auDRP Overview

You probably know that the auDRP is the dispute resolution policy for the .au domain name space. You may not know that there have been about 330 decisions in its roughly 12 years of operation.

Prof Andrew Christie, with a help from James Gloster, Jeffry Kadarusman and Daniel Lau, has prepared an “Overview” outlining how the decisions have treated the various issues arising under the auDRP. And he is launching the auDRP Overview at a Workshop on Wednesday 27 August at 9:15 am to 10:45. Venue the Crown Promenade.

Details here.

Prof Christie is the Professor of Intellectual Property at the University of Melbourne a very experienced domain name panelist, having amongst other things written the seminal decision Telstra v Nuclear Marshmallows D2000-0003If you find yourself with a dispute over a domain name registered in the .au domain name space, I anticipate you will find your first stop being this overview. Given the influence of UDRP decisions on auDRP decisions, although there are some important differences, you will also probably find it helpful in the context of the UDRP too. Make sure you read it.

The WIPO Overview to the UDRP version 2.0 here.

Five Judges speak with one voice on Australian Patent Law Construction and Fair Basis*

The Rosuvastatin case is that rare beast – a decision of a 5 member Full Bench of the Federal Court. It canvases many issues and, no doubt, we shall be picking over it for years to come. Susan Gatford, at the Victorian Bar, has kindly provided a guest post on the section 40 issues. Take it way Sue:

The judgment in AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99 is an authoritative statement by a Full Court of the Federal Court of current patent law in Australia on novelty, obviousness, fair basis and indirect infringement. Further, neither the parties nor the Full Court at [37] demurred from the primary judge’s summary of the relevant authorities as to what constitutes common general knowledge and the attributes of the hypothetical skilled addressee. Likewise, neither the parties nor the Full Court at [90] disagreed with the primary judge’s exposition of the principles governing the construction of the claims and body of a specification of a patent.

The Full Court was principally constituted with five justices so as to address issues in regard to obviousness[1]. But the decisions at first instance and on appeal, taken together, also provide a “go to” exposition of most of the legal issues that commonly arise in Australian patent cases.

The Court’s views on the different validity grounds and on indirect infringement each warrant separate commentary and analysis. This article considers one of the construction issues, the decision as to fair basis and the interplay between construction and fair basis.

Background

Statins are a group of drugs that reduce the levels of cholesterol in the blood. Rosuvastatin (marketed in Australia as CRESTOR) is a very successful statin. No patent was ever filed in Australia for the rosuvastatin chemical compound. But AstraZeneca (Az) owns a number of secondary Australian patents relating to rosuvastatin. Two such patents are the subject of the appeal decision. One (the low dose patent) is for the administration of a particular dose or dosage range of rosuvastatin for the treatment of excess cholesterol in the blood stream. The other (the cation patent) is for a pharmaceutical composition (combination) of rosuvastatin mixed with certain inorganic salts.

The Full Federal Court’s decision affirms, although with some differences of reasoning and grounds, Apotex’s victory last year before Justice Jagot, in which it obtained orders revoking both patents.

The outcome of the appeal

The low dose patent was held:

  • to have named the wrong inventor (with a discussion of the current and former entitlement provisions of the Patents Act);
  • to be obvious (with a discussion of the starting point at which obviousness is to be considered and the impact of section 7 of the Patents Act); and
  • not to have been infringed (with a discussion of section 117 of the Patents Act)
  • 

However, reversing the decision of the primary judge, the Full Court held that the low dose patent was novel despite the existence of prior publications disclosing both rosuvastatin and a dosage range that covered the dosage range the subject of the claims.

The cation patent was held:

  • to have impermissibly claimed too early a priority date;
  • to have been anticipated (not novel);
  • to be obvious; and
  • not to be fairly based on the specification (despite the presence of claim 1 as a consistory clause within the body of the specification).

The five judges agreed with each other on all issues. Justices Besanko, Foster, Nicholas and Yates wrote a joint judgment which dealt with all issues except obviousness. Justice Jessup wrote a separate judgment on obviousness with which the rest of the Court agreed.

Patent construction and section 40 issues in relation to the cation patent.

The cation patent was for rosuvastatin mixed with certain multivalent cation inorganic salts. The salts were not therapeutic – their role was said to be simply to stabilize the rosuvastatin and prevent it from degrading. The patent specification described rosuvastatin and various salts being mixed together into a tablet which was then coated.
There was a disagreement between the parties as to the meaning of the words “pharmaceutical composition” in claim 1 of the cation patent. Apotex submitted that in the context of the cation patent “pharmaceutical composition” referred only to the rosuvastatin-salt mixture, and did not include the tablet coating. This was because the proposed Apotex product did not have a rosuvastatin-salt mixture – in its tablet the salt was placed into the coating, not mixed with the rosuvastatin.

Az, in order to maintain its infringement case, argued that the words “pharmaceutical composition” in claim 1 meant the whole tablet i.e. the means by which rosuvastatin is administered or delivered to the patient, whatever form that takes. The primary judge agreed with Az, as did the Full Court.

But, Apotex said, if this is what claim 1 means then it is not fairly based on the specification, as there is no real and reasonably clear disclosure in the specification of a pharmaceutical composition in which the relevant inorganic salt is contained solely within the coating of the pharmaceutical composition and not mixed with the active ingredient, being rosuvastatin. They noted that every disclosure in the cation patent of the use of a relevant salt, including in each of the examples, involved the salt being mixed or blended with rosuvastatin. They also noted that the only theory advanced in the specification to explain how the multivalent cation salt improved the stability of rosuvastatin was that it stabilised its chemical structure, which the experts’ evidence confirmed required “intimate mixing”.

Az did not dispute this evidence but submitted that the fact that claim 1 was repeated in the body of the specification as a consistory clause was itself sufficient for fair basis, relying on statements in Lockwood Security Products Pty Limited v Doric Products Pty Limited (2004) 217 CLR 274 (Doric No 1) at [38] and [91] to [93]. The primary judge had agreed with that submission.

The Full Court, however, disagreed. It said at [421]

“The question that must be addressed is whether there is a real and reasonably clear disclosure in the specification of an invention in which there might be no mixture of the active ingredient and inorganic salt. In our opinion, the specification, when read as a whole, does not make any such disclosure even in the most general sense.”

In other words, the claim was for a composition which contained three things – rosuvastatin, salt and a coating. The claim did not require the salt and the rosuvastatin to be mixed, so the salt could either be with the rosuvastatin or in the coating. In the invention disclosed in the specification, though, the salt and the rosuvastatin were always mixed. The possibility of the salt not being mixed with the rosuvastatin was not contemplated and not disclosed.

Section 40(3) of the Patents Act as applied to this patent (i.e. as it stood before the 2013 amendments to the Patents Act) requires that “the claim or claims must be … fairly based on the matter disclosed in the specification”.

The Court’s finding of lack of fair basis refocuses attention on the construction of claim 1 contended for by Apotex. But the Court was not prepared, in light of the authorities, to read claim 1 as requiring the salt and the rosuvastatin to be mixed, as it considered that to do so would be to draw an impermissible gloss from the specification.

The Court was, however, prepared to use section 40 to strike down what it evidently regarded as a claim that was too widely drawn. Whether the judgment will result in an increase in the number of successful challenges based on section 40 grounds remains to be seen.

AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99

 

Thanks, Sue.


  1. As to which see Mark Summerfeild’s recent blog post  ?

Additional damages are procedural …

In June, Perram J awarded the Halal Certification Authority $10 nominal damages and $91,005.00 by way of additional damages for trade mark infringement pursuant to s 126(2).

Section 126(2) was inserted in the Act by the Raising the Bar Act and commenced operation on 15 April 2013.

The conduct which attracted the award of additional damages, however, occurred between August 2012 and September 2013. So, Quality Kebabs came back to argue that the award should be reduced to (about) $35,000; arguing that the Court could only award additional damages for the period from 15 April 2013.

Noting that the right to seek damages had been in place throughout the period and viewing s 126(2) as affecting the quantum only, Perram J rejected this argument. His Honour considered the situation was more like those cases where the amendment was treated as ‘procedural’ rather than ‘substantive’ and so could apply to all the conduct.

His Honour did note, however, that Quality Kebabs made no argument that additional damages were punitive in nature and so should be treated as a penal law – which would presumably not be permitted to have retrospective effect.

Hmm …. additional damages (at least in the context of copyright) are (at least in part) intended to punish the defendant and deter others from engaging in similar conduct.[1] So this debate may well arise again.

The reasons also have a short determination on the form the corrective advertising for contravention of the ACL should take.

Perram J was able to entertain Quality Kebabs’ application because, the corrective advertising order not having been finalised, the decision was still interlocutory and not final.

Halal Certification Authority Pty Limited v Quality Kebab Wholesalers Pty Limited (No 2) [2014] FCA 840


  1. See the discussion in Facton v Rifai [2012] FCAFC 9 at [33] – [37] (Lander and Gordon JJ) and Vaysman v Deckers Outdoor Corporation [2014] FCAFC 60 at [23] – [31] (Besanko J). Of course, s 115(4) of the Copyright Act does have all those “extra” paragraphs, but they are probably equally applicable to the Trade Marks Act and the Patents Act too.  ?

The rosuvastatin patents are still invalid

If you have been waiting for the outcome of the appeals from Jagot J’s decision to revoke 3 of AstraZeneca’s patents relating to rosuvastatin and the treatment of hypercholesterolemia

  • one of the extremely rare 5 member Full Benches of the Federal Court -

the decision is out and the patents are still invalid.

Jessup J agreed with Besanko, Foster, Yates and Nicholas JJ, but delivered separate reasons on the question of obviousness.

At 180 pages, further comment will have to wait.

AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99

Patent application data in Australia

IP Australia has published a report looking at patent backlogs, inventories and pendency. [1]

The Report has been prepared using the same framework used by the USPTO and UK IPO.

Apparently, the number of pending applications peaked in 2009 at 100,000. By 2013, it was down to 90,000. The number of applications being filed has finally recovered to “pre-GFC” levels.

There are 278 pending applications per examiner; the lowest number since 2001. In the USA (which has a much larger number of applications) the number is 169 applications per examiner and, in the UK, 198 per examiner.

There were 26,394 applications filed in 2008. Approximately 52% passed through examination and opposition (if any) to grant. Some 9.4% were still “pending” as at May 2013.

About 20% of applications made in 2008 were the subject of a voluntary request for examination; almost all of the remainder are subject to a direction to request examination.

Almost 20% of all applications lapsed or were withdrawn when the Commissioner directs the applicant to request examination. Almost 15% lapsed or were withdrawn at the first report stage. A further 2% lapsed or were withdrawn after further reports.

950 of the applications made in 2008 (0.36%) have been subject to opposition (to date). Of those, the opposition led to only 68 (0.026%) being rejected or withdrawn.

You can read the Report here.

The UK IPO and USPTO ‘Working draft‘ from last year (pdf) (media release).

Patently-O has been looking at aspects of the US data here, here and here.


  1. Ahmer Iqbal Siddiqui, Report on patent backlogs, inventories and pendency. IP Australia Economic Research Paper 01.  ?