Intellectual Property Laws Amendment Bill 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).  ?

Summer must be over …

IP Australia has released a consultation paper (pdf) (with exposure draft bill (pdf) and draft EM (pdf)) on the proposed Intellectual Property Laws Amendment Bill 2014.

According to the overview, the proposed bill will:

  • implement the Protocol amending the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property (TRIPS Protocol – links via here), enabling Australian medicine producers to manufacture and export patented pharmaceuticals to countries experiencing health crises, under a compulsory licence from the Federal Court
  • extend the jurisdiction of the former Federal Magistrates Court, the Federal Circuit Court, to include plant breeder’s rights matters
  • allow for a single trans-Tasman patent attorney regime and single patent application and examination processes for Australia and New Zealand, as part of the broader Single Economic Market (SEM) agenda
  • make minor administrative changes to the Patents, Trade Marks and Designs Acts to repeal unnecessary document retention provisions that are already adequately governed by the Archives Act 1983
  • make minor technical amendments to the Patents Act to correct oversights in the drafting of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 which was passed by Parliament in March 2012.

The proposed bill succeeds the Intellectual Property Laws Amendment Bill 2013, which proved rather more controversial than the former government, or its advisors, expected (see, for example, here (pdf)) and lapsed with the calling of the election.

According to the consultation paper, the proposed bill largely replicates the lapsed bill, but there have been changes in 5 key areas.

The provisions relating to Crown Use in the lapsed bill have been withdrawn and will be the subject of a separate bill in the future.

The provisions to implement the TRIPS Protocol drew much of the controversy. According to the consultation paper, these have been amended in a number of important respects. First, it is proposed that separate applications will be required for each patent that a person seeking a licence to manufacture under the TRIPS Protocol requires. It is hoped that this will address concerns about an imbalance of negotiating power if the patentee of one patent also required access to someone else’s patent(s) to take advantage of the proposed compulsory licence.

Secondly, the proposed compulsory licence will be to exploit the patent for the relevant purpose rather than the more limited “work” the patent.

To preclude the need to change the regulations when (perhaps that should be “if”) there is a change in a country a country qualifies as a permissible import destination, and the notification requirements according to whether the country is a member of the WTO or an LDC, the regulations will refer simply to the relevant lists maintained by the WTO and/or the UN.

Whether these changes will meet the substantive objections raised against the lapsed bill remains to be seen.

Unfortunately, the draft bill fails to address one important oversight from the Raising the Bar Act. The Raising the Bar Act replaced the standard applicable during examination and opposition to the grant of a patent from one of practically certain to be invalid to one of balance of probabilities: see Sch. 1 Part 2 items 39 to 54.

It has not been determined finally what standard applies in trade mark proceedings, although the preponderance of authority in the Federal Court appears to support the “practically certain to be invalid” standard to the examination and opposition of trade marks. See for example NV Sumatra v BAT at [16] – [38]. This position was adopted by analogy to, and for conformity with, the position then prevailing for patents. The reasons why this was changed for patents are equally applicable for trade mark applications. One would think it was high time to address this.

Comments and submissions are required by 7 February 2014.

Links to IP Australia’s documents via here.

Intellectual Property Laws Amendment Bill 2012 – exposure draft

IP Australia has released for public comment an exposure draft of the proposed Intellectual Property Laws Amendment Bill 2012. The Bill has 2 purposes:

  1. to amend the Patents Act 1990 in light of the DOHA Declaration / TRIPS Protocol; and
  2. to confer original jurisdiction in matters arising under the Plant Breeder’s Rights Act 1994 on the Federal Magistrates Court in addition to the Federal Court’s existing jurisdiction.

DOHA Declaration[1] / TRIPS Protocol

Article 31 (scroll down) of the TRIPS Agreement permits members of the WTO to permit the use of patented inventions without the permission of the rightholder in the circumstances set out in the article.

The HIV/Aids crisis in Africa revealed a problem in this regime in that a number of countries which needed to rely on these provisions did not have the infrastructure, or were otherwise unable effectively, to take advantage of this regime. The basic idea underlying, first, the DOHA Declaration and, then, the TRIPS Protocol is to enable such countries to take advantage of the facilities and expertise in other countries by having the relevant drug made under compulsory licence in the foreign country.

So far, only Canada has notified the WTO pursuant to the DOHA Declaration that it has granted a compulsory licence to Apotex to export TriAvir[2] to Rwanda.[3]

Following on from consultations begun in 2010, the Government announced its intention to amend the Patents Act to implement the DOHA regime in March last year. The object of the proposed amendments is to introduce a regime for the grant of compulsory licences of pharmaceutical products on public health grounds for export to least-developed or developing countries (to be defined in the Bill as “eligible importing countries”).
As the TRIPS Protocol is not yet in force,[4] schedule 1 of the Bill is intended to implement the interim regime adopted under the DOHA Declaration. When the TRIPS Protocol does come into force, the regime in schedule 1 will be superseded by the regime to be enacted by schedule 2 of the Bill.

In either case, the regime will be separate from, and independent of, the existing compulsory licensing regime relating to domestic non-use which is currently the subject of a reference to the Productivity Commission.

As with the existing “non-use” regime, any compulsory licences would be granted only on application to the Federal Court, and not the Commissioner of Patents. If the patents in question are innovation patents, it would be necessary to apply for certification (where that has not occurred already).

Federal Magistrates Court

The extension of jurisdiction over PBR matters to the Federal Magistrates Court, which “is designed to deal with less complex matters more quickly and informally than the Federal Court”, follows several years experience with copyright matters and the extension of jurisdiction over patent, trade mark and registered design matters enacted by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012, which comes into effect on 15 April 2013.

Onus in trade mark oppositions

I wonder why the bill doesn’t fix up the onus for oppositions to the registration of trade marks to the “balance of probabilities” standard in line with the amendments – see Part 2 – that will apply in patent oppositions from 1 April 2013?

Submissions should be made by 1 October 2012.

Intellectual Property Laws Amendment Bill 2012 – exposure draft

Exposure draft Explanatory Memorandum

IP Australia’s Home Page for the exposure draft process.


  1. This is not strictly accurate terminology: I am using it as shorthand to refer to the WTO Council decision in December 2003 on paragraph 6 of the DOHA Declaration made in 2001. The WTO’s overview page is here.  ?
  2. A fixed-dose combination product of Zidovudine, Lamivudine and Nevirapine, according to Rwanda’s notification: see View Notifications.  ?
  3. The compulsory licence was issued by the Commissioner of Patents on 19 September 2007 for a period of 2 years: click on View notifications.  ?
  4. Australia has already accepted the TRIPS Protocol, but it does not come into force until two thirds of WTO’s 155 members accept it. If one counts the EU as “one” member – not sure on the politics of this as there are currently 27 members of the EU, as at May this year 44 members had accepted the TRIPS Protocol.  ?

Phillip Morris sues Australia!

Phillip Morris has announced that it plans to sue Australia under the Australia-Hong Kong (SA) Bilateral Investment Treaty over the planned plain packaging legislation.

What the Government is proposing to do

Under the proposed Tobacco Plain Packaging Bill 2011, tobacco companies would be required to adopt a prescribed form of packaging for tobacco products.

In its most recent form, this would involve all tobacco companies using the same olive brown colour for their packaging with large, graphic images and health warnings. Some illustrations here. The contemplated regulations would limit brand names to be positioned on the top, bottom and a designated position on the front of the box in Lucida sans serif font, point size 14. (See pp. 12 and 13 of the Consultation Paper (pdf).

The trade mark lawyers amongst us will notice that clause 15 of the proposed bill will preclude a registered trade mark from being removed for non-use resulting from the strictures imposed by the proposed legislation.

The announced intention is for the laws to come into full operation on 1 July 2012. The proposal is only in exposure draft form at this stage, with public comment being scheduled to have closed by 6 June. However, the Opposition has apparently indicated its support for the Government’s position.

What Phillip Morris claims

If you read a newspaper in Australia, you can hardly have failed to notice the advertisements taken out by the tobacco companies violently opposed to this plan. There is also a website.

Phillip Morris has taken matters a step further and lodged a notice of claim against Australia under the Australia-Hong Kong (SAR) Bilateral Investment Treaty.

Unlike Free Trade Agreements and WTO / TRIPS, apparently, companies can bring claims against a party (alleged) to be in breach of its treaty obligations, not just another country party.

It would appear that Phillip Morris is not just after compensation but also an order requiring Australia to suspend operation of the law.

Details about the basis of Phillip Morris’ claim are sketchy at this stage. According to Phillip Morris’ own News Release:

“The forced removal of trade marks and other valuable intellectual property is a clear violation of the terms of the bilateral investment treaty between Australia and Hong Kong. We believe we have a very strong legal case and will be seeking significant financial compensation for the damage to our business”.

The speculation is that Phillip Morris will argue that the proposed law is an expropriation of Phillip Morris’ investments (trade mark rights) without fair compensation: see Article 6.

According to its Press Release, Phillip Morris has apparently garnered support from an eminent Georgetown professor (and Harvard graduate) for its position.

The Government has previously denied its plans will breach its international obligations.

Assoc. Prof. Jurgen Kurtz at Melbourne University has a very interesting consideration of the issues, noting that there is case law which would support the Government’s position as well as a contrary line. Prof. Rothwell from the ANU also explores the issues. He also reportedly contends that Phillip Morris may well have lodged its complaint too soon as the bill is not law yet, although, presumably, that would not preclude another complaint at a later stage.

The News Release also indicates that a period of 3 months’ negotiating follows before an arbitration proceeding is implemented under the Arbitration Rules of the United Nations Commission on International Trade Law 2010. The process will not be a short one!

Compulsory licences for patented medicines

The Australian government has announced its intention to amend the Patents Act by the end of 2011 to empower the Federal Court to grant “to manufacture and export patented pharmaceuticals to countries trying to deal with epidemics and other types of health crises.”

This announcement appears to implement the DOHA declaration (in 2001) on the compatability of TRIPS and public health issues particularly in developing countries.

Press announcement here. WHO on DOHA here and here (pdf). DOHA itself, Chairman’s statement and notifications (only Canada has made it on to the list as an exporting country, so far) and the 2005 amendment Protocol (of which, so far, only 34 members have notified acceptance (68 to go)).

TRIPs protocol: Australian implementation consultation

IP Australia has issued a consultation paper on implementing the TRIPS protocol.

The TRIPS protocol is the modification (or is that clarification?) of TRIPS obligations to improve the availability of “crisis” pharmaceuticals in least developed and developing countries. From the discussion paper:

The TRIPS Protocol seeks to address this problem by amending the TRIPS Agreement to permit WTO members to issue compulsory licences to produce patented pharmaceutical products for export to least-developed and developing countries. The main features of the Protocol are:
• Licences may only be issued for products of the pharmaceutical sector needed to address public health concerns.
• Countries eligible to import pharmaceuticals under the system comprise any least-developed WTO country or any other WTO country that has notified the TRIPS Council.
• Importing countries are obliged to provide the TRIPS Council with details such as the names and quantities of the products needed and whether they need to issue a compulsory licence in their own country.
• Exporting countries are obliged to notify the TRIPS Council of a range of details and ensure that importing countries have done the same.
• Both importers and exporters must have in place anti-diversion measures to ensure the products produced under the system reach the intended market and are not re-exported.

Read the paper here (pdf).

Submissions due by 4 June 2010.

Patents, pharmaceuticals and exports

I’m not quite sure why, but the blogosphere is increasingly chattering again about relaxing the rules against infringing a patent by making the protected product (esp. a pharmaceutical) for export:

IP’s What’s Up reviews the TRIPS status including the DOHA declaration and its rather tentative take up.