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Last year, the Supreme Court of Canada handed down 5 decisions on the same day relating to fair dealing and other issues arising from digital transmission of copyright material.

In a number of respects, its decisions are directly opposite to conclusions that have been reached by our High Court (one example – but it appeared to turn on different statutory language). In others, such as the ‘digital taxi’ theory, the issue may well be regarded as still highly controversial here.

Anyway, a number of Canadian experts have published  a book looking at the ramifications of these wide ranging decisions.

In an interesting experiment, you can buy it in the traditional way through the publisher or you may also download an ebook version for free. For more details, see the 1709 blog post.

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The patent war over escitalopram in Australia is still going!

One aspect of the Alphapharm / Lundbeck case I had forgotten (if I appreciated it at the time) was that Lindgren J quashed the extension of the patent’s term under s 70ff.

In June 2009, after the Full Court upheld Lindgren J’s decision, Lundbeck made a new application for an extension of term and also applied under s 223 for an extension of time to make that application – an extension of some 10 years or so.

In June 2011, the Commissioner granted Lundbeck’s application for an extension of time over oppositions by Alphapharm, Aspen and others. The AAT dismissed an appeal Aspen et al. and Aspen et al. have appealed from the AAT’s decision to the Full Court. That appeal is still pending.

Pending the outcome of the appeal, Yates J has now refused Aspen et al. a stay on the Commissioner’s decision to extend the term of the patent.[1]

Accepting that it was not ordinarily desirable that there be parallel proceedings before both the Commissioner and the Court, Yates J considered it was not appropriate to exercise his discretion to stay the proceedings before the Commissioner in this case.

While a number of considerations were advanced by both sides, the central consideration was that Lundbeck could well lose the ability to sue for some infringements if it was successful in extending the term of its patent. The issue here is that under s 120(4) proceedings for infringement must be brought within 6 years of the infringing conduct. Aspen et al. were not able to point to any real prejudice outweighing that.[2]

It may be of interest to note that the point in common between the 2 sets of proceedings is Aspen _et al._’s contention that the Commissioner has no power to grant the extension of term now under s 70(4) as she has already exercised the power (albeit invalidly) in granting the extension quashed by Lindgren J.[3]

Aspen Pharma Pty Ltd v H Lundbeck A/S [2013] FCA 324

ps [4]

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Various members of Schapelle Corby‘s family, like most other people who take photographs, do own copyright in the photographs they have taken and Allen & Unwin, which published 5 of their photographs in The Sins of the Father, has to pay damages for the unauthorised use of those copyrights.

Buchanan J awarded:

• between $500 and $5,000 compensatory damages pursuant to s 115(2) for each photograph; and
• $45,000 by way of additional damages pursuant to s 115(4) for the deliberate and studied disregard of the applicants’ copyrights.

Allen & Unwin has also been ordered to remove the photographs from its existing stocks and not to reproduce them again.

The evidence disclosed that some 44,000 copies of the book had been sold up to March 2013, from several print runs, including print runs after the proceeding commenced. The larger amounts reflected his Honour’s perception of greater commercial significance largely indicated by the accompanying text in the book. The $5,000 award was for the last photograph of Ms Corby with her father in Australia and, in addition to being used in the book, was reproduced on the back cover with relevant text.

Given the (reported) content of the book, it might seem surprising that the main defence was licence. The photographs had been given to Fairfax, not Allen & Unwin, for publication in relation to one or another newspaper article. Buchanan J found at [85]:

whatever photographs had been given by any member of the Corby family to media organisations for some other purpose, photographs had never been given by any member of the family to the respondent to reproduce. [The respondent's publisher] accepted that no member of the Corby family had granted permission to the respondent to reproduce the photographs. It is clear that the respondent had never sought any such permission.

There was no attempt to justify any publication through a fair dealing defence but, on the other hand, Buchanan J expressly rejected any insult to the Corby family as relevant to the calculation of additional damages:

120   In the present case, I do not regard as relevant to the assessment of additional damages any criticism of the Corby family, its individual members and its associates (actual or presumed) which is to be found in the book. Those damages will not be fixed to address any perceived insult to the Corby family or any of its members but will be fixed having regard to the seriousness, amongst other things, of the studied disregard of the regime of copyright protection established by the Copyright Act. In my view, the present case suggests a need to deter the respondent and others from conduct of a similar kind.

Contrast von Doussa J’s approach to personal and cultural harm in the Milpurrurru case from [146]ff.

The decision is also our third (?) moral rights case: the authors’ moral rights of attribution being infringed. Buchanan J, however, did not award damages for this having regard to s 195AZGG(3), the unlikelihood that any of the author’s would want to have been identified as participating in the production of the book and the damages awarded for copyright infringement.

Corby v Allen & Unwin Pty Limited [2013] FCA 370

The defamation action arising from the book’s publication is still making its way through the NSW courts.

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The NSW Department of Education is looking for someone who:

will lead negotiations on behalf of the TAFE sector in respect of statutory copyright collecting agencies Copyright Agency and Screenrights and other voluntary agreements as appropriate with other collecting societies.

The Manager will also support the National Copyright Director to provide specialist copyright advice to the school and TAFE sector, and implement smart copying initiatives in Schools and TAFEs.

If you think this might be you, find out more here.

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Most of the substantive Raising the Bar amendments came into force today.

Amongst other things, schedule 1 of the Raising the Bar Act introduced a raft of changes designed to raise the threshold of patentability – i.e., make it harder to get a patent.

These include:

• introducing the really diligent searcher of prior art for obviousness via changes to s 7(3)[1] so that it will be permissible to combine any piece of prior art with common general knowledge (if the skilled addressee could reasonably be expected to combine the two), not just those elements of the prior art that the skilled addressee could be reasonably expected to have found;
• a new concept of utility based on the US approach; and
• doing away with the ’old’[2] fair basis requirement in s 40 as interpreted by the High Court in that Lockwood ruling.

Instead of fair basing, a patent will be required by s 40(2) to disclose:

(a) the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art; and

(aa) the best method known to the applicant of performing the invention; and …

and s 40(3) will read:[3]

“The claim or claims must be clear and succinct and [fairly based on the matter described] supported by matter disclosed in the specification.”

Provisional specifications will have to meet the requirements set out above in s 40(2)(a) also.

This is intended to introduce into Australian law the requirements under the UK’s 1977 Act: s 72(1)(c).

The Court of Appeal[4] provides an interesting example of how these new rules should work in it Merial ruling. Merial had (at least) 2 patents relating to its Frontline brand of flea-treatment products. One of these, the 881 patent survived the attack on sufficiency of description, but the other, the 564 patent did not.

Kitchin LJ identified the crucial difference between the 2 patents at [85] – [86]:

…. This was a matter to which the judge expressly referred at [77]:

”77. In contrast to the examples in 881, the examples of 564 simply specify different concentrations of the active ingredients. The examples do not contain any formulation details beyond saying that there should be present a crystallisation inhibitor, an organic solvent and an organic co-solvent.”

This then was the critical difference between the disclosures of the two patents. Omnipharm failed to establish that the practical guidance given by the examples of the 881 patent was not sufficient to enable the skilled team to work across the breadth of the claims. But the 564 patent claimed a combination of actives and did so without any worked examples at all. It provided no real practical assistance over and above the common general knowledge.

Kitchin LJ accepted Merial’s argument that the UK Act did not impose an obligation to include examples of the way the claimed invention worked. However, his Lordship considered that was not why the trial judge, Floyd J, upheld the attack. Rather, the description was insufficient because it did not give sufficient guidance about which ingredients to choose and in what proportions. So, Kitchin LJ explained at [89]:

I reject these submissions. I think it is clear from [151] – [152] that the judge did not find that the absence of any detailed examples was, in itself, fatal to the sufficiency of the 564 patent. What rendered it insufficient, in his view, was the absence of proper exemplification of a formulation of the invention in the context of a specification which was generally inadequate to guide the skilled person to success and provided no real practical assistance beyond the teaching of the prior art and the common general knowledge. The specification contains no more than a very broad indication of the components of the formulation and, as the judge found, it is not a sufficient description to enable the skilled person to arrive at formulations across the breadth of the claims without undue effort.

One illustration of the problem with the 564 patent was set out earlier at [83]:

The disclosure in relation to solvents and co-solvents is something the judge also had well in mind, as is clear from [66]-[67]. Here he referred to the dielectric constant ranges which the solvent and co-solvent must meet, and that the co-solvent must have a boiling point below 100°C. He also referred to the lists of suitable solvents and co-solvents. This information would not, however, be of any practical use to the formulator who, as Dr Walters explained, would have to fall back on his general knowledge of solvents and techniques for enhancing spreading and skin penetration in order to decide on the appropriate solvent system to use.

Neither the Court of Appeal nor Floyd J at first instance set out at length the legal principles underlying insufficiency for these purposes. However, Floyd J had earlier set out his understanding of ‘classical insufficiency’, Biogen insufficiency and ‘insufficiency through ambiguity’ at [361] – [454] in Zipher.

Omnipharm Ltd v Merial [2013] EWCA Civ 2 via IPKat

ps.: those who attended David Brennan’s talk last year will find his ‘Monash paper’ in 38(1) Monash University Law Review 78.

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The Commonwealth Government’s Pharmaceutical Patents Review has published a draft report.

The draft Report is some 200 or so pages long; contains 4 draft findings and 15 draft recommendations (although recommendation 5 relating to the extension of term regime proposes 2 different alternatives).

There appears to be considerable, fascinating data reported. The scope and detail of the draft report will plainly require much further consideration.

At the policy level, the draft report considers there has been a significant failure of co-ordination between the various regulatory bodies that deal with issues relating to pharmaceuticals and patent protections:

Draft recommendation 10.1: The Government should establish a non-statutory Pharmaceutical System Coordinating Committee (PSCC) that reports to Parliament on an annual basis on the success and effectiveness of the patent, marketing approval and PBS systems, particularly where these interface. The PSCC should ensure there is sufficient engagement and coordination between the relevant agencies and take account of costs to government, efficiency of registration and approval processes and respond to issues raised by industry. The PSCC should comprise senior officials from at least DIICCSRTE, IP Australia, DoHA (Pharmaceutical Benefits Division and TGA), DFAT, Finance and Treasury (as chair).

This appears to reflect a general concern with the need for greater policy and practical concern throughout the report. See e.g. draft recommendation 7.2 (calling for an external (to IP Australia) patent oversight committee) and draft recommendation 3.2.

Recommendation 6.1 proposes retaining extension of term just for pharmaceutical products and not extending it to methods of use or manufacture. The bipolar recommendations 5.1 and 5.2, however, explore different ways of prescribing the term of the extension.

Other topics addressed in the draft report include: the impact of international agreements on Australia’s welfare, evergreening and follow-on patents, data protection

Comments on the draft report are required to be submitted by 30 April 2013.

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Big week for parallel imports last week:

(1) the US Supreme Court declared US law applies a doctrine of international exhaustion for copyright material

(2) Adobe, Apple and Microsoft fronted the Australian Parliament to explain why digital “things” cost so much more in Australia than elsewhere (i.e., the USA).

Apple’s defence said, amongst other things, it was the price it had to pay to the owners of Australian copyright – lovely chart here. Other reports (with more analysis) here and here (which may be challenges Apple’s explanation a bit for its own products).

That didn’t really work as an explanation for Adobe, which gets lambasted here.

Perhaps, just maybe, treating digital downloads as a single global market might lead to some lowering of prices, but the beauty of digital delivery (from the content owner’s perspective) is that you can set your price and the customer can buy or not.

Is there a link between (1) and (2)?

In his analysis, Prof. Goldman sets out a number of reasons why he thinks Kirtsaeng, while it may provide some good news in terms of lower prices, will have only a short term effect.

(I suppose we can trumpet the fact that our technological protection measure protections don’t extend to protecting region coding (here and here), although I do wonder how one would prove that was the purpose of the (ac)tpm.)

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The 1709 Blog has a report about the operation of the resale royalty right scheme (here or here) given by the (then) Minister for the Arts to the Senate.

Some highlights:

• since the scheme started in 2011, CAL (the official collecting agency) has paid out just over $805,000
• 150 “rights holders” (I guess that would be painters or their heirs) have received the top 600 payments which totalled just under $300,000
• 59% of the payments went to indigenous artists; of which there were 301 payments of the top 600 payments going to 91 “right holders”

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While the European Commission is trying to reduce the number of licensors you have to deal with (and so reduce transaction costs), the Australian legislation as interpreted by the courts is causing them to proliferate:

IPKat on Max Planck comments on draft directive on collective rights management

Phonographic Performance Company of Australia Limited v Commercial Radio Australia Limited [2013] FCAFC 11

Yes, I know the EU is grappling with territorial issues and not, or not just, subject matter issues and, if someone were trying to set up an umbrella licence in Australia, it would be important to know who had what rights to include, but …

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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

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