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  ?

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.  ?

ACIP on innovation patents

ACIP’s final report into Innovation Patents has been published.

Key points / recommendations:

  • ACIP can’t find evidence to support conclusion that innovation patents promote innovation

 

  • ACIP recommends that, if the innovation patent system be retained:

 

    • there be a new “innovation” threshold:

amending the Patents Act 1990 (Cth) to raise the level of innovation to a level above the current innovative step level, but below the inventive step level that applies to standard patents. A suitable level of innovative step would be provided by the test of inventiveness described by the High Court of Australia in Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd [1980] HCA 9: (1980) 144 CLR 253; (1980) 29 ALR 29 with a modification to that test to include the current definition of what is relevant CGK. In order to be innovative an invention would need to be non-obvious by reference to CGK either within or outside the patent area but not by reference to prior art information that is not part of CGK at the priority date of the relevant claims of the innovation patent. This would be a lower threshold than is applied to standard patents, where the invention must be non-obvious by reference to the CGK and any piece of prior art.

I suppose that would at least be a test that requires some advance over the prior art and is (at least in theory) something which those of us who started growing up under the 1952 Act should be familiar with.

    • a request for examination must be filed within 3 years
    • the term “patent” be reserved for certified “patents” only;
    • exclude from innovation patents “all methods, all processes and all systems “.

The Government has indicated it will respond in due course.

ACIP’s Innovation Patent Inquiry page.

Link to the Final Report (pdf).

A patents case goes to the High Court

The High Court has granted special leave to Alphapharm to appeal from the Full Federal Court’s decision to allow Lundbeck to apply to extend the term of its Lexapro patent 10 years late. The High Court was not interested at all in the exercise of the discretion to allow a 10 year extension. the question is whether a power to extend time exists at all.

The extension of term provisions for pharmaceutical patents are found in s 70 and s 71(2). Section 71(2) provides that:

An application for an extension of the term of a standard patent must be made during the term of the patent and within 6 months after the latest of the following dates:

(a) the date the patent was granted;

( b) the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, any of the pharmaceutical substances referred to in subsection 70(3);

(c) the date of commencement of this section.

It was common ground that Lundbeck’s application was outside the latest of the possible dates.

However, the Patents Act also provides a power to grant extensions of time in s 223.

Lundbeck’s problem – if it turns out to be a problem – is that s 223(11) says that s 223 cannot be used to extend the time for doing “prescribed actions” and reg. 22.11 specifies as one of the prescribed actions:

filing, during the term of a standard patent under subsection 71(2) of the Act, an application under subsection 70(1) of the Act for an extension of the term of the patent;

In the Federal Court,[1] Yates J at [50] found that Lundbeck’s “application” for an extension of time fell outside this because it really involved 2 requirements:

The making of an application under s 70(1) of the Act is governed by two time limits: the application must be made “during the term of the patent” and within six months of the applicable date in s 71(2)(a) to (c). Both time limits must be observed in order to make an application.

While the requirement that the application be made “during the term of the patent” was caught and so excluded by s 223(11), the second requirement – within 6 months of the applicable date – was not.

The High Court (Kiefel J and Keane J) have granted Alphapharm special leave to argue that, as a matter of construction, there was really only one application.

Lundbeck boldly tried to argue that special leave should not be granted because the issue raised no question of general importance: there not that many applications for an extension of time to apply for an extension of the term of a pharmaceutical patent. Kiefel J retorted sharply:

KIEFEL J: But the extension of a patent is itself an important matter, is it not?

MR NIALL: It is.

KIEFEL J: Very important.

It does raise an interesting question. The extended term expired back in December 2012. Alphapharm and others, however, had entered the market when the original term of the patent expired on 13 June 2009 and before Lundbeck’s application for an extension of time in which to file its application to extend the term had been finalised. Therefore, it would appear that the potential exposure of the generics companies to damages awards (or an account of profits) is up for grabs; i.e., another 3 years.

Alphapharm Pty Ltd v H Lundbeck A/S [2014] HCATrans 79

Lid dip: Opinions on High

Some other commentaries: here, here and here.


  1. Aspen Pharma Pty Ltd v H Lundbeck A/S [2013] FCAFC 129 (Jessup and Jagot JJ agreeing).  ?

Abstract principle, fine art or just unknowable

Mr Lisica applied for a patent, claim 1 of which reads:

An auscultative method that expounds upon the Natural Harmonics Series (NHS) and Mr Svetko Lisica’s Scientific Theory for Music’s decipherability and attunement, from the Invention’s Programmatic Specificity in a soniferous or visual realm for a new, useful, innovative and original Composition Engine and via its computations, providing the compositional harmonic materials that are put in the states of being manifested by the Invention’s unprecedented and original Musical Instrument and Sonic Biodynamical Brain Entrainment Bridge for Binaural Beats, into a stable unit of measure in exactitude for a tuning medium, herewith this Invention is the state or fact of existence, a practical Universal Intonation System that belongs with Music, The Absolute and The Beyond.

(The other claims are all dependent.)

Despite submissions to the Examiner, the Delegate at a hearing and an appeal to the Court, no-one (apart from Mr Lisica) really has any idea what the claimed invention is.

The Delegate rejected Mr Lisica’s application on the grounds that it was not a manner of manufacture and contravention of s 40(2) – the old form.[1]

Jessup J found only one objection was necessary: non-compliance with s 40(3) (in its old form):

The claims are, of course, critical to the exercise in which the court is now involved. It is here that the applicant encounters what is, for a court operating without the assistance of expert evidence, a fundamental difficulty. In my view, Claim 1, set out above, is not clear and succinct, as required by s 40(3) of the Patents Act. As a statement marking out the area of the public monopoly which the applicant seeks, the claim falls well short of the standard of clarity required. The ground of objection referred to in s 59(c) is substantiated in relation to the claim. I do not, therefore, consider that there is no lawful ground of objection of the kind referred to in s 49(1)(b). I would exercise the discretion arising under s 49(2) adversely to the applicant.

The Commissioner (or, rather, her officers) were a bit naughty. Mr Lisica had submitted 6 files in support of his application. The Examiner and the Delegate only opened and read 2 of them. Apparently, the other files were in SCM format, which the Patent Office couldn’t open.[2]

The naughty bit: no-one told Mr Lisica that the Patent Office didn’t read the files (because they couldn’t open them) until everyone got to Court for the trial. As Jessup J explained:

It may have required a modicum of ingenuity to open the SCM files – in a demonstration in court, the applicant himself did so. But the troubling aspect of the omission referred to above is not whether it was reasonable of the applicant to have expected the examiner and the delegate to open the files, but that the applicant was never informed of the difficulty which they were, apparently, experiencing, nor invited to remedy it. The examiner’s report was supplied to the applicant in the normal course, and it gave him no reason to suspect that four out of the six files which he had submitted had not been viewed or considered for such assistance as they may have provided in conveying the nature of the invention and how it was best performed. In that state of ignorance, the applicant made his submissions to the delegate, and he too dealt with the problems which the application involved without viewing all the files which constituted the application.

(His Honour did note that he was not suggesting any different result might have occurred if the correct process had observed.) Jessup J seems to be contemplating not allowing the Commissioner her costs:

In the orders which accompany these reasons, I shall lay out a timetable for the making of written submissions on costs. I shall, of course, consider any submission which the Commissioner makes in that regard, but I think I should say at this stage that one issue upon which I would expect to be addressed in that submission is whether the circumstances most recently discussed above in these reasons should be considered relevant to such entitlement to costs as the Commissioner might otherwise have as the successful party in this appeal.

Lisica v Commissioner of Patents [2014] FCA 433


  1. Relying amongst other things on Research Affiliates.  ?
  2. His Honour drily noted, even a file in .doc format does not comply with the Commissioner’s requirements.  ?

IP and antitrust in Australia

Wow! I think this is a first in Australia: the ACCC – Australia’s competition “watchdog” – is suing Pfizer for antitrust breaches over its (then expiring) patent for Lipitor.[1]

According to the ACCC’s press release:

At its peak, Lipitor was prescribed to over one million Australians with annual sales exceeding AU$700 million.

Pfizer had a patent over the active ingredient, atorvastatin, but it expired in May 2012.

Early in 2012 (before the patent expired), the ACCC alleges that Pfizer offered to supply Lipitor to pharmacies at “significant discounts and the payment of rebates previously accrued” so long as they agreed to buy from Pfizer a minimum volume of up to 12 months’ generic atorvastatin after the patent expired.

The ACCC alleges this constituted a misuse of market power contrary to s 46 and exclusive dealing contrary to s 47 of the Competition and Consumer Act because:

(1) the offers were made before the patent expired and so at a time when other generic suppliers could not make offers; and

(2) “Pfizer engaged in this conduct for the purpose of deterring or preventing competitors in the market for atorvastatin from engaging in competitive conduct, as well as for the purpose of substantially lessening competition”.

If the ACCC is right, it wants penalties, declarations and costs. Under the Act, the pecuniary penalties could be up to the greater of $10 million, 3 times the benefit gained from the contravention or 10% of annual turnover.

More generally, as the ACCC’s chairman flagged:

This case also raises an important public interest issue regarding the conduct of a patent holder nearing the expiry of that patent and what constitutes permissible competitive conduct.

Now, patentees’ efforts, while their patent is in force, to tie customers into taking the product after the patent has expired, were so controversial that, just over one hundred years ago, Parliaments introduced legislation to permit licensees to terminate patent licences once the patent expired.[2]

Beyond that, s 46 also prohibits any corporation from taking advantage of a substantial degree of power in a market for the purpose of:

(a) eliminating or substantially damaging a competitor of the corporation or of a body corporate that is related to the corporation in that or any other market;

(b) preventing the entry of a person into that or any other market; or

(c) deterring or preventing a person from engaging in competitive conduct in that or any other market.

So, to contravene s 46, the ACCC will have to establish two conditions:

(1) Pfizer had a substantial degree of power in a market; and

(2) it took advantage of that power for an anti-competitive purpose.

The first issue turns on what is the market: the market for Lipitor or some wider market such as a market for the treatment of high cholesterol? This question highlights the reference in the ACCC’s press release to the succes of Lipitor “at its peak”. I don’t know much about the market for treatment of high cholesterol but, by the time Pfizer did this allegedly dastardly deed, there were presumably some alternatives to prescribing Lipitor.[3]

In an earlier proceeding involving copyright,[4] the Full Court of the Federal Court held that a record company which had less than 20% of the market did not have a substantial degree of power in the market. So, unless the ACCC can tie the market narrowly to the market for Lipitor, it may well face considerable difficulties.[5]

Those difficulties may mean that the s 47 allegation has greater significance as, in that earlier case, the Full Federal Court still found the record companies contravened s 47 even though they did not have market power. Although their conduct could not have the effect of substantially lessening competition (because they did not have sufficient market power), their purpose was anti-competitive.

Plainly, Pfizer was trying to sign up the pharmacies to this deal so that they would not buy at least the minimum amount from these generic suppliers who were apparently waiting in the wings, but is that anti-competitive? Maybe it depends on how large the minimum requirement is in relation to the pharmacy’s expected needs for the period. But, it was only for 12 months!

Normally,[6] one would expect the pharmacies could readily calculate whether they were better off taking the deal or continuing to pay the “list” price for Lipitor and then taking advantage of spot prices in the market after the patent expired. If the alleged contravention, however, was that Pfizer refused to supply Lipitor at all while the patent was in force unless the pharmacies agreed to buy “generic” Lipitor after the patent’s expiry, that might have put the pharmacies in a very difficult position of being unable to fill prescriptions.

A further potential complication is that s 47 does not apply to conditions in a licence (or assignment) of a patent to the extent the conditions related to the patented invention or articles made by the use of the patented invention. No-one really knows what that means. Could a pharmacy that agrees to buy Lipitor from Pfizer be a licensee? Certainly, in keeping the drug for sale and selling it, the pharmacy would be exploiting the patent (while it was still in force), but has an implied licence to do those acts. Could agreement to buy “generic” Lipitor after the patent has expired relate to the invention?

At this stage, the parties have filed their respective pleadings,[7] discovery is taking place to be followed by affidavits and a return to Court for further directions in September.

The ACCC’s press release

Lid dip: Patentology


  1. Federal Court Proceeding No. NSD 146/2014, filed on 13 February 2014.  ?
  2. As this case demonstrated, however, it has limited effect.  ?
  3. And it may often be the case that different drugs have different side effects or have particular advantages over other treatments so it is not quite the same as comparing, say, Pink Lady apples with Fuji apples or ….  ?
  4. Universal Music Australia Pty Ltd v Australian Competition & Consumer Commission [2003] FCAFC 193  ?
  5. That said, the price of Lipitor in Australia, even off-patent, has managed to attract unfavourable headlines.  ?
  6. Maybe there is some complexity arising from the arcane operations of pricing under the Pharmaceutical Benefits Scheme?  ?
  7. If anyone cares to provide a copy, I’d love to read them :-).  ?

Software patents in the USA

Yesterday, the US Supreme Court heard oral argument on the question of the patentability of Alice Corporation’s software system for a method of payment, in denying the validity of which 10 judges of the Federal Circuit famously came up with 7 different opinions.

Several patents and claims are in issue, all relating to a computerized trading platform used for conducting financial transactions in which a third party settles obligations between a first and a second party so as to eliminate “counterparty” or “settlement” risk.

The question presented:

Whether claims to computer-implemented inventions-including claims to systems and machines, processes, and items of manufacture-are directed to patent-eligible subject matter within the meaning of 35 U.S.C. § 101 as interpreted by this Court?

As petitioner, the patentee (Alice Corp) will argue first. Respondent’s time will be split between CLS Bank and the US Government who has filed an amicus brief highlighting a misguided argument that “the abstract idea exception is patent law’s sole mechanism for excluding claims directed to manipulation of non-technological concepts and relationships.”

Transcript here. Some extracts here

One interesting point: the questioning of the advocates about which of the competing options proposed by the amici they preferred as solutions to the issue.

Summary of briefs with links to the briefs

Washington Post preview

Our own battles in this front are still proceeding with a decision awaited in the Research Affiliates appeal and RPL Central.

Meanwhile the USPTO has issued revised guidelines: 2014 Procedure For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving
Laws Of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products
.

Intellectual Property Laws Amendment Bill 2014

After the consultation, the Intellectual Property Laws Amendment Bill 2014 has been introduced.

  • Schedules 1 and 2 aim to implement the TRIPS Protocol:

    According to the EM:

    Under the new scheme, Australian laboratories will be able to apply to the Federal Court for a compulsory licence to manufacture generic versions of patented medicines under specific conditions, and export these medicines to developing countries. Adequate compensation for the patent holder will be negotiated, to ensure that they are not disadvantaged by the arrangements.

    Schedule 1 introduces provisions to implement the “interim waiver” agreed in the Doha Declaration 2001; Schedule 2 implements the TRIPS Protocol regime agreed in 2003 (or, I think, 2005).

    According to the EM, only one licence has been issued under these regimes – Canada in 2007. Apparently, Canadian generics would like to engage in further licensing, but the procedures are too complicated. Also, Least Developed Countries do not need to provide patent protection until 2016 and there is said to be a lack of awareness of the regime.[1]

  • Schedule 3 confers jurisdiction over plant breeder’s rights matters on the Federal Circuit Court (in addition to the Federal Court)
  • Schedule 4:
    • introduces the “single examination” model for patent applications in Australia and New Zealand;[2]
    • the single regulatory regime for patent attorneys and trade mark attorneys in both countries – the so-called trans-Tasman regulatory regime; and
    • provides for a single address for service in either Australia or New Zealand to be used under the patents, trade marks, registered designs and plant breeder’s rights legislation.
  • Schedule 5 is headed “Technical Amendments” which include repealing “unnecessary document retention provisions” and addressing “minor oversights in the drafting of” the Raising the Bar Act. These include:
    • amending s 29A so that an international applicant under the PCT cannot require anything to be done in Australia until the application enters the national phase;
    • amending s 29B so that only the prescribed period under s 38(1A) applies to Paris Convention applications;
    • amending ss 41 and 43 in relation to disclosure requirements for micro-organism inventions
    • amending s 43 to permit reference to the combination of prescribed documents, not just to individual prescribed documents alone
    • the defence in s 119(3)(b) will be amended to bring it into line with the amended form of s 24(1)(a)
    • amending s 191A so that the requirement for the Commissioner to hear both parties prescribed in s 191A(4) applies only in entitlement disputes.

Intellectual Property Laws Amendment Bill 2014

Explanatory memorandum


  1. The Regulatory Impact Statement included in the EM estimates that 63 in-house legal professionals and 128 patent attorneys in external firms will need to familiarise themselves with these changes for a total start up cost to business of $13,782.60 and an ongoing annual cost of $105. These costs include allowance for savings in legal costs because it will be possible to bring proceedings for infringement of plant breeder’s rights in the Federal Circuit Court, rather than the Federal Court. Perhaps confusing costs with earnings, the Regulatory Impact Statement relies on the ABS Employee Earnings and Hours Survey to estimate the average cost of patent and trade mark attorneys as $50 per hour (junior solicitors $60 per hour, IP attorneys $74.10 per hour and barristers $92.70 per hour, after including a 50% loading for overheads). The Statement does recognise that charge out rates “for lega”for legal professionals can range from $120 per hour to $800 per hour or more, viewed on 4 December 2013 at http://www.legallawyers.com.au/legal-topics/law-firm-sydney/solicitor-prices/. These costs do not reflect the opportunity cost of labour.” You may also be interested to know that the Regulatory Impact Statement estimates the costs of an application to the Federal Court for a licence at around $21,650 for the applicant.  ?
  2. The substance of the two countries’ respective patent laws is not being harmonised (yet).  ?

Sanofi v Apotex – infringement

The previous post looked at the High Court’s ruling that Sanofi’s patent for a method of medical treatment was patentable subject matter as a manner of manufacture. This post looks at the infringement ruling.

You will recall that the patent for leflunomide itself has expired, but claim 1 of Sanofi’s relevant patent is for:

[a] method of preventing or treating a skin disorder, wherein the skin disorder is psoriasis, which comprises administering to a recipient an effective amount of [leflunomide].

Dermatologists do not prescribe leflunomide for the treatment of psoriasis, but rheumatologists do prescribe leflunomide for the treatment of rheumatoid arthritis (RA) and psoriatic arthritis (PsA). Apparently, almost every person who has PsA will have, or will also develop, psoriasis. When leflunomide is prescribed for the treatment of PsA, “it is usually expected to also prevent or treat the patient’s psoriasis, if that person has a concurrent case of psoriasis.”[1]

Apotex had received marketing approval from the TGA for the treatment of RA and PsA (but not psoriasis specifically). Its product information stated:

“INDICATIONS

Apo-Leflunomide is indicated for the treatment of:

. Active Rheumatoid Arthritis.

. Active Psoriatic Arthritis. Apo-Leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease.”

The Federal Court – Jagot J at first instance and the Full Court had agreed with Sanofi that Apotex’ supply of leflunomide in these circumstances infringed s 117. While the reasoning was a bit different in each case, it essentially turned on 2 propositions:

First, s 117(2)(b): Apotex had reason to believe its leflunomide would be used to treat psoriasis because its administration to PsA sufferers would usually involve treatment of psoriasis too.

Secondly, s 117(2)(c): in any event, Apotex’ product information was an instruction to use leflunomide in the treatment of psoriasis when it was being prescribed to treat PsA.

Crennan and Kiefel JJ (with whom French CJ and Gaegeler J agreed) rejected both bases and held that Apotex did not infringe.

The patent gave Sanofi a very limited monopoly – use of leflunomide for a particular purpose. This appears to have led to an important point of policy at [302]:

…. It is difficult to understand how the supply of an unpatented product, the use of which by a supplier would not infringe a method patent, can give rise to indirect infringement of a method patent by a recipient of the unpatented product from the supplier. The difficulty reflects the prior art and Sanofi’s limited novelty in the hitherto unknown therapeutic use of the pharmaceutical substance, which is the claimed subject matter of the Patent.

Notwithstanding the interpretation of the product information reached by all four Federal Court judges below, there was no instruction or recommendation of the kind required by s 117(2)(c). Bearing in mind the regulatory regime imposed by the TGA at [303]:

…. In light of the provisions of the TGA, to which reference has been made, the expression “indication” in the product information document is an emphatic instruction to recipients of Apo?Leflunomide from Apotex to restrict use of the product to uses other than use in accordance with the patented method in claim 1. ….

It was simply an instruction to use leflunomide for the treatment of PsA or RA. Nor was s 117(2)(b) engaged. Rather than looking to the effect of the administration of Apotex’ leflunomide, it was necessary to look at the purpose it was being prescribed for: in the relevant cases, the treatment of PsA. At [304] therefore:

it was not shown, nor could it be inferred, that Apotex had reason to believe that the unpatented pharmaceutical substance, which it proposes to supply, would be used by recipients in accordance with the patented method, contrary to the indications in Apotex’s approved product information document.

This suggests that it will be very difficult to establish infringement of a claim to the use of a medicine for a patented purpose where the therapeutic compound itself is no longer patented and the the patented purpose is not one of the indications for which the supplier has obtained TGA approval. One might wonder about the situation where the supplier / respondent was aware of significant off-label use. In this case, however, the High Court seems to have characterised the infringing effect as purely incidental. That was no doubt supported by the different specialists who might prescribe leflunomide for the different purposes.

The High Court did not find it necessary to discuss the trial judge’s finding [2] that leflunomide was not a staple commercial product so that s 117(2)(b).

So, after all that, Apotex did not infringe the patent. We at least have a clear ruling (albeit obiter dicta in that special High Court way) about the patentability of methods of medical treatment so far as the courts (and the current High Court) are concerned. I wonder how much the pecuniary remedies for Apotex’ infringement of copyright in the product informtion is worth?

Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50


  1. Crennan and Kiefel JJ at [182].  ?
  2. Sanofi v Apotex (No 2) at [270] – [273], on the footing that the relevant product for the purposes of s 117(2)(b) was the product as supplied by Apotex (and not leflunomide generally), which could be supplied and traded only for the 2 limited purposes indicated in the product information.  ?