The American Medical Association stands with healthcare providers, labs, researchers, and cancer patients who say that gene sequences isolated from the body should not be patentable, but not all doctors agree with this position.
The Association of American Physicians and Surgeons filed an amicus brief this week with the US Supreme Court in the lawsuit, Association for Molecular Pathology et al. v Myriad Genetics et al., in which plaintiffs represented by the American Civil Liberties Union and the Public Patent Foundation are challenging Myriad's patents on isolated gene sequences. The Supreme Court hearing is slated for April 15.
"This Supreme Court case ... has become a sweeping attempt by the ACLU, the American Medical Association, and the Obama Administration to invalidate property rights for much medical innovation," the AAPS wrote in a statement. The organization urged the court to "limit its inquiry to the narrow claims in this case, rather than using it as a means to exclude vast areas of medical research from patent protection."
By contrast, the AMA has taken an anti-gene patenting stance. "The AMA is opposed to gene patenting because it has the potential to inhibit access to genetic testing for patients and hinder research on genetic disease," the association, which is historically one of the most medical powerful lobbies in Washington, states on its website.
In supporting gene patents, the AAPS also says it is taking the position that will benefit patients. "The incentives created by such patents [on genetic and medical research] are essential to encourage medical innovation that saves patients' lives," the organization states. "Patents, like other forms of private property, are essential to progress. Valuable cures are being developed based on patents in many medical fields, including adult stem cells — cures that would not be possible without the incentives established by patents."
Beyond gene patenting, the AAPS stands ideologically apart from the AMA on many issues. The AAPS, founded in 1943, is founded on principles of limited government and backs policies that would "preserve the practice of private medicine." The group's website includes a statement from past-president Lee Hielb in which he notes that the AMA and other physician-focused societies no longer espouse principles he holds dear, including "individual liberty, personal responsibility, limited government, and the ability to freely practice medicine according to time honored Hippocratic principles."
What most of the medical and
What most of the medical and clinical establishments fail to realize is that without patent protection, the motivation to develop new genetic tests goes away. No company is going to pay tens of millions of dollars to develop tests, run clinical trials, and have the test FDA cleared when it's competitors can simply then duplicate the test at very little cost - not a livable business model. Nor will investors be interested in supporting companies without IP protection. Result? The field will have fewer tests developed in the future, not more.
I do not agree with that
I do not agree with that genes should be patentable. Giving patents to a genetic sequence would make many whole genome sequencing projects illegal and not allow for further more sensitive developments of ways to investigate these genes. Give patents to specific assays, drugs, processes, but not to information about how the body function.
Setting aside for a moment
Setting aside for a moment the fact that most medical inventions are discovered, developed, and refined using hundreds of millions of taxpayer dollars via federal grants to nonprofit or academic research institutions [which runs counter to the AAPS position of “limited government,”] a patent is, by definition, an INVENTION. It is something new, or a new refinement – not merely the description of something that already exists in nature. In Diamond v. Chakrabarty, the court held that as long as the substance or organism was sufficiently “man-made,” it could be patentable. BRCA1/2 sequences are not man-made, though Myriad’s test may be. As a cancer patient and as a scientist, I would fully understand and support the issuing of a patent to a company or other organization that develops a new clinical test, a new series of algorithms to gather and analyze the medical literature, or some other innovative approach to USE the genetic sequences of a particular gene or genes. However, neither Myriad nor any other company invented the BRCA1 or BRCA2 gene sequences, nor did they invent the mutations that confer an increased risk for cancer. In fact, most of those mutations were discovered with taxpayer-funded research and published in the scientific literature. [Though if Myriad does own the mutated BRCA1/2 sequences, can I sue them for trespass and damages to get their mutated sequences out of my body??] It is deplorable that the sequencing of these genes by another organization can violate the Myriad patent. The courts that have upheld that actual gene sequences existing in nature are “inventions” demonstrate their severe lack of understanding of basic science. Given the AAPS statement on this issue, the fact that I cannot receive a second opinion/sequencing of my BRCA1/2 genes from another medical provider other than Myriad shows that the AAPS seems to care more about profits and political statements and less about quality patient care.
While it is reasonable for
While it is reasonable for companies to patent novel technologies,testing methods and equipments, it does not sound reasonable to patent a body part, an organ, a cell type, or a gene, which is a biological component of an organism on which a testing is performed.
Given that much of genetic
Given that much of genetic testing will be done using multiple parallel sequencing approaches, patents on individual genes would be highly restrictive.
IP protection will be based on platforms and not individual genes.
Lobby groups with blatantly ideological agendas do not deserve the airtime and printspace that they are getting.
Body parts are not
Body parts are not patentable. but genetic testing patents are not patenting body parts -- instead, they patent the knowledge obtained on top of a lot of money, the knowledge that a genetic variant is associated with a specific trait.
Otherwise, I totally agree with dnapro, that no private companies has the incentive to obtain the knowledge of association that is needed for genetic testing.
"they patent the knowledge
"they patent the knowledge obtained on top of a lot of money, the knowledge that a genetic variant is associated with a specific trait" which is, of course, the result of many other researchers´ work - published or not yet published.