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As biotechnology patents continue to grow in importance, uncertainty remains on both sides of the Altantic as to exactly what is patentable. Simon O’Brien and David Gass take a look.

A market is developing for the application of biomarker assays as clinical diagnostics. Moreover, at a time when the number of prospective blockbuster drugs is dwindling, pharmaceutical companies are investing heavily in the potential benefits of targeted medicine—such as delivering specific treatments to specific patient populations whose genetic profile may make them more receptive to particular treatments.

While there has been a pronounced downturn in the number of biotechnology patent applications in industrialised countries since 2002, possibly due to the declining number of new human genes to be identified since the Human Genome Project, patent filings for cancer diagnostics have apparently shown very little decline since 2001. Indeed, patent activity in the biotechnology area is becoming increasingly focused on diagnostic uses of genetic information.

One of the most important and sweeping challenges with biomarker-based therapies and diagnostics is how to develop intellectual property policies that will bring opportunity and entrepreneurship in balance with meeting unmet market needs and clinical value. Te challenges were emphasised by Alan Greenspan, the former Chairman of the Federal Reserve, who noted that “arguably the single most important economic decision our lawmakers and courts will face in the next 25 years is to clarify the rules of intellectual property”.

Gene and diagnostic patents in the US

Myriad Genetics is the owner or exclusive licensee of a series of patents claiming isolated DNA molecules (related to the genes known as BRCA1 and BRCA2) and methods for testing for the presence of mutations in these genes. Seven US patents had claims that sought protection for: isolated DNA containing all or portions of the BRCA1 and BRCA2 gene sequences, and methods for ‘comparing’ or ‘analysing’ BRCA1 and BRCA2 gene sequences to identify the presence of mutations correlating with a predisposition to breast or ovarian cancer.

Te US patent law provides that, subject to meeting other patentability requirements: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor....” For several decades, the US Supreme Court has construed this provision broadly: while laws of nature, physical phenomena and abstract ideas are not patentable, “anything under the sun that is made by man” is patentable. Te Patent and Trademark Office (USPTO) and lower federal courts have interpreted the law to mean that genes that have been isolated by man from their natural environment (isolated nucleic acids) are patent-eligible, and have issued or sustained the validity of many such patents.

Tis long-standing practice was called into question by a declaratory judgment challenge to the validity of selected claims in Myriad’s BRCA gene and diagnostic patents brought by several parties, including researchers who purportedly wanted to perform the patented genetic tests in their laboratories; various individuals, some of whom were breast cancer sufferers or survivors; as well as political and medical organisations.

On March 29, 2010, the US District Court for the Southern District of New York issued a decision in Association for Molecular Pathology v U.S. Patent & Trademark Office (Myriad) in which the patent claims at issue were declared invalid under 35 USC 101.

Patentability of isolated DNA

On motion for summary judgment, the US District Court decided that the claims to the isolated BRCA genes were not patentable because the claims encompass “products of nature”. Te court reasoned that, to be patentable, a purified product must posses “markedly different characteristics” from the naturally occurring product.

Te court concluded that the isolated DNA did not possess the requisite “markedly different characteristics”.

Te court did not decide how much a patent applicant needs to have changed isolated DNA from the DNA that exists in nature in order to

Life Sciences Intellectual Property Review 2011


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