I. Introduction: PCT and Emerging Technologies

1. What is the PCT?

The Patent Cooperation Treaty (PCT) is an international treaty administered by WIPO that allows inventors to file a single international patent application to seek protection in multiple countries.

Key features:

International filing date recognized in all PCT member states

International Search Report (ISR) and Written Opinion guide patentability

National phase entry occurs in countries of interest

2. Why AI and Biotech Need PCT Reforms

Challenges with AI and biotech patents:

Reform Objectives:

Clarify AI inventorship and ownership

Define biotech patentable subject matter

Standardize search and examination guidelines for AI and biotech

Ensure consistent treatment across national phases

II. Key PCT Reforms Relevant to AI and Biotech

AI Inventorship Recognition

Some proposals suggest allowing AI to be listed as inventor, but ownership rests with human operators or organizations.

WIPO has issued AI-specific guidance for patent examiners.

Biotech-Specific Search Protocols

AI-driven prior art search for sequences and proteins

Enhanced scrutiny of sequence identity and function

Standardized Disclosure Requirements

AI: full disclosure of algorithms, data sets, model architecture, and training methods

Biotech: clear description of biological material, experimental results, and reproducibility

Accelerated Examination

Fast-track PCT processing for AI/biotech due to rapid market developments

Ethical and Regulatory Compliance

For biotech inventions (e.g., human embryo modification), PCT allows filing with restrictions in some countries

III. Important Case Laws Relevant to PCT Reforms for AI and Biotech

Below are more than five significant cases shaping patentability, AI inventorship, and biotech under international frameworks:

CASE 1: Thaler v. Commissioner of Patents (Australia, 2021–2022)

Facts:

Dr. Stephen Thaler applied to patent an invention created entirely by AI system “DABUS”

Australian Patent Office initially refused, claiming AI cannot be an inventor

Legal Issue:

Can an AI be recognized as an inventor under patent law?

Court Findings:

Full Federal Court of Australia held: AI can be listed as inventor

Ownership still resides with the human who operates or controls the AI

Implications for PCT:

Raises question whether PCT international applications can list AI as inventor

WIPO has issued consultations on AI-generated inventions

CASE 2: DABUS Patent Applications (UK, EPO, and US)

Facts:

Multiple jurisdictions received PCT filings naming AI as inventor

EPO and UK Intellectual Property Office rejected them

US USPTO also rejected DABUS filings

Key Issues:

Inventorship requires human contribution

AI alone cannot meet the statutory requirement

Outcomes:

UK & EPO: AI cannot be inventor

Australia: AI can be inventor

US: Congress/USPTO currently requires human inventor

Implications:

PCT reforms may need harmonization for AI inventorship

Current law leads to fragmented global protection

CASE 3: Myriad Genetics, Inc. v. Association for Molecular Pathology (2013, US Supreme Court)

Facts:

Myriad patented isolated BRCA1 and BRCA2 genes

Plaintiffs challenged patent eligibility

Issue:

Are naturally occurring DNA sequences patentable?

Court Ruling:

Naturally occurring DNA is not patentable

Complementary DNA (cDNA) is patentable because it is synthetic

Implications for PCT:

Influences how biotech sequences are treated under international applications

PCT examiners require novelty, inventive step, and synthetic modification

CASE 4: AMP v. USPTO and Mayo Collaborative Services (2012–2013)

Facts:

Biotech method patents challenged for being laws of nature

Involved diagnostic methods using natural correlations

Court Ruling:

Abstract ideas, natural laws, and phenomena are not patentable

Patents must involve additional inventive steps

Implications for PCT:

International search and examination must filter naturally occurring correlations

Biotech inventions require practical applications to qualify

CASE 5: Alice Corp. v. CLS Bank International (2014, US Supreme Court)

Facts:

Software patent for financial transaction methods challenged

Alice argued for patentability

Court Ruling:

Abstract ideas implemented on a computer are not patentable

Requires technical innovation

Relevance to AI under PCT:

AI algorithms must be tied to technical solutions

Merely using AI for business methods or predictions may fail patentability

CASE 6: Enzo Biochem, Inc. v. Applera Corp. (2006, Federal Circuit)

Facts:

Biotech patent for genetic research methods

Dispute over whether methods were obvious

Court Ruling:

Emphasized objective evidence of non-obviousness

Courts consider technical challenges and unpredictability

Implications:

PCT examiners must assess inventive step rigorously in biotech inventions

AI-designed biotech solutions can be scrutinized similarly

CASE 7: CRISPR-Cas9 Patent Dispute (Broad Institute vs. UC Berkeley)

Facts:

Dispute over who invented CRISPR gene-editing technology

Involves multiple patents and overlapping claims

Key Issues:

Priority dates and experimental evidence critical

Biotech inventions involve complex experimental validation

Outcome:

US: Broad Institute patents upheld for eukaryotic CRISPR

Europe: Different claim scopes recognized

PCT Relevance:

Highlights need for clear disclosure and priority claims under PCT

PCT reforms aim to streamline cross-jurisdiction evaluation of biotech patents

IV. Emerging Reforms Under Discussion at WIPO

AI Inventorship Guidelines

Update PCT forms to allow AI-assisted inventions

Clarify human ownership

Enhanced Search Tools

AI-assisted search for prior art in AI and biotech

Ethics Compliance

Biotech inventions involving embryos or human genes require ethics declaration

Expedited Examination

Rapid commercialization drives fast-track examination

Global Harmonization

Reduce discrepancies like Australia vs. EPO/US in AI inventor recognition

V. Key Takeaways

VI. Conclusion

The PCT is adapting to AI and biotech innovations through:

Clearer inventorship rules

Stricter disclosure and enablement requirements

Standardization of patentability criteria across jurisdictions

Case laws from AI (Thaler/DABUS), biotech (Myriad, Mayo, CRISPR), and software (Alice) form the backbone for international reforms, ensuring that cutting-edge inventions get protection while respecting human inventorship, ethics, and patentability standards.