clarity

ToolGen’s CRISPR/Cas9 patent application rejected

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Nicholas J has ruled that ToolGen’s application for a patent, AU 2013335451, for “what is now a well-known gene editing system known as the CRISPR/Cas9 system” for editing target DNZ sequences in eukaryotic cells. His Honour has allowed ToolGen until 11 August 2023 to bring any application for leave to amend pursuant to s 105(1A).

As the complete specification was filed after 15 April 2013, the Patents Act in the form amended by the Raising the Bar Act applied.

The matter came before his Honour on ToolGen’s “appeal” from an opposition in which the Commissioner’s delegate found that all but one of the claims should be refused but allowed ToolGen 2 months to amend.

At [13], Nicholas J summarised his Honour’s findings:

For the reasons that follow I have concluded:

(a)          None of the claims are entitled to priority based on P1 (s 43(2A)). 

(b)          All of the claims lack novelty or do not involve an inventive step (s 18(1)(b)).

(c)          The complete specification does not provide an enabling disclosure of the invention (s 40(2)(a)).

(d)          The claims are not supported by matter disclosed in the specification (s 40(3)).

(e)          Claim 19 lacks clarity (s 40(3)).

More detailed consideration will have to wait for another day.

ToolGen Incorporated v Fisher (No 2) [2023] FCA 794

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Abstract principle, fine art or just unknowable

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Mr Lisica applied for a patent, claim 1 of which reads:

An auscultative method that expounds upon the Natural Harmonics Series (NHS) and Mr Svetko Lisica’s Scientific Theory for Music’s decipherability and attunement, from the Invention’s Programmatic Specificity in a soniferous or visual realm for a new, useful, innovative and original Composition Engine and via its computations, providing the compositional harmonic materials that are put in the states of being manifested by the Invention’s unprecedented and original Musical Instrument and Sonic Biodynamical Brain Entrainment Bridge for Binaural Beats, into a stable unit of measure in exactitude for a tuning medium, herewith this Invention is the state or fact of existence, a practical Universal Intonation System that belongs with Music, The Absolute and The Beyond.

(The other claims are all dependent.)

Despite submissions to the Examiner, the Delegate at a hearing and an appeal to the Court, no-one (apart from Mr Lisica) really has any idea what the claimed invention is.

The Delegate rejected Mr Lisica’s application on the grounds that it was not a manner of manufacture and contravention of s 40(2) – the old form.[1]

Jessup J found only one objection was necessary: non-compliance with s 40(3) (in its old form):

The claims are, of course, critical to the exercise in which the court is now involved. It is here that the applicant encounters what is, for a court operating without the assistance of expert evidence, a fundamental difficulty. In my view, Claim 1, set out above, is not clear and succinct, as required by s 40(3) of the Patents Act. As a statement marking out the area of the public monopoly which the applicant seeks, the claim falls well short of the standard of clarity required. The ground of objection referred to in s 59(c) is substantiated in relation to the claim. I do not, therefore, consider that there is no lawful ground of objection of the kind referred to in s 49(1)(b). I would exercise the discretion arising under s 49(2) adversely to the applicant.

The Commissioner (or, rather, her officers) were a bit naughty. Mr Lisica had submitted 6 files in support of his application. The Examiner and the Delegate only opened and read 2 of them. Apparently, the other files were in SCM format, which the Patent Office couldn’t open.[2]

The naughty bit: no-one told Mr Lisica that the Patent Office didn’t read the files (because they couldn’t open them) until everyone got to Court for the trial. As Jessup J explained:

It may have required a modicum of ingenuity to open the SCM files – in a demonstration in court, the applicant himself did so. But the troubling aspect of the omission referred to above is not whether it was reasonable of the applicant to have expected the examiner and the delegate to open the files, but that the applicant was never informed of the difficulty which they were, apparently, experiencing, nor invited to remedy it. The examiner’s report was supplied to the applicant in the normal course, and it gave him no reason to suspect that four out of the six files which he had submitted had not been viewed or considered for such assistance as they may have provided in conveying the nature of the invention and how it was best performed. In that state of ignorance, the applicant made his submissions to the delegate, and he too dealt with the problems which the application involved without viewing all the files which constituted the application.

(His Honour did note that he was not suggesting any different result might have occurred if the correct process had observed.) Jessup J seems to be contemplating not allowing the Commissioner her costs:

In the orders which accompany these reasons, I shall lay out a timetable for the making of written submissions on costs. I shall, of course, consider any submission which the Commissioner makes in that regard, but I think I should say at this stage that one issue upon which I would expect to be addressed in that submission is whether the circumstances most recently discussed above in these reasons should be considered relevant to such entitlement to costs as the Commissioner might otherwise have as the successful party in this appeal.

Lisica v Commissioner of Patents [2014] FCA 433

  1. Relying amongst other things on Research Affiliates.  ?
  2. His Honour drily noted, even a file in .doc format does not comply with the Commissioner’s requirements.  ?

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Innovation review

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I’m still wading my way through the Innovation Review.

Meanwhile Duncan Bucknell is highly critical, particularly of recommendation 7.2:

Recommendation 7.2: Patent law should be reviewed to ensure that the inventive steps required to qualify for patents are considerable, and that the resulting patents are well defined, so as to minimise litigation and maximise the scope for subsequent innovators.

As Duncan points out, what does this actually mean?  Well, Ben Roxborough at IPRoo thinks we should pay much more attention to this recommendation as it appears to be, or be very close to, what IP Australia thinks should happen.  Follow Ben’s link from here.

If that is right, then there must be a very good chance that, whatever it means, it is going to happen.

One certainly can’t quibble with the idea that patents should be certain and clear in scope.  Indeed, Besson & Meurer contend that one of the main reason why the patent system in the USA is not working properly is precisely because patents there are not clear and certain in scope. (Blog summaries here and here.)

Given Australia’s role as an IP importer, and bearing in mind we have the innovation patent too, one can’t really quibble with the idea that we shouldn’t be granting standard or “real” patents for things that wouldn’t get patented overseas – well, I suppose one can quibble, but I’m not at all sure what would be the justification for allowing patents in Australia which are not patentable elsewhere.  

(As an aside, I wonder how requiring more inventiveness, if it can be defined, fits in with having innovation patents – which are certainly real – but for rather more limited, limited terms.)

In the Alphapharm case (see esp. [80 -81], however, the majority of the High Court pointed out that there didn’t seem to be a “standard” international approach.  On the other hand, there is some evidence emerging that it may be easier to get patents in Australia than Europe and Japan but, possibly, not the USA.

If that is what the evidence does suggest, one might then have to go on to ask (amongst other things) how much of the difference is due to, say, EU-centric rules like no patents on computer programs as such?

Now, I have previously mentioned that Prof. Mark Lemley provides one of the clearest explanations I have come across on whay that is not a good idea (listen to podcast #62).  And that was in the context of considering patentable subject matter.

And guess what, that is the subject of another Australian governmental review.  So, it looks like change is coming.  Perhaps, you should get involved?

On recommendation 7.3:

Recommendation 7.3:  Professional practitioners and beneficiaries of the IP system should be closely involved in IP policy making.  However IP policy is economic policy. It should make the same transition as competition policy did in the 1980s and 90s to being managed as such.

I can’t do better than quote the new DG:

In this regard, it is useful to remember that intellectual property is not an end in itself. It is an instrumentality for achieving certain public policies, most notably, through patents, designs and copyright, the stimulation and diffusion of innovation and creativity on which we have become so dependent, and, through trademarks, geographical indications and unfair competition law, the establishment of order in the market and the countering of those enemies of markets and consumers: uncertainty, confusion and fraud. In the end, our debates and discussions are about how intellectual property can best serve those underlying policies: whether modifying the international framework will enhance or constrain innovation and creativity and contribute to their diffusion, and whether it will add confusion, rather than clarity, to the functioning of the market.

Unfortunately, that doesn’t tells us in any particular case whether more protection or better exceptions are required.  It does, however, remind us what the rules are trying to balance.

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