Working draft · internal strategy review · not legal advice
Case 和法规依据关系图
本项目不能只列历史诉讼。需要把每个 source 放到“专利覆盖、有效性、救济、deal 分配”四层里，才能说明它到底影响哪个谈判变量。
查看逐案事实、文件、分析和结论
1. 四层结构
- 专利覆盖层：目标 claim 是否覆盖 Cocal-G 354 equivalent position。
- 有效性层：宽 claim 是否满足 written description / enablement。
- 救济层：如果侵权成立，赔偿、禁令、律师费如何产生。
- Deal 分配层：这些风险在 out-license 里由谁承担、如何封顶。
2. 专利覆盖层
| Source |
Rule / fact |
与本案关系 |
| EP3684786B1 |
Claim 1 covers VSV Indiana SEQ ID NO:1 and homologs retaining at least 70% identity, with equivalent 47/354 mutation and functional limitations. |
Europe 风险最大；Cocal 约 71.7% identity 使 70% claim 形成直接谈判压力。 |
| US12091434B2 |
Granted claim 1 is at least 90% identical to SEQ ID NO:1 or listed homologs; claim 2 includes sequence groups that cover Cocal-related examples. |
U.S. 风险存在，但比 EP 的 70% generic homolog claim 更容易限定。 |
| Local analysis |
Patent family not laid out in China mainland; Canada/HK not yet granted per local file. |
China mainland should be excluded from damages / indemnity base unless later review changes this. |
3. 有效性 / claim scope 层
| Case |
Holding / principle |
用法 |
| Juno v. Kite |
CAR-T patent judgment reversed because asserted claims lacked written description for broad genus. |
反击 MNC 用 $1.2B headline 压价；说明宽基础 claim 会崩。 |
| Amgen v. Sanofi |
Supreme Court held full claimed genus must be enabled; roadmap / trial-and-error is not enough. |
支撑对 EP 70% homolog + functional limitation 的 overbreadth attack。 |
| Baxalta v. Genentech |
After Amgen, functional antibody genus claims invalid for lack of enablement. |
说明 Amgen 不是抽象原则，已经在 biologics 中落地。 |
| Idenix v. Gilead |
$2.54B HCV verdict wiped out for lack of enablement / written description. |
巨额 verdict 不等于最终 payable exposure。 |
4. U.S. statutes
| Rule |
Content |
Deal relevance |
| 35 U.S.C. §271 |
Defines direct, induced, contributory, and export-related infringement. |
Determines whether MNC activities, manufacturing, import, or supply chain acts trigger U.S. exposure. |
| 35 U.S.C. §283 |
Injunctions may be granted according to principles of equity. |
Injunction risk is a settlement lever, but not automatic after eBay. |
| 35 U.S.C. §284 |
Damages adequate to compensate, not less than reasonable royalty; damages can be enhanced up to 3x. |
Core damages statute; drives reasonable royalty floor and willfulness stress. |
| 35 U.S.C. §285 |
Exceptional cases may allow attorney fee award. |
Secondary stress item; should not be broadly indemnified if caused by MNC litigation conduct. |
| 35 U.S.C. §112(a) |
Written description and enablement. |
Main validity attack against broad homolog / functional claims. |
5. U.S. damages cases
| Case |
Principle |
Use in our model |
| Georgia-Pacific |
Hypothetical negotiation / reasonable royalty factor framework. |
Use to structure royalty rate discussion, not as a mechanical checklist. |
| Panduit |
Lost profits require demand, absence of acceptable non-infringing substitutes, capacity, and profit amount. |
Patentee may struggle to claim full lost profits if it is primarily licensing or not a direct product substitute in territory. |
| Lucent v. Gateway |
Comparable licenses and damages theory must support the award. |
Push for real comparable license evidence. |
| LaserDynamics v. Quanta |
Entire market value rule limited; use smallest salable patent-practicing unit unless patented feature drives demand. |
Strong support against using full CAR-T product sales as default base. |
| Halo v. Pulse |
Enhanced damages are discretionary for egregious conduct. |
Prevent MNC launch-at-risk conduct from being passed through. |
| eBay v. MercExchange |
Injunction requires equitable four-factor analysis. |
Injunction is leverage, not automatic certainty. |
6. Biotech / CAR-T commercial comps
| Case / event |
Economic result |
Relevance |
| Juno v. Kite |
$585M upfront + 27.6% running royalty theory; judgment reached about $1.2B; reversed. |
High-pressure litigation anchor. |
| Juno v. Novartis |
$12.25M upfront + milestones + mid-single-digit U.S. royalty. |
More realistic settlement / license anchor. |
| Bayer v. Baxalta |
17.78% royalty supporting $155M+ damages affirmed. |
High-case biologic royalty anchor if claim survives. |
| Idenix v. Gilead |
$2.54B jury verdict wiped out. |
Headline verdict discount. |
| Kelonia / Lilly |
Lilly announced acquisition of Kelonia to advance in vivo CAR-T and gene delivery. |
Raises commercial enforcement incentive and negotiation leverage. |
7. Europe / UPC layer
| Rule |
Content |
Deal relevance |
| Directive 2004/48/EC Art. 11 |
Injunctions against continuing infringement. |
EP risk can create EU launch leverage even before final damages are known. |
| Directive 2004/48/EC Art. 13 |
Damages may account for negative economic consequences, unfair profits, moral prejudice, or lump sum based on royalties/fees. |
Supports royalty-equivalent settlement modeling; national implementation varies. |
| UPC Agreement Art. 68 |
Damages appropriate to harm actually suffered where infringer knew or had reasonable grounds to know. |
Relevant if EP patent is asserted in UPC-participating countries. |
| EPO opposition |
Any person except proprietor may oppose within nine months of grant publication. |
EP3684786B1 opposition status is strategically central. |
8. Relationship summary
EP/US claim scope
-> decides whether the 354 equivalent position creates prima facie exposure
§112 / Amgen / Juno / Idenix / Baxalta
-> attacks broad genus / functional scope and reduces settlement value
§271 / Art. 11 / UPC Art. 68
-> maps where and when infringement remedies can be triggered
§284 / Georgia-Pacific / Lucent / LaserDynamics / Bayer
-> determines damages base, royalty rate, and apportionment
Halo / §285 / eBay
-> defines stress factors: willfulness, fees, injunction leverage
Deal terms
-> allocate all of the above through cap, offset, territory, consent, and conduct exclusions