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DNA sequence patents … a sigh of relief

September 2011 - Intellectual Property. Legal Developments by Norrbom Vinding Law Firm, member of ius laboris.

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The US Court of Appeals has ruled that isolated DNA sequences are patentable. But the issue will most likely only be finally determined when the US Supreme Court has ruled.
Isolated human DNA sequences have long been patentable in both the US and Europe. An isolated DNA sequence (a gene) is one that has been removed from the human organism.
A number of human rights organisations are fundamentally opposed to this because, in their opinion, this corresponds to patenting parts of the human body. They therefore sued a US company which had patented the DNA sequences BRCA1 and BRCA2, which are believed to be associated with the occurrence of breast and ovarian cancer in women.
Not a product of nature
The plaintiffs succeeded in convincing the first instance judge. He believed that patents on isolated DNA sequences in reality patent something which exists naturally in the human body. He therefore ruled the BRCA1 and BRCA2 patents invalid.
The patent holder appealed the case to the United States Court of Appeals for the Federal Circuit, which is the court which hears all patent appeals in the US.
The Court did not agree with the first instance judge. The Court noted in its judgment that the molecules – that is, the invention of the patent – in an isolated DNA sequence do indeed differ from the corresponding molecules such as they are found in nature.
The Court also dissociated itself from the position taken by the US Administration when it intervened in the case as a friend of the court. The US Administration’s position was that the practice of the US patent authorities had been too relaxed. According to the US Administration, patents should only be available on isolated DNA sequences that are the product of human action such as genetic engineering – not on isolated DNA sequences which are the result of evolution.
An appeal to the US Supreme Court is expected.
Norrbom Vinding notes:
  • that the ruling has been awaited with baited breath in the global biotech industry, where the future chances of attracting investment very much depend on the degree to which as many research results as possible can be patented in the US; and

  • that the Court of Appeal also considered a number of method claims in the patents at issue, ruling some claims concerning ‘analysis and comparison of DNA sequences’ invalid because they only represented an abstract mental process and therefore were not of a technical nature.
The above does not constitute legal advice and should not be relied upon as such

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