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29 Mar 12
BRCA gene patents - hold the Mayo

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Our patent law expert, Dr Amanda McBratney discusses the latest development in the US gene patent litigation, Association for Molecular Pathology v Myriad Genetics Inc.

Current status

On 26 March, the US Supreme Court handed down a short summary disposition as the latest instalment in a long-running case that questions whether human genes can be patented. The Court simply vacated the 2011 decision by the Court of Appeals for the Federal Circuit (CAFC), which upheld Myriad Genetics Inc's (Myriad) patents relating to the BRCA genes, and sent the case back down to the CAFC for rehearing in light of a Supreme Court case on patenting laws of nature, handed down just six days earlier (Mayo Collaborative Services v Prometheus Laboratories, 10-1150) (Mayo).

Background

In 2009, the Association for Molecular Pathology together with many others filed suit against Myriad, the US Patent Office, and others, seeking to overturn 15 claims in seven of Myriad’s patents. The patents at issue relate to both process claims (method for detecting increased risk of breast cancer) and composition-of-matter claims (the BRCA1 and BRCA2 isolated genes).

In 2010, Judge Sweet in the US District Court (SDNY) held that both the genes and methods were not patentable. In relation to the genes, they were not ‘markedly different’ to naturally occurring genes. Myriad’s argument that the technique of purifying the genes rendered the compounds patent-eligible was rejected. Judge Sweet noted the dual nature of genes as both compositions of matter and carriers of information. The fact that, even after the purification process, the information provided by the genes remained the same meant that they were unpatentable products of nature.

As for the method claims, Judge Sweet relied on a ‘machine or transfer’ (MOT) test developed in an earlier CAFC decision (Bilski v Kappos) to conclude that the claims to the process of analysis or comparison in the technique were no more than ‘abstract mental processes’. However, the Supreme Court later qualified the CAFC opinion, leaving this aspect of Judge Sweet’s opinion particularly vulnerable to appeal.

Unsurprisingly Myriad appealed, and last year the CAFC overturned parts of the first instance decision, finding that because isolated DNA had been ‘cleaved’ (covalent bonds in its backbone chemically severed) it was rendered a different molecule, just a fraction of a native DNA molecule, and thus patentable. However, on the method claims the CAFC largely upheld the prior decision, invalidating all claims except one on the basis that they were merely abstract mental processes. The surviving method claim was directed to a method for screening potential cancer therapies. This claim included a transformative step, satisfying the MOT test.

Where to now?

Speculation has now turned to exactly how much guidance the Mayo case can provide for the CAFC, given that it deals with process patenting, rather than compositions of matter. In Mayo, the Supreme Court found that a process for determining dosages for a person with auto-immune disease was unpatentable. The relationship between certain concentrations of metabolites in a patient’s blood and the likelihood of under or over-dosing were merely laws of nature.

Accordingly, the claimed processes were unpatentable unless they contained steps that genuinely applied the laws of nature, rather than merely constituting an attempt to monopolise the natural correlation itself. The additional steps in the claims did not transform an unpatentable law of nature into a patent-eligible application.

Myriad will now have to wait for the CAFC to consider and apply the ramifications of Mayo, and decide on the composition of matter issue – probably late 2012 or 2013. For this reason, some analysists are predicting the CAFC may well uphold Myriad’s composition claims. In any event, Myriad has a suite of other patents protecting its BRACAnalysis technique which would likely deter others from its use, at least in the short term. So Myriad remains bullish on the issue, stating that it will ‘vigorously defend’ its claims because of their ‘great importance to the medical, pharmaceutical, biotechnology and other commercial industries’.  Its share price has dipped only slightly.

In Australia, a similar case was filed against Myriad’s Australian patent, with hearing dates set in mid-February. While US and Australian patent laws vary, no doubt the Australian courts will be looking closely at the US developments. So for now, on this hotly contentious issue, it’s currently a matter of ‘watch this space …’ 

The intellectual property team at McCullough Robertson will keep you posted on future developments.

 

Focus covers legal and technical issues in a general way. It is not designed to express opinions on specific cases. Focus is intended for information purposes only and should not be regarded as legal advice. Further advice should be obtained before taking action on any issue dealt with in this publication.

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