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Patent protection for DNA sequences – Part 1 – Myriad (USA)

September 2010 - Intellectual Property. Legal Developments by Hertin Anwaltssozietät .

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2010 may turn out to be a challenging year for applicants and attorneys in the field of biotech patents, especially when it comes to protecting or enforcing existing rights over your favourite stretch of DNA. Recent legal decisions on the patentability and enforceability of biotech patents have produced significant uncertainty regarding what kind of protection remains for product and method claims directed towards DNA sequences.

Importantly, these recent rulings touch upon the fundamental nature of DNA itself - as an information coding molecule - and the outcome that its coding nature may have on the validity and scope of nucleic acid molecule claims.

Isolated DNA - A ‘product of nature' or ‘made by man'?

Since the landmark Supreme Court ruling in Diamond v. Chakrabarty in 1980, patent claims directed towards ‘isolated DNA' have been common place; some estimate that approximately 20% of the human genome has now been ‘patented'.

However, in March 2010 a United States District Court issued a judgement in Association for Molecular Pathology v. USPTO that invalidated the Myriad Genetics' patents related to the BRCA 1 and 2 breast and ovarian cancer susceptibility genes (for an in depth analysis see Genomics Law Report).

Regarding the DNA sequence product claims it was ruled that patentable subject matter must be ‘markedly different' from a product of nature, which does not constitute patentable subject matter without a change that results in the creation of a fundamentally new product. The ‘purification' of a natural compound is also insufficient to render a product of nature patentable.

The ruling went on to state that:

"In light of DNA's unique qualities as a physical embodiment of information, none of the structural and functional differences cited by Myriad between native BRCA1/2 DNA and the isolated BRCA1/2 DNA claimed in the patents-in-suit render the claimed DNA ‘markedly different.' This conclusion is driven by the overriding importance of DNA's nucleotide sequence to both its natural biological function as well as the utility associated with DNA in its isolated form. The preservation of this defining characteristic of DNA [its information content] in its native and isolated forms mandates the conclusion that the challenged composition claims are directed to unpatentable products of nature."

Essentially the absence of change in the information content of the DNA molecules rendered the claimed isolated DNA molecules to be insufficiently modified from their natural state in order to constitute patentable subject matter.

Machine or Transformation

Regarding Myriad's process claims an equally strong stance was taken by following the "machine or transformation" test laid out by the Federal Circuit in Bilski v. Kappos. The Bilski requirement relates to a business method patent, but its logic can be applied to diagnostic methods. According to Bilski a method must be directly related to a particular machine, or transform a substance or product into a materially different state.

Such a requirement bodes ominously for advanced medical diagnostic techniques, especially those involving analysis and comparison of DNA sequences.

The court concluded that all the Myriad process claims (essentially for comparing patient DNA sequences to known mutant BRCA 1 and 2 sequences) failed the Federal Circuit's "machine or transformation" test for method claims, in that none of the methods were tied to any particular machine, nor did they bring about a tangible transformation of anything. The court ruled that because the claimed comparisons of DNA sequences are abstract mental processes, they also constitute unpatentable subject matter.

Supreme Court Bilski ruling sheds little light for Biotechnology

Interestingly, on appeal, the Supreme Court's take on the Bilski case in June 2010 provided no clear path forward for biotechnology, keeping its decision focused on the business method case at hand. However, doubt was cast as to whether the machine or transformation test should be applied as the sole criterion when assessing the patentability of ‘information age' technology.

Whether this has a significant impact on the Myriad case remains unclear, although the issue should certainly surface in the next round of arguments when the Myriad appeal makes its way to the Federal Circuit.

Information content a decisive factor?

This may all seem quite straightforward. However, the line of reasoning in the Myriad decision - that the information coding nature of DNA plays a significant role in its patentability - is new.

Since the patenting of DNA sequences began in the 1980s (see New England Journal of Medicine for review) attorneys have argued that DNA is just a chemical. The constant property of information content (before and after purification) has been avoided in order to demonstrate that, once isolated away from its natural environment of the cell, isolated DNA is materially transformed.

The Myriad case casts new light on this argument, ruling essentially that the information content of DNA is precisely what renders its isolation insubstantial in determining whether isolated DNA is indeed materially transformed and as such ‘made by man'. What this means exactly for the validity of patents directed towards isolated DNA remains unclear, at least until the Myriad appeal to the Federal Circuit has been heard.

 


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