IP Australia Expands Genetic Material Seen Patent Ineligible

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By Murray Griffin

Jan. 20 — More types of genetic material are considered patent ineligible under an Australian Patent Office final policy interpreting the country's High Court ruling rejecting Myriad Genetic Inc.'s patents on isolated DNA.

IP Australia's final practice note released Dec. 15 expanded an interpretation the agency proposed last fall in response to the unanimous October 2015 High Court ruling that isolated nucleic acid sequences encoding the BRCA1 mutant polypeptide, which indicate an increased risk of breast or ovarian cancer, weren't patent-eligible subject matter.

The court held in D'Arcy v. Myriad Genetics Inc. that the substance of the invention was the information embodied in the nucleotides of the molecule and this was an inherent part of the molecule and not created by human action.

Karen Bentley, Sydney-based senior associate with Freehills Patent Attorneys, Jan. 20 told Bloomberg BNA by e-mail that IP Australia's new approach remains less broad than that taken by the U.S. Patent and Trademark Office. The U.S. PTO applied a 2013 U.S. Supreme Court ruling that Myriad's isolated DNA patents were patent ineligible to other naturally occurring materials such as proteins.

More DNA Types Ineligible

The new IP Australia practice note indicated that examiners will from now on object to all isolated or man-made DNA and nucleic acids that replicate the genetic information that exists in any human's or in any other organism's DNA blueprint or genome, whether the DNA is coding or non-coding.

That will encompass so-called junk DNA and regulatory DNA, as well as naturally occurring genes, according to the note, titled “Examination Practice following the High Court decision in D'Arcy v Myriad Genetics Inc.”

It marks an expansion on the scope of patent-ineligible genetic material proposed by IP Australia in its draft response to the court ruling, which focused only on isolated DNA and other forms of isolated or man-made genetic material coding for naturally occurring genes.

In particular, it drops an intention signaled in the draft response to treat naturally occurring isolated regulatory DNA and isolated junk DNA as patent eligible.

Not About ‘Gene Patenting’ Generally

The note cautioned that the High Court “made clear that it was not concerned with ‘gene patenting’ generally.”

“The majority did not deliberate about ‘products of nature' versus ‘artificially created products' but found that, in a case where the substance of the claimed invention was genetic information that was not ‘made,' the claiming of the alleged invention as an isolated product did not confer eligibility,” it said.

The practice note said that complementary DNA and synthetic nucleic acids, probes and primers and isolated interfering/inhibiting nucleic acids won't be deemed patentable if they merely replicate the genetic information of a naturally occurring organism.

However, these types of materials “may be patentable where the utility of the invention lies in genetic information that has been ‘made' (e.g. non-naturally occurring chimeric nucleic acid),” it said.

Different Approach

Bentley said the practice note confirmed that IP Australia would take a different approach from the U.S. PTO.

“There has been no suggestion in Australia that claims to, for example, proteins or chemicals isolated from nature would be patent ineligible,” Bentley said.

“Indeed, the IP Australia guidelines confirm that ‘isolation or purification can represent making or modification when the substance of a claim is properly directed to a chemical product,'” she said.

“Such subject matter may not be patent eligible in the U.S. if the isolated protein or chemical has the same characteristics as its naturally-occurring counterparts,” Bentley said.

To contact the reporter on this story: Murray Griffin in Melbourne at correspondents@bna.com

To contact the editor responsible for this story: Randy Kubetin at rkubetin@bna.com

For More Information

 

The final practice note and related materials are available at http://src.bna.com/b9h.

 

 

An outline of the draft approach is at http://src.bna.com/b9g.

 

 

Submissions made in response to the draft approach are at http://src.bna.com/b9f.