PD-1/PD-1 항체 면역 항암제, 옵디보 Opdivo 특허발명은 일본 교토대학에서 발명되어, 오노 제약에서 라이선스 후 신약으로 개발된 주목받은 신약입니다. Ono BMSMSDKeytruda 제품이 원천특허에 해당하는 용도특허를 침해한다고 주장하는 소송을 제기하였습니다. 위 소송에서 당사자 사이 합의내용에 관한 보도자료를 참고로 첨부합니다.

 

1. 특허소송 화해결과 보도자료

 

오노의 용도특허 및 물질특허의 유효성 확인 + MSD의 키트루다 판매용인 대가로 MSA는 특허권자 오노제약에게 일시금 625백만불 지급 + 2017. 1. 1. ~ 2023. 12. 31. 기간 전세계 매출액의 6.5%를 로열티로 지급 + 2024. 1. 1. ~ 2026. 12. 31. 기간 전세계 매출액의 2.5%를 로열티로 지급 + 특허권자는 진행 중인 소송 전부 취하

 

2. 특허권 공유자 중 1인 개인의 이익분배 청구소송 제기 보도자료  

 

용도특허의 공유자 중 1인 本庶 佑 (개인 발명자)2020. 6. 19. 특허공유자 중 1인 오노제약(회사 법인)을 상대로 이익분배 청구의 소 제기함 + 請求金額:22623331677

 

오노제약의 주장 - 社は、PD-1特許にするライセンス契約を2006年に本庶佑氏と合意の下に締結し、同契約に基づいて適切に特許使用料をお支いしております。また、同契約締結時はがん免疫療法にする疑的な見方が多く、他の製薬会社が開況下にあって、社として大きなリスクを取って究開に踏み切ったものであり、契約の水準も妥であると考えております。

 

첨부: 오노제약 보도자료 2

Press Release_n17_0121.pdf

Press Release_n20_0706.pdf

KASAN_블록버스터 신약 Keytruda 관련 PD-1PD-L1 항체 면역 항암제 용도특허 소송 Ono Pharmaceutical & BMS vs MSD 합의 용도특허의 공유자의 후속 소송제기 뉴스.pdf

 

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작성일시 : 2020. 7. 20. 14:00
:

 

 

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 항체 면역 항암제 신약, 옵디보 Opdivo 특허발명의 공동발명자 분쟁 - 미국법원 판결 Dana-Farber Cancer Institut.pdf

 

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작성일시 : 2019. 6. 3. 08:43
:

 

 

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 항체 면역 항암제 신약, 옵디보 Opdivo 특허발명의 공동발명자 분쟁 - 미국법원 판결 Dana-Farber Cancer Institute vs On.pdf

 

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작성일시 : 2019. 5. 30. 17:11
:

 

 

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 미국특허의 공동발명자 분쟁 – 미국법원 판결 Dana-Farber Cancer Institute vs Ono Pharmaceutical & BMS 사건.pdf

 

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작성일시 : 2019. 5. 30. 09:08
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