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

As 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.

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Tags: Australia, Genetic technology, Patent law, Patentable subject matter

New Zealand’s New Patent Laws

The 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 4^th, 7^th, 10^th and 13^th 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’.

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Tags: Law reform, New Zealand, Regulations

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

Australia 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.

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Tags: Innovation, Politics, Public policy, Science

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

As 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.

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Tags: Intellectual Asset Management, Strategy, Trademarks

Australian Court Backs Patents on Isolated Genes

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

A 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.

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Tags: Australia, Genetic technology, Patent law, Patentable subject matter