The availability of patent protection for human genes continues to fuel debate around the world.
Patent offices have cumulatively granted thousands of patents directed to isolated nucleic acids, deoxyribonucleic acid (DNA) and genes. The commonly held view in most jurisdictions has been that, while naturally occurring material including nucleic acids, DNA and genes, is not eligible for patent protection, isolated, modified or altered versions of such naturally occurring material are considered patentable.
The question as to whether isolated forms of naturally occurring compounds that lack artificial generation or modification should continue to be patentable, has been addressed in the United States and recently re-addressed in Australia. However, it should be noted that DNA patenting in the last decade has advanced beyond the mere isolation of natural genes. Furthermore, the publication of the complete human genome sequence over a decade ago, has long precluded the patentability of isolated genes per se for novelty reasons. Therefore, these legal decisions questioning the patentability of isolated genes will have little impact on DNA patenting and will only impact older patent cases that have expired or are close to expiry.
The validity of gene patents owned by Myriad Genetics directed to breast and ovarian cancer, marker genes BRCA1 and BRCA2, has been the basis of the recent legal rulings directed to the patentability of gene debate in both the United States and Australia.
The Court of Appeals for the Federal Circuit had previously upheld the patentability of isolated nucleic acid molecules. However, on 13 June 2013, the U.S. Supreme Court ruled that Myriad's isolated BRCA genes are not patentable. The rationale for this decision, made by Justice Clarence Thomas, was that the discovery of a useful naturally occurring gene is important, but merely separating that gene from its surrounding genetic material is not an act of invention. This decision was probably heavily influenced by mounting opinion by medical groups that companies, like Myriad, should not be allowed to use its gene patents to sue clinics and prevent others from doing independent tests to diagnose serious medical conditions like breast cancer.
The end result of this decision means that, in the United States, more companies may develop alternative BRCA1 and BRCA2 tests and the public may have greater access to such genetic testing. The decision also impacts the validity and enforceability of existing granted patents that rely on claims directed to isolated, naturally occurring, genes. However, it is important to note that the decision does not impact the patentability of nucleic acid molecules that have been modified or don't occur in nature, such as lab generated DNA (cDNA) which remains patentable in the United States. In addition, the extent that the decision will impact Myriad and other companies may depend on the scope and wording of the gene patent claims that have been granted. For example, companies like Myriad may still have valid patent claims directed to cDNA and method claims that allow for certain exclusive rights to continue enforcing their specific diagnostic testing for breast cancer. Going forward, diagnostic patents based on genetic testing will need to continue to rely more on patenting artificial primers, probes, and innovative testing methods or methods of manipulating genes for diagnostic screens to obtain valid gene related patent claims in the United States.
In Australia, past decisions from both senate enquiries and the Federal Court of Australia have supported maintaining the patentability of isolated nucleic acid molecules. It was held that, although naturally occurring DNA and ribonucleic acid (RNA) as they exist inside the cells of the human body cannot be the subject of a valid patent, the Myriad disputed claims did not cover naturally occurring DNA but isolated and extracted DNA from cells of a human body that was regarded as patentable. However, the Australia Federal Court decision was appealed in March this year and submissions for this case will include consideration of the U.S. Supreme Court ruling. The Australian appeal judgment is yet to be finalised. Will the Australian courts mirror the opposing decision of the United States? Presently, countries such as Australia, Europe, Canada, India and Japan are harmonized with regard to permitting the patenting of human genes provided the genes are isolated and the patent application teaches useful applications of the isolated genes. Therefore, the United States currently stands alone with the Supreme Court decision that isolated forms of naturally occurring DNA sequences cannot be patented.
Will the Myriad Cases Have an Impact on Gene Patenting?
If the Australian appeal decision follows the U.S. ruling, then it will impact the validity and enforceability of past granted gene patents directed to isolated genes. However, even if the Australian Full Federal Court rules against Myriad Myriad's isolated BRCA genes, it will certainly not be the end of patenting of DNA subject matter.
In the last decade, biotechnology developments have been primarily based on the generation of modified or artificial DNA and recombinant proteins expressed from cDNA sequences that do not occur in nature. Therefore, it is likely that the Australian appeal decision will not hugely impact the patentability of modified or altered forms of genes, recombinant DNA, plasmids and methods of generating or application of such DNA compounds. Applicants are still likely to be able to obtain patent protection for DNA based molecules where the claimed molecule can be distinguished from the native molecule.
Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 12-398 (2013)
Cancer Voices Australia v Myriad Genetics Inc  FCA 65
Yvonne D'Arcy v Myriad Genetics Inc & Anor filed Notice of Appeal 04-Mar-2013