Can I patent a human gene?

Can I Patent a Human Gene?

Patenting human genes has been a contentious and evolving area of intellectual property law. The legal landscape regarding the patentability of human genes varies by jurisdiction and has undergone significant changes in recent years.

Key Points

**Naturally Occurring Genes**: Naturally occurring human genes, in their isolated form, are generally not patentable. This was established by the landmark U.S. Supreme Court case *Association for Molecular Pathology v. Myriad Genetics, Inc.* in 2013, which ruled that naturally occurring DNA sequences cannot be patented because they are products of nature.
**cDNA**: Complementary DNA (cDNA), which is synthetically created and does not occur naturally, is patentable. The court ruled that cDNA is sufficiently different from natural DNA to be eligible for patent protection.
**Gene Editing and Synthetic Biology**: Innovations involving gene editing technologies (like CRISPR) and synthetic biology, where human genes are modified or entirely new genetic sequences are created, may be patentable.

Legal Landscape

**United States**: The *Myriad* decision has significantly restricted the ability to patent naturally occurring human genes. However, methods of using genes, genetically modified organisms, and synthetic genes can still be patented.
**Europe**: The European Patent Office (EPO) follows similar principles, where naturally occurring substances are generally not patentable unless isolated from their natural environment and significantly altered. However, the Biotech Directive allows for the patenting of biological material that is isolated or produced by means of a technical process.
**Other Jurisdictions**: Countries like Canada and Australia have also seen legal battles over gene patenting, with varying outcomes. The trend has been towards restricting patents on naturally occurring genetic material while allowing patents on synthetic or modified genes.

Implications for Research and Innovation

**Research Freedom**: The restriction on patenting naturally occurring genes has been seen as a win for the research community, allowing greater freedom to study and experiment with genetic material without infringing on patents.
**Incentives for Innovation**: The ability to patent synthetic genes and genetic technologies provides incentives for companies and researchers to invest in developing new medical treatments, diagnostic tools, and biotechnological innovations.
**Ethical Considerations**: The debate over gene patenting also involves ethical considerations about ownership of human genetic material and its implications for access to healthcare and genetic resources.

Examples of Patented Genetic Innovations

**CRISPR Technology**: CRISPR-Cas9, a revolutionary gene-editing technology, has been the subject of numerous patents. These patents cover the methods of using CRISPR for gene editing, as well as specific applications in medicine and agriculture.
**Synthetic Biology**: Patents have been granted for synthetic genes and organisms designed for specific purposes, such as producing biofuels, pharmaceuticals, or agricultural products.

International Patent Classification (IPC)

Relevant IPC classifications for genetic patents include:

C12N – Microorganisms or Enzymes; Compositions Thereof
A61K – Preparations for Medical, Dental, or Toilet Purposes
G06F – Electric Digital Data Processing

Questions about Patenting Human Genes