In Life Sciences SpotlightIssue 5, we discussed the then current state of the law regarding the patentability of isolated genetic material and other naturally occurring products in the US and Australia, and the impact of those decisions.

As discussed in detail in that article, at that time:

  • The US Supreme court had held that isolated genetic material was not patent eligible under US law, and US courts and the US Patent and Trademark Office (USPTO) had been consistently extending that decision to hold  claims directed to other naturally occurring products, such as proteins and cells, as well as claims to methods utilising those products, to also be patent ineligible under US law.
  • Australian law stood in stark contrast, with an expanded 5 judge appeal court unanimously affirming a lower court decision and confirming long held understanding and Australian patent office practice that isolated genetic material was patentable subject matter in Australia.

Since that article, there have been significant developments in each jurisdiction. In Australia, the high court of Australia (Australia’s highest court – high court) recently overturned  the decision of the expanded appeals court referred to above and held that the claims-in-suit to isolated genetic material did not claim patentable subject matter under Australian law, and the Australian patent office has since issued for comment details of its proposed revised examination practice following that decision. In the US, the US court of Appeals for the Federal circuit (cAFc) recently held that a patent directed    to a method for detecting a paternally inherited nucleic acid sequence of fetal origin (cell-free fetal dnA (cffdnA)) in maternal serum or plasma from a pregnant woman is invalid and ineligible for patent protection. In this article, we discuss the high court’s decision in Australia and its implications in more detail and on pages 15 – 16, dr. Lisa haile discusses the cAFc’s decision and its implications.

THE HIGH COURT OF AUSTRALIA – D’ARCY v MYRIAD

In D’Arcy v Myriad Genetics Inc [2015] hcA 35 (D’Arcy v Myriad) the high court unanimously held1 that the claims-in-suit to isolated nucleic acids coding for mutations or polymorphisms of the BRCAI gene2, do not meet the requirements of a “manner of manufacture” within the meaning of the Patents Act 1990 (cth) (Act) and are therefore not a patentable invention in Australia.

The high court’s decision overturned Justice nicholas’ decision at first instance, and a unanimous decision of an expanded bench of five judges of the Full Federal court of Australia. The earlier decisions had held that the claimed isolated nucleic acid sequences in question were indeed “manners of manufacture” on the basis that they were an “artificially created state of affairs of economic significance”, following the criteria identified in the longstanding high court authority on patentable subject matter in Australia, National Research Development Corporation v Commissioner of Patents (1959) 102 cLR 252 (NRDC), and that an invention that satisfies these criteria will constitute a “manner of manufacture.”

In D’Arcy v Myriad, the majority of the high court rejected the primary judge and the Full court’s application of the principles propounded in NRDC, stating that they rested upon an unduly narrow characterisation of the effect of that decision, and that the terminology “artificially created state of affairs of economic significance” is not a formula, the satisfaction of which will mandate a finding of inherent patentability.

The majority held that the lower courts had asked the wrong question:

“The question for… determination… was not whether a claimed invention, prima facie patentable, should be denied patentability by judicial fiat. The question was whether the claimed invention lay within the established concept of a manner of manufacture and, if not, whether it should nevertheless be included in the class of patentable inventions as defined in s 18(1)(a) of the Act.”

The majority then held that, properly characterised in accordance with substance rather than formthe subject matter of myriad’s claims was to the “genetic information” of the nucleotide sequences which coded for mutated or polymorphic BRcA1 polypeptides, rather than to classes of chemical compounds. Based on this construction, their honours held the claims in issue were not within the established boundaries of the concept of a “manner of manufacture” as developed through case law.

The majority further held that where such a new class of claim involves a significant new application or extension of the concept of “manner of manufacture”, the following factors, including those derived from the NRDC decision (being the first two factors listed below), may be relevant to determining whether that concept should be extended by judicial decision to include that class of claim, including:-

  1. Whether the invention as claimed is for a product made, or a process producing an outcome as a result of human action.
  2. Whether the invention as claimed has economic utility.3
  3. Whether patentability would be consistent with the purposes of the Act; in particular:
  • Whether the claimed invention could give rise to a  large new field of monopoly protection with potentially negative effects on innovation;
  • Whether the claimed invention could have chilling effects on activities beyond those within the formal scope of the claims; and
  • Whether according patentability would require the court to assess important and conflicting public and private interests and purposes.
  1. Whether according patentability to the claimed invention would enhance or detract from coherence of the law relating to inherent patentability.
  2. Factors relevant to Australia’s place in the international community:
  • Australia’s international legal obligations; and
  • The patent laws of other  countries.
  1. Whether according patentability would involve law-making of a kind which should be done by the legislature.

The majority held with respect to the first factor that the genetic information was not modified by mere isolation and was not “made” by human action:

“The information is not “made” by human action. It is discerned. That feature of the claims raises a question about how they fit within the concept of a “manner of manufacture.” “As appears from s 6 of the Statute of Monopolies, an invention is something which involves “making”... Whatever it is, it must be something brought about by human action. The requirement, in each claim, that the sequence in the isolate bear specified mutations or polymorphisms raises the same problem in a particular way. Satisfaction of that integer depends upon a characteristic of the human being from whom the nucleic acid is isolated, a characteristic which is not shared by all human beings. It has nothing to do with the person who isolates the nucleic acid bearing the mutant sequence.”

and

“[T]he fact of the existence of the requisite mutations or polymorphisms is a matter of chance. It is not something “made.” It is not “artificially created.”

As to the second factor, the majority can be understood to have considered that this factor was also not satisfied by the claims as the isolated genetic sequence (which is not sold  and therefore does not have a direct economic benefit) is  but a step in the process in which the economic significance resides, the genetic screening test:

“The economic significance necessary to the patentability of an ‘artificially created state of affairs’ in the sense used in NRDC is not demonstrated by stating that the artificially created state of affairs is a step along the way to a process or method itself claimed as an artificially created state of affairs of economic significance.”

The majority held that the above wider considerations also militated against characterising the claimed invention as a “manner of manufacture.” The majority stated:

“Claims 1 to 3 include the products of applying any process, known or unknown, to the cells of a human being which extracts or replicates from them nucleotides which code for mutant or polymorphic BRCA1 in the sequences specified in the Patent, whether or not the isolate contains other components and sequences. The size of the class of the products as defined is large… The boundaries of the class are not defined by a limiting range of chemical formulae. There is a real risk that the chilling effect of the claims, on the use of any isolation process in relation to the BRCA1 gene, would lead to the creation of an exorbitant and unwarranted de facto monopoly on all methods of isolating nucleic acids containing the sequences coding for the BRCA1 protein. The infringement of the formal monopoly would not be ascertainable until the mutations and polymorphisms were detected. Such a result would be at odds with the purposes of the patent system.”

and also:

“[if the] claims are properly the subject of a patent, the patent could be infringed without the infringer being aware of that fact. That consequence coupled with the very large, indeed unquantified size of the relevant class of isolated nucleic acids, all of which bear the requisite information, raises the risk of a chilling effect upon legitimate innovative activity outside the formal boundaries of the monopoly and risks creating a penumbral de facto monopoly impeding the activities of legitimate improvers and inventors.”

Factor 6 also played an important role in the majority’s analysis:

“The proposition that a broad statutory concept [manner of manufacture] applies to a new class of case on the boundaries of existing judicial development of that concept requires consideration of the limits of judicial law-making... Where an affirmative application of the concept is likely to result in the creation of important rights as against the world, to involve far-reaching questions of public policy and to affect the balance of important conflicting interests, the question must be asked whether that application is best left for legislative determination. The patentability of nucleotide sequences derived from human DNA is in that category. The inherent patentability of the invention as claimed would powerfully imply patentability of any claim for an isolated nucleic acid coding for a specified polypeptide.”

and its ultimate conclusion:

“The substance of the invention as claimed and the considerations flowing from its substance militate against that characterisation. To include it within the scope of a “manner of manufacture” involves an extension of that concept, which is not appropriate for judicial determination.”

However, in assessing the impact of the high court’s decision,  it is important to note that the patentability of the other claims of the patent-in-suit, directed to probes, vectors, methods of production, and methods of diagnosis, had not been challenged in the litigation. Thus, the high court did not make any finding with respect to those claims.

AUSTRALIAN PATENT OFFICE’S PROPOSED REVISED EXAMINATION PRACTICE

On 16 October 2015, the Australian Patent Office published for consultation its proposed revised examination practice in view of the D’Arcy v Myriad decision. Unlike the several guidances issued by the USPTO following the US Supreme court’s Myriad decision, which adopted an expansive interpretation of that and subsequent decisions (see the detailed discussion of both these decisions and the USPTO guidances in our earlier article), the Australian patent office has proposed a narrow interpretation of the D’Arcy v Myriad decision, stating that that decision concluded that a claim to an isolated nucleic acid that merely represents information coding for a polypeptide is not patent eligible, and that on that basis, it considers the following are not patent eligible in Australia:

  • Naturally occurring human and non-human nucleic acid sequences encoding polypeptides or functional fragments thereof – either isolated or synthesised;
  • cDNA;
  • Naturally occurring human and non-human coding RNA – either isolated or synthesised.

The Australian Patent Office proposal further indicates that it will continue to treat claims directed to the following as patent eligible as “they do not merely represent information coding for a polypeptide”;

  • Naturally occurring isolated regulatory DNA (e.g. promoters, enhancers, inhibitors, intergenic DNA);
  • Isolated non-coding (e.g. “Junk”) dnA and RnA (e.g. miRnA);
  • Naturally occurring isolated bacteria and  viruses;
  • Isolated polypeptides and synthesised/modified polypeptides;
  • Isolated polyclonal antibodies and monoclonal antibodies;
  • Chemical molecules purified from natural sources (e.g. new chemical entities, antibiotics, small molecules);
  • Isolated cells including isolated stem cells;
  • Probes and primers;
  • Isolated interfering/inhibitory nucleic acids (e.g. antisense, ribozymes) and fusion/chimeric nucleic acids; and
  • Transgenes comprising naturally occurring gene sequences and vectors, microorganisms, animals, and plants comprising a transgene.

Comment was sought by 6 november 2015. The Australian Patent Office is currently considering these comments before finalising examination practice and has placed on hold the examination of patent applications containing claims directed to technology that could be impacted by the D’Arcy v Myriad decision until patent office practice is settled.

CONCLUSION

The majority’s decision in D’Arcy v Myriad suggests that the high court’s decision is a narrow one, the majority explicitly stating:

“This court is not concerned in this appeal with ‘gene patenting’ generally but whether the invention as claimed in claims 1 to 3 falls within the established concept of manner of manufacture.”

The proposed examination practice issued for comment by the Australian patent office in light of that decision indicates that the patent office intends to apply that decision reasonably narrowly. It thus appears that Australia will not head down the path adopted by US courts and the USPTO (discussed in our earlier article and in the below counterpart article in this edition, where broad areas of technology have been deemed patent ineligible. The Australian legal environment thus remains one conducive to research and development, and investment, in the Australian biotechnology industry.