Australia is now at the centre of the global gene patent debate with a Senate inquiry that began last week in Melbourne. Senators in Australia began hearing public submissions on August 4th about the topic of gene patents in relation to the impact they have on health care costs. The inquiry centres around a bid to stop gene patenting in Australia because of claims that the patents are stifling research efforts.

Professor Ian Olver, representing the Cancer Council of Australia, stated, “We don’t think people should have a monopoly just because they have discovered a gene.” However, Olver does agree that treatments should be patentable:

“If they invent a treatment as a result, by all means.”

On Monday, Heather Drum, breast cancer survivor and member of Breast Cancer Network Australia, spoke to the panel about patenting cures, not genes, as well. ”If someone owns a patent to one gene and someone else owns a patent to another gene associated with breast cancer, my question is, will they ever talk?” she began, “If you discover a treatment or cure, then patent that. Don’t patent the gene. Patent the cure.”

Perhaps the era of gene patents is coming to an end.

Last year, Genetic Technologies of Melbourne requested that hospitals stop conducting breast cancer gene tests because the company owns the patent for the genetic mutation and the $2 100 screening test in Australia. The controversy surrounding Genetic Technologies is similar to a current situation here in North America. Myriad Genetics’ patent on the BRCA1 and 2 genes is currently under heavy scrutiny in the United States as well. This past May, a lawsuit was filed again the USPTO, Myriad Genetics, and the University of Utah Research Foundation by breast cancer patients as well as many prominent medical researchers across the United States. The plaintiffs introduced a novel argument by stating that gene patents are in violation of free speech rights and therefore are unconstitutional according to the First and Fourteenth Amendments to the US Constitution.

The University of Utah and Myriad genetics asked a New York federal judge to dismiss the high-profile case against them in mid July. They argue that the plaintiffs in the case cannot prove that they were injured by the patents granted to the university fifteen years ago. Myriad stated that, “If the plaintiffs in this case have standing, then virtually anyone can challenge any patent at any time.” The USPTO filed a motion asking for a dismissal as well. However, one could argue that because Myriad holds a patent for genes that are in every female’s DNA, it would make sense that almost anyone could have standing to challenge their patent. As I have mentioned before, one of the problems with some gene patents seems to be their overly-broad nature, which inevitably leads to conflicts such as the rights to breast cancer gene screening tests as outlined above. These are over-reaching implications that (likely) the USPTO and parallel organizations in other countries facing similar controversy did not desire.

Should cures for genetic diseases be patentable, but not the actual gene that causes or contributes to the disease? What if the cure involves genes, such as in gene therapy? Gene therapy is currently being considered for cancer treatment. Gene therapy is a procedure where the genetic mutation that is causing or contributing to an illness, such as in breast cancer, is changed. The mutant allele, or section of DNA, is replaced with a functional piece of DNA, thereby stopping the production of the “cancer-causing” proteins and thus halting the progression, or reversing the damage, of the disease.

P53 gene therapy is one example that has shown positive results in mouse ovarian and breast cancers and is being considered for human treatment. P53 gene therapy may even be effective against tumours that lack p53 mutations because p53 can also serve as a growth inhibitor in certain settings. Since cancer is caused by a proliferation of cell reproduction, p53 may stop this process from occurring. Right now, the main limiting factor of gene therapy for cancer treatment is the degradation of the vector by the host’s immune system, which may be rectified in the near future with more research.

Is gene therapy distant enough from a standard gene patent that it should be patentable? Or is gene therapy still fundamentally using genetic information that, according to some people, is a product of nature and should not be patentable? As someone who is strongly in support of genetics, I believe that most diseases have, at their fundamental level, a root in genetics, and thus many cures for diseases will involve genetics to some degree. Whether this means that I think that cures for diseases such as breast cancer should be patentable, I am still unsure.

The patent debate was not always so complicated, as demonstrated by the famous comment of Dr. Jonas Salk who invented the polio vaccine. When journalist Edward R. Murrow asked Dr. Salk who owns the polio vaccine patent, Salk replied, “Well, the people, I would say. There is no patent. Could you patent the sun?”

Well, almost, according to Diamond v. Chakrabarty, which stated that “anything under the sun that is made by man” could qualify for patent protection.

Posted in Infringement, Patentability, Uncategorized