Scintilla – a flash, a spark, an iota. Shorthand for creativity and an indicator of inventiveness under Australian law.

Friday, September 30, 2016

ACCC launches first action under the revised Franchising Code of Conduct

By Kaelah Ford, Associate

The Australian Competition and Consumer Commission (ACCC) has commenced proceedings in the Federal Court of Australia against a franchisor for an alleged breach of the Franchising Code of Conduct (the Code). This marks the first time the ACCC has sought to exercise its enforcement powers under the Code since significant revisions to the Code took effect on 1 January 2015.

The proceedings were commenced against Morild Pty Ltd (Morild), the franchisor of the 'Pastacup' chain of restaurants in Western Australia, as well as the co-founder of Pastacup, Stuart Bernstein. The ACCC alleges that as franchisor, Morild had a mandatory obligation to disclose to prospective franchisees that Mr Bernstein had previously been a director of two Pastacup franchisors that became insolvent. The ACCC also alleges that Mr Bernstein was knowingly concerned in Morild's conduct. The ACCC is seeking declarations, injunctions, penalties, findings of fact and costs.

The ACCC has stated that ensuring compliance with the Code is an enforcement priority – meaning that understanding your rights and obligations under the Code should be a priority for all franchisors and franchisees. In this post we provide an overview of the disclosure obligations that currently have Pastacup in hot water. For a more detailed look at the entire Code, take a look at our Focus.

Thursday, September 29, 2016

Most of the Sansom review's recommendations have been accepted but is the Government really prepared to dispense the changes Sansom has prescribed?

By Sarah Matheson, Partner, and Ric Morgan, Special Counsel

In March and July 2015, the Expert Panel Review of Medicine and Medical Devices Regulation – which became known as the Sansom Review – reported its findings and recommendations to the Government. The Sansom Review was tasked with undertaking a systematic examination of how Australia regulates the sale of medicines and medical devices in this country. It offered up a raft of recommendations touching on legislative reform, who should have a say in making these decisions and how the process should work.  Now, more than 15 months later, we have the Government's response. So, does this mean we can expect a healthier regulatory scheme for medicines and medical devices?

Don't get your hopes up – it’s not clear that the Government will be taking the medicine Sansom has prescribed. While only two of the 58 recommendations have been rejected, the remaining responses from the Government cover a spectrum from  deferral to support of intent to  in principle support and also acceptance, with the overriding impression being that there will only be incremental change to the Government regulation of medicines and medical devices.

Tuesday, September 27, 2016

Productivity Commission hands Final Report on IP Arrangements to Government

By Lauren John, Associate

The Productivity Commission has met its deadline to provide its Final Report on Australia's Intellectual Property Arrangements to the Australian Government. The Final Report was handed to the Government on 23 September 2016.

The Government is required to table the report in each House of the Parliament within 25 sitting days of receipt. The Final Report will not be publically available until it has been tabled. As there are less than 25 sitting days left in the year in both Houses, we may not see the Final Report until next year.

We will keep you updated on the Productivity Commission's recommendations and what they mean for you, once the Final Report is made public. In the meantime, you can read our report on the recommendations made in the Draft Report released earlier this year, and what happened at the public hearings held before the Productivity Commission in July.

Monday, September 19, 2016

Defining the relationship (again). Are we really exclusive?

By Lauren John, Associate

If you thought your love life was complicated, wait until you try to unravel the meaning of 'exclusive licensee' in the Patents Act, which has again arisen for interpretation, this time by the Full Federal Court in Actavis Pty Ltd v Orion Corporation [2016] FCAFC 121.

It is crucial to have a firm grasp of what is meant by 'exclusive licensee' when commencing infringement proceedings as a failure to establish this relationship can be a 'deal breaker'. Whether or not you are an exclusive licensee is determinative of whether you have standing to commence infringement proceedings under s120(1) of the Patents Act, and, in seeking interlocutory injunctions, will impact the ability of a party to demonstrate that it has suffered damage in relation to balance of convenience arguments, and whether it is necessary to provide a bank guarantee in order to obtain an interlocutory injunction.

Wednesday, September 7, 2016

Biosimilar Interchangeability – The PBAC's consideration of Brenzys (etanercept)

By Sarah Matheson, Partner, and Ric Morgan, Special Counsel

We now know that the PBAC is prepared to have Brenzys, MSD's biosimilar version of etanercept, 'a-flagged' to Pfizer's as Enbrel.

It appears that the PBAC has continued with its unique position and allowed in-pharmacy substitution in the absence of evidence specifically addressing interchangeability.

The PBAC identifies six matters that it considered in deciding to 'a-flag'.  Of these, only two actually address issues beyond the assessment of whether Brenzys is safe and efficacious as a biosimilar product. 

The first of these relates to study of a "one-way switch from Enbrel to Brenzys".  As noted in our previous post,  such switching and interchangeability involve different risks.

The second is to say that:

"The drug, etanercept, is not immunogenic per se, and anti-drug antibodies are rare. Switching between brands of etanercept is unlikely to change this."

Whether this addresses the real concerns about the PBAC's approach is questionable. Because the PBAC does not refer to any studies or evidence on interchangeability, it appears that there are no studies on which it has relied.

It also suggests that the PBAC is conflating switching (on a single occasion) with interchangeability, as allowed by 'a-flagging'.

It seems that the PBAC is relying on prescriber control and patient choice to suggest that by allowing 'a-flagging' they are not really supporting full interchangeability. The PBAC states:

"…the substitution process allows for patient and prescriber choice and is not automatic. For any individual prescription, a prescriber may choose to not permit brand substitution. If substitution has been permitted by the prescriber, the patient may choose which brand they wish to receive from the pharmacist."

Thursday, September 1, 2016

A Poisonous Path for Patents?

By Richard Hamer, Partner, and Suzy Roessel, Senior Associate

A number of patents which would not be at risk in major jurisdictions have recently been invalidated in Australia. These cases involve three grounds of invalidity where Australian law departs significantly from the law of major filing countries - best method, inutility and false suggestion.

Since 2013, patent amendments which disclose new matter are not permitted in Australia, so there is limited opportunity to amend a complete specification to fix these issues in the Australian national phase, particularly in relation to adding best method disclosures.