Archive for the ‘Patents’ Category

IP and antitrust in Australia

Tuesday, April 22nd, 2014

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

Wednesday, April 2nd, 2014

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

Thursday, March 20th, 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).  ?

The statutory right to terminate a patent licence

Tuesday, March 11th, 2014

Section 145 provides the licensee of a patent with a statutory right to terminate the licence on 3 months’ written notice after the patent has expired. What happens, however, if more than one patent has been licensed?

MPEG LA is the patent pool vehicle which licenses the essential patents for the production of DVDs, DVD players and some other video codecs.[1] It granted a licence of a number of patents to Regency Media. In June 2012, after some, but not all, of the patents had expired, Regency Media sent a notice seeking to exercise its right to terminate under s 145. By the trial, some other patents had expired, but some of those licensed were still extant.

Section 145 provides:

Termination of contract after patent ceases to be in force

 (1)  A contract relating to the lease of, or a licence to exploit, a patented invention may be terminated by either party, on giving 3 months’ notice in writing to the other party, at any time after the patent, or all the patents, by which the invention was protected at the time the contract was made, have ceased to be in force.

(2)  Subsection (1) applies despite anything to the contrary in that contract or in any other contract.

The short answer: according to Flick J it appears the licensee has to wait until all the licensed patents have expired before the licensee can exercise the right under s 145.

A bit longer answer: Acknowledging the force of Regency Media’s argument that each patent could be described as being for a patented invention (a term not otherwise defined in the Act), Flick J accepted MPEG LA’s argument. According to MPEG LA, the licence granted rights over three groups of technologies:

  • the MPEG–2 Decoding Products;
  • the MPEG–2 Encoding Products; and
  • the MPEG–2 Packaged Medium,

each of which groups constituted a patented invention for the purposes of s 145 and so s 145 could not be triggered until all had expired.

At [40], Flick J appears to arrive at this conclusion because each of the three groups constituted a “manner of manufacture” in the NRDC sense irrespective of how many patents fell within the particular group. His Honour also thought s 145 was drafted before modern licensing administrators came on to the scene and so may well be inaptly worded to deal with such creatures. However, his Honour considered at [43]:

A court, should be slow to prefer a construction which would permit the termination of an agreement in respect to patents which have not ceased to be in force and which would deny to a patent holder the benefit of the payment of royalties in amounts that have been the subject of agreement. Section 145 manifestly does not permit a contract to be terminated where “all of the patents, by which the invention [is] protected” have not ceased to be in force.

MPEG LA, L.L.C. v Regency Media Pty Ltd [2014] FCA 180


  1. A modern day American antitrust miracle: the official version; Wikipedia’s version.  ?

Securities over IP

Thursday, January 23rd, 2014

IP Australia has published a reminder:

The transitional period to register any securities (charges, mortgages etc.) you may have taken out over IP ( registered trade marks, patents, designs etc.) on the Personal Property Securities Register expires on 31 January 2014.

The Personal Properties Security Register is a national register of claims to security interests over personal property (which includes our imaginary subject matters) in essence to provide a one stop shop for notice about such claims.

If you (or your client) has taken out a security over someone else’ intellectual property or where the other person’s intellectual property is being used as collateral for repayment, the security should be registered on the Personal Property Securities Register. In very broad terms: if the security isn’t registered in the Personal Property Securities Register, its claim to priority over any later security or even enforceability could be lost.

IP Australia’s warning points out that it is not enough to have registered the security interest in a register of IP such as the Trade Marks Register, the Patents Register, the Register of Designs or the Register of PBR. These registrations will not be transferred automatically to the Personal Property Securities Register. Morever, registration of the security interest on one or more of those IP Registers will not take priority over a later registration on the Personal Property Securities Register.

So, if you or your client have taken out such a security and haven’t registered it in the Personal Property Securities Register yet, ‘hurry, hurry, hurry; quick, quick, quick’ (with apologies to Alexis Jordan).

Although IP Australia’s warning relates specifically to the registered IP it administers, the legislation also applies to unregistered IP such as copyright.

IP Australia’s media release.

IP Australia’s general overview of PPS

PPS R.

Summer must be over …

Friday, January 17th, 2014

IP Australia has released a consultation paper (pdf) (with exposure draft bill (pdf) and draft EM (pdf)) on the proposed Intellectual Property Laws Amendment Bill 2014.

According to the overview, the proposed bill will:

  • implement the Protocol amending the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property (TRIPS Protocol – links via here), enabling Australian medicine producers to manufacture and export patented pharmaceuticals to countries experiencing health crises, under a compulsory licence from the Federal Court
  • extend the jurisdiction of the former Federal Magistrates Court, the Federal Circuit Court, to include plant breeder’s rights matters
  • allow for a single trans-Tasman patent attorney regime and single patent application and examination processes for Australia and New Zealand, as part of the broader Single Economic Market (SEM) agenda
  • make minor administrative changes to the Patents, Trade Marks and Designs Acts to repeal unnecessary document retention provisions that are already adequately governed by the Archives Act 1983
  • make minor technical amendments to the Patents Act to correct oversights in the drafting of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 which was passed by Parliament in March 2012.

The proposed bill succeeds the Intellectual Property Laws Amendment Bill 2013, which proved rather more controversial than the former government, or its advisors, expected (see, for example, here (pdf)) and lapsed with the calling of the election.

According to the consultation paper, the proposed bill largely replicates the lapsed bill, but there have been changes in 5 key areas.

The provisions relating to Crown Use in the lapsed bill have been withdrawn and will be the subject of a separate bill in the future.

The provisions to implement the TRIPS Protocol drew much of the controversy. According to the consultation paper, these have been amended in a number of important respects. First, it is proposed that separate applications will be required for each patent that a person seeking a licence to manufacture under the TRIPS Protocol requires. It is hoped that this will address concerns about an imbalance of negotiating power if the patentee of one patent also required access to someone else’s patent(s) to take advantage of the proposed compulsory licence.

Secondly, the proposed compulsory licence will be to exploit the patent for the relevant purpose rather than the more limited “work” the patent.

To preclude the need to change the regulations when (perhaps that should be “if”) there is a change in a country a country qualifies as a permissible import destination, and the notification requirements according to whether the country is a member of the WTO or an LDC, the regulations will refer simply to the relevant lists maintained by the WTO and/or the UN.

Whether these changes will meet the substantive objections raised against the lapsed bill remains to be seen.

Unfortunately, the draft bill fails to address one important oversight from the Raising the Bar Act. The Raising the Bar Act replaced the standard applicable during examination and opposition to the grant of a patent from one of practically certain to be invalid to one of balance of probabilities: see Sch. 1 Part 2 items 39 to 54.

It has not been determined finally what standard applies in trade mark proceedings, although the preponderance of authority in the Federal Court appears to support the “practically certain to be invalid” standard to the examination and opposition of trade marks. See for example NV Sumatra v BAT at [16] – [38]. This position was adopted by analogy to, and for conformity with, the position then prevailing for patents. The reasons why this was changed for patents are equally applicable for trade mark applications. One would think it was high time to address this.

Comments and submissions are required by 7 February 2014.

Links to IP Australia’s documents via here.

Sanofi v Apotex – infringement

Thursday, December 12th, 2013

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.  ?

Apotex v Sanofi: manner of manufacture

Tuesday, December 10th, 2013

As briefly noted last week, the High Court handed down its ruling in Apotex’ appeal. Although the case will be mainly remembered because Apotex lost its challenge to the patentability of Sanofi’s method of medical treatment, Apotex actually won on the patent infringement point. (As there was no appeal on that point, however, it was still liable for infringing the copyright in Sanofi’s product information.)

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].

The patent for leflunomide itself has expired.

Apotex had received marketing approval from the TGA for the treatment of rheumatoid arthritis (RA) and psoriatic arthritis (PsA).

By a majority of 4 – 1,[1] the High Court held that:

  1. a a method of medical treatment is indeed patentable subject matter – a manner of manufacture[2] – under Australian law;
  2. a second or subsequent use of a known substance could also be patentable subject matter; but
  3. Apotex did not infringe by selling or supplying its generic leflunomide according to its product information.

manner of manufacture

All 5 judges accepted the orthodoxy of the NRDC decision as defining the approach to whether a claim was to a manner of manufacture. And all 5 judges accepted it was a broad and widening concept.

Crennan and Kiefel JJ identified NRDC as essentially requiring 2 conditions to be satisfied. For example, at [235], their Honours quoted the Wellcome case:

This principle [in the NRDC Case] extends to a process which does not produce a new substance but results in ‘a new and useful effect’. If the new result is ‘an artificially created state of affairs’ providing economic utility, it may be considered a ‘manner of new manufacture’ within s 6 of the Statute of Monopolies. (Crennan and Kiefel JJ’s emphasis)

At [278] – [285], their Honours identified 7 reasons why a method of medical treatment could be patentable. Gaegler J agreed with these 7 reasons and proposed an eighth.[3] Given the broad scope of the concept, Crennan, Kiefel and Gaegler JJ considered the crucial consideration was that there was no economic or ethical basis for distinguishing between the patentability of a pharmaceutical (or other medical) product and a method.[4] French CJ’s reasoning was similar to this point; considering the historical exclusion from patentability to be an anomaly for which no clear and consistent foundation had been established.[5]

In contrast, Hayne J in dissent considered at [143] – [150] that it could well be possible to distinguish between patenting medical products and methods of treatment. Instead, his Honour considered that a process would only be patentable if the product (in the sense of the result, outcome or effect) of the process, and not just the process itself, had economic utility. Hayne J considered that a method of medical treatment did not satisfy that criterion because (at [163]):

The effect of using the process is personal to the individual. It is not an effect which the person who owns the right to use the process, or any person other than the individual who has been treated, can turn to economic account in any way, whether directly or indirectly. If the individual who has been treated can turn the effect to economic account, he or she can do so only indirectly: by taking advantage of better health to make a more valuable contribution to national production. The individual is not a subject of commerce. The product of the process in the individual (having better health than might otherwise have been the case) cannot be sold. ….

Perhaps reflecting Hayne J’s approach to some extent, Crennan and Kiefel JJ at [287] did consider that there was a distinction to be drawn between uses of therapeutic substances and the activities and procedures of doctors when treating patients on the basis that the latter are “non-economic”:

There is, however, a distinction which can be acknowledged between a method of medical treatment which involves a hitherto unknown therapeutic use of a pharmaceutical (having prior therapeutic uses) and the activities or procedures of doctors (and other medical staff) when physically treating patients. Although it is unnecessary to decide the point, or to seek to characterise such activities or procedures exhaustively, speaking generally they are, in the language of the NRDC Case, “essentially non?economic” and, in the language of the EPC and the Patents Act 1977 (UK), they are not “susceptible” or “capable” of industrial application. To the extent that such activities or procedures involve “a method or a process”, they are unlikely to be able to satisfy the NRDC Case test for the patentability of processes because they are not capable of being practically applied in commerce or industry, a necessary prerequisite of a “manner of manufacture”.[6]

French CJ, however, at [1] and [44] expressly included surgical procedures in his Honour’s finding in favour of patentability.

second use of a known substance

As Crrennan and Kiefel JJ pointed out, NRDC itself involved a second or subsequent use of a known substance, the hitherto unsuspected properties of which squarely satisfied the requirements for inventiveness. Apotex’ reliance on this basis, therefore, failed at [291] in succinct terms.

the infringement question

… will have to wait for another day.

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


  1. French CJ, Crennan, Kiefel and Gaegler JJ; Hayne J dissenting.  ?
  2. Patents Act 1990 s 18(1)(a). The claim would, of course, also have to satisfy the other requirements including novelty, inventive step, utility etc.  ?
  3. Gaegler J appears to be alone in attributing weight to the potential disruption to business investments if the endorsement by Bristol-Myers v Squibb of the patentability of methods of medical treatment was overturned after 13 years.  ?
  4. See [282] for Crennan and Kiefel JJ; [314] for Gaegler J.  ?
  5. At [50]. See also [44] – [49].  ?
  6. Earlier, at [266] – [271], their Honours had noticed that Congress amended the US Patents Act to include §287(c)  ?

    “the effect of which is to permit the patenting of surgical methods to continue but to bar actions for patent infringement against medical practitioners (and ”related health care entit[ies]“) for ”the performance of a medical or surgical procedure on a body“.”

Alice corp

Monday, December 9th, 2013

The Full Federal Court has reserved its decision in Research Affiliates’ appeal; the Commissioner’s appeal in RPL Central is still pending.[1]

In the USA, Alice Corp. had a patent for a computerised method of reducing “settlement risk”, a type of escrow arrangement: the 10 judges in the Federal Circuit Court of Appeals came up with 5 different opinions of which Justice Newman memorably said:

[The 5 judgments have] propounded at least three incompatible standards, devoid of consensus, serving simply to add to the unreliability and cost of the system of patents as an incentive for innovation. With today’s judicial deadlock, the only assurance is that any successful innovation is likely to be challenged in opportunistic litigation, whose result will depend on the random selection of the panel.

Now, the US Supreme Court has agreed to try to sort it out.

ALICE CORPORATION PTY. LTD. V. CLS BANK INTERNATIONAL, ET AL., Docket No. 13–298 (Supreme Court 2013) via Patently-O


  1. The Full Court has also reserved in Cancer Voices re isolated DNA (although one might think there’s little scope for that to get up after Apotex v Sanofi.  ?

Apotex v Sanofi

Wednesday, December 4th, 2013

The High Court has upheld the patentability of methods of medical treatment.

High Court’s summary

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

Analysis to follow (once digested)