On 30 May 2013, the Australian Parliament was presented with a Bill for an Act to amend legislation relating to intellectual property called the Intellectual Property Laws Amendment Bill 2013 ('the Bill'). This is not to be confused with the Intellectual Property Laws Amendment Act 2012 (aka the Raising the Bar legislation), which came into effect on 15 April 2013. However, the announcement of a Federal Election in Australia means that implementation of the Bill is still some time off (likely early next year).
The Bill focusses on a number of areas, which were not addressed in the Raising the Bar legislation. It also seeks to clarify some of the Raising the Bar provisions on each of the Patents Act 1990, Trade Marks Act 1995, Designs Act 2003 and the Plant Breeder's Rights Act 1994.
A recent Australian Productivity Commission report into 'Compulsory Licensing of Patents', found that there was a lack of transparency and some ambiguity relating to Crown use. Crown use relates to the notion of government use of IP rights, without the authorisation of the owner of the IP.
The Bill proposes amending existing provisions to:
- Clarify that Crown use can be invoked for the provision of a service that the Australian, State and/or Territory Governments have the primary responsibility for providing or funding
- Require that the Crown attempt to negotiate use of the patented invention prior to invoking Crown use
- Require that the Crown provide the patentee with a statement of reasons no less than 14 days before such use occurs
- Require that Crown use be approved by a Federal Minister or State Attorney General
- Require that in instances of Crown use, the patentee is entitled to remuneration determined on the same basis as that for a compulsory licence.
The Productivity Commission report (upon which the proposed amendments in the Bill are based), considered that Crown use would be a more efficient and cost effective way for governments to make use of patented inventions than compulsory licensing. If the Bill becomes law, we may start to see increased reliance on Crown use from government entities.
TRIPS protocol amendments: compulsory licensing of pharmaceutical patents
Under the Trade-Related Aspects of Intellectual Property (the TRIPS Agreement), products made under compulsory licence must be predominantly for the supply of the domestic market, and are not allowed to be exported. This creates a problem for less economically developed countries (LEDCs), which may have insufficient capacity to obtain or manufacture necessary pharmaceuticals during a public health crisis.
The Bill proposes amendments to enable LEDCs to source generic versions of patented pharmaceutical products from Australia to treat public health crises. Effectively, this is a proposal for a 'manufacture for export' exception to pharmaceutical patent rights in Australia. These proposed amendments are to apply to all existing patents and patents for which the application was filed before the commencement of the changes.
A rough outline of the proposed process for obtaining and exercising a compulsory licence is as follows:
1. Identify a need for a pharmaceutical, and establish an insufficient manufacturing need in a country
2. Identify an Australian manufacturer and identify the relevant patent(s)
3. Attempt to obtain authorisation from the innovator (patentee)
4. Notify an intent to use the system
5. Apply to the Federal Court for a compulsory licence
6. Notify the grant of the compulsory licence
7. Determine remuneration
8. Manufacture and export the patented pharmaceutical
9. Notify details of shipment
10. Take reasonable measures to prevent re-exportation.
The Bill proposes to allow Australian pharmaceutical manufacturers 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. Compensation for the patent holder will be negotiated, although there appears to be no indication as to who will negotiate adequate compensation or how such negotiation will occur.
Federal Circuit Court now available to owners of plant breeder's rights
The Bill proposes changes to provide the owners of plant breeder's rights (PBR) in a plant variety with the option of taking action in the Federal Circuit Court (previously known as the Federal Magistrates Court) against alleged infringers.
The amendments address the need for a way to resolve disputes about the infringement of a PBR that is quicker and less formal than taking action in the Federal Court. As most disputes over PBR are less complex matters than say a patent dispute, and many of the parties involved are small businesses with limited resources, the Federal Circuit Court is well placed to hear such cases.
Further alignment of Australian and New Zealand patent systems
The Bill proposes a single patent Examination model, which provides that if separate patent applications for the same invention are filed in both Australia and New Zealand, then both applications are examined by a single Examiner in either country. However, the Bill will take into account the separate national laws. In theory, a single patent application process will remove duplication and reduce costs to intellectual property owners.
Also proposed is the implementation of a bilateral arrangement between the Australian and New Zealand governments for the trans- Tasman regulation of patent attorneys in both Australia and New Zealand. Effectively this will allow for a single register of patent attorneys, a single set of qualifications for registration, a single governing Board and single Disciplinary tribunal.
Administrative changes and amendments to the Raising the Bar Act
The Bill proposes administrative changes to the Patents, Trade Marks and the Designs Acts to repeal document retention provisions which currently require IP Australia to physically retain patent, trade marks and designs documents for a certain period of time (25 years in some cases).
This Bill also proposes a number of technical amendments to the Patents Act to address oversights in the drafting of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012.
Should you require any further information on the Bill and how it may affect your IP interests, please do not hesitate to contact us.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.