Can genes be Patentable?

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Could someone own my genes? Can the genes of living humans be patented? And what would be the consequence of gene patents? Many of us wonder about these questions.

Patents are generally granted for invention that is either a product or process and that should be new (or ‘novel’); involve an inventive step (or ‘not obvious’); and capable of industrial application (or have ‘utility’, or be ‘useful’). The patent system rewards the inventor and companies by granting exclusive rights over the intellectual creativity that is the ‘invention’.

The scope of patent system has been expanded to accommodate fast evolving technologies. However, the field of biotechnology pose greatest challenge for patent regime where a clear distinction between patentable inventions and unpatentable discoveries is blurred. Biotechnological inventions revolve around living material which is a product of nature.

In US, a gene patent can be granted for a claim on an isolated nucleic acid that is a fragment of DNA or RNA sequence, or gene chips and microarrays, or diagnostic kit tests or for a method of diagnosing a genetic condition, or a method of identifying the existence of a specific DNA or RNA sequence in an individual. Isolated nucleic acid includes both coding and non-coding DNA. So, a patent can be granted for a stretch of gene sequence responsible for a predisposition to a genetic disorder.

According to a 2007 study, nearly 20% of human genes are explicitly claimed in some way in US patents.  This represents 4382 of the 23,688 of genes in the NCBI’s gene database. Similarly large proportion of the human genome is the subject of patent claims at EPO.

The flurry of human gene patenting sparked a furious debate in legal, political, health, and philosophical circles. Since the practice of gene patent began in 1990, questions have been raised in these circles whether or not it’s in the public’s best interest.

There is a generalized and amorphous public opposition to the concept of gene ownership.  Patents on human genes will result in a lack of respect for human life and a devaluation of human dignity. It would restrict free flow of scientific information.

Arguments for gene patent are that, patent protection is critical to honor the interests of investors & Venture Capitalists, who invest in a small biotech companies. These investments in turn translate into more research and health care benefits.

However an important case that began back in 2009 has questioned the practice of gene patents that has broad practical, clinical and ethical consequences for the future of gene-patents.

The Myriad Genetics Case

Myriad Genetics, a US company was granted patents for two human genes: BRCA1 on chromosome number 17 and BRCA2 on chromosome number 13, two genes predisposing to breast and ovarian cancers, were isolated in 1994 and 1995, respectively. Mutations, in particular those arising at a young age in these two genes cause serious disruption to the open reading frame of the transcriptional unit and are linked to an increased risk of breast and ovarian cancer.  Women with specific genetic mutations in these two genes are estimated to have up to an 85 percent risk for breast cancer and 50 percent risk for ovarian cancer.  The patent legally entitled Myriad Genetics for the life of the patent to exclude all others from using these genes in breast & ovarian cancer research, diagnostics, and further treatment.

In May 2009, the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) filed a lawsuit in the Federal District Court for seeking to overturn the Myriad Genetics patents on BRCA1 and BRCA2. The suit charges that the patents stifle diagnostic testing and research that could lead to cures and that they limit women’s options regarding their medical care.

The lawsuit was filed on behalf of researchers, genetic counselors  women patients, cancer survivors, breast cancer and women’s health groups, and scientists (the plaintiffs). The lawsuit was filed against the U.S. Patent and Trademark Office, as well as Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the genes, BRCA1 and BRCA2. The lawsuit charges that patents on human genes violate the First Amendment and patent law because genes are “products of nature” and therefore can’t be patented.

In 2010, a New York federal judge ruled that the patents on the BRCA1 and BRCA2 genes are invalid. But in 2011, the appeals court ruled that companies can obtain patents on the genes but cannot patent methods to compare those gene sequences.

In March 2012, the U.S. Supreme Court threw out that decision of the appeals and  instructed the lower courts for rehearing the case in light of Mayo v. Prometheus, a Supreme Court decision invalidating patents on tests that could help doctors set drug doses for autoimmune diseases, stating that the laws of nature are unpatentable.

But in August 2012, the federal circuit upheld Myriad’s patents again, saying that companies can obtain patents on the genes, but invalidated patents on methods to compare gene sequences.

In September 2012, the plaintiffs again asked the Supreme Court to rule on the patentability of genes.

In November 2012, the Supreme Court agreed to hear argument on whether companies can patent human genes. The decision is expected sometime this year.

Implication of Myriad Genetics Case on future of personalized medicine

Many gene patents have been granted world over and many of these patents claim gene sequences. Those investigating genetic testing should thoroughly analyse the patent landscape of that particular chromosomal unit to understand the scope of freedom to operate. Gene patents, unlike patents in most other technical areas, are difficult to invent around. Even if it is possible to invent around a gene patent, it may be very costly, time consuming to do so.

Again, for a complex genetic disorder many different mutations in many different genes are required to be tested. The transaction costs of investigating the patent landscape, including identifying relevant patents, determining whether the investigation in question falls within the claims, and then negotiating necessary licences, or defending infringement proceedings, becomes too expensive.

In Myriad genetics case, Chris Hansen, staff attorney of the ACLU said, “It’s wrong to think that something as naturally occurring as DNA can be patented by a single company that limits scientific research and the free exchange of ideas”.

It creates a difficult situation if a single laboratory could use its patents to control most of the data about a gene especially when that gene affects life of many.

The discovery and development of pioneering diagnostics and therapeutics require a huge investment and patents provide access to commercial funding in the absence of institutional, charitable or government support. But broad claims on gene patents could have a damaging effect on the conversion of basic biomedical research into clinical application.

David Koepsell, author of  ‘Who Owns You: The Corporate Gold Rush to Patent Your Genes’, discusses practice of gene patenting and develops arguments regarding moral realism. He states biotech companies and corporations should compete with the actual values of their products.

Biotechnology companies, universities, and laboratories, could develop and patent new tests, therapies, diagnostic methods, methods of isolating genes, drugs, and other inventions based on genetic information and sequencing but broad claims on gene pose serious concerns.

Myriad genetics case could have broad practical, medical and ethical consequences for the future of personalized gene-based medicine for millions of people worldwide.

Picture Courtesy: Google Pictures

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One Response so far.

  1. WONDERFUL Post.thanks for share..more wait .. …

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