IPwars.com

Mainly intellectual property (IP) issues Down Under

Selected links,from last week

Here is a selection of links to IP-related matters I found interesting this week:

Patents

Trade marks

Copyright

Remedies

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 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

Productivity Commission reports on IP (in draft)

The Productivity Commission has released its draft report into Intellectual Property Arrangements.

You will be startled to learn that the Productivity Commission has discovered Australia is a net importer of intellectual property. We buy more IP from the rest of the world than we sell to it. Fig. 2 in the Report indicates Australian IP earned AUD1 villion from overseas, but we paid out about AUS4.5 billion for the use of their IP. The Productivity Commission then notes that we provide surprisingly strong IP protection for a country in our position.[1] This finding guides the Productivity Commission’s recommendations which might broadly be characterised as: take the least restrictive option in terms of IP protection (where our international obligations permit).

The Productivity Commission explained its position this way:

Intellectual property (IP) arrangements need to balance the interests of rights holders with users. IP arrangements should:[2]

• encourage investment in IP that would not otherwise occur;

• provide the minimum incentives necessary to encourage that investment;

• resist impeding follow-on innovation, competition and access to goods and services. (emphasis supplied)

So, for example, after much gnashing of economists’ teeth about the (let’s face it, indefensible) term of copyright protection, the Productivity Commission considers that the appropriate term of protection is somewhere between 15 and 25 years.[3] However, what it actually recommends is rather more limited:

4.1: remove the current unlimited term of protection for published works.[4]

5.1: implement Parliament’s At What Cost? IT pricing and the Australia Tax recommendation to make it clear that it is not an infringement of copyright to circumvent geoblocking.

5.2 repeal the remaining parallel import restrictions for books.

5.3 amend the Copyright Act 1968 to replace the current fair dealing exceptions with a broad exception for fair use.

The latter two, so far, have elicited the loudest complaints here and here.[13] Meanwhile, the US’ Register of Copyrights is celebrating the first anniversary of her Fair Use Index.

18.1 expand the safe harbours to online service providers.[5]

Patents

The Productivity Commission reports that there are 120,000 active patents registered in Australia. 93% of these have been granted to non-residents. There are also 25,000 – 30,000 applications each year; of which about 60% ultimately proceed to grant.

According to the Productivity Commission, however, there are too many granted patents which do not contribute social value and are not “additional” – in the sense that they would not have been made if there was no patent protection.[6]

This needs to be remedied. However, the Productivity Commission acknowledges that international agreements put constraints on our freedom of action. There are 10 recommendations for patents.

The key recommendation for standard patents is yet another go at raising the threshold of inventive step.

an invention is taken to involve an inventive step if, having regard to the prior art base, it is not obvious to a person skilled in the relevant art.

This looks very similar to what we already have. As the Productivity Commission envisages matters, however, there are important differences. First, it reverses the onus currently expressed in s 7(2). According to the Productivity Commission, the current position is the opposite of where the onus lies in the USA, Japan, the EU and the UK (amongst others). Rather than a challenger having to prove the invention is obvious, therefore, the patentee will have to prove it is not.

Secondly, the Productivity Commission sees the current requirement that there be only a scintilla of invention being raised. The Productivity Commission sees this low threshold being reflected in the limitation on “obvious to try” being something which the skilled addressee would be directly led as a matter of course. Instead, the Productivity Commission considers that the test should be at least:

whether a course of action required to arrive at the invention or solution to the problem would have been obvious for a person skilled in the art to try with a reasonable expectation of success (as applied by the Boards of Appeal of the EPO).[7]

This change would be buttressed with appropriate comments in the Explanatory Memorandum and, additionally, the insertion of an objects clause into the Act. The latter would be intended to ensure that the Courts focused on the social objectives of the Patents Act including, in particular, the public interest.[8]

On the more colourful fronts, the Productivity Commission also recommended repeal of the abomination innovation patent and amendment of s 18 explicitly to exclude from patentable subject matter business methods and software.[9]

Pointing to analysis which estimates the net present value to R & D of the extension of term for a pharmaceutical patentat at year 10 at $370 million – of which only $7.5 million would accrue to Australia because our industry is so small – while the cost to the Australian government and consumers of the same extension of term is estimated at $1.4 billion, the Productivity Commission also wants a significant tightening up of the regime for extending the term of pharmaceutical patents. The Productivity Commission also opposes any extension of the period of data protection for therapeutic goods, including biologics.[10]

The Productivity Commission also recommends exploring raising the renewal fees payable, particularly in later year’s of a patent’s life.

Registered designs

The Productivity Commission considers the registered design system deficient but, as we have committed to it internationally and there is no better alternative, we are stuck with it.

However, continuing the net importer theme, Australia should not go into the Hague system “until an evidence-based case is made, informed by a cost–benefit analysis.”

Trade marks

I’m just going to cut and paste here: the Government should:

  • restore the power for the trade mark registrar to apply mandatory disclaimers to trade mark applications, consistent with the recommendation of the Advisory Council on Intellectual Property in 2004 (the only people that won’t support this are in the place that counts – IP Australia)
  • repeal part 17 of the Trade Marks Act 1995 (Cth) (Trade Marks Act)
  • amend s. 43 of the Trade Marks Act so that the presumption of registrability does not apply to the registration of marks that could be misleading or confusing
  • amend the schedule of fees for trade mark registrations so that higher fees apply for marks that register in multiple classes and/or entire classes of goods and services.
  • require the Trade Marks Office to return to its previous practice of routinely challenging trade mark applications that contain contemporary geographical references (under s. 43 of the Trade Marks Act). Challenges would not extend where endorsements require goods and services to be produced in the area nominated
  • in conjunction with the Australian Securities and Investments Commission, link the Australian Trade Mark On-line Search System database with the business registration portal, including to ensure a warning if a registration may infringe an existing trade mark, and to allow for searches of disclaimers and endorsements.

Also, s 123 should be fixed up so that parallel importing does not infringe.

Like the rest of us, the Productivity Commission is bemused by the Circuits Layout Act and recommends implementing “without delay” ACIP’s 2010 recommendation to enable “essentially derived variety declarations to be made in respect of any [plant] variety.”

On competition policy, s 51(3) should be repealed and the ACCC should develop guidelines on the application of our antitrust rules to IP.

Innovatively, the Productivity Commission also recommends free access to all publications funded directly by Government (Commonwealth, State or Terriroty) or through university funding.

There are also at least 17 requests for further information.

If you are inspired to make a further submission, you should get it in before 3 June 2016.[11]


  1. Not much discussion here whether the best way to get more technological development is through a strong IP regime or to,scrap the IP system and fully commit to free riding.  ?
  2. Despite the tentative nature of this declaration, it is the first “Main key points”.  ?
  3. Draft finding 4.2.  ?
  4. The Government is trying to do this – see schedule 3 of the exposure draft of the Copyright Amendment (Disability Access and Other Measures) Bill (pdf).  ?
  5. See schedule 2 of the Disability Access and Other Measures bill.  ?
  6. You will have to read Appendix D to find out how the Productivity Commission works out which patents are socially valuable and “additional”.  ?
  7. The EPO cases the Productivity Commission referred to are T 149/93 (Retinoids/Kligman) (1995) at 5.2 and T 1877/08 (Refrigerants/EI du Pont) (2010) at 3.8.3.  ?
  8. Here, the Productivity Commission notes that the Full Federal Court rejected reference to the public interest in Grant.  ?
  9. Dr Summerfield tells you why he thinks that’s a bad idea over here and of course, the Europeans (including the UK in that) do not have all sorts of complications carrying out their nice, clean exclusion.  ?
  10. In an interesting departure from its overarching premise that patents do not really contribute much to innovation because there are other protections such as lead time and trade secrets, the Productivity Commission warns that reliance on data secrecy is sub-optimal compared to patent protection.  ?
  11. Bearing in mind they have to submit their Final Report to Government by 18 August 2016.  ?
  12. In between buying your books from Amazon and Bookdepository, some references to the larger economic issues affecting booksellers here.  ?

Canada’s IP and antitrust enforcement guidelines

The Canadian Competition Bureau has published updated guidelines relating to the enforcement of intellectual property rights and the antitrust (competition) rules.

The Bureau does not presume that the exercise of IP rights violates competition rules but, in assessing whether there are competition law ramifications, it distinguishes between two types of conduct: conduct “involving something more than the mere exercise of the IP right, and those involving the mere exercise of the IP right and nothing else.” Special rules, which may be applied in “very rare circumstances” apply to the latter. While the general competition rules apply to the former.

According to the Canadian firm, Tories, the updated guidelines include consideration relating to:

  • patent litigation settlement arrangements including reverse payment settlements
  • product switching
  • patent assertion entities
  • standard essential patents

Why should someone in Australia care?

For one thing (bearing in mind the ACCC’s challenge to Pfizer’s practices when its Lipitor patent was expiring – judgment is reserved in the appeal), the US Supreme Court is expected to hand down a decision this year on how US antitrust laws apply to reverse payment settlements.

For another thing, following the Competition Review here in Australia:

  • the Government announced its intention to implement the Harper Review’s recommendation that s 51(3) be repealed and, if that happens, the ACCC is supposed to produce its own guidelines; and
  • in the meantime, at the Government’s direction, the Productivity Commission is undertaking a review of Intellectual Property Arrangements including its alleged anti-competitive effects.[1]

Lid dip: Peter Willis

  1. The draft report is due to published “any day now”.  ?

Productivity Commission to review all IP laws

The Harper Review[1] recommended that the Government should direct the Productivity Commission to undertake an overarching review Australia’s IP laws.

The Treasurer and the Minister for Small Business have now announced that review.

According to the Harper Review:

an appropriate balance must be struck between encouraging widespread adoption of new productivity-enhancing techniques, processes and systems on the one hand, and fostering ideas and innovation on the other. Excessive IP protection can not only discourage adoption of new technologies but also stifle innovation.

Given the influence of Australia’s IP rights on facilitating (or inhibiting) innovation, competition and trade, the Panel believes the IP system should be designed to operate in the best interests of Australians.

The Panel therefore considers that Australia’s IP rights regime is a priority area for review. (emphasis supplied)

In reaching that view, the Harper Review flagged concern about entering into new treaties with extended IP protections.

The terms of reference state:

In undertaking the inquiry the Commission should:

  1. examine the effect of the scope and duration of protection afforded by Australia’s intellectual property system on:

    a. research and innovation, including freedom to build on existing innovation;

    b. access to and cost of goods and services; and competition, trade and investment.

  2. recommend changes to the current system that would improve the overall wellbeing of Australian society, which take account of Australia’s international trade obligations, including changes that would:

    a. encourage creativity, investment and new innovation by individuals, businesses and through collaboration while not unduly restricting access to technologies and creative works;

    b. allow access to an increased range of quality and value goods and services;

    c. provide greater certainty to individuals and businesses as to whether they are likely to infringe the intellectual property rights of others; and

    d. reduce the compliance and administrative costs associated with intellectual property rules.

Then follows a catalogue of 9 matters for the Commission to have regard to. These include the Government’s desire to retain appropriate incentives for innovation, the economy-wide and distributional consequences of recommendation and the Harper Review’s recommendations in relation to parallel imports.[2]

The Commission must report within 12 months.


  1. The Competition Policy Review, recommendation 6.  ?
  2. Rec. 13 and section 10.6 of the Competition Policy Review: i.e., repeal any remaining restrictions unless the benefits outweigh the costs and the objectives of the restrictions can only be achieved by restricting competition. Cue diatribe about “restricting competition” especially given the oft mouthed formula that IP rights rarely (if ever) restrict competition.  ?

ACCC loses antitrust case against Pfizer

Flick J has ruled that Pfizer did not breach antitrust rules by trying to maintain sales of Lipitor after it came off patent.

Pfizer’s patent on atorvastatin (Lipitor) was due to expire on 18 May 2012.[1] Its analysis showed it was facing a revenue cliff: from $771 million a year in 2011 to $70 million a years by 2015. Pfizer came up with a 3-part plan:

  1. in the 18 months prior to expiry, it stopped supplying Lipitor through wholesalers and started supplying pharmacies directly (thereby earning the wholesale margin for itself);
  2. it offered a 5% discount to those pharmacies it supplied + a 5% “rebate” credited to an accrual fund. The “rebate” was repayable to the pharmacy if it committed to buy from Pfizer a specified proportion of its anticipated generic atorvastatin needs after the patent expired – the amount of “rebate” repaid would vary according to the proportion of generic needs committed to and the time frame for the commitment. For example, the pharmacy would receive 100% if it committed to taking 75% of its anticipated needs for 12 months. but only 50% if it committed to taking 75% for only 6 months.
  3. Pfizer also made a bundled offer – it could offer to supply both Lipitor and its generic product “atorvastatin Pfizer”.

The ACCC brought action alleging by implementing this plan, Pfizer had contravened:

  • section 46 of the Competition and Consumer Act (CCA), which prohibits a corporation with a substantiall degree of power in a market from taking advantage of that power for proscribed anti-competitive purposes; and
  • section47 of the CCA which prohibits exclusive dealing that has the purpose or effect of substantially lessening competition in a market.

Flick J has dismissed the ACCC’s action.

Relevant market

His Honour found that the relevant market was the market for the supply to community pharmacies in Australia of atorvastatin as the ACCC contended. Pfizer argued the market was the market for the wholesale supply of pharmaceutical products and over the counter products to community pharmacies.

Substantial degree of power in the market

His Honour also found that Pfizer had a substantial degree of power in that market until late 2011 and had taken advantage of that power by implementing its scheme. Pfizer did not have a substantial degree of power in the market from January 2012 on wards.

Before January 2012, Pfizer was the only supplier of atorvastatin and the constraints on the price it could charge imposed by the PBS was “not sufficient to render its market power anything other than “substantial”.” Flick J recognised that there was no precise date which could be identified as the point where Pfizer’s market power ceased to be substantial. By late 2011, however, that power was no longer “enduring” as the expiry date of the patent loomed closer. By February 2012, Ranbaxy was able to enter the market offering its generic atorvastatin for sale[2] and the other intending generic suppliers had registered their products on the Therapeutic Goods Register and were starting sales discussions with potential customers.

Flick J found Pfizer took advantage of its power to impose the direct sales to pharmacies model because the pharmacies were opposed to it, but Pfizer was able to impose it on them as the only possible source of atorvastatin. Similarly, the rebate scheme took advantage of that power because it created an expection of payments in the future on terms that were unclear and yet to be decided. Flick J found that the amount of money accumulated within the rebate scheme by the time the patent expired was very substantial – $35 million – a powerful incentive to buy product from Pfizer. One might wonder, however, why the position would have been any different if the terms on which the rebate could be claimed had been clear.

No anti-competitive purpose

Even in the period before January 2012 when it had a substantial degree of power in the market, however, there was no contravention of 2 46 because it did not take advantage of its market power for a proscribed anti-competitive purpose.

Pfizer also did not contravene s 47 because in implementing the scheme it did not have the purpose of substantially lessening competition.

Rather than having a purpose of deterring competition by the generics, Flick J accepted that Pfizer was motivated by rationale business objectives. For example, selling directly to pharmacies rather than through wholesalers:

But my question, Mr Latham, was directed to Lipitor and generic atorvastatin, not some dream of establishing a generics business? — But once again you’re asking me to make a decision on – on one product, when I have seven products, over $1 billion, coming off patent. And it’s not just Pfizer Australia. It’s around the world. And to try to get the best business organisation that’s going to deliver continuing operations through those generic products, plus, they have these additional benefits of being closer to pharmacy. Going through the licensee doesn’t tick that important box.

The requirement to take 75% of the pharmacies needs to qualify for the “rebate” also did not have an anti-competitive purpose. Rather, Flick J found that the requirement had been reduced from 100% to 75% – sacrificing $30 million in potential revenue – to enable the pharmacy to establish a second source of supply.

s 51(3)

Section 51(3) exempts from s 47 conditions in, amongst other things, licences of patent to the extent they relate to the invention to which the patent relates or articles made according to the invention.

Although its operation did not fall to be determined because there was no contravention of s 47, Flick J would have found it did not apply in this case. His Honour considered that the sale of atorvastatin to the pharmacies would not involve any licence. More importantly, his Honour would have held that the condition was collateral to the patent and so outside the scope of the exemption.

What actually happened

In the event, Pfizer went from selling 100% of the prescribed atorvastatin (as Lipitor) in March 2012, to 32% of prescription in April and settling around 22 – 23% by June 2012. While Pfizer antiticpated marketing advantages in being the only supplier likely to supply generic atorvastatin in pills the same shape, size and colour as Lipitor, the evidence showed it held 100% of the generic market until September 2012, after which its share fell away to 16 – 17% by March/April 2013.

Australian Competition and Consumer Commission v Pfizer Australia Pty Ltd [2015] FCA 113


  1. PBS figures for the year to June 2012 showed Lipitor was the highest cost to the scheme ($593 million) followed by rosuvastatin ($359 million) and ranibizumab ($308 million).  ?
  2. Pfizer and Ranbaxy had settled other litigation on terms which enabled Ranbaxy to enter the market before the patent expired.  ?

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 :-).  ?

Compulsory Licensing of Patents – Productivity Commission

The Productivity Commission’s report on Compulsory Licensing of Patents has been published.

One key recommendation is to replace the compulsory licence provisions in the s 133 of the Patents Act with a compulsory licence regime in the Competition and Consumer Act:

The Australian Government should seek to remove s. 133(2)(b) from the Patents Act 1990 (Cwlth), so that a compulsory licence order based on restrictive trade practices of the patent holder is only available under the Competition and Consumer Act 2010 (Cwlth). The remedy provisions in the Competition and Consumer Act should be amended to explicitly recognise compulsory licence orders to exploit a patented invention as a remedy under the Act.

The Productivity Commission also recommends that the “reasonable requirements of the public” test in s 135 of the Patents Act be replaced with a “public interest” test:

The Australian Government should seek to amend the Patents Act 1990 (Cwlth) to replace the ‘reasonable requirements of the public’ test for a compulsory licence with a new public interest test. The new test should specify that a compulsory licence to exploit the patented invention would be available if the following conditions are met:

  • Australian demand for a product or service is not being met on reasonable terms, and access to the patented invention is essential for meeting this demand.
  • The applicant has tried for a reasonable period, but without success, to obtain access from the patentee on reasonable terms and conditions.
  • There is a substantial public interest in providing access to the applicant, having regard to:
    • –  benefits to the community from meeting the relevant unmet demand
    • –  commercial costs and benefits to the patent holder and licensee from

      granting access to the patented invention

    • –  other impacts on community wellbeing, including those resulting from greater competition and from the overall effect on innovation.

Section 136 should be repealed and future Treaty obligations should be incorporated into the Patents Act directly.

The Productivity Commission would also like to see s 51(3) of the CC Act repealed:

but any changes to s.51(3) will need to be based on a consideration of the implications for all types of intellectual property, including those beyond this inquiry’s terms of reference.

Further recommendations relate to Crown Use,which appear to have been largely adopted already in the Intellectual Property Laws Amendment Bill 2013.

Download Full Report, or interesting chapters, here.

Class actions and antitrust

Following on from the post earlier this week about the findings that AstraZeneca had misused its market power in the EU over Losec, the Full Federal Court in Australia (Moore, Jessup and Dodds-Streeton JJ) has largely upheld an appeal against the primary Judge’s decision to strike out a Statement of Claim.

Unlike the AstraZeneca case, this case does not involve allegations of misuse of market power relating to a patented product; it concerns allegations about a price-fixing cartel for rubber compounds.

One interesting aspect about the case is that the litigation in Australia derives from a European Commission finding that Bayer AG and others had engaged in a global price fixing cartel for the rubber compounds. The applicants in this case allege that that cartel had ramifications in Australia causing them damage.

Another interesting aspect is that the applicants are bringing a class action to recover damages for the impact of the alleged cartel in Australia. In the IP field, we have recently seen the class action mechanism deployed to challenge the validity of patenting genes. Incidentally, the applicants’ solicitors in that case are the same as the applicants’ solicitors in this action.

Wright Rubber Products Pty Ltd v Bayer AG [2010] FCAFC 85

Misusing a patentee’s market power

The Court of General Instance (formerly (?) the EU’s CFI) has upheld the European Commission’s ruling that AstraZeneca abused its dominant position in the market by practices designed to block or delay generic drugs competing with Losec from entering the market.

The abusive practices were:

  1. submitting deliberately misleading statements to patent agents, national patent offices and national courts in order to acquire or preserve supplementary protections certificates for omeprazole to which AstraZeneca was not entitled or to which it was entitled for a shorter duration; and
  2. requesting (and obtaining) the withdrawal of regulatory marketing authorisations for Losec capsules and replacing those marketing authorisations with marketing authorisations for Losec MUPS tablets.

The result of the second practice was to delay entry on to the market of competing generic products as they could not use the abridged marketing approval process.

The Court did reduce, however, the fine from Euros 60 million to Euros 52.5 million.

The case concerned patents for omeprazole, the patent protection for which has generated some controversy in Australia.

Like the EU, Australian law does provide for supplementary protection certificates and there is the potential for abridged marketing approval processes for generics (pdf – e.g). Art. 82 of the Treaty also has some resemblance to s 46 of the TPA and, while we might think that the EU has a fairly idiosyncratic approach to determining market power, the Hoffman-La Roche ruling relied on by the Court of General Instance has been referred to with approval by the High Court in Australia.

Case T?321/05 AstraZeneca AB v Commission

which has been conveniently summarised by Linklaters and Gibson Dunn.

Now, we might think this is an application of the peculiar EU approach to