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






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.

Background


'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

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."

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).

Wednesday, August 17, 2016

Interchangeability – should science or economics prevail?

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

We are about to find out a little more about Australia's unique stance on interchangeability for biosimilars.  Later this week, the PBAC's consideration of Brenzys, MSD's biosimilar version of etanercept, currently marketed only by Pfizer as Enbrel will be made public, including whether it will be 'a-flagged'.

In our recently released discussion paper, Biologic medicines and biosimilars in the Australian landscape we raise this important issue and we have explored this further in a more detailed white paper Costs before Caution—Australia's unique approach to the interchangeability of biosimilars developed in support of our discussion paper.

Thursday, August 11, 2016

Unjustified threat, genuine step, or misleading or deceptive conduct: where is the line?

By Lauren John, Associate

A patentee should be alert to the dangers of firing off a communication which threatens a person with patent infringement proceedings – as the saying goes, it may come back to bite you. Where a person makes unjustified threats of infringement proceedings, the Patents Act 1990 (Cth) allows action to be taken against the person. We consider two recent Federal Court cases which shed light on the sorts of communications that are likely to land a patentee in trouble.

The cases, CQMS Pty Ltd v Bradken Resources Pty Limited [2016] FCA 847 (Case 1) and NSL Engineering Pte Ltd v Australian Mobile Mining Equipment Systems and Accessories Pty Limited [2016] FCA 614 (Case 2), give guidance as to what constitutes an unjustified threat. Case 1 considers the impact of the Civil Dispute Resolution Act 2011 (Cth) (CDRA), and in particular the obligation imposed on an applicant in civil proceedings to file a genuine steps statement, on the application of the unjustified threats provision. Case 2 serves as a warning that the allegedly threatening communication may also be found to constitute misleading or deceptive conduct in contravention of the Australian Consumer Law (ACL).

Monday, August 8, 2016

Productivity Commission's Report extension might push IP inquiry out to 2017

By Suzy Roessel, Senior Associate

September 2016 is the new deadline for the Productivity Commission to provide its Inquiry Report on IP Arrangements to the Australian Government. The deadline for the inquiry report was previously August 2016.

The Commission has revised the date, stating that the inquiry timetable was "impacted by the caretaker period associated with the federal election which precluded full engagement with government department and agencies".