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AUSTRALIA: LIFE-CYCLE INSIGHTS 

World Map Highlighting Australia Litigation Coverage

IPD’s Australia/New Zealand subscription provides for improved
forecasting of litigation events happening around the world
and stronger competitive intelligence, offering:

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  • ƒEasy-to-use Australian brand,

       biosimilar, and generic drug

       launch tracking schedules

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  • Australian litigation, opposition, and patent
    term extension tracking alongside

       courtroom coverage and

       accompanying email updates

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  • Personalized consults with local Australian intellectual property analysts ​

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  • Weekly reports on trending Australian drug topics, recent publications, and​

       loss-of-exclusivity information

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  • Complete drug information with locally reviewed Australian indications
     

  • Comprehensive Australian clinical development tracking in every major disease class
     

  • Competitive intelligence in New Zealand including extensive information about
    pending brand and generic drug applications not available in other countries, the identity of API/finished dose manufacturers, and brand and generic competitors
    within the marketplace

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Our International Legal Analysts discuss the ins and outs of the Australian patent and regulatory system, including:

  • Australia's Regulatory System

    • Therapeutic Goods Administration (TGA)

    • Regulatory Exclusivity Under TGA

  • Orphan Drugs

    • No Additional Period of Exclusivity

  • Australian Patent Office (APO)

    • Patent Term Extensions (PTE)

  • Patent Linkage

    • Absence of a Process Similar to Hatch-Waxman/ANDA Filing

    • Generic Approval Process

      • Preliminary Injunctions

        • Australia's Pharmaceutical Benefit's Scheme (PBS)

        • Granting Preliminary Injunction

          • Prima Facie Infringement

          • Balance of Convenience Assessment

        • Injunction Hearing Processes

        • Agreements to Avoid Hearings

        • Change in Landscape: 2018

  • Litigation

    • Patent Infringement Trial Process

      • "Hot Tub" (Concurrent Expert Witness Evidence Sessions)

    • Pre-Grant Oppositions

    • Appeals

      • Opposition Cases Involve Rehearings

    • Access to Patent and Court Information

      • Accessible to the Public

  • Differences Between the United States and Australia

    • Patent-Linkage and Absence of Hatch-Waxman

    • PBS Influence on Strategy in Australia

    • Trial Conduct

Listen to our podcast to learn more about the Australian Patent and Regulatory System

Australia Play

"Are preliminary injunctions easily obtained by the brands in Australia, and can generics launch at risk?"

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"I’ll give you the classic attorney answer, “It depends.” Let me explain, but before I do, I need to explain two concepts that we haven’t talked about yet.

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First, I mentioned the approval system for drugs in Australia.  Once a drug is approved—and this is the case for brands and generics—the MA holder will typically want to list its drug on Australia’s Pharmaceutical Benefits Scheme or PBS.  The PBS is Australia’s government-subsidized scheme that subsidized the costs of many medicines for eligible patients.  What is relevant to our discussion of preliminary injunctions is that when a first generic version of a brand drug lists on the PBS, it results in an automatic 25% statutory price reduction and it triggers several other processes such as price disclosure price reductions.

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Second, are the legal requirements for a court to award a preliminary injunction.  A PI is a temporary court order that prevents or enjoins a person from doing something. In most pharmaceutical patent litigation, this is an order that prevents the generic from launching its drug (including listing it on the PBS) pending the determination of the lawsuit. To obtain an injunction, a brand must prove two things: (1) that it has a prima facie case of infringement and (2) that the “balance of convenience” favours the award of the PI.  In return for the PI, and this is significant for what I’ll come to discuss, the brand company—that is, the company seeking the PI—must agree to compensate any person who is adversely affected by grant of the PI—that is, by the generic company not launching their product—in the event that the brand company is unsuccessful and the patent is ruled to be invalid or not infringed.

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OK, now to bring these concepts together.  So, we have a lawsuit, the generic is saying it will launch at risk (including list on the PBS), and the brand wants a PI to stop this.  What we often see at this point, is the parties agree to a PI and this is then granted by the court without a contested hearing.  Often, this is negotiated by the parties in the context of both of them wanting an expedited trial.

If the parties do not agree to a PI, then there is a preliminary injunction hearing—a trial before the trial—whereby the parties file evidence and make written and oral arguments about whether a preliminary injunction should be granted or not."

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