Posts Tagged ‘ACIP’

Designs Act 2003 review

Friday, September 6th, 2013

In May 2012, ACIP was directed to investigate the effectiveness of the Designs Act 2003 which commenced operation on 17 June 2004.

Now ACIP has published an issues paper.

Chapter 3 sets out 22 questions ACIP is seeking answers to. However, ACIP does also say:

the main purpose of the paper is to provoke discussion and any other relevant comments are very welcome.

The topics identified (so far) for comment include:

  • Duration of design protection
  • Grace period
  • Statement of Newness and Distinctiveness
  • Publication
  • Unregistered Designs Rights (UDRs)
  • Harmonisation with international practices (i.e. The Hague Agreement)
  • Border Protection Measures
  • Design overlap with other IP rights
  • Threshold of registrability
  • Confusion regarding the registration/publication/examination process;
  • The (potential) impact of new technologies, such as 3D printing technologies and graphical user interfaces.

There are some interesting statistics:

  • about 6,000 design applications filed each year (the Germans do 50,000+ a year, the Chinese are a whole order of magnitude bigger)
  • 90% proceed to registration (wonder how the other 10% manage to stuff up filling in the form?)
  • 20% of registrations have examination requested (so you can sue someone for infringement or try and revoke them)
  • 10% of those examined fail (i.e., 90% get certified)

Table 4 sets out the classes in which most applications are being made and Table 5 outs those who file the most applications.

The closing date for submissions is 31 October 2013.

Download the issues paper from here (pdf).

Lid dip: Janice Luck

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Myriad wins Down Under

Sunday, February 17th, 2013

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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Innovation patents – further chance to protest

Monday, September 24th, 2012

IP Australia is seeking comments on how the innovation patent system is working.

Since 2001, Australia grants 2 types of patent: the standard patent with a normal term of 20 years and an innovation patent with a term up to 8 years.

Ann innovation patent need show only an innovative step over the prior art to be valid. According to the Full Court in Delnorth, this requires a difference that the person skilled in the art would understand makes a substantialmaterial contribution to how the product / method works. As the Full Court acknowledged, this is nothing like the inventive step requirement for a standard patent.  See also the SNF case.

According to IP Australia’s website:

Since the Delnorth (2009) decision in the Federal Court, relatively obvious minor improvements to inventions have been patentable.  There has been an unusual growth of innovation patent applications for certain technologies. There is some evidence that larger companies might be using the innovation patent system to extend the life of their patents and deliberately targeting competitors.

ACIP is already undertaking a review into the innovation patent system as a whole. The consultation paper for this (IP Australia’s) review explains:

The Advisory Council on Intellectual Property is presently conducting a review of the Innovation Patent system as a whole. In the mid term, this will provide valuable insights and recommendations for improvements.

In the short term, however, there is a pressing need to address emerging risks of the Innovation Patent system being used in ways which would lead to undue costs to consumers and to businesses that compete with owners of Innovation Patents. For example, there is a need to ensure that Innovation Patents do not inappropriately extend the life of pharmaceutical patents and delay the introduction of less expensive generic medicines, leading to increased costs to consumers and an increase in government expenditure through the Pharmaceutical Benefits Scheme.

As a result, the Government proposes to amend the Patents Act 1990 to raise the threshold for inventiveness to the same level as for Standard Patents (Attachment A refers). This approach is consistent with the second tier patent systems operating in countries such as Germany and Japan.

Comments are requested by 25 October 2012.

You can download the consultation paper, Innovation Patents – Raising the Step (sic), via this page.

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Gene (no)patenting bill going down

Friday, September 23rd, 2011

The Senate’s Legal and Constitutional Affairs Committee has, by majority, recommended that the Senate should not pass the Patent Amendment (Human Genes and Biological Materials) Bill 2010.

The Bill is a private members’ effort and, perhaps not surprisingly, the three of its sponsor still in the Senate dissented.

(At the time of writing, it is proving difficult to get a working link to the text of the Bill itself.) According to the EM it was considered desirable to expand the ban in s 18(2) on patenting human beings and the biological processes for their generation:

The purpose of this Bill is to advance medical and scientific research and the diagnosis, treatment and cure of human illness and disease by enabling doctors, clinicians and medical and scientific researchers to gain free and unfettered access to biological materials, however made, that are identical or substantially identical to such materials as they exist in nature.

These biological materials even if they have been isolated, purified or synthetically made have not been transformed from products of nature into products of humankind.

Thus the Bill (a) reinforces the applicability of the proviso in section 6 of the Statute of Monopolies within the meaning of section 18(1)(a) and section 18(1A)(a), (b) reinforces the applicability of the distinction between discovery and invention and (c) applies that distinction by expressly excluding from patentability, biological materials which are identical or substantially identical to such materials as they exist in nature, however made.

Notwithstanding this, it is rather difficult to find an Australian research institute researching genes etc. which supported the idea.

The ALRC of course had previously recommended leave well enough alone.

The issue doesn’t seem likely to go away. Apart from whatever the Bill’s sponsors and their allies may get up to, the majority concluded:

5.26 Like many of those who gave evidence, the committee prefers the solutions offered in the proposed amendments of the Raising the Bar Bill. However, the committee does not consider that the amendments in the Raising the Bar Bill will resolve all of the issues in the patent system. In the opinion of the committee, serious consideration should also be given to the proposals for legislative enactment of the patentable subject matter test and the general ‘ethical’ exclusion made in the ACIP report on patentable subject matter. Other reforms may also be necessary in the future, particularly in relation to ensuring equitable access to healthcare. In this context, the committee recognises that the Senate Community Affairs References Committee has indicated it will maintain a ‘watching brief’ in relation to the impact of gene patents in Australia.[5] Despite the need for further reform to the patent system, the committee agrees that removing an area of patentable subject matter, as proposed by the Bill, is not an appropriate solution to this complex set of issues. (emphasis and hyperlink supplied)

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ACIP reviews innovation patents

Wednesday, August 24th, 2011

On 28 February, the Minister directed ACIP to report on the innovation patent system.

On 17 August, ACIP published an issues paper (pdf) and now seeks your comments by 14 October 2011.

According to the announcement of the issue paper’s release:

In recent years a variety of concerns have been raised about the innovation patent system and whether it is meeting its original objectives. A key concern is that an innovation patent is overly difficult to invalidate and the remedies for infringement are overly generous. Another concern is that innovation patents are being used to obtain a form of quick protection for higher level inventions while a standard patent is being pursued. Also, the innovation patent system has never been reviewed to assess whether it remains effective and appropriate for Australia now and in the future.

Innovation patents (which are not for business schemes) are difficult to invalidate after Dura-Post? The Full Court confirmed that the test of ‘innovative step’ does not involve a sort of obviousness penumbra over common general knowledge. Rather, the patent is innovative unless it can be shown that the difference between the patent and the prior art do not make a substantial contribution to the working of the ‘invention’. This was apparently derived from Griffin v Isaacs. As the trial judge explained with the apparent approval of Kenny and Stone JJ at [70] and [79]:

Be that as it may, the feature of what Dixon J said was the disjunctive nature of the concepts – one was ‘make no substantial contribution to the working of the thing’; the other was ‘involve no ingenuity or inventive step’. The first alternative has been taken by Parliament virtually verbatim from the judgment. The focus is upon working of the invention (as claimed) not to the degree or kind of variation from the kinds of information set out in s 7(5). In other words, the variation from the kinds of information might be slight but, if a substantial contribution is made to the working of the invention, then there is an innovative step. … In my view the provenance of the phrase ‘make no substantial contribution to the working of the invention’ indicates that ‘substantial’ in this context means ‘real’ or ‘of substance’ as contrasted with distinctions without a real difference.

Rather than a modified inventive step test, it is a modified novelty test.

The Issues Paper runs to some 28 pages.

Interestingly, just over 11,000 innovation patents have been granted and 1,790 certified.Over 80% are to Australian inventors and around half are to Australian individuals as opposed to corporations (the proportion of certifications falls to 41%). The proportion of Australian grantees vs foreign appears to be falling over time.

1,011 of the grants are divisionals from applications for standard patents. For the first few years, that was about 5% of all divisional applications, but it has been at least 10% since 2006 with a couple of years getting closer to 14%. This leads to concerns that innovation patents are being used to get ‘quick’ rights.

There are also concerns that the pharmaceutical industry is using the system to ‘evergreen’ its patent portfolios.

The questions (although ACIP would like to take this opportunity to provoke discussion generally):

  1. Effectiveness in stimulating innovation
  2. Does Australia need a utility model?
  3. Does it cost too much?
  4. Is the cost of certification dissuading people from seeking certification?
  5. How do (people in) other jurisdictions jurisdictions perceive the innovation patent?
  6. Are there concerns about the uncertainty arising from the delays in getting certification?
  7. Are the current remedies appropriate?
  8. If the available remedies are reduced (e.g. you couldn’t get an injunction) would costs of (getting) an innovation patent be justified?
  9. How do you think the use of divisionals is working (and why did you do it)?

ACIP announcement

Issues paper (pdf)

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Government responses to ACIP enforcement reviews

Friday, June 3rd, 2011

The Government has announced its responses to ACIP’s reviews of:

On a quick skim, the main recommendation to introduce a Patents Tribunal to determine “IP” disputes has been found non-viable due to the limitations on the Commonwealth’s repository of judicial powers. With WIPO’s arbitration and mediation service in mind, however, IP Australia is to work with alternative dispute resolution providers to provide a new ADR resource. In the PBR context, the Government states that it does not consider it appropriate for IP Australia, as a regulatory agency, to provide post-grant mediation services itself.

The review on PBR has received rather mixed results.

The Government has not accepted the proposal to introduce a “purchase” right.

The PBR Act will be amended to clarify that harvested material which can also be used as propagating material qualifies as propagating material for the purposes of the Act’s prohibitions.

The Government accepts that no changes to the operation of ss 14 and 15 are required.

At this stage, the Government considers that the making of “mendacious” declarations of PBR is adequately covered by the prohibitions on misleading or deceptive conduct in trade or commerce.

Lots of recommendations for more education.

No doubt, you will have your own favourite recommendation(s), but (as I am not a Kat, ip or otherwise) that is all there is time for today!

The Minister’s Getting Tougher on Imitators press release.

ACIP’s “patents” review (pdf).

ACIP’s PBR review (pdf).

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Patentable subject matter in Australia

Wednesday, February 16th, 2011

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.

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Enforcement of PBR in Australia

Monday, February 1st, 2010

ACIP has published its final report into the Enforcement of plant breeder’s rights in Australia.

The report is here (pdf) – be warned 138pp, Exec Summary is 10pp.

Some recommendations:

 

Recommendation 1.

A new “purchase” right be added to s.11. This new right would only apply to those taxa that are specifically declared in the regulations. Industry sectors such as wheat breeders would apply to the PBR Office to have particular taxa so declared.

 

Recommendation 2.

The PBR Act be amended to clarify that harvested material that is also propagating material is to be considered as propagating material for the purposes of s.11, even if it is not being used for that purpose.

 

Recommendation 4.

There be no change to the operation of farmer’s privilege under s.17.

However, s.17 should be amended to state in easily understood terms that s.17 does not provide the farmer with the right to perform the acts listed in s.11(a) to (g). For example, the farmer will still require the PBR owner’s authorisation to sell the reproduced propagating material, the harvested material or the product of the harvested material.

Recommendation 5.

As part of IP Australia’s education and awareness programs, raise industry awareness of the opportunity under s.17(2) to have specific taxa excluded from the farmer’s privilege exemption.

Recommendation 6.

Encourage PBR owners to make clear to growers the conditions of sale of propagating material and their obligations in relation to future generations of it. This includes making clear that growers require the authorisation of the PBR owner to sell crops grown from farm-saved seed.

 

 

Recommendation 17.
Introduce an Information Notice system into the PBR Act based on the UK Information Notice system.
This would enable PBR owners to obtain information from suspected infringers on the
source of plant material. Where this is not supplied within a reasonable time, legal proceedings may be commenced in which the presumption is made that the plant material was obtained through unauthorised use of propagating material and that the PBR owner did not have a reasonable opportunity to exercise its rights in relation to the material.

Recommendation 14.

The jurisdiction of the second tier of the Federal Court of Australia to include PBR matters.

Appropriately qualified magistrates must be made available and there should be appropriate measures taken to ensure the processes of the second tier are faster and cheaper than in the first tier. Examples include simplifying and standardising procedures for expert evidence and DNA testing through the issuing practice notes, use of alternate dispute resolution where appropriate, and curtailing of the discovery phase.

Recommendation 12.

An on-going Expert Panel be established to provide guidance and opinions on general issues or specific cases concerning the PBR Act and related law. The Panel should comprise appropriate people with expertise in relevant areas who provide their services as required.

Upon request from any person and for a moderate fee, the Panel may provide detailed guidance and opinions on general issues or specific cases concerning the PBR Act and related law. The Panel should focus on the enforcement of granted rights and not provide advice on the registrability of individual applications for PBR. The Panel’s opinions should be made publicly available in a manner that respects commercially sensitive material. The Panel may refer matters to the Government or ACIP as it sees fit.

 

 

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Patentable Subject Matter: ACIP options paper

Monday, September 21st, 2009

ACIP has published an Options Paper in connection with its review of “patentable subject matter”.

Press release here.

Options Paper here.

The options under consideration are too far reaching for a “sound bite”.

For example (from the Press Release)

“The test for patentable subject matter in Australia is linked to legislation introduced
in England in 1623 so it really does need addressing within the context of modern
research and business,”

“The test for patentable subject matter in Australia is linked to legislation introduced in England in 1623 so it really does need addressing within the context of modern research and business”.

Of course, the fact that this disparaged Jacobean test is perhaps the most  modern, flexible, telelogical concept on our statute book since the NRDC case (in 1959) could be overlooked.

Also (from the Press Release):

ACIP have also proposed possible safeguards to ensure public concerns are reflected in decisions to grant patents.

Submissions by Friday 13th (!) November 2009.

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ACIP: Post grant patent enforcement

Monday, August 24th, 2009

ACIP’s interim report on Post-Grant Patent Enforcement Strategies is now available on the internet (pdf).

The main recommendation is that:

Proposal 1: That IP Australia establish an IP dispute resolution centre along the lines of WIPO’s Arbitration and Mediation Center, which in the first instance focuses on patent disputes. Funding for the centre should be on a “user pays” basis.

A number of “implementation” recommendations hang off that. For example:

Proposal 2: That IP Australia establish a validity and infringement opinion service (taking into account the needs of SMEs), along similar lines to that provided by the UKIPO, and incorporated within the IP dispute resolution centre.

Proposal 4: That IP Australia establish, within the IP dispute resolution centre, a determinative ADR process in the form of a Patent Tribunal along the following lines:

(a) each Tribunal hearing panel to comprise up to 3 people, integrating legal and technical expertise;

(b) Tribunal hearing panel members to be drawn from the register of experts established under Proposal 3;

(c) patent attorneys to have a right to appear;

(d) the Tribunal to have more streamlined procedures and simplified evidentiary requirements;

(e) the Tribunal to take a pro-active and inquisitorial role;

(f) mechanisms be introduced to encourage parties to comply with the Tribunal’s determinations, and to discourage parties from using the courts instead of the Tribunal where it would be appropriate to do so; and

(g) that the effectiveness of the Patent Tribunal be monitored from its date of establishment.

Also, there should be a power of customs’ seizure (as already exist for copyright and trade marks).

Submissions need to be in by Wednesday 30 September 2009.

Interim Report (pdf); press release (pdf too)

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