On March 4, 2014, the USPTO issued guidance to examiners on patent eligibility.
The memo addresses claims involving:
Products of nature
Laws of nature
It follows Supreme Court decisions in Myriad and Prometheus.
Although not legally binding, it significantly impacts U.S. patent prosecution.
The scope of the guidance is broad.
Contents
Legal Background
U.S. patent law broadly defines patentable subject matter.
The Supreme Court recognizes three exceptions:
Products of nature
Laws of nature
Abstract ideas
This guidance focuses on:
Products of nature
Laws of nature
Products of Nature (After Myriad)
Key Supreme Court Holding
Isolated genomic DNA = not patent eligible.
cDNA (not naturally occurring) = patent eligible.
Standard: the claimed invention must be “made different by human hands.”
USPTO Position
Applies a broad interpretation.
Claims must be:
Non-naturally occurring
“Markedly different” in structure from the natural product.
Examples of natural products:
Plasmids
Small molecules
Minerals
Antibodies
PCR primer pairs
Practical Impact
“Markedly different” is unclear and will be decided case-by-case.
Even isolated or purified natural products may face rejection.
Strategies for Protecting Product-Based IP (U.S.)
Include multiple claim variations with increasing levels of modification.
The more structural modification, the stronger the eligibility argument.
Still include broad claims (pre-Myriad style) for:
International protection
Future legal developments
Comparison with Europe (EPO)
European Patent Office (EPO) rules differ.
In Europe:
Isolated elements from the human body can be patentable.
Even if structurally identical to natural elements.
Industrial application must be disclosed.
Europe currently allows broader protection for isolated molecules.
Best practice:
Draft claims suitable for both U.S. and European standards.
Laws of Nature (After Prometheus)
Key Supreme Court Holding
Methods based solely on natural correlations are not patent eligible.
Example: Adjusting drug dosage based on metabolite levels.
USPTO Approach
Applies a “significantly different” standard.
Claims must:
Include additional steps beyond the natural law.
Apply the law in a meaningful, specific way.
Add “significantly more” than the natural principle itself.
USPTO Examples
Patent-eligible examples include:
Diagnostic method specifying:
A particular antibody
A specific detection method (e.g., flow cytometry)
PCR method specifying:
Particular primer pairs
Full reaction details
Implication:
Generic claims are likely to be rejected.
Specific, detailed claims are more defensible.
Strategies for Protecting Law-Based IP (U.S.)
Do not claim the natural law itself.
Claim a specific, practical application.
Avoid preempting all uses of the natural law.
Include unconventional or additional steps integrating the law.
Also file broader claims for international protection.
Europe vs. U.S. on Laws of Nature
EPO excludes discoveries and scientific theories.
However, practical applications of discoveries remain patentable.
Example:
The invention in Prometheus was allowed in Europe as an in vitro method.
Europe has its own limits (e.g., medical treatment methods).
Key Takeaways
The USPTO has adopted a broad reading of Myriad and Prometheus.
Many biotech and diagnostic inventions face higher eligibility hurdles.
Patent applicants must:
Assess whether claims involve products or laws of nature.
Draft carefully with U.S. standards in mind.
Coordinate U.S. and European filing strategies.
Early cross-jurisdictional review is essential for strong global protection.
