Biotech Companies No Longer Have the Right to Patent Human Genes

Companies can still patent DNA they build themselves, methods for isolating genes or specialized knowledge they gain through genetic research

Argonne National Laboratory

Today, the Supreme Court decided that human genes attained by extracting DNA from individuals cannot be patented, the New York Times reports. The case started when a company called Myriad Genetics tried to patent several genes implicated in breast cancer called BRCA1 and BRCA2. Scientists cried foul, saying that the patent would hamper medical research. The Times explains the overall issue:

The central question for the justices in the case, Association for Molecular Pathology v. Myriad Genetics, No. 12-398, was whether isolated genes are “products of nature” that may not be patented or “human-made inventions” eligible for patent protection.

The Supreme Court sets the stage in a syllabus of the case, Association for Molecular Pathology v. Myriad Genetics Inc:

Respondent Myriad Genetics, Inc. (Myriad), obtained several patents after discovering the precise location and sequence of the BRCA1 and BRCA2 genes, mutations of which can dramatically increase the risk of breast and ovarian cancer. This knowledge allowed Myriad to determine the genes’ typical nucleotide sequence, which, in turn, enabled it to develop medical tests useful for detecting mutations in these genes in a particular patient to assess the patient’s cancer risk. If valid, Myriad’s patents would give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes, and would give Myriad the exclusive right to synthetically create BRCA cDNA.

These genes received considerable attention in May when Angelina Jolie announced that she had undertaken a double mastectomy. The actress made the decision after taking a genetic test that spun off from Myriad’s patent, the Times reports. The patent assured that that test carried a hefty price tag – around $3,000 – which scientists and doctors argue is unnecessary and likely excludes many women who don’t enjoy the same economic standing as Jolie.

The ruling today will likely mean that that test’s price tag will drop, which is good news for women, but it may also impact the pace of research since businesses interested mainly in profit may be less likely to get involved in genetic research, the Times writes.

The decision hewed closely to the position of the Obama administration, which had argued that isolated DNA could not be patented, but that complementary DNA, or cDNA, which is an artificial construct, could. The patentability of cDNA could limit some of the impact on industry from the decision.

The Times adds, though, that only a few companies hold patents based on isolated genes, so biotechnology shouldn’t suffer many immediate economic reverberations.

Not everyone is satisfied with the outcome, however. ASBMB Policy Blotter argues that even though cDNA is not a natural product, it is still obviously based upon natural products and thus should not be eligible for patents since they are not novel inventions. The fact that cDNA can still be patented, ASBMB writes, will hamper research:

The patents on the cDNA versions of BRCA1 and BRCA2 make important scientific tools unavailable to researchers and may slow progress in developing new tools for diagnosing heritable breast cancer.

The Times adds that companies can still patent particular methods for isolating genes or for “new applications of knowledge gained from genetic research.”

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