바이오신약__글9건

  1. 2019.06.14 국제계약, 영문계약 실무 - 기술이전, 특허실시, 신제품 개발판매 계약서에서 상표라이선스 관련 계약 조항 샘플
  2. 2019.06.03 공동발명자 성립요건의 입증책임 및 기준 – corroboration 판단 미국 판결문: PD-1/PD-L1 항체 면역 항암제 신약, 옵디보 Opdivo 특허발명의 공동발명자 분쟁 - 미국법원 판결 Dana-Farber Cancer Institute vs O..
  3. 2019.05.30 공동발명자 성립의 입증책임 및 기준 - corroboration 인정 판결문 인용 : PD-1/PD-L1 항체 면역 항암제 신약, 옵디보 Opdivo 특허발명의 공동발명자 분쟁 - 미국법원 판결 Dana-Farber Cancer Institute vs Ono Phar..
  4. 2019.05.30 세계적 블록버스터 신약, PD-1/PD-L1 항체 면역 항암제, 옵디보 Opdivo, 관련 6건의 미국특허의 공동발명자 분쟁 – 미국법원 판결 Dana-Farber Cancer Institute vs Ono Pharmaceutical & BMS 사건
  5. 2019.05.15 Licensor – 벤처회사, 발명자 대학교수, 특허권자 대학, 연구소 vs 제약회사 - Licensee 사이 바이오신약 후보물질 특허기술 라이선스 계약서에서 라이센시의 임상시험 수행 등 개발의무 관련 간략..
  6. 2019.05.15 대학소유 특허의 기술이전, 라이선스 계약에서 재실시허용 조건 위반 사례 - 특허권자 Licensor 미국대학 vs Licensee 벤처회사 + Sub-licensee 대기업 AbbVie : 라이선스 계약분쟁 중 라이센시 특허무효 ..
  7. 2019.05.15 대학교수 발명특허의 기술이전, 라이선스 계약서에서 sublicense 조항, 후속 개량발명의 특허출원 및 등록, 공동발명, Sublicense 및 Royalty 등 Collaboration 분쟁 사례 미국 판결
  8. 2019.05.15 Licensor - 대학교수, 대학, 연구소 및 벤처회사 vs 제약회사 Licensee 사이의 바이오신약 후보물질 특허기술 라이선스 계약서에 포함된 sublicense 관련 계약조항 샘플
  9. 2016.04.29 Repatha® (Evolocumab) 미국특허소송 Amgen v. Sanofi & Regeneron 특허유효 + 침해인정 배심평결

 

0. TRADEMARKS.

10.1 Licensed Product Marks.

(a) LICENSEE and LICENSOR agree that (i) LICENSEE shall be responsible for the selection, registration and maintenance of all Trademarks which it employs in connection with the Commercialization of any Licensed Product in the Territory under this Agreement and (ii) LICENSOR shall be responsible for the selection, registration and maintenance of all Trademarks which it employs in connection with the Commercialization of any Licensed Product outside of the Territory under this Agreement;

 

provided that each Party shall use Commercially Reasonable Efforts to differentiate Licensed Products from products marketed as of the Closing by, for example, not utilizing any Trademark in connection with the Commercialization of any Licensed Product that would be confusingly similar to any Trademark utilized in connection with the Commercialization of products marketed as of the Effective Date but, provided further that, neither Party shall be obligated to utilize, or not to utilize, any Trademark if, in such Party’s sole opinion, such utilization would (i) have a material adverse impact on Commercialization of such Licensed Product or (ii) result in material delay in achieving Regulatory Approval for Commercialization of such Licensed Product.

 

(b) Subject to Section 10.1(a), LICENSEE shall own and control all Trademarks which it employs in connection with the Commercialization of any Licensed Product in the Territory under this Agreement (“LICENSEE Licensed Product Marks”) and shall pay all costs relating thereto.

 

LICENSEE shall have the right to brand the Licensed Products in the Territory using LICENSEE Licensed Product Marks it determines appropriate for the Licensed Products, which may vary by country or within a country, and shall have the right, but no obligation, to use the LICENSOR Trademarks, subject to the license granted by LICENSOR to LICENSEE with respect to the LICENSOR TRADEMARKS pursuant to Section 10.1(c), on the labeling and packaging for Licensed Products in the Territory, and on all marketing, advertising and promotional materials associated with such Licensed Products (collectively the “LICENSEE Licensed Product Materials”);

 

provided that LICENSEE shall not, and shall ensure that its Affiliates and Sublicensees will not, make any use of (i) the Trademarks or house marks of LICENSOR (including LICENSOR’s corporate name) other than the LICENSOR Trademarks or (ii) any trademark confusingly similar to the Trademarks or house marks of LICENSOR (including LICENSOR’s corporate name), in the case of both (i) and (ii), on any LICENSEE Licensed Product Materials. Subject to the license granted by LICENSOR to LICENSEE with respect to the LICENSOR TRADEMARKS pursuant to Section 10.1(c), LICENSEE shall own all rights in the LICENSEE Licensed Product Materials.

 

(c) Subject to the terms and conditions of this Agreement, during the Term of this Agreement, LICENSOR hereby grants to LICENSEE a non-exclusive, royalty-free, sublicenseable license (i) to use LICENSOR Trademarks on all LICENSEE Licensed Product Materials in the Territory and (ii) to reproduce, prepare derivative works, distribute copies, perform, display and otherwise use LICENSOR Copyrights in connection with the exercise of the rights granted by LICENSOR to LICENSEE under the terms of this Agreement. All representations of the LICENSOR Trademarks that LICENSEE intends to use shall first be submitted to LICENSOR for approval (which shall not be unreasonably withheld or delayed) of design, color, and other details or shall be exact copies of those used by LICENSOR. All representations of the LICENSOR Trademarks that are used by LICENSEE shall comply with the reasonable usage guidelines provided by LICENSOR.

 

(d) During the Term, LICENSOR may make a written request to LICENSEE for permission to use the LICENSEE Licensed Product Marks in relation to Licensed Products in Korea. If LICENSEE consents to such use (such consent not to be unreasonably withheld), the Parties shall discuss in good faith the terms and conditions applicable to such use of the LICENSEE Licensed Product Marks, including any reasonable consideration payable with respect to such use. In the event that LICENSEE provides its consent and the Parties agree upon terms and conditions applicable to such use, all representations of the LICENSEE Licensed Product Marks that LICENSOR intends to use shall first be submitted to LICENSEE for approval (which shall not be unreasonably withheld or delayed) of design, color, and other details or shall be exact copies of those used by LICENSEE, and all representations of the LICENSEE Licensed Product Marks that are used by LICENSOR shall comply with the usage guidelines provided by LICENSEE.

 

(e) Subject to Section 10.1(a), LICENSOR shall own and control all Trademarks which it employs in connection with the Commercialization of any Licensed Product outside the Territory and in Japan under this Agreement (“LICENSOR Licensed Product Marks”) and shall pay all costs relating thereto.

 

LICENSOR shall have the right to brand the Licensed Products outside the Territory and in Japan using LICENSOR Licensed Product Marks it determines appropriate for the Licensed Products, which may vary by country or within a country, and on the labeling and packaging for Licensed Products outside the Territory and in Japan, and on all marketing, advertising and promotional materials associated with such Licensed Products (collectively the “LICENSOR Licensed Product Materials”);

 

provided that LICENSOR shall not, and shall ensure that its Affiliates and sublicensees will not, make any use of (i) the Trademarks or house marks of LICENSEE (including LICENSEE’s corporate name) or (ii) any trademark confusingly similar to the Trademarks or house marks of LICENSEE (including LICENSEE’s corporate name), in the case of both (i) and (ii), on any LICENSOR Licensed Product Materials. LICENSOR shall own all rights in the LICENSOR Licensed Product Materials.

 

10.2 No Challenge.

(a) LICENSOR recognizes the exclusive ownership by LICENSEE of all LICENSEE Licensed Product Marks. LICENSOR shall not, either while this Agreement is in effect, or at any time thereafter, register, use or challenge or assist others to challenge the LICENSEE Licensed Product Marks. LICENSOR shall not attempt to obtain any right in or to any name, logotype, trademark or trade dress confusingly similar for the marketing, sale or distribution of any goods or products, notwithstanding whether such goods or products have a different use or are dissimilar to the Licensed Products.

 

(b) LICENSEE recognizes the exclusive ownership by LICENSOR of all LICENSOR Licensed Product Marks. LICENSEE shall not, either while this Agreement is in effect, or at any time thereafter, register, use or challenge or assist others to challenge the LICENSOR Licensed Product Marks. LICENSEE shall not attempt to obtain any right in or to any name, logotype, trademark or trade dress confusingly similar for the marketing, sale or distribution of any goods or products, notwithstanding whether such goods or products have a different use or are dissimilar to the Licensed Products.

 

10.3 Proceedings.

(a) Only LICENSEE will be authorized to initiate at its own discretion legal proceedings against any infringement or threatened infringement of any LICENSEE Licensed Product Marks.

 

(b) Only LICENSOR will be authorized to initiate at its own discretion legal proceedings against any infringement or threatened infringement of any LICENSOR Licensed Product Marks.

 

10.4 Domain Names.

(a) LICENSEE shall be responsible for the registration, hosting, maintenance and defense of any domain name based on the LICENSEE Licensed Product Marks. LICENSEE may at its sole and absolute discretion register in its own name or in name of others, host on its own servers or on Third Party servers, maintain and defend such domain names and use them for websites.

 

(b) LICENSOR shall be responsible for the registration, hosting, maintenance and defense of any domain name based on the LICENSOR Licensed Product Marks. LICENSOR may at its sole and absolute discretion register in its own name or in name of others, host on its own servers or on Third Party servers, maintain and defend such domain names and use them for websites.

 

KASAN_국제계약, 영문계약 실무 - 기술이전, 특허실시, 신제품 개발판매 계약서에서 상표라이선스 관련 계약 조항

 

[질문 또는 상담신청 입력하기]

 

 

작성일시 : 2019. 6. 14. 09:11
Trackback 0 : Comment 0

댓글을 달아 주세요


 

 

실무적으로 매우 중요한 쟁점입니다. 공동발명자로 주장하는 측에 그 주장을 구체적 증거로 입증해야 하는 책임이 있습니다. 미국법원은 그 입증책임을 corroborating evidence, 즉 구체적 증거로 상세하게 입증할 것을 요구합니다. 위 사안에서 공동발명 여부를 입증하는 방법과 정도를 어떻게 판단했는지 판결문에서 해당 부분을 인용하면 다음과 같습니다.

 

미국 특허법 공동발명자 규정 - 35 U.S.C. § 116(a) - Joint Inventorship

“When an invention is made by two or more persons jointly, they shall apply for patent jointly and each make the required oath, except as otherwise provided in this title. Inventors may apply for a patent jointly even though (1) they did not physically work together or at the same time, (2) each did not make the same type or amount of contribution, or (3) each did not make a contribution to the subject matter of every claim of the patent.”

 

 

미국 Opdivo 판결문 – 58면 이하

An individual qualifies as a joint inventor only if he contributes to the conception of the claimed invention. Conception requires a ‘definite and permanent idea of an operative invention, including every feature of the subject matter sought to be patented.’ An idea is definite and permanent when the inventor has a specific, settled idea, a particular solution to the problem at hand, not just a general goal or research plan.

 

Conception is complete when only ordinary skill would be necessary to reduce the invention to practice, without extensive research or experimentation. A conception is not complete if the subsequent course of experimentation, especially experimental failures, reveals uncertainty that so undermines the specificity of the inventor’s idea that it is not yet a definite and permanent reflection of the complete invention as it will be used in practice.

 

There is no explicit lower limit on the quantum or quality of inventive contribution required for a person to qualify as a joint inventor. In particular, a putative joint inventor “need not demonstrate that he made a contribution equal in importance to the contribution made by the listed inventors.” Instead, courts ask whether the contribution is “not insignificant in quality, when . . . measured against the dimension of the full invention.”

 

Inventorship is determined on a claim-by-claim basis, and a putative co-inventor need only show that he contributed to the conception of one claim.

 

A joint inventorship analysis proceeds in two steps. First, a court must construe the claims to determine the subject matter encompassed thereby. Second, a court must compare the alleged contributions of each asserted co-inventor with the subject matter of the correctly construed claim to determine whether the correct inventors were named.

 

To meet the clear and convincing evidence standard, putative joint inventors must provide some corroborating evidence instead of relying solely on their own testimony. This requirement for corroboration addresses the concern that a party claiming inventorship might be tempted to describe his actions in an unjustifiably self-serving manner in order to obtain a patent.

 

Courts use a “rule of reason” analysis to determine if a putative joint inventor has sufficiently corroborated his testimony.

 

This analysis requires considering all pertinent evidence to judge “the credibility of the inventor’s story.” There is no particular formula that an inventor must follow in providing corroboration of his testimony.

 

“Records made contemporaneously with the inventive process” are the most reliable corroborating evidence, but courts also consider “circumstantial evidence of an independent nature” and “oral testimony from someone other than the alleged inventor.”

 

Oral testimony of one putative joint inventor is not enough on its own to corroborate the oral testimony of another. Courts have generally been most skeptical of oral testimony that is supported only by testimonial evidence of other interested persons. But such testimony can help to corroborate along with other evidence.

 

The record includes agendas from all but one of the three scientists’ collaboration meetings, slides from the meetings, numerous emails and letters exchanged by the three scientists in 1999 and 2000, and published journal articles. These documents explain Dr. Freeman’s and Dr. Wood’s hypotheses, experimental results, and conclusions and are alone sufficient to constitute corroborating evidence.

 

In addition to the plethora of documents, Dana-Farber provided corroboration from a number of witnesses. Dr. Brown corroborated Dr. Freeman’s testimony about his antibody and IHC work. Dr. Carreno, a former GI scientist, confirmed that the trio met in May 2000 in Seattle. Dr. Collins at GI testified that Dr. Freeman reached out about finding 292’s receptor and that Dr. Wood discovered that 292 is a ligand for PD-1. 

 

Especially significantly, Dr. Honjo, who was present for the trial, confirmed most of the events to which Dr. Freeman and Dr. Wood testified. The “cohesive web of allegedly corroborative evidence” leaves no doubt that Dr. Freeman and Dr. Wood testified truthfully about the experiments they conducted, the communications they exchanged, and the substance of the meetings they attended.

 

KASAN_공동발명자 성립요건의 입증책임 및 기준 – corroboration 판단 미국 판결문 PD-1PD-L1

 

[질문 또는 상담신청 입력하기]

 

 

작성일시 : 2019. 6. 3. 08:43
Trackback 0 : Comment 0

댓글을 달아 주세요


 

 

실무적으로 매우 중요한 쟁점입니다. 공동발명자로 주장하는 측에 그 주장을 구체적 증거로 입증해야 하는 책임이 있습니다. 미국법원은 그 입증책임을 corroborating evidence, 즉 구체적 증거로 상세하게 입증할 것을 요구합니다. 위 사안에서 공동발명 여부를 입증하는 방법과 정도를 어떻게 판단했는지 판결문에서 해당 부분을 인용하면 다음과 같습니다.

 

Courts a “rule of reason” analysis to determine if a putative joint inventor has sufficiently corroborated his testimony.

 

This analysis requires considering “all pertinent evidence” to judge “the credibility of the inventor’s story.” There is no particular formula that an inventor must follow in providing corroboration of his testimony.

 

“Records made contemporaneously with the inventive process” are the most reliable corroborating evidence, but courts also consider “circumstantial evidence of an independent nature” and “oral testimony from someone other than the alleged inventor.”

 

Oral testimony of one putative joint inventor is not enough on its own to corroborate the oral testimony of another.

 

“We have generally been most skeptical of oral testimony that is supported only by testimonial evidence of other interested persons.” But such testimony can help to corroborate along with other evidence.

 

The record includes agendas from all but one of the three scientists’ collaboration meetings, slides from the meetings, numerous emails and letters exchanged by the three scientists in 1999 and 2000, and published journal articles. These documents explain Dr. Freeman’s and Dr. Wood’s hypotheses, experimental results, and conclusions and are alone sufficient to constitute corroborating evidence.

 

In addition to the plethora of documents, Dana-Farber provided corroboration from a number of witnesses. Dr. Brown corroborated Dr. Freeman’s testimony about his antibody and IHC work. Dr. Carreno, a former GI scientist, confirmed that the trio met in May 2000 in Seattle. Dr. Collins at GI testified that Dr. Freeman reached out about finding 292’s receptor and that Dr. Wood discovered that 292 is a ligand for PD-1.

 

Especially significantly, Dr. Honjo, who was present for the trial, confirmed most of the events to which Dr. Freeman and Dr. Wood testified. The “cohesive web of allegedly corroborative evidence” leaves no doubt that Dr. Freeman and Dr. Wood testified truthfully about the experiments they conducted, the communications they exchanged, and the substance of the meetings they attended.

 

KASAN_공동발명자 성립의 입증책임 및 기준 - corroboration 인정 판결문 인용 PD-1PD-L1 항

 

[질문 또는 상담신청 입력하기]

 

 

작성일시 : 2019. 5. 30. 17:11
Trackback 0 : Comment 0

댓글을 달아 주세요


 

 

PD-1/PD-1 항체 면역 항암제, 옵디보 Opdivo 특허발명은 일본 교토대학에서 발명되어, 오노 제약에서 라이선스 후 신약으로 개발된 주목받은 신약입니다. BMS의 신약 Keytruda 제품을 커버하는 특허청구범위로 BMS와도 특허소송 중 화해로 라이선스 계약을 체결한 것으로 알려져 있습니다. 앞으로 적용 범위가 넓은 매우 중요한 특허입니다. 그와 같이 중요한 특허에 대해 미국에서 2015년 공동발명을 주장하는 소송이 제기되었습니다.

 

지난 2019. 5. 17. 미국 매사추세츠주 연방지방법원에서 Dana-Farber 연구소의 연구원 Dr. Freeman, Dr. WoodOno 제약 6건의 Opdivo 미국특허의 공동발명자라는 판결을 하였습니다. 미국법원은 111페이지라는 장문의 결정문에서 발명의 경위, 공동발명자로 판단한 이유 등을 상세하게 설명하고 있습니다. 중대한 이해관계가 걸린 중요한 판결로 보입니다. 미국법원의 소장과 판결문을 참고자료 첨부합니다. 한번 읽어 보시기 바랍니다.

 

첨부: 1. 미국소장

1_소장_complaint.pdf

 2. 미국법원 중간 판결문

2_ 중간판결_Fact & Law.pdf

KASAN_세계적 블록버스터 신약, PD-1PD-L1 항체 면역 항암제, 옵디보 Opdivo, 관련 6건의 미국특허

 

[질문 또는 상담신청 입력하기]

 

 

작성일시 : 2019. 5. 30. 09:08
Trackback 0 : Comment 0

댓글을 달아 주세요


 

 

1.3 “Commercially Reasonable Efforts” shall mean the efforts, expertise and resources normally used by a Party to develop, use, Manufacture and commercialize a product owned by it or to which it has rights, which is of similar market potential at a similar stage in its development or product life, taking into account issues of safety and efficacy, product profile, difficulty in developing the product, competitiveness of the marketplace for the product, the proprietary position of the product, the regulatory structure involved, the availability and level of reimbursement for such treatment by Third Party payors or health insurance plans, the potential total profitability of the applicable product(s) marketed or to be marketed and other relevant factors affecting the cost, risk and timing of Development and the total potential reward to be obtained if a product is commercialized.

 

7.1 Research and Development Efforts. The Licensee Kite shall use its Commercially Reasonable Efforts to conduct such research, development and preclinical and human clinical trials as are necessary to obtain regulatory approval to manufacture and market Licensed Products, and shall use good faith efforts to obtain regulatory approval to market, and following approval to commence marketing and market each such Licensed Product in such countries as Kite determines are commercially feasible. Kite, shall be responsible, at its sole cost and expense, for the development of Licensed Products in the Field. Kite, shall be responsible for: clinical trials with respect to the Licensed Products and filing required regulatory submissions and dealings with Regulatory Authorities with respect to Licensed Products. Kite shall also be responsible for reporting to the appropriate regulatory authorities adverse events related to Licensed Products as required by applicable law. Kite, shall also be responsible for communications with the FDA regarding such filings and Licensed Products; provided that Cabaret shall be consulted regarding any discussions or meetings with the FDA regarding Licensed Products, and following each meeting between the FDA and Kite regarding a Licensed Product, Kite shall provide Cabaret with a written summary of such meeting. Kite undertakes to use its Commercially Reasonable Efforts to ensure that the Licensed Products marketed by it will, and it shall, in carrying out its obligations hereunder, comply with all legal requirements. Kite shall notify Cabaret within [*] after Kite becomes aware of the First Commercial Sale of a Licensed Product in each country. Kite shall have the right to perform all such obligations on its own behalf, or through an Affiliate, Sublicensee or contractor (which shall constitute performance by Kite hereunder).

 

7.2 Records. The Licensee Kite shall maintain records, in sufficient detail and in good scientific manner, which shall reflect all work done and results achieved in the performance of its research and development regarding the Licensed Products.

 

7.3 Reports. Within [*] following the end of each June and December during the term of this Agreement, the Licensee Kite shall prepare and deliver to the Licensor Cabaret a written summary report which shall describe (a) the research performed to date employing the Licensed IP Rights, (b) the progress of the development, and testing of Licensed Products in clinical trials, and (c) the status of obtaining regulatory approvals to market and its commercialization activities for Licensed Products. Kite promptly shall notify Cabaret upon the initiation of any formal investigation, review or inquiry of Kite by regulatory authorities or governmental authorities concerning (i) non-clinical or clinical research relating to a Licensed Product; or (ii) the distribution, promotion or sale of a Licensed Product.

 

KASAN_Licensor – 벤처회사, 발명자 대학교수, 특허권자 대학, 연구소 vs 제약회사 - Licensee

 

[질문 또는 상담신청 입력하기]

 

 

작성일시 : 2019. 5. 15. 17:30
Trackback 0 : Comment 0

댓글을 달아 주세요


 

 

1. 사안의 개요

 

Gonadotropin releasing hormone (GnRH)은 전립선암, 자궁암, 유방암을 포함하여 많은 내분비계 질환과 관련된 것으로 알려져 있습니다. NY 소재 Mt. Sinai 의과대학 Dr. Sealfon 교수는 1998년경 GnRH 관련 질병치료제 개발의 기본 tool에 해당하는 연구개발성과에 대한 2건의 특허를 등록하고, 1999. 8. 27. San Diego 소재 벤처기업 Neurocrine Biosciences nonexclusive license를 허여하는 계약을 체결하였고, Neurocrine10여년간의 연구개발 끝에 2010년경 대기업 Abbott(현재 AbbVie)와 신약연구개발 성과(신약후보 물질 Elagolix )에 대한 exclusive license 계약을 체결하였습니다.

 

최초 라이선스 계약서 중 sublicense 허용조항은 다음과 같습니다. – The Licensee Neurocrine may "grant sublicenses under the License only with the prior written consent" of the Licensor Mt. Sinai.

 

Neurocrine에서 AbbVie와 라이선스 계약을 체결하면서 Mt. Sinai 의과대학의 사전동의를 받지 않았습니다. 그것이 라이선스 계약위반에 해당하는지, 손해배상책임 여부가 문제됩니다.

 

한편, Elagolix는 현재 FDA 허가심사 중인데, Mt. Sinai 의과대학에서 향후 신약에 대한 Royalty를 받을 수 있는지 등이 중대한 문제입니다.

 

2. 특허라이선스와 Licensee의 특허무효 부쟁의무   

 

원칙적으로 licensee 입장에서 대상특허의 무효항변을 제기하는 것은 허용됩니다. 미국연방대법원 Lear v. Adkins (1969) 판결: a licensee cannot be estopped from challenging the validity of a patent merely because it benefitted from the license agreement.

 

그러나, 라이선스 계약위반으로 이미 성립된 책임을 회피하기 위해 사후적으로 제기하는 특허무효주장은 허용되지 않는다는 것이 미국법원 판결입니다. Studiengesellshaft Kohle v. Shell Oil (CAFC 1997) 판결: Lear does not apply where a licensee seeks to avoid contractual obligations already owed at the time of the suit. It "must prevent the injustice of allowing a licensee to exploit the protection of the contract and patent rights and then later to abandon conveniently its obligations under those same rights."

 

3. 미국법원의 Licensee Neurocrine의 대상특허 무효 항변 배척 판결 

 

미국법원은 sublicense 허용조건으로 licensor의 사전동의를 받도록 한 계약조항을 위반한 행위에 대한 손해배상을 구하는 범위내에서 licensee의 특허무효 항변이 허용되지 않는다고 판결하였습니다.

 

다만, 사안을 구별하여, 특허권자가 특허기술 사용에 대한 장래 royalty를 청구하는 경우는 licensee의 특허무효 항변이 허용될 수 있다는 취지의 판결입니다. 이 부분에 대한 라이선스 계약위반 사항은 없기 때문입니다.

 

참고로 licensee특허비침해 주장도 하였지만, 미국법원은 위 사안에서 라이선스 계약위반에 대한 항변으로 허용될 수 없다고 명확하게 판결하였습니다.

 

대학의 특허발명에 출발하여 벤처기업에서 10여년간 연구개발한 성과를 다시 대규모 제약회사에 라이선스하여 최종적으로 신약허가신청까지 성공한 사례입니다. 여기서 최초 대학과 체결한 라이선스 계약에 관한 분쟁으로 라이선스 실무자들에게 흥미로운 사건입니다.

 

중도 합의로 종결되어 최종 손해배상금액까지 결정한 최종 판결이 나오지 않을 가능성이 높지만 비록 중간판결일지라도 모니터링해볼 흥미로운 사례라고 생각합니다.

 

미국법원 사건 정보 Case: Icahn School of Medicine at Mount Sinai v. Neurocrine Biosciences, Inc., No. 15 Civ. 9414, S.D.N.Y.

 

KASAN_대학소유 특허의 기술이전, 라이선스 계약에서 재실시허용 조건 위반 사례 - 특허권자 Licensor 미국

 

[질문 또는 상담신청 입력하기]

 

 

작성일시 : 2019. 5. 15. 16:30
Trackback 0 : Comment 0

댓글을 달아 주세요


 

 

1. 머리말

 

대학기술을 license하여 산학공동협력연구 Research Collaboration Agreement를 체결하는 경우 후속 연구개발성과에 대한 권리귀속, 그 기술을 대기업 등 제3자에게 다시 license하거나 이전하는 등 사업화하여 수익을 창출할 수 있는 sublicense 단계에서의 수익배분 문제는 핵심쟁점 중 하나입니다.

 

최대한 파이를 키워야만 서로 나누어 가질 조각도 커진다는 기본전제는 분명합니다. 먼저 파이를 키우는 후속 연구개발과 sublicense는 서로 적극적으로 지원해야 합니다. 그 다음 파이조각 나누기는 쉽지 않습니다. 왜냐하면, 후속 연구개발성과에 대한 권리관계 판단이 쉽지 않기 때문입니다. 통상 sublicense는 원천기술보다 후속 연구개발성과를 본 후 원천기술에 그것을 포함하여 대상으로 하거나 원천기술보다 후속 연구개발성과를 주된 대상기술로 하기 때문입니다. 후속연구개발에 대한 기여도가 똑같지 않기 때문에 소유권 또는 지분권 등에 관한 분쟁 가능성이 높습니다.

 

특히 대학교수가 licensee 기업으로부터 위탁연구용역을 수주하는 경우도 많기 때문에 위탁연구 관련 발명의 발명자에 해당하는지 아니면 단순 외주 용역에 불과한지, 특히 소속대학은 직무발명 법리에 근거한 지분권이 있는지 등등 복잡한 문제가 생깁니다. 아래에서 미국대학 중 기술이전 실적이 많고 또 소송 등 권리행사에 적극적인 Wisconsin 대학의 분쟁사례 판결을 참고로 소개합니다.

 

2. 기술이전 및 산학협력연구

 

. 대학기술 라이선스 및 산학협동연구

 

1999 Wisconsin 대학교수는 SCD 저해화합물의 콜레스테롤 저하 효능을 발견하였고, Wisconsin 대학산학협력단에서 2000년 연구결과에 대한 provisional patent application을 출원하였습니다. 그 후 캐나다 제약회사 Xenon에서 특허출원기술을 포함한 exclusive license agreement Wisconsin 대학교수를 포함한 연구진과 콜레스테롤 저하 효능의 신약개발에 관한 공동연구개발계약을 체결하고, 공동연구개발을 진행하여 다수 신물질의 효과를 확인하였습니다. Xenon사는 그 다음 해 2001 provisional patent application에 대한 우선권을 주장하면서 추가 연구성과를 포함하여 대학과 공동 특허출원을 하였습니다.

 

. 후속 연구개발성과에 대한 회사의 단독 특허출원

 

한편, Xenon은 계속하여 license 대상 물질을 넘어서 그 범위를 확대하여 수천개의 화합물의 약효를 확인하는 추가 연구개발 프로젝트를 추진하였고, 이때 위스콘신 대학이 아닌 제3의 외부 전문 연구기관과 위탁연구용역을 진행하였습니다.

 

그 결과 효능이 뛰어난 PPA 군 화합물 20여개를 선택한 후, 다시 Wisconsin 대학의 교수에게 보내 효능을 재확인하는 위탁연구용역을 하였습니다. 그 최종 결과물을 갖고 Xenon사 단독으로 PPA군 화합물에 대한 후속 특허출원을 하였습니다.

 

. Norvatis sublicense 성사 및 분쟁발생  

 

Xenon사는 후속으로 단독 출원했던 신약후보물질 PPA 관련 기술에 대해, 대형 제약회사 Novartis와 특허출원 후 3,4년이 지나 기술이전 및 license하는 계약을 체결하였습니다.

 

Wisconsin 대학은 Xenon의 후속 연구성과물에 대한 단독 특허출원 기술내용, PPA 기술내용도 Wisconsin 대학과 공동 출원한 선행 특허출원의 청구범위에 속하고, 대학과 체결한 exclusive license 적용대상이므로 계약상 sublicense에 해당하고, 따라서 약정한 sublicense fee를 대학에 지불해야 한다고 주장합니다.

 

반면, licensee Xenon사에서는 후속 연구성과 PPA 관련 기술내용은 대학과 무관하게 독자적인 연구개발의 성과물로서 단독소유라고 주장하였습니다.

 

또한, 설령 그 기술내용이 선출원 특허의 청구범위에 속한다고 하더라도 미국법상 공동 출원인 Xenon사는 타 공유자의 동의 없이 자유롭게 license 하는 등 실시할 권리가 있다고 주장합니다. , 특허공유자는 타 공유자에게 수익 배분의 부담 없이 자유롭게 공유 특허발명을 양도 또는 라이선스를 할 수 있기 때문에 Norvatis로부터 받은 로열티 수입 중 일부를 위스콘신 대학에 배분해 주어야 할 의무는 없다고 주장합니다.

 

3. 미국법원 판결

 

Xenon사의 방어논리 중 핵심포인트는 미국특허법상 공동출원인, 특허공유자의 특허기술전체에 대한 자유로운 실시권에 기초한 것입니다. 미국법원은 특허법상 공유자의 권리의무관계는 당사자 사이의 계약으로 달리 정할 수 있고, 그 경우 당사자 사이 계약내용이 이 우선 적용된다는 기본원칙을 명확하게 밝혔습니다.

 

Xenon사는 Wisconsin 대학 산학협력단과 체결한 계약서에서 sublicense를 허용하고 그 경우 대학에 일정한 sublicense fee를 지불하기로 약정하였고, 그와 같은 계약은 공동출원인, 공유특허권자 사이에서도 유효한데, Xenon사에서 그와 같은 계약을 위반했다고 판결하였습니다.

 

결국 Xenon사는 exclusive license agreement에서 약정한 바에 따라 Norvatis로부터 받은upfront payment는 물론 향후 running royalty 중 일부를 sublicense fee로서 위스콘신 산단에 지불해야 한다는 판결입니다.

 

한편, 추가 PPA 화합물 20여개를 Wisconsin 대학교수에게 보내 효능을 재확인하기 위한 위탁연구용역에 관련 쟁점이 있습니다. Wisconsin 대학은 공동연구개발계약 범위 내에 속하고 대학교수는 공동발명자, 대학은 그 직무발명의 승계인으로서 권리 공유자라는 입장입니다. 미국법원은 회사 단독 소유권을 부정하고 산단에 공유자 권리를 인정하였습니다.

 

우리나라에서도 대학교수와 위탁연구용약을 자주 합니다. 그 결과물에 대해 대학 산학협력단의 지분권을 부인하고 의뢰자 회사의 단독 권리를 주장하는 경우가 많습니다. 해당 교수가 발명자로 인정된다면, 직무발명 등 관련 법에 따라 판단해 본다면, 설령 해당 대학교수가 용인하더라도 회사의 단독 소유 주장은 인정받기 어렵다 생각합니다.

 

KASAN_대학교수 발명특허의 기술이전, 라이선스 계약서에서 sublicense 조항, 후속 개량발명의 특허출원 및

 

[질문 또는 상담신청 입력하기]

 

 

작성일시 : 2019. 5. 15. 15:30
Trackback 0 : Comment 0

댓글을 달아 주세요


 

 

1.26 “Sublicense” shall mean any right granted, sublicense conferred or agreement entered into, between the Licensee and a Third Party permitting any use of the Licensed IP Rights, directly or indirectly, to make, or have made, develop, offer for sale, sell or otherwise commercialize any Licensed Product; provided, however, that a Sublicense shall exclude a bona fide agreement for the evaluation, testing, research, development on behalf of Kite or its Affiliates, or manufacturing on behalf of the Licensee or its Affiliates, or a distributor or reseller agreement, all pursuant to which no Sublicense Revenues are paid to the Licensee.

 

1.27 “Sublicense Revenues” shall mean, with respect to a Sublicense, the aggregate cash (or cash equivalent) or stock or securities (or their equivalent) consideration received by the Licensee or its Affiliates to the extent in consideration for such Sublicense, including consideration for an option to obtain such Sublicense. Such consideration shall include without limitation any upfront, license initiation or signing fees, license maintenance fees, milestone payments, unearned portion of any minimum annual royalty payment or equity. Sublicense Revenues shall exclude [*].

 

3. LICENSE GRANT 

3.1 Licensed IP Rights. Subject to Section 3.2 below, the Licensor Cabaret hereby grants to the Licensee Kite an exclusive (other than as set forth in Section 3.2 and 3.4 below) worldwide royalty bearing license (with the right to grant sublicenses through multiple tiers as set forth hereunder) under the Licensed IP Rights to research, have researched, develop , have developed, make, have made, use, offer for sale, sell, import, export, commercialize and otherwise exploit Licensed Products for use in the Field. Subject to the conditions set forth in Section 3.9 the foregoing license includes the right to grant sublicenses under the Licensed IP Rights, provided that, with respect to sublicenses granted under, Kite shall (a) grant such sublicenses only for consideration and at arm’s-length transactions, and (b) grant such sublicenses only pursuant to written agreements that contain such terms and conditions as may be required for Kite to comply with this Agreement.

 

3.2 License Restrictions. The license granted in Section 3.1 above is and shall remain at all times subject to the following restrictions (and Kite shall ensure that any of its Sublicensee’s shall be subject such restrictions): (i) the Licensor Dr. Eshhar, the Regents and the Government of the United States (the “Government”) reserve the right to use the Patents Rights and associated technology licensed under the Inter-Institutional Agreement last executed on June 22, 2012 (“UCSF IIA”), between Dr. Eshhar, BioSante and The Regents, and disclosed to Kite under Section 2.2.5 above, and the Inter-institutional Agreement dated 19.11.2013 (“NIH Agreement”), for educational and research purposes; (ii) nothing in this Agreement shall confer by estoppel, implication or otherwise, any license or rights under any patents of the Regents other than those patents rights detailed in the USCF IIA, regardless of whether such patents are dominant or subordinate to the Patents Rights defined in the UCSF IIA; (iii) Kite shall not use the name or trademark or logo of the University of California or any campus thereof; in each case to the extent required by the UCSF HA; (iv) the license is subject to the provisions of 37 C.F.R. Part 401 and the rights retained by the Government under the NIH Agreement; and (v) until the last to expire of U.S. Patent 8,211,422 issued July 3, 2012 from Patent Application 08/547,263 filed October 24, 1995 entitled “Chimeric Receptor Genes and Cells Transformed Therewith” and US Patent Application 13/281,560 filed October 26, 2011 entitled “Chimeric Receptor Genes and Cells Transformed Therewith” (hereinafter referred to as the “NIH Patent Estate”) any products embodying the Licensed Patent Rights, or produced through use of the Licensed Patent Rights, shall be manufactured substantially in the United States unless a waiver is granted by the NIH; provided that NIH may waive this requirement upon Kite’s written request which shall not be unreasonably denied; (vi) until the last to expire of the NIH Patent Estate, the Government shall have the irrevocable, royalty-free, paid-up right to practice and have practiced the NIH Patent Estate and Eshhar patents 5,906,936 and 7,741,465, throughout the world by or on behalf of the Government and on behalf of any foreign government or international organization pursuant to any existing or future treaty or agreement to which the Government is a signatory; (vii) until the last to expire of the NIH Patent Estate, the NIH reserves the right to require Cabaret, or its licensees, to grant sublicenses to the patent rights to responsible applicants, on terms that are reasonable under the circumstances when necessary to fulfill health or safety needs or when necessary to meet requirements for public use specified by Federal regulations; and (viii) until the last to expire of the NTH Patent Estate, in addition to the reserved right of Section 3.2(vi), the NIH reserves the right to require Cabaret to grant research licenses to the patent rights on reasonable terms and conditions, for the purpose of encouraging basic research, whether conducted at an academic or corporate facility.

 

3.4 No implied licenses are set forth herein. Except for those licenses expressly granted hereunder in the Field, Cabaret does not grant to Kite any other licenses, either within or without the Field. Kite specifically understands and agrees that except as explicitly set forth herein, Cabaret reserves all rights under the Licensed IP Rights to make, have made, use, sell, offer for sale, import, export, distribute and otherwise exploit products incorporating the Licensed IP Rights outside the Field. Without derogating from the generality in Section 3.2 above, Dr. Eshhar and Cabaret reserve the right to use all Licensed IP Rights licensed hereunder for educational and noncommercial research purposes in any and all fields.

 

3.5 In-Licenses. The Licensor Cabaret shall timely pay in full all amounts required to be paid by Cabaret, and timely perform in full all obligations required to be performed by Cabaret, under all In-Licenses. Cabaret promptly shall provide the Licensee Kite with copies of all notices and other deliveries received under the In-Licenses. Without the prior express written consent of Kite, Cabaret shall not (and shall take no action or make no omission to) modify or waive any provision of any In-License that could impair the value of the licenses to Kite herein, or to terminate or have terminated any In-License. If any In-License is terminated for any reason, Cabaret shall make all reasonable efforts to ensure that the Licensor thereunder shall grant a direct license under the Licensed IP Rights thereunder to Kite containing terms and conditions no less favorable to Kite than the terms (including the payment terms) of such In-License, and Kite shall have the right to offset all payments thereunder against any amounts owing to Cabaret hereunder.

 

3.6 Availability of the Licensed IP Rights. The Licensor Cabaret shall provide the Licensee Kite with a copy of all information available to Cabaret relating to the Licensed IP Rights or Licensed Products.

 

3.7 Technical Assistance. Cabaret and Dr. Eshhar shall provide such technical assistance to Kite as Kite reasonably requests regarding the Licensed IP Rights. Kite shall pay to Cabaret and Dr. Eshhar their documented reasonable out-of-pocket costs of providing such technical assistance.

 

3.8 Right of First Offer. In the event that Cabaret proposes to enter into an agreement with any Third Party for the grant to any Third Party of any license, immunity, right or interest of any type whatsoever in or under the Licensed Patent Rights outside the Field, Cabaret shall as soon as practicable notify Kite of such intention (the “Company Notice”), and the Licensee Kite shall have the right, to be exercised by notice to Cabaret to express its interest to negotiate with Cabaret regarding receipt of such license within a period of [*] after the date of the Company Notice (such period, the “Negotiation Period”). During the Negotiation Period, Kite will notify Cabaret within [*] of its interest to negotiate with Cabaret, and in such event Cabaret shall negotiate in good faith with Kite regarding receipt of such license. To the extent that Kite notified Cabaret of its interest to negotiate with Cabaret, as set forth above, prior to the expiration of the Negotiation Period, Cabaret shall not enter into any definitive binding agreement of any kind with a Third Party in relation to such license (other than relating to access to information).

 

3.9 Sublicenses. The Licensee Kite shall be entitled to grant Sublicenses, provided, however, that all Sublicenses shall be subject to the following conditions:

 

3.9.1 The Licensee Kite shall execute a written sublicense with each Sublicensee, which mirrors the restrictive terms hereof and shall provide Cabaret with a copy of each such written sublicense within [*] of execution (and all amendments and modifications thereto within [*] of execution). Kite shall report pursuant to the terms of this Agreement Net Sales of the Licensed Product by all Sublicensees and

 

3.9.2 The Licensee Kite shall use reasonable efforts to add to the Sublicense agreement a clause stating that, in case of a default of payment due by Kite of royalties owing on Net Sales by a Sublicensee, which is not cured within [*] after notice in accordance with this Agreement, then upon the written request of Cabaret, such Sublicensee will make future royalty payments and furnish the reports and documents that are required to be paid or furnished by Kite pursuant to this Agreement with respect to Net Sales by such Sublicensee directly to Cabaret.

 

3.9.3 The Licensee Kite shall, and by this Agreement herewith does, agree to cause its Sublicensees to assume and agree to perform all of the relevant covenants and obligations of Kite to Cabaret contained in this Agreement as fully and to the same extent as if its Sublicensees were Kite hereunder and guarantees Cabaret that its Sublicensees shall abide by each and every applicable provision of this Agreement.

 

4.5 Sublicense Fees. Subject to the terms and conditions of this Agreement, with respect to each Sublicense with respect to a Licensed Product, Kite shall pay to Cabaret sublicense fees equal to the applicable percentage set forth below of the Sublicense Revenue therefrom (based on the effective date of such Sublicense) (“Sublicense Fees”):

Notwithstanding the foregoing, with respect to any Sublicense Fees paid to Cabaret on account of Sublicense Revenues received by Kite from a Sublicensee in connection with the achievement of any technical, development, regulatory through commercial launch milestone event for a Licensed Product, Kite shall deduct from such Sublicense Fees the milestone payments made by Kite to Cabaret pursuant to Section 4.5 above with respect to the same Licensed Product.

 

KASAN_Licensor - 대학교수, 대학, 연구소 및 벤처회사 vs 제약회사 Licensee 사이의 바이오신약

 

[질문 또는 상담신청 입력하기]

 

 

작성일시 : 2019. 5. 15. 14:30
Trackback 0 : Comment 0

댓글을 달아 주세요


-- Repatha® (Evolocumab) 미국특허소송 Amgen v. Sanofi & Regeneron 특허유효 + 침해인정 배심평결 -- 

                         

                

미국 델라웨어지방법원에서 2016. 3. 16. 암젠의 특허유효 + 사노피 후발제품의 특허침해를 인정하는 배심평결(Jury Verdict)이 났다는 뉴스입니다.

 

암젠 특허는 USP No. 8,829,165 & No. 8,859,741로서 proprotein convertase subtilisin/kexin type 9 (PCSK9)에 대한 human monoclonal antibody 발명입니다. 암젠의 신약 상품명은 Repatha, 유효성분 일반명칭은 evolocumab, 효능효과는 혈액에서 LDL cholesterol 레벨을 낮추는 것입니다.

 

배심평결은 특허유효 + 특허침해라는 것에 한정되므로, 암젠은 향후 손해배상청구를 추가할 예정이라고 밝히고 있습니다. 미국법원에서 배심평결에 따라 조만간 특허침해 판결을 먼저 한 후 손해배상 쟁점을 추가 재판할지 아니면 손해배상까지 심리한 후 하나의 판결을 할지는 조금 더 지켜보아야 할 것입니다.

 

작성일시 : 2016. 4. 29. 08:53
Trackback 0 : Comment 0

댓글을 달아 주세요