1. 사안의 개요

 

(1) 등재특허 존속기간 만료일: 2018. 11. 7.

(2) 제네릭 제품의 출하일시 및 배송처 도달일시 존속기간 만료 전일 또는 당일 출하함  

(3) 식약처 2020. 7. 14. 품목허가 취소 제재처분  - 처분 사유 등재특허권의 존속기간이 만료된 후에 판매하기 위해 허가받은 이 사건 의약품을 등재특허권의 존속기간이 만료되기 이전에 판매한 사실이 있음”

 

2. 대상 제약회사의 주장요지

 

이 사건 등재특허권의 기간만료일인 2018. 11. 7. 하루 전날 혹은 당일 이 사건 의약품을 출하 하였는데, 이는 위 근거규정에서 품목허가 취소사유로 정하고 있는판매가 아니라판매를 위한 예비 내지 준비행위에 불과하다.

 

3. 서울행정법원 판결요지

 

[별표8] ’행정처분의 기준‘ II. 개별기준362호 가목 - 약사법 제50조의4 1항 제2호를 위반하여 등재특허권의 존속기간이 만료된 후에 판매하기 위해 품목허가 또는 변경허가를 신청한 자가 해당 기간이 만료되기 전에 의약품을 판매한 경우에는 1차 위반시 바로 해당 품목허가를 취소할 수 있도록 정하고 있고, 위 위반행위에 대해서는 품목허가 취소 외에 다른 제재처분을 정하고 있지 않다.

 

약사법에서는약국개설자의 소비자들에 대한 소매행위의약품의 품목허가를 받은 제조업자 등의 약국개설자, 의약품 도매상 등에 대한 판매행위‘를 모두판매로 규정하고 있다. 따라서 의약품 제조업자의 시중약국 또는 도매상에 대한 의약품 판매행위는판매를 위한 예비 또는 준비행위가 아니라판매‘ 자체에 해당한다.

 

이 사건 근거규정은 등재특허권자의 특허권을 침해할 위험이 있는 판매행위에 대해 제재를 가하고자 하는 목적에서 마련된 것인바, 비록 이 사건 출하행위 자체는 이 사건 등재특허권의 존속기간 만료일 전일 혹은 당일에 이루어졌으나, 판매행위를 이루는 일련의 주문, 생산 과정은 만료일보다 전에 이루어졌을 것인 점, 이 사건 등재특허권의 존속기간 중에 이 사건 의약품에 대한 주문이 이루어짐으로써 이 사건 등재특허권에 따른 의약품에 대한 수요가 감소되어 특허권자에게 대한 손해가 발생되었을 가능성이 있는 점 등에 비추어 보면, 이 사건 출하행위를 판매행위로 보아 이를 규제할 필요성도 충분히 인정된다.

 

등재특허권의 존속기간 만료 전에 주문, 생산, 출하가 모두 이루어지는 경우에도 이 사건 근거규정에서 정한판매에 해당하지 않는다고 본다면, 등재특허권의 존속기간이 만료되지 않았음에도 제조업자가 관련 의약품을 제조판매하여 이익을 얻고 등재특허권자에게 손해가 발생하더라도 이에 대한 행정적 제재를 가할 수 없는 문제가 발생된다. 이러한 해석은 이 사건 근거규정의 취지를 몰각시키는 것이어서 받아들일 수 없다.

 

첨부: 서울행정법원 2021. 7. 8. 선고 2020구합69236 판결

 

KASAN_등재특허권의 존속기간 만료일 전일 또는 당일 의약품 출하행위에 대한 제재처분 – 품목허가취소 적법 서울행정법원 2021. 7. 8. 선고 2020구합69236 판결.pdf
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서울행정법원 2021. 7. 8. 선고 2020구합69236 판결.pdf
0.13MB

 

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작성일시 : 2022. 5. 25. 10:00
:

 

1. 원심 특허법원 판결요지

 

(1) 판결주문 특허권자 패소한 심결의 위법 판단 및 전부 취소 판결, 특허권자 전부 승소

(2) 판결 이유 존속기간연장 일부 위법, 무효 BUT 일부 기간의 연장은 적법

(3) 판결 이유 요지 - 이 사건 심결에서 무효로 판단한 187일 중 원심판시 기간 1(132)은 특허권자인 원고에게 책임 있는 사유로 인하여 소요된 기간이라고 볼 수 없으므로 이 부분 심결의 판단은 위법하고, 원심판시 기간 2(55)는 원고에게 책임 있는 사유로 인하여 소요된 기간이라고 할 것이므로 이 부분 심결의 판단은 적법하다.

 

2. 특허권자 상고의 이유

 

원심 판결 이유에서 특허권자 책임으로 판단한 기간2(55), 불이익한 판단 이유에 불복하여 상고

 

3. 상고심 쟁점 판결주문이 아니라 판결이유에 제시된 판단만을 다투는 경우도 상고의 이익이 인정되는지 여부

 

4. 대법원 판결요지 상고 이익 불인정, 각하 판결

 

(1) 법리 - 상고의 이익 판단 기준

 

상소는 자기에게 불이익한 재판에 대하여 자기에게 유리하도록 그 취소, 변경을 구하는 것이므로 전부 승소한 원심판결에 대한 상고는 상고를 제기할 이익이 없어 허용될 수 없고, 이 경우 비록 그 판결의 이유에 불만이 있더라도 특별한 사정이 없는 한 상고의 이익이 없다(대법원 2009. 7. 23. 선고 20082770 판결 등 참조).

 

(2) 구체적 사안의 판단

 

원심은 이 사건 심결의 취소를 구하는 원고의 청구를 그대로 인용(전부 승소)하였는데, 원고는 그 판결이유에 제시된 원심판시 기간 2(55) 부분의 판단을 다투면서 상고를 제기하고 있음을 알 수 있고, 이 부분 판단에 대하여는 취소판결의 기속력이 발생하는 것도 아니므로, 전부 승소한 원고로서는 원심의 판결이유에 불만이 있다 하더라도 상고를 제기할 이익이 없다.

 

첨부: 대법원 2021. 10. 28. 선고 202011752 판결

 

KASAN_노바티스 가브스 특허의 존속기간연장등록 일부기간의 무효 심판 대법원 사건 – 상고 각하 판결 대법원 2021. 10. 28. 선고 2020후11752 판결.pdf
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대법원 2021. 10. 28. 선고 2020후11752 판결.pdf
0.06MB

 

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작성일시 : 2021. 11. 9. 11:36
:

 

 

7. REGULATORY MATTERS.

7.1 Ownership of Product Regulatory Approvals and Documentation. Licensee shall own all Product Regulatory Approvals and Documentation in respect of each country in the Territory.

 

7.2 Conduct and Management of Regulatory Activities. Licensee will use its Commercially Reasonable Efforts:

(a) to maintain the First Approved NDA in the United States;

(b) to obtain Regulatory Approval for the Product for the Nocturia Indication in each other country in the Territory in accordance with the Development Plan;

and

(c) to obtain Regulatory Approval for the Product for the PNE Indication in each country in the Territory in accordance with the Development Plan.

 

Any breach by Licensee of its obligations under Section 7.2(a) shall be deemed to be a material breach of this Agreement for purposes of Article 14.

 

7.3 Transfer to Licensee of Product Regulatory Approvals and Documentation. Following the transfer to Licensee of ownership of the Product Regulatory Approvals and Documentation in each such country in the Territory pursuant to Section 2.3(b),

(a) Licensee or its designee shall be the owner of any and all Product Regulatory Approvals and Documentation in each such country in the Territory, subject to the Right of Reference or Use hereby granted by Licensee to Licensor in Section 2.5(c) for purposes of Development and Commercialization of Products outside the Territory;

(b) Except for the Development and Commercialization of Products by Licensor in the Territory pursuant to Section 6.3, Licensee shall have the responsibility, at its expense, for all regulatory activities (including, without limitation, Development Activities undertaken to support obtaining or maintaining Regulatory Approvals) and interactions relating to the Product in each country in the Territory, including without limitation preparing, obtaining, and maintaining Regulatory Approvals in each country in the Territory and all substantive interactions with such Regulatory Authorities relating thereto; and

(c) Licensee shall determine, in its sole discretion, the content of all such submissions and of all correspondence with Regulatory Authorities relating to the Product in the Territory.

(d) To the extent Licensor has not undertaken any Product Development Activities in the Territory under Section 2.5(c), Section 2.6, Section 6.1 and/or Article 14, Licensor hereby grants to Licensee a Right of Reference or Use in all Regulatory Approvals and Regulatory Documentation in respect of the Compound and any Products in respect of which Licensor is the sponsor for purposes of Licensee’s Development and Commercialization of Products in the Field and in the Territory. In consideration of such grant, Licensee will make one or more payments to Licensor determined in accordance with the same provisions set forth in clauses (ii) and (iii) in Section 2.5(c) in respect of Licensee’s grant of the Right of Reference or Use set forth in clause (i) of Section 2.5(c).

 

7.4 Regulatory Documentation for Generic Products.

(a) Each Party shall deliver written notice to the other Party of any notice it receives as to the submission, filing, or approval of an application, including, without limitation, an Abbreviated New Drug Application in the United States or the equivalent thereof in any other country in the Territory, in respect of a Generic Product within three (3) days after receipt or such notice thereof.

 

(b) Licensee shall have the sole right to respond to each such application, provided that Licensee shall consult with Licensor regarding any such application and the response thereto.

 

7.5 Audits. Licensor will have the continuing right during the Term of this Agreement, upon reasonable prior written notice to Licensee, to inspect, audit, and investigate any facilities, equipment, record-keeping procedures, and records utilized by Licensee and its subcontractors in connection with the Manufacture and Commercialization of the Product and any Development (including, without limitation, the conduct of Clinical Studies) of the Product.

 

7.6 Regulatory Authority Communications Received by a Party.

(a) Each Party shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection, or communication by or from any Person, including, without limitation, any Regulatory Authority in any country in the Territory, that may affect the safety or efficacy claims of the Product, have a material adverse effect on the Commercialization of the Product, or that otherwise suggests the Product may be in violation of Applicable Laws in such country.

 

(b) Upon receipt of such information described in Section 7.7(a), the Parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for Licensee to take at Licensee’s expense.

 

(c) Each Party shall keep the other Party informed, in a timely manner consistent with the reporting requirements of Regulatory Authorities, of notification of any action by any Regulatory Authority, or notification or other information that the Party receives (directly or indirectly) from any such Regulatory Authority, and provide to such other Party copies of all documents, if any, it received from such Regulatory Authority.

 

(d) Each Party will provide the other Party in a timely manner with a copy of all correspondence received from a Regulatory Authority specifically regarding the matters referred to in this Section 7.7.

 

7.7 Adverse Event Reporting and Safety Data Exchange.

(a) Licensee shall be responsible, at Licensee’s expense, in each country in the Territory for the monitoring of all clinical experiences, post-marketing experiences, and filing of all required reports with respect to the Product.

 

(b) Licensor shall transfer to Licensee the patient database, including without limitation the databases, in their entirety, containing pharmacokinetic, pharmacodynamic, efficacy, and safety information, developed in connection with the conduct of Clinical Studies for the Product under U.S. IND 076667, and all information relating thereto, in the format requested by Licensee. Licensor shall have the right to retain a copy of any and all such information transferred to Licensee.

 

(c) Each Party shall (i) notify the other Party immediately, but in no event later than three (3) Business Days, after becoming aware of any information concerning any complaint involving the possible failure of Product to meet any requirement of Applicable Laws, and any Unexpected Adverse Drug Experience or other serious or unexpected side effect, injury, toxicity, or sensitivity reaction or any unexpected incidents associated with the distribution or use of the Product and (ii) with respect to adverse events, comply with the provisions of this Section 7.7, and the applicable agreements described herein. Specific details regarding the exchange and management of information relating to adverse events related to the use of the Product shall be delineated and product labeling personnel of each Party shall work in good faith together during such time to negotiate an agreement that:

 

(i) identifies which safety information shall be exchanged, which shall include without limitation all adverse events for any Indication or condition;

 

(ii) identifies when such information shall be exchanged (which SAE information shall be provided within two (2) Business Days after notification of such SAE);

 

(iii) provides that Licensee shall (i) have regulatory reporting responsibilities, (ii) manage the global safety database, (iii) be obligated to obtain follow-up information on incomplete safety reports, (iv) review the literature for safety report information, and (v) prepare required periodic safety updates;

 

(iv) sets forth the roles and responsibilities of the Parties related to review and approval of safety information for inclusion in the Product labeling; provided that Licensee shall have the final decision-making authority with respect to any disputes regarding such activities with respect to Product in accordance with the terms and conditions hereof;

 

(v) identifies any other details required to appropriately manage safety information for the Product; and

 

(vi) as soon as reasonably practicable following the Effective Date, but in no event later than sixty (60) days thereafter Licensor and Licensee will agree upon the terms and conditions of the Pharmacovigilance Agreement and will thereupon execute and deliver to the other Party a copy of such Agreement.

 

7.8 Remedial Actions.

(a) Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that the Product in the Field may be subject to a Remedial Action.

 

(b) The Parties will assist each other in gathering and evaluating such information as is required to determine the necessity of conducting a Remedial Action with respect to the Product in the Field in the Territory; provided, however, that Licensee shall have sole responsibility for collecting information from its customers in the Territory, including, without limitation, customer complaints, in accordance with the terms and conditions hereof.

 

(c) Each Party will maintain adequate records to permit the Parties to trace the manufacture of the Product in the Field and the distribution and use of the Product in the Field. In the event Licensee determines that any Remedial Action with respect to the Product in the Field in the Territory should be commenced or Remedial Action is required by any Governmental Authority having jurisdiction over the matter, Licensee will control and coordinate all efforts necessary to conduct such Remedial Action, provided that Licensee shall consult with Licensor or its designee regarding any such Remedial Action.

 

(d) The cost and expense of a Remedial Action (including the Parties’ reasonable costs and expenses in conducting such Remedial Action, but excluding claims described in Article 10) shall be allocated as follows:

 

(i) If such Remedial Action is due to Licensee’s gross negligence or willful misconduct, material breach of this Agreement, or material violation of or substantial noncompliance with any Law, but only to the extent such Remedial Action is due thereto, such costs and expenses shall be borne and paid by Licensee;

 

(ii) if and to the extent that such Remedial Action is due to Licensor’s gross negligence or willful misconduct, Licensor’s material breach of this Agreement, or Licensor’s material breach of or substantial noncompliance with any Law, but only to the extent such Remedial Action is due thereto, such costs and expenses shall be borne and paid by Licensor; and

 

(iii) if and to the extent that such Remedial Action is due to reasons other than as set forth in Sections 7.8(d)(i) and (ii), then: (A) Licensor shall bear and pay the costs and expenses incurred by the Parties in connection with a Remedial Action with respect to any lots of the Product subject to such Remedial Action that were manufactured by or for Licensor, as Licensor’s predecessor in interest; and (B) except for the Development and Commercialization of Product in the Territory by Licensor pursuant to Section 6.3, Licensee shall bear and pay the costs and expenses incurred by the Parties in connection with a Remedial Action with respect to any lots of the Product subject to such Remedial Action that were manufactured by or for Licensee and its contractors; provided, however, that nothing in this Section 7.8(d)(iii) is intended to limit or supersede any obligation that Renaissance may have in respect of any such lots of the Product subject to such Remedial Action.

 

KASAN_제약회사의 API 공급, 완제품 생산위탁, 완제품구매 계약서에서 정부의 제조품목허가 관련 계약조항 영문 샘플.pdf

 

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작성일시 : 2019. 5. 17. 10:47
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