reglugerð þessari. Nauðungarleyfi skal einungis veitt að fullnægðum þeim skilyrðum sem tilgreind eru í

ákvæðum reglugerðar þessarar.

2. gr. Orðskýringar.

Í reglugerð þessari er merking eftirfarandi orða og skammstafana sem hér segir: a. Með orðinu „nauðungarleyfi“ er átt við nauðungarleyfi skv. 5. mgr. 49. gr. laga nr.

17/1991 um einkaleyfi, með síðari breytingum, vegna útflutnings lyfja til þróunar- ríkja og ríkja, sem stríða við alvarlegan heilbrigðisvanda, í samræmi við ákvörðun aðalráðs Alþjóðaviðskiptastofnunarinnar frá 30. ágúst 2003 um samninginn um hugverkarétt í viðskiptum og heilbrigði almennings.

b. Með orðinu „einkaleyfishafi“ er átt við eiganda einkaleyfis eða handhafa viðbótar- vottorðs um vernd lyfja skv. 65. gr. a í lögum nr. 17/1991 um einkaleyfi, með síðari breytingum.

c. Með orðinu „lyf“ er átt við einkaleyfisvernduð lyf eða lyf vernduð með viðbótar- vottorði um vernd lyfja skv. 65. gr. a í lögum nr. 17/1991 um einkaleyfi, með síðari breytingum, lyf sem framleidd eru með einkaleyfisverndaðri aðferð, virk efni sem nauðsynleg eru fyrir framleiðsluna og nauðsynlegan sjúkdómsgreiningarbúnað.

d. Með „TRIPS“ er átt við samninginn um hugverkarétt í viðskiptum (Trade-related Aspects of Intellectual Property Rights) en hann er viðauki við samninginn um stofnun Alþjóðaviðskiptastofnunarinnar (WTO) sem undirritaður var í Marakess 15. apríl 1994.

e. Með „TRIPS-ráðinu“ er átt við það ráð sem hefur umsjón með framkvæmd samn- ingsins um hugverkarétt í viðskiptum og starfar undir almennri umsjón aðalráðs Alþjóðaviðskiptastofnunnarinnar.

3. gr. Innflutningsríki.

Eftirfarandi ríki fullnægja skilyrðum fyrir því að geta flutt inn lyf sem framleidd eru samkvæmt nauðungarleyfi:

a. minnst þróuðu ríkin eins og þau eru skilgreind af Sameinuðu þjóðunum á hverjum tíma;

b. ríki sem eru aðilar að Alþjóðaviðskiptastofnuninni, en falla ekki undir a-lið, og sent hafa TRIPS-ráðinu tilkynningu í samræmi við b-lið 1. gr. og a-lið 2. gr. ákvörðunar

Nr. 1011 23. nóvember 2006

aðalráðs Alþjóðaviðskiptastofnunarinnar frá 30. ágúst 2003 um samninginn um hugverkarétt í viðskiptum og heilbrigði almennings.

4. gr. Umsókn um nauðungarleyfi.

Einstaklingar og lögaðilar geta sótt um nauðungarleyfi samkvæmt reglugerð þessari. Umsókn skal undirrituð af umsækjanda eða umboðsmanni hans og skal þar tilgreina:

a. nafn, kennitölu og heimilisfang umsækjanda og umboðsmanns hans ef við á; b. númer og heiti einkaleyfisins eða viðbótarvottorðs skv. 65. gr. a í lögum um einka-

leyfi, sem umsókn um nauðungarleyfi tekur til, auk nafns og heimilisfangs eiganda þess;

c. heiti lyfjanna, sem umsækjandi hyggst framleiða og selja til útflutnings samkvæmt nauðungarleyfinu, og alþjóðleg samheiti, samþykkt af Alþjóðaheilbrigðismála- stofnuninni, ef unnt er;

d. magn lyfjanna sem umsækjandi hyggst framleiða samkvæmt nauðungarleyfinu; e. þau ríki sem umsækjandi hyggst flytja lyfin til; f. gögn, sem sýna fram á að umsækjandi hafi án árangurs reynt að öðlast heimild til

framleiðslu frá einkaleyfishafa í þrjátíu daga áður en umsókn um nauðungarleyfi var lögð inn, eða gögn sem sýna fram á að um neyðartilvik eða alvarlegt hættuástand sé að ræða, sbr. 5. mgr. 49. gr. laga nr. 17/1991 um einkaleyfi, með síðari breytingum;

g. gögn sem sýna fram á að ríkin, sem hyggjast flytja lyfin inn, hafi sent TRIPS-ráðinu tilkynningu í samræmi við b-lið 3. gr. þar sem tilgreint sé heiti og magn þeirra lyfja sem þörf er á;

h. gögn sem sýna fram á að lyfin séu hvorki einkaleyfisvernduð né vernduð með viðbótarvottorði um vernd á lyfjum í innflutningsríki, að veitt hafi verið nauðungar- leyfi í innflutningsríki eða að innflutningsríki hafi sent TRIPS-ráðinu tilkynningu um að það hyggist veita nauðungarleyfi í samræmi við a-lið 2. gr. ákvörðunar aðalráðs Alþjóðaviðskiptastofnunarinnar frá 30. ágúst 2003;

i. önnur atriði eftir því sem þurfa þykir, í samræmi við ákvörðun aðalráðs Alþjóða- viðskiptastofnunarinnar frá 30. ágúst 2003.

5. gr. Tilkynning til einkaleyfishafa.

Héraðsdómur skal eins fljótt og unnt er tilkynna einkaleyfishafa um umsókn um nauð- ungarleyfi og skal gefa honum kost á að gera athugasemdir við umsóknina áður en að nauð- ungarleyfið er veitt.

6. gr. Könnun á skilyrðum, veiting nauðungarleyfis og efni þess.

Héraðsdómur kannar hvort umsókn fullnægi skilyrðum reglugerðar þessarar og er dóminum heimilt að leita álits Einkaleyfastofunnar við meðferð málsins. Skorti upplýsingar, sem kveðið er á um í 4. gr., skal héraðsdómari gefa umsækjanda tveggja vikna frest til að leggja þær fram. Fullnægi umsókn ekki skilyrðum 4. gr. eða hafi upplýsingar ekki borist innan framangreinds frests skal umsókn um nauðungarleyfi synjað.

Telji héraðsdómari efni til að verða við umsókn veitir hann nauðungarleyfi. Í efni nauð- ungarleyfis skal koma fram:

a. heiti þeirra lyfja sem nauðungarleyfishafa er heimilt að framleiða og flytja úr landi; b. þau ríki sem sem flytja má lyfin til;

Nr. 1011 23. nóvember 2006

c. magn þeirra lyfja sem einkaleyfishafa er heimilt að framleiða og flytja úr landi en það skal ekki vera umfram þörf þeirra ríkja er flytja á lyfin til;

d. að lyfjunum skuli pakkað í umbúðir og þau merkt í samræmi við ákvæði 8. gr.; e. að nauðungarleyfishafi skuli birta upplýsingar í samræmi við ákvæði 9. gr. á vef

sínum áður en til útflutnings kemur; f. gildistími nauðungarleyfis. Héraðsdómari skal samhliða ákvörðun sinni um að veita nauðungarleyfi ákvarða hversu

hátt endurgjald skuli greitt einkaleyfishafa. Samrit af ákvörðun héraðsdóms skal sent einkaleyfishafa og Einkaleyfastofunni sem skal

færa upplýsingar um nauðungarleyfi í einkaleyfaskrá og birta tilkynningu þess efnis í ELS- tíðindum.

7. gr. Gildissvið nauðungarleyfis.

Nauðungarleyfishafa er einungis heimilt að framleiða þau lyf, sem tilgreind eru í nauð- ungarleyfi, og í því magni sem þar er tiltekið. Honum er óheimilt að markaðssetja, selja og flytja lyfin til annarra ríkja en þeirra sem tilgreind eru í nauðungarleyfinu.

8. gr. Merkingar og umbúðir.

Þau lyf, sem framleidd eru samkvæmt nauðungarleyfinu, skal vera unnt að greina frá lyfjum, framleiddum af einkaleyfishafa. Lyfin skal aðgreina frá lyfjum, framleiddum af einka- leyfishafa, með öðrum umbúðum, lit eða lögun verði því komið við án verulegs kostnaðar. Lyfin skulu merkt þannig að ljóst sé að varan sé framleidd á grundvelli nauðungarleyfis skv. 5. mgr. 49. gr. laga um einkaleyfi, með síðari breytingum, og reglugerð þessari.

9. gr. Upplýsingar á vef nauðungarleyfishafa.

Áður en til útflutnings lyfjanna kemur skal nauðungarleyfishafi birta á vef sínum upp- lýsingar, á íslensku og ensku, um magn þeirra lyfja, sem flytja á út samkvæmt nauðungar- leyfinu, og þau ríki sem flytja skal lyfin til. Jafnframt skal þar tilgreint hvernig megi greina lyf, framleidd samkvæmt nauðungarleyfinu, frá framleiðslu einkaleyfishafa. Upplýsingarnar skal nauðungarleyfishafi hafa á vef sínum svo lengi sem nauðungarleyfi er í gildi.

Haldi nauðungarleyfishafi ekki úti vefsíðu í eigin nafni skulu upplýsingar skv. 1. mgr. sendar Alþjóðaviðskiptastofnuninni sem birtir þær á vef sem tengist ákvörðun aðalráðsins frá 30. ágúst 2003.

Nauðungarleyfishafi skal senda Einkaleyfastofunni og einkaleyfishafa tilkynningu um að upplýsingar skv. 1. mgr. séu komnar á vef hans eða Alþjóðaviðskiptastofnunarinnar ásamt veffangi.

10. gr. Tilkynningar til TRIPS-ráðsins.

Einkaleyfastofan skal tilkynna TRIPS-ráðinu um að nauðungarleyfi hafi verið veitt. Í tilkynningunni skal m.a. koma fram:

a. nafn og heimilisfang nauðungarleyfishafa; b. þau lyf sem nauðungarleyfið tekur til; c. magn lyfjanna sem flytja skal út; d. þau ríki sem flytja á lyfin til;

Nr. 1011 23. nóvember 2006

e. gildistími nauðungarleyfisins; f. veffang nauðungarleyfishafa þar sem fram koma upplýsingar skv. 1. mgr. 9. gr.

11. gr. Framlenging á gildistíma nauðungarleyfis.

Nauðungarleyfishafi getur farið fram á að héraðsdómur framlengi gildistíma nauðungar- leyfis hafi honum ekki tekist að flytja út það magn lyfja sem nauðungarleyfið kveður á um að hann megi flytja út. Einkaleyfishafa skal tilkynnt beiðni um framlengingu eins fljótt og unnt er og honum gefinn kostur á að gera athugasemdir við beiðnina. Héraðsdómur skal því aðeins verða við slíkri beiðni að hann telji sýnt að nauðungarleyfishafi hafi að öðru leyti fullnægt þeim skilyrðum sem sett eru í nauðungarleyfinu.

12. gr. Afturköllun nauðungarleyfis.

Einkaleyfishafi getur farið fram á að héraðsdómur afturkalli nauðungarleyfi. Héraðs- dómari getur orðið við slíkri beiðni ef hann telur sýnt að nauðungarleyfishafi hafi ekki full- nægt þeim skilyrðum sem sett eru í nauðungarleyfinu. Ákvörðun um afturköllun skal tilkynnt nauðungarleyfishafa og einkaleyfishafa.

Samrit ákvörðunar um að afturkalla nauðungarleyfi skal sent Einkaleyfastofunni og skal hún tilkynna TRIPS-ráðinu efni hennar eins fljótt og unnt er.

Komi til afturköllunar á nauðungarleyfi skal nauðungarleyfishafi eins fljótt og unnt er sjá til þess að umframbirgðir af lyfjum, sem framleidd hafa verið samkvæmt ákvæðum reglu- gerðar þessarar, verði komið til þeirra ríkja, sem tilgreind eru sem innflutningsríki í nauð- ungarleyfinu, eða sjá til þess að þeim verði fargað.

13. gr. Gildistaka.

Reglugerð þessi, sem er sett með heimild í 5. mgr. 49. gr. laga nr. 17/1991 um einkaleyfi, með síðari breytingum, öðlast þegar gildi.

Iðnaðarráðuneytinu, 23. nóvember 2006.

Jón Sigurðsson. Kristján Skarphéðinsson.

__________

B-deild – Útgáfud.: 7. desember 2006


لا توجد بيانات متاحة.

ويبو لِكس رقم IS080