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

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.

Tuesday, August 30, 2016

Access denied: counterfeiters not welcome online

By Emma Gorrie, Lawyer

Legislation in the UK and Australia expressly provides for injunctions against ISPs in the context of copyright infringement, but not for trade mark infringement. A recent UK Court of Appeal decision, Cartier International AG v British Sky Broadcasting Ltd [2016] EWCA Civ 658, confirmed that there is a power to grant injunctions against ISPs to defeat trade mark infringement.

Friday, August 26, 2016

To be human, or not to be human: that is the [patentability] question

By Claire Gregg, Patent Attorney, and Dr Trevor Davies, Partner 

Advances in biological manipulation of cells and stem cell technology continue to test the law on what can be patented.

A recent decision of the Australian Patent Office makes clear that an invention that includes a step on the pathway to the production of a potential human being, even if the end result is not a human being, is not patentable. Claims to the use of cellular structures that may mimic the embryonic process but cannot result in a human being are patentable.


'Human beings, and the biological processes for their generation' is one of the few legislated exclusions from patentability under Australian law. In one of only a handful of decisions of its kind, the Patent Office recently considered the scope of this exclusion in International Stem Cell Corporation [2016] APO 52

Wednesday, August 24, 2016

Same, same but different – design infringement

By Anna Conigrave, Law Graduate.

Good news for designers

A recent Federal Court decision, in Hunter Pacific International Pty Ltd v Martec Pty Ltd, has provided good news for registered design owners, in that liability for design infringement is not avoided by tweaking a registered design to create minor differences.

Hubs at ten paces

Hunter Pacific International Pty Ltd owns registered design No. 340171 for a ceiling fan hub. Martec Pty Ltd imports and sells a ceiling fan known as the 'Martec Razor' . 

Hunter alleged that Martec infringed the Registered Design on the basis that the Razor is a product that is substantially similar in overall impression to the Registered Design.

Appendix 3 of judgment: Registered Design (left) and photograph of Razor (right)

Friday, August 19, 2016

Fee Changes at IP Australia – what action should you take?

By Claire Gregg, Patent Attorney, and Lena Balakrishnan, Associate 

IP Australia has announced changes to its fee structure for patents, trade marks, designs and plant breeder's rights, which are due to commence on 10 October 2016. While certain fees are set to increase, the news isn't all bad, with some significant savings on the horizon.

The key changes include:
  • A significant reduction of $1,250 in International Type Search fees for Patents;
  • An increase in renewal fees for both Patents and Trade Marks;
  • An increase in filing fees for Trade Marks;
  • Removal of the registration fees for Trade Marks filed after 10 October 2016; and
  • Removal of certain opposition fees for Patents, Designs and Trade Marks.
In light of the impending fee changes, we suggest you consider taking the following steps:
  • Paying patent renewal fees (10th anniversary onwards) before 10 October 2016 (saving between $50 and $250 per year)
  • Paying any trade mark renewal fees due in the next 12 months before 10 October 2016 (saving $100 per class per renewal)
  • Filing trade mark applications after 10 October 2016 in order to avoid having to pay any registration fees at a later stage (saving $300 per class).