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Black Box Innovation: Building Robust IP and Regulatory Strategies for AI-Discovered Therapeutics
In the modern era of AI-driven in silico approaches for target selection and lead compound identification, companies must navigate nuanced and unresolved patentability issues, centred on inventorship, disclosure, novelty and non-obviousness. In parallel, regulatory agencies are scrutinising AI algorithms, data provenance and transparency within MA dossiers. To combat this, companies must tightly align their IP and regulatory strategies to secure defensible IP and exclusivity positions for their AI-assisted inventions.
This session will address the key unanswered questions surrounding AI patentability and examine the strategies available to you for securing comprehensive patent protection and straightforward regulatory approval for your latest AI-assisted inventions.
- Should you disclose the use of AI in generating a lead compound on a patent application?
- What are the potential consequences of not disclosing AI use for downstream litigation?
- How are patent offices evaluating key issues around inventorship, disclosure, novelty and non-obviousness for AI-assisted inventions?
- How are regulatory authorities handling AI use during drug discovery processes?
- How should patent drafting strategies for AI-assisted invention be shaped to align with downstream regulatory requirements?
- To what extent should human decision-making be documented during the AI-assisted drug discovery process?
- How and to what extent should IP and Regulatory leads brief R&D teams on their use of AI?
This session will address the key unanswered questions surrounding AI patentability and examine the strategies available to you for securing comprehensive patent protection and straightforward regulatory approval for your latest AI-assisted inventions.
- Should you disclose the use of AI in generating a lead compound on a patent application?
- What are the potential consequences of not disclosing AI use for downstream litigation?
- How are patent offices evaluating key issues around inventorship, disclosure, novelty and non-obviousness for AI-assisted inventions?
- How are regulatory authorities handling AI use during drug discovery processes?
- How should patent drafting strategies for AI-assisted invention be shaped to align with downstream regulatory requirements?
- To what extent should human decision-making be documented during the AI-assisted drug discovery process?
- How and to what extent should IP and Regulatory leads brief R&D teams on their use of AI?
