Human gene patents – a quick snapshot
| What | What it means | Current status (US & EU) |
|------|---------------|--------------------------|
| Natural DNA sequences | The exact, unaltered stretch of DNA that occurs in the human genome (e.g., the BRCA1 gene). | Not patent‑eligible in the U.S. (post‑Myriad 2013) and in the EU (since 2005, European Court of Justice). |
| cDNA | A copy of a gene’s coding sequence, made by reverse‑transcribing mRNA and then re‑synthesizing the DNA. | Patent‑eligible if it’s not a simple copy of the natural sequence (U.S. & EU). |
| Methods | Techniques for detecting, amplifying, or using a gene (e.g., PCR protocols, diagnostic kits). | Generally patent‑eligible if they involve a novel, non‑obvious step. |
| Gene‑based therapeutics | Drugs or therapies that target or use a gene (e.g., gene‑editing tools, RNAi). | Often patent‑eligible, but must be tied to a specific, inventive use. |
| Derived or modified genes | Altered sequences that are not found naturally (e.g., engineered mutations). | Patent‑eligible. |
---
Why it matters
1. Access & Pricing – If a company holds a patent on a diagnostic test for a gene, it can set the price and control who sells the test.
2. Research Freedom – Researchers need to navigate a patchwork of patents when studying a gene, even for basic science.
3. Drug Development – Patents on gene‑targeting therapies can be crucial for recouping R&D costs, but they can also slow down competition.
---
Key legal milestones
| Year | Case / Decision | Outcome |
|------|-----------------|---------|
| 2003 | Association for Molecular Pathology v. Myriad Genetics (U.S. Supreme Court) | Initially allowed Myriad to patent the BRCA1/BRCA2 genes. |
| 2013 | Myriad Genetics, Inc. v. Ashcroft (U.S. Supreme Court, 2nd Circuit) | Overruled Myriad – natural DNA is not patent‑eligible. |
| 2005 | European Court of Justice, M. v. A | Declared that naturally occurring DNA fragments are not patentable. |
| 2020s | Various U.S. and EU decisions on gene‑editing tools (CRISPR, TALEN) | Methods of editing are patent‑eligible if they involve novel, non‑obvious steps. |
| 2021 | U.S. Patent and Trademark Office (USPTO) policy updates | Emphasized the need to distinguish between natural sequences and engineered constructs. |
---
Practical take‑aways
| For a researcher | For a pharmaceutical company | For a patient |
|-----------------------|-----------------------------------|-------------------|
| Use public domain sequences or obtain a license if the gene is protected. | File patents on cDNA, methods, or therapeutics; avoid claiming the natural sequence itself. | Know that most diagnostic tests for natural genes are free of patent claims (in the U.S. and EU), though commercial kits may still be sold. |
---
Quick FAQ
1. Can you patent a naturally occurring human gene?
No – in the U.S. since 2013; in the EU since 2005.
2. Can you patent a copy of a gene (cDNA)?
Yes, if it is not a trivial copy of the natural sequence and includes a novel arrangement or use.
3. What about CRISPR‑based therapies targeting a gene?
The CRISPR technology itself can be patented (e.g., Cas9 protein modifications). The method of using CRISPR to edit a specific human gene can also be patented if it meets the novelty and non‑obviousness criteria.
4. Do diagnostics that detect a gene need a patent?
Diagnostic methods can be patented, but the underlying natural gene sequence cannot be the sole basis for a claim.
5. Is there any international consensus?
The U.S. and EU diverge on some aspects (e.g., the U.S. allows patenting of some natural gene‑derived methods that the EU may view as more restrictive). Always check local laws.
---
Further reading
- U.S. Supreme Court: Myriad Genetics v. Ashcroft (2013) – Link to opinion.
- European Court of Justice: M. v. A – 2005 decision on DNA patentability.
- USPTO Patent Policy on Gene‑Based Patents – USPTO website.
- WHO/World Bank: Gene Patents & Access to Medicines – a policy brief.
Feel free to ask if you want deeper dives into a specific gene, a particular jurisdiction, or how gene patents affect drug development pipelines!