Originally published in World Intellectual Property Review 3 2021 After surviving the Great Patent Cliff of 2011–2016,...
Strategies for generic/biosimilar market entry in Australia
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Naomi Pearce
Naomi is listed in IAM Patent 1000 as one of Australia's leading patent litigators. Underpinning Naomi’s legal work is a deep understanding of the pharma/biopharma industries, resulting from first hand experience and knowledge as VP of IP in-house at global pharma giants, and Partner of a top-tier international law firm.
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Pearce IP BioBlast®: w/e 15 October 2021
05 Oct 21 | EU | Celltrion announced that it has submitted a Marketing Authorisation Application to the EMA seeking...
Pearce IP BioBlast®: w/e 08 October 2021
27 Sep 21 | CA | Apobiologix announced that Health Canada has approved Bambevi® (biosimilar bevacizumab) in...
Pearce IP BioBlast®: w/e 01 October 2021
27 Sep 21 | Hikma Pharmaceuticals announced that it will acquire Custopharm for an initial cash consideration of USD...
Pearce IP BioBlast®: w/e 24 September 2021
18 Sep 21 | Merck announced that the first results from Ph III trials of Keytruda® (pembrolizumab) showed a...
New .au domain names coming to Australia
New .au domain names will be available in Australia from 24 March 2022. From this date, individuals, businesses and...
Pearce IP BioBlast®: w/e 17 September 2021
13 Sep 21 | Samsung Bioepis reported on a five-year follow-up study comparing ONTRUZANT® (trastuzumab biosimilar) with...
Pearce IP BioBlast®: w/e 10 September 2021
02 Sep 21 | US | Amgen and Hospira appear ready to settle the ongoing dispute relating to Neupogen® (filgrastim). The...
Federal Court Confirms Higher Bar for Sufficiency and Support in Australian Patent Law
Nalco Patent Application Claiming Inhibitors of Silica Deposits Invalid: a Question of Scale
A recent decision of Justice Burley in the Federal Court of Australia confirms that the bar for sufficiency and...
Pearce IP BioBlast®: w/e 03 September 2021
26 Aug 21 | US | Two former executives of JHL Biotech plead guilty to conspiracy to steal trade secrets and commit...
Pearce IP BioBlast®: w/e 27 August 2021
24 Aug 21 | UCB announced that it has gained EU marketing approval for Bimzelx® (bimekizumab), an IL-17A and IL-17F...
Pearce IP BioBlast®: w/e 20 August 2021
17 Aug 21 | US | The USPTO Patent Trial and Appeal Board (PTAB) will review Amgen’s US 8,273,707 Patent (related to...
Pearce IP BioBlast®: w/e 13 August 2021
05 Aug 21 | A new study reported that the safety profiles and pharmacokinetic parameters of Amgen’s ABP980 (biosimilar...
Pearce IP BioBlast®: w/e 06 August 2021
29 Jul 21 | US | The American Academy of Ophthalmology pushed back against insurance company pressure to use new...
Pearce IP BioBlast®: w/e 30 July 2021
27 Jul 21 | Abenza and BioXpress Therapeutics announced they have formed a new partnership to support biosimilar...
Pearce IP BioBlast®: w/e 23 July 2021
19 Jul 21 | Shanghai Henlius Biotech announced that the first patient has been dosed in its Ph I clinical trial of...