Another Controversy laid to rest: Naturally ocurring DNA is patent ineligible but cDNAs are, rules US Supreme Court

are_your_genes_somebody_elses_propertyThe US Supreme Court, it seems, is on a mission to keep the biotech industry on its toes. After last month’s ruling in the Bowman Vs Monsanto case, the Court has delivered another landmark judgment yesterday in the AMP Vs Myriad Genetics  involving patents on BRCA1 and BRCA2 genes and diagnosis of breast cancer.

A unanimous ruling by 9 US Supreme Court judges have held that a naturally occurring DNA segment is a product of nature and therefore not patent eligible. However, they also clarified that complementary DNA or cDNA being a non-naturally occurring material is patent eligible.

Brief background on the case: It was a long known fact that occurrence of breast cancer in women was hereditary. Myriad discovered that two genes  i.e. BRCA 1 and BRCA 2 located on chromosomes 17 and 13 played an important role in the onset of breast cancer. Particularly they discovered that individual having mutations in the BRCA1 and BRCA2 genes were more susceptible to developing breast cancer. This information in turn enabled Myriad to develop medical tests that are useful for detecting mutations in a patient’s BRCA 1 and BRCA 2 genes and thereby assess whether the patient has an increased risk of breast cancer. Myriad sought and obtain a number of patents after this discovery.

Myriad’s patent gave it exclusive right to isolate and individual’s BRCA 1 and BRCA 2 genes and also to synthetically create a cDNA strand of the genes. In Myriad’s view, manipulating BRCA DNA in either of these fashions triggers its right’s to exclude others from making its patented invention. But isolation is necessary to conduct genetic testing and Myriad was not the only entity to offer BRCA testing after the genes were discovered. Petitioner Dr. Harry Ostrer, who was a medical practitioner, would routinely send his patients DNA samples to Pennsylvania’s Genetic Diagnostic Laboratory (GDL) which provided diagnostic testing for BRCA genes. After learning about GDL testing and Dr. Ostrer’s activity, Myriad sent them and other entities offering BRCA gene testing, letters asserting its patent. As a result, Dr. Ostrer along with medical patients advocacy groups, and other doctors, filed the present suit seeking a declaration that Myriad’s patents were invalid.

Gene

Claims of Myriad’s patents in question were essentially directed to a DNA segment that codes for the amino acids produced by BRCA 1 genes while dependent claims were directed to a cDNA molecule of the claimed DNA segment. A naturally occurring gene, which is a DNA segment, contains a mix of coding and non-coding regions called Exons and Introns.

One can identify coding and non-coding region of a gene by studying either the mRNA strand or the protein produced by the gene.  mRNA is produced by the body prior to translation to protein molecule, using the original gene segment as a template and contains only the coding region required to produce the protein. Scientist have been able to develop means to convert this mRNA strand, back to a DNA strand in laboratories using modern biotechnology techniques. The DNA strand so obtained is called cDNA or complementary DNA and this also contains only the coding region of the original gene.

Issue with the Myriad’s Patents: It was noted by the Court that Myriad did not dispute the fact that it neither created nor altered any of the genetic information encoded in the BRCA 1 and BRCA 2 genes. It was further observed by the Court that Myriad’s principal contribution lay in uncovering the precise location and genetic sequence of the BRCA 1 gene and BRCA 2 gene within chromosome 17 and 13. This discovery by itself does not render the BRCA genes new ‘compositions of matter’ that are patent eligible. Besides, Myriad’s patent description simply details the routine biotech process using which Myriad was able to narrow down onto the location of the BRCA genes.

As far as claims of Myriad patents are concerned, the Court observed that they primarily focus on the information contained in the genetic sequence and not with the specific chemical composition of any particular molecule. The Court also observed that there were no method claims, claims to application concerning the new knowledge on BRCA genes or DNA segment in which order of naturally occurring nucleotides are altered, asserted before this court.  In view of these observations, the Court held that genes and the information coded by them are patent ineligible as they are simply isolated from the surrounding genetic material. The Court also clarified that cDNA, being a non-naturally occurring molecule, forms part of patent eligible subject matter. Court observed that creation of cDNA sequence from mRNA results in an exon-only molecule that is not naturally occurring. Hence, cDNA does not present the same obstacles to patentability as naturally occurring isolated DNA segments.

The above decision only invalidates Myriad’s claim to BRCA DNA segments but does not affect Myriad’s other patents that relate to BRCA gene analysis and tests. The ruling also does not affect claims directed towards cDNA or synthetic DNA. However, the ruling does allow other companies to offer BRCA gene testing services and seek second opinion, which was what at the heart of this controversy.

Source: Association for Molecular Pathology v. Myriad Genetics, U.S. Supreme Court, No. 12-398

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