Patentability eligibility of gene: isolated gene is patentable in Australia

While Myriad’s breast cancer gene patents were challenged in US, they were also challenged in Australia.  However, before the US Supreme Court declared isolated gene as non-patentable subject matter in AMP v. Myriad on June 13, 2013, an Australian federal court reached the opposite decision holding that the isolated gene is patentable in Australia on February 15, 2013.

 

The case Cancer Voices Australia v Myriad Inc was the Australian version of AMP v Myriad.  Similar to the case in US, the validity of Myriad’s patents including claims for isolated DNA and RNA were challenged.  The question that was considered by the court is:

-        whether claims to composition comprising naturally occurring DNA and RNA that has been isolated are for a manner of manufacture for purposes of s 18(1)(a) of Patents Act 1990 (Cth);

-        when isolated DNAs and RNAs have been extracted from cells removed from human body and purged of other biological material with which it is associated in the cell, whether the isolation of these naturally occurring DNA and RNA results in an artificial state of affairs with a discernible effect;

-        whether claims to isolated DNA and RNA are to a “mere discovery” and therefore not patentable; and

-        whether claims to isolated DNA and RNA are to a “product of nature” and therefore not patentable .

On a judgment issued on February 13, 2013, Judge Nicholas J from the Federal Court of Australia held that each of challenged claims is to a manner of manufacture and therefore satisfies the  requirements of s 18(1)(a) of Patents Act 1990 (Cth). 

 

So what’s the take away? Don’t give up your gene patents in Australia yet.

Thanks for reading.

Connie

cwan@patentonomy.com