Strategies for generic/biosimilar market entry in Australia

Effective patent strategies that minimise the risk of the originator (or third party patentee) delaying market entry through an interlocutory injunction include:

• Circumvent: where possible, design around any blocking patents. This will involve consideration of any Australian patents early in the development process. Where pre-launch risk certainty is important, it is possible to seek a declaration of non-infringement in Australia, but this involves a reversal of the onus and is rarely used.
• Challenge: unless all market blocking patent hurdles are cleared in advance of launch, a generic/biosimilar applicant should expect to be off the market and embroiled in litigation for years after its target launch date, as shown in Figure 1. To enable pre-patent expiry market entry, applicants should consider challenging the validity of relevant patents in Federal court proceedings, or in re-examination before the patent office to “clear the way”. Start early to ensure that the relevant proceedings (including any appeals) are completed in advance of the target launch date, but not too early, at risk of clearing the way for competitors in the event that their development is ahead of the applicant’s, or the applicant’s launch slips.
• License: obtain a licence(s) from the originator or third party patentee supporting launch. The patentee is unlikely to sanction a supplier’s launch of a competing product unless there is a significant risk of the supplier entering the market without a licence. Such risk will become apparent to the originator if the infringement or validity positions are shown to be weak. This is best demonstrated in early correspondence, allowing time for a challenge to follow if negotiations fail.
• Market dynamics: where possible, present a case on the market dynamics which disrupts the balance of convenience favouring the patentee in the award of an injunction. This means establishing that the market dynamics are such that damages will be an acceptable remedy so generic/biosimilar launch should not be restrained. This will include biosimilars, authority script medicines, and products that are heavily licensed or genericised.