FF ff-codex In Vivo CAR-T BD IP risk desk

Internal strategic working draft · not legal advice

把 VSV-G / Cocal-G 354 位点风险 变成可谈判的 deal term

当前目标不是证明“没有风险”。
我们要把已知第三方专利族拆成三件事:
地域。专利状态。封顶机制。
避免它变成对 MNC 的无限 IP 赔偿责任。

Legal validity
Commercial leverage
挑战空间
许可谈判
诉讼高压
EP 70%
US narrower
CN out

Executive summary

一屏结论

Base exposure 1%-4% covered territory net sales + small reserve
Highest risk Europe EP 70% homolog language has strongest leverage
Red line No uncapped indemnity no global-sales pass-through or MNC willfulness
Best anchor Juno / Novartis license economics over full damages reimbursement

Current strategic answer

风险真实存在,但可以边界化、定价和谈判。应把目标专利族写成已披露的 Known Third-Party IP Matter,通过 territory-specific economics、royalty offset、cap、settlement consent 和 launch-at-risk exclusion 控制。

Talk deal?Yes, with scheduled known IP risk.
Base reserve1%-4% of covered sales + upfront reserve.
High case5%-15%; 20%+ only stress.
Next proofClaim chart + EP opposition + territory economics.

Risk matrix

Territory 风险矩阵

Territory Claim coverage Validity discount Damages / remedy Deal action
Europe / EP High EP claim 1 70% homolog language is the broadest text. Medium breadth creates support / enablement attack. High injunction and damages leverage can drive settlement. Separate economics; reopener if EP narrows/revokes; cap and offset required.
U.S. Medium US claim architecture is narrower than EP but lists homologs. Medium Amgen/Juno/Idenix support discount. Medium §284 royalty and willfulness stress, controlled by conduct. Only valid/enforceable/asserted claims; exclude MNC launch-at-risk enhanced damages.
China mainland Low local analysis shows no mainland layout. Low no active local claim identified. Low exclude from base unless new coverage appears. Express exclusion from patent-family indemnity and royalty base.
RoW Watch depends on granted claims by country. Watch varies by jurisdiction. Watch no automatic global inclusion. Country-by-country schedule; no coverage, no pass-through.

Damages scenarios

固定场景测算

这些场景用于内部谈判准备。真正条款应限定 covered product、covered territory、valid/enforceable/asserted claim、post-notice period,并排除 China mainland。

Deliverables

成文产出

01 赔偿范围预估与计算方法

把 exposure 拆成 sales base、territory、valid claim、apportionment、royalty、willfulness 六个变量,并给出 low/base/high 区间。

02 Case 和法规依据关系图

把 EP/US claim、§112、§284、Juno/Kite、Idenix、Bayer、EU/UPC 救济规则映射到谈判变量。

03 Deal 约束与谈判策略

给出 Known IP Risk schedule、limited indemnity、royalty offset、settlement consent 和 launch-at-risk 排除措辞。

04 Case 事实、文件、分析和结论

逐个 case 罗列事实背景、source file、对本 deal 的作用和可直接进入谈判 memo 的结论。

05 Claim Chart 工作稿

把目标 claim element、我方技术事实、match 状态、counterargument 和 confidence level 放在同一张表里。

06 Deal Term Sheet 包

把 MNC demand、我方回应、fallback、red line 和 sample wording 变成谈判桌可直接使用的结构。

07 Source Library

按 primary source、secondary report、internal analysis 分类列出专利、判例、法规和本地文件。

Current answer

建议谈判姿态

可以继续谈 deal

MNC 获得商业权不应以我方承担 uncapped third-party patent exposure 为代价。风险应被写成已披露的 known IP encumbrance,并通过 royalty stacking、offset、cap 和 settlement consent 控制。

不能承认完整产品侵权

目前只确认一个位点进入目标专利族的 asserted zone,另一位点没有落入。赔偿基数应围绕 covered territory 和 incremental value,不应直接套用产品全球销售额。

核心风险在 US/EP

EP claim 1 的 70% identity 写法最宽;US 授权 claim 更窄但列明 homolog 和 Cocal 相关 SEQ ID。中国大陆不应进入该 patent family 的赔偿基数。

Patent posture

专利族如何影响 deal

`EP3684786B1` claim 1 把 VSV Indiana ectodomain 的 47/354 位点突变扩展到 70% identity homolog,并要求仍能膜融合但不与 LDL receptor 互动。这个结构天然给对方 enforcement leverage,但也暴露了 overbroad genus / insufficient support 的攻击点。

`US12091434B2` 授权 claim 1 不同:它写成至少 90% identical to SEQ ID NO:1 或列明 homolog,claim 2 涵盖包括 Cocal 相关 SEQ ID 的组合。美国风险存在,但不是 EP 那种纯 70% 泛化。

Deal typeOut-license to MNC
Territory leverGlobal / ex-China / ex-US must be priced separately
Known issue354 equivalent position; second mutation outside target patent
Practical assumptionAssertion expected after commercial visibility

Historical anchors

可用于谈判桌的 case comps

Case 为什么相关 经济结果 对本 deal 的含义

Exposure model

赔偿 / 许可负担测算

Low case $0-15M invalidity / narrowing / defense-only posture
Base reserve $65M reasonable royalty + settlement reserve
High stress $120M adverse judgment before indemnity cap

该模型用于谈判准备,不是法律意见。真正 term sheet 应把 sales base 限定在 covered products、 covered countries、valid and enforceable claims、post-notice period,并排除 China mainland。

Term sheet stance

条款建议

Must have

  • Known IP Risk schedule 明确列入 Paris-Saclay / CNRS / Kelonia / Lilly patent family。
  • Indemnity cap 限定为我方已收现金或单独较低上限,不含 MNC lost profits / consequential damages。
  • Third-party license fee 先进入 royalty offset / stacking cap。
  • Settlement consent:MNC 单方和解不得自动传导给我方。

Fallback

  • 若 MNC 坚持 IP indemnity,可限定在已披露 patent family、已授权且未无效 claim、covered territory。
  • 费用分担可随 milestone 递增,但 commercial launch-at-risk 后我方责任递减。
  • 共同推进 EP opposition / US invalidity / non-infringement strategy。

Reject

  • Uncapped third-party patent indemnity。
  • 把全球产品销售额作为默认赔偿基数。
  • 把 MNC 自行选择的 launch-at-risk、拒绝 design-around 或拒绝挑战专利的后果转嫁给我方。

Apply next

下一步工作包

  1. 锁定 territory 和 economics。 用 global / ex-China / ex-US 三套销售曲线分别测算。
  2. 补齐 patent file wrapper。 下载完整 US/EP prosecution history、EP opposition 文件、family status。
  3. 做 claim chart。 只围绕 354 equivalent position 和 functional limitations,明确 second mutation 不落入。
  4. 准备谈判附件。 一页 risk allocation term sheet + 一份完整 internal memo。

Source file

引用和证据