28 September 2014

Gene Patent Questions Answered, As High Court Asked to Weigh In

Green Question MarkAs expected, lawyers representing Yvonne D’Arcy in her fight to have Myriad Genetics’ BRCA ‘cancer gene’ patent claims declared invalid have filed an application with the High Court of Australia for special leave to appeal the decision of a Full Bench of the Federal Court upholding the claims.  At some time in the coming months, therefore, the High Court will decide whether or not it will review the Federal Court’s decision.  My prediction remains that it will not, although the policy implications are certainly significant enough that Australia’s top court may feel that there is value in having its say.

In the meantime, unfortunately, the patent itself, the technical and legal issues, and the decision of the Full Federal Court remain poorly-understood by most people.

Helpfully, Fairfax Media has published an ‘explainer’, to get people up-to-speed on some of the issues in the case, and the differences dividing the two sides of the debate over gene patents.

However, missing from the Fairfax article are questions and answers about the underlying legal issues, which is (unsurprisingly) where many of the misunderstandings and misconceptions arise.

Do private corporations own your genes?  What rights does Myriad’s patent actually give it?  What is the effect on the cost of healthcare?  What is the impact on research?  Will a positive outcome for Myriad lead to more companies seeking gene patents?  And is all this just a sign that, as a society, we have lost our moral compass?

Read on for my answers to these questions, and more.

22 September 2014

New Zealand’s New Patent Laws

New ZealandThe New Zealand Patents Act 2013 commenced operation on 13 September 2014. 

As I wrote last year, when the New Zealand parliament passed the legislation, the new law replaces the 1953 Act, and brings New Zealand’s patent laws into line with the majority of developed nations.  Among numerous other changes, examiners at the Intellectual Property Office of New Zealand (IPONZ), are now able to reject claims for lack of inventive step, and to base objections on prior disclosures that took place anywhere in the world, and not just in New Zealand.

Other key features of the Patents Act 2013 include:
  1. introduction of a new requirement to request examination, either voluntarily or when directed to do so by the Commissioner of Patents (under the 1953 Act examination was automatic);
  2. a utility requirement that the claimed inventions have a specific, credible, and substantial use that meets the promise set out in the specification;
  3. claims must be supported across their full scope by matter disclosed in specification (in place of the old ‘fair basis’ test);
  4. applications opened to public inspection (i.e. published) at 18 months from the earliest priority date (previously, applications were not published until acceptance);
  5. introduction of annual maintenance fees payable from the fourth anniversary of filing, whether before or after grant (previously renewal fees were due only after grant, in the 4th, 7th, 10th and 13th years);
  6. patentability is now determined according to the ‘balance of probabilities’ standard (previously, applicants were accorded the benefit of any doubt); and
  7. a new exclusion from patent-eligibility in respect of computer programs ‘as such’.

13 September 2014

Why Science Is Not An Industry (and Our Petals Are Precious)

Science and despairAustralia currently has no minister (or department) for science.  One of the first acts of Prime Minister Tony Abbott when his government was elected last year was to name a cabinet in which, for the first time since 1931, there was no minister with the word ‘science’ anywhere in his title (I use the masculine pronoun intentionally, because one of the other characteristics of the current cabinet is that it includes only one woman in a total of 19 members).

In October 2013, Abbott defended this decision in front of an audience of scientists, saying:

It’s been remarked upon, ladies and gentlemen, that we don’t have a minister for science as such in the new government. I know there are some in this room who might have been momentarily dismayed by that, but let me tell you, neither does the United States have a Secretary for Science, and no nation on earth has been as successful at innovating as the United States and I’d say to all of you, please, judge us by our performance, not by our titles; judge us by our performance, not by our titles.

The difference, in case it is not obvious enough, is that the US has never had a Secretary for Science, whereas Abbott made a conscious decision, after 82 years of there having been a science portfolio in every Australian government, to erase the word from his ministry.  Where the previous government had a Department of Innovation, Industry, Science and Research, the current government has a Department of Industry, headed by Minister Ian Macfarlane

Supposedly, responsibility for science continues to lie with the Minister for Industry.  However, it seems that Macfarlane is starting to get a bit tetchy with people who think, just because he does not have the word ‘science’ in his title, that he is not, in all but name, the Minister for Science.  And when I say ‘people’, I mean ‘scientists’.  And when  I say ‘scientists’, I mean (according to Macfarlane) ‘precious petals’.  Because last week Australia’s Minister for Industry, the Honourable Ian Macfarlane, MP, said:

I’m just not going to accept that crap [criticism of the lack of a science minister].  It really does annoy me, because there is no one, no one, more passionate about science than I am. I am the grandson and son of a scientist, and I give science more than their share of my time, and just because I’m not the minister for energy, do I hear the whinge from [the energy sector]? No.

But I hear it constantly from some of the precious petals, can I say, some of the precious petals in the science fraternity, and if you can’t guess, I won’t accept it.

Of course, this angered a few scientists, although I think they should wear the label with pride, because they are precious, in the nicest sense of the word!  And responding to name-calling is a distraction from the real issue, which is this government’s rather poor record, to date, on Australian science.

06 September 2014

So What’s the Real Reason Twitpic is Shutting Up Shop?

TwitpicAs regular readers will be aware, I do not usually write about trade mark matters on this blog.  However, I am completely mystified by Twitpic’s announcement this week that it will be closing down on 25 September 2014, allegedly because it lacks the resources to take on Twitter in a trade mark dispute, and so I want to put the question out there: what is really going on at Twitpic?

Twitpic, if you are unfamiliar with the company, launched in February 2008, providing a service to enable users easily to ‘attach’ photos or other images to their tweets on Twitter.  A tweet cannot actually contain an image, but it can include a link to an image which is stored anywhere on the internet.  Services like Twitpic (there are now many others, including Instagram, and Twitter’s own image-hosting platform) upload users’ images to their own servers, and post tweets on behalf of the users which contain links to the images.

The implication seems to be that Twitter is trying to deprive Twitpic of the right to use its name, and that this is why the service is shutting down.

The problem I have with this is that it is not true.

Twitter has no problem with Twitpic continuing to use the Twitpic name.  What Twitter will not do, however, is to allow Twitpic to register its name as a trade mark.

Australian Court Backs Patents on Isolated Genes

D'Arcy v Myriad Genetics Inc [2014] FCAFC 115 (5 September 2014)

Isolated jeansA special expanded bench of five judges of the Federal Court of Australia has thumbed its collective nose at the US Supreme Court, finding that isolated genetic material is patent-eligible in Australia, and that (‘with respect’, of course) the emphasis of the US’ top court (in Association for Molecular Pathology v Myriad Genetics, Inc. 569 U.S. ___) ‘on the similarity of “the location and order of the nucleotides” existing within the nucleic acid in nature … is misplaced.’  The decision upholds the ruling of a single judge of the court, handed down in February 2013.

The unanimous judgment of the Australian court expresses a preference for the approach taken by Judges Lourie and Moore in the US Court of Appeal for the Federal Circuit (CAFC), who focussed on the differences between the isolated and naturally occurring DNAs.  Under Australian law, the court has stated, ‘the analysis should focus on differences in structure and function [of the isolated molecule] effected by the intervention of man and not on the similarities’ (at [155]).

Furthermore, the Australian court noted that, contrary to the dissenting position adopted by Judge Bryson in the CAFC, and by the US Supreme Court, the subject matter of the claims in the Myriad patent is ‘a compound; a nucleic acid. It is not a claim to information’ (at [210]).  Thus, even if the ‘information content’ of the isolated genetic material is, in some sense, unchanged, this does not determine patent-eligibility:

What is being claimed is not the nucleic acid as it exists in the human body, but the nucleic acid as isolated from the cell. The claimed product is not the same as the naturally occurring product. There are structural differences but, more importantly, there are functional differences because of isolation. (At [212])

In short, Australian law differs from US law – in Australia, claims directed to isolated genetic materials are patent-eligible.

31 August 2014

‘Software Patents’ – Time to End the Uncertainty!

STOPNobody – other than the most deluded fantasists among the anti-software-patents brigade – actually believes that all computer-implemented inventions are, or should be, unpatentable.  To deny patent protection to an invention merely on the basis that it involves the use of a programmed computer leads to absurd outcomes, such as an improved control system for an industrial process being patentable when implemented using gears and pulleys, or using resistors, capacitors and transistors, but not if it is implemented by way of a microprocessor programmed to provide precisely the same functions.

This is a result of the kind of muddled thinking that treats ‘digital’ as a magical incantation rather than what it actually is – another (admittedly powerful) tool in the engineer’s toolkit.

Having said that, it is also apparent that only the most deluded pro-patent fantasist would believe that absolutely anything created on a computer is, or should be, patentable.  In Europe, and many other jurisdictions with similar provisions (including, very soon, New Zealand), patents are expressly prohibited on computer programs ‘as such’.  The recent Alice decision by the US Supreme Court clearly establishes that there are at least some forms of computer-implemented financial processes that are nothing more than ‘abstract ideas’ accompanied by directions to ‘do it on a computer’, and thus unpatentable.

So, we can conclude with some certainty that some computer-implemented inventions are patentable, and some are not.  The problem is that nobody – not the courts, not the national patent offices, not the law-makers – seems to wish to take any responsibility for deciding exactly where to draw the line.  I have no idea where the line is, despite the fact that I read and write about this subject all the time, and practice in this area on behalf of clients every day.  I do not know anyone, inside or outside the profession, in Australia or anywhere else, who knows where the line is – and I would not trust or choose to work with anyone who claims that they do!

24 August 2014

Australia’s Patent Application Backlog Revealed

2013 IPAU BacklogEarlier this month, IP Australia released a ‘report on patent backlogs, inventories and pendency’.  The cover page states that it is ‘an independent report commissioned by IP Australia’, and that ‘[f]indings and opinions are those of the researchers, not necessarily the views of the IP Australia or the Government.’  My understanding is that the author, Ahmer Iqbal Siddiqui, worked on the report as an intern within IP Australia for around three months during 2013.

The research is based upon historical data of pendency for applications disposed of (i.e. either granted or abandoned) between January 2000 and January 2013, i.e. prior to the commencement of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012.  During this period IP Australia’s inventory (i.e. number of pending applications at any stage between filing and grant or abandonment) rose from just under 45,000 to a peak of almost 100,000 in October of 2009, before falling back to hover around 90,000.

This represents an inventory of around 278 applications per examiner, as compared with the UK Intellectual Property Office with 198, and the USPTO with just 169.  Patents granted in January 2013 had been pending for an average of about three-and-a-half years, up from just two years in 2000, but down from a peak of four years in 2010.

Rainbow Loom Patent Claims Rejected … For Now

LoomI recently noted a potential patent battle brewing in Australia over the popular loom band products originally developed by Malaysian-born and US-based inventor, Cheong Choon Ng, and sold under the RAINBOW LOOM brand. 

Specifically, Ng has recently filed a series of five innovation patents, while local RAINBOW LOOM distributor Funtastic Limited sent letters placing Headstart International Pty Ltd and Moose Enterprise Pty Ltd, distributors of the competing CRA-Z-LOOM and FUNLOOM products in Australia, on notice of the prospective patent rights.  Headstart and Moose fired back by filing notices at the Australian Patent Office, along with numerous prior art documents and other information, contending that Ng’s innovation patent claims are invalid.

First examination reports have now issued in relation to all five innovation patents.  In four cases, all of the claims have been found to lack novelty (and innovative step) in view of various prior art documents, most of which were raised in the submissions made by Headstart and Moose.  All four of these patents include claims directed to the loom device itself, and the difficulty faced by Ng is that there is little structural difference between a loom suitable for use in weaving together rubber bands, and many older looms that have been used for weaving yarn.

For example, one of the documents cited against all of the innovation patents is US patent application publication no. 2008/0156043, entitled ‘Knitting Loom and Method of Use’.

17 August 2014

What is the Starting Point for Inventive Step?

AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99 (12 August 2014)

Running raceAn expanded panel of five judges of the Federal Court of Australia has held that two patents owned by AstraZeneca relating to the cholesterol-lowering drug marketed as CRESTOR (active ingredient rosuvastatin) are invalid.  Subject to the possibility of a High Court appeal, the decision opens the way for generic competition to CRESTOR in Australia, which has been prevented by interlocutory injunctions since 2011.

A particular point of interest in this case lies in the reason for the rare expansion of the Full Court panel from the usual three judges to five.  The judge at first instance (in Apotex Pty Ltd v AstraZeneca AB (No 4) [2013] FCA 162) had found that the AstraZeneca inventions claimed in the patents at issue lacked an inventive step based, in part, on the reasoning of an earlier Full Court panel in Apotex Pty Ltd v Sanofi-Aventis [2009] FCAFC 134.  AstraZeneca contended that the approach taken by the primary judge was wrong, and requested a panel of five judges to enable the earlier Full Court decision to be overruled, if necessary.

So, five judges is better than three, and this decision is inherently important because anything it stands for has precedence over any ‘normal’ judgment issued by a three-judge Full Court panel.  In the event, the appeal court did overrule the reasoning of the primary judge on the approach to the inventive step question at issue.  However, it also found a way to avoid actually overruling the earlier Full Court decision in Sanofi-Aventis.

The key question addressed by the court in this regard is: what is the appropriate ‘starting point’ for assessing whether or not a claimed invention involves an inventive step or, conversely, is obvious? 

The answer to this question is that inventiveness must be assessed by reference to the relevant prior art information, in light of the ‘common general knowledge’ of the person skilled in the art.  The assessment should not be influenced by the description of the invention provided in the patent specification, or by consideration of any problem that the invention is explicitly or implicitly directed at solving, except to the extent that these are, in fact, part of the prior art or common knowledge in the field.

10 August 2014

Rainbow Loom Patents Under Attack in Australia

Rainbow LoomUnless you have been living under a rock, or you literally know no tween-age children (or their parents), you have probably encountered the loom band craze in some form or another.  The brightly coloured rubber bands, which are woven into wearable items such as bracelets using a small plastic loom, have reportedly become one of the top ten toys of all time, and earned their Malaysian-born and US-based inventor, Cheong Choon Ng, well in excess of $100 million.

The original loom band products are marketed by Ng's company under the brand name RAINBOW LOOM.  However, there is no shortage of imitators hoping to cash in on the loom band craze.  Late last year Ng sued Zenacon LLC, makers of FUNLOOM, LaRose Industries LLC, makers of CRA-Z-LOOM and Toys 'R' Us, distributors of CRA-Z-LOOM, alleging (among other things) that the rival products infringe his US Patent No. 8,485,565, which was granted on 16 July 2013.

In Australia, however, it appears that Ng may have a battle on his hands even to secure enforceable patent rights.  Ng's primary patent application is no. 2011324026, which is derived from international PCT application no. PCT/US2011/041553 originally filed on 23 June 2011.  And while this application is encountering some resistance from the Australian patent examiner, Ng has (so far) filed no fewer than five associated divisional innovation patents!

However, all of the innovation patents are currently under attack by various parties who have filed prior art information and corresponding submissions under the provisions of section 28 of the Patents Act 1990.  One of the five (no. 2014100245) has already even been the subject of an application to the Federal Court of Australia, following what appears to have been a rather unfortunate error on the part of the Patent Office (more on that later).

Certainly, there is big money in small coloured rubber bands, and it is unlikely that either Ng, or any of the copycat competitors, are going to give in without a fight.