D'Arcy v Myriad Genetics Inc

What happened?

Myriad held a patent whose claims 1 to 3 were expressed as product claims to isolated nucleic acid coding for all or part of a mutant or polymorphic BRCA1 polypeptide — a sequence associated with breast and ovarian cancer risk. D'Arcy challenged the claims on the ground that they were not a "manner of manufacture" under s 18(1)(a) of the Patents Act 1990 (Cth). She succeeded neither at first instance nor in the Full Court of the Federal Court.

What did the Court decide?

The appeal was allowed: claims 1 to 3 did not meet s 18(1)(a) ([95]).

The Court began by characterising what was claimed rather than how it was expressed. The claims were "formally expressed as product claims", and the Court looked past that form to what they were claims to ([6]). D'Arcy invoked the United States Supreme Court's description of the claims before it — that they were "not expressed in terms of chemical composition", did not rely "on the chemical changes that result from the isolation of a particular section of DNA", and instead "focus on the genetic information encoded in the BRCA1 and BRCA2 genes" — and submitted that the chemical, structural and functional differences Myriad relied on played no part in the definition of the invention as claimed here ([90]). The Australian claims in issue concerned BRCA1.

The conclusion follows from that characterisation, and its terms are careful. Bringing this class of claim inside "manner of manufacture" would extend the concept rather than apply it, and the Court held that the extension was one for Parliament and not for it, and would not contribute to coherence in the law ([94]).

Note what the Court did not say. This is not a holding that isolating a natural substance can never be patentable, nor that "natural" and "artificial" is the governing line. It is a holding about these claims, whose substance was genetic information.

Why does this case matter?

Because the requirement bit, and bit here. Manner of manufacture is usually argued about computer-implemented inventions, and it is easy to treat it as a niche objection with a settled answer everywhere else. A patent over an isolated human gene sequence, granted, upheld at first instance and upheld again by a Full Court, failed on it.

It is also a case that shows how consequences enter a subject-matter argument. The Court was not indifferent to policy — it weighed the chilling effect on innovation and the breadth of the monopoly a claim of this kind would confer ([8], [93]) — and it did not disclaim incremental judicial development of the concept, which it treated as proper ([5], [23]–[25]). What it declined was this particular extension, on this class of claim, for those reasons. So when you argue that a boundary should or should not move, argue the consequences of moving it here, rather than in the abstract.

Exam and application relevance

Characterise the claim before you test it. Ask what the substance of what is claimed actually is, not what the applicant did to get there, and not what the claim is formally labelled. An inventive process producing a natural product may support a claim to the process and still fail on the product.

Keep the requirements separate, and state them correctly. Manner of manufacture (s 18(1)(a)) asks what is being claimed. Novelty (s 18(1)(b)(i), s 7(1)) asks whether the invention is anticipated by the prior art base. Inventive step (s 18(1)(b)(ii), s 7(2)–(3)) asks whether it would have been obvious to a person skilled in the relevant art in the light of common general knowledge and specified prior art information. None of the three measures how much effort was expended, and an answer that treats "they worked very hard" as an argument has not engaged with any of them.

Finally, keep the holding narrow. Myriad is authority about claims whose substance is genetic information; do not run it as a general rule that isolating anything natural is unpatentable.

Check your understanding

Your client's claim is to a purified compound found in a plant, and the purification took a decade. Which requirement does the decade go to, and which does it not touch?