1. License 대상특허 범위 쟁점: 미국 Endo Pharm Opana® ER 특허분쟁 판결

특허 license에서 자주 쟁점이 되는 사항이고 실제 발생할 수 있는 사안입니다. 아래 그림에서 표시한 각 특허 사이의 관계와 License Agreement 조항의 문언표현을 살펴보시기 바랍니다.

 

 

 

(1) license 대상특허 범위 및 쟁점

License 계약서에 라이선스 대상특허 '250 및 그 후속특허 "including any continuation, continuation-in-part and divisional patent applications that claim priority to Opana® ER Patents"로 표현되어 있습니다. 여기서 '250 특허가 Opana® ER Patents에 해당합니다.

 

계약체결 후 등록된 위 '216 특허와 '122 특허가 위와 같은 계약문언의 범위에 해당하는지 여부가 쟁점입니다. 그림에서 보듯 노란색 '250 특허와 녹색의 쟁점 특허 2건은 직접 연결된 관계가 아닙니다.

 

다만, 청색으로 표시한 '357 출원이 중간에 개입되어 있습니다. 그것을 매개로 녹색표시특허들도 노란색 특허와 동일하게 license 대상특허로 해석할 수 있는지 문제됩니다.

 

(2) 미국법원 판결

CAFC 판결은 위와 같은 상황에서 '216 특허와 '122 특허는 license 대상 특허범위에 포함되지 않는다고 판결하였습니다. 기타 묵시적 license도 인정하지 않았습니다. , licensor Endolicensee Actavis, Roxanegeneric 제품 발매에 대해 기존 등록특허에 관하여 체결한 license의 존재에도 불구하고 다시 추가 등록한 '216 특허와 '122 특허에 기초한 특허권을 행사할 수 있다고 보았습니다.

 

Generic 제품발매 회사로서는 불의타에 해당하는 황당한 상황을 맞았습니다. CAFC 3인 합의재판부 중 1명의 소수의견 Dissent Opinion에서는 license 대상을 특허로 표현한 것과 제품으로 표현한 것을 엄격하게 구별해야 하고, 적어도 제품을 기준으로 라이선스 계약을 체결한 경우 위 특허도 라이선스 대상특허에 해당한다는 의견 설시가 흥미롭습니다. 공감할 내용이 많은데도 불구하고 아쉽게도 소수의견에 그쳤습니다. 특허 라이선스 실무공부 삼아 읽어 보시기 바랍니다.

 

(3) No Implied License 조항

CAFC 판결에서는 계약서의 다음과 같이 묵시적 라이선스를 허용하지 않는다는 계약조항을 중요한 판단근거로 삼았습니다. 라이선스 계약 실무상 매우 중요한 포인트입니다.

 

“Endo does not grant to Actavis [or Roxane] . . . any license, right or immunity, whether by implication, estoppel or otherwise, other than as expressly granted herein.”

 

참고자료로 다른 계약서에서 표준형식의 조항을 인용합니다. "No Other Rights. No rights, other than those expressly set forth in this Agreement are granted to either Party hereunder, and no additional rights will be deemed granted to either Party by implication, estoppel, or otherwise. All rights not expressly granted by either Party to the other hereunder are reserved."

 

Licensee의 묵시적 라이선스 주장은 부제소조항(not to sue)에도 근거를 두고 있습니다. licensee에 대한 소송을 제기하지 않는다는 계약조항은 곧 후속 등록 특허권에 대한 license 합의로도 해석할 수 있다는 주장입니다.

 

그라나, CAFC 판결은 위와 같이 묵시적 허락을 배제하는 명시적 계약조항을 우선해야 한다고 명확하게 밝혔습니다. 묵시적 라이선스 이론이 적용될 수 있고, 따라서 상충되는 해석이 가능한 상황에서도, 처분문서에 해당하는 계약서에 명시적으로 기재된 묵시적 라이선스를 배제한다는 문언이 훨씬 더 강력한 효력을 발휘한다는 점을 명확하게 판시하였습니다.

 

위 판결은 Licensee 입장에서 조금 억울한 면이 있을 것입니다. 실무적 대응방안으로는 특허만을 라이선스 대상범위의 기준으로 설정하는 것보다 여기에 더하여 제품기술을 라이선스 범위설정의 기준으로 함께 설정한다면 안정할 것입니다.

 

기술이전이나 license 당시에는 등록되지 않았고 독립된 특허출원도 아니었으나 그 후 분할출원, 연속출원 등을 통해 등록되는 특허문제는 매우 중요합니다. 관련 쟁점에 관한 좋은 참고가 될 분쟁사례와 판결입니다. CAFC 판결문을 소수의견까지 모두 꼼꼼하게 살펴보시길 권합니다.

 

2. 영문계약조항 사례 샘플

(1) Example Definition, 계약대상 특허정의 조항

Patent Rights” means, with respect to each country in the Territory (except as otherwise stated to be with respect to any country in or outside the Territory), (a) patent applications (including provisional applications) pending in such country, (b) any patents issuing in such country from such patent applications (including certificates of invention), (c) all patents and patent applications issued or pending, as applicable, in such country based on, corresponding to or claiming the priority date(s) of any of the foregoing, (d) rights in such country derived from any of (a), (b) or (c), including any substitutions, extensions (including supplemental protection certificates), registrations, confirmations, reissues, divisionals, continuations, continuations in part, reexaminations, renewals, revalidations, revivals, patents of addition, and (e) all patents and patent applications issued or pending, as applicable, in such country claiming overlapping priority therefrom.

 

(2) Example 라이선스 계약조항 샘플

9. INTELLECTUAL PROPERTY MATTERS.

9.1 Existing Intellectual Property.

(a) Other than as provided in this Agreement, neither Party grants any right, title, or interest in any Patent Right, information, or other intellectual property right Controlled by such Party to the other Party.

 

(b) Except as otherwise provided herein, Licensor shall be responsible for the preparation, filing, prosecution (including, without limitation, any interferences, inter partes proceedings, reissue proceedings, cancellations, oppositions, and reexaminations), and maintenance of any and all Licensed Serenity Patent Rights. Licensor shall consult with Licensee, and consider Licensee’s comments, in good faith with respect to the preparation, filing, prosecution, and maintenance of any Licensed CPEX Patent Rights or Licensed Reprise Patent Rights to the extent that Licensor has the right, under any agreement with any applicable licensor, to file, prosecute, and maintain such Licensed Patent Rights.

 

(c) Licensee agrees and acknowledges that Licensor intends to continue to use, in Licensor’s discretion, patent counsel currently retained by Licensor to prosecute and maintain the Licensed Serenity Patent Rights. Licensee shall execute, acknowledge and deliver any instruments, and to do all such other acts, as may be necessary or appropriate in order to enable such patent counsel to continue to prosecute and maintain such Licensed Serenity Patent Rights. The Parties shall reasonably consult with each other, and shall consider any comments from each other in good faith, with respect to the preparation, filing, prosecution, and maintenance of such Licensed Serenity Patent Rights and patent strategy for the Licensed Serenity Patent Rights. Licensee shall reimburse Licensor for all costs and expenses incurred by Licensor after the Effective Date in the preparation, filing, prosecution, and maintenance of any Licensed Serenity Patent Rights in the Territory, up to an amount not to exceed [*] Dollars ($[*]), which is the estimated cost set forth on Schedule 9.1(c). Licensor shall provide to Licensee copies of any papers relating to the filing, prosecution or maintenance of the Licensed Serenity Patent Rights promptly upon their being filed or received. Licensee shall not knowingly take any action during prosecution and maintenance of the Licensed Serenity Patent Rights.

 

(d) Licensor shall not knowingly permit any of the Licensed Serenity Patent Rights to be abandoned in any country in the Territory without Licensor first giving Licensee an opportunity to assume full responsibility for the continued prosecution and maintenance thereof. In the event that Licensee decides not to continue the prosecution or maintenance of a Licensed Serenity Patent Rights in any country in the Territory, Licensor will provide Licensee with notice of this decision at least thirty (30) days prior to any pending lapse or abandonment thereof. In the event that Licensee elects to assume responsibility for such prosecution and maintenance within thirty (30) days of Licensor’s notice, Section 9.1(c) shall thereafter apply to such Licensed Serenity Patent Rights except that the role of Licensee and Licensor shall be reversed thereunder (except further that Licensee will continue to be responsible for all costs and expenses thereafter incurred in the preparation, filing, prosecution, and maintenance of any Licensed Serenity Patent Rights). Any such Serenity Patent Right that is subject to such election by Licensee shall otherwise continue to be subject to all of the terms and conditions of the Agreement in the same way as the other Licensed Serenity Patent Rights.

 

9.2 Inventions by Licensee.

Disclosure. Licensee shall promptly disclose to Licensor the invention of any Licensee Inventions.

 

Ownership. As between the Parties, all Licensee Inventions will be owned and Controlled by Licensee.

 

Patent Filings.

(i) Licensee, at its expense, will have sole discretion and responsibility to prepare, file, prosecute, and maintain any patent applications and patents claiming Licensee Inventions. The Parties’ respective patent counsel shall meet no fewer than once per Calendar Year to discuss strategies for the preparation, filing, prosecution, and maintenance of any such patent applications and patents claiming Licensee Inventions. Licensee shall consider in good faith any comments provided by Licensor with respect to the foregoing. In the event of any dispute between Parties with respect to such strategies, either Party may notify the Alliance Managers for purposes of resolving such dispute; provided, however, that Licensee shall have the final decision-making authority with respect to any such dispute.

 

(ii) Licensee shall not knowingly permit any Patent Rights with claims to any Licensee Inventions to be abandoned in any country without Licensee first giving Licensor an opportunity to assume full responsibility for the continued prosecution and maintenance thereof. In the event that Licensee decides not to continue the prosecution or maintenance of any Patent Right claiming a Licensee Invention in any country, Licensee will provide Licensor with notice of this decision at least thirty (30) days prior to any pending lapse or abandonment thereof. In the event that Licensor elects to assume responsibility for such prosecution and maintenance within thirty (30) days of Licensor’s notice, Section 9.1(c) shall thereafter apply to such Patent Right claiming such Licensee Invention except that the role of Licensee and Licensor shall be reversed thereunder.

 

9.3 Infringement, Violation, or Misappropriation by Third Parties.

 

(a) Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement, violation, or misappropriation by any Third Party of the Licensed Rights or the Sublicensed Rights of which it becomes aware, and following such notification, the Parties shall confer as to any response thereto. The notice shall set forth the facts of such infringement, violation, or misappropriation in reasonable detail.

 

(b) Response to Infringement, Violation, or Misappropriation by Third Parties.

(i) If a Third Party is infringing, violating, or misappropriating, or either Party reasonably believes a Third Party may be infringing, violating, or misappropriating any Enforceable IP Right in any country in the Territory, Licensee shall have the first right, but not the obligation, to institute, prosecute, and control any action or proceeding with respect to such infringement, violation, or misappropriation by counsel of its own selection, at its expense. Licensor shall have the right to participate in such action and be represented, if it so desires, by counsel of its own selection and at its own expense. To the extent required by Applicable Laws, Licensor agrees to be joined as a party plaintiff (with Licensor having the right to be represented, if it so desires, by counsel of its own selection and at its own expense) if necessary for Licensee to bring and prosecute such action or proceeding, and to give Licensee reasonable assistance and authority to bring and prosecute such action or proceeding. If Licensee fails to bring an action or proceeding within ninety (90) days after receiving or giving written notice pursuant to Section 9.3(a), then Licensor shall have the right, but not the obligation, to bring and control any such action by counsel of its own selection, at its expense (with Licensee having the right to participate in such action and be represented, if it so desires, by counsel of its own selection and at its own expense). To the extent required by Applicable Laws, Licensee agrees to be joined as a party plaintiff (with Licensee having the right to be represented, if it so desires, by counsel of its own selection and expense therein) if necessary for Licensor to bring and prosecute such action or proceeding, and to give Licensor reasonable assistance and authority to bring and prosecute such action or proceeding. No settlement of any such action or consent judgment or other voluntary final disposition which restricts the scope, or adversely affects the enforceability, of an Enforceable IP Right may be entered into by either Party without the prior written consent of the other Party, which consent shall not be unreasonably withheld, delayed or conditioned.

 

(ii) Each Party shall share in any recoveries obtained in connection with any action or proceeding described in Section 9.3(b)(i) as follows:

(A) each Party’s costs and expenses incurred in connection with bringing and prosecuting any such action or proceeding, including without limitation attorneys’ fees, first shall be reimbursed from such recoveries, and if such recovery is insufficient to cover all such costs and expenses of both Parties, it shall be shared in proportion to the total of such costs and expenses incurred by each Party, and

(B) if Licensee controlled such action or proceeding Licensee shall receive one hundred percent (100%) of such remaining recoveries, provided that such recoveries shall be deemed Net Sales for purposes of Section 8.3(a)(i); and if Licensor controlled such action or proceeding, each Party shall receive fifty percent (50%) of such remaining recoveries, provided that Licensee’s portion shall not be deemed as Net Sales for purposes of Section 8.3(a)(i) in such case.

 

(c) Withdrawal. If either Party brings an action or proceeding under Section 9.3(b)(i) and subsequently ceases to pursue or withdraws from such action or proceeding, it shall promptly notify the other Party and the other Party may substitute itself for the withdrawing Party under the terms of Section 9.3(b)(i).

 

(d) Oppositions by Parties. If either Party desires to bring an opposition, action for declaratory judgment, nullity action, interference, reexamination, inter partes proceeding, or other attack upon the validity, title, or enforceability of any intellectual property right Controlled by a Third Party that Covers the Product in the Field in any country in the Territory, such Party shall so notify the other Party and the Parties shall promptly confer to determine whether to bring such action or the manner in which to settle such action. Each Party shall be entitled to separate representation in any such action by counsel of its own choice and at its own expense, and shall cooperate fully with the other Party. The costs of any such action shall be borne by the Party bringing the action, and such Party shall retain any recoveries obtained in connection therewith.

 

9.4 Infringement of Third Party Rights.

(a) Notice. If the Exploitation of the Product pursuant to this Agreement results in a claim, action, suit, or proceeding that such activity infringes or misappropriates the intellectual property rights of a Third Party (“Third Party Infringement Claim”), the Party first receiving notice thereof shall promptly notify in writing the other Party thereof. The notice shall set forth the facts of the Third Party Infringement Claim in reasonable detail.

 

(b) Litigation.

(i) Licensee shall have the sole right, but not the obligation, to defend, at its expense, against any Third Party Infringement Claim. Licensee shall have full control over the defense and settlement of such Third Party Infringement Claim, provided that Licensee shall not settle any Third Party Infringement Claim that is subject to indemnification pursuant to Section 11.1 without the prior written consent of Licensor, which consent shall not be unreasonably withheld, delayed, or conditioned. Licensor shall cooperate with Licensee, at Licensee’s expense and reasonable request, in such defense and shall have the right to be represented by counsel of its own choice, at Licensor’s expense. Licensee will pay any losses incurred in defense or settlement of, or imposed pursuant to settlement of or judgment on, such Third Party Infringement Claim.

 

(ii) If Licensee decides not to commence a defense against any Third Party Infringement Claim pursuant to Section 9.4(b)(i), then Licensee will promptly notify Licensor of such decision in a timely manner so as to allow Licensor, who shall have the right, but not the obligation, to commence such a defense by counsel of its own selection, at its expense (with Licensee having the right to participate in such defense and be represented, if it so desires, by counsel of its own selection and at its own expense). Licensor shall thereupon have full control over the defense and settlement of such Third Party Infringement Claim, provided that Licensor shall not settle any Third Party Infringement Claim without the prior written consent of Licensee, which consent shall not be unreasonably withheld, delayed, or conditioned. Licensee shall cooperate with Licensor, at Licensor’s expense and reasonable request, in such defense and shall have the right to be represented by counsel of its own choice, at Licensee’s expense. Licensor will pay any losses incurred in defense or settlement of, or imposed pursuant to settlement of or judgment on, such Third Party Infringement Claim, subject to Section 11.1.

 

(iii) Notwithstanding any provisions set forth herein to the contrary, Licensor shall be responsible for continuing to manage, at Licensor’s expense, that certain litigation with Ferring Pharmaceuticals that is described in Schedule 10.2. Notwithstanding the foregoing, any settlement of any such action or consent judgment or other voluntary final disposition with respect to the litigation with Ferring Pharmaceuticals described in Schedule 10.2, which restricts the scope, or adversely affects the enforceability, of an Enforceable IP Right may not be entered into by Licensor without the prior written consent of the Licensee, which consent shall not be unreasonably withheld, delayed or conditioned.

 

(c) Oppositions by Third Parties. If any patent, trademark, copyright, or other intellectual property right within the Licensed Rights or the Sublicensed Rights becomes after the Effective Date the subject of any proceeding commenced by a Third Party in connection with an opposition, reexamination request, action for declaratory judgment, nullity action, interference, inter partes proceeding, or other attack upon the validity, title, or enforceability thereof, then Licensee shall control such defense at its sole cost. Licensee shall permit Licensor to participate in the proceeding to the extent permissible under Applicable Laws, and to be represented by its own counsel in such proceeding, at Licensor’s expense. If Licensee elects not to defend against such action with respect to any such intellectual property right with the Licensed Rights or the Sublicensed Rights within ninety (90) days after first receiving notice or otherwise becoming aware of such action or proceeding, then Licensor shall have the right to assume defense of such Third Party action at its own expense. Any awards or amounts received in bringing any such action shall be first allocated to reimburse the Parties’ expenses in such action, and any remaining amounts shall be retained by the Party defending against such proceeding.

 

KASAN_기술이전, 라이선스 계약서에서 License 대상 IP 및 특허 정의조항, 적용범위, 계약체결 후 발명

 

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기술이전 License 중 많은 경우가 기술이전 이후부터 상업적 발매까지 추가 연구개발에 많은 비용과 시간이 필수적으로 투입되어야만 합니다. 대표적으로 신약기술 이전 License 케이스가 이와 같습니다.

 

Licensor 수입의 대부분은 Running Royalty이므로 상업적 판매까지 제품개발이 성공적으로 완료되는지 여부는 License 양 당사자 모두에게 매우 중대한 영향을 미칩니다. 그와 같은 중대한 development 관련 사항 중 License 계약서에 반영되어야 할 내용은 어떤 것인지 사례를 통해 살펴보겠습니다.

 

아래에서 일본제약회사와 다국적 제약회사가 체결한 신약의 물질특허에 대한 Exclusive License Agreement Development 조항을 간략하게 살펴보겠습니다. Licensor 일본회사 Shionogi에서 신약물질 특허권을 보유하고, Licensee AstraZeneca에 대해 해당 특허의 전용실시권 허여 및 상업화 권리를 부여하는 기술이전 license 계약입니다.

 

비록 Crestor License Agreement는 조금 오래 된 계약서이지만, 실제 엄청난 성공을 거둔 신약개발 기술이전 프로젝트로서 실무자가 참고자료로 살펴볼 필요가 있다고 생각합니다.

 

참고로, 최근에는 양 당사자가 참여하는 Joint Steering Committee (JSC), Joint Development Committee (JDC)를 구성하여, 정기적 회의를 통해 후속 연구개발의 진행, 성과평가, 조정, 결정 등을 해나가는 방식이 자주 활용되고 있습니다. 이를 위해 처음부터 License Agreement에 이와 같은 JSC 등에 관한 계약조항을 두는 경우가 많습니다.

 

Article 3.  Development

 

3.1

SHIONOGI shall disclose the KNOW-HOW, which is necessary, useful or advisable for ZENECA to obtain the HEALTH REGISTRATION APPROVAL and to develop, manufacture, use, distribute, market and sell the LICENSED PRODUCTS, in each country of the TERRITORY, after the execution of this Agreement without delay to the extent not done so already.  If the visits of SHIONOGI’s representative(s) to ZENECA’s facilities are reasonably requested by ZENECA relating to the disclosure of KNOW-HOW to ZENECA, SHIONOGI will send an appropriate representative(s) to ZENECA’s facilities; provided that ZENECA shall bear the expenses of travel and accommodations for such representative(s).

 

SHIONOGI will provide ZENECA with all reasonable assistance required in order to transfer the KNOW-HOW to ZENECA in a timely manner.  Such assistance will include, but shall not be limited to those items listed in the Schedule attached.

 

3.3

ZENECA shall develop and register the PRODUCTS in the TERRITORY on its sole responsibility as if the PRODUCTS had been derived from ZENECA’s own research pipeline.  Prior to October 31, 1998, ZENECA shall prepare a development schedule (hereinafter referred to as the “DEVELOPMENT SCHEDULE”), and shall allow SHIONOGI the opportunity to comment upon it.  The DEVELOPMENT SCHEDULE shall contain the estimated time schedule of pre-clinical studies, clinical trials, New Drug Application (“NDA”) filings, launches and other related activities to be conducted by ZENECA with respect to the PRODUCTS in Europe, the U.S.A. and Japan.  The first DEVELOPMENT SCHEDULE (hereinafter referred to as the “ORIGINAL DEVELOPMENT SCHEDULE”) shall be attached to this Agreement as Appendix III.

  

3.4

ZENECA may also pursue the feasibility for the development and commercialization of the COMBINATION PRODUCTS.  If ZENECA decides to carry out the development of any COMBINATION PRODUCTS leading to their commercialization, ZENECA shall promptly inform SHIONOGI of such intention in writing and provide SHIONOGI with the development schedule therefor.

 

3.5

If ZENECA reasonably foresees or becomes aware of any delay of six (6) months or more in the actual development of the PRODUCTS as compared with the timing set forth in the ORIGINAL DEVELOPMENT SCHEDULE or any later modified DEVELOPMENT SCHEDULE, ZENECA shall promptly inform SHIONOGI of such delay in writing.  Whereupon ZENECA may modify such DEVELOPMENT SCHEDULE upon consultation with SHIONOGI, but for the avoidance of doubt, such consultation shall be for information only and ZENECA will not be required to obtain SHIONOGI’s approval to any such modification.

 

3.6

Any and all development costs for the LICENSED PRODUCTS in the TERRITORY shall be solely borne by ZENECA.

 

3.7

ZENECA shall provide SHIONOGI with a bi-annual report on the progress in the development of LICENSED PRODUCTS in the TERRITORY in order to keep SHIONOGI informed of the progress.  ZENECA also agrees to have meetings with SHIONOGI in a timely manner (at least once a year) in order to report on the progress in the development of LICENSED PRODUCTS in the TERRITORY.  If any application of Investigational New Drug (“IND”), Clinical Trial Exemption (“CTX”) and/or NDA is filed with the competent authorities in Europe, the U.S.A. and Japan, ZENECA shall provide SHIONOGI with a summary of all dossier submitted to such authorities (including any amendments thereto).  The provisions of Article 8.1 shall apply to any information disclosed hereunder, and SHIONOGI shall not be permitted to use any such information for any purpose other than evaluating the progress of ZENECA’s development of the LICENSED PRODUCTS.

 

3.8

Upon completion of phase II clinical trials for the LICENSED PRODUCTS, ZENECA shall have the right to terminate this Agreement by informing in writing SHIONOGI of its intention to terminate this Agreement as well as the background of such decision.  On termination of this Agreement pursuant to this Article 3.8, ZENECA shall not be obliged to make any further payments under Article 4.

3.9

If and when the HEALTH REGISTRATION APPROVAL is obtained in any country of the TERRITORY, ZENECA shall promptly inform SHIONOGI of such HEALTH REGISTRATION APPROVAL and send to SHIONOGI a copy of the approval letter, along with an English translation thereof, of such HEALTH REGISTRATION APPROVAL issued by the competent health authority of such country.  The provisions of Article 8.1 shall apply to any information disclosed hereunder, and SHIONOGI shall not be permitted to use any such information for any purpose other than evaluating the progress of ZENECA’s development of the LICENSED PRODUCTS.

 

3.10

If ZENECA chooses to market the LICENSED PRODUCTS in Japan and/or Taiwan with a partner other than ZENECA’s AFFILIATE in such countries, ZENECA shall offer to SHIONOGI the first opportunity to be ZENECA’s marketing partner for the LICENSED PRODUCTS in Japan and/or Taiwan.  With regard to the terms and conditions of the marketing of LICENSED PRODUCTS in Japan and/or Taiwan, SHIONOGI and ZENECA shall negotiate such terms and conditions in good faith.  If the PARTIES are unable to agree upon such terms and conditions, ZENECA shall be free to offer the opportunity to a THIRD PARTY on terms and conditions no more favorable than those offered to SHIONOGI.

 

KASAN_[국제계약실무] 신약 물질특허 기술이전 Exclusive License 계약서 중 Development

 

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작성일시 : 2019. 4. 12. 18:00
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  1. 영문계약서 2019.08.30 18:57 [댓글주소] [수정/삭제] [댓글에 댓글달기]

    영문계약서때매 골치아픈데
    나이스한 정보입니다
    감사드립니다
    즐거운하루보내세요


 

 

세계적 블록버스터 신약의 물질특허에 대한 Exclusive License 및 추가 R&D Collaboration Agreement 중에서 특허관련 계약조항을 인용하고 간략하게 살펴보겠습니다. 신약물질을 개발한 일본 제약회사 Shionogi에서 신약물질 특허권을 보유하고, 대형 제약회사 AstraZeneca에 대해 해당 특허의 전용실시권 허여 및 상업화 권리를 부여하는 기술이전 license 계약입니다. 이미 상당한 시간이 지난 오래 된 계약서이지만, 실제 엄청난 성공을 거둔 신약개발 기술이전 프로젝트로서. 실무자가 참고자료로 살펴볼 가치가 높다 생각합니다.

 

Article 7.  Inventions (추가 연구개발 발명에 대한 권리관계 규정. 단독 발명의 경우 개발회사에 권리귀속 확인 + 공동발명은 공동으로 결정 권한 보유 및 비용 등 책임도 분담 규정)

 

Inventions which are made and which relate to the COMPOUNDS and/or LICENSED PRODUCTS shall belong to the PARTY making such invention.  Each PARTY shall have the right to file, prosecute and maintain patent applications and patents covering inventions made solely by that PARTY.  

 

If an invention is made jointly by the PARTIES, such invention shall be jointly owned.  Neither PARTY shall file any patent application(s) containing such joint invention and/or any information or data received from the other PARTY without the prior written consent of the PARTY providing the information or data.  

 

SHIONOGI and ZENECA shall mutually determine whether or not patent applications should be filed concerning such joint inventions, which PARTY shall be responsible for filing and prosecuting any patent applications filed, and share the costs in filing any patent applications, obtaining and maintaining any patents covering joint inventions.

 

Article 9.  Representation and Warranty (진술 및 보증조항. 특허유효 및 권리 소유관계, 타인의 권리침해 여부 등에 관한 성실한 조사 및 그 결과에 따른 인식범위로 보증책임 제한. 무제한 보증 아님.)

 

9.1

SHIONOGI represents and warrants that it is the owner of the entire right, title and interest in the PATENTS listed in Appendix II hereto and KNOW-HOW, and is entitled to grant the licenses specified herein.  SHIONOGI further hereby represents and warrants that, to the best of its knowledge, the PATENTS owned or controlled by SHIONOGI or SHIONOGI’s AFFILIATES are being procured from the respective Patent Offices in accordance with all applicable laws and regulations.

 

9.2

SHIONOGI represents and warrants that it has full corporate power to enter into this Agreement and to carry out the provisions hereof.

 

9.3

ZENECA represents and warrants that it has full corporate power to enter into this Agreement and to carry out the provisions hereof.

 

9.4

SHIONOGI represents that, as of the EFFECTIVE DATE, it is not aware of any infringement or threatened infringement of the PATENTS or KNOW-HOW by a THIRD PARTY.

 

9.5

SHIONOGI represents and warrants that, to the best of SHIONOGI’s knowledge, ZENECA’s exploitation or use of the PATENTS and/or KNOW-HOW hereunder will not infringe any patent or other intellectual property right enjoyed by any THIRD PARTY (with the exception of Hoechst European Patent Applications No.  88120057.0 and any foreign applications or patents corresponding thereto).

 

9.6

SHIONOGI represents that, as of the EFFECTIVE DATE, SHIONOGI has no knowledge from which it can reasonably be inferred that the PATENTS are invalid.

 

Article 11.  PATENTS (특허출원, 심사 및 등록과장에서 라이센시의 검토 및 참여권리 보장. 특허권리 확보에 라이센시 참여권 부여)

 

11.1

SHIONOGI has the responsibility to file, prosecute and maintain the PATENTS and shall bear all cost for the PATENTS, including fees and expenses paid to outside legal counsel and experts, direct costs of in-house counsel and filing, prosecution and maintenance expenses associated therewith.

 

11.2

SHIONOGI shall provide ZENECA with an opportunity to review and comment on the nature and text of new or pending applications for the PATENTS.

 

11.3

SHIONOGI shall advise ZENECA on an annual basis of progress in the prosecution of all patent applications and in the maintenance or extension of patents falling within the PATENTS and shall, on request, furnish ZENECA with a copy of the patent application, patent or other document pertinent to prosecution, maintenance or extension of such applications and patents.

 

11.4

No significant steps regarding prosecution of the PATENTS will be taken by SHIONOGI without prior consultation with ZENECA.  In particular, no steps concerning European Patent Application No.  92111090.4 or US Patent 5,260,440 will be taken by SHIONOGI without prior consultation with ZENECA.

 

11.5

If SHIONOGI elects not to continue to prosecute a patent application or not to maintain or extend any patent application or patent within the PATENTS, SHIONOGI shall notify ZENECA not less than two (2) months before any relevant deadlines.  Thereafter ZENECA shall have the right to pursue at its expense, and at its sole discretion, the prosecution, extension or maintenance of such application or patent.  Any costs incurred by ZENECA pursuant to this shall be offset against royalties payable under Article 4.

 

11.6

ZENECA may request SHIONOGI to seek additional patent protection for the COMPOUNDS or LICENSED PRODUCTS in the TERRITORY, for example, by way of patent registration, patent of importation or revalidation, or the like.  If SHIONOGI chooses to seek such additional patent protection, it shall do so at its own cost and in its own name.  If SHIONOGI chooses not to seek such additional patent protection, ZENECA may require SHIONOGI to do so; provided ZENECA reimburses SHIONOGI for any reasonable expenses incurred in doing so.  Such patent property shall then be included within the definition of PATENTS.

 

11.7

SHIONOGI shall immediately advise ZENECA of any certification filed under the U.S.  “Drug Price Competition and Patent Term Restoration Act of 1984” (“ANDA ACT”) claiming that any PATENTS are invalid or claiming that the PATENTS will not be infringed by the manufacture, use or sale of a product for which an application under ANDA ACT is filed.

 

11.8

The PARTIES will cooperate with each other in gaining patent term extension(s) or the like, where applicable to the PATENTS in the TERRITORY, for example, under the U.S.  “Drug Price Competition and Patent Term Restoration Act of 1984” or under a supplementary protection certificate in European countries.

 

11.10

Upon reasonable request of ZENECA, SHIONOGI will provide ZENECA with all necessary assistance relating to the PATENTS, including allowing ZENECA access to SHIONOGI’s files and documents and access to SHIONOGI’s personnel who may have possession of relevant information.

 

Article 12.  Infringement of PATENTS (라이선스 대상 특허권을 제3자가 침해할 경우 양당사자의 침해대응 책임 및 협력 방안, 대상 특허실시로 타인 권리를 침해하는 경우 분쟁 대응 책임 및 협력 방안 규정)

 

12.1

In the event that ZENECA or SHIONOGI supposes that a THIRD PARTY may be infringing any of the PATENTS by the manufacture, use, distribution, marketing or sale of the COMPOUNDS and/or LICENSED PRODUCTS, ZENECA or SHIONOGI shall promptly notify the other PARTY in writing, identifying the infringer and the infringement complained of and furnishing the information upon which such determination is based.  ZENECA shall be entitled, in its sole discretion but after notifying SHIONOGI, to take any measures deemed appropriate to stop such infringing activities by such THIRD PARTY in the TERRITORY or to grant to the infringing THIRD PARTY adequate rights and licenses necessary for continuing such activities in the TERRITORY so long as ZENECA remains in compliance with Article 4.  Upon reasonable request by ZENECA and at ZENECA’s cost, SHIONOGI shall give ZENECA all reasonable information and assistance including allowing ZENECA access to SHIONOGI’s files and documents and access to SHIONOGI’s personnel who may have possession of relevant information, and if necessary to prosecute any legal action, joining in the legal action as a party.

 

12.2

ZENECA shall bear the cost of any action or measures taken in accordance with Article 12.1 and shall be entitled to receive any damages or remuneration received as a result of such action or measures.

 

12.3

In the event ZENECA decides, within sixty (60) days of becoming aware of an infringement, in its sole discretion, not to take any action against a THIRD PARTY deemed to infringe the PATENTS, ZENECA shall inform SHIONOGI in writing and SHIONOGI thereafter shall be entitled to pursue an action to stop such infringement in its own name and for its own account.  Upon reasonable request by SHIONOGI and at SHIONOGI’s cost, ZENECA shall give SHIONOGI all reasonable information and assistance.  Any damages or remuneration received as a result of such action shall be received by SHIONOGI.

 

12.4

In the event of any actual or threatened suit against ZENECA or its AFFILIATES, SUBLICENSEES or customers alleging that the exploitation or use of the PATENTS and/or KNOW-HOW hereunder infringes the patent or other intellectual property rights of a THIRD PARTY, ZENECA shall promptly give written notice to SHIONOGI.  SHIONOGI will provide to ZENECA all reasonable assistance requested by ZENECA to defend or settle such suit and in particular SHIONOGI will promptly make available to ZENECA, free of charge, all information in its possession or control which will assist ZENECA in defending or otherwise dealing with such suit.  ZENECA shall have the right to defend in its sole discretion such suit but shall consult with SHIONOGI before settling such suit.  ZENECA shall not settle the suit without obtaining prior written consent of SHIONOGI which consent shall not be unreasonably withheld.  If damages or costs are awarded against ZENECA for such infringement, or if the outcome of the suit is that ZENECA is ordered to or agrees to make payments or pay royalties to a THIRD PARTY in order to secure the right to continue the exploitation or use of the PATENTS and/or KNOW-HOW hereunder, then the following percentages of such damages, payments, or royalties shall be offset against royalties payable by ZENECA under Article 4: [***].

 

Notwithstanding the foregoing, in any event described above, SHIONOGI shall be entitled to receive at least [***] percent ([***]%) of the royalties due under Article 4 hereof from ZENECA in any one calendar year.

 

KASAN_[국제계약실무] 신약물질 기술이전 License 계약서 중 특허관련 계약조항 사례.pdf

 

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작성일시 : 2019. 4. 12. 16:00
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License 후 공동연구개발을 진행하지만 완료까지 오랜 기간이 소요되는 경우, 기술보유 licensor 벤처회사가 투자유치 또는 M&A 등으로 지배권 변동이 발생하기도 합니다. Licensee의 경쟁회사에서 licensor 회사를 M&A하는 경우는 물론, 제품라인이 중복되거나 연구개발전략이 전혀 달리하는 등 다양한 사유로 collaboration 관계를 지속하기 어려운 상황을 맞기도 합니다.

 

이와 같은 상황에 대비하여 미리 해결방안을 계약조항으로 규정해 두는 것이 바람직합니다. 다양한 쟁점이 있겠지만, 최근 올려드린 자문의 계약서 중 해당 조항을 뽑아 아래와 같이 인용합니다. 찬찬히 읽어 보고 살펴보시기 바랍니다.

 

정의 - "CHANGE IN CONTROL" shall mean, with respect to either Party, any of the following events: (i) the acquisition by any Major Pharmaceutical Company of "beneficial ownership" directly or indirectly, of 50% or more of the shares of such Party's capital stock, the holders of which have general voting power under ordinary circumstances to elect at least a majority of such Party's Board of Directors or equivalent body (the "Board of Directors") (the "Voting Stock"); (ii) the approval by the shareholders of such Party of a merger, share exchange, reorganization, consolidation or similar transaction of such Party (a "Transaction"), if any party to the transaction is a Major Pharmaceutical Company other than a Transaction which would result in the beneficial owners of Voting Stock of such Party immediately prior thereto continuing to beneficially own (either by such Voting Stock remaining outstanding or being converted into voting securities of the surviving entity) more than 50% of the Voting Stock of such Party or such surviving entity immediately after such Transaction; or (iii) approval by the shareholders of such Party of a complete liquidation of such Party or a sale or disposition of all or substantially all of the assets of such Party.

 

처리방안 계약조항 - CHANGE IN CONTROL. In the event there shall be a Change in Control with respect to either Party, the Party not involved in the Change in Control shall have a period of ninety (90) days following the Change in Control to give notice to the other Party that it desires to terminate this Agreement. If such notice is given, then the Parties shall arrange for a valuation of the value of their respective interests in this Agreement using the procedures set forth in Section 12.7(b)(i).

 

Upon receipt of the valuation, the Party not involved in the Change in Control shall have the option within thirty (30) days of receipt of the valuation either to (i) withdraw its notice terminating this Agreement or (ii) confirm its desire to terminate, in that case the Party experiencing the Change in Control shall elect either to (a) purchase the other Party's interest at the established value or (b) sell its own interest to the other Party at the appraised value of its interest. The Parties shall negotiate in good faith such other terms and conditions and take such other actions as shall be necessary to effect the sale or purchase contemplated hereby within the shortest possible time.

 

신약 기술이전 및 공동연구개발 계약

 

8.5. Change of Control.

 

8.5.1. Change of Control Notice. Astellas will notify Ironwood in writing, referencing this Section 8.5.1 of this Agreement, immediately upon any Change of Control of Astellas, and will provide such notice where possible at least 60 days prior to the Change of Control.

 

8.5.2. Consequences of a Change of Control.

 

(a) In the event that Astellas is subject to a Change of Control which could reasonably be expected to lead to an Impairment (as defined below), Astellas will notify Ironwood at least [**] days prior to the closing of such transaction, and Ironwood may elect, in its sole discretion, to (i) continue this Agreement in accordance with its terms, (ii) terminate this Agreement on [**] months notice, during which period this Agreement would continue in effect in accordance with its terms, such notice to be delivered within [**] days after the Fair Market Value is determined pursuant to this Section 8.5.2(a). Within [**] days following Ironwood’s receipt of notice from Astellas of a Change of Control that could reasonably be expected to lead to an Impairment, Ironwood will provide notice to Astellas requesting a determination of the Fair Market Value upon a termination of this Agreement pursuant to this Section 8.5.2(a), and the failure to so request such valuation will be deemed the election to continue this Agreement in accordance with its terms. Such determination must be made by the Parties in good faith, and if such determination is not made within [**] days of the request, then as determined by a Valuation Panel. In connection with such termination, Ironwood will be required to pay Astellas an amount equal to the upfront portion of the Fair Market Value within ten days of the effective date of the termination, and, as they become due, payment of any ongoing, and/or recurring license fees, royalties, and other payments that may be part of Fair Market Value.

 

(b) For purposes of this Section 8.5.2, an “Impairment” will only be deemed to occur if (a) it is reasonably anticipated that the entity resulting from such Change of Control will be unable to perform its obligations in accordance with the terms of this Agreement, as reasonably determined based on objective criteria available to both Parties, including without limitation, the new entity’s financial position and product pipeline, (b) the product line of the entity that survives following the Change of Control includes a product in an Oral Formulation in the Field that is in clinical development which is indicated for the treatment of IBSC, CC, OIC (unless as to any such indication, the JSC has determined not to pursue Development for such indication) or any other indication for which the Product is then being Commercialized in the Territory pursuant to this Agreement.

 

KASAN_[국제계약실무] License, Collaboration Agreement 당사자의 M&A 등 경영권 변

 

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작성일시 : 2018. 8. 30. 18:00
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