24 March 2021 | EirGenix announced that its Ph III clinical trial of EG12014 (proposed trastuzumab biosimilar) has met its primary endpoint. EirGenix announced that EG12014 has...
Pearce IP BioBlast®: w/e 26 March 2021
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When exclusive licensees have no rights to sue or recover damages during patent term extensions
A primer on the questions to be answered by the High Court in the Lundbeck Appeal
In February 2021, H. Lundbeck A/S (Lundbeck) was granted special leave by the High Court to appeal the 2020 Full Court decision[1] involving the long running litigation in...
The COVID-19 pandemic prioritises an Australian medical products’ manufacturing road map
Background In October 2020, the Australian Government announced a $1.5 billion investment in a Modern Manufacturing Strategy (MMS) to help Australian manufacturers become more...
Pearce IP BioBlast®: w/e 19 March 2021
15 March 2021 | Alvotech announced it has completed a second round of its US$100 million private placement. In the first round, Alvotech raised US$65 million, including...
Federal Court expedites another pharma patent trial
Juno Pharmaceuticals Pty Ltd v Celgene Corporation [2021] FCA 236
Date: 19 March 2021 Court: Federal Court of Australia Judge: Beach J Background Celgene Corporation (Celgene) markets lenalidomide for a number of blood cancers including...
Pearce IP BioBlast®: w/e 12 March 2021
04 Mar 21 | US | The US Senate unanimously passed the Ensuring Innovation Act and the Advancing Education on Biosimilars Act. The Ensuring Innovation Act aims to stop...
True inventor of a patent successfully opposes the patentee’s attempt to surrender it
Michael John Arieni v Sun-Wizard Holding Pty Ltd [2021] APO 20
Date: 11 May 2021 Forum: Australian Patent Office Delegate: Ranganath Subbarayan Background Mr Arieni was a former colleague of one of the named inventors (Mr Fry) of Innovation...
Pearce IP BioBlast®: w/e 05 March 2021
01 Mar 2021 | EU | Biocon and Viatris announced that the CHMP has adopted a positive opinion recommending the marking authorisation of Abevmy® (biosimilar bevacizumab). If...
Pearce IP BioBlast®: w/e 26 February 2021
23 Feb 2021 | In its Q4 2020 investor presentation, Fresenius Kabi announced it will launch its biosimilar adalimumab in Australia in Q2 2021 and in Brazil in Q3 2021....
Pearce IP BioBlast®: w/e 19 February 2021
13 Feb 2021 | Saudi Arabia's Tabuk Pharmaceuticals announced it has reached an exclusive licensing and distribution agreement with Korea's Prestige Biopharma for the...
Amazon invention a mere business solution and not patentable
Amazon Technologies, Inc. [2021] APO 7
Date: 16 February 2021Forum: Australian Patent OfficeDelegate: Kevin Restrick Background Under Australian law, business methods are not patent eligible because they are not...
How medicine repurposing could unravel the pharma industry in Australia
TGA seeks consultation on issues relating to the registration of off-label medicines: Part 2
As discussed in Part 1 of this blog series, TGA has invited submissions by 23 March 2021 on its consultation paper released last Thursday designed to facilitate indication...
Pearce IP features its Women in Science
In honour of UN International Day of Women and Girls in Science Last Thursday was the International Day of Women and Girls in Science, marking 6 years since the United Nations...
Pearce IP BioBlast®: w/e 12 February 2021
04 Feb 2021 | Roche reported a huge erosion of its year on year CER growth in key areas, attributing this decline to COVID-19 impacts and biosimilars. Roche reported the YoY CER...
Exclusive licensees: are you stuck in a “No Standing” zone?
Under Australian law, patent infringement proceedings may be started in the Australian Federal Court only by a patentee or an exclusive licensee.[1] When it comes to determining...
TGA seeks consultation on issues relating to the registration of off-label use of medicines: Part 1
TGA has invited submissions on its consultation paper released last Thursday designed to facilitate indication "repurposing", a phrase coined by TGA to describe the Australian...
Pearce IP BioBlast®: w/e 05 February 2021
29 Jan 21 | EU | The CHMP recommended 13 medicines for approval. Among the recommendations were two bevacizumab biosimilars, Mabxience's Alymsys® and STADA's Oyavas®. 01 Feb 21 |...
Pearce IP BioBlast®: w/e 29 January 2021
25 Jan 21 | Samsung Bioepis announced the opening of its new headquarters in Incheon. The building was complete in December 2020, and will house approximately 1000 new employees,...
Pearce IP BioBlast®: w/e 22 January 2021
18 Jan 21 | Prestige Biopharma announced it is set for an IPO in early February 2021. The IPO is expected to be worth US $348 million, with the majority of the funds to be...
Pearce IP BioBlast™: w/e 15 January 2021
07 Jan 21 | ADQ announced it will acquire Pharmax Pharmaceuticals, as well as investing in a minority stake in Biocon Biologics. 13 Jan 21 | Kamada announced it has entered into...
Clinical trial information can invalidate an Australian patent
On 5 November 2020, the High Court of Australia refused a special leave application by Mylan Health Pty Ltd to appeal the decision of the Full Federal Court (FFC) in which three...
Pearce IP BioBlast™: w/e 08 January 2021
05 Jan 21 | EU | The Centre for Biosimilars reported a study presented at the 2020 San Antonio Breast Cancer Symposium found strong uptake of Amgen's Kanjinti (biosimilar...
Pearce IP BioBlast™: w/e 01 January 2021
27 Dec 20 | CN | Innovent announced China's NMPA has approved Byvasda® (biosimilar bevacizumab) for the additional indication of adult recurrent glioblastoma. 30 Dec 20 |...
Pearce IP BioBlast™: w/e 25 December 2020
21 Dec 20 | Celltrion announced Ph III trials of its proposed ustekinumab biosimilar CT-P43 will be completed by the second half of 2022. Celltrion also announced plans to launch...
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