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AUSTRALIA: LIFE-CYCLE INSIGHTS 

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

  • ƒEasy-to-use Australian brand,

       biosimilar, and generic drug

       launch tracking schedules

  • Australian litigation tracking and

       in-the-courtroom coverage with

       accompanying email updates

  • Personalized consults with local Australian intellectual property analysts

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

       loss-of-exclusivity information

  • 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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"Let's get started with some of the biggest differences between the Australian patent and regulatory landscape as compared to the United States...

 

The first is that in Australia, there is no Hatch-Waxman or ANDA filing process when a generic company wants to launch a drug. So, we don't have a system where patents are recorded in an Orange Book. And what that means is that in the initial stages of litigation, when a generic seeks registration and the originator company is trying to block that generic from launching, it can be quite a complex process. It can be a bit messy. The generic is trying to launch its product, and the originator is trying to seek a preliminary injunction to prevent the launch.

The second aspect would be the role of Australia's Pharmaceutical Benefits Scheme, and the role that has on litigation and strategy for both generic and brand companies. The PBS is a scheme through which the Australian government subsidizes the cost of many drugs for Australian citizens. What that means, is that for many common drugs and many big drugs included on the PBS, the government pays for those medicines up until a certain point. The reason this is important for litigation is when a generic company wishes to list its generic product on the market, it will try to seek PBS listing. If a generic obtains PBS listing, then it will trigger an automatic 25% price reduction to the originator brand on the PBS. So, the PBS system plays an important role when it comes to the litigation strategy and trying to either launch or prevent the launch of a new generic medicine.

 

And then the third thing I'd say around the differences between Australia and United States is that while, litigation practice can be very similar, in Australia, there are some important differences..."

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

  • Unique features of the Australian patent and regulatory system

    • Absence of a Hatch-Waxman/ANDA filing process

    • Australia's Pharmaceutical Benefits Scheme

    • Litigation practices

  • Infringement

    • Trial processes

    • "Hot tubs" (concurrent expert witness evidence sessions)

    • Grounds of invalidity

  • Pre-grant opposition hearings

  • Absence of a patent linkage system

  • Preliminary injunctions

    • At-risk launches

    • Interlocutory injunction hearings processes

    • Mutual agreements that avoid hearings

    • Granting preliminary injunctions

      • Prima facie infringement

      • Balance of convenience assessment

  • Availability of documentation​ (preliminary discovery)

    • Third party access​ to court documents

    • APO website

  • Trial timing

  • Appellate processes

  • Jury trials

    • Judge-only trials​

    • Markman hearings

  • Regulatory exclusivity​

    • Therapeutic Goods Administration​ data exclusivity

    • Orphan drugs​

    • Patent term extensions

  • New Zealand

    • Competitive intelligence​

Listen to our podcast to learn more about the Australian patent and regulatory system