News from Abroad: Myriad Patent Upheld by Full Federal Court of Australia

By Claire Gregg* and Martin O'Brien** --

The Full Federal Court of Australia has handed down its long awaited decision in D'Arcy v Myriad Genetics Inc today, affirming that isolated DNA and RNA are patentable subject matter under Australian law.

The first instance decision of Nicholas J was appealed to the Full Federal Court on the grounds that the earlier Federal Court decision erred in its conclusion that isolating a gene is sufficient to render it a manner of manufacture.  We refer you to our article of 15 February 2013 for a more detailed discussion of the first instance Federal Court decision.

Under Australian law, s 18(1)(a) of the Patents Act 1990 requires that, in order to constitute patentable subject matter, the claimed invention must be 'a manner of manufacture within the meaning of section 6 of the Statute of Monopolies'.  The meaning of 'manner of manufacture'was broadly construed by the High Court of Australia in National Research Development Corporation v Commissioner of Patents (NRDC), which held that a claim directed to a product found in nature may constitute a manner of manufacture provided that the claimed product involves an artificially created state of affairs and has utility in a field of economic significance.

In view of the principles laid down in NRDC, the Full Federal Court unanimously upheld the decision of Nicholas J, emphasizing that '[t]his case is not about the wisdom of the patent system.  It is about the application of Australian patent law, as set out in the Act and as developed by the courts since the Statute of Monopolies'.

The Court went on to note that it is not the role of the courts to decide 'whether, for policy or moral or social reasons, patents for gene sequences should be excluded from patentability', re-iterating that the Australian Parliament has previously considered such questions and chosen not to exclude gene sequences from patentability.

The Court concluded that an isolated gene sequence is different to the gene as it exists in nature, with specific reference to the functional differences that arise as a result of isolation.  The Court further rejected the view of the U.S. Supreme Court that Myriad's claims are concerned 'primarily with the information contained in the genetic sequence'.  Rather, the Full Court emphasized that the claim in question 'is to a compound; a nucleic acid.  It is not a claim to information'.

The Full Court's decision that the isolated nucleic acid in question has 'resulted in an artificially created state of affairs for economic benefit' and is therefore capable of defining patentable subject matter, has maintained the status quo in Australia in relation to the patentability of isolated gene sequences.  However, the possibility of an application for Special Leave to Appeal to the High Court still exists, and thus it may be some time before this matter is finally put to rest in Australia.

The decision of the Full Federal Court of Australia can be found here.

* Dr. Gregg is a Patent Scientist with the Chemical / Life Sciences Team of Spruson & Ferguson in Sydney, Australia.

** Dr. O'Brien is a Principal / Patent Attorney with the Chemical / Life Sciences Team of Spruson & Ferguson in Sydney, Australia.

Comments

[Dan Feigelson]

"Rather, the Full Court emphasized that the claim in question 'is to a compound; a nucleic acid. It is not a claim to information'."

It's refreshing that at least one court out there understands the basics of patent law. Any chance these judges can come stateside to give SCOTUS a tutorial?

[Paul Cole]

@ Dan

Where in the BRCA1 patent does it say that the full length gene was in fact isolated as a discrete molecule? What procedures were used to fragment and cut the chromosomal DNA to give just the BRCA1 full-length sequence?

It has been said that the ruling in a case is based on the facts as found by the court. In US and in Australia the court found different facts.

[Moocow]

Paul - you're asking a good question. The patent describes a process of manipulating yeast and bacteria into reproducing overlapping fragments of DNA, sequencing these cloned fragments, aligning the sequence information in a computer, thereby generating a computer representation of the human BRCA gene. So, the gene was cloned piecemeal in the laboratory and then assembled only in a computer; it was never extracted as a discrete unit from a human chromosome.

The ACLU's favorite metaphors, on the other hand, very deliberately relied on misleading notions of extraction or mining. "Gold plucked from a riverbed " and "kidneys cut from a human body," and a "BRCA gene "snipped" out of a person's chromosome." The better metaphor, perhaps, would have been a cloned kidney and synthetic gold, but that wouldn't have helped their case as much.
In any event, they got the U.S. judges to worry about patents on natural elements and extracted human body parts and other ghoulish things that nobody ever could or would want to patent. This really helped them get favorable rulings, but was pretty far from reality. Unfortunately, Justice Thomas's careless talk of "longstanding rules against patents on naturally-occurring things" then directly and predictably led to rampant rejections now in the USPTO of patent applications on vaccines, industrial enzymes, drug substances and other things having nothing to do with genes and diagnostics.