On 13 June 2013, the US Supreme Court unanimously held that isolated genomic DNA is a product of nature and therefore is not considered to be patentable subject matter in the US. The decision arose from the case – Association for Molecular Pathology v. Myriad Genetics, Inc.
Myriad Genetics have patents in the US covering the genes BRCA1 and 2. These genes are known as tumour suppressor genes, which mean that the proteins they code for help cells from dividing too quickly or in an uncontrolled manner.
Myriad Genetics discovered the precise location and sequence of these genes. This information, in turn, enabled it to develop medical tests that are useful for detecting mutations in a patient’s genes and thereby assessing whether the patient has an increased risk of cancer, particularly breast cancer.
Myriad Genetics’ patents contain claims that were directed towards isolated DNA molecules defined by nucleotide sequences & amino acid sequence. Their monopoly over these genes began in 1996.
The Association for Molecular Pathology (AMP), a consortium of scientists and civil rights activists, is opposed to the patenting of such gene sequences and has argued that genes are products of nature and, as such, not patentable.
Myriad Genetics’ patents were earlier ruled invalid in 2010 by a US district court in the state of New York. Myriad Genetics appealed this decision. On appeal, the Court of Appeals for the Federal Circuit reversed the US district court’s decision and held the genes were patentable.
This latest decision is a result of an appeal to the US Supreme Court initiated by AMP.
There has been a long history of US cases on the patentability of genes in the US. Such gene sequences are generally allowed so long as the gene sequence is isolated from nature and it must have at least one specific, substantial and credible utility that is either well-established or asserted in the patent application.
Naturally, Myriad Genetics used this argument that isolated DNA was different from its existence in nature and, hence, patentable. Myriad Genetics argued that it had to break covalent bonds in the natural DNA to isolate the DNA. In doing so, the isolated DNA had a different chemical structure. In other words, a non-naturally occurring molecule was created.
However, the Supreme Court disagreed and found that Myriad Genetics did not create or alter any of the genetic information encoded in the genes. In particular, it found that separating that gene from its surrounding genetic material is not an act of invention. In response to Myriad Genetics’ argument that chemical bonds were severed and a non-naturally occurring molecule was created, the Court emphasized that Myriad Genetics’ patent claims are concerned primarily with the information contained in the genetic sequence, and not with the specific chemical composition of the molecule.
This decision focused on claims that are directed towards isolated gene sequences. It did not address the applications of the genes in a patent, for example claims that may be directed towards host cells, diagnostic kits, method of diagnosis etc., which are commonly found in patents where the invention is associated with isolated genes. This decision also did not address the patentability of genes where the sequence was altered from a sequence found in nature, i.e. recombinant gene sequences.
The US Patent and Trademark Office has responded to the latest decision and issued guidelines to its examiners. In particular, with this decision, US patent examiners should now reject product claims solely drawn to naturally occurring nucleic acids (or fragments) whether isolated or not.