In this edition
Court Halts Release of Generic Antidepressant
On 3 June 2009, Justice Sundberg granted an interlocutory injunction in the latest patent stoush between a pharmaceutical originator and a generic pharmaceutical company. The decision in Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [1] continues the recent trend towards granting interlocutory injunctions in pharmaceutical patent cases.
The decision is notably different from some of the other recent interlocutory injunction cases in that Sigma had not applied to list the generic drug under the Pharmaceutical Benefits Scheme, thus avoiding the usual price drop that was important in previous cases.
Wyeth owns a patent for an extended release formulation of venlafaxine hydrochloride, more commonly known as Australia’s best selling antidepressant, Efexor-XR.
Sigma registered a bioequivalent product, branded Evelexa-XR, on the ARTG. It launched Evelexa-XR in May 2009.
Sigma moved to have Wyeth’s patent revoked, and Wyeth sought an interlocutory injunction to stop Sigma marketing, selling or exploiting its generic Evelexa-XR drug.
Justice Sundberg considered the three general principles governing interlocutory injunctions:
- whether there was a serious question to be tried; i.e. whether, if the evidence remained the same, it was probable that at trial Wyeth would be entitled to relief;
- whether damages would be an adequate remedy; and
- whether the balance of convenience was in Wyeth’s favour.
Wyeth’s prima face case
Sigma conceded that there was a serious question to be tried on infringement. The Judge thought Wyeth’s prima facie case was “reasonably strong”.
The situation was complicated by Sigma’s claim that the patent is invalid. Justice Sundberg had to determine what role Sigma’s case on invalidity should play in his assessment of Wyeth’s prima facie case. He adopted the position from Interpharma [2]: the bottom-line question is whether the patentee has a serious question to be tried. Because the focus is on the patentee’s prima facie case, the case about invalidity must be “sufficiently strong” if it is to qualify the conclusion that, overall, there is a serious question to be tried on infringement.
Sigma unsuccessfully argued that Wyeth bore the onus to show that it was entitled to a priority date prior to the amendment of the patent. It failed to establish a prima facie case for a priority date other than that claimed by Wyeth.
It did establish a prima facie case that the invention lacked the requisite inventive step.
Sigma also established a prima facie case that the ‘invention’ was not a manner of new manufacture.
The Court’s decision implies that, although Sigma succeeded in making out a prima facie case on invalidity, that case was not sufficiently strong so as to displace the finding that Wyeth had made out a serious question to be tried on infringement.
Irreparable harm (damages an inadequate remedy)
In finding that Wyeth would suffer irreparable harm if it did not obtain an interlocutory injunction, Justice Sundberg noted that Wyeth Australia was a wholly owned subsidiary of Wyeth (the patentee), and any losses it suffered would in fact flow through to the patentee. The Court considered that those losses would be very difficult to quantify.
It also noted that the losses suffered by Wyeth would be even greater if other generic companies entered the market. It was concerned that, if that occurred, the loss caused to Wyeth from Sigma’s conduct would become impossible to quantify. The Court thought other generics may well be emboldened and might enter the market if it did not grant the injunction.
Sigma had offered undertakings to retain records and proceeds of its sales of the generic drug. Although those undertakings may have allowed Wyeth to assess the sales lost to Sigma, they did not address the quantum of damage that would be done to Wyeth from sales by other generic companies or by price erosion, assuming Wyeth would be forced to make sales at a discount from its former monopoly prices.
It is noteworthy that unlike many of the recent cases, Sigma had not applied for its bioequivalent drug to be listed under the Pharmaceutical Benefits Scheme. The first listing of a generic drug on the PBS can give rise to a potentially irreversible price drop for the originator’s product, and is often pointed to as a source of irreparable harm to the originator. Nevertheless, the Court still found that Wyeth was likely to suffer irreparable harm, for which damages would not be adequate compensation, if no injunction was granted.
Balance of convenience
Sigma launched Evelexa-XR on 1 May 2009. It had not yet made any deliveries of the drug. There was no evidence it had assumed any contractual obligations to do so.
Wyeth, on the other hand, has an established trade in Efexor-XR. It was far more likely to suffer from a disturbance to the status quo.
Wyeth also pressed an argument that vulnerable patients should not be subjected to the confusion of switching back from Sigma’s generic drug in the event that Wyeth was ultimately successful at trial.
Justice Sundberg found that the balance of convenience favoured the grant of interlocutory relief, and ordered Sigma not to market, take orders for, sell, supply, offer to supply or otherwise exploit Evelexa-XR in Australia.
Key points
The case continues the recent trend towards granting interlocutory injunctions in pharmaceutical patent cases. The message coming from the Federal Court in recent times has been: if you want to take on a patent, revokefirst, launch later.
The judgment differs importantly from other recent interlocutory injunction cases, because Sigma had strategically refrained from applying for listing under the PBS. It makes it clear that a pharmaceutical patentee can demonstrate irreparable harm without relying on the likely effect of the first listing of a generic on the PBS.
The decision leaves open a significant question: where irreparable harm and balance of convenience favour the patentee, in what circumstances will the potential invalidity of the patent outweigh the case on infringement?
Stephen Cartwright, Lawyer & Scott Sloan, Partner
Footnotes
- Sigma Pharmaceuticals (Australia) Pty Ltd (ACN 004 118 594) v Wyeth [2009] FCA 595.
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Interpharma Pty Ltd v Commissioner of Patents [2008] FCA 1498.
The Importance of Intellectual Property Due Diligence in Insolvency
In these recessionary times, insolvency practitioners are being inundated with work, and cash rich businesses are bargain hunting, picking at the bones of failed businesses. The Federal Court decision in Prismex Technologies [1] is a telling example of how the intricacies of intellectual property rights and licensing can complicate life for insolvency practitioners, and prove a pitfall for the purchaser of a business in liquidation.
Whilst Prismex Technologies is a case from late 2006, current business conditions mean that it is a case with even more relevance to business owners, and insolvency and legal practitioners today. This article will look at some of the facts in the case and the lessons that can be learned.
The case
Prismex Technologies Pty Limited (Prismex) is the owner of an Australian patent for an illuminated display system invention (the Patent). Prismex’s role was primarily as an IP holding company. Another company called Interium Pty Limited (Interium) was incorporated to exploit the Patent. Prismex granted Interium an exclusive licence for these purposes, although a formal licence agreement was never executed by the parties.
Interium carried on the business of developing, manufacturing, marketing and selling signage utilising the technology protected by the Patent. It obtained registration of the trade mark “PRISMEX” and, to an observer, Interium would have appeared to have been the only company involved in the Prismex name and technology. Interium used the name “PRISMEX” in trade and, on a number of occasions, it took proceedings to protect its interest in the Patent, including bringing opposition proceedings against third parties attempting to register patents too similar to the Patent.
Interium subsequently became insolvent and an administrator was appointed. Around the same time, solicitors for Prismex wrote to the administrator asserting their client’s rights in the Patent and also the formulae for ink mixtures and films necessary for the manufacture of the “Prismex panel”. They asserted that although there appeared to be a number of parties interested in purchasing the business and assets of Interium, Interium was unable to assign the licence to exploit the Patent, or disclose the ink formulae to interested purchasers, without Prismex’s permission. The administrator was put on notice that in the event that Interium did not trade on, the licence agreement with Prismex would be immediately terminated. Accordingly, any interested purchaser who wished to use the Patent, or the formulae for ink mixtures and films, would need to seek Prismex’s permission.
Soon after, it was resolved that Interium be wound up and a liquidator appointed. The liquidator accepted an offer from Keller Industries Pty Limited (Keller) to purchase Interium’s business and assets.
At the same time, however, Prismex granted to a third party (X-Position) an exclusive licence to use and exploit the invention that was the subject of the Patent.
A stand-off ensued, with, on the one side, Prismex asserting that the licence agreement with Interium had been terminated by the liquidation of Interium, and X-Position asserting that it now had the right to exploit the invention the subject of the Patent. On the other side, Keller asserted that it had purchased from Interium a perpetual licence to exploit the invention the subject of the Patent.
Proceedings were commenced by Prismex against Keller for patent infringement.
This article does not intend to consider in detail the reasons for the Court’s decision, but it is worth noting a couple of the aspects that the Court took into account when reaching its decision.
It was not disputed that Interium had a licence to use the Patent in return for paying royalties to Prismex. Prismex’s ability to terminate the licence was, however, in dispute. The Court looked at the Prismex/Interium relationship and noted that the two companies had been set up with Prismex as the IP holding company, to protect the Patent against the risks that may arise from insolvency and/or litigation. To hold that the licence was perpetual would effectively have amounted to an assignment of the Patent, and would have defeated the very purpose of the two-company structure. The Court determined that the licence was at least revocable by Prismex. Use by Keller of the Patent was held to be an infringement of Prismex’s rights in the Patent.
So the outcome of this wonderfully awkward case (this article has not touched upon the issues of trespass and conversion that were also involved) was that Keller had bought a business from the liquidator without the business’ key IP asset, the Patent, although it had successfully purchased the trade mark for the name PRISMEX. Prismex was able to license the right to exploit the Patent to X-Position but neither Prismex nor X-Position were able to use the Prismex trade mark, as this was now owned by Keller. The outcome was not entirely satisfactory for any of the parties.
What can we learn?
Intellectual property and technology issues are not always so obviously on display, nor do they always so markedly govern the outcome of an insolvency. Nonetheless, today’s commercial reality is that IP rights may form a substantial part of many companies’ balance sheets, and a crucial part or their businesses.
(a) The importance of due diligence
A purchaser of a business in liquidation (or of a business from an administrator or receiver) should undertake careful due diligence to minimise the risk of ending up in Keller’s situation. Whilst a liquidator is highly unlikely to give any warranties or guarantees in respect of IP ownership, the lack of a formal licence agreement between Prismex and Interium should have rung some alarm bells. Whether or not Keller thought that it was purchasing a business for a bargain price, it certainly did not get what it wanted for its money. This is a reminder to purchasers of businesses (whether or not they are in liquidation) to do their homework and ensure that they are buying what they think they are paying for.
(b) Insolvency practitioners should do their homework
Whilst a liquidator will generally sell without recourse, and rarely with any form of warranty or guarantee in respect of the assets being sold, this case is still a reminder as to the sorts of difficulties that intellectual property related issues can cause. The licensing issue could well have made it very difficult for the liquidator to find any purchaser for Interium’s business.
In many circumstances a liquidator with an understanding of the IP issues may be able to add real value to what is realised out of the liquidation. The ability to identify the significance of the IP to the business could substantially affect the value achieved by the liquidator for a business.
(c) Nothing unusual
Although the facts in Prismex Technologies created an unusually messy situation, two key elements that had a bearing on the outcome and the determination of the patent infringement were very common.
The first was the termination of the licence agreement by Prismex upon the liquidation of Interium. Whilst in this case, the right to terminate had to be implied into the arrangement between the parties, the right for a licensor to terminate a licence immediately upon the licensee entering into any form of insolvency is common in many formal licence arrangements.
The second was the dual company structure adopted by Primex to assist with the protection of the Patent. The purpose of such a structure is frequently to separate the trading operations from the IP ownership. This can aid the protection of the IP in the event the trading company becomes insolvent or is the subject of a damages or costs claim arising out of litigation – the IP is not an asset of the trading company, but an asset of the separate, asset holding company.
As the importance of IP to almost every business grows, it is equally important that those involved in advising businesses have due regard for any IP and ensure that the relevant expertise and advice is sought.
Michael Sutton, Senior Associate
Footnotes
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Prismex Technologies Pty Limited & Anor v Keller Industries Pty Limited & Ors [2006] FCA 1504 (14 November 2006)
Full Federal Court Clarifies Test for Novelty Concerning Patents for Enantiomers
There is something for everyone in the majority decision of the Full Federal Court on Alphapharm’s appeal in its fight with Lundbeck over Lundbeck’s patent for the antidepressant drug escitalopram. The majority of the Full Court largely upheld the primary judge’s findings on validity and infringement, clarifying the test for novelty along the way, but also upheld the finding that the term of Lundbeck’s patent was not properly extended.
On the one hand, the decision supports the ability of patentees to obtain and enforce patents for specific enantiomers. On the other, generic drug manufacturers will recognise the significance of practical difficulties for patentees in obtaining extensions to such patents.
Primary decision
At first instance, Alphapharm Pty Ltd sought revocation of Lundbeck A/S’s Australian Patent No. 623144 (the Patent) on the grounds that it lacked novelty, inventive step, definition, fair basis, clarity, utility and was not a manner of manufacture. It also sought an order that the Register of Patents be rectified to remove the record of the extension of the term of the Patent.
Lundbeck and its exclusive Australian licensee, Lundbeck Australia Pty Ltd, cross-claimed against Alphapharm for infringement.
In Alphapharm Pty Ltd v Lundbeck A/S [2008] FCA 559, Justice Lindgren of the Federal Court found that certain claims were valid, and that Alphapharm had infringed the Patent. His Honour found that claim 5 of the Patent was invalid for inutility.
On the issue of the extension of the patent term, Lindgren J held that citalopram “contains” escitalopram, since citalopram is a racemic mixture comprising of escitalopram in the amount of 50%. As a result, the time limit for applying for an extension of the patent term was triggered when citalopram was first listed on the Australian Register of Therapeutic Goods (ARTG). Lundbeck’s application for extension had been made outside the statutory six month period from the inclusion of citalopram on the ARTG, and accordingly the extension that had been granted by the Commissioner was held invalid.
The Federal Court’s findings in respect of validity and the patent term also applied in respect of similar proceedings brought by Arrow Pharmaceuticals.
The patent
The Patent claims the antidepressant drug escitalopram (a single enantiomer of citalopram), pharmaceutical compositions containing escitalopram and a method of preparing escitalopram. Escitalopram is the S-enantiomer or (+)-enantiomer of the compound citalopram, which is also used to treat depression. Citalopram itself is a chiral molecule, also patented by Lundbeck under Australian Patent No. 509445 (the Citalopram Patent). Citalopram is a racemic mixture comprising two enantiomers, escitalopram (i.e. (+)-citalopram)) and (-)-citalopram, in a 50:50 mixture.
The Patent was filed on 13 June 1989 with a priority date of 14 June 1988. The 20 year term of the Patent was due to expire on 13 June 2009. Following an application by Lundbeck for a term extension under section 70 of the Patents Act 1990 (Cth), the Commissioner initially granted an extension to 13 June 2014.
The appeal
Alphapharm appealed the findings on validity and infringement. It was largely unsuccessful on this front.
The majority decision of the Full Federal Court in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, considered the meaning of “enabling disclosure” with respect to novelty and clarified the Australian test for novelty. In particular, the Full Federal Court agreed that certain claims of the Patent were valid and that Alphapharm had infringed, although it disagreed with the primary judge to the extent that he thought Alphapharm had infringed one of the method claims. The Full Federal Court upheld the finding of the primary judge that claim 5 of the Patent was invalid for inutility and that it should be revoked, together with the finding that the Patent expired on 13 June 2009.
Construction of the patent
The Full Federal Court held that the primary judge was entitled to accept the evidence that the skilled addressee would read claim 1 as referring to the isolated (+)-enantiomer. The Full Federal Court did not accept Alphapharm’s contention that claim 1 was a reference to the (+)-enantiomer as present in the racemate or in a mixture with the (-)-enantiomer.
However, it did not agree with the primary judge that the skilled addressee could import a measure of purity into claim 1. In particular, the Full Federal Court did not accept that the convention of at least 95% purity could be attributed to the reference of the (+)-enantiomer in claim 1 of the Patent.
Novelty
The Full Federal Court clarified the test for novelty, and in doing so cautioned that care must be taken in applying United Kingdom jurisprudence to Australian patents. In particular, it noted that the primary judge had incorrectly applied the concept of “enabling disclosure” in considering the novelty of the product claims, stating that an enabling disclosure: “must point unmistakably to the (+)-enantiomer of citalopram, as distinct from the racemate as a drug desirable to obtain.” The primary judge had found that the Citalopram Patent did not expressly or impliedly disclose the individual enantiomer, and that the relevant prior art taught away from the invented product because it suggested that the R-enantiomer rather than the S-enantiomer could be expected to be more potent. Thus the primary judge found that the prior disclosure of the racemic mixture was not an anticipation of the single (+)-enantiomer.
Although the Full Federal Court upheld the novelty of claims 1, 2, 3, 4 and 5 of the Patent and agreed with the conclusion of the primary judge on the question of novelty, it did not agree that claim 1 was limited to the enantiomer as a drug desirable to obtain or otherwise. In reaching its decision, the Full Federal Court found that the Citalopram Patent did not anticipate the Patent because although the skilled addressee would have understood that citalopram consisted of the (+) enantiomer and the (-)-enantiomer, he/she would not have known, without further experimentation, which was the (+) enantiomer and which was the (-)-enantiomer.
Utility
The Full Federal Court upheld the conclusion of the primary judge that claim 5 failed for inutility. The invention disclosed in claim 5 was not patentable because the claimed range of 0.1 to 100 mg per unit dose spanned quantities well below the useful minimum dose of 5mg and above the useful maximum dose of 40 mg.
Infringement
Lundbeck contended that Alphapharm had infringed and threatened to infringe claims 1, 3 and 5, which are product claims, and claim 6(b), which is a method claim. However, the Full Federal Court upheld the Federal Court’s finding that claim 5 was invalid. Alphapharm accepted that it infringed claims 1 and 3, but successfully appealed the primary judge’s finding that it had infringed claim 6(b) of the Patent.
Claim 6(b) is for a 3-step method of preparing escitalopram. Alphapharm argued that the method it uses departs from the method disclosed by claim 6(b) in that it involves use of a bromo-diol rather than the cyano-diol. The Full Federal Court held that if the method disclosed by claim 6(b) was to be interpreted as being confined to use of the cyano-diol, represented by the symbol “NC”, the symbol “R” could have been substituted in place of the symbol NC. Claim 6(b) of the Patent does not use “R” symbol, thus the cyano-diol is an essential integer of the method disclosed in claim 6(b). Thus, the Full Federal Court found that a method that involved substitution of the bromo-diol for the cyano-diol does not infringe the method disclosed by claim 6(b).
Extension of term
Section 70 of the Patents Act 1990 allows for an extension of term for a standard patent under certain conditions in recognition of the delay in exploiting a patent due to obtaining listing of the relevant goods on the ARTG under the Therapeutic Goods Act 1989. The Patent had originally had its term extended [by the Commissioner for Patents] for 5 years to 13 June 2014 on the basis that the first regulatory approval of escitalopram (marketed as Lexapro) had occurred on 16 September 2003.
However, the majority of the Full Federal Court agreed with the primary judge finding that citalopram (marketed as Cipramil) contained escitalopram since citalopram, despite being a racemic mixture, contained escitalopram molecules. Accordingly, Lundbeck could only base an extension of term application on the date of inclusion of Cipramil on the ARTG which was 9 December 1997 (i.e. the first regulatory approval date). Lundbeck’s application for an extension was made in December 2003, well outside the statutory 6 month period since the ARTG listing of Cipramil. **
Conclusion
The decision significantly strengthens the ability of potential patentees to obtain patents for specific enantiomers. Arguably, this approach rewards the high risk pathway of separating and analysing various enantiomers and, potentially, other types of high risk research and development. Viewed in this light, the decision is a positive outcome for the innovators.
However, while the decision is a win for the patentee in terms of validity, the construction of section 70(3)(a) of the Patents Act (and, by implication, section 70(5)(a) of the Patents Act) is a positive step for the generics as it imposes practical limitations on the availability of extensions to the patent term. In particular, where an extension of term is sought for a drug, and one or more pharmaceutical substances per se within that drug are already included on the ARTG, the first regulatory approval date will be taken to be the day the relevant pharmaceutical substance was first included on the ARTG.
Innovators may now face some very real practical problems attempting to stave off the generics by seeking an extension of the term of patents for specific enantiomers following the expiry of the initial 20 year term of such patents.
** Note: A stay has been imposed on the order removing the extension of term for Escitalopram (Lexapro) pending any appeal by Lundbeck to the High Court.
Helen Kavadias, Associate & Scott Sloan, Partner
Australian Innovation Set To Triumph in the Tough Times Ahead
In the lead up to the Government’s delivery of the most anticipated budget in recent times, many in the fields of science, research, and innovation would have been concerned over whether the Government would be able to further develop Australian innovation during the crippling global financial crisis.
In a significant boost to innovation, the Government has proposed to expend from the 2009/2010 budget close to $8.58 billion dollars over the next 4 to 6 years in various projects under the header of Innovation and Higher Education System for the 21st Century.
This portion of the budget will see an increase of about 25% in expenditure from the last two budgets ($6.56 billion in 2007/2008 and $6.88 in 2008-2009) for innovation. Here is a snap shot of some of what Australian innovators can expect:
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$36.5 million over 4 years for the operational costs of the Anglo Australian Observatory.
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$114.1 million over 6 years to establish the Collaborative Research Networks program to assist regional universities to develop their research strengths.
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$196.1 million over 4 years to establish the Commonwealth Commercialisation Institute which will support research into commercialization and early stage development by small and medium sized enterprises.
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$906.9 million over 5 years to support a range of research projects under the headings Education Super Fund and Super Science – strengthening Australia’s research infrastructure. The range of projects are varied, covering fields of science and research including marine, nuclear, bio-molecular, IT, medical, pharmaceutical, and environmental science.
- $35.8 million over 4 years to establish the Excellence in Research for Australia (ERA) initiative to evaluate the quality and quantity of research conducted by Australia’s tertiary education institutions, and to identify research areas which are emerging, competitive and can be developed for further research investment.
- $1.2 billion will be redirected over 4 years from the Institutional Grants Scheme for a new Joint Research Engagement program to give greater emphasis to end-user research.
- $38.2 million over 4 years to develop a National Enabling Technologies Strategy in setting the direction of future technology development in particular biotechnology and nanotechnology.
- $51.7 million over 4 years to increase study allowances to postgraduate research students.
- $1.4 billion over 4 years to replace the existing Research and Development Tax Concessions with a new Research and Development Tax Credit effective from 1 July 2010. This is discussed in more detail in a separate article by Stephen Cartwright in this newsletter.
- $29.7 million over 5 years to establish a 3 year postdoctoral fellowship program to encourage postdoctoral research into space science, astronomy, marine science, climate change and future industries such as nanotechnology and life sciences.
- $14.7 million over 4 years to assist Standards Australia and the National Association of Testing Authorities.
- $813 million over 5 years to supplement the Research Infrastructure Block Grants to assist universities meet indirect costs of research.
- $50 million over 4 years to establish a competitive grant program to facilitate research in developing a functional bionic eye.
- $15 million over 1 year to establish the Royal Institution of Australia as a leading national institute in the fields of science and technology.
- $10 million over 2 years to assist small businesses take advantage of e-business opportunities and online presence.
- $10 million over 2 years to establish a small business support line and referral service to assist small businesses better manage in the current global recession.
Riding on the back of Venturous Australia, the August 2008 Review of the National Innovation System, the budget has delivered a major win for Australian innovation.
William Vallati, Lawyer & David Richardson, Partner
Innovative Tax Reforms
This year’s Federal Budget contained the most significant overhaul of the system for supporting R&D and innovation in recent times. The system for supporting eligible R&D expenditure by giving tax concessions will change dramatically.
The Commonwealth currently offers 4 tax incentives for R&D expenditure. The R&D Tax Concession allows companies to claim a 125% tax deduction on their R&D expenditure. The R&D Tax Offset gives small firms with tax losses the option to take an early cash payment based on their eligible R&D expenditure, rather than accrue a future entitlement to a deduction. It does not increase the eligible rate of deduction but, rather, allows all deductions available under the R&D Tax Concession (and Premium Concession if eligible) to be ‘cashed out’. The 175% Incremental (Premium) Concession and the 175% International Premium Concession are additional tax deductions that are intended to reward firms for increasing their R&D spending over time.
As at 1 July 2010, these measures will be withdrawn and replaced with a far simpler and more predictable R&D tax credit.
Those Australian companies with group turnover of less than $20 million will receive a tax credit equivalent to 45% of their R&D spending when they file their tax returns. Given the 30% corporate tax rate this gives these smaller firms a net benefit of 15 cents for each R&D dollar spent, double the current 7.5 cent net benefit. For companies in this group that are in a tax loss position, the tax credit will be able to be "cashed out" - i.e. paid to the company by the Tax Office.
For foreign-owned companies, and Australian companies turning over more than $20 million per year, the R&D tax credit will be set at 40% of their eligible R&D expenditure. This increases the net benefit for these Australian companies to 10 cents for each R&D dollar spent, and introduces this tax incentive to international companies with foreign-owned IP that incur R&D expenditure in Australia. The 40% tax credit will not be refundable if these companies are in a tax loss position.
There will not be any cap on the amount of eligible R&D expenditure for which a tax credit can be claimed, however the eligibility criteria will be tightened in an effort to ensure that only genuine R&D qualifies for the tax incentives. The government intends to consult on a new definition of R&D and the eligibility criteria later this year. It will need to walk a fine line between legitimately tightening the criteria and introducing the same complexity that the new system aims to avoid.
The government claims the changes will increase R&D and innovation activity for 5 reasons:
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it gives the greatest support to small – medium businesses, which are more likely to respond to fiscal incentives;
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cash refunds of the tax credit will be available to more firms than under the present system;
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it’s a simpler and more predictable system;
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there is more certainty about the value of the concession because the R&D support offered under the new system is uncoupled from the corporate tax rate; and
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it meets the best practice of the US, Japan and parts of Europe, and may make Australia a more attractive destination for foreign R&D investment.
For many companies, July 2010 is a long way off. As an interim measure, small firms in tax loss positions will be allowed to ‘cash’ out under the existing R&D Tax Offset for eligible spending of up to $2 million (an increase from the current cap of $1 million).
The government also announced that it would establish a Commonwealth Commercialisation Institute, to assist innovative firms to bridge the gap between the experimental development stage and commercial exploitation. It is not yet clear how this will operate.
Stephen Cartwright, Lawyer
Trade Mark Alert: Beware Of Trade Mark Scams
Owners of Australian Trade Marks should take note that upon applying for a trade mark, basic details of a trade mark application including the name and address of the applicant are made available to the public and are accessible via IP Australia’s ATMOSS database.
Whilst public access is required for the proper functioning of the Trade Marks system, an unfortunate side-effect is that disreputable individuals and companies are able to obtain applicant contact details and send unsolicited correspondence offering to register trade marks in jurisdictions other than Australia for a typically inflated fee.
If a law firm or firm of patent/trade mark attorneys has applied for trade mark protection in Australia on your behalf, it is recorded as the Address for Service and will receive all official correspondence in relation to your trade mark application and/or registration.
Trade mark owners should be wary of any correspondence related to trade marks which doesn’t come from its own lawyers/trade mark attorneys, especially if such correspondence offers registration services. "Trade mark scammers" have no official or government authority and the services they offer do not affect official trade mark registration or
trade mark rights in Australia.
IP Australia has issued warnings in relation to a number of these companies that have identified themselves as:
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TM Collection, Hungary
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Institute of Commerce, Trade and Commerce based in Switzerland
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ZDR-Datenregister GmbH based in Frankfurt (their letter is in German, English and French)
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Globus Edition SL of Palma de Mallorca, Spain
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Company for Publications and Information Anstalt of Liechtenstein
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Company for Economic Publications Ltd, Vienna, Austria
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European Institute for Economy and Commerce - EIEC, based in Brussels
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IT & TAG of Switzerland
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Edition The Marks KFT
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INFOCOM, Schaan, Switzerland
Registration of a trade mark in Australia grants the owner of a trade mark a monopoly in Australia to use that trade mark in relation to the specific goods and services, in respect of which the mark is registered. If goods are to be manufactured or sold, or services provided, under a trade mark in jurisdictions other than Australia, trade mark owners should consider seeking trade mark protection in those specific jurisdictions.
Should you have any queries as to whether trade mark - related correspondence is legitimate, please contact DibbsBarker’s Intellectual Property & Technology Team.
Stuart Green, Lawyer
Ad-Venturous Australia – From Boom Times to Tough Times for Innovation
Back in January 2008, the Government commissioned a national review of Australian innovation to help show the way forward for Australia to renew and re-focus on innovation to compete on the world stage. The report, entitled Venturous Australia - building strength in innovation, looks at various issues pertaining to Australia’s commercial development with respect to national innovation.
The conclusions and submissions of the report resounded well in many scientific and commercial circles. However what would have been a concern at the time was the initial impact of the global financial crisis, leading many to question whether the ideas and proposals put forward in the report would still be viable.
The report expressed the view that innovation pre-eminently determines the prosperity of the nation, and then identified how Australian innovation should be overhauled to be more competitive on the global stage.
The report looked at a wide variety of areas ranging from Tax, Investment, Education, and Infrastructure through to appropriate government policies, promotion, and adoption of research. In relation to commercialisation, one area of particular interest was the importance the report gave to Intellectual Property Law and its direct correlation to innovation. In this respect the report states that Australia’s current patent laws are “hampering” developments in the software and business methods industry, where continual usage of previously established knowledge is vital. On a legal level, the report made 3 specific recommendations with respect to patent law:
1. Patent law should be reviewed to ensure that the inventive steps required to qualify for patents are considerable, and that the resulting patents are well defined, so as to minimise litigation and maximise the scope for subsequent innovators.
The report suggests one of the faults in Australia’s IP system is that patent rights are too easily granted and, where they are ambiguously defined, it is difficult to determine what innovations might be subject to prior claims of patent holders [1]. The High Court of Australia has recognised that the level of invention required to obtain a patent in Australia is lower than the level of invention set in some other jurisdictions [2].
The report accordingly suggests that in the interests of jurisdictional harmonisation and better public policy, the hurdle for registering a patent in Australia should be at least as high as in other countries.
2. Professional practitioners and beneficiaries of the IP system should be closely involved in IP policy making. However, IP policy is economic policy. It should make the same transition as competition policy did in the 1980s and 90s to being managed as such.
Often economic considerations prevent or impede innovation. Where innovation will result in significant expenditure, companies may be reluctant to undertake such expenditure where it is anticipated that it may be difficult or impossible to either:
(a) innovate without the fear of infringing someone else’s innovation; and/or (b) protect the innovation and prevent others from commercially exploiting it.
As such, it is a “Catch-22” situation, where many innovative ideas tend to go unrealised due to the lack of sufficient incentive or leeway to innovate.
What this recommendation identifies is that while IP rights are available to protect and incentivise the creation of innovation, the monopoly rights given to IP owners, through that protection, can be a disadvantage to others who wish to innovate. The use of protected innovation in a legitimate attempt to create newer and better innovations could be unaffordable or illegal as a result of over-monopolising IP rights and thereby possibly hampering new innovation.
3. Firms asserting or defending intellectual property should have a right to opt out of ‘appellate double jeopardy’.
IP Australia’s submission to the report noted that the costs associated with IP enforcement are generally quite onerous. “There is a view within the small business community that litigation is all about who has the greater financial resources rather than whether the IP right is valid or infringed.[3]” What this Recommendation suggests is that, essentially, parties in IP litigation should agree to be bound by the decision in first instance, and then any decision to appeal the matter would require the appellant to meet the legal costs of the other party as well as its own.
Some commentators believe this is likely to be of little benefit: relatively few cases are appealed, and when they are they are usually of high commercial importance. Where large amounts of money have been spent on a case at first instance, the obligation to pay the other side’s appeal costs would be unlikely to deter many unsuccessful from appealing - the appeal process would still cost significantly less then the costs at first instance [4]
.
Looking forward
Whether the recommendations of Venturous Australia will be adopted and become successful in the current financial climate remains to be seen. Most commentators feared, as we ride the waves of the global financial crisis, that despite innovation being a tool that could stimulate economic activity and increase the prosperity of the nation, it could easily take a back seat. This fear continued right up until the recent budget. In a pleasant surprise to many, Australia has taken the initiative to innovate with significant increases in expenditure to bring Australia forward as a global player. As a result, there is a sense of hope that we will still see the recommendations of Venturous Australia truly take off. Watch this space.
William Vallati, Lawyer & David Richardson, Partner
Footnotes
- Venturous Australia-building strength in innovation (84)
- Lockwood Security Products Pty ltd v Doric Security Products Pty Ltd (No. 2) [2007] HCA 21, Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59.
- Venturous Australia (86)
- Richard Szabo, 1 October 2008, IP recommendations to federal government an empty shell, Australian Legal Bulletin.