12 November 2015

Source IP - Digital Marketplace

IPAustralia have developed Source IP as a digital marketplace for sharing information, indicating licensing preferences and facilitating contact for IP generated by the public research sector in Australia.

Source IP is specifically aimed at making it easier for Australian businesses, including small business to access public sector innovation and technology and will strengthen the aims of Australian Government's Industry Innovation and Competitiveness Agenda - particularly the focus on boosting collaboration between science and industry.

Source IP is due for release late 2015.  For more information on Source IP please contact:

SourceIP@ipaustralia.gov.au

See the IPAustralia website for more information:

http://www.ipaustralia.gov.au/understanding-intellectual-property/commercialise-your-ip/source-ip-site/?utm_medium=email&utm_campaign=What%27s+New+at+IP+Australia+-+5+November+2015&utm_content=Source+IP&utm_source=www.vision6.com.au


Australian High Court clarifies inventive step threshold

On 2 September 2015, the High Court handed down a decision in the long-running AstraZeneca v Apotex battle, dismissing AstraZeneca’s appeal and finding the patent claims of its Australian CRESTOR (rosuvastatin) patent invalid for lack of inventive step. 


The decision is consistent with the appealed Full Federal Court decision and has been described as a “conventional” decision. However, it is also significant in that, to date, invalidating a patent for lack of inventive step has been very difficult due to the somewhat convoluted requirements of the inventive step provisions under the Australian Patents Act (the Act). This has applied to both opposition process and litigation in the courts.

What does this decision mean for patent applicants in Australia? 

In summary, on a practical level, the decision clarifies that the inventive step of an Australian patent will be considered in reference to “relevant prior art information”, as it existed at the priority date, in light of the “common general knowledge” of the person skilled in the art. The decision clearly highlights that it is not permissible for an Examiner or the Court to use information from the body of the patent specification to determine inventive step when that information does not form part of the common general knowledge of a skilled person and is not disclosed in the prior art information.  The information in the body of the specification may be used in considering the inventive step of a patent if it is, in fact, disclosed in a prior art document or part of common general knowledge of a skilled person in the field. 

The High Court Decision

The High Court decision confirmed that:

(i) Different prior art documents may be considered separately as long as they meet the threshold requirement (“ascertained, understood and regarded as relevant”)(for patent applications filed before the Raising the Bar Amendments came into force in 2013). 
(ii) “The skilled person may well sort through all manner of information with a view to finding something that is regarded as relevant” and section 7(3) “places no embargo on the skilled person using combinations of sources of information”. 
(iii) It is not permissible to use information from the body of the specification to determine inventive step when that information does not form part of the CGK and is not disclosed in any prior art document falling within the scope of section 7(3) of the Act.  

This decision is considered a “sensible” and “conventional” decision from the High Court regarding the interpretation of sections 7(2) and 7(3) of the Act. Although the “ascertained, understood and regarded as relevant” restriction on prior art documents has now been removed from the Patents Act, there are still a considerable number of patents prosecuted and granted under the previous Act to which these interpretations will apply. 

See the link to our full article for a more detailed discussion of the case. 


by Sarah Herbert


20 October 2015

Consultation on IPAustralia’s Proposed Examination Practice following the High Court Decision in D'Arcy v Myriad Genetics Inc

Further to our blog post last week on the High Court’s D’arcy v Myriad Genetics decision http://frankehyland.blogspot.com.au/2015/10/a-new-look-at-patentable-subject-matter.html IPAustralia have released a consultation paper regarding their examination practice in light of the decision.

http://www.ipaustralia.gov.au/about-us/public-consultations/Consultation-on-our-proposed-examination-practice-following-the-High-Court-decision-D'ArcyvMyriad-Genetics-Inc/

If you would like to discuss the matter further or wish to make any comment on the paper, please let us know. 

by Sarah Herbert

12 October 2015

A New Look at Patentable Subject Matter in Australia: D’arcy v Myriad Genetics

On 7 October 2015, the High Court of Australia unanimously held that isolated nucleic acids are not a manner of manufacture under Australian law.

http://eresources.hcourt.gov.au/showCase/2015/HCA/35 

This is somewhat surprising and overturns the previous unanimous decision of the Full Federal Court of Australia, which upheld the initial Federal Court judgement. The decisions of the Full Federal Court held that isolated nucleic acids are a manner of manufacture as an “an artificially created state of affairs in a field of economic endeavour” that are a result of human intervention.

The test for patentable subject matter in Australia has long been that set out in the National Research Development Corporation v Commissioner of Patents (“NRDC“) case (1959).  That is, patentable subject matter is an ‘artificially created state of affairs’ in a field of economic endeavour.  The Full Federal Court concluded that an isolated nucleic acid sequence involved human intervention and was therefore an artificially created state of affairs.  However, the High Court took a different approach and concluded that the sequence information content of isolated nucleic acids is not “made” by humans but is instead naturally-occurring.  According to the High Court, isolation was the only man-made aspect of the invention, which they held was not sufficient to constitute “an artificially created state of affairs” as required by NRDC.

In D’Arcy v Myriad Genetics, the High Court cautioned against a formulaic application of the principles in the NRDC case.  The question of whether a new class of invention is patentable should be decided on a case-by-case basis, having regard to 6 key factors:

  • Could patentability give rise to a large new field of monopoly protection with potentially negative effects on innovation?
  • Could patentability have chilling effects on activities beyond the exclusive rights granted to a patentee?
  • Would according patentability involve assessing important and conflicting public and private interests and purposes?
  • Would according patentability enhance or detract from the coherence of the law relating to patentability?
  • Is according patentability consistent with Australia’s obligations under international law and the patent laws of other countries?
  • Does according patentability involve law-making which should be done by the legislature?

The High Court decision clearly highlights that  isolated nucleic acids are not a manner of manufacture, and therefore are not patentable subject matter.  The Court criticised the characterisation of isolated nucleic acids as a class of artificial chemical compounds as “elevating form over substance”.  The Court considered that the information stored in the nucleic acids coding for mutant or polymorphic BRCA1 polypeptide was an essential element of the claims in issue and concluded that information was the same as the information contained in the DNA of a person from which the nucleic acids were isolated.  Unlike the corresponding US Supreme Court’s Myriad decision, there was no decision by the High Court that cDNA or other nucleic acids sufficiently altered  by human intervention would constitute patentable subject matter.  It remains to be seen how this decision is interpreted by the Australian Patent Office and the existing holders of Australian patents to isolated nucleic acid sequences.

D’Arcy v Myriad Genetics has implications for the definition of patentable subject matter in Australia. While NRDC remains a relevant precedent, satisfying the criteria in NRDC alone is now unlikely to make contentious subject matter patentable.  This includes inventions relating to other naturally occurring substances, as well as business methods and computer-implemented inventions.  This decision suggests that broader policy factors will also need to be considered.  Rather than clarifying the position, the refining of the NRDC test and the focus on the “substance” or “essential element” of the invention in the decision may introduce uncertainty as to the scope of “patentable subject matter” in Australia.

by Sarah Herbert



07 October 2015

IP and Free Trade Agreements

The era of bilateral and smaller multilateral trade agreements culminated on 5 October 2015 with the signing of the 12-nation Trans-Pacific Partnership, covering 40 per cent global economy. Like all trade deals, the TPP is primarily a political deal negotiated by politicians, and is seen as an attempt by the US and Japan to set up a Pacific rim economic zone that doesn’t include the world’s second largest economy, China. Intellectual property was one of the sticking points in the negotiations for this agreement, along with the time period for data lock-up for biologic drugs and tobacco and public health issues, among others. In regard to the inclusion of intellectual property in free trade agreements, the Australian Competition Policy Review (the Harper Review) issued its Final Report in March 2015. Recommendation 6 of that Report was an Intellectual property review by the Productivity Commission focusing on:
competition policy issues in intellectual property arising from new developments in technology and markets; and
the principles underpinning the inclusion of intellectual property provisions in international trade agreements.

As we reported on the 20 August 2015, the Treasurer and the Minister for Small Business asked the Productivity Commission to examine Australia’s intellectual property system, in light of the shift towards an innovation economy.

See: http://frankehyland.blogspot.com.au/2015/08/productivity-commission-to-look-at-ip.html

Economically, Australia needs to shift away from its heavy reliance on resources and primary industry. Business leaders and politicians alike are calling for Australia to focus on innovation and technology development in a number of different areas. This shift to innovation as a driving force in the economy is very much based on intellectual property. The Productivity Commission’s recommendations will need to factor in this shift to an innovation economy in its review.

The Commission will also need to consider the fact that Australia is currently party to 10 bilateral or plurilateral trade agreements which include IP chapters. Recently, Australia has recently signed Free Trade Agreements with Korea, Japan and China. In regards to IP protection in their respective countries, Korea, Japan and China have all agreed to provide Australian nationals with equally favourable treatment in relation to IP protection and enforcement. The IP chapter of the Trans Pacific Partnership will also need to be taken into consideration when this agreement is ratified by all signature countries. Free trade agreements largely designed to “reduce or eliminate tariffs and other barriers to trade”. While these free trade agreements are designed to increase trade between the signatory countries,  the Productivity Commission reported in 2010 that it had found 'little evidence from business to indicate that bilateral agreements to date have provided substantial commercial benefits' and that the 'increase in national income from preferential agreements is likely to be modest'. Regardless of whatever economic benefit Australia has or is likely to gain from the free trade agreements it is party to, the Productivity Commission will have to take into account Australia’s obligations under these free trade agreements in its review of Australia’s intellectual property system.

Further details can be found in the link to our full article below.

https://www.dropbox.com/s/vuoknbhr4fj8eaf/Article%20-%20IP%20and%20free%20trade%20agreements_full%20article.pdf?dl=0

by Sarah Herbert