24 May 2015

On Extensions of Patent Term and Genetic Technologies

Recombinant formation of plasmidsTwo recent decisions issued by the Australian Patent Office address the requirements for extending the term of a patent encompassing a pharmaceutical substance ‘when produced by a process that involves the use of recombinant DNA technology’: ImmunoGen, Inc. [2014] APO 88 and Novartis Vaccines and Diagnostics S.r.l. [2015] APO 2.

What is interesting about both these cases is that, while recombinant DNA techniques are employed in manufacturing the pharmaceutical products, neither patent directly claims a new product resulting from the use recombinant DNA technology.  In both cases, the patent claims are principally directed to processes for making the products, and extensions of term have nonetheless been granted. 

The decisions relate to the anti-cancer drug KADCYLA, and the meningitis vaccine BEXSERO, both of which will now enjoy an extended term of patent protection in Australia.

17 May 2015

Can the High Court Fix Australia’s Obviousness Problem?

StepsAustralia has an obvious problem with obviousness.  For over three decades, we have been out-of-step on inventive step.  The law of obviousness under the Patents Act 1952 was originally messed up by the High Court in the ‘3M Case’ (Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd [1980] HCA 9).  There have since been three legislative attempts to fix it – with the original enactment of the Patents Act 1990, with the changes in the Patents Amendment Act 2001, and most recently with the passage of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012.

I have written previously about Australia’s Four Laws of Inventive Step, and I once called the 3M Casepossibly the second worst ever patent judgment by the High Court of Australia’.  I was wrong.  In terms of its lasting negative impact on Australian patent law, 3M is clearly Number One.  The judgment I called the worst, Philips v Mirabella [1995] HCA 15 – for all its intrinsic awfulness – has been effectively quarantined, and for the most part no longer causes us too much trouble.  3M, however, lives on in the continuing failure of all attempts at legislative correction to produce laws consistent with the approach taken in the rest of the developed world.

In the latest chapter of this ongoing saga, on the 13th and 14th of May the Australian High Court heard oral arguments in the appeal by pharmaceutical company AstraZeneca AB against last year’s ruling of an expanded five-judge Full Bench of the Federal Court of Australia that its two patents relating to the cholesterol-lowering drug marketed as CRESTOR (active ingredient rosuvastatin) are invalid.  (I previously wrote about that decision in What is the Starting Point for Inventive Step?)

For truly dedicated watchers of Australian patent law, transcripts of day 1 and day 2 of the hearing are available.  Alternatively, the High Court web site hosts audio-visual recordings of the proceedings – each of day 1 and day 2 being in excess of four hours of not-always-riveting television.

It is clear from the arguments presented to the Court that Australia’s troubles with obviousness are not over.  And while the High Court now has an opportunity to make things a little better (or, at least, to avoid making them any worse again), ultimately I think that the only real solution will be to scrap our existing prescriptive approach to inventive step in favour of the kind of open enquiry into obviousness that is available under the laws of other developed nations.

10 May 2015

‘Software Patents’ Back Under the Appeals Court Microscope

Artificial IntelligenceOn Thursday, 7 May 2015, a full bench of the Federal Court of Australia, comprising Justices Bennett, Kenny and Nicholson, heard the appeal of the earlier single-judge decision in RPL Central Pty Ltd v Commissioner of Patents [2013] FCA 871.  The case relates to Australian innovation patent no. 2009100601, which covers a computer-implemented invention (i.e. a so-called ‘software patent’) in which a computer system is used to centralise and automate mechanisms for prospective students to provide evidence of their prior education and experience for the purpose of potentially receiving course credit under a ‘recognition of prior learning’ (RPL) procedure.

Specifically, the case addresses the question of whether the computer-implemented evidence-gathering method and system is eligible for patent protection under the ‘manner of manufacture’ test for subject matter in Australia.

As always when I write about this case, I need to point out that I am not an impartial observer, and that I have to be reasonably circumspect in what I say about the matter.  RPL Central Pty Ltd is a client of my employer, Watermark Intellectual Asset Management.  I drafted the patent specification which is under scrutiny in the case.  My colleagues within Watermark’s IP Law firm have been running the Federal Court appeals on behalf of RPL Central.

However, my involvement does mean that I was in court for the hearing, and I am therefore in a position to provide a brief report on the proceedings.  For the most part, the parties were in furious agreement on the relevant legal principles, with the differences lying primarily in the way each side contended that these should be applied to the RPL Central invention.

03 May 2015

Patent Attorneys Invoke Constitution in Myriad Gene Case

Australian ConstitutionThe Institute of Patent and Trade Mark Attorneys of Australia (IPTA) has applied to intervene as amicus curiae (i.e. ‘a friend of the court’) in the High Court appeal by Yvonne D’Arcy in the Myriad Genetics BRCA gene patent case.  In doing so, IPTA is seeking to raise a Constitutional matter, namely ‘whether the concept of “patents of inventions” in section 51(xviii) of the Commonwealth of Australia Constitution Act (the Constitution) encompasses isolated genetic material and other materials isolated from nature.’

The publicly-available documents filed in the appeal, including IPTA’s written submissions in support of its application for leave to intervene, can be viewed on the High Court’s page for the case, no. S28/2015.

It probably goes without saying that IPTA’s overriding objective is to ensure that the High Court does not overturn the decision of the five-judge panel of the Federal Court of Australia which found unanimously that Myriad’s claims directed to the isolated BRCA genes were patentable.

Historically, the High Court of Australia has been reluctant to entertain amici curiae in civil disputes between private parties.  The Constitutional matter being raised by IPTA is one which has not arisen in arguments before the lower courts, and appears to be unnecessary in order to decide the specific question of whether or not Myriad’s claims directed to isolated BRCA genes are patentable.  Furthermore, in my opinion IPTA’s argument is misconceived, although I am obviously not an expert on constitutional law, so there could be something I am missing. 

Overall, I think it unlikely that the court will allow IPTA’s application, but it could make things more interesting if I am wrong!

28 April 2015

Australian Government Seeks $60M Damages Over Invalid Patent

Gold BarsA court ruling has revealed that the Commonwealth of Australia (i.e. the Federal Government) is seeking to recover $60 million it considers has been ‘overpaid’ for the anti-clotting drug marketed by Sanofi (formerly Sanofi-Aventis) and Bristol-Meyers Squibb under the brand name PLAVIX: Commonwealth of Australia v Sanofi-Aventis [2015] FCA 384.

Sanofi was the owner of Australian Patent No. 597784, which includes claims directed to the compound having the international non-proprietary name clopidogrel.  As noted above, clopidogrel has anti-clotting activity, and is prescribed primarily to prevent heart attack and stroke in high-risk patients, such as those who have a history of these conditions.  The brand-name drug PLAVIX was immensely profitable – according to Wikipedia, it was the second best-selling drug in the world, grossing over US$9 billion in global sales in 2010.  (And, since this is the Internet, Wikipedia also reveals that clopidogrel may have beneficial uses in cats.)

In 2007, generic pharmaceutical manufacturer Apotex Pty Ltd, wanting to introduce its own clopidogrel product to the Australian market, commenced proceedings against Sanofi in the Federal Court of Australia seeking revocation of its patent.  Sanofi, in turn, accused Apotex of threatening infringement.

For the duration of the resulting proceedings, injunctions imposed by the court, along with undertakings that Apotex provided, prevented it from introducing a generic product, leaving patients, and the Australian Government, with no alternative to the premium-priced brand-name product PLAVIX.  Eventually, Sanofi’s patent was found to be invalid, implying that a cheaper generic version of the drug could have been made available all along. 

The notional difference in price between the brand-name product and a hypothetical generic alternative is the basis for the Government’s claim for $60 million in damages.