Apotex v Sanofi

The High Court has upheld the patentability of methods of medical treatment.

High Court’s summary

Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50

Analysis to follow (once digested)

Myriad wins Down Under

Nicholas J has ruled that Myriad’s patent for isolated gene sequences relating to BRCA1 are patentable subject matter for the purposes of Australia’s Patents Act 1990.

Claim 1 of the Patent (No. 686004 entitled “In vivo mutations and polymorphisms in the 17q-linked breast and ovarian cancer susceptibility gene”) is for:

An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:l one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19.

At [70], Nicholas J explained the scope of this claim:

Claim 1 extends to isolated DNA, RNA and cDNA that has a BRCA1 polypeptide encoding sequence as shown in SEQ ID No.1 with one or more of the mutations or polymorphisms specified in the relevant tables.

To qualify as patentable subject matter in Australia s 18(1)(a) prescribes that the claimed invention must be a “manner of manufacture”.

This term, much to the chagrin of modernising law reformers, derives from s 6 of the Statute of Monopolies 1623. In the “watershed” NRDC ruling in 1959, Dixon CJ, Kitto and Windeyer JJ declared that the meaning of “manner of manufacture” is not to be derived as a matter of mere etymology. Rather it poses a question:

“Is this a proper subject of letters patent according to the principles which have been developed for the application of s. 6 of the Statute of Monopolies?”

and in answering that question, it must be recognised that the concept has a “broad sweep” intended to encourage developments that are by their nature unpredictable. Hence, their Honours indicated the processes at issue in that case were patentable subject matter because they led to, or resulted in, an artificially created state of affairs, that had some discernible effect, which had economic significance.  A very teleological approach from the supposed patron saints of strict legalism!

Nicholas J found that the isolated gene sequences claimed in Myriad’s patent were an artificially created state of affairs having economic significance.

His Honour at [105] rejected Myriad’s first line of defence claiming that there was a change in chemical structure simply by the process of isolating the gene sequence. Rather, more generally, the nucleic acid or gene sequence in its isolated form was sufficient to qualify as an artificially created state of affairs:

First, the concept of patentable subject matter is expressed in very expansive language.

Secondly, at [108] the nucleic acid did not exist in isolated form in the cell:

in the absence of human intervention, naturally occurring nucleic acid does not exist outside the cell, and “isolated” nucleic acid does not exist inside the cell. Isolated nucleic acid is the product of human intervention involving the extraction and purification of the nucleic acid found in the cell. Extraction of nucleic acid requires human intervention that necessarily results in the rupture of the cell membrane and the physical destruction of the cell itself. And purification of the extracted nucleic acid requires human intervention that results in the removal of other materials which were also originally present in the cell. It is only after both these steps are performed that the extracted and purified product may be properly described as “isolated” in the sense that word is used in the disputed claims.

Thirdly, at [109] isolating the substance could require “immense research and intellectual effort”.

In that case, it was only as a result of an intensive research effort that the isolated micro-organism in question could be made available for use in the manufacture of the new antibiotic. It was fortuitous for the patentee that it was its employees who were first to isolate the new micro-organism and first to deploy it in the manufacture of the new drug. That will not always be so. It would lead to very odd results if a person whose skill and effort culminated in the isolation of a micro-organism (a fortiori, an isolated DNA sequence) could not be independently rewarded by the grant of a patent because the isolated micro-organism, no matter how practically useful or economically significant, was held to be inherently non-patentable. In my view it would be a mistake, and inconsistent with the purposes of the Act, not to give full effect in such situations to the broad language used by the High Court in NRDC.

His Honour had earlier noted at [75] that, while the isolated substances contained genetic information, the patent did not claim information per se, rather, it was for a substance. Furthermore, at [76] because the claim was limited to the gene sequences in isolated form, it did not cover or extend to the naturally occurring DNA or RNA.

Nicholas J also noted that it was longstanding practice for the Commissioner to grant patents over gene sequences. Both ACIP (pdf) and the ALRC had recommended that this not be changed. The Government had announced (pdf) it accepted those recommendations and Parliament had implemented a different range of measures through the Raising the Bar Act, especially by introducing an explicit experimental use exception in s 119 C and the extension of the usefulness requirement by the introduction of new s 7A which was likely to affect the patentability of ESTs or expressed sequence tags.


Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65

EU bans stem cell patents

The European Court of Justice has ruled that human embryonic stems cells are not patentable subject matter in the EU.

Article 6 of the Biotechnology Directive, 98/44/EC, provides:

1. Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation.

2. On the basis of paragraph 1, the following, in particular, shall be considered unpatentable: (a) processes for cloning human beings; (b) processes for modifying the germ line genetic identity of human beings; (c) uses of human embryos for industrial or commercial purposes; (d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

A Mr Brüstle had a patent in Germany relating to isolated and purified neural precursor cells, processes for their production from embryonic stem cells and the use of neural precursor cells for the treatment of neural defects. It would appear this involved use of isolated and purified precursor cells having neural or glial properties, obtained from embryonic stem cells. That in turn appears to have involved removal of stem cells from the embryo at the blatocyst stage which, in turn, resulted in destruction of the embryo.

Greenpeace sought to invalidate it.

The ECJ had to consider first the meaning of human embryo:

– any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’ within the meaning of Article 6(2)(c) of the Directive;


– it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of the Directive.

Secondly, the ECJ considered that the use of human embryos in research for patentable subject matter was prohibited by paragraph 6(2)(c), but use for the development of therapeutic or diagnostic purposes applied to human embryos could be patentable if useful.

Thirdly, the ECJ ruled that:

Article 6(2)(c) of the Directive excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.

IPKat here; Scientific American here; Patent Docs here.  Lid dip Ian Pascarl and Penny Smith

S 18(2) of our Act provides:

(2) Human beings, and the biological processes for their generation, are not patentable inventions.

As a result of that prohibition, the Deputy Commissioner has rejected the patentability of

40. Claims 10 to 23 are directed to a method of growing preblastocyst human embryos. It is a method applied to a human embryo. The method has clear advantages in better simulating the natural environment, and reducing apoptosis of cells in the blastocyst, resulting in greater success in implantation, and babies of greater body mass and having fewer complications compared to IVF babies born without the benefit of the method – all of which demonstrates that the process is one that directly relates to the generation of a human being. The process is a biological process – it is a process involving the presence of a chemical such that the in vitro environment better simulates the natural fallopian tube environment. I am satisfied that these claims fall within the ambit of `biological processes for {the generation of human beings}’ as proscribed by s.18(2).

Fertilitescentrum AB and Luminis Pty. Ltd [2004] APO 19. There is presumably some scope to patent embryonic stem cells at least where they do not relate to the biological processes for the generation of human beings. Thus, in H Bion Inc v Commissioner of Patents [2010] FCA 539 a patent application entitled “Embryonic Stem Cell Line and Method of Preparing the Same was accepted. The acceptance was subsequently withdrawn, however, on grounds of fraud or misrepresentation. The decision does not make it clear what the fraud related to.






Raising the bar – some differences between the Exposure draft and the Bill

As noted previously, the Intellectual Property Laws (Raising the Bar) Amendments Bill was introduced earlier this week, following fairly extensive consultations on an exposure draft of the Bill.

Patentology has now looked at some of the differences in the proposed changes to the Patents Act between the exposure draft and the Bill as introduced here. His earlier post looked at the different transitional regime for the new standards for patentability.

Business method patents before the Commissioner

Patent Baristas has a guest post from Bill Bennett at Pizzeys considering the Deputy Commissioner’s recent rejection of the “Iowa Lottery” patent application.

1. A prize pool for a lottery game played among a plurality of member lotteries, at least two of which are from diverse jurisdictions, the prize pool comprising:

a system of prize levels including a jackpot prize and at least first and second subordinate prizes;

a super pool of accumulated funds that is used to pay the jackpot prize and inflate the second subordinate prize; and

wherein, in a drawing having a jackpot prize winner in at least one jurisdiction, a member lottery in a jurisdiction without a jackpot prize winner pays out of its own funds the first subordinate prizes and contributes money to the jackpot winner and second subordinate prize winners in each jurisdiction having a jackpot winner, and

wherein one or more of the jurisdictions sets a jackpot prize limit such that money in the super pool in excess of the jackpot prize limit is awarded as second subordinate prizes.”

The third independent claim, claim 12 for a method added in (at least) using a computing device to calculate the allocations to the different prize pools.

In a world where Tattslotto and Powerball have existed for donkey years, apparently, the “exciting” element in this claimed invention was the ability of lottery operators in different states to combine.

The Deputy Commissioner appears to have considered that the claim was just to a mere scheme:

  1. I consider that the same can also be said in relation to all the subject matter of the present application. What is claimed, in whatever guise, is a scheme and not an artificially created state of affairs within the principles articulated in the NRDC decision. In considering the applicant’s submissions I note that in relation to claims 1-2 and 17 it is argued that Grant is distinguished because what is claimed is not a method and more significantly that the claimed prize pool is an artificially created state of affairs whose significance is economic. While clearly of economic significance and a creation of human activity, I however consider the prize pool to be merely information (ie the size of a potential future payment) generated in or reflective of the operation of the scheme defined in the claims. Information even if represented in a physical way has never been considered sufficient for patentability save for some material advantage or mechanical effect in the arrangement of the information. See for example Re Cooper’s Application for a Patent (1901) 19 RPC 53 and Re Virginia-Carolina Chemical Corporation’s Application (1958) RPC 35).
  2. I further do not consider the claiming of a product characterised by the features of a scheme by which it is produced or is affected, even if a real, physical thing, fundamentally alters the question of patentability over the claiming of the scheme as a method. Clearly Mr Grant would have had no better success had he claimed a house characterised by his asset protection scheme. As observed in the Virginia-Carolina decision care should be taken not to allow the form of words use to claim an alleged invention to cloud the real issues of manner of manufacture and it should not be the case that:

“claiming clauses ostensibly directed towards a manner of manufacture cloak the real nature of the applicant’s disclosure”

The Deputy Commissioner went on to reject another set of claims on the grounds that:

15 Obviously a financial transaction, or otherwise, the legal transfer of an asset, is not the sort of physical or observable effect that the Court [in Grant’s case] was referring to, and this is apparent from its reference to the situation in Welcome Real-Time v Catuity Inc [2002] FCA 445 finding at [30] that Mr Grant’s method [was not patentable]

The Deputy Commissioner did not think that reciting in a computer to do all the calculations helped. The change in state or information in the computer was not sufficiently substantial to secure a patent. In this connection, at Patent Baristas, Mr Bennett is concerned by the Deputy Commissioner’s statement in [17] that:

…. As I indicated in my decision in Invention Pathways Pty Ltd [2010] APO 10 I do not believe there is any authority in Australian law for the proposition that the mere identification of a physical effect is sufficient for patentability. It must in my view be an effect “…of such substance or quality that the method considered as a whole is “proper subject of letters patent according to the principles which have been developed for the application of s. 6 of the Statute of Monopolies” ”.

Iowa Lottery [2010] APO 25

Gene patents invalid in USA

District Court Judge Robert Sweet has ruled that Myriad’s patents for the BRCA1 and 2 isolated gene sequences are invalid on the grounds that isolation of the “pure” form of the gene is insufficient to confer patentability.

The New York Times has a lengthy report.

Patently-O summarises, with a link to the 152 page judgment. Prof. Crouch goes on to note that the reasoning effectively invalidate almost all gene patents but expresses the view that the Federal Circuit will reverse, setting up the matter for the US Supreme Court.

These are the patents which sparked controversy in Australia in 2008 and 2009 as a result of which the Senate is now holding an inquiry, currently due to report by 17 June 2010. The ALRC had earlier in 2004 recommended that patents should continue to be available for genetic material.

Association for Molecular Pathology and ACLU v. USPTO and Myriad (S.D.N.Y. 2010) (Judge Sweet)