30 March 2011

Patent Reform Exposed Part VI – ‘Experimental’ and ‘Regulatory’ Exemptions to Infringement

The current Australian Patents Act 1990, in section 119A, provides an exemption (i.e. defence) to patent infringement in respect of acts for obtaining regulatory approval of pharmaceuticals.  This enables ‘generic’ pharmaceutical manufacturers to conduct the trials and experiments necessary to obtain data for approval of a drug for inclusion in the Australian Register of Therapeutic Goods (ARTG), during the term of a patent covering the drug. 

This limited ‘experimental’ use exemption enables so-called ‘springboarding’, i.e. the preparation during the patent term to commence sales of a generic product immediately upon expiry of the patent.  The exemption does not cover registered goods other than drugs, such as medical or therapeutic devices.

There are also infringement exemptions in section 118 and section 119 covering, respectively, use of patented technology on vessels in transit, and prior use – i.e. where someone other than the patentee was already using an invention in secret and without making an anticipating public disclosure, prior to the patentee filing a patent application.

IP Australia’s proposed reforms include new exemptions covering acts for obtaining regulatory approval of goods other than pharmaceuticals, and acts conducted for ‘experimental purposes’.

28 March 2011

‘Late’ Submissions to Senate Inquiry on ‘Gene Patent’ Ban

A few weeks back, we reported on the 100 submissions received by the Australian Senate inquiry into the Patent Amendment (Human Genes and Biological Materials) Bill 2010, which seeks to outlaw the patenting of human genes, and other biological materials that are ‘substantially identical to such materials as they exist in nature’.

At that time, the score-card was 67 opposed to the Bill, and 23 in favour, with the remaining ten being generally supportive of the intent of the Bill, but opposed to it in its current form.

We also noted the absence of any submission from Dr Luigi Palombi, who was mentioned in the Senate as a potentially interested party and who, so it was rumoured, was largely responsible for drafting of the Bill.

Since our previous summary, ten further submissions have been added to the list on the Inquiry’s web site.  Five of these are opposed to the Bill, three are supportive, and the remaining two are listed as ‘confidential’ (confidentiality can be considered on the request of the person making the submission, but is not guaranteed).

25 March 2011

Patent Reform Exposed Part V – Support

Failure of support - Tacoma
Narrows bridge
In our previous article on IP Australia’s proposed reforms (before we were distracted by Ministerial announcements) we looked at the UK/European-style enablement provision in the reform Bill, and suggested that the US law might provide a better model.  At the very least, when the US Act intends to make ‘enablement’ a requirement for a valid patent, it at least uses the word ‘enable’!

We also suggested that if the intention is to require enablement commensurate with the scope of the claims, the legislation should say so.  In other jurisdictions this result has only been achieved through the development of a body of case law, and IP Australia’s hope that this will somehow be magically imported could well be misplaced.

The reason for recapping our main points on enablement is that the subject of this article – the requirement for claims to be ‘supported’ by the description – is one that even IP Australia concedes involves some overlap with enablement, as well as with inventive step.  We question whether this conflation of distinct requirements for a valid patent is useful or productive.

But, to get to the point, IP Australia is proposing to abolish the ‘fair basis’ requirement of subsection 40(3), and replace it with a requirement that ‘the claim or claims must be … supported by matter disclosed in the specification’.

23 March 2011

Surprise! New Pharmaceutical Compulsory Licenses Proposed

We cannot speak for any other interested parties (although we will gladly quote them – see below) but we were blind-sided by the joint announcement yesterday by Senator Kim Carr (the Australian Minister for Innovation, Industry, Science and Research) and the Hon Dr Craig Emerson MP (Minister for Trade) of the Government’s intention to ‘introduce legislation to allow Australian courts to grant compulsory licences to manufacture and export patented pharmaceuticals to countries trying to deal with epidemics and other types of health crises.’

According to the joint media release:

The new system implements an international agreement on public health in the World Trade Organization, amending the Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Protocol).

Developing countries and other interested organisations will now be able to apply to the Federal Court for a licence to manufacture and export patented pharmaceuticals from Australia to countries in need.

Apparently (and this is entirely independent of the reforms currently in-train on the initiative of IP Australia), the Government intends that the new system will be in-place by the end of 2011.

Divisional ‘Case Management’ Still Occupying Patent Office Time

We last reported on the effects of IP Australia’s ‘case management’ approach to divisional applications back in mid-February, when we speculated as to whether or not the rate of refusals under the new processes might drop off.  It seems that, to date, there is no real sign of abatement.

By this time last year, the Patent Office had issued only four written decisions, all in relation to inter partes matters.  As of the time of writing, there have been 21 written decision issued in 2011, of which 15 are refusals of divisional applications under the case management approach.

As far as more substantial matters are concerned, therefore, the rate of issuance of decisions is on par with previous years.  However, the corpus of published Patent Office decisions is clearly becoming bloated with stock refusals of divisional applications, which is unfortunate since it adds nothing of any real substance to the body of administrative decision-making.

This is not to say, however, that there has been no refinement of the case management approach, or that IP Australia is not listening to the concerns of stakeholders.

22 March 2011

Minister Announces Greater Cooperation between Canadian, UK and Australian IP Offices


Picturesque Vancouver
 On Thursday 17 March 2011, Senator Kim Carr – the Australian Minister for Innovation, Industry, Science and Research, announced the launch of a pilot program to be conducted between the Canadian, UK and Australian Patent Offices, to enable examiners in each office to gain electronic access to documents, such as search and examination reports, relating to corresponding patent applications filed with the other two offices.

The supporting IT system, known as Centralised Access to Search and Examination, or CASE (because every good project deserves an acronym), has been developed in partnership with the World Intellectual Property Organisation (WIPO).

Believe it or not, the three cooperating IP offices – collectively calling themselves the ‘Vancouver Group’, for the location of their first formal meeting in 2008 – have dubbed this particular initiative ‘Mutual Exploitation’.

20 March 2011

Patent Reform Exposed Part IV – Enablement

This article focuses on IP Australia’s proposed changes to Section 40 of the Patents Act 1990, which are intended to introduce a formal ‘enablement’ requirement into the Australian patent law.

Presently, paragraph 40(2)(a) requires a complete (i.e. nonprovisional) specification to ‘describe the invention fully, including the best method known to the applicant of performing the invention’.  Broadly speaking, the requirement to ‘describe the invention fully’ encompasses aspects of what in the US would be termed ‘written description’ and ‘enablement’, but without fully encompassing either of these distinct concepts.

More particularly, a sufficient description under the current law must make the nature of the invention plain, and must make it plain how to make or perform the invention.  Recent Australian case law confirms, however, that these requirements will be met if the description enables the skilled person to produce something falling within the scope of each claim without exercise of inventive ingenuity or undue experimentation or study to overcome any initial difficulties in following the teachings in the specification (Kimberly Clark Australia Pty Ltd v Arico Trading International Pty Ltd [2001] HCA 8).

There is currently no requirement in Australia, as exists in most other jurisdictions, that the description provide enablement across the ‘full scope’ of the claims.  IP Australia therefore proposes to raise the enablement requirement to this international standard.

18 March 2011

Patent Reform Exposed Part III – Provisional Specifications

In this article on IP Australia’s proposed reforms to the Patents Act 1990 we look at a change to subsection 40(1) of the Act, which relates to the level of disclosure required in a specification associated with a provisional patent application.

We presume that most readers ‘know’ that the purpose of a provisional application is to secure a priority date without having to meet the full burden of disclosure and formalities associated with a complete (nonprovisional) application.

Or is it?  It is legitimate to ask – what is the value of a provisional specification that provides less that a full and detailed disclosure of the invention, including at least one working embodiment?

DISCLOSURE REQUIRED IN A PROVISIONAL APPLICATION

The short answer to the above question is: not much value at all.  Even if it is the case that the Australian law is somewhat permissive regarding the level of disclosure required to establish priority from a provisional application, no other jurisdiction is remotely interested in according any special status to Australian provisional specifications.  Thus, for example, when an Australian filing is used as the basis for a priority claim in the US, or Europe, or Japan, or any other country (directly, or via an International Application under the Patent Cooperation Treaty), the level of disclosure required to sustain the priority date is no different whether the Australian application was provisional or complete.


13 March 2011

Patent Reform Exposed Part II – Usefulness

This second article in our series on IP Australia’s proposed reforms looks at the new section 7A in the Draft Intellectual Property Laws Amendment (Raising the Bar) Bill 2011.

The purpose of this amendment is to extend the meaning of the word ‘useful’, as it is applied in section 18(1)(c) of the Patents Act 1990, which requires that an invention must be ‘useful’ in order to be patentable.  (This requirement is also termed ‘utility’.)

The purpose of requiring that an invention be ‘useful’ has traditionally been to prevent the granting of patents that have no practical application, or that do not work.  The specific requirements for utility have been developed by the courts, and can broadly be characterised as requiring that the claimed invention must actually achieve what has been promised by the patentee, in the patent specification.

11 March 2011

Patent Reform Exposed, Part I – Raising the Inventive Step

This is the first in a series of articles discussing the various reforms proposed in IP Australia’s Draft Intellectual Property Laws Amendment (Raising the Bar) Bill 2011.  We previously reported (here) on the public release of the Exposure Draft.  IP Australia has invited the submission of comments, which are due by 4 April 2011.

In this article, we look at the proposed changes to the requirements for establishing the presence or absence of an inventive step (otherwise known as ‘obviousness’).

WHAT IS THE EXISTING PROBLEM?

The standard for assessing inventive step in Australia is widely regarded as being lower than the corresponding standard under the patent laws of many of the country’s major trading partners.

There are two main reasons for this, both of which may be regarded as aspects of a peculiar ‘parochialism’ in the Australian law.  Generally speaking, an invention will involve an inventive step so long as a person skilled in the relevant art would not, at the priority date, have considered it obvious in light of the common general knowledge in the field, together with pertinent publicly-available information.  So far, so similar to the law in most jurisdictions.

06 March 2011

Senate Submissions Overwhelmingly Oppose ‘Gene Patent’ Ban

Senate secretary sorts submissions...
As we have previously reported, the Australian Senate Legal and Constitutional Committee is currently conducting an inquiry in relation to the Patent Amendment (Human Genes and Biological Materials) Bill 2010, which seeks to outlaw the patenting of human genes, and other biological materials that are ‘substantially identical to such materials as they exist in nature’.

The deadline for submissions to the inquiry was Friday, 25 February 2011.  The Committee is due to report by 16 June 2011.

Copies of the submissions received by the Senate Committee have now been published on the web.  To date, 100 submissions have been published – although the deadline has passed, it remains possible that there are more to come. 

We do not claim to have read all 100 submissions in detail.  However, we have looked over them and concluded that if the fate of the Bill were to be decided by a poll of those who have made submissions, it would be soundly defeated!  Of the 100 submissions, we consider that 67 are clearly opposed to the Bill, with only 23 substantially in support of the Bill.  The remaining 10 submissions are mostly supportive of the stated intent of the Bill, i.e. to outlaw the patenting of isolated human genes, but opposed to the actual amendments proposed by the Bill.

04 March 2011

Could the US Really Move to 'First-to-File'?

As many readers will be aware, a Bill to reform the US patent system is currently being considered in the United States Senate.  Recently renamed the 'America Invents Act', the proposed amendments to the US Patent Code most controversially include a change from the current system of 'first-to-invent' to a 'first-to-file' (or, more correctly, 'first-inventor-to-file') system, which is the basis for patent entitlement throughout most of the rest of the world.

The first-to-file amendments include a change to the novelty provisions in section 102 of the US Patent Code that would alter the existing 'grace period' from a potential exclusion of all prior art arising within the 12-month period preceding filing, to an exclusion of only that prior art arising directly or indirectly from the inventor's own disclosures.  This would effectively result in a grace period having similar effect to that which currently exists in a number of 'first-to-file' countries, including Australia.

03 March 2011

IP Australia's Exposure Draft Exposed!

Last month, we reported on the non-exposure of IP Australia's 'exposure draft' of proposed patent reform legislation, and expressed our concerns about the apparent secrecy surrounding a matter of such broad public interest as the workings of Australia's patent system.

We are therefore very pleased to report that the exposure draft of the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011, along with the draft Explanatory Memorandum, is now available to the public.

IP Australia is inviting submissions, which are due by 4 April 2011.  For those to whom the exposure draft has been exposed since December, this has been a relatively generous time period.  For everyone else, one month is a challenging timeframe for the digestion of the 102 page draft Bill, and 118 page Draft Explanatory Memorandum, and preparation and filing of any submissions. 

We note that IP Australia has preempted the possible submission of comments relating specifically to the vexed issue of gene patents.  We would likewise encourage anybody considering a submission to focus on issues specifically raised by this Bill.  There have been ample opportunities already for submission to inquiries directed to the gene patents issue, which is currently being addressed by the Senate Legal and Constitutional Affairs Legislation Committee.



01 March 2011

Is IP Australia the Envy of the Patent World?


USPTO Director David Kappos
turns green with envy at IP
Australia's successful reduction
of the examination backlog!

How many Patent Offices in the world’s major economies can say that since 2009 they have reduced the time spent by an application waiting for examination by 30%?

We do not know for sure, but we suspect that it may be only one – the Australian Patent Office.

(For those that doubt the claim that Australia qualifies as a ‘major economy’, we note that as at the time of writing the most recent rankings, by GDP, produced by the International Monetary Fund, the World Bank, and the CIA World Factbook, all place Australia at number 13, ahead of Mexico and South Korea, and not very far behind Spain, India, Russia and Canada.)

In any event, IP Australia proudly announced last week – in a news item modestly titled ‘Patents examination time slashed!’ – that:

The impact of a number of strategies has helped IP Australia to significantly reduce the average examination time for patents from an average of 16 months in 2009 to 11 months.