Selected links,from last week

Here is a selection of links to IP-related matters I found interesting this week:

Patents

Trade marks

Copyright

Remedies

Not categorised

I hope you find some interesting. If you did or have a question, leave a comment or send me an email

Selected links from last (couple of) weeks

Here is a selection of links to IP-related matters I found interesting this past week (or two):

Patents

Trade marks

Copyright

Not categorised

I hope you find some interesting. If you did or have a question, leave a comment or send me an email

RPL Central also refused special leave

The High Court has also refused RPL Central special leave to appeal.

RPL Central had applied for the grant of an innovation patent entitled ‘Method and System for Automated Collection of Evidence of Skills and Knowledge’.

Middleton J had upheld RPL’s appeal from the Commissioner’s decision to reject the application on the grounds it was not a manner of manufacture. The Full Court allowed the Commissioner’s appeal. In rejecting special leave, the High Court baldly stated:

The Full Court was plainly correct and, accordingly, none of the applicant’s proposed grounds of appeal enjoys sufficient prospects of success to warrant the grant of special leave to appeal. Pursuant to r 41.11.1 of the High Court Rules 2004 (Cth), we direct the Registrar to draw up, sign and seal an order dismissing the application with costs.

So, so far as patenting business methods goes in Australia, it looks like Research Affiliates will be the last word … for a long time.

If you have a question or wish to make a comment, feel free to post it in the comments box or send me an email.

RPL Central Pty Ltd v Commissioner of Patents [2016] HCASL 84

Myriad’s BRCA1 claims – take 2

As previously noted, the High Court has unanimously ruled that Myriad’s 3 claims for isolated nucleic acids for the BRCA1 gene that codes for specific mutations and polymorphisms are invalid.[1]

Claim 1 was:

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:1 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.

Claims 2 and 3 were subsidiary claims for narrower formulations.

The sole issue in the case was whether claims 1 to 3 of Myriad’s patent were a “manner of manufacture” within the meaning of s 18(1)(a) of the Patents Act – what the American’s refer to as subject matter or patentable subject matter. There was no challenge to the novelty or inventive step of the claim – the basis on which the corresponding patent was rejected in Europe.

There was also no challenge to claims 4 – 30, which Gordon J at [191] and [257] characterised as applications of the isolated gene sequences to various purposes such as a probe (claim 4), vectors (claims 5 – 7), methods of producing mutant or polymorphic BRCA1 polypeptides (claims 8 – 9), preparations and uses of polypeptides (claims 10 – 16) and methods of diagnosis (claims 17 – 30).

Previously, this question fell to be determined according to the principles declared in the “watershed” NRDC case. All 3 sets of reasons acknowledged the continued relevance of that decision, but appear to have qualified its teaching in potentially far-reaching ways.

French CJ, Kiefel, Bell and Keane JJ

The majority judgment was delivered by French CJ, Kiefel, Bell and Keane JJ.

A narrow approach

At one level (one might hope the right level), their Honours’ judgment can be seen as focusing very specifically on the singular nature of Myriad’s claim. Thus, at [6], their Honours said:

Despite the formulation of the claimed invention as a class of product, its substance is information embodied in arrangements of nucleotides. 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”. It must reside in something. It may be a product. It may be a process. It may be an outcome which can be characterised, in the language of NRDC, as an “artificially created state of affairs”. Whatever it is, it must be something brought about by human action. ….

In their Honours’ conception, that was not the case here. The judgment continues at [6]:

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.

That is, nothing was “made”. Rather, the gene sequence with the relevant mutation(s) and/or polymorphism(s) was made in the individual from whom the genetic material had been extracted. “All” that Myriad did was whittle that genetic material down to identify whether or not the relevant mutation or polymorphism was present.[2]

Further, at [8]:

…. The size of the class of the products as defined is large. No upper limit was suggested in argument. 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.[3]

One might wonder how one works out whether or not the “monopoly” that would arise would be “exorbitant and unwarranted”. The size of the class claimed seems problematic, the “chilling effect” also might be thought something that flows from the grant of any patent. Why for example would that be any more of a problem than for the patents granted originally over compounds such as omeprazole or rosuvastating or any number of other drugs?

Moreover, the problem of infringement loomed very large. No-one could know in advance whether or not what they were doing would infringe. It would depend on whether a relevant mutation or polymorphism was present in the individual from whom the genetic material was extracted. One might say, of course, that one would not be at risk of infringing unless one was looking for the BRCA1 sequence. One might also say, at least up until today, that there was no bar to patenting omeprazole or rosuvastatin or any other chemical substance just because one had found a specific use for it such as treating disease A when, after the compound had been discovered, someone else might be precluded from investigating its use, surprisingly, to treat disease B.[4]

The problem seems particularly to come back to the nature of the claim as being tosomething generated in an individual naturally and independently of any action by the patentee.

Wider ramifications

French CJ, Kiefel, Bell and Keane JJ did not just declare that claims 1 to 3 were not patentable subject matter. Their Honours went on to explain the principles that should be applied in future.

First, their Honours accepted at [18] that the NRDC test was still the appropriate 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?”

As I tell my patents class students, that provides us with an awful lot of guidance! Their Honours continued:

That question is to be answered according to a common law methodology under the rubric of “manner of manufacture” as developed through the cases, but consistently with “a widening conception of the notion [which] has been a characteristic of the growth of patent law.” That widening conception is a necessary feature of the development of patent law in the 20th and 21st centuries as scientific discoveries inspire new technologies which may fall on or outside the boundaries of patentability set by the case law which predated their emergence.

So far, still so good; particularly the recognition of the need for the concept to continue developing.

The “common law methodology” is further explained in [5] – [7] and troubled French CJ in Apotex v Sanofi. The first point appears to be, if the claim falls within an existing recognised class of patentable subject matter, it is a manner of manufacture. If it is a new class, however, “policy factors informed by the purpose of the Act and considerations of coherence in the law” need to be considered. Moreover, there are limits in judicial law-making “inherent in common law methodology”:

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.

Notwithstanding 50+ years of the Courts successfully applying the NRDC formula, this High Court is plainly very uncomfortable with that role.

For those 50+ years since NRDC, we had been thinking there were 2 (or 3) requirements for patentable subject matter:

  1. Whether the invention as claimed is for a product made, or a process producing an outcome as a result of human action; and
  2. Whether the invention as claimed has economic utility.[5]

French CJ, Kiefel, Bell and Keane JJ confirmed that requirements 1 and 2 are still necessary. As foreshadowed in paragraph [6], however, their Honours said that requirements 1 and 2, while necessary, are not in themselves sufficient.[6] Other factors must be taken into account. At [28], their Honours laid out four further considerations:

  1. Whether patentability would be consistent with the purposes of the Act and, in particular:
    1. whether the invention as claimed, if patentable under s 18(1)(a), could give rise to a large new field of monopoly protection with potentially negative effects on innovation;
    2. whether the invention as claimed, if patentable under s 18(1)(a), could, because of the content of the claims, have a chilling effect on activities beyond those formally the subject of the exclusive rights granted to the patentee;
    3. whether to accord patentability to the invention as claimed would involve the court in assessing important and conflicting public and private interests and purposes.
  2. Whether to accord patentability to the invention as claimed would enhance or detract from the coherence of the law relating to inherent patentability.
  3. Relevantly to Australia’s place in the international community of nations:
    1. Australia’s obligations under international law;
    2. the patent laws of other countries.
  4. Whether to accord patentability to the class of invention as claimed would involve law-making of a kind which should be done by the legislature.

The new, additional factors 1, 2 and 4 above were described as the most important in the balancing process the inquiry envisaged by their Honours.[7]

Having regard to these considerations, French CJ, Kiefel, Bell and Keane JJ declared at [94]:

Although it may be said in a formal sense that the invention as claimed, referring to isolated nucleic acids, embodies a product created by human action, that is not sufficient to support its characterisation as a manner of manufacture. 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. Further, to include this class of claim within that concept would not contribute to coherence in the law as was the case in Apotex. Nor do Australia’s international obligations and the differently framed patent laws of other jurisdictions, which were referred to earlier in these reasons, support the conclusion that this class of claim should fall within the concept.

The “substance of the invention” and the considerations flowing

In the decision of the Full Federal Court under appeal, it had been pointed out that isolated DNA was in fact man made – it didn’t occur in nature. French CJ, Kiefel, Bell and Keane JJ, however, considered that was to elevate form over substance. So at [90], their Honours accepted a submission from the appellant:

“Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes.”

That characterisation, so far as it emphasises the focus of the claims on genetic information, is applicable to the claims in this case and, contrary to the view of the Full Court, should be accepted.

At [93], their Honours then emphasised:

When proper regard is paid to their emphasis on genetic information, the subject matter of the claims lies at the boundaries of the concept of “manner of manufacture”. That it does lie at the boundaries is further evidenced by the odd consequence that 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.

The characterisation of the claims as “information”[8] has some affinity for Gordon J’s approach, discussed briefly below, ruling that the claims were to a mere discovery rather than invention. As discussed above under A narrow approach, this seems to flow from the singular nature of the claims in suit with the consequent uncertainties, particularly for infringement.

An extension of the concept

How do you tell that Myriad’s claim involved an extension of the concept of manufacture?

It is true that no court in Australia had ruled on the patentability of isolated gene sequences until the Myriad litigation. However, the Patent Office has been granting patents for ‘man made’ microbes since 1976 and for isolated genetic material since 1995. The legislative history showed that Parliament rejected an attempt to exclude genetic material from patentable subject matter when passing the 1990 Act. A further attempt to exclude human genetic material was rejected in the Senate in 2011. Two inquiries by Government agencies in the 2000s had also endorsed the status quo and recommended against exclusion. Indeed, the Government of the day had publicly announced its acceptance of the ALRC’s recommendation not to exclude isolated genetic materials from patentability. French CJ, Kiefel, Bell and Keane JJ said at [37]:[9]

This Court is not concerned in this appeal with “gene patenting” generally, but with whether the invention as claimed in Claims 1 to 3 falls within established applications of the concept of manner of manufacture. If it does not, then the question is one of inclusion not exclusion. The legislative history cannot be read as impliedly mandating the patentability of claims for inventions relating to isolated nucleic acids coding for particular polypeptides. The legislative history does not assist the Court in answering the question posed in this appeal.

Contribute to coherence

[Apotex][apotex] had (more or less) upheld the status of methods of medical treatment as patentable subject matter. That contributed to coherence because there was no rational basis to distinguish between patenting medical products and patenting methods of treatment.

Here, arguable, the nature of the claim as already discussed means it is impossible to assess the risks of infringement in advance. That presumably does not promote coherence. Their Honours also focused on the broad range of what was claimed and the potential impacts on future researchers. As already discussed, it may be difficult to distinguish those aspects from claims to other chemical compounds.

Gageler and Nettle JJ

Given the length of this post already, I shall only comment briefly on the remaining judgments.

Like French CJ, Kiefel, Bell and Keane JJ, Gageler and Nettle JJ considered at [125] that “an artificial state of affairs” and “economic utility” were necessary requirements for patentable subject matter, but not sufficient.

Also like French CJ, Kiefel, Bell and Keane JJ, Gageler and Nettle JJ stated at [144] that the question of patentable subject matter must be looked at as a matter of substance rather than form.

Invoking Microcell and Philips v Mirabella, their Honours considered at [133] that patentable subject matter involved a threshold inquiry of “inventiveness”.

Products of nature therefore did not qualify as at [136] they lacked the necessary quality of inventiveness. Gageler and Nettle JJ considered that Myriad’s claims were properly characterised as merely claims to products of nature.

Earlier at [128], Gageler and Nettle JJ had said:

Regardless, however, of the amount of labour involved or the differences between the product and the raw natural material from which it is derived, it is necessary that the inventive concept be seen to make a contribution to the essential difference between the product and nature.

Then, at [134], their Honours said:

Here, the essence of claim 1 is the correlation between the incidence of cancer and the presence of the specified mutations and polymorphisms in the mutated BRCA1 gene. Such ingenuity as that entails consists in the idea of examining an isolated fragment of a patient’s naturally occurring DNA constituted of the BRCA1 gene for the presence or absence of the specified mutations and polymorphisms. The subject matter of the claim does not make any contribution to the inclusion of the specified mutations and polymorphisms in the mutated BRCA1 gene. Their presence or absence in or from it is the result of the isolated BRCA1 gene being part of the naturally occurring DNA from which the sequence is isolated. To adopt and adapt the reasoning in NV Philips’ Gloeilampenfabrieken Application, it is “the inevitable result of that which is inherent in the [DNA]”.[10]

Like the reasons of French CJ, Kiefel, Bell and Keane JJ, this passage emphasises that Myriad did not itself make, or cause to be made, the relevant material. Rather, it was generated in the human body independently of any action by Myriad.

Thus, Gageler and Nettle JJ said at [139]:

…. the BRCA1 gene is not patentable as such because it is a naturally occurring phenomenon which lacks the quality of inventiveness necessary to qualify as a manner of new manufacture.

Gordon J

Gordon J at [222] – [225] specifically rejected D’Arcy’s argument that “naturally occurring things, or products or phenomena or principles of nature are excluded as a proper subject matter of a patent.” These were too vague, malleable and imprecise to be useful tools.

Instead, her Honour focused on the role isolation of the nucleic acid played: it simply allowed identification of the presence, or absence, of naturally occurring mutations or polymorphisms. Gordon J then advanced five reasons why the claims did not qualify as patentable subject matter:

  1. The claim is to multiple products, not a single product: [231]-[239];
  2. Although Myriad claims a class of chemical compounds as a product, it cannot delineate the bounds of its claim by reference to chemical composition: [240]-[243];
  3. Myriad did not create, make or alter the characteristic, the code: [244]-[249];
  4. There is no idea, concept or principle embodied in a manner of new manufacture: [250]-[258]; and
  5. The claim is too broad: [259]-[264].

Points 1, 2 and 5 focus on the sheer number and variety of compounds or sequences which were embraced. So at [241] and [242], her Honour recorded that Myriad could not identify the boundaries of the claims:

…. it is not possible for Myriad to record all of the various chemical compounds (or products) that might be produced by isolating an individual’s nucleic acid. For example, as Myriad accepted during argument, the claim is to an “extremely wide number” of chemical compounds where the compound formulae would vary according to the number of sequences extracted but the compound would nevertheless contain one or more of the specific mutations or polymorphisms.

As has been seen, changes in chemical composition are not limited to variation in the number of nucleotides. So, although the claimed product is a chemical compound, Myriad did not and cannot delineate the bounds of the class of compounds by reference to the chemical composition of the class of the claimed product. Instead, Myriad sought to delineate the boundaries of the claim by reference to what it described as the “characteristics identified within the claim” – the specific mutations and polymorphisms, represented by the code.

I am not sure why delineation by class of compound would be any more precise than the method chosen by Myriad – if you know, please leave a comment.

Under point 5, her Honour also pointed out the concern that no-one could know in advance whether they infringed or not and, if the role of the claim, is to identify the boundaries of the monopoly, that does rather cause a problem.

Under point 4, Gordon J referred to the nature of invention as discussed in the Hickton Patent Syndicate case:

In my opinion, invention may lie in the idea, and it may lie in the way in which it is carried out, and it may lie in the combination of the two; but if there is invention in the idea plus the way of carrying it out, then it is good subject-matter for Letters Patent. (Gordon J’s emphasis)

Her Honour considered that claims 1 to 3 failed to qualify because they did not carry out Myriad’s discovery that certain mutations or polymorphisms indicated increased risk of breast cancer. Gordon J said:

[254] Here, having located the BRCA1 gene and identified its nucleic acid sequence, Myriad’s idea, concept or principle is that specific mutations or polymorphisms in that sequence suggest a predisposition to breast cancer and ovarian cancer.

[255] How then is that idea carried out in claim 1? It is not. It is not and could not be carried out – as claim 1 suggests – by creating a product comprising isolated nucleic acid from a patient which contains the identified characteristic in any one of its many forms. As has been seen, Myriad does not claim the methods by which it isolates the nucleic acid or the methods by which it identifies the sequence of the patient’s nucleic acid. Myriad does not claim the characteristic. Claim 1 is not a claim to the idea, concept or principle.

Gordon J contrasted these claims to claim 4 which used the discovery to create a probe to test for the presence or absence of mutations. That was an invention. So analysed, claims 1 to 3 might be seen to be ‘mere’ discoveries’ rather than an application or now to offend against the enablement and sufficiency requirements.

Some other scary thoughts

First, it is not entirely clear from the decision whether cDNA is patentable subject matter as the US Supreme Court accepted. French CJ, Kiefel, Bell and Keane JJ said at [73]:

Nor, as previously noted, are the claims subject to any process?based limitation involving the breaking up and physical stitching together of the sequences comprising the isolated nucleic acids which are the products the subject of the claims. The “conceptual” stitching together, which may be regarded as the ordered compilation of information defining the relevant sequence, falls outside the claims entirely. The claims encompass molecules comprising isolated nucleic acids containing coding nucleotides arranged in the same sequence as appears in the DNA from which they were derived, whether or not introns and other non-coding sections have been removed from the relevant stretch of that DNA.

That might leave room for debate that cDNA could qualify. Also, the exclusion of introns or other “non-conding regions” might ameliorate the “chilling effects”. Gageler and Nettle JJ, however, at [116] characterised the claims as claiming “the uninterrupted sequence of nucleotides without introns”, i.e., cDNA. According to Gordon J at [283], the parties agreed that, if the claims were not patentable subject matter, they would not be saved where they extended to cDNA.

Philips v Mirabella!

Dr Patentology has called Philips the second worst ever patent judgment by the High Court. No argument from me. Turns out, we’re both wrong. At least 6 judges of the current High Court consider it good law[11] and appear to use it as their touchstone of patent principles.

I would say we need legislative reform but, as the Angel of Lake said, “Before you choose your wish son You better think first ….”

D’Arcy v Myriad Genetics Inc [2015] HCA 35


  1. According to Gordon J at [205] a “mutation” is a variation in a gene sequence “private to an individual or that indiviual’s immediate family.” In contrast, at [207] a “polymorphism is a genetic variant which has arisen in a distant common ancestor and is therefore not unique to an individual or that individual’s immediate family. Forty per cent of women in the general female population have one or more polymorphisms in the BRCA1 gene that are not found in the remaining 60 per cent of the population.”  ?
  2. Gageler and Nettle JJ also focused on this point at e.g. [162]. See also Gordon J at [248].  ?
  3. Citing Cornish, Llewellyn and Aplin for the final conclusion.  ?
  4. Of course, these days, s 119C would probably provide one with a defence to infringement, at least for the research into the possible use.  ?
  5. In fact, the Full Federal Court in Grant has told us there is a the third requirement: a physical transformation of something. Arguably, that was not in issue in Myriad as the isolated gene sequence was physically different to the unisolated genetic material in the human body to an extent.  ?
  6. Insofar as the claim falls within existing concepts of “manner of maufacture” as it has been developed through the cases, their Honours said at [28] requirements 1 and 2 “will also ordinarily be sufficient.” (emphasis supplied)  ?
  7. The survey of foreign laws didn’t really help as it was only the USA following the US Supreme Court’s Myriad decision that appears to have ruled out patent protection for isolated genetic material.  ?
  8. Optimistically hoping it was the claim to “information” rather than just genetic information which was important.  ?
  9. Gageler and Nettle JJ took a similar position at [171]. Nicholas J reviewed the legislative history at [113] – [123] in Cancer Voices.  ?
  10. A different Philips case, which their Honours read as endorsed by NRDC: (1954) 71 RPC 192 at 194, quoted in NRDC (1959) 102 CLR 252 at 279.  ?
  11. In addition to Gageler and Nettle JJ, see French CJ, Kiefel, Bell and Keane JJ at [12].  ?

Apotex v Sanofi: manner of manufacture

As briefly noted last week, the High Court handed down its ruling in Apotex’ appeal. Although the case will be mainly remembered because Apotex lost its challenge to the patentability of Sanofi’s method of medical treatment, Apotex actually won on the patent infringement point. (As there was no appeal on that point, however, it was still liable for infringing the copyright in Sanofi’s product information.)

Claim 1 of Sanofi’s relevant patent is for:

[a] method of preventing or treating a skin disorder, wherein the skin disorder is psoriasis, which comprises administering to a recipient an effective amount of [leflunomide].

The patent for leflunomide itself has expired.

Apotex had received marketing approval from the TGA for the treatment of rheumatoid arthritis (RA) and psoriatic arthritis (PsA).

By a majority of 4 – 1,[1] the High Court held that:

  1. a a method of medical treatment is indeed patentable subject matter – a manner of manufacture[2] – under Australian law;
  2. a second or subsequent use of a known substance could also be patentable subject matter; but
  3. Apotex did not infringe by selling or supplying its generic leflunomide according to its product information.

manner of manufacture

All 5 judges accepted the orthodoxy of the NRDC decision as defining the approach to whether a claim was to a manner of manufacture. And all 5 judges accepted it was a broad and widening concept.

Crennan and Kiefel JJ identified NRDC as essentially requiring 2 conditions to be satisfied. For example, at [235], their Honours quoted the Wellcome case:

This principle [in the NRDC Case] extends to a process which does not produce a new substance but results in ‘a new and useful effect’. If the new result is ‘an artificially created state of affairs’ providing economic utility, it may be considered a ‘manner of new manufacture’ within s 6 of the Statute of Monopolies. (Crennan and Kiefel JJ’s emphasis)

At [278] – [285], their Honours identified 7 reasons why a method of medical treatment could be patentable. Gaegler J agreed with these 7 reasons and proposed an eighth.[3] Given the broad scope of the concept, Crennan, Kiefel and Gaegler JJ considered the crucial consideration was that there was no economic or ethical basis for distinguishing between the patentability of a pharmaceutical (or other medical) product and a method.[4] French CJ’s reasoning was similar to this point; considering the historical exclusion from patentability to be an anomaly for which no clear and consistent foundation had been established.[5]

In contrast, Hayne J in dissent considered at [143] – [150] that it could well be possible to distinguish between patenting medical products and methods of treatment. Instead, his Honour considered that a process would only be patentable if the product (in the sense of the result, outcome or effect) of the process, and not just the process itself, had economic utility. Hayne J considered that a method of medical treatment did not satisfy that criterion because (at [163]):

The effect of using the process is personal to the individual. It is not an effect which the person who owns the right to use the process, or any person other than the individual who has been treated, can turn to economic account in any way, whether directly or indirectly. If the individual who has been treated can turn the effect to economic account, he or she can do so only indirectly: by taking advantage of better health to make a more valuable contribution to national production. The individual is not a subject of commerce. The product of the process in the individual (having better health than might otherwise have been the case) cannot be sold. ….

Perhaps reflecting Hayne J’s approach to some extent, Crennan and Kiefel JJ at [287] did consider that there was a distinction to be drawn between uses of therapeutic substances and the activities and procedures of doctors when treating patients on the basis that the latter are “non-economic”:

There is, however, a distinction which can be acknowledged between a method of medical treatment which involves a hitherto unknown therapeutic use of a pharmaceutical (having prior therapeutic uses) and the activities or procedures of doctors (and other medical staff) when physically treating patients. Although it is unnecessary to decide the point, or to seek to characterise such activities or procedures exhaustively, speaking generally they are, in the language of the NRDC Case, “essentially non?economic” and, in the language of the EPC and the Patents Act 1977 (UK), they are not “susceptible” or “capable” of industrial application. To the extent that such activities or procedures involve “a method or a process”, they are unlikely to be able to satisfy the NRDC Case test for the patentability of processes because they are not capable of being practically applied in commerce or industry, a necessary prerequisite of a “manner of manufacture”.[6]

French CJ, however, at [1] and [44] expressly included surgical procedures in his Honour’s finding in favour of patentability.

second use of a known substance

As Crrennan and Kiefel JJ pointed out, NRDC itself involved a second or subsequent use of a known substance, the hitherto unsuspected properties of which squarely satisfied the requirements for inventiveness. Apotex’ reliance on this basis, therefore, failed at [291] in succinct terms.

the infringement question

… will have to wait for another day.

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


  1. French CJ, Crennan, Kiefel and Gaegler JJ; Hayne J dissenting.  ?
  2. Patents Act 1990 s 18(1)(a). The claim would, of course, also have to satisfy the other requirements including novelty, inventive step, utility etc.  ?
  3. Gaegler J appears to be alone in attributing weight to the potential disruption to business investments if the endorsement by Bristol-Myers v Squibb of the patentability of methods of medical treatment was overturned after 13 years.  ?
  4. See [282] for Crennan and Kiefel JJ; [314] for Gaegler J.  ?
  5. At [50]. See also [44] – [49].  ?
  6. Earlier, at [266] – [271], their Honours had noticed that Congress amended the US Patents Act to include §287(c)  ?

    “the effect of which is to permit the patenting of surgical methods to continue but to bar actions for patent infringement against medical practitioners (and ”related health care entit[ies]“) for ”the performance of a medical or surgical procedure on a body“.”

Patentable subject matter reform

IP Australia has issued an Issues Paper on the proposed amendments to the Patents Act:

(1) to insert an “objects” clause; and

(2) to exclude from patentable subject matter inventions which it would be “offensive” to commercially exploit.

These plans arise out of a recommendations made by ACIP which the Government announced it accepted. The consultation now is on the wording to implement those policies.

An objects clause

The consultation paper proposes 2 alternative “objects” clauses:

Option 1

…. the purpose of the legislation as being to provide an environment that promotes Australia’s national interest and enhances the well-being of Australians by balancing the competing interests of patent rights holders, the users of technology, and Australian society as a whole.

Option 2

the purpose of the patent system is to provide an environment that enhances the well-being of Australians by promoting innovation and the dissemination of technology and by balancing the competing interests of patent applicants and patent owners, the users of technology, and Australian society as a whole.

Now, one could very well wonder what possible help either of these statements might give a court if they were enacted. The consultation paper even notes that the Parliamentary Draftsman is rather ambivalent about the value of objects clauses in general:

Some objects provisions give a general understanding of the purpose of the legislation…Other objects provisions set out the general aim or principles that help the reader to interpret the detailed provisions of the legislation.

The first option is what ACIP proposed. ACIP considered its proposal a simplified version of the Objects identified in art. 7 of TRIPS:

The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

The consultation paper thought that Option 1 does not sufficiently recognise the economic and social welfare concerns of patent law and did not sufficiently recognise the interests of patent applicants as well as patent owners (formerly known in Olde English as patentees). As the consultation paper explains:

The economic goals of the patent system are to promote economic growth, trade and investment by encouraging innovation and the dissemination of knowledge and technology.

The patent system encourages innovation by giving patentees a period of market exclusivity in which to recoup their development costs through commercialisation of their inventions. In exchange, patentees are required to disclose the details of their inventions to the public. The patent system contributes to social welfare by providing Australians with access to new technologies and developments that otherwise would not have occurred and that improve our quality of life (for example new pharmaceuticals and medical technologies and improvements to safety and waste management technologies).

However, the patent system will only meet its economic goals if the positive effects of the patent system in stimulating investment in innovation and providing society with access to new technology are balanced against the potential negative effects of patents restricting access to follow-on innovation and increasing costs, and so restricting supply of new patented technologies.

This is better, at least the first 2 paragraphs (if one bears in mind that economists – to the extent they accept the role of patents – think of the market exclusivity as providing an incentive rather than a “reward”). The third paragraph is rather more ambivalent.The danger the third paragraph raises is that it could be used as a basis for excluding something from patentability because someone might use the patent to raise prices or the other evils identified. But, while there are some provisions in the Patents Act that address, or attempt to deal with, these issues, in many respects they seem more properly the territory of (take a deep breath) competition law.

Offensive commercial exploitation

What the consultation proposes is a new exclusion to be added to s 18:

…  for an invention the commercial exploitation which would be wholly offensive to the ordinary reasonable and fully informed member of the Australian public.

Wholly offensive?

Apparently, the test of the ordinary reasonable and fully informed member of the Australian public is intended to ensure that the exclusion is “applied in a consistent, predictable and neutral manner”. However, it is also proposed to assist the Commissioner by explicitly empowering the Commissioner  in his or her discretion to seek “non-binding” advice on ethical matters.

What seems to trigger the exclusion commercial exploitation in an wholly offensive way rather than at the specific subject matter itself. At what point is the appropriateness of the commercial exploitation determined? Will it be enough that the invention could be exploited in an wholly offensive way? The BRCA controversy erupted when Myriad announced it was going to start charging licence fees for its products. Would the ordinary, reasonable and fully informed Australian have considered its patent wholly offensive before that announcement? This rather suggests that the problem falls within the second type issue identified by ACIP: about how the patent is used, are better dealt with through Crown Use and other compulsory licence arrangements.

 

If you have views you want to inflict, they should be submitted by 27 September 2013.

Find the issues paper here.

A business method patent (not yet)

RPL applied for an innovation patent of a method entitled ‘Method and System for Automated Collection of Evidence of Skills and Knowledge’.

The applied for innovation relates to a method for people to obtain recognition for their prior learning. Apparently, there are some 35,000 qualifications and 34,000 units in the vocational educational and training sector in Australia. Hence it can be difficult for people to identify a particular qualification which they have qualified for as there is no single point of access to the system. The applied for innovation claimed methods for using technology, particularly the internet, to automate the process of identifying relevant criteria and applying for the relevant recognition.

Claim 1 claimed:

1. A method of gathering evidence relevant to an assessment of an individual’s competency relative to a recognised qualification standard, including the steps of:

  • a computer retrieving via the Internet from a remotely-located server a plurality of assessable criteria associated with the recognised qualification standard, said criteria including one or more elements of competency, each of which is associated with one or more performance criteria;
  • the computer processing the plurality of assessable criteria to generate automatically a corresponding plurality of questions relating to the competency of an individual to satisfy each of the elements of competency and performance criteria associated with the recognised qualification standard;
  • an assessment server presenting the automatically-generated questions via the Internet to a computer of an individual requiring assessment; and
  • receiving from the individual via said individual’s computer a series of responses to the automatically generated questions, the responses including evidence of the individual’s skills, knowledge and/or experience in relation to each of the elements of competency and performance criteria,
  • wherein at least one said response includes the individual specifying one or more files stored on the individual’s computer, which are transferred to the assessment server.
Myall opposed alleging lack of novelty based on prior use. The applicant didn’t even need to file evidence to defend this allegation which failed on the evidence submitted by the opponent.
However, it appears that the delegate hearing the opposition raised the objection that the innovation claimed was not a manner of manufacture (see [62]).
The delegate noted (at [45]) that the Full Federal Court’s decision in Grant had qualified NRDC so that a manner of manufacture required
‘an artificial state of affairs, in the sense of a concrete, tangible, physical, or observable effect’
and
A physical effect in the sense of a concrete effect or phenomenon or manifestation or transformation is required.
This had been further explained by the Deputy Commissioner in Invention Pathways:
I do not take [Grant] to suggest that patentability is merely determined on the presence of a physical effect. Rather it clearly must 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”.
Accordingly, the Deputy Commissioner considered:
… the “concrete effect or phenomenon or manifestation or transformation” referred to must be one that is significant both in that it is concrete but also that it is central to the purpose or operation of the claimed process or otherwise arises from the combination of steps of the method in a substantial way. Consequently while the step of building a house involves a concrete physical effect it is peripheral to the method of acquiring a house and indeed could hardly be said to characterise the subject matter of the method such that it is considered an artificially created state of affairs. I consider the same to apply to a business scheme implemented in some part by computer and do not believe the patentability of such a method can arise solely from the fact that, in a general sense, it is implemented in or with the assistance of a computer or utilises some part a computer or other physical device in a incidental way.
In this case, the delegate considered at [54]:
54. It is clear that the claim relates to gathering information where the internet is used for transmitting and receiving data, and a computer is used for data retrieval, processing, presentation and storage of information in a well known manner. The process of automatically generating questions based on assessable criteria, as stated in the description, includes applying a question template into which the text of the relevant assessable criteria may be merged. In a simple form, a question may be generated from the criteria by prepending the text such as ‘How can you show evidence that’.
and so found at [55]:
55. The claimed invention defines a method for gathering information where the data retrieval, processing and storage of information appear to have no physical effect other than that would arise in the computer with standard software in conventional use. Furthermore, there is no substantial effect or transformation in generating the questions by concatenating text matters. While the internet and the computer facilitate the operation of the claimed method by retrieving, generating and conveying information, they are not central to the purpose of the claimed invention. [So unlike the loyalty card in Welcome-Catuity], the claimed invention simply monopolises a scheme where the internet and the computer are used for mere convenience for operating the scheme.
Accordingly, the delegate rejected the application in that form. However, at [59], the delegate considered there could nonetheless be patentable subject matter:
the description of the opposed patent contemplates generating the questions automatically based upon the identification of particular keywords within the assessable criteria, and upon additional contextual information obtained from Evidence Guides, Range Statements and Employability Skills associated with Qualifications and Units of Competency without requiring human intervention.
and so allowed 60 days for amendments to be brought in (the delegate also flagged a potential fair basing problem for the proposed amendment).
Myall Australia Pty Ltd v RPL Central Pty Ltd [2011] APO 48 (link to be provided when available)
Lid dip: Patentology


        

Patentable subject matter in Australia

The Minister has released ACIP’s report into what should be patentable subject matter under Australian law.

At the moment, s 18 defines a ‘patentable invention’ and the Dictionary in Sch. 1 defines and “invention” as:

“invention” means any manner of new manufacture the subject of letters patent and grant of privilege within section 6 of the Statute of Monopolies, and includes an alleged invention.

and, from NRDC (for example) :

Section 6 of the Statute of Monopolies provides that the declarations of invalidity contained in the preceding provisions of the Act “shall not extend to any letters patents and graunts of privilege . . . hereafter to be made of the sole working or makinge of any manner of new manufactures within this realme, to the true and first inventor and inventors of such manufactures, which others at the tyme of makinge such letters patents and graunts shall not use, soe as alsoe they be not contrary to the lawe or mischievous to the state by raisinge prices of comodities at home, or hurt of trade, or generallie inconvenient”

From the Key Points and recommendations:

We recommend changing the Patents Act 1990 to codify the principles of inherent patentability (as developed by the High Court in the NRDC case and in subsequent Australian court decisions). …

Consequently:

These reforms envisage amending the legislation by:
  • replacing the words ‘is a patentable invention’ in subsections 18(1) and18(1A) with the words ‘is patentable’;
  • replacing the words ‘if the invention, so far as claimed in any claim’ in subsections 18(1) and 18(1A) with the words ‘if it’;
  • replacing the current words of paragraphs 18(1)(a) and 18(1A)(a) with the words ‘an artificially created state of affairs in the field of economic endeavour’;
  • changing the definition of ‘invention’ in Schedule 1 to be ‘the subject matter of any claim’; and
  • deleting the definition of ‘patentable invention’ in Schedule 1.

So far, so good. These proposals would keep the teleological approach adopted in NRDC that was (and is) so forward looking and which has served us so well. It looks like they would also do away with all the problems of the “threshold” requirement introduced by Phillips v Mirabella (the nature of the problem is laid out at paragraphs 19 to 27 of Bristol-Myers Squibb v Faulding).

Then, things start to get a bit hairy:

Because the principles of inherent patentability address only the economic goals of the patent system, we also recommend specific and general exclusions to address certain ethical concerns that may arise. The current specific exclusion preventing the patenting of human beings and biological processes for their generation should be retained. Instead of the general inconvenience proviso, a general exclusion would preclude the patenting of inventions the commercial exploitation of which would be wholly offensive to the ordinary reasonable and fully informed member of the Australian public. (my emphasis)

Now, I would be happy with the recommendation insofar as it gets rid of the “general inconvenient proviso” as no-one knows what it means, or is intended to mean. But to replace it with an exclusion of “something wholly offensive to the ordinary reasonable and fully informed member of the Australian public”? That will be “fun”.

In Bristol-Myers Squibb, Finkelstein J pointed out (especially at 140 to 142) that courts are not particularly happy hunting grounds for that type of inquiry; still less so, one might have thought, the Commissioner (whomever he or she might be). For example, in a different field, Lady Chatterley’s Lover was famously offensive, although apparently no more. Today, we have controversy over whether or not to fly some people at taxpayer’s expense to funerals (here vs here and here). Which side of that debate represents the ordinary reasonable and fully informed member …?

Meanwhile, the Senate’s Legal and Constitutional Affairs Committee is waiting (until 25 February 2011) for your submissions on the Patent Amendment (Human Genes and Biological Materials) Bill 2010, the private Senators’ bill (introduced by Senators Coonan, Heffernan, Siewert and Xenophon) to amend the Patents Act 1990 to prevent the patenting of human genes and biological materials existing in nature.

ACIP’s report.

ACIP’s press release.

A new approach to business method patents Down Under?

Patent Baristas has a guest post from Bill Bennett at Pizzeys on the Deputy Commissioner’s rejection of a patent application for (as described by the Deputy Commissioner):

“a method for commercialising inventions that includes the step of applying for patent protection. The specification indicates that the method is intended to facilitate the uptake of commercialisation of inventions taking into account the restricted timeframe to file for intellectual property rights and the effect of automatic patent publication. The latter is a reference to the practice in most jurisdictions of publishing patent applications 18 months after their earliest priority date.”

Claim 1 reproduced in the Deputy Commissioner’s decision reads:

1. An invention specific commercialization system to facilitate success of inventions, the system including the steps of:
a) applying for patent protection for the invention in a country which is party to the Paris Convention,
b) conducting a review of specific commercialization process required by the invention,
c) preparing a research and development plan, testing the business dynamics of the invention,
d) conducting prototype testing, developing a prototype cost/benefit analysis,
e) determining product positioning and packaging,
f) conducting a manufacturing checklist,
g) entry of the information collected in steps a) to f) into an electronically fillable checklist having a prescribed time limit for each step to form a commercial entry strategy (CES) with a number of sub-steps, the CES prepared on the basis that each of the sub-steps in the CES are to be completed by a corresponding deadline, all deadlines falling within 30 months from the earliest priority date of the patent application, the checklist being computer-implemented and stored in computer or human readable format in data storage means and associated with processing means to allow updating of the checklist; and
h) policing compliance with the deadlines for the completion of the sub-steps through the production of reminders based on the prescribed time limits in the checklist to ensure that all sub-steps are completed within the deadlines.

At the risk of seeming glib and/or flip, one might think this was a checklist for the commercialisation of “an invention”, where one of the items on the checklist includes applying for patent protection, and using a calendaring system to generate reminders so you don’t miss a deadline.

Wonder what business managers and patent managers have been using Excel, Outlook and any number of computerised database for until now?

Any how, Mr Bennett’s blog, focusing on the “electronically fillable” and “computer-implemented” wording in the claim, contends that the Deputy Commissioner has reinterpreted Grant (you remember: the asset protection method (formerly known as a trust) in light of the US Supreme Court’s ruling in Bilski so that the production of a physical effect will lead to a “manner of manufacture” only where the effect is:

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”.

(Do read Mr Bennett’s more detailed consideration.)
However, this seems to confer on the Commissioner a rather wide discretion. Was it really necessary?

Invention Pathways Pty Ltd [2010] APO 10

EU: patentability of stem cell

Greenpeace’s attempts to have “stem cell” patents of Oliver Brüstle revoked moves to the European Court of Justice: The Budnesgerichtshof (German Federal Supreme Court) has referred to the ECJ several questions about the patentability of the use of stem cells to treat various neural diseases.

IPKat has details here, summarising the issues as :

The ECJ will now have to rule on the interpretation of “human embryo” in the sense of art. 6 Directive 98/44/EC. Is a stem cell derived from a blastocyst which has lost its ability to develop into a human still an embryo? If so, is a blastocyst a human embryo? If so, is purely therapeutic use of stem cells a “commercial or industrial purpose” in the sense of art. 6?

By way of comparison, section 18(2) of our Act baldly declares:

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

This provision was introduced at a late stage of the legislative process. Deputy Commissioner Herald had to try and work out its meaning in Fertilitescentrum AB and Luminis Pty Ltd’s Application [2004] APO 19 where he considered that:

36. It seems to me that of these three approaches, only the third approach provides a satisfactory interpretation of s.18(2). Accordingly, in my view the correct interpretation of s.18(2) is ascertained by recognising a human being as being in the process of generation (in either of the two ways I refer to in paragraph 31) from the time of the processes that create a fertilised ovum (or other processes that give rise to an equivalent entity) up until the time of birth.
37. The prohibition of `human beings’ in my view is a prohibition of patenting of any entity that might reasonably claim the status of a human being. Clearly a person that has been born is covered by this exclusion. But to the extent that there is a process of generation of a human being that lasts from fertilisation to birth, I consider that a fertilised ovum and all its subsequent manifestations are covered by this exclusion.

36. It seems to me that of these three approaches, only the third approach provides a satisfactory interpretation of s.18(2). Accordingly, in my view the correct interpretation of s.18(2) is ascertained by recognising a human being as being in the process of generation (in either of the two ways I refer to in paragraph 31) from the time of the processes that create a fertilised ovum (or other processes that give rise to an equivalent entity) up until the time of birth.

37. The prohibition of `human beings’ in my view is a prohibition of patenting of any entity that might reasonably claim the status of a human being. Clearly a person that has been born is covered by this exclusion. But to the extent that there is a process of generation of a human being that lasts from fertilisation to birth, I consider that a fertilised ovum and all its subsequent manifestations are covered by this exclusion.

In application of that ruling, the Examiner’s Manual indicates that the Commissioner’s policy with respect to stems cells is that:

it follows that human stem cells and human stem cell lines per se are patentable because these cells are not considered to be human beings or potential human beings within the meaning of s18(2).