Significant biosimilar activities this week include 12 Feb 20 | Wockhardt announced divestment of assets to Dr Reddy's, under which 62 products and a manufacturing facility will...
Pearce IP BioBlast™: w/e 21 February 2020
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Pearce IP BioBlast™: f/e 07 February 2020
Significant biosimilar activities this fortnight include 05 Feb 20 | Merck announced a new spin-off company which will incorporate products from its Women's Health, Legacy Brands...
Pearce IP BioBlast™: w/e 24 January 2020
Significant biosimilar activities this week include Jan 20 | Genentech and Roche commenced recruitment for Ph III clinical trials of their ranibizumab Port Delivery System (PDS)...
The innovation patent system is nearing its end
The Intellectual Property Laws Amendment (Productivity Commission Response Part 2 and Other Measures) Bill 2019 clears the Senate and heads to the House of Reps What is in the...
New Zealand Introduces Excess Claims Fee in Patent Examination
The Intellectual Property Office of New Zealand (IPONZ) has announced the introduction of excess claims fee, an increase in the examination fee, and increases in...
R’mAb AU: “step down” inj’n saved for another day – short, fixed term, blanket injunction for Sandoz
Today the Federal Court ordered an interlocutory injunction against Sandoz, restraining it from selling biosimilar rituximab (Riximyo) in Australia until 11 August 2019. The 4...
Remicade™ Biosimilars US: Key Remicade™ patent revoked by Fed Cir
J&J suffered another blow today as a key Remicade® (infliximab) patent was revoked by US Court of Appeals (Federal Circuit). Upholding the USPTO decision on reexamination...
Remicade™ Biosimilars US: Pfizer sues J&J for anticompetitive conduct
Biosimilar development is not for the faint hearted. The time and costs involved in R&D, clinical, and regulatory are exorbitant, and the patent barriers to launch are...
First wave of patent reform in AU: consultation period ends 17 Nov 2017
IP Australia is inviting submissions by 17 November 2017 on the first wave of IP reform initiatives arising from the Government's response to the Productivity...
Medicines for Europe Issues 2017 Biosimilar Market Review
Eleven years after the launch of the first biosimilar product in EU, we are now in a position to calibrate our biosimilar market expectations with market experience, rather than...
Case Note: Humira™case confirms no AU PTE for swiss style claims
In a case relating to patents for global blockbuster biologic Humira™ (Adalimumab), the Full Federal Court has drawn a bright line around the limitations of the PTE regime in...
Green light for patent reform in Australia
This afternoon, the Australian Government released its response to the report of the Productivity Commission Inquiry into IP released 20 December 2016. In its 25 page response to...
Amgen v Hospira: BPCIA dance lessons in the Federal Circuit
Just over a week ago, the US Federal Circuit provided BPCIA “dance lessons” for reference product sponsors and biosimilar applicants, as it handed down its decision in Amgen v...
TGA seeks input on biosimilar naming in Australia
The TGA consultation paper can be found here. The TGA paper outlines the biosimilar naming conventions implemented in EU (INN), Japan (BSn), and the planned US 4 letter biologics...
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