17 December, 2014

Australian IP Amendment Bill Tackles Trans-Tasman Initiatives and TRIPS Protocol

Australian IP Amendment Bill Tackles Trans-Tasman Initiatives and TRIPS Protocol

As Australian patent applicants, their representatives, and the Australian Patent Office settle into life after the substantial changes to patents legislation brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012, the Parliament of Australia is progressing the next instalment of IP amendments.

The Intellectual Property Laws Amendment Bill 2014 (‘the Bill’), which was introduced into Parliament on 19 March 2014 and most recently read in the Senate on 25 November 2014, will introduce, amongst other amendments, two key changes to the current Patents Act 1990.

Trans-Tasman Initiatives

The first change proposed by the Bill is the insertion of provisions enabling a trans-Tasman patent attorney regime and a Single Application Process (‘SAP’) and Single Examination Process (‘SEP’) for patents in Australia and New Zealand. [1]

These changes have been introduced as part of the broader Single Economic Market agenda, which aims to provide a seamless business environment and to deepen economic linkages between Australia and New Zealand.

Trans-Tasman Patent Attorneys

The proposed trans-Tasman patent attorney regime will establish common registration requirements for attorneys trained in Australia or New Zealand, [2] and will create a single register of trans-Tasman qualified attorneys governed by a trans-Tasman Code of Conduct. [3] Through such measures, it is hoped that business confidence in the quality and standard of service provided by patent attorneys in both Australia and New Zealand will be increased.

Trans-Tasman Application and Examination Processes

Currently, patent applicants wishing to file an application in Australia and New Zealand must do so by separately filing an application in each country and paying the respective official filing fees. Under the proposed SAP, patent applicants who wish to file a patent application in both Australia and New Zealand will be able to do so through a single process with either the Australian or New Zealand IP Office and have that filing recognised in both countries. [4] A single filing fee (amount yet to be set) can then be paid in one currency at the time of filing. [5] Accordingly, amendments proposed in the Bill include provisions for delegating powers of the Australian Commissioner of Patents to a New Zealand patent official. [6] The nature of the powers to be delegated will be set out at a future date in a bilateral arrangement to be signed by both countries.

In addition to the SAP, the Bill also introduces, in what is understood to be a world first, [7] a single examination process (SEP), which will allow patent applications for the same invention filed under the SAP to be examined by a single examiner in either Australia or New Zealand. [8] Currently, patent applicants have their Australian and New Zealand patent applications separately examined by the respective national IP Offices. Under the SEP, an examiner in either Australia or New Zealand will simultaneously examine an application under each country’s laws. [9] As the details of the SEP are yet to be finalised, it is not yet clear how examiners will be allocated to patent cases and therefore whether the country in which the application is filed will play a role.

A preliminary overview of the proposed changes to the Patents Regulations 1991 required to implement the trans-Tasman regime and the SAP/SEP is currently in the public consultation stage (see IP Australia’s website). A separate consultation process setting out the operational details of the SAP and SEP is set to occur upon completion of further work by Australia and New Zealand.

TRIPS Protocol

The second change is to insert compulsory licencing provisions intended to allow patented pharmaceuticals to be exported from a country with manufacturing capacity to a foreign country in need. Such provisions form part of the Doha Declaration on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and Public Health (the ‘TRIPS Protocol’), which Australia accepted in September 2007 but is yet to implement in its domestic laws.

The aim of the TRIPS Protocol is to encourage patent owners to provide medicines to least developed and developing countries in need at affordable prices, or to issue voluntary licences to generic manufacturers to do so. It achieves this aim by providing a mechanism to force a patent owner to issue a compulsory licence in circumstances where the patent owner is unwilling to provide the medicines themselves or to issue a voluntary licence and/or in cases of extreme urgency. [10] Accordingly, the Bill proposes to insert provisions to allow the Federal Court to grant patented pharmaceutical invention compulsory licences (‘PPI compulsory licences’) in circumstances where [11]

  • An applicant for a licence makes the application in good faith; and
  • The pharmaceutical product is to be imported by an eligible importing country; [12] and
  • The proposed use of the pharmaceutical product is to address a public health problem in the eligible importing country, i.e., in circumstances of national emergency or other circumstances of extreme urgency; or in other circumstances – by the public non-commercial use of the pharmaceutical product; and
  • Exploiting the patented pharmaceutical invention is necessary to enable the import and proposed use of the pharmaceutical product.

The PPI compulsory licence applicant and eligible importing country must also take reasonable measures to prevent the medicine exported under a PPI compulsory licence from being used for purposes other than addressing the public health problem. [13]

In this way, the Bill aims to ensure that countries in need are able to obtain supply of vital medicines whilst also supporting and encouraging innovation.

The proposed PPI compulsory licence provisions will not affect compulsory licence provisions as currently provided for in Chapter 12 of the Patents Act 1990 (Cth).

The PPI compulsory licence provisions are also proposed to be supplemented by additional changes to the Patents Act 1990 (Cth). These include amendments to Sections 70 and 71 of the Act to specify that inclusion of a pharmaceutical substance in the Australian Register of Therapeutic Goods (ARTG) for the sole purpose of exporting goods containing that substance is to be disregarded when determining the first regulatory approval date (and hence determining the period in which an extension of patent term must be made and the actual extension period).[14] This is proposed to be the case whether the first inclusion in the ARTG is sought by the patentee, a voluntary licence holder, or a PPI compulsory licence holder.

The Intellectual Property Legislation Amendment Regulation 2014 (No. 1) Exposure Draft, which includes proposed changes to the Regulations implementing the TRIPS Protocol-related provisions, is available for public viewing and comment on IP Australia’s website.

[1] See IP Australia, Regulation Changes Proposed to Implement Trans-Tasman Initiatives: Consultation Paper (December 2014) s 3 <http://www.ipaustralia.gov.au/pdfs/216785/Consultation_Paper_on_SEM_ Regulations.pdf>. [2] Ibid s 2.2. [3] Intellectual Property Laws Amendment Bill 2014 sch 4 items 39–58. See also IP Australia, above n 1, s 2. [4] Explanatory Memorandum, Intellectual Property Laws Amendment Bill 2014 sch 4 items 26–7. It appears at this time that the patent applicant will be able to choose to file this single application in either Australia or New Zealand. However, this cannot be confirmed until the operational details of the SAP are released (pending further public consultation and work by the Australian and New Zealand governments). [5] Intellectual Property Laws Amendment Bill 2014 sch 4 items 35–6; IP Australia, above n 1, ss 6–7. IP Australia and the New Zealand Ministry of Business, Innovation & Employment are developing a framework for calculation of fees, taking into account fluctuations in exchange rates. [6] Intellectual Property Laws Amendment Bill 2014 sch 4 items 23–5. Corresponding amendments will also be required in New Zealand’s Patents Act 2013 (and corresponding regulations) to allow for New Zealand documents to be filed with IP Australia. [7] Commonwealth, Parliamentary Debates, Senate, 25 November 2014, 63–4 (Nigel Scullion). [8] At this stage, it is not clear how examiners will be appointed – i.e., whether they will automatically be assigned based on the country in which the application is filed, or whether they will be assigned in some other manner. [9] Explanatory Memorandum, Intellectual Property Laws Amendment Bill 2014 sch 4 items 23–5. [10] Explanatory Memorandum, Intellectual Property Laws Amendment Bill 2014 para 12. [11] Intellectual Property Laws Amendment Bill 2014 sch 1 item 19. [12] Ibid sch 1 item 27. [13] See Intellectual Property Laws Amendment Regulation 2014 (No. 1) (Exposure Draft) reg 12.2C, which includes restrictions on the labelling or marking of the pharmaceutical product such that it is distinguishable from the same product as sold in Australia or as exported other than under the PPI compulsory licence. [14] Explanatory Memorandum, Intellectual Property Laws Amendment Bill 2014 sch 1 items 11–13.

Latest Tweets

Follow @sprusons on twitter.