Patenting Medical Treatments – An Overview

Healthcare is one of the most economically-important areas in which patents are granted.  In no small part, this is due to the great expense and risk involved in discovering, developing, trialling, gaining regulatory approval for, and ultimately commercialising new drugs and other forms of therapy. 

For better or worse, governments in the developed world have largely abdicated responsibility for research and development in this area, in favour of allowing private enterprise to bear the cost and risks.

In exchange, the patent system fulfils the role of ensuring that the companies taking on these risks are able to gain a commensurate economic benefit if, and when, their efforts pay off.  In fact, special treatment is provided in the patent laws of various countries for therapeutic inventions in particular, to ensure that the rewards outweigh the risks, including:

1. granting broad protection for new chemical compounds that have been shown to have at least one therapeutic use;
2. granting protection for known chemical compounds when they are first discovered to have at least one therapeutic use;
3. permitting further periods of more-limited protection for known chemical compounds when shown to be useful for a second, previously unknown, therapeutic purposes; and
4. extended terms of patent protection to compensate for time required to obtain regulatory approval to actually commence marketing of a therapeutic product (I have written about extensions of patent term on many previous occasions, and will not be covering them again here).

One aspect in which there is far less international uniformity is whether or not patents should be available for methods of treatment and/or diagnosis that are practised on the human body.  Indeed, in most countries medical treatment methods are considered unpatentable on policy grounds. 

As has been recently confirmed by the High Court, however, methods of medical treatment are patentable in Australia.  Such methods have also long been considered patentable in the US, although there has recently been concern that the decision of the Supreme Court in Mayo Collaborative Services v Prometheus Laboratories, Inc has imposed significant limitations on the types of treatment methods that can be patented.

The purpose of this article is not to get into the details, but rather to provide an overview of how patent laws protect (or not) medical treatments for readers who may be unfamiliar with this topic.

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Tags: Patent law, Patentable subject matter, Pharmaceuticals, Public policy

Patentability of Genes May Turn on Claim Construction

A Full Bench of all seven judges of the High Court of Australia heard oral arguments in the appeal by Yvonne D’Arcy in the Myriad Genetics BRCA gene patent case starting on Tuesday 16 June 2015, and continuing through the morning of Wednesday 17 June 2015.  Transcripts of the first day and the second day of the proceedings are available.

As a preliminary matter, the High Court determined on Monday 15 June 2015 that it would not allow the application by the Institute of Patent and Trade Mark Attorneys of Australia (IPTA) to intervene in the case as amicus curiae.  I wrote previously about IPTA’s application, and subsequently about the opposition by the Commonwealth, and I am not at all surprised that the High Court turned IPTA down.

Based on the transcripts, it appears that there are up to four key issues that may determine the outcome of the appeal, i.e. whether or not Myriad’s claims to the isolated BRCA genes (and, by extension, all other patent claims directed to naturally-occurring genes that have been isolated from their natural environment) are proper subject matter for a patent under Australia’s ‘manner of manufacture’ test for patent-eligibility.

Those four issues are:

1. the proper construction (i.e. interpretation) of Myriad’s claims – more particularly whether they are, in substance, directed to a molecule or to ‘information’;
2. whether or not the test for ‘manner of manufacture’ requires a nexus between what is ‘artificial’ in an invention, and its economic value (and, if so, whether such a nexus exists in the case of isolated genes);
3. the desirability of consistency with the laws of Australia’s major trading partners and, if this is desirable, which of these other countries we should follow; and
4. the significance of the Australian Parliament’s repeated decisions not to introduce an express exclusion from patentability for ‘products of nature’ when the opportunity has arisen.

Reading the transcripts, it is not at all clear to me which way the seven judges (individually, or as a group) are likely to rule in this case.  While they certainly interrogated David Shavin QC (Queen’s Counsel appearing for Myriad) far more vigorously than David Catterns QC (Queen’s Counsel appearing for Ms D’Arcy), my impression is that Mr Shavin had answers for all of the judges’ questions and that, on balance, Myriad’s case is more consistent with the Australian authorities on patent-eligibility.  At the same time, however, it appears that at least some of the judges are disposed to rule against the patentability of isolated genes.

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

ACIP Says ‘Abolish Innovation Patents’ Based on IP Australia Report

On 25 May 2015, IP Australia published a report entitled The Economic Impact of Innovation Patents.  The innovation patent is Australia’s second-tier patent right, characterised by a shorter term (eight years), a lower threshold of innovation (‘innovative step’ rather than ‘inventive step’), and lower cost (largely because substantive examination of an innovation patent is optional, unless enforcement is required) than a regular ‘standard’ patent.

The new report is the result of analysis conducted under the auspices of IP Australia’s Office of the Chief Economist, as part of its ongoing studies of the Economics of IP, and concludes that ‘the innovation patent is not fulfilling its policy goal of providing an incentive for Australian SMEs to innovate’.

And while the IP Australia report does not quite go so far as to explicitly recommend abolition of the innovation patent system (merely pointing out that some other countries have abolished their second tier patent rights on the basis of similar considerations), the Australian Government’s Advisory Council on Intellectual Property (ACIP) has been very quick to come out against the innovation patent in response, stating that it has failed to achieve its policy objectives, and that the Government should consider its abolition.

There is, in fact, a great deal of interesting and thought-provoking analysis and information in the IP Australia report.  Whether the facts actually support all of the inferences and conclusions set out in the report is another matter.  It is an even greater leap to conclude that the innovation patent system should be abolished.

In my opinion, the facts laid out in the report need to be considered from the perspective of a range of different stakeholders in Australia’s patent system.  ACIP’s new recommendation appears to have been reached on purely economic grounds, taking the many inferences and conclusory statements in the report at face value.  I believe that the facts support more than one possible set of conclusions, and that abolishing the innovation patent system rather than considering some sensible reforms could well be a case of throwing out the baby with the bathwater.

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Tags: Australia, Economics, Innovation patent, Law reform, Public policy

Help the Homeless by Sending a Patent Attorney Out to Sleep Rough!

Would you like to see one of the leaders of the Australian patent attorney profession sleeping rough on one of the coldest nights of the year?

I hope you would, which is why I am asking Patentology readers to sponsor the efforts of Karen Sinclair, Principal and Chairman (her preferred title) of Watermark, in the upcoming Vinnies CEO Sleepout on Thursday 18 June 2015.

Click to view Karen's profile and donate

Funds raised through the Vinnies CEO Sleepout will go towards helping the more than 100,000 Australian men, women and children who are experiencing homelessness to find the warmth, safety and dignity that they desperately deserve.

Vinnies support people experiencing homelessness through a range of support services including crisis accommodation, domestic violence support, access to budget counselling, lifeskills courses and legal advice, as well as assisting in planning for change and their return to independent living.

It only takes a moment to make a difference and help contribute to breaking the cycle of homelessness.

Jason’s Story

I would like to share Jason’s story with you.

Jason had a troubled childhood, growing up with an abusive alcoholic father Jason was constantly walking on egg shells. He isolated himself from others, scared of what they might see.

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Tags: Personal

Myriad Hearing Date Set, Commonwealth Opposes IPTA Intervention

Oral arguments in the High Court appeal by Yvonne D’Arcy in the Myriad Genetics BRCA gene patent case will be heard in Canberra on Tuesday, 16 June 2015.

In the latest development in the case, on 26 May 2015, the Solicitor General of the Commonwealth of Australia filed an application to intervene in the Myriad proceedings.  The Commonwealth intervention will be triggered in the event that the High Court grants the request by the Institute of Patent and Trade Mark Attorneys of Australia (IPTA) (which I wrote about back in May) to intervene in the High Court proceedings as amicus curiae.

IPTA is seeking to raise a constitutional question, namely whether the concept of ‘invention’ within the Patents Act 1990 should be interpreted as extending to the full limit of the power granted to the Commonwealth to make laws ‘with respect to … patents of inventions’ under section 51(xviii) of the Commonwealth of Australia Constitution Act (the Constitution), in the absence of any express contrary intention.

As an Australian taxpayer, I find this development intensely irritating, and my annoyance is not directed at the Government, but at IPTA.  In effect, the Australian people are now footing the bill for Commonwealth intervention in High Court proceedings between two private parties as a direct result of IPTA’s decision to introduce a constitutional issue into the case.  With interpretation of the Constitution potentially at stake, the Government has not really had any choice in the matter.

The Commonwealth is opposing IPTA’s application to intervene.  However, in the event that the High Court grants the application, the Commonwealth will make submissions urging the Court to reject IPTA’s interpretation of the scope of the constitutional power to make laws with respect to patents.

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Tags: Australia, Constitution, Genetic technology, Patentable subject matter

Five Years of Patentology, or, How I Learned to Love Marketing!

Today is Patentology’s fifth anniversary.  It was on 6 June 2010 that I published the very first post on this blog.  It is fair to say that I had very little idea of what I was doing, or just how big a part of my professional and personal life blogging would become.  It simply seemed like a good idea at the time.

I may not have had much of an inkling about the ‘what’ or the ‘how big’, but at least I had some idea of why I was starting my own blog.  Put simply, it was because I hated marketing.  And when I say ‘marketing’, I mean the kind of things in which lawyers, patent attorneys, accountants and other professional service providers have traditionally engaged – activities such as attending ‘networking’ events, ‘researching’ prospective clients, hitting up existing clients for referrals or additional business, handling random enquiries in the vague hope that one of them will be the ‘next big thing’, and (most horrifying of all) cold-calling prospects.

In short, I just could not abide all of that ‘selling’ stuff.  So much do I despise it still, that I cannot help putting almost all of its key terminology in scare quotes.  I know that this is not how everybody feels.  We all know a few magically silver-tongued people who can small-talk like it is an Olympic sport, who love nothing more than getting out and pressing the flesh, and who seem shameless in asking for business, and fearless of the rejection that so often ensues. 

I suspect, however, that most of those people naturally gravitate to sales.  From experience, I would suggest that not too many are completing technical undergraduate degrees, going on to work in research labs, earning PhDs, doing a bit of technical R&D and commercialisation, and ultimately going on to yet more study in order to obtain a specialist law qualification and become a patent attorney.  The type of personality that is drawn to these kinds of experiences – my type of personality – is far more likely to enjoy an evening at home with a good book or a DVD than schmoozing the crowds at a conference dinner.  I have never taken a formal Myers Briggs personality assessment, but my guess is that it would tell me that I am INTJ.  (Whatever that is worth.  I am sceptical of such tools – which is just so typical of an INTJ personality!)

It is hard not to hate something you are not good at, and which goes against your very character and self-image.  So, if I could not bring myself to go to ‘marketing’, I would have a go at getting ‘marketing’ to come to me.  My strengths (as I see myself) are intelligence, knowledge/expertise, creativity and communication.  I love to share knowledge and to exchange ideas – it is small-talk and social conversation that I am not so great at.

In short, I started a blog.

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Tags: Patentology admin, Personal