20 Dec 21 | US | Sandoz announced that it has submitted a BLA to the FDA for a proposed biosimilar trastuzumab. 20 Dec...
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Naomi Pearce
PTE Alert (part 2): Bad Patent Term Extension Enables Generics to Avoid Preliminary Injunction in Australia
Newly appointed Justice Rofe delivered an early Christmas gift for generic and biosimilar companies in Australia in...
Pearce IP BioBlast® w/e 17 December 2021
11 Dec 21 | Samsung Bioepis announced that SB12 (proposed eculizumab biosimilar) met all the endpoints in a Ph I...
PTE Alert – interlocutory injunction refused in Tecfidera® dispute
In early November Pearce IP reported on a number of Federal Court decisions which appear to indicate flaws in the...
Vague proposals do not an inventor make
In this patent infringement/validity dispute, Hanwha failed to establish that REC infringed its “old Act” Australian patent No 2008323025, and its dependant ACL claims were dismissed.
Pearce IP BioBlast® w/e 10 December 2021
06 Dec 21 | AU | Australia’s TGA provisionally approved Celltrion’s Regkirona® (regdanvimab) for the treatment of...
Full Court finds another computer-implemented scheme unpatentable
Date: 29 January 2021 Court: Federal Court of Australia Judge: McKerracher J Date: 08 December 2021 Court: Full Court...
Vague proposals do not an inventor make
Date: 08 December 2021Court: Full Court of the Federal Court of AustraliaJudges: Nicholas, Yates and O'Bryan JJ...
Pearce IP BioBlast® w/e 03 December 2021
01 Dec 21 | CN | Tot Biopharm announced that China’s NMPA has approved Pusintin® (biosimilar bevacizumab) for the...
Pearce IP BioBlast® w/e 26 November 2021
21 Nov 21 | CN | Innovent released the results of a Ph III study of sintilimab and BYVASDA® (bevacizumab biosimilar)...
Breaking News – Parliament delivers early Christmas present for Health Care
In the last sitting of Parliament for 2021, the House of Representatives delivered the long-awaited Zimmerman Report,...
Disclaimer amendment allowed in mastitis patent
Date: 25 November 2021Court: Federal Court of AustraliaJudge: Besanko J Background This appeal from a decision of the...
Pearce IP BioBlast®: w/e 19 November 2021
15 Nov 21 | EU | Celltrion announced that the EC has approved Regkirona® (regdanvimab, CT-P59) for adults with...
No jackpot for Aristocrat as Full Court finds electronic gaming machine claim unpatentable
Date: 19 November 2021Court: Full Court of the Federal Court of AustraliaJudges: Middleton, Perram and Nicholas JJ...
Pfizer quest for Samsung Bioepsis etanercept documents continues
Date: 18 November 2021Court: Federal Court of AustraliaJudge: Burley J Background In December 2016 Pfizer Ireland...
Hold onto your Hats! – Expedited Patent Litigation in Australia
The speed of getting a case to trial is a key metric of any litigation system. Pharmaceutical patent litigation often...