The High Court has unanimously dismissed AstaZeneca’s appeal from the finding that its low dose patent for rosuvastatin was invalid as obvious. The main issue was whether the Courts below had impermissibly allowed one or other prior publication to be “added” to common general knowledge under the then narrow version of section 7(3). This was unanimously rejected.
Last month, Yates J found that Otsuka’s patent for aripiprazole was invalid. As a consequence, his Honour ordered that the interlocutory injunction preventing Generic Health from listing its product on the PBS and selling it be dissolved. Otsuka has appealed and now Nicholas J has granted a stay to preserve the interlocutory injunction pending the appeal.
While not being prepared to characterise Otsuka’s prospects on the appeal as higher than arguable, Nicholas J considered the balance of convenience favoured continuation of the interlocutory injunction.
Otsuka relied principally on the fact that there would be an automatic reduction of 16% the price payable under the PBS for Abilify once Generic Health’s product was listed. It contended that it would not be possible to recover that price drop if its appeal were successful.
Generic Health countered that it risked losing the benefits of first mover advantage if it were enjoined and other generic producers were not. Generic Health’s evidence was that pharmacists would usually only carry one generic brand of each drug and that was likely to be the first brand “in”. This would exacerbate the difficulties in calculating its losses. Nicholas J did not dismiss that argument, but Otsuka said it would be seeking interlocutory injunctions against any other generics who tried to enter the market pending the appeal. Nicholas J noted further that, if Otsuka failed in an injunction applications against a second or further generic, that would be a strong basis to terminate the stay.
The Commonwealth also sought a specific undertaking to pay damages from Otsuka as the price of the injunction. It argues it will suffer loss, in the form of the higher prices payable under the PBS, if Generic Health continues to be enjoined but the appeal ultimately fails.
Nicholas J noted that a case has been stated to the Full Court on whether the Commonwealth can indeed claim under the “usual undertaking as to damages”. Subject to the outcome of that case, his Honour considered the Commonwealth was sufficiently within the scope of the usual undertaking and so did not need a separate, specific undertaking.
Nicholas J increased the security for costs that Otsuka had to provide to Generic Health in the amount of an additional $8.7 million and, in addition, required a security of $6 million separately to the Commonwealth. His Honour also noted that the Commonwealth could apply to extend that security if the appeal was not decied in the first half of 2016.
The commercial name under which aripiprazole is marketed by Otsuka and its licensee. ?
Otsuka has already provided $6.5 million pursuant to the orders made by Yates J at first instance. ?
At , Nicholas J recored that the Commonwealth estimated its losses from the continuation of the interlocutory injunction would be $6 million over the next 12 months and $15 million over the next 18 months. ?
Each document seeks to present in summary form factual information about how various Member States deal with these issues under their respective patent laws, identifying where possible common themes and approaches and differences.
Last year, ACIP ducked the question of keeping or abolishing the controversial innovation patent system. Last week, ACIP issued an “updated” statement in which it recommended abolition of the innovation patent system.
According to ACIP, in the intervening period, IP Australia’s Chief Economist took advantage of data that became available through the Government’s Intellectual Property Government Open Data (IPGOD) “to undertake a comprehensive analysis of the economic impact of the innovation patent system”. That study disclosed:
The great majority of Australian SMEs and private inventors appear to gain little benefit from the system… Only 23 SMEs have become moderate users of the innovation patent system … The average SME or private inventor files once and never again (74%), does not receive any enforceable right (83%) and lets their patent expire early because they see its value at less than the $110-$220 cost of renewal (78%).
While 94% of innovation patent applications are made by private inventors or SMEs and they incur 95% of the regulatory costs of the system, larger firms who are already well served by the standard patent system tend to reap a disproportionate share of the benefits.
Taking into account regulatory costs and costs to public welfare generally, ACIP considers that the costs of the innovation system outweigh the benefits and so recommends abolition.
Having had the interlocutory injunction he granted overturned on appeal, Rares J has now determined at the substantive trial that both of Glaxo’s syringe variants infringed Reckitt Benkiser’s “flat-nosed syringe” patent.
You will recall that Reckitt has patented a bottle and syringe combination to simplify “feeding” medicines to babies and toddlers in particular. Claim 1 in part provides:
A liquid dispensing apparatus comprising a bottle, a bottle neck liner and a flat-nosed syringe having a plunger and a barrel, the barrel terminating at its distal end in a generally flat face having a diameter corresponding to the diameter of the syringe barrel and being perpendicular to the longitudinal axis of the barrel ….
… the claim goes on at some length to elaborate in further detail the features of the various elements.
Glaxo had two variants of its competing product:
For present purposes, I found two points of interest: the finding that the second variant infringed and the failure of Glaxo’s entitlement attack.
After dealing with construction issues at some length, Rares J found the first version infringed claim 1, but Glaxo’s second version did not. This was because, at , the indented “tip” at the distal (bottom) end of the syringe meant the end was not substantially the same diameter as the barrel itself.
Notwithstanding this, Rares J found the second version did infringe claim 9, the omnibus claim:
A liquid dispensing apparatus, substantially as described with reference to the drawings and/or examples.
Rares J considered that the second variant functioned the same as the preferred embodiment described in the specification and drawing. While the indented tip was a difference, claim 9 required only substantial compliance and there was no difference in substance between the second variant and the patent description. At , his Honour explained:
…. The alternate syringe has exactly the same function as that described in the patent and the drawings. The alternate syringe is a flat-nosed syringe that has a distal end that fits into the liner and achieves a good seal with it so that it can draw up liquid without leaking from the bottle or the syringe. The mere fact that there is a corresponding tip on both the barrel and the reciprocating plunger used in the alternate syringe in the second product complained of should not be allowed to disguise that that product has taken the substantial configuration resulting from the patentee’s invention and its character for the dispensing of liquids from bottles without mess using an apparatus with a flat-nosed syringe: Radiation 60 CLR at 52; Raleigh 65 RPC at 160. The alternate syringe, as incorporated into the second product complained of, is not a substantially new or different combination ….
Earlier, his Honour had pointed out that the bottle liner of Glaxo’s second variant was shaped to complement the configuration of the indented tip of the syringe to sealingly engage as required by the patent. Although liquid was drawn into the indented tip from the bottle, it was essentially “dead space” as the tip of the syringe’s plunger had a correspondingly indented end so that the barrel measured volumes in the same as as the patented description. Accordingly at :
The alternate syringe takes the substance of the flat-nosed syringe described in the patent and drawings as stated in claim 9.
In coming up with the claimed apparatus, Reckitt had engaged a contractor. Glaxo argued that it was the contractor’s operative, a Mr Pearce, who was actually the inventor. Even though Reckitt’s posited inventors did not give evidence, Rares J rejected this attack without needing to resort to s 22A or s 138(4).
Glaxo’s challenge essentially ran into two problems. First, when the contractor discovered the early version of the patent application leading to the patent, it did challenge Reckitt about it. It’s concern, however, was to ensure its continued ability to use the “liner” element, only one integer of the claimed invention as a whole. Arising from this, Reckitt did make some modifications to its application and the contractor reached agreement with Reckitt preserving the contractor’s ability to use features of the liner for other projects freely.
Secondly, although Mr Pearce did give evidence, it was limited to claiming inventive contribution only to the liner element and it was not suggested to him that he, rather than Reckitt’s employees, came up with the idea for the features of the other elements comprising the invention.
Glaxo’s claim based on false suggestion similarly failed:
the documentary evidence suggests that the idea that conceived of a combination of a flat-nosed syringe co-operating with a bottle neck liner and a bottle in the form of the apparatus had nothing to do with Mr Pearce or HDB and was Ms Dallison’s inspiration. She also had envisaged the features of that combination, being the way in which the flat-nosed syringe would co-operate with the liner, and, with Mr Harrison, the need for the liner to be adapted suitably to pour, without mess, the liquid contents from the bottle ….
Sanofi sued Apotex (then known as GenRx) for infringement of its “clopidogrel patent”. It obtained interlocutory injunctions against Apotex against the sale of Apotex’ product and preventing Apotex from applying to list its product under the Pharmaceutical Benefits scheme (PBS). As a condition of the grant of those interlocutory injunctions, Sanofi gave the “usual undertaking as to damages”:
“(a)submit to such order (if any) as the Court may consider to be just for the payment of compensation, to be assessed by the Court or as it may direct, to any person whether or not a party, adversely affected by the operation of the interlocutory injunction or any continuation (with or without variation); and
“(b)pay the compensation referred to in subpara (a) to the person or persons there referred to.”
Sanofi won at trial, but lost on appeal with the Full Court ordering its patent be revoked. Sanofi’s application for special leave to appeal to the High Court was refused on 12 March 2010.
Apotex sought compensation under the undertaking by motion in May 2010. Sanofi and Apotex resolved that application by negotiation.
The Commonwealth also sought compensation under the undertaking as to damages by application made in April 2013. If we did not know before, we now know the Commonwealth is seeking $60 million. Essentially, the Commonwealth contends that is how much less it would have had to pay out under the PBS if the interlocutory injunctions had not prevented Apotex applying to list its product under the PBS:
“The Commonwealth has provided some particulars of its damages. It alleges it has suffered financial loss in excess of $60 million as a result of Apotex being prevented by the various interlocutory orders and undertakings from achieving a listing for its clopidogrel products under the PBS. Most of the Commonwealth’s loss is said to flow from statutory price reductions and price disclosure reductions that would have occurred had Apotex not been the subject of the relevant interlocutory restraints.”
The case is a long way off resolution. Nicholas J has allowed Sanofi to amend its points of defence to the Commonwealth’s claim to rely on the Commonwealth’s delay in making its application for compensation and to rely on infringement of copyright in Sanofi’s product information documents. Sanofi will be required to particularise the prejudice its claims it suffered as a result of the delay.
Nicholas J however refused leave to amend to plead that the Full Court’s decision invalidating Sanofi’s patent was wrong in light of the Full Bench’s subsequent decision in AstraZeneca (rosuvastatin). That would be inconsistent with res judicata and the principle of finality of litigation.
The High Court has allowed special leave to appeal from the Full Federal Court’s decision in AstraZeneca v Apotex (“Rosuvastatin”).
From the special leave transcript, it looks like the main issue will be the operation of s 7(3) and the basis on which a reference ascertained for the purposes of s 7(3) may be combined with common general knowledge under s 7(2).
In Rosuvastatin, a Full Bench of 5 justices held that the “starting point” identified in the patent could be used as the “starting point” for testing whether the solution in the patent was obvious only when shown to be part of the prior art base. The Full Court nonetheless held the patent was invalid as a s 7(3) reference, the Watanabe paper, was added to the common general knowledge.
From the special leave transcript, it appears that all parties were in agreement that the person skilled in the art would undertake a literature search. The resulting search would have thrown up a number of documents. AstraZeneca argues that the Full Court erred in allowing the Watanabe paper to be used as a s 7(3) reference. Its main argument appears to be that the search would have thrown up at least 2 papers, Watanabe and Aoki. AstraZeneca argues that, before the Watanabe paper can be combined with common general knowledge under s 7(2), it needs to be shown that the person skilled in the art would have chosen the Watanabe paper over Aoki. According to AstraZeneca, however, the evidence did not establish that. Again according to Astrazeneca, there was evidence that the skilled person could choose either paper and, if Aoki was chosen, would fail:
If you had gone down the NK-104 path you fail – a relative fail. If you had gone down the other one, you win. The evidence of Professor O’Brien was – others can reasonably make one choice or another. Dr Reece did not even venture on the issue as to which one he would go down.
A second point that AstraZeneca argues is that to choose Watanabe the skilled person would have needed to refer first to Aoki. That is, it argues that it was necessary to engage in impermissible masoning.
If AstraZeneca succeeds, there will also be a dispute about entitlement issues and the operation of new s 22A and 138(4).
No doubt more will become clearer when the appeal documents are posted on the High Court’s website.
Astrazeneca AB & Anor v Apotex Pty Ltd; Astrazeneca AB & Anor v Watson Pharma Pty Ltd; Astrazeneca AB & Anor v Ascent Pharma Pty Ltd  HCATrans 58
In finding (2:1) that the primary judge had wrongly held that most of the claims in Damorgold’s patent were invalid because they lacked novelty, the Full Court confirmed that the novelty test under the 1990 Act is stricter than the old law.
Damorgold’s patent relates to a mechanism for raising and lowering a blind. As characterised by Bennett J at , claim 1 was a combination of some 27 integers.
The Full Court upheld the primary judge’s finding that a Mr Horner had imported into Australia and shown to some potential customers a product which embodied all the integers in the relevant claims of Damorgold’s patent notwithstanding the imperfections in the evidence.
Although Mr Horner had been showing the product to potential customers to solicit sales, the evidence was that he did not in fact sell any. Nor did he leave any samples with anyone.
Mr Horner only showed the product to his potential customers in its assembled form. It was not possible, however, to tell how the product worked in its assembled form. To ascertain the internal componentry and how all the parts worked together, it was necessary to dissassemble it – to pull the product apart. And that was never done.
Section 7(1)(a) in the form applicable  provided that a claim in a patent was taken to be novel unless it was shown not to be novel in light of prior art information made publicly available in a single document or through doing a single act.
The trial judge considered that a potential customer could have asked to see how the product worked and, if they had done so, Mr Horner would have shown them or allowed them to disassemble it; disassembly (and re-assembly) would have been easy. Therefore, his Honour held the novelty destroying information was made publicly available.
On appeal, Bennett J and Yates J held that the requirement in 7(1)(a) that the information be made publicly available meant the question was what information did the prior use communicate (or make available) to the public. As the demonstrations to the public in the assembled form did not disclose the internal workings of the product, the information communicated to the public did not disclose all the integers of any claim. Therefore, the attack on novelty failed.
Bennett J pointed out at  that different consequences flowed from whether the prior art relied on was a document or an act:
The question is whether an act can be identified that did in fact make the information being the integers of the invention publicly available. This is not the same requirement for anticipation by prior publication, which is satisfied if the information is in a document which is publicly available. (emphasis supplied)
In his opinion concurring with Bennett J, Yates J was at pains to stress that nothing he said should be taken as dealing with the situation where there had in fact been a sale or a sample had been given to and retained bya potential customer.
In dissent, Jessup J agreed with the primary judge that the appropriate question was what information would have been conveyed by the use.
According to a media release by Maurice Blackburn, the High Court has granted Ms D’Arcy special leave to appeal the decision that Myriad’s BRCA patent for isolated genes is patentable subject matter, as a manner of manufacture, in Australia.
Although it rejected the primary judge’s interpretation of s145 of the Patents Act 1990, the Full Court has nonetheless dismissed Regency’s appeal seeking to terminate its licence of MPEG patents.
In 2009, Regency took a licence of a bundle of patents from the MPEG patent pool so that it could make, amongst other things, DVD and Blu-Ray players. All the patents were necessary to make MPEG–2 compliant equipment, but they related to different inventions. By July 2012, some of the patents, but not all, had expired. Regency sought to terminate the licence early, relying on s145.
(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 Full Court agreed with Regency that the trial judge`s interpretation of,s145 was wrong but, even so, the right to terminate the licence under s145 did not accrue until all the patents licensed at the time the licence was granted had expired. As there were patents still on foot, therefore, Regency did not have the right under s145 to terminate.
The Full Court considered that the reference to “a patented invention”, an expression not defined in the Patents Act was simply a reference to an invention that was patented, rather than something which was patentable subject matter.
Further, s23(b) of the Acts Interpretation Act 1901 meant that the reference to the singular – a patented invention – could be read as including the plural. While recognising that s145 was intended to protect licensees from being unfairly required to pay licence fees after the patents had expired, Bennett and Pagone JJ pointed out that, as the licensor could also invoke s145, a licensee could be exposed to even greater unfairness if the licence could be terminated after the expiry of one or only some patents:
30 … if MPEG were entitled to terminate the licence when one of the patents or all of the patents for one of the inventions had expired, Regency would be in the position that, having implemented the Standard, it would be required to cease exploitation of the outstanding patents or negotiate a fresh licence.
31 The primary judge recognised the lack of commercial reality and potential unfairness in such circumstances and so do we. It would lead to the absurd result that parties wishing to negotiate for a patent pool would necessarily have to enter into multiple contracts or face the uncertainties and possible damage caused upon the expiry of a single patent of that patent pool. This would be of particular difficulty for a licensee which had “tooled up”, or entered into financial obligations on the faith of the right to exploit the necessary patent, and could also affect third party end users of a product.
Earlier at , Bennett and Pagone JJ had emphasised the importance of certainty provided by contracts:
Regency points to commercial and policy reasons why a licensee should not continue to pay royalties where an invention the subject of the licence is no longer the subject of a subsisting patent. However, this possible disadvantage to a licensee can be taken into account during negotiations for a contract. Regency negotiated a licence fee that included patents now expired but must be taken to have been aware of the expiry of patents during the term of the Contract when it negotiated that fee. This is supported by the fact that the October 2009 amendment to the Contract provided for royalty rates, those rates decreasing over specified periods of time in recognition of the ever approaching end to each of the patents (as observed by the primary judge at ).
While this case did not explicitly turn on questions of misuse of market power, that analysis does not bode well for the ACCC`s pending antitrust action against Pfizer.