DNA Patenting in the United States

On June 13, 2013, the U.S. Supreme Court made a historic decision regarding intellectual property. Since DNA is a part of nature, it cannot be patented. You can only patent synthesized genes.

Since the 1990s, the biotechnological industry has undergone an increase in patent filing, especially those involving genetics. That's due to the interest in raising capital. One of the biggest issues involving genetics involves genetic variation or mutation.

The Patent System

The patent system promotes innovation by giving inventors exclusive rights. They can use their inventions for a specific timeframe. The patent holder can give others permission to use the invention by issuing a license. In return, the patent holder receives ongoing royalty collections.

Some scientists have an issue with patents and other intellectual property protections. That's due to basic logic dictating that science advances faster if other researchers have free access to information. However, exclusive rights to intellectual property are needed for investments in research and development.

In the United States and Europe, you can patent genes if you fulfill other requirements, such as isolating the gene and showing there's a nucleotide sequence. Treating a DNA sequence as a complex chemical is eligible for a patent if you produce recombinant drugs and vaccines with it.

Historical Precedent

The basis for patenting human genes began in 1980 thanks to the case of Diamond v. Chakrabarty. In this case, the U.S. Supreme Court ruled that people could manufacture living organisms because they didn't occur naturally. Combined with patenting chemical compounds, this made it possible for biotechnology companies to patent human genes.

The Patenting of DNA

For more than two decades, there's been an increase in biotechnology growth. The United States Patent and Trademark Office (USPTO) realizes that those in the biotechnology community have concerns about how DNA-based patents affect the industry.

Some bioinformatics businesses are working on a proprietary sequence database, while certain pharmaceutical companies are creating public databases about sequence information. There's some concern that patents shouldn't go to these new discoveries and that a newer form of intellectual property protection is necessary.

However, according to the USPTO, newer technology doesn't necessitate the need for new specialized patent law. The same analysis is used for every patent application, regardless of what the patent is for. In all technology fields, you must meet all patentability conditions before you can have a claim.

There are some concerns when using existing patent law to DNA sequence inventions.

  • Does the invention consist of patentable matter? The application must state that the invention is purified or isolated.
  • Does it fulfill the enablement requirement? This includes chromosome mapping or identification, tagging of a gene, or identifying the tissue type of origin. Enablement occurs when a skilled person can make and use the invention without experimenting.

One area of patent law still under discussion involves the type of information you must include on the application to distinguish it from others. For instance, in the case of the Regents of the University of California v. Eli Lilly, the court said that in order to claim a certain DNA sequence, there must be more information than just a mere statement, reference, and fragment of the claimed nucleic acid.

There is continuing debate about how patents on DNA fragments of a gene will affect full-length gene patents. The USPTO used an example of patenting a picture television. The picture television tube patent doesn't prevent someone from owning a patent on a television set. However, the tube patent could sue the set makers for patent infringement if they use the tube without securing a license.

Once a product obtains a patent, the patent goes toward any use. It includes uses that are not included in the patent. For the DNA to be patentable, it must be new and nonobvious. You cannot obtain a patent if one of the following occurs:

  • If the invention exists in a patent or printed publication anywhere across the globe.
  • If the invention is in public use in the United States for more than a year prior to the application date.

Without the involvement of patents, several aspects could happen.

  • There might be fewer opportunities for investment in DNA research.
  • Scientists might not disclose new DNA products to the public.
  • Patents might only occur within the scientific community.

If you need help with patenting DNA, you can post your legal need on UpCounsel's marketplace. UpCounsel accepts only the top 5 percent of lawyers to its site. Lawyers on UpCounsel come from law schools such as Harvard Law and Yale Law and average 14 years of legal experience, including work with or on behalf of companies like Google, Stripe, and Twilio.