The Association of American Physicians and Surgeons (AAPS) a national organization representing physicians in all specialties, earlier today filed an amicus brief with the U.S. Supreme Court in defense of patents for genetic and other medical research, including isolated BRCA1 and BRCA2 genes, which are important risk factors in breast and ovarian cancer.
The AAPS considers the incentives created by such patents as essential to encourage medical innovation that saves patients’ lives and urges the Supreme Court not to exclude research on genes from patentability inAss’n for Molecular Pathology v. Myriad Genetics, Inc., Sup. Ct. No. 12-398.
Over the last decades, patenting genetic discoveries has proven controversial. Re recent survey showed that there are now patents associated with almost 25% of the genes in the human genome. These patents can be extremely valuable for companies involved in developing targeted therapies and companion diagnostic test that are based on these genetic discoveries. In most cases, these patents are issued to encourage innovation, while at the same time, provide protection to allow those investing in medical research the opportunity to maximize the profit from these investment.
Essential to progress
Like any other form of private property patenting genetic discovery is essential to progress. Many valuable cures are being developed based on the patented discoveries. This includes the development of adult stem cells for specific targeted therapies in cancer. Without the incentives created by patents, these potential cures would not be possible.
However, while the protection of property rights is essential, whenpatents limit the use of basic genetic information, they may threaten to inhibit or limit biomedical research. The American Medical Association (AMA) together with the ACLU and the Obama administration are concerns that the large number of patents associated with the human genome may limit the integration of personalized medicine into health care either because of restrictive patents or prohibitive costs. In these cases, patents directly inhibit the translation of genetic discoveries into health care benefits.
On the other hand, the AAPS and individual physicians who joined its amicus brief “oppose categorical judicial exclusion of certain medical inventions from patentability because that will result in fewer advances for patients.”
According to the AAPS, limiting patentability is attempt invalidate property rights for medical innovation. To protect the property rights of researchers, lawyers of the organization urge 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.According to the AAPS general policy questions should be are decided by Congress, not by courts, which are constitutionally empowered only to decide cases in controversy.
Patent claims
The patent claims refer to specific isolated sequences of DNA. The U.S. Patent and Trademark Office (“PTO”) has issued rules and published examination procedures regarding the patenting of DNA sequences, and has granted numerous patents for such sequences.
Are humans patentable?
While AAPS supports innovation in medicine, others want the Court to rule on the broad hypothetical question of whether a “human gene” is patentable. This is controversy is the central element debate. If the Court considers that genetic discoveries are patentable, what are the criteria that should determine which genes – and why – are patentable. On the other hand, the Court may considers genes to be part of the collective heritage that should not be patentable at all. But if genetic discoveries are patentable, how should such a discovery be defined? Is the isolation and purification of genes from their natural state sufficient as a basis for a patent, or should the patent applicant have to be demonstrate a medical use – either in the form of a diagnostic test or in the form of a potential treatment – for their discovery?
An answer
National Human Genome Research Institute (NHGRI) is working with other organizations to find answers about patents and licensing. While the NHGRI recognizes theimportancein hope of maintaining the level of access to basic genomic data that will ultimately benefit researchers, care providers and patients.Somewhat controversially recommendations have been made that genetic tests are exempted from patent infringement, along with a research use exemption. However, a lawsuit against Myriad Genetics, the USPTO, and the University of Utah Research Foundation, challenging the constitutionality and validity patents for human genes, such as BRCA1 and BRCA2 resulted in a rulingin favor of the plaintiffs and against Myriad Genetics. In this ruling, the Court found that the BRCA1 and BRCA2 genes are products of nature and therefore not patentablel.
While the Court’s decision only applies to BRCA1 and BRCA2 patents held by Myriad, the AAPS’ amicus briefwith the U.S. Supreme Court in is part of the ongoing struggle to defend of patents for genetic and other medical research.
Legal Question
The legal question for the Supreme Court justices is whether the isolated genes are indeed a ?product of nature? that cannot be patented or should be considered ?human-made inventions? eligible for patent protection. While the AAPS reasons that these products are not found in nature, are obtained in alaboratory and are “human-made,” and the result of humaningenuity, and as a result patentable, a great number ofscientists and doctors claim that their research and ability to help patients has been frustrated as a result of these patents. They claim that by misuse of the patent system companies like Myriad have gained the right to exclude the rest of the scientific community from examining the naturally occurring genes of every living person.
The U.S. Supreme Court is expect to rule in this case later this year.
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