Generic ABILIFY (Aripiprazole) Ban to be Reviewed

Generic Health Pty Ltd v Otsuka Pharmaceutical Co Ltd [2012] FCA 412 (23 April 2012)

Practice and procedure – interlocutory injunction – whether application for leave to appeal should be referred to a Full Court

Generic Health Pty Ltd will have the opportunity to appeal the decision of a single judge of the Federal Court of Australia granting a preliminary injunction preventing it from launching a generic version of the antipsychotic drug ABILIFY (see Australian Federal Court Blocks Generic ABILIFY (Aripiprazole)).

In general, any decision of a single judge of the Federal Court can be challenged by appeal to the Full Court – a panel of three judges.  In the case of a final ruling, i.e. after a full trial, any party to the proceedings automatically has the right to appeal.  However, a Full Court review of a preliminary judgement requires permission, i.e. ‘leave’ to appeal.

As a result, appealing a preliminary injunction is generally a two-step process – first the appellant must obtain leave to take the matter to a Full Bench of the court and then, if leave is granted, it is still necessary for the appeal proper to be heard.

In this case, Justice Katzmann has granted a request by Generic Health for its application for leave to be heard by a Full Bench of the court, and for the appeal itself to be heard either simultaneously, or immediately following the leave hearing.  Regular readers of this blog may recall that Justice Foster made a similar ruling in favour of Samsung last year (see Samsung Over First Hurdle in Bid To Overturn Apple Injunction).

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Tags: Appeal, Federal Court practice, Interlocutory injunction, Pharmaceuticals

Samsung Seeks Technical Knock-Out of Apple Patents

Samsung has filed an application with the Federal Court of Australia, under the Administrative Decisions (Judicial Review) Act 1977, for a review of decisions by the Australian Patent Office to grant four of the patents currently being asserted against it by Apple in the ongoing Australian litigation.

The application, and details the patents in question, have been reported in the past days by both iTnews and ZDNet.

If Samsung’s application is successful, it could see the four patents, all of which relate to touch-screen functionality (including the famous ‘slide-to-unlock’ patent), declared null and void by the Federal Court.

In our opinion, however, Samsung’s prospects of success are at best even, and probably somewhat less than that.  There are, as we shall explain, a number of hurdles which Samsung must leap in order to prevail, and should it fall at any one of them then its whole case will fail.

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Tags: Apple-v-Samsung, Double patenting, Judicial review

‘Professional’ Provisionals – Now More Important Than Ever

Anybody filing a provisional patent application now, and waiting the full 12 months before filing complete (non-provisional) applications in Australia and/or the United States, may be subject to revised patent laws in both countries.

Most of the substantive provisions of the Australian Raising the Bar Act commence on 15 April 2013, while the new ‘first-inventor-to-file’ provisions on the America Invents Act commence on 13 March 2013.  Both reforms have potentially significant impact on applications filed after these dates, even if these claim the benefit of provisional applications filed prior to commencement of the amendments.

In particular, as a result of the reforms, even though they have not yet fully commenced, it is now effectively imperative that any priority document, including a provisional application, provide full support for the invention as it is ultimately claimed in the complete, non-provisional, application.
‘…any provisional application filed now, and forming the basis for a complete application filed in 12 months time, will be completely worthless for priority purposes in Australia and the US unless it supports the invention across the full scope of the ultimate claims…’
The notion that a provisional application can provide a lower standard of disclosure, without prejudice to the applicant, was never really true.  But is is now more crucial than ever that this myth be dispelled.

There are a number of people ‘out there’ – principally serial inventors, inventor advocates and invention promotion companies – who are keen to tell you (often for a price) that you do not need a patent attorney to assist in the preparation and filing of a provisional patent application.  This, they say, is something any inventor can do for themselves, in order to obtain ‘meaningful’ protection for an invention at a low initial cost.

Sorry, but this is simply not true.  If you do not really know what you are doing, your provisional application may be worthless.  Indeed, it may be worse than worthless, if it provides you with a false sense of security that your invention is protected.

No doubt cynical readers will be thinking that this is exactly what you would expect a self-serving patent attorney to say.  Maybe so.  But after reading this article we hope you will at least be in a position to make an informed decision.

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Tags: Australia, Priority claim, Provisional applications, US

‘Gene Patents’: Lies, Damn Lies, and Statistics

The adage that ‘there are three kinds of lies: lies, damned lies, and statistics’ has been variously attributed, most famously by Mark Twain to 19th-century British Prime Minister Benjamin Disraeli.  However, it is not very important who said it first, or why, more than 100 years ago.  Its continuing currency stems from the underlying truth that any argument, no matter how weak, can be bolstered by an array of suitably impressive numbers. 

Unless you are a statistician, qualified by years of study and experience to assess the validity of the empirical and mathematical processes used to obtain the numbers, it is healthy to take your statistics with a good dose of scepticism.  After all, over 99.9% of statistics are made up on the spot!

However, the level of scepticism not only varies from person-to-person, but also depends upon the topic at hand.  The persuasive power of statistics among non-experts is clearly influenced by confirmation bias – the tendency to favour information that supports a person’s pre-existing beliefs.

It is perhaps no coincidence that the ‘damned lies’ adage is commonly attributed to a politician.  Of all people, politicians are perhaps the most adept at quoting facts and figures to support their positions, while denouncing those of their rivals as unfounded, inaccurate, or based upon dubious research. 

A couple of weeks ago we wrote about a new push by political opponents of so-called ‘gene patents’ to introduce legislation in the Australian parliament to ban the patenting of genetic materials, including human genes (see Gene Patent Opponents Take the Fight Back to Australian Parliament).  An argument in favour of such a ban runs along the following lines:

1. every person is made up of 23,000 genes;
2. they determine everything about you, including your susceptibility to disease;
3. 4,000 of these genes have been patented by organisations hoping to profit through exclusive research on them;
4. this means each gene is effectively owned by the patent holder;
5. if you can just get a patent for just discovering the presence of a gene, then you really block everyone else from being able to work on that gene;
6. corporations can take out patents over human genes and thereby monopolise those genes;
7. if an organisation can monopolise a gene, that means the world's scientists can't collaborate and swap their results; and
8. this could potentially delay a cure for cancer or the invention of a vaccine.

Every one of the above statements is copied directly from either the Lateline report, or the subsequent interview with anti-gene-patent proponents Senator Bill Heffernan and Mellissa Parke MP.  It all seems quite reasonable, except for the fact that most of these statements fall into one of the three categories of lies.

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

Apple Not ‘The Developer for the World’ Says Hypocritical Cook

As presented in Walter Isaacson’s biography, it seems that Steve Jobs did not require a rational justification to ‘go thermonuclear war’ against Google and Android.  As we wrote back in October last year, Jobs was willing to ‘spend my last dying breath if I need to, and I will spend every penny of Apple's $40 billion in the bank, to right this wrong.’  To him, the battle over smartphone technology was not about business or money.  Isaacson reports Jobs telling former Google CEO Eric Schmidt, ‘I don't want your money. If you offer me $5 billion, I won't want it. I've got plenty of money. I want you to stop using our ideas in Android, that's all I want.’

Jobs had built Apple into the world’s biggest tech company, and so he could really do no wrong in the eye’s of Apple shareholders and aficionados.  But the fact is that starting a global thermonuclear war, or spending every cent of the company’s money in pursuit of a principle, is not good business.  That path leads ultimately to shareholder revolt!

Jobs’ successor, Tim Cook, has therefore inherited a potential ticking time-bomb.  Apple had some early wins in the patent disputes which it started, but as the various court proceedings drag out over months – and those months will become years, unless there is a settlement – the company is finding itself increasingly mired in suits, countersuits, side issues and appeals.

It should therefore some as no surprise that Cook is trying to recast the battle as one which has a rational business foundation, and in which Apple is on the side of goodness and light.  The cost and distraction of all these law suits must now be justified to observers and shareholders as something more than the result of one person’s outrage.

So, when questioned about the ongoing IP disputes, Cook has taken to responding that, while he would prefer to settle, Apple will not be the world’s developer.  At Apple’s quarterly conference call on 24 April 2012 (as reported by CNET) Cook said ‘I would highly prefer to settle than to battle.  But it’s important that Apple not become the developer for the world. We need people to invent their own stuff.’

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Tags: Android, Apple-v-Samsung, FRAND, Smartphone wars