Harvard College v. Canada (Commissioner of Patents) (2002 SCC 76)
Quick Summary
Harvard developed a method to make a transgenic animal (the “oncomouse”). The process patent was allowed. The product patent for the animal itself was refused. The Supreme Court of Canada (5–4) said higher life forms are not patentable inventions under Section 2. Parliament—not courts—must change the law if broader protection is desired.
Issues
- Can a higher life form be an “invention” as a manufacture or composition of matter under Section 2?
- Does the Patent Act allow product patents for living organisms beyond microorganisms and plants?
- Who should set policy on patenting life—courts or Parliament?
Rules
- Patent Act, s. 2: An invention is any new and useful art, process, machine, manufacture, or composition of matter, and any new and useful improvement of these.
- Interpretation principle: Courts apply the statute’s text and purpose; major shifts in policy are for Parliament.
- Scope to date: Lower life forms (e.g., microorganisms) may be patentable; higher life forms raise distinct policy concerns.
Facts (Timeline)
Arguments
Appellants (Harvard College)
- The engineered animal is a composition of matter with human-made genes.
- Patents on products encourage innovation and investment in biotech.
- Other countries granted similar claims, showing international acceptance.
Respondent (Commissioner)
- Section 2 does not clearly cover higher life forms as “manufacture” or “composition.”
- Patenting animals raises ethical and policy questions—Parliament should decide.
- Existing schemes (e.g., Plant Breeders’ Rights Act) show a different path for living matter.
Judgment
Appeal allowed in part. The Supreme Court, by 5–4 majority, held that higher life forms are not patentable as a product under Section 2. The process claim remained unaffected.
- Statutory reading: “Manufacture” / “composition of matter” do not extend to complex, self-replicating life forms.
- Institutional role: Broad policy change belongs to Parliament, not the courts.
- Context: Separate protection for plants suggests a limited patent scope for living things.
Ratio Decidendi
Section 2’s words, read in context and purpose, do not clearly include higher life forms within “manufacture” or “composition of matter.” Absent clear legislative direction, courts should not extend patentability to such products.
Why It Matters
- Draws a legal line: processes yes; higher life form products no (under current law).
- Signals that bioethics & policy should be addressed by the legislature.
- Guides biotech strategy: focus on methods, genes/vectors, or devices, not whole animals.
Key Takeaways
No clear text to cover higher life forms as patentable products.
Protect the method, even if the living product cannot be patented.
Major policy shifts on patenting life need legislation.
Plant Breeders’ Rights show distinct protection paths for living matter.
Mnemonic + 3-Step Hook
Mnemonic: “PROcEss YES, PROduct NO” — Remember: PROcess allowed; living PROduct denied.
- Spot the Claim: Is it a process or a product (animal)?
- Read Section 2: Does the text clearly include the claimed product?
- Think Policy: If big ethical issues appear, it’s for Parliament.
IRAC Outline
| Issue | Rule | Application | Conclusion |
|---|---|---|---|
| Are higher life forms patentable under Section 2? | Section 2: invention = art, process, machine, manufacture, or composition of matter. | Higher life forms are complex, self-replicating; statute lacks clear text to include them; separate plant-rights regime exists. | No. Product claim fails; process claim stands. |
Glossary
- Higher Life Form
- A complex, sentient organism (e.g., animal) distinct from microorganisms or cells.
- Composition of Matter
- A combination of substances; in patents, often chemical or biological compositions.
- Plant Breeders’ Rights
- A separate regime that protects plant varieties outside standard patent rules.
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