Selected links from last (couple of) weeks

Here is a selection of links to IP-related matters I found interesting this past week (or two):

Patents

Trade marks

Copyright

Not categorised

I hope you find some interesting. If you did or have a question, leave a comment or send me an email

Selected links from the last week

I am going to try an experiment. With the rise of “week in review” style blogposts and your day job probably means you don’t have all day to watch Twitter streaming by, here is a selection of links to IP-related matters I found interesting this week:

Patents

Trade marks

  • MACCOFFEE? We’re not lovin’ it, says General Court here

    The “Mac” family of trade marks are too well known for someone esle to register MACCOFFEE in the EU

  • “Own Name” defence in Singapore–when “honest practices” does the heavy lifting here
  • CJEU says operators of physical marketplaces may be forced to stop trade mark infringements of market-traders

    although you could contrast that to Dowsett J’s decision

  • Book Review: The law and practice of trademark transactions – A global and local outlook

Not categorised

  • Employees Bound By Clickthrough Agreements–ADP v. Lynch (USA)

Bit of a slow week in the northern hemisphere, but I hope you find some interesting. If you did or have a question, leave a comment or send me an email

Rosuvastatin goes to the High Court

The High Court has allowed special leave to appeal from the Full Federal Court’s decision in AstraZeneca v Apotex (“Rosuvastatin”).

From the special leave transcript, it looks like the main issue will be the operation of s 7(3) and the basis on which a reference ascertained for the purposes of s 7(3) may be combined with common general knowledge under s 7(2).

In Rosuvastatin, a Full Bench of 5 justices held that the “starting point” identified in the patent could be used as the “starting point” for testing whether the solution in the patent was obvious only when shown to be part of the prior art base. The Full Court nonetheless held the patent was invalid as a s 7(3) reference, the Watanabe paper, was added to the common general knowledge.

From the special leave transcript, it appears that all parties were in agreement that the person skilled in the art would undertake a literature search. The resulting search would have thrown up a number of documents. AstraZeneca argues that the Full Court erred in allowing the Watanabe paper to be used as a s 7(3) reference. Its main argument appears to be that the search would have thrown up at least 2 papers, Watanabe and Aoki. AstraZeneca argues that, before the Watanabe paper can be combined with common general knowledge under s 7(2), it needs to be shown that the person skilled in the art would have chosen the Watanabe paper over Aoki. According to AstraZeneca, however, the evidence did not establish that. Again according to Astrazeneca, there was evidence that the skilled person could choose either paper and, if Aoki was chosen, would fail:

If you had gone down the NK-104 path you fail – a relative fail. If you had gone down the other one, you win. The evidence of Professor O’Brien was – others can reasonably make one choice or another. Dr Reece did not even venture on the issue as to which one he would go down.

A second point that AstraZeneca argues is that to choose Watanabe the skilled person would have needed to refer first to Aoki. That is, it argues that it was necessary to engage in impermissible masoning.

If AstraZeneca succeeds, there will also be a dispute about entitlement issues and the operation of new s 22A and 138(4).

No doubt more will become clearer when the appeal documents are posted on the High Court’s website.

Astrazeneca AB & Anor v Apotex Pty Ltd; Astrazeneca AB & Anor v Watson Pharma Pty Ltd; Astrazeneca AB & Anor v Ascent Pharma Pty Ltd [2015] HCATrans 58

 

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  ?

Did the Earth move for you too?

Most of the substantive Raising the Bar amendments came into force today.

Amongst other things, schedule 1 of the Raising the Bar Act introduced a raft of changes designed to raise the threshold of patentability – i.e., make it harder to get a patent.

These include:

  • introducing the really diligent searcher of prior art for obviousness via changes to s 7(3)[1] so that it will be permissible to combine any piece of prior art with common general knowledge (if the skilled addressee could reasonably be expected to combine the two), not just those elements of the prior art that the skilled addressee could be reasonably expected to have found;
  • a new concept of utility based on the US approach; and
  • doing away with the ’old’[2] fair basis requirement in s 40 as interpreted by the High Court in that Lockwood ruling.

Instead of fair basing, a patent will be required by s 40(2) to disclose:

(a) the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art; and

(aa) the best method known to the applicant of performing the invention; and …

and s 40(3) will read:[3]

“The claim or claims must be clear and succinct and [fairly based on the matter described] supported by matter disclosed in the specification.”

Provisional specifications will have to meet the requirements set out above in s 40(2)(a) also.

This is intended to introduce into Australian law the requirements under the UK’s 1977 Act: s 72(1)(c).

The Court of Appeal[4] provides an interesting example of how these new rules should work in it Merial ruling. Merial had (at least) 2 patents relating to its Frontline brand of flea-treatment products. One of these, the 881 patent survived the attack on sufficiency of description, but the other, the 564 patent did not.

Kitchin LJ identified the crucial difference between the 2 patents at [85] – [86]:

…. This was a matter to which the judge expressly referred at [77]:

”77. In contrast to the examples in 881, the examples of 564 simply specify different concentrations of the active ingredients. The examples do not contain any formulation details beyond saying that there should be present a crystallisation inhibitor, an organic solvent and an organic co-solvent.”

This then was the critical difference between the disclosures of the two patents. Omnipharm failed to establish that the practical guidance given by the examples of the 881 patent was not sufficient to enable the skilled team to work across the breadth of the claims. But the 564 patent claimed a combination of actives and did so without any worked examples at all. It provided no real practical assistance over and above the common general knowledge.

Kitchin LJ accepted Merial’s argument that the UK Act did not impose an obligation to include examples of the way the claimed invention worked. However, his Lordship considered that was not why the trial judge, Floyd J, upheld the attack. Rather, the description was insufficient because it did not give sufficient guidance about which ingredients to choose and in what proportions. So, Kitchin LJ explained at [89]:

I reject these submissions. I think it is clear from [151] – [152] that the judge did not find that the absence of any detailed examples was, in itself, fatal to the sufficiency of the 564 patent. What rendered it insufficient, in his view, was the absence of proper exemplification of a formulation of the invention in the context of a specification which was generally inadequate to guide the skilled person to success and provided no real practical assistance beyond the teaching of the prior art and the common general knowledge. The specification contains no more than a very broad indication of the components of the formulation and, as the judge found, it is not a sufficient description to enable the skilled person to arrive at formulations across the breadth of the claims without undue effort.

One illustration of the problem with the 564 patent was set out earlier at [83]:

The disclosure in relation to solvents and co-solvents is something the judge also had well in mind, as is clear from [66]-[67]. Here he referred to the dielectric constant ranges which the solvent and co-solvent must meet, and that the co-solvent must have a boiling point below 100°C. He also referred to the lists of suitable solvents and co-solvents. This information would not, however, be of any practical use to the formulator who, as Dr Walters explained, would have to fall back on his general knowledge of solvents and techniques for enhancing spreading and skin penetration in order to decide on the appropriate solvent system to use.

Neither the Court of Appeal nor Floyd J at first instance set out at length the legal principles underlying insufficiency for these purposes. However, Floyd J had earlier set out his understanding of ‘classical insufficiency’, Biogen insufficiency and ‘insufficiency through ambiguity’ at [361] – [454] in Zipher.

Omnipharm Ltd v Merial [2013] EWCA Civ 2 via IPKat

ps.: those who attended David Brennan’s talk last year will find his ‘Monash paper’ in 38(1) Monash University Law Review 78.


  1. Austlii doesn’t seem to have caught up with all the minutiae yet.  ?
  2. The ‘old’ rules will continue to apply for all standard patents granted before 15 April and any pending applications for which a request for examination had been made before 15 April. (This the pre–15 April 2013 version of s 40 will break when the new rules come in.)  ?
  3. where the words in between [ and ] are deleted by the new Act  ?
  4. For England and Wales (of course).  ?

Draft Intellectual Property Laws Amendment (Raising the Bar) Bill 2011

A few weeks back now, IP Australia released a draft Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (pdf) and draft Explanatory Memorandum (pdf).

You can probably guess its overall objective from the exposure draft bill’s longer short title. The range of matters covered extends across 6 schedules:

  • Schedule 1- Raising the quality of granted patents
  • Schedule 2– Free access to patented inventions for research and regulatory activities
  • Schedule 3– Reducing delays in resolving patent and trade mark applications
  • Schedule 4- Assisting the operations of the IP profession
  • Schedule 5- Improving mechanisms for trade mark and copyright enforcement
  • Schedule 6 – Simplifying the IP system

Of the many things that struck my eye, the proposals:

  • seek to introduce the diligent searcher standard for testing the obviousness of patents;
  • seek to have patent applications and oppositions (but not, so far, trade mark oppositions) tested on the balance of probabilities instead of being practically certain not to be valid
  • introduce the new statutory experimental use defence;
  • seek to introduce a presumption of registrability for trade mark applications;
  • introduce the patent opposition “pleading” system to trade mark oppositions; and
  • confer original jurisdiction in trade mark and registered design mattters on the Federal Magistrates Court.

As IP Australia’s announcement says:

Bill does not deal with gene specific issues, rather it seeks to raise patentability standards across all technologies. Gene specific issues are being considered separately by the Senate Legal and Constitutional Affairs Legislation Committee, and by the Government in its response to the Senate Community Affairs Committee’s Gene Patents report.

Over at Patentology Dr Mark Summerfield gives very detailed consideration to the pros and shortcomings of the obviousness reform, the changes to the requirement that patents be useful,  the attempt to fix the law of fair basis (at least insofar as provisional specs are concerned), the new enablement requirement. Dr Summerfield seems to be on a roll, so there may well be more to come.

Comments and submissions should be provided by 4 April 2011.

Upholding a patent opposition on appeal

Adrian Crooks, at IPnow, provides his summary of Besanko J’s ruling in Aspirating IP v Vision Systems [2010] FCA 1061.

Obvious to try (typos corrected)

IP Australia (for present purposes, the Commissioner of Patents) has been exploring ways to improve the quality of patents by, amongst other things, raising the threshold of inventiveness. (Consultation Paper, November 2009 (pdf) see section 1.2ff).

One might have thought that this would require legislative reform given the extremely strict approach to common general knowledge and, for that matter, s 7(3) taken in Australia.

Perhaps because the election so indecisively intervened, however, and professedly because the submissions agreed, IP Australia now appears to believe it can resolve our problems by simply adopting a new approach at the examination stage, so that legislation is no longer required. As from 1 August 2010, therefore, IP Australia has amended its approach to examining applications:

The Patent Manual of Practice and Procedure was amended on 1 August to indicate that where the application relates to the solving of a problem, being either a problem that is recognised in the art or a problem that is reasonably inferred from the specification, it is appropriate for examiners to consider the question:
Would the person skilled in the art (in all the circumstances) directly be led as a matter of course to try the claimed invention in the expectation that it might well produce a solution to the problem?

Patentology points out the way the Courts have been approaching this may not sit too well with the Commissioner’s idea.

Now, it is true that the majority in Alphapharm did say:

[52]  …. Thirdly, in a case such as the present, the relevant question was that posed in the first part of the passage. Were the experiments “part of” that inventive step claimed in the Patent or were they “of a routine character” to be tried “as a matter of course”? If the latter be attributable to the hypothetical addressee of the Patent, such a finding would support a holding of obviousness.

[53]  That way of approaching the matter has an affinity with the reformulation of the “Cripps question” by Graham J in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd[57]. This Court had been referred to Olin in the argument in Wellcome Foundation[58]. Graham J had posed the question[59]:

“Would the notional research group at the relevant date, in all the circumstances, which include a knowledge of all the relevant prior art and of the facts of the nature and success of chlorpromazine, directly be led as a matter of course to try the -CF3 substitution in the ‘2’ position in place of the -C1 atom in chlorpromazine or in any other body which, apart from the -CF3 substitution, has the other characteristics of the formula of claim 1, in the expectation that it might well produce a useful alternative to or better drug than chlorpromazine or a body useful for any other purpose?” (emphasis added)

That approach should be accepted.

The first thing to note about this proposition is that it is introduced by “thirdly”. There are a few hurdles to get over before one gets to the reformulated Cripps question.

One of the hurdles, recognised in the Commissioner’s Official Notice, is that one first has to be able to posit that the patent is attempting to propose a solution to some identified or identifiable problem. In the Lockwood (No. 2), however, the High Court made it very plain at [63] – [65] that may not always be appropriate.

Another hurdle expressed by the majority in Alphapharm were repeated doubts that “obvious to try” could be applied, if at all, to anything other than a simple step from the prior art to the claimed invention rather than, as in that case, a combination patent. In such cases, the majority rejected the approach of more recent English cases in favour of US cases such as In re O’Farrell

The admonition that ‘obvious to try’ is not the standard under §103 has been directed mainly at two kinds of error. In some cases, what would have been ‘obvious to try’ would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful. … In others, what was ‘obvious to try’ was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.

More generally, one may wonder how well the Commissioner’s attempt to use administrative procedural reform to obviate perceived deficiencies in the High Court’s interpretation of the legal meaning of the terms used in the Act will work. Given what the High Court has repeatedly said “common general knowledge” means and the limitations written into s 7(3), how would a Court on appeal deal with the Commissioner’s rejection of a patent application on the Commissioner’s new approach?

As the High Court itself made plain in Alphapharm, the divergence between Australian law and UK and for that matter US law lies in the prior art that may be used to found an attack on obvousiousness. Thus

in [43]:

…. The holding for which Minnesota Mining is celebrated is the rejection, as inapplicable to the terms of the 1952 Act, of the reasoning in certain English decisions. This might have permitted the basing of an argument of obviousness upon prior publicly available publications, without evidence that they had become part of the common general knowledge at the priority date. ….

and in [44]:

…. obviousness was not determined by asking whether a diligent searcher might have selected the elements of the claimed invention by taking pieces from those prior publications and putting them together…

and in [49]:

The result in Britain of the shift in grundnorm is exemplified in the observation by Laddie J[53] that the skilled worker (identified in s 3 of the 1977 UK Act):

“is assumed to have read and understood all the available prior art”. (High Court’s emphasis)

The treatment of the point by Aickin J in Minnesota Mining, as indicated above, expressly rejected any assumption as to what in such a way may be expected of and attributed to the hypothetical addressee. ….

If that is the foundation of the problem, it seems very hard to see how anything but a legislative solution will suffice for, as the High Court also made very plain, it is the function of the legislature to set (and if thought appropriate) change the parameters.

Official Notice (with link to Manual)

Leading the expert

PAC Mining has successfully appealed the finding that it infringed Esco’s patents for wear assemblies protecting excavating buckets, but failed in its appeal against the finding that the patent was valid.

The point that mainly struck my eye was that PAC Mining’s independent expert’s attack on the patent as obvious failed:

The primary Judge took the view that the value of Prof Wightley’s evidence was compromised by reason of the circumstance that, from the outset, he had been exposed to the shortcoming to which Toplok was perceived to be subject, and to the terms of Jones I, as well as to those of the patents in suit. In other words, Prof Wightley, from the outset, knew the problem, and he knew the solution. The authorities make it clear that the caution with which his Honour approached the evidence of Prof Wightley was both justified and desirable: Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19; (1977) 137 CLR 228, 242; Alphapharm 212 CLR at 423-424 [21]; Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) [2007] HCA 21; (2007) 235 ALR 202, 215 [46]. At this level of analysis, nothing put on behalf of the appellants on appeal has cast any doubt upon the approach which his Honour took. Within the confines of that approach, the matter of obviousness was essentially one of fact. We are not persuaded that his Honour erred in declining to be satisfied that Prof Wightley’s evidence, of itself, warranted the conclusion that the adjustment assembly introduced by Jones II and Jones III was obvious.

The Full Court went on to find no error in the trial judge’s assessment of the inventor’s evidence.

PAC Mining Pty Ltd v Esco Corporation [2009] FCAFC 18 (Sundberg, Jessup and Middleton JJ)