Genetic Patent Law & Strategy

According to the U.S. government, about 20 percent of the genes comprising the human genome are patented.

In the U.S., general patent laws prohibit patenting natural products. Yet genetic patent law skirts this by requiring isolation of the material, which simply means identification. When filing with the United States Patent and Trademark Office (USPTO), genetic patent-seekers follow a strategic plan based on the components of disclosure, specification and access.

Disclosure

The disclosure component requires the patent applicant to identify and describe the newly discovered genetic material, usually a sequence or fragment. A patent can be claimed on naturally occurring genetic material simply by first discovery and identification without any product creation or alteration.

Specification

The specification component requires a description of the predicted product and how it is expected to function. However, applications sometimes contain vague definitions giving broad rights. Because applications are confidential prior to patent issue, it is impossible to know what genes or products are under investigation at any given time.

Access

The access component requires the patent application to sufficiently describe the genetic material or product to a degree that a skilled practitioner in the field can use it for the stated purpose. However, the patent holder can charge any desired royalty for access to the genetic material or product.

References

• Department of Energy: Human Genome Project Information--Genetics and Patenting
• Singularity Hub: Who Owns You? 20% of the Genes in Your Body are Patented
• United States Patent and Trademark Office