TRIPS Protocol

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The provisions relating to Crown Use in the lapsed bill have been withdrawn and will be the subject of a separate bill in the future.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

Summer must be over … Read More »

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.  ?

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