Neurolaw Patent Enforcement In AI-Generated Neural Therapies.
Neurolaw Patent Enforcement in AI-Generated Neural Therapies
I. Background
Neurolaw refers to the intersection of neuroscience, artificial intelligence, and law. In recent years, AI-generated neural therapies—like AI-designed neural implants, brain-computer interfaces (BCIs), and neuropharmacological agents—have raised unique patent issues.
Key challenges in patent enforcement include:
Patent Eligibility
Is an AI-designed therapy patentable if the AI makes significant inventive contributions?
Are algorithms patentable when applied to neurological treatments?
Inventorship
Who is the “inventor”—the AI, the human operator, or both?
Novelty and Non-Obviousness
Can AI-generated therapies be considered non-obvious to a skilled practitioner?
Ethical and Regulatory Overlap
Neurological interventions may implicate safety regulations or patient rights, indirectly affecting patent enforcement.
II. Litigation Strategies in AI-Generated Neural Therapies
A. For Patent Holders
Emphasize human oversight in AI-generated inventions.
Focus on specific application of AI to neural therapy, not the AI algorithm itself.
Claim functional outcomes of therapy—e.g., improved cognition, symptom relief.
B. For Challengers
Argue AI output is not eligible for patent protection due to lack of human inventorship.
Claim obviousness, citing AI as a routine design tool.
Question whether the therapy is merely a natural process or biological effect of treatment, not a patentable invention.
III. Case Law Analysis
Here are detailed discussions of landmark or relevant cases:
1. Thaler v. USPTO (DABUS AI Inventorship Case, 2021)
Facts
Stephen Thaler filed patents naming his AI, DABUS, as the sole inventor for inventions including AI-generated neural devices.
USPTO rejected, arguing an AI cannot be a legal inventor.
Legal Issue
Can an AI be recognized as a legal inventor under patent law?
Court Findings
USPTO & Federal Court ruled only humans can be inventors.
AI contributions can support patentability, but human must be designated as inventor.
Strategic Implications
Patent holders must document human involvement in AI-generated therapies.
AI can be a tool, not the inventor, for enforcement purposes.
Challenges: Proving “human contribution” is sufficient for novelty and inventorship.
2. Artificial Inventor Project – European Patent Office (EPO) Decisions, 2022
Facts
European filings claimed AI as inventor for neurotechnology inventions.
EPO rejected applications, citing inventorship must be human.
Court Reasoning
Aligns with global trend: AI cannot legally hold inventorship rights.
Patents may issue if humans oversee AI design or incorporate AI output creatively.
Enforcement Strategy Lesson
AI-assisted neural therapies can still be patented if humans guide the inventive process.
Broad claims covering therapy outcome may be enforceable.
3. Alice Corp. v. CLS Bank (2014)
Facts
Alice Corp claimed a computerized system for financial transactions (software patent).
Supreme Court invalidated it as abstract idea implemented on a computer.
Relevance to AI Neural Therapies
Neural therapy algorithms or AI models may be considered abstract ideas unless applied to specific, technical medical interventions.
For enforcement, claims must show:
Concrete implementation
Specific therapeutic outcome
Technical improvement over natural neural processes
4. Thaler v. Commissioner of Patents (Australia, 2021)
Facts
Similar to US Thaler case, AI named as inventor for neural device inventions.
Outcome
Australian Federal Court ruled AI cannot be listed as inventor.
Patent applications may proceed if human contribution is recognized.
Key Strategic Insight
Courts worldwide consistently reject AI-only inventorship.
For enforcement, patent holders should identify the AI-human collaboration explicitly.
5. Myriad Genetics v. Association for Molecular Pathology (2013)
Facts
Myriad patented isolated BRCA genes; challenged as products of nature.
Relevance
AI-generated neural therapies may involve:
Naturally occurring neurotransmitters
Neural signaling pathways
For enforceable patents:
AI-generated therapies must alter neural function materially
Cannot merely observe or replicate natural processes.
6. Stanford v. Roche (2011)
Facts
Dispute over ownership of inventions developed in university labs.
Court emphasized proper assignment and inventorship.
Relevance
In AI neural therapy patents:
Clear assignment agreements are critical
Human supervisors of AI must have inventor or co-inventor status
Enforcement may fail if inventorship or assignment is unclear
7. Enfish, LLC v. Microsoft (2016)
Facts
Patent on a software database method upheld because it improved the technical function of a computer.
Application to AI Neural Therapies
Courts may enforce AI-generated therapy patents if:
They improve neurological treatment outcomes
Represent a technical advancement in neural devices
Abstract AI models alone are insufficient for enforcement.
IV. Litigation Themes
Human Inventorship is Crucial
AI cannot hold patents.
Human oversight must be well documented.
AI as a Tool vs. AI as an Inventor
Patent claims should emphasize the AI-assisted process but credit humans as inventors.
Functional and Technical Specificity
Claims should focus on:
Specific neural therapy outcomes
Improvement over standard care
Abstract Idea Rejection
Pure AI algorithms may be invalid.
Concrete applications to human neural systems strengthen enforcement.
Global Consistency
US, EPO, and Australia consistently reject AI-only inventorship.
Enforcement requires careful drafting to survive international challenges.
V. Strategic Recommendations for Enforcement
For Patent Holders
Emphasize human-in-the-loop inventorship
Clearly define technical neural therapy improvements
Draft narrow claims on concrete applications
Maintain detailed lab notebooks showing AI-human collaboration
For Challengers
Attack claims for:
Lack of human inventorship
Abstract AI application
Overlapping with natural neural functions
Use prior art of AI or standard neural therapy methods to argue obviousness
VI. Conclusion
AI-generated neural therapies are patentable, but human inventorship is legally required.
Enforcement depends on:
Technical specificity
Documentation of human contribution
Clear demonstration of improvement over natural processes
Cases like Thaler, Alice, Myriad, Enfish, and Stanford v. Roche provide the roadmap for both patent drafting and enforcement strategies.
RELATED Blog
comments