Patents

Abilify interlocutory injunction continues pending appeal

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Last month, Yates J found that Otsuka’s patent for aripiprazole was invalid.[1] 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[2] 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[3] 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.[4]

Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd [2015] FCA 848

  1. Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4) [2015] FCA 634. Patentology looked at the ‘swiss claims’ aspects of his Honour’s decision.  ?
  2. The commercial name under which aripiprazole is marketed by Otsuka and its licensee.  ?
  3. Otsuka has already provided $6.5 million pursuant to the orders made by Yates J at first instance.  ?
  4. At [35], 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.  ?

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Productivity Commission to review all IP laws

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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.  ?

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Innovation patent consultation on the consultation

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IP Australia has issued a consultation paper seeking the public’s view on (the now departed) ACIP’s recommendations for the innovation patent. Specifically:

IP Australia is seeking feedback from interested stakeholders on:

  • the ACIP recommendation that the government should consider abolishing the innovation patent system
  • any alternative suggestions to encourage innovation amongst SMEs.

Get your comments in by 25 September 2015

IP Australia’s consultation paper here (pdf or word). The ACIP report being “consultated” upon, via here and updated here.

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WIPO patent studies

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In connection with the 22nd session of WIPO’s Standing Committee on Patent Law, the International Bureau has published 2 studies on patent law issues:

(1) a study on inventive step(pdf); and

(2) a study on sufficiency of disclosure(pdf).

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.

WIPO patent studies Read More »

Are innovation patents going?

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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.

What happened?

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%).

Further

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.

ACIP Review of the Innovation Patent System: Final Report May 2015 (updated to include new statement) (pdf)

The Statement

At the time of writing, the link to the comprehensive analysis of the economic data does not appear to be working.

Dr Summerfield takes a different view.

Are innovation patents going? Read More »

Of flat nosed syringes or if at first you don’t succeed

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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:

Glaxo Version 1
Glaxo Version 1
Glaxo Version 2
Glaxo Version 2

For present purposes, I found two points of interest: the finding that the second variant infringed and the failure of Glaxo’s entitlement attack.

Infringement

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 [126], 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:

  1. 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 [149], 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 [150]:

The alternate syringe takes the substance of the flat-nosed syringe described in the patent and drawings as stated in claim 9.

Entitlement

In coming up with the claimed apparatus, Reckitt[1] 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 ….

Reckitt Benckiser Healthcare (UK) Ltd v Glaxosmithkline Australia Pty Ltd (No 5) [2015] FCA 486

  1. The named inventors were actually employees of Boots, the pharmacy chain, and Reckitt’s predecessor in title.  ?

Of flat nosed syringes or if at first you don’t succeed Read More »

Commonwealth seeks $60 million on the undertaking as to damages

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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.

Commonwealth of Australia v Sanofi-Aventis [2015] FCA 384

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Australian Intellectual Property Report 2015

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IP Australia has released its Australian Intellectual Property Report 2015.

In addition to reporting on a range of statistics and some commentary, the report includes a number of “interactive” graphs that you may explore. Much, if not all, of the data is available through the Government Open Data initiative.

The headline point is that applications for trade marks and plant breeder’s rights increased over 2013, while applications for patents and registered designs decreased. The report attributes the decline in patent applications to the increased threshold arising from the commencement of most of the substantive reforms in the Raising the Bar and the rush to file before their commencement.

Australians are the largest source of filings for trade mark, registered designs and pbr. US-based applicants the largest source of patent applications; Australian residents being the second largest.

There were 25,947 applications for standard patents in 2014, a decrease of 13% on 2013. 19,034 standard patents were granted; an increase of 13% over 2013. Over 94% were granted to non-residents. The average number of months from filing to request for examination fell from 16.3 to 13.6 months; the average time from request to first report is just over 9 month and, on average, the time from first examination report to acceptance was a further 14 months. Australians filed 9,012 patent applications abroad in 2013 (41% in the USA), up 3% on 2012.

There were 1523 applications for innovation patents, down from 1676 in 2013. Australians accounted for 66% of the filings.

There were 64,381 trade mark applications filed in Australia in 2014, up 2% from 2013; correspondingly, Australians filed 16,267 applications overseas (in 2013). The top 3 filing destinations were the USA, China and NZ – accounting for 50%. The USA supplanted China as the “top destination”. Apparently, this is in line with a global trend.

6550 designs were registered in 2014, and 1452 were certified – almost double the number certified in 2013. IP Australia speculates that there are few applications to register designs because:

According to Lim et al (2014) the role of IP rights in the market for designs is limited.9 Buyers and sellers in the market view designs as a service that is co-created. As IP rights protect the artefact, not the service, IP rights are perceived as a secondary issue in the marketplace. This view of design rights provides insights into the low volume of design registrations relative to patents and trade marks.

The number of applications for plant breeder’s rights skyrocketed from 330 in 2013 to 341!

The report notes that IP Australia is aiming in 2015 to complete research projects into innovation trends in the mining industry, who and in which areas in the textile, clothing and footwear industry is filing patents and the role of geographical indicators.

Australian Intellectual Property Report 2015 Read More »

Rosuvastatin goes to the High Court

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

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

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

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

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

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

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

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

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

 

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What conduct makes novelty destroying information publicly available

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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.[1]

Damorgold’s patent relates to a mechanism for raising and lowering a blind. As characterised by Bennett J at [6], 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 [2] 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.[3]

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 [11] 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.[4]

Damorgold Pty Ltd v JAI Products Pty Ltd [2015] FCAFC 31

  1. As I was junior counsel for the appellant, this post will aim just to identify the court’s ruling.  ?
  2. The applicable prior art base was the form before the amendments made by the Patents Amendment Act 2001 so acts of prior use had to be done in Australia.  ?
  3. Bennett J’s emphasis.  ?
  4. For example at [61], [64], [68] (emphasis supplied).  ?

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