IP SPOTLIGHT 25 MAY 2020

IP SPOTLIGHT NEWS FROM AUSTRALIA

25 May 2020

COMMONWEALTH FAILS IN $325 MILLION RECOVERY BID

Nicholas J has rejected the Commonwealth’s claim for damages in the long-awaited decision of Commonwealth of Australia v Sanofi (No 5) [2020], handed down on 28 April 2020.

In this proceeding, the Commonwealth sought compensation for its payments under the Pharmaceutical Benefits Scheme ( PBS ) to subsidise Sanofi’s drug Plavix (clopidogrel). The Commonwealth argued that it had suffered loss of up to $325 million because Apotex was delayed from listing its generic form of clopidogrel on the PBS and triggering a price reduction, due to a wrongly granted interlocutory injunction. The Commonwealth’s claim was rejected because it did not show that Apotex would have listed its products on the PBS in the absence of the injunction on the balance of probabilities. BACKGROUND TO PROCEED I NGS Sanofi is the originator of the blockbuster multi-billion-dollar drug clopidogrel, an antiplatelet medication which is used to reduce the risk of stroke and heart disease. In Australia, Sanofi Australia Pty Ltd ( Sanofi ) sold clopidogrel under the name Plavix while Bristol-Myers Squibb Australia Pty Ltd sold it under the name Iscover. Both products were registered on the ARTG on 2 December 1998 and listed on the PBS on 1 November 1999. On 21 August 2007 Apotex Pty Ltd ( Apotex ) registered its clopidogrel products on the ARTG. Shortly thereafter, Apotex commenced proceedings against Sanofi to invalidate the Sanofi clopidogrel patent to clear the way for Apotex to launch its generic version of Plavix ( Apotex Product ) in Australia. Sanofi counter-claimed for infringement.

The Pharmacist Price is reduced from time to time by virtue of statutory provisions. The listing of the first generic version of a listed drug results in an automatic reduction (now 25% 1 ) in the Pharmacist Price. Additional price reductions 2 also occur once the first generic is listed, such as an annual drop on nominated dates, and reductions calculated based on the weighted average disclosed price for the drug. 3 Therefore, the listing of the first generic on the PBS triggers an immediate and continuing reduction in the Pharmacist Price, and the reduction in the Pharmacist Price represents a saving to the Commonwealth, and a loss to the originator. COMMONWEALTH ’S DAMAGES CLA IM The Commonwealth claimed compensation under the undertaking as to damages. The Commonwealth’s argument was that but for the interlocutory injunction, Apotex would have listed the Apotex Product on the PBS on 1 April 2008, which would have triggered the price reductions, with resulting savings to the Commonwealth. All in all, the Commonwealth claimed $325 million in compensation excluding interest and costs. COURT ’S DECI S ION The Commonwealth had to show the following in order to succeed: – – Apotex would have listed the Apotex Product on the PBS on 1 April 2008, triggering a price reduction but for the interlocutory injunction – – that the loss flowed directly from the interlocutory injunction – – that the loss could have been foreseen at the time the interlocutory injunction was granted.

Would Apotex have filed an application to list on the PBS on 1 April 2008? The Commonwealth failed at the first hurdle. Nicholas J found [at 349] on the balance of probabilities that Apotex would not have applied to list on the PBS the Apotex Products on 1 April 2008 if the interlocutory injunction had not been granted. The Commonwealth’s claim for compensation had to be dismissed. While Apotex Australia’s Managing Director provided evidence that he would have pursued PBS listing and launched at risk if the interlocutory injunction was not granted, contemporaneous documents indicated that any such action had to be authorised by senior decision makers from Apotex Canada (Apotex HQ) due to the financial implications of the decision. The documents indicated the decision makers were reluctant to launch at risk and list on the PBS because of the significant exposure to damages caused by the automatic reduction in Pharmacist Price triggered by the listing. Evidence from these decision makers was not adduced by the Commonwealth so the court drew an adverse inference that such evidence would not have assisted the Commonwealth. This was fatal to the Commonwealth’s case. Nicholas J however went on to make the following additional findings based on the evidence and arguments of the parties: – – The Minister would have approved the application for PBS listing (if it had been filed) even though the pending litigation may have ultimately restrained Apotex’s ability to supply product in the future. The Minister would have taken Apotex’s assurance of supply (provided in the application process) on face value, and noted the absence of an interlocutory injunction restraining the supply. – – The appropriate hypothetical scenario was that the interlocutory injunction had been refused , and that the opportunity for Sanofi to obtain an interlocutory injunction was foreclosed, and not (as Sanofi contended) that Sanofi had not made an application for an interlocutory injunction but may yet do so. – – The Commonwealth’s loss was not directly caused by the interlocutory injunction because PBS listing was not an act of infringement covered by the interlocutory injunction. While the practical effect of the interlocutory injunction was that Apotex could not obtain PBS listing (because it could not guarantee supply), the Commonwealth’s loss did not directly flow from the Other findings by the Court

In September 2007, Apotex applied for a PBS listing but its application was filed too late to be listed on the PBS from 1 December 2007. Apotex subsequently withdrew that application. On 25 September 2007, the court awarded an interlocutory injunction to Sanofi restraining Apotex from infringing Sanofi’s clopidogrel patent. Sanofi gave the usual undertaking as to damages in support of the injunction. In short, it undertook that it would pay any amount as assessed by the Court as just payment of compensation to any person, whether or not that person is a party, adversely affected by the operation of the interlocutory injunction. Apotex also voluntarily gave the Court an undertaking that it would not list its products on the PBS until the proceedings were determined or until further order ( Apotex First Undertaking ). Sanofi did not provide an undertaking as to damages in return for the Apotex First Undertaking. At first instance, Gyles J decided that certain claims in Sanofi’s clopidogrel patent were invalid but found that claims 2 to 5 were valid and infringed. As such, he ordered a final injunction restraining Apotex from infringing the patent. Apotex appealed and Sanofi cross appealed that finding to the Full Federal Court and on 13 October 2009, the Full Court made orders allowing Apotex’s appeal and revoked the patent. In doing so it also set aside the final injunction. The High Court then rejected Sanofi’s application for special leave on 12 March 2010 leaving Sanofi’s clopidogrel patent revoked. PHARMACEUT I CAL BENEF I TS SCHEME PR I CE REDUCT ION Pharmaceutical products which are listed on the PBS are subsidised by the Commonwealth. The maximum amount charged by manufacturers/wholesalers of a drug to pharmacists ( Pharmacist Price ) is set by agreement with the Minister. The patient pays a contribution, which is capped. The remainder of the cost is paid by the Commonwealth to the pharmacist.

interlocutory injunction. The Commonwealth’s loss was a direct consequence of Apotex not being able to list on the PBS and that was a consequence of the Apotex First Undertaking, which stopped Apotex from listing its products on the PBS. As noted above Apotex’s undertaking was volunteered and Sanofi did not provide an undertaking as to damages in return. If the interlocutory injunction had not been granted, the Apotex First Undertaking would not have been given and there would have been no restraint in place to stop the PBS listing application. However, the terms of the injunction itself did not explicitly or implicitly prevent Apotex from applying for a listing, and did not directly affect the legal rights, obligations or interests of the Commonwealth. The loss suffered by the Commonwealth was a result of Apotex not securing registration for the Apotex Product on the PBS from 1 April 2008. That was not a loss that flowed directly from the interlocutory injunction, but was the direct and immediate consequence of the Apotex First Undertaking. – – The Commonwealth’s loss was reasonably foreseeable , as Sanofi was aware of and understood the various price reduction mechanisms provided in the PBS scheme. The fact that the Commonwealth had not sought compensation of this nature in previous proceedings did not indicate that the loss itself was not foreseeable. – – The appropriate hypothetical scenario for assessing damages was how things would have turned out if the

1 In accordance with division 3A of Part VII of the National Health Act 1953 a statutory price reduction of 25% is applied to existing PBS-listed products when the first new brand or item that is bioequivalent or biosimilar and has the same manner of administration as an existing brand or item lists on the PBS. This reduction increased from 12.5% to 16% on 1 February 2011, then again from 16% to 25% on 1 October 2018. 2 Drugs listed on F1 are subject to statutory price reductions on the fifth (5%), tenth (10%), and fifteenth (5%) year anniversary of the date that the drug was listed on the PBS. 3 The National Health Act 1953 provides that listed drugs be assigned to formularies identified as F1 or F2. Generally F1 is intended for single brand drugs and F2 for drugs that have multiple brands, or are in a therapeutic group with other drugs with multiple brands. Drugs on F2 are subject to the provisions of the Act relating to statutory price reductions, price disclosure and guarantee of supply. Allocation to F1 or F2 is determined by legislative instrument. Single brand combination drugs are not included in either the F1 or F2 formulary.

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“ Sanofi is the originator of the blockbuster multi-billion- dollar drug clopidogrel, an antiplatelet medication which is used to reduce the risk of stroke and heart disease. ”

market share” approach to calculating market share which was based on actual sales figures in the post injunction period, over the “bottom up” approach which was based on an analysis of the clopidogrel market during the injunction period. CONCLUS ION Nicholas J’s decision demonstrates the considerable difficulties that parties will face when seeking to draw on the usual undertaking as to damages. It also shows the importance of adducing evidence directly from the relevant decision makers where possible. The Court’s finding that the Commonwealth’s loss did not directly flow from the interlocutory injunction indicates that the Commonwealth may face difficulties establishing a claim for damages suffered due to delayed PBS price drops in other wrongful injunction cases, even if it is able to adduce sufficient evidence to prove a generic would have listed in the absence of the injunction. This decision comes after Justice Jagot’s decision in Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2018] FCA 1556 which also addressed the entitlement to damages pursuant to the usual undertaking. Interestingly, Nicholas J did not refer to Jagot J’s decision in his judgment. Nicholas J’s approach to some questions appears to be distinct from Jagot J’s approach. For example, Nicholas J considered that the appropriate counterfactual scenario was that the interlocutory injunction had been refused, whereas Jagot J preferred the approach that the application for the interlocutory injunction simply had not been prosecuted, rather than refused. There is clearly much to be deliberated in this developing area of law. Further, the significant difficulties faced by claimants to establish an entitlement to damages in the present environment may well draw interest from policy makers.

relevant event (i.e. interlocutory injunction) was removed from the equation. Other real world facts such as the timing of trial, final judgment or findings made are not assumed away. – – On the evidence, it was unlikely that Apotex would have continued to supply after the first instance decision was handed down due to exposure to damages, so the likely scenario was that Apotex would de-list the Apotex Product and cease supply until the determination of the appeal, rather than simply continuing to supply. – – The Commonwealth would have likely exercised its power to reverse the automatic price reduction of 12.5% caused by the initial listing of the Apotex Product (thereby reducing the damage suffered by the Commonwealth) once Apotex de-listed, because this power had been exercised by the Commonwealth in similar circumstances previously. – – The Commonwealth did not need to show that no other generics listed on the PBS as a direct result of the interlocutory injunction (rather than the patent proceeding), because even if other generics were deterred for other reasons, it does not follow that the Commonwealth did not suffer loss as a result of Apotex not being listed before them. – – The Commonwealth was “adversely affected” by the interlocutory injunction . –– None of the discretionary factors raised by Sanofi were sufficient to deny the Commonwealth’s claim for compensation . The delay in the Commonwealth notifying Sanofi that it would make a claim was explained; that the supply of the PI for the Apotex Products would have constituted an infringement of Sanofi’s copyright in its PI was irrelevant when the evidence showed that Sanofi would never have pursued Apotex for copyright infringement in its PI; it was not established that the manufacture of Apotex Products in Canada would have infringed a valid claim of the Canadian patent; and no further public interest considerations arose. –– To determine quantum, it was necessary to identify the market share that the Apotex Product would have achieved . Nicholas J preferred the “backdated actual

COMMON PATENT MISCONCEPTIONS

Many people, even those with significant experience with patents, harbour some misconceptions about the patent system, its advantages and risks. This article debunks a few of the more common mistakes.

ONLY GEN IUS I DEAS CAN BE PATENTED An invention need not be a genius idea to be patentable. An Australian standard patent (which provides 20 years’ protection) requires that the invention is “inventive” compared with what was known and published before the patent. A good way to think of an invention is as a solution to a problem. A solution is inventive if, at the date the patent was filed, the ordinary person working in the field would not have been directly led to try that solution with an expectation that it might well work. This is a relatively low bar to clear, and often allows patent protection to be obtained for relatively minor, incremental improvements over existing technology.

BINDHU HOLAVANAHALLI Associate

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A PATENT OPERATES THROUGHOUT THE ENT I RE WORLD Each country has its own patent system, and a patent only applies in the country in which it was granted. When applying for a patent, it is important to consider your existing markets as well as your potential future markets. Once the time has passed for selecting your countries, it may not be possible to file the patent in any other countries, which may be a disaster if you subsequently find out that you have a lucrative market in a country but no patent protection there. If part of your manufacturing chain is based overseas, you should also consider whether it is prudent to seek patent protection in that country even if it is not one of your markets. CONCLUS ION The patent system is full of complexity and nuance, and even experienced operators can fall into its many traps. However, when fully understood and properly utilised, it holds great potential for innovators.

technologies for other reasons. There may be no market for the invention. A critical part of managing your patent portfolio is assessing the ongoing value of each of your patents to determine which should be retained and which should be allowed to lapse. A PATENT CAN ONLY BE COMMERCI AL I SED BY MONOPOLY AND L I T IGAT ION A common way of commercialising a patent is to maintain a monopoly over the supply the patented goods and services, and charge customers a premium. If a competitor seeks to intrude on that monopoly, it may be tempting to immediately call in the litigation lawyers to protect that monopoly. However, this is only one way of capitalising on your patent rights. Some patentees sell (“assign”) their patent rights. Other patentees profit by licensing out their technology to other parties and charge a royalty. This may provide a patentee with a regular, guaranteed income stream without them having to undertake any work. Alternatively, the patentee may supply one product or service to the market whilst licensing others (for a fee) to supply another product that does not compete directly. Patent rights may thus be used in a multitude of ways. I F A PATENT EX I STS, I CAN NOT USE THE TECHNOLOGY If you plan on launching a new product or service, finding that it is covered by an existing patent does not automatically mean that you should shelve your plans. There may be ways of circumventing the patent issue. First, it may be possible to modify your technology in a way that avoids the patent whilst still taking the advantages. That modification may itself be patentable. Second, the patentee may be willing to license or sell its patent to you. The patentee may not have the capital, the expertise or the desire to commercialise the invention and be grateful for the opportunity to license or assign it to another party. Third, the patent may have invalidity issues that would discourage the patentee from taking any action against you. Fourth, and as a last resort, it may be possible to revoke the patent, clearing the path for you. All of these avenues be explored before taking the drastic step of discontinuing a lucrative new project.

This situation can arise if a patent is granted for a product with additional advantageous features over an existing, patented product. If the existing patent is broad enough, it may well cover subsequent improvements. It may also arise where a patent is granted for a new way of using an existing patented product; again, the earlier patent might be broad enough to prevent all uses of the patented product, even if those uses were not mentioned in the earlier patent. A GRANTED PATENT I S A VAL I D PATENT A patent must comply with a number of requirements for it to be valid. It must be new and inventive (or innovative) compared with everything that was known and published before the patent was filed. It must be useful. It must not have been used in secret before the patent was filed. There are also other formality requirements surrounding the way the patent describes and claims the invention. The Australian Patent Office does its best to search for information that was published before the patent’s filing date, but its limited resources may mean it does not identify all relevant publications. For example, the Office may be unable to search some academic and trade journals. Without identifying all relevant and publicly available information, the Office may not realise that the invention, or something very similar, was published before the patent was filed. It may not be apparent from reading the patent that the invention will not work, or will not satisfy promises made in the patent. The Office may not know that the patentee secretly used the invention before filing the patent. Further, the validity of some patents involves complex technical and legal arguments, and a Court may take a different view to the Office. A GRANTED PATENT I S A VALUABLE PATENT There are many reasons why a granted patent may hold little value. A patent may be invalid and thus effectively unenforceable. A patent may also be so narrow that it is easy for others to work around it, taking the advantages of the invention without infringing it. Technology may evolve and overtake the invention, such that there is no longer any market demand for a patented invention. The patented invention may not be able to compete with existing Until a patent has been through the rigours of litigation, its validity cannot be assumed.

The bar for innovation patents (which provide 8 years’ protection) is lower. They require that the invention is “innovative”. A solution will be innovative if it is different to what was known and published before the patent in a way that makes a substantial contribution to the way the invention works. Provided the difference is relevant to the working of the invention, it does not matter how obvious that difference may have been. As a result, an invention does not need to involve a quantum leap forward over, or a radical departure from, the existing technology. Many patents are granted for small changes to existing technology. ALL TECHNOLOGY SHOULD BE PATENTED A patent is a great tool for protecting your intellectual property. But it is not the only tool available, and is not always the best. There are instances where you may be better served by relying on keeping the technology secret (including by way of non-disclosure agreements with employees and other third parties). Alternatively, you might be better served by relying on your trade mark rights and reputation, design rights or copyright. Sometimes, it might be best to innovate so quickly that the competition simply cannot keep up with you. You should consider all of these strategies when deciding how to best protect your intellectual property. A standard patent must be granted, and an innovation patent must be certified, by the Australian Patent Office before it can be enforced against an infringer. Both processes involve the Office reviewing the patent application carefully and considering whether there are any reasons that it might be invalid. Once the patent has been granted you, can pursue them for infringements that occurred before the patent was granted. I CAN STOP AN I NFR I NGER WI TH A “PATENT PEND I NG” I F I OBTA I N A PATENT, I HAVE A R IGHT TO USE AND SELL THE I NVENT ION A patent gives you the right to prevent others from using your invention. However, it does not guarantee that your invention will not infringe another parties’ patent rights. An earlier patent may stop you commercialising your technology even if you have a granted patent for it.

ANDREW MULLANE Special Counsel

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“ The data exclusivity provisions only protect a new active component. ”

AN UPDATE ON DATA EXCLUSIVITY PROTECTION IN AUSTRALIA

It is important to note that the protection provided by the Act may be forfeited if the confidentiality of the information is not maintained. For example, should clinical trial results be published for any reason, a subsequent applicant seeking approval of an equivalent product will be permitted to use the results in their own application. With that said, in practice, supporting a subsequent application by relying solely on information available in the public domain in Australia is rare. However, although this situation is not common, it does provide an avenue for competitors to bypass the data exclusivity period. For more information on data exclusivity in Australia, please see: – – Section 25A(2) Therapeutic Goods Legislation Amendment Act 1998 and Section 25A Therapeutics Goods Act 1989 – – TGA Approach to Disclosure of Commercial Confidential Information.

This data exclusivity period runs for 5 years, beginning on the date of marketing approval. It applies in relation to therapeutic goods which contain a “new active component” which has not been previously included in the Australian Register of Therapeutic Goods ( ARTG ). The protection covers an active component having a therapeutic effect, and includes both biologics and small molecule actives. The data exclusivity provisions only protect a new active component . It does not protect secondary products with a prior-registered active component, for example, a new dosage of a prior registered drug, a combination multiple active components which are already individually registered, new formulations, new routes of administration or new indications of prior registered drugs. This provision prevents a situation where the data exclusivity period is reset by filing for second generation product of an old active (such as a new formulation) every 5 years. A consequence of the “new active component” provision is that any subsequent applicant who seeks to register will be unable to rely on a data exclusivity period to protect their product and thus must rely on patent protection as their only mechanism to block a competitor from entering the market. However, in some cases the relevant information is often still protected by the data exclusivity for the prior registered active because the 5 year term has not yet expired. There is no separate or additional period of data exclusivity for products which relate to biological pharmaceutical products, or have paediatric indications or which have orphan drug status. These products enjoy the same protection as discussed above. Under the Australian provisions, it is still possible for a third party to seek regulatory approval during the data exclusivity period. However, the applicant cannot rely on or reference any confidential information provided to the TGA by the first applicant in support of their subsequent request for approval. In practical terms, this means that if a third party wishes to obtain approval of a generic or biosimilar product during the data exclusivity period, they can, but they must submit their own data package to the TGA to support their application.

Data exclusivity is a significant form of protection to branded pharma in Australia, yet many companies may not be aware of the subtle differences that protection has compared to protection provided by other countries. In Australia, innovators enjoy data exclusivity protection by which certain information provided to the regulatory authority (the Therapeutic Goods Administration of Australia ( TGA )) for the purposes of obtaining regulatory approval for prescription medicine remains confidential and cannot be accessed or referenced by a third party. This includes the results of safety and efficacy clinical trials.

Under the Therapeutics Goods Act (1989) (“the Act”), the Secretary is prohibited from using information which is deemed “protected” under the Act. The Act provides that certain information is ‘protected’ if it meets the following criteria: – – the information concerns a new active compound (i.e. not a device) which is contained in an application to register a therapeutic good and which has not been previously included in the ARTG – – the information is not in the public domain and the sponsor has not given written permission for the Secretary ( of the ARTG ) to use the information – – the therapeutic good has been included in the Register for less than 5 years. In effect, the data exclusivity provisions prevent others from relying on and referencing this data in order to obtain regulatory approval for their generic or biosimilar product during the data exclusivity period, even in the absence of patent protection.

DONNA MEREDITH Associate

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GRACE PERIODS AND WHOLE OF CONTENTS UNDER AUSTRALIAN PATENT PRACTICE

Australian patent law provides applicants with a ‘grace period’ in certain circumstances permitting disclosure of an invention prior to filing a patent application, provided a complete application is filed within 12 months of the disclosure. Recent decisions from the Australian Patent Office have held that this grace period applies to whole of contents disclosures filed prior to but published after the patent application has been filed. In Rozenberg & Co Pty Ltd v Velin-Pharma A/S [2017] APO 61 ( Rozenberg ), the Patent Office considered the relevant regulations that prescribe the circumstances under which a disclosure may be disregarded for the purposes of novelty and inventive step and the time frame in which an applicant must file the application. Regulation 2.2(1A) provides that the grace period will apply in the circumstances that there was a publication or use of the invention within 12 months before the filing date of the complete application . Regulation 2.3(1A) provides that the prescribed period for filing a complete application is the period of 12 months after the information was first made publicly available . It would appear that for the grace period to apply, the relevant citation must have been published before the filing of the patent application under consideration. However, the Patent Office interpreted Regulation 2.2(1A) as a start date for the prescribed circumstances of the Act but not an end date for the prescribed period. As the publication occurred after the filing date of the application, it was considered to meet the prescribed circumstances in accordance with Regulation 2.2(1A). The Patent Office then interpreted Regulation 2.3(1A) as a final deadline by which the complete application must be filed without providing a start date.

Rozenberg was decided prior to the Raising the Bar amendments which came into effect on 15 April 2013. Under the current provisions, the Regulations no longer provide a specific date or time period, specifying that a prescribed circumstance is any self-disclosure that is not covered by a separate regulation. However, the Rozenberg decision has been followed by a decision under the new provisions in CNH Industrial Italia S.p.A. [2020] APO 16 ( CNH ). In CNH, the Patent Office was considered to be bound by the decision in Rozenberg, even post Raising the Bar and the information in the whole of contents citation was disregarded when considering novelty. Following these decisions, it appears that the Patent Office has pushed the boundaries of the grace period provisions beyond their original intention. However, they have identified this as a potential issue for resolution. Until such a time or until there is judicial decision, patent applicants may be able to rely on the provisions of the grace period to have certain whole of contents prior art disregarded.

BRENDAN PEACHEY Principal

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