Supreme Court made a ruling on June 13, 2012 that DNA sequences found in nature is not patentable. This seems obvious since this is the product of nature and so a company or a person cannot patent a fish or a frog as it occurs in nature. The ruling can be found in this PDF or by going on the link below.
There are many implications of this decision, and has lead to active discussion on forums but if one follows what has been patented with small molecules that are used in pharmaceuticals, then things are not surprising. However, there may be a question about this since DNA sequences are not completely new chemical entities and in some way or form occur in nature, whereas chemical compounds may be so novel that they would never occur in nature unless invented or created by the chemist.
The ruling mentions that cDNA (copy of the gene without the introns) are also not directly patentable but modified cDNA can be patented. So, if a company were making a test that used exact gene sequences then they could not patent but if they modified the sequences, then they could patent.
So, hypothetically, a diagnostic company, they could do the following to enable it to patent their test or gene:
- File one or more patents with multiple claims as it’s done for Biologics: The gene sequences that the company is patenting should be with a “use” patent. In Biologics, companies file the patent for the sequence of the antibody that they use but also its use for a specific purpose. So, the company patent could state a) this sequence is patented and b) it will be used for the following diagnostic test: so use of a specific DNA sequence for a specific diagnostic test.
- Use Deuterated derivate of the sequence: This is a gray area. Deuterium occurs in a very small but sometimes negligible percentage. If the company makes their DNA/RNA sequence Deuterated then it is not something that occurs naturally, but the final product is functional equally. This strategy has not been questioned in courts so there might be some flexibility.
- Modify the sequence so that though it is specific for the specific gene still is different from the original sequence. In some cases, it might be possible to actually increase the binding affinity and get a better probe.
- Use a portion of the DNA that is mostly intron but modify the DNA so that it enhances the binding in some way. Methylation is one example but any chemical modification, like fluorescent tag or other tag that may serve as a label and sometimes may help enhance its binding/activity. Other modifications possible for the company test would be couple it to beads or something that enhances the test but also makes it patentable.
- Change the sequence so that it uses a small portion of the actual sequence for binding and the remaining sequences form a tertiary structure that enhances the binding.