최근 PD-1/PD-L1 분야 암치료 신약은 뜨거운 관심의 대상입니다. 키트루다의 경우 이미 매출이 급성장하고 있을 뿐만 아니라 현재도 수많은 적응증에 대한 임상시험이 진행중이라는 소식입니다. 오노제약의 PD-1/PD-L1 항체 면역 항암제 신약, 옵디보 Opdivo 또한 높은 매출성장을 기대하고 있습니다.

 

옵디보 Opdivo 특허의 주된 발명자인 Tasuku Honjo 교수는 노벨상까지 받았습니다. 그런데 미국 Dana-Farber Cancer Institute 소속 연구진이 수건의 미국특허에 대해 공동발명을 주장하는 소송을 미국법원에 제기하였고, 그 결과는 혼조교수와 공동발명자에 해당한다는 판결이 나왔습니다. 판결문 중 중요부분을 소개하는 블로그 포스팅은 아래와 같습니다. 공동발명자 성립요건의 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 Pharmaceutical & BMS 사건 판결

 

이번에 일본매체에 Tasuku Honjo 교수가 Ono Pharmaceutical Co.를 상대로 오는 9월경 약 ¥15 billion을 청구하는 소송을 오사카지방지재법원에 제기할 예정이라는 기사가 나왔습니다. 실제 청구할지 여부는 모르겠지만 거론되는 직무발명 보상금의 액수가 천문학적 숫자입니다.

 

실제 청구여부나 판결여부를 떠나서 흥미로운 내용의 뉴스라서 참고로 소개합니다. 원문기사 링크: Japanese Nobel laureate Tasuku Honjo to sue Ono Pharmaceutical over cancer drug patent royalties

 

기사 중 주요 내용 인용

In the planned lawsuit with the Osaka District Court, Honjo will claim that he is entitled to 10 percent, or about ¥15.4 billion, of the amount Ono Pharmaceutical and U.S. drug maker Bristol-Myers Squibb Co. received from U.S. drug giant Merck & Co. when they settled a patent infringement lawsuit. Ono Pharmaceutical set aside some ¥400million at a regional legal affairs bureau from January 2017 to March 2018 to make payments to Honjo.

 

Honjo, a professor at Kyoto University, won the 2018 Nobel Prize in Physiology or Medicine with a U.S. scientist for their immunology research that led to the development of the cancer drug Opdivo, which is at the center of the royalty dispute.

 

In October 2006, Honjo and Ono Pharmaceutical entered into a contract that limited his compensation to 1 percent or less of the drug’s sales. He is now claiming the compensation rate should be raised and considering filing a separate lawsuit.

 

KASAN_PD-1PD-L1 항체 면역 항암제 신약, 옵디보 Opdivo 특허의 발명자, 노벨생리학상 수상자 Tas

 

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작성일시 : 2019. 8. 2. 16:49
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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

 

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작성일시 : 2019. 6. 3. 08:43
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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

 

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작성일시 : 2019. 5. 30. 17:11
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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

 

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작성일시 : 2019. 5. 30. 09:08
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