Cross-Border Enforcement Of AI-Assisted Genomic Patents.
I. Introduction: Cross-Border Enforcement Challenges
AI-assisted genomic patents combine algorithmic innovations, data-driven models, and biological/genomic methods. Cross-border enforcement involves multiple challenges:
Patent Jurisdiction – Patents are territorial; a U.S. patent is not enforceable in Europe or Asia.
Algorithm vs Biological Material – AI algorithms may be patentable in some jurisdictions but not others.
Trade Secrets and Data Rights – Genomic AI relies on datasets; enforcement may involve trade secrets.
Regulatory Compliance – Genomic data is highly sensitive (GDPR in EU, HIPAA in the US), complicating cross-border litigation.
Evidence Collection – Collecting infringement evidence across borders can be challenging due to privacy rules.
Hence, enforcement strategies combine patent litigation, licensing, and strategic jurisdiction selection.
II. Key Approaches to Cross-Border Enforcement
1. Direct Patent Litigation
Suing infringers in the country where patent is granted.
Example: U.S. patents enforceable in the U.S., EU patents in EU courts.
Courts require infringing activity within the jurisdiction.
2. Parallel Litigation
Filing lawsuits in multiple jurisdictions.
Requires alignment of legal strategies across jurisdictions.
Avoids gaps due to territoriality but increases cost and complexity.
3. Forum Selection Clauses and Arbitration
Licensing agreements can specify neutral international arbitration.
Effective for AI-assisted genomics where patents are embedded in software and datasets across borders.
4. Customs and Border Measures
Use patent enforcement via customs authorities to prevent import/export of infringing genomic AI products.
5. Injunctions and Damages
Jurisdictions vary on granting injunctions or monetary damages.
Some (like the U.S.) favor damages; others (like Germany) are more injunction-prone.
III. Judicial Approaches and Key Cases
Here are eight notable cases relevant to cross-border enforcement of genomic or AI-assisted patents.
1. Myriad Genetics, Inc. v. Association for Molecular Pathology (2013, U.S.)
Facts
Myriad held patents on isolated BRCA1 and BRCA2 genes.
Challenge: Are naturally occurring genes patentable?
Holding
Isolated DNA sequences are not patentable; cDNA (complementary DNA) may be patentable.
Established the principle that laws of nature cannot be patented, even if AI algorithms are used for analysis.
Cross-Border Implication
Enforcement in U.S. is limited to synthetic sequences, affecting international licensing.
European Patent Office (EPO) allows patents on biotechnological inventions with technical effect, creating cross-border enforcement asymmetry.
Relevance to AI-Genomics
AI algorithms alone may be patentable, but using natural genomic sequences may not.
Enforcement must distinguish algorithmic invention from natural phenomena.
2. AMP v. USPTO (Association for Molecular Pathology, 2010)
This is the preliminary case leading to Myriad.
Reinforced that patents on natural genomic sequences are invalid.
Courts emphasized that cross-border patent holders must carefully draft claims to include technical application of AI, not just sequences.
3. Illumina v. BGI Genomics (2018, U.S. & China)
Facts
Illumina held patents on high-throughput DNA sequencing using AI-assisted data analysis.
BGI allegedly infringed patents and sold sequencers internationally.
Key Issues
Enforcement in U.S. for imported instruments.
Chinese courts were reluctant to grant full injunctions on foreign patent infringement claims.
Holding
U.S. courts granted partial damages for sales in U.S.
China enforced only domestic Chinese patents, highlighting territorial limitation.
Takeaway
For AI-assisted genomic tools, cross-border patent enforcement requires strategic filing in multiple jurisdictions.
AI algorithms embedded in instruments require careful claim drafting for hardware/software combinations.
4. Amgen v. Sanofi/Regeneron (2017, U.S.)
Facts
Amgen sued for infringement of antibody and genomic-based therapeutic patents.
Patents involved AI-assisted identification of genomic targets.
Holding
Courts applied doctrine of equivalents, considering whether non-identical methods infringe.
Enforced U.S. patents aggressively, granting damages and injunctions.
Cross-Border Lesson
Doctrine of equivalents can help enforce AI-assisted genomics patents where exact implementation varies.
Other jurisdictions, like Germany or UK, may be more restrictive.
5. EPO T 1063/18 – CRISPR and AI Patent Dispute (Europe)
Facts
European patent dispute over CRISPR gene-editing method assisted by predictive AI models.
Applicant claimed AI improved guide RNA efficiency.
Holding
EPO emphasized technical contribution of AI to the biotechnological process.
Patents granted because AI-enabled optimization was considered a technical solution, not just a mathematical algorithm.
Cross-Border Implication
Aligns with EU enforcement trends: AI must contribute technical effect, not just automate research.
European enforcement may favor AI-enhanced methods even if genomic targets are natural.
6. Shanghai Genomics v. WuXi AppTec (China, 2019)
Facts
Dispute over AI-assisted genomic sequencing methods.
Shanghai Genomics held patents for AI-driven mutation detection.
Holding
Chinese courts required evidence of commercial exploitation in China.
Courts did not consider sales outside China for enforcement.
Lesson
Cross-border enforcement in China is limited; filing local patents is essential.
AI-enhanced genomic patents must show domestic use to be actionable.
7. Oxford Nanopore v. Illumina (2020, UK)
Facts
Dispute over nanopore sequencing patents enhanced by AI basecalling.
Issue: Is software-assisted genomic readout patentable?
Holding
UK courts held software implementing technical innovation in genomics is patentable.
Patents enforceable only in UK territory, despite international sales.
Implication
AI-assisted genomic inventions are often software-heavy, needing patent coverage in every enforcement jurisdiction.
8. CRISPR Therapeutics v. Broad Institute (2018–2022, Multiple Jurisdictions)
Facts
Dispute over CRISPR patents where AI-assisted design algorithms were used.
Multiple jurisdictions involved: U.S., Europe, China.
Holding
Split outcomes:
U.S.: Broad Institute held primary patents.
EU: Patents granted for AI-assisted optimization methods.
China: Local filings had priority.
Lesson
Cross-border enforcement requires jurisdiction-specific strategy.
AI contributions must be highlighted as technical innovations in patent claims.
IV. Practical Strategy for Cross-Border Enforcement of AI-Genomic Patents
Patent Drafting
Emphasize AI as a technical solution, not abstract algorithm.
Include hardware, software, and method claims.
Jurisdiction Planning
File patents in key markets: U.S., EU, China, Japan.
Consider regional nuances (e.g., AI algorithms often patentable in EU if tied to technical effect).
Evidence Collection
Use digital forensics to trace infringement.
Combine genomic datasets, AI logs, and instrument sales.
Licensing and Arbitration
Use international licensing with arbitration clauses.
Helps enforce patents without relying solely on national courts.
Injunctions vs Damages
U.S.: Focus on damages for infringement and lost profit.
Germany/UK: Injunctions may be more effective.
V. Summary
Cross-border enforcement is territorially constrained; patents must be filed strategically in all jurisdictions.
AI-assisted genomic patents are most enforceable when AI adds a technical contribution, not merely automation.
Evidence of commercial exploitation in each jurisdiction is critical.
Courts worldwide may vary:
U.S.: Strong on damages, doctrine of equivalents.
EU: Focus on technical effect, software integration.
China: Domestic exploitation required.
Key takeaway: For AI-assisted genomic patents, enforcement is a multi-jurisdictional strategy, combining technical claim drafting, local filing, licensing, and careful litigation planning.
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