Defining Gene Patents

Advances in exome and whole-genome sequencing have brought about an explosion in genomic data, and concerns about biotechnology patents have exploded accordingly. The term “gene patent” is loosely defined, and it has been used in the media to cover a wide variety of patents related to genetics. A gene patent is considered intellectual property. It gives the patent holder the right to keep others from utilizing the information in the patent for a period of 20 years on average. Gene patents typically base their claims mostly on whole genes, but they also cover Inventions that involve the components of genes and genetic technologies. They include:

  • The association between a DNA variant and disease, function, or condition
  • A DNA sequence that creates a specific protein, regulates gene function or can be used for the study of genetic variations
  • RNA sequences that turn genes off and on and/or control functions
  • Cell lines that are used for treatment and diagnostics
  • Transgenic animal models for disease and the genes that go into making them

It's important to understand the different claims covered by the term “gene patent” for the proper interpretation and application of patent law as it applies to the development of genetic medicine.

Gene Patenting Background and the Myriad Case

The first gene patent was granted in December 1980 for a recombinant DNA method. It came 6 months after the United States Supreme Court ruled that a life form could be patented. But it took 20 years for the concept of gene patents to take off. The complete mapping of the human genomes unleashed an avalanche of patent requests for genes and gene sequences. About 80% of DNA patent holders are nonprofits and universities that have never enforced the patents they hold.

Myriad Genetics, however, decided to exercise its legal right as a patent holder and co-owner of the patents for two breast cancer genes known as BRCA1 and 2. It co-owns the patents with the University of Utah. The university discovered the genes along with Myriad while using financing from a National Institutes of Health grant. The University of Utah licensed the technology to Myriad Genetics per common practice. Myriad then sent letters in 2001 to laboratories around the world informing them that testing had to be done through the company's labs or through licensed laboratories.

It wasn't until 2009 that the ACLU and the Public Patent Foundation filed a lawsuit against Myriad Genetics with the claim that patents on human genes violate the First Amendment and patent law due to the fact genes are "products of nature" and can't be patented. The case made its way through the court system until it wound up at the United States Supreme Court in June 2013. The court made a unanimous ruling that naturally isolated DNA cannot be patented, but synthetic DNA can. The Supreme Court's decision invalidated the breast cancer gene patents held by Myriad and all other gene patents. Multiple biotech companies announced competing tests for the BRCA1 and 2 genes in the hours after the court announced its ruling.  But this decision has left the USPTO and patent-holders unsure of the future of their patents with more litigation likely in the future. 

Important Factors to Consider

All of the claims in a patent have to be separately analyzed to determine what it covers. The examiners at the patent office are charged with a duty to do analysis, but the potential for mistakes is always there. All it takes is one mistake or oversight for an applicant to get something patented.

US patents come with a safeguard in the form of a challenge after they are granted, offering a check and balance to make sure that mistakes are caught, but it's not a foolproof system. There's always the risk that an innovator won't fully disclose the patented invention to the public in order to gain a limited monopoly granted by a patent. There is a strong possibility that  Ventures using private money will turn towards secrecy to protect the new DNA technologies that they create. This could frustrate overall progress and work against the greater good.

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