Posts Tagged ‘raising the bar’

Intellectual Property Laws Amendment Bill 2014

Thursday, March 20th, 2014

After the consultation, the Intellectual Property Laws Amendment Bill 2014 has been introduced.

  • Schedules 1 and 2 aim to implement the TRIPS Protocol:

    According to the EM:

    Under the new scheme, Australian laboratories will be able to apply to the Federal Court for a compulsory licence to manufacture generic versions of patented medicines under specific conditions, and export these medicines to developing countries. Adequate compensation for the patent holder will be negotiated, to ensure that they are not disadvantaged by the arrangements.

    Schedule 1 introduces provisions to implement the “interim waiver” agreed in the Doha Declaration 2001; Schedule 2 implements the TRIPS Protocol regime agreed in 2003 (or, I think, 2005).

    According to the EM, only one licence has been issued under these regimes – Canada in 2007. Apparently, Canadian generics would like to engage in further licensing, but the procedures are too complicated. Also, Least Developed Countries do not need to provide patent protection until 2016 and there is said to be a lack of awareness of the regime.[1]

  • Schedule 3 confers jurisdiction over plant breeder’s rights matters on the Federal Circuit Court (in addition to the Federal Court)
  • Schedule 4:
    • introduces the “single examination” model for patent applications in Australia and New Zealand;[2]
    • the single regulatory regime for patent attorneys and trade mark attorneys in both countries – the so-called trans-Tasman regulatory regime; and
    • provides for a single address for service in either Australia or New Zealand to be used under the patents, trade marks, registered designs and plant breeder’s rights legislation.
  • Schedule 5 is headed “Technical Amendments” which include repealing “unnecessary document retention provisions” and addressing “minor oversights in the drafting of” the Raising the Bar Act. These include:
    • amending s 29A so that an international applicant under the PCT cannot require anything to be done in Australia until the application enters the national phase;
    • amending s 29B so that only the prescribed period under s 38(1A) applies to Paris Convention applications;
    • amending ss 41 and 43 in relation to disclosure requirements for micro-organism inventions
    • amending s 43 to permit reference to the combination of prescribed documents, not just to individual prescribed documents alone
    • the defence in s 119(3)(b) will be amended to bring it into line with the amended form of s 24(1)(a)
    • amending s 191A so that the requirement for the Commissioner to hear both parties prescribed in s 191A(4) applies only in entitlement disputes.

Intellectual Property Laws Amendment Bill 2014

Explanatory memorandum


  1. The Regulatory Impact Statement included in the EM estimates that 63 in-house legal professionals and 128 patent attorneys in external firms will need to familiarise themselves with these changes for a total start up cost to business of $13,782.60 and an ongoing annual cost of $105. These costs include allowance for savings in legal costs because it will be possible to bring proceedings for infringement of plant breeder’s rights in the Federal Circuit Court, rather than the Federal Court. Perhaps confusing costs with earnings, the Regulatory Impact Statement relies on the ABS Employee Earnings and Hours Survey to estimate the average cost of patent and trade mark attorneys as $50 per hour (junior solicitors $60 per hour, IP attorneys $74.10 per hour and barristers $92.70 per hour, after including a 50% loading for overheads). The Statement does recognise that charge out rates “for lega”for legal professionals can range from $120 per hour to $800 per hour or more, viewed on 4 December 2013 at http://www.legallawyers.com.au/legal-topics/law-firm-sydney/solicitor-prices/. These costs do not reflect the opportunity cost of labour.” You may also be interested to know that the Regulatory Impact Statement estimates the costs of an application to the Federal Court for a licence at around $21,650 for the applicant.  ?
  2. The substance of the two countries’ respective patent laws is not being harmonised (yet).  ?

Did the Earth move for you too?

Monday, April 15th, 2013

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.


  1. Austlii doesn’t seem to have caught up with all the minutiae yet.  ?
  2. The ‘old’ rules will continue to apply for all standard patents granted before 15 April and any pending applications for which a request for examination had been made before 15 April. (This the pre–15 April 2013 version of s 40 will break when the new rules come in.)  ?
  3. where the words in between [ and ] are deleted by the new Act  ?
  4. For England and Wales (of course).  ?

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

Raising the Bar update

Monday, January 21st, 2013

Following the conclusion of consultations about the draft Intellectual Property Legislation Amendment Regulations (the regulations to implement the “Raising the Bar” amendments), IP Australia has published a document outlining the outcomes of the consultation process.

The document outlines what IP Australia is proposing to do/implement in relation to:

 

Schedule 1

 

  • preliminary search and opinion
  • search fee
  • priority date
  • other things

 

Schedule 3

 

  • filing of evidence in oppositions
  • extensions of time to file evidence
  • confidentiality
  • fees for notice of intention to defenddefence (TM oppositions) (lid dip: Andrew Sykes)
  • cooling off period for patent oppositions (not in the public interest)
  • dismissing trade mark oppositions for inadequately particularised grounds
  • document service
  • no changes to basis for adding grounds / particulars to a notice of opposition
  • no change to costs provisions

 

Schedule 4

 

  • suspension regime for patent / trade mark attorneys will be retained

 

Schedule 5

 

  • customs seizure: regulations will be amended to require importers to provide full name, telephone number and address for service in ‘claim for release’ forms
  • email address will not be made mandatory

 

Schedule 6

 

  • applicants for patents will have 2 months to respond to a direction to request examination after examination has been deferred
  • acceptance period after 1st report on patent application has been issued will be reduced to 12 months
  • “IP Australia will not require a statement of entitlement at filing for standard patents (or at national phase entry for PCT applications). Instead, the statement will be required when the applicant requests examination, as part of the approved form.” Applicants for an innovation patent will still need to provide the statement when filing the application
  • The Commissioner / Registrar will retain discretion to decide whether hearings should be decided on the papers without oral presentation
  • Apparently, there are technical corrections that will be implemented to

Links to:

 

Public Consultation Update papers

IP Australia’s Press Release

 

 

IP Australia’s helicopter summary of Raising the Bar, more links and IP Australia’s summaries for patents, copyrighttrade marks and designs.

Patentology looks at the good news for SMEs and some of the things rejected, here.

Raising the bar reg.s 2.2

Monday, October 15th, 2012

Dr Summerfield has updated his marked up version of the reg.s to reflect the second tranche of the exposure draft regulations, here.

He also draws attention to the shortening time frames the exposure draft regulations will introduce.

You still need to get your comments in by 21 November 2012.

2nd tranche of Raising the Bar draft regulations

Thursday, October 11th, 2012

IP Australia today released the second tranche of exposure draft regulations implementing the Intellectual Property Laws Amendment (Raising the Bar) Act 2012.

This tranche deals with schedule 3 (reducing delays in resolving patent and trade mark applications) and schedule 6 (simplifying the IP system).

Comments still need to be submitted by 21 November 2012.

Go here, and scroll down (past the first tranche if you already have them).

Dr Summerfield prepared a marked up version of the regs as the first tranche would amend them and discussed the new search fee implications.

Raising the Bar regulations

Friday, September 21st, 2012

IP Australia has published the first tranche of draft regulations to implement the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (most of which comes into force on 15 April next year).

This tranche includes the draft regulations for:

  •  Schedule 1 – Raising the quality of granted patents,
  • Schedule 4 – Assisting the operations of the IP profession, and
  • Schedule 5 – Improving mechanisms for trade mark and copyright enforcement.

Comments should be submitted by 21 November 2012.

Download all the gory details, including draft EMs, here.

Lots have people have had a go at trying to explain some, or all, of the ramifications of the Act. If you don’t want to Google, or bing, or duck duck go, the EM can be found on Parliament’s site here and the Bills Digest prepared by the Parliamentary secretariat is here.

Raising the Bar Act

Tuesday, April 17th, 2012

Apparently, the Governor-General signed the Royal Assent to the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 on 15 April 2012.

According to IP Australia, most of the amendments will not come into force until 15 April 2013, but the exceptions to patent infringement for (1) regulatory use or (2) experimental use are now in force.

Many of the changes yet to come into force do relate to patents. There are, however, important changes to trade mark registrability (amongst other things) and conferral of original jurisdiction (from 15 April 2013) on the Federal Magistrates Court in matters concerning registered designs, trade marks or PBR , including appeals from the Registrar, infringement and revocation proceedings.

The Act (AUSTLII doesn’t have a link at the time or writing).

IP Australia’s announcement. Links to some previous commentary here.

The Raising the Bar bill comes alive

Tuesday, February 28th, 2012

News from IP Australia that the Senate finally passed the Intellectual Property Laws Amendment (Raising the Bar) Bill without further amendment.

It is now expected to be passed by the House of Representatives in the “autumn” sittings.

Some earlier posts here, here, here and here. IP Australia’s summary. The EM.

IPSANZ and patent amendments

Monday, September 5th, 2011

One of the interesting sessions at the IPSANZ conference was David Catterns QC and the 2 Gregs talking about amending patent specifications – before and after grant.

I certainly wouldn’t disagree with the view that, all other things being equal, you should amend before litigation rather than during (although how often are all other things equal, especially for patents in multiple jurisdictions). Australian law, at least insofar as it concerns amendments before the Commissioner, however, may be moving closer to the New Zealand situation.

The Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 includes in Sch 1 at item 31 an amendment to s 102:

(2D) An amendment of a patent request or a complete specification is not allowable if it is of a kind prescribed by regulations made for the purposes of this section.

For some reason I have a (vague) recollection that this provision may be used to confer on the Commissioner through the Regs a discretion similar to that which the Court has under s 105. I am afraid I have not been able to re-locate wherever it was that I read or heard this.

Does anyone know any better or differently?

It doesn’t seem to be what the EM contemplates as the role for item 31 and one might have thought that there might be scope to expand the regulations made for the purposes of s 104 to effect that goal (if it were intended to be achieved) as it is the “narrowness” of those regulations which leads to the present situation.

One might question the constitutional desirability of putting such ‘substantive’ matters in the Regs rather than expressing them in the Act itself. However, that fight seems, sadly, to have been well and truly lost. In any event, if the introduction of such a discretion in the Commissioner be intended, it would surely be in everyone’s interests to amend the terms of s 104 itself to track the terms of s 105(1) rather than bury it away in the Regs.