Sequences of natural occurring DNA cannot be patented, rules US Supreme Court

The Court said that whilst it may be possible for "synthetically created DNA" (cDNA) to be patented, companies cannot obtain patent protection for sequences of "naturally occurring" human genes (22-page / 139KB PDF) on the grounds that those DNA segments are "a product of nature".

"Genes and the information they encode are not patent eligible ... simply because they have been isolated from the surrounding genetic material," Supreme Court said in its judgment. "cDNA is patent eligible because it is not naturally occurring."

Patent law expert Adrian Murray of Pinsent Masons, the law firm behind Out-Law.com, said that it will still be possible to patent inventions based on isolated human gene sequences in the US. However, he said the ruling would force patent attorneys to be more creative in the way they set out the subject matter of patents.

"The exclusion from patentability to 'products of nature' has existed in US patent law for many years," Murray said. "Previously, practice before the US Patent Office was that isolation of a section of DNA from the full strand resulted in a product – the isolated sequence – that does not exist naturally and is therefore not a 'product of nature', thus not excluded from patentability."

"This was the stance previously taken by the US Court of Appeals in this case, and is also the interpretation that has been introduced into statute in Europe by the Biotech Directive. The Supreme Court’s decision therefore has the effect of broadening the statutory exclusion in US patent law," he said.

"However, this does not mean that companies will be unable to patent inventions based on isolated DNA sequences in the US. It will still be possible to do so, although patent claims covering such material will have to be worded differently. While it will not be possible to obtain per se product protection on isolated sequences, it will still be possible to protect applications of those sequences using ‘method of treatment’ claims, ‘diagnostic method’ claims, composition claims and other types of claims," Murray added.

"Indeed, in the patent under scrutiny in this case, many of the method claims, involving uses of the sequences in question, were found to be valid by the Appeals Court and this was not challenged. I envisage that this judgment will force drafting attorneys to be more creative as to how such subject matter is claimed going forward," the expert said.

The Supreme Court was ruling in a case brought in appeal by the Association for Molecular Pathology against a previous judgment of the US Court of Appeals. The Court of Appeals had held that isolated genes can be patented, but the decision was appealed to the Supreme Court by the Association for Molecular Pathology in a bid to render invalid patents held by pharmaceutical firm Myriad Genetics. The patents covered two isolated genes linked to breast and ovarian cancer, known as BRCA1 and BRCA2.

Under US patent laws, material related to laws of nature cannot be patented. However, US case law has established that "anything under the sun that is made by man" can be patented. That was the view taken by the Supreme Court in a case in 1980 and since then it has been used as a legal test in US courts for determining whether a particular subject matter is patentable.

The Supreme Court ruled that Myriad's patents "fell squarely within the law of nature exception".

"Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes," the Court said. "The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myr­iad create or alter the genetic structure of DNA. In­stead, Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes."

"That discovery, by itself, does not render the BRCA genes 'new . . . composition[s] of matter,' that are patent eligible," it said.

The Supreme Court said that Myriad's gene sequences could not be validly patented by virtue of the fact that "isolating DNA from the human genome severs chemical bonds and thereby creates a non-naturally occurring molecule". The pharmaceutical giant's patent claims focused on "the genetic information encoded in the BRCA1 and BRCA2 genes" rather than the "chemical composition" of them, it said.

Because synthetically created DNA segments involve the creation of "something new", those gene sequences cannot, in most cases, be said to be "naturally occurring", the Supreme Court said. The Court said, though, that it was not offering a view on whether cDNA could be said to satisfy other legal requirements for patentability.

"The lab technician unquestionably creates something new when cDNA is made," the Court said. "cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a 'product of nature' and is patent eligible ... except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA."