Following a trend of cases being filed by employers against ex-employees in the Federal Court for breach of confidence and copyright infringement, Justice Jackson in Austin...
Pearce IP joins GBMA: Working with GBMA to enable access to affordable medicines
Pearce IP, an award-winning Australian boutique Intellectual Property firm, specialising in the pharma, biopharma and life sciences industries, has joined Australia’s peak body...
BioBlast w/e 26 May 23
26 MAY 2023 | EU | Celltrion files MAA with EMA for biosimilar to Janssen’s Stelara® (ustekinumab) Korea Biomed has reported that Celltrion filed a marketing authorisation...
Beware the shifting sands of patent term extensions (PTE) in Australia
Recent Australian decisions have resulted in both new opportunities to challenge patent term extensions in Australia and new patent prosecution practices to shield against them....
PiPCast™ | Patent oppositions & litigation – what about estoppel?
PiPCast™ | Patent oppositions & litigation – what about estoppel?
BioBlast w/e 22 May 23
22 MAY 2023 | US | Janssen and Amgen settle Stelara® (ustekinemab) biosimilar patent dispute The US District Court of Delaware has dismissed with prejudice. The parties agreed...
Pearce IP leaders recognised as 2023 MIP Patent Stars
Pearce IP congratulates two of its leaders, Founder and CEO Naomi Pearce, and Special Counsel Jacinta Flattery-O’Brien PhD, who were honoured this week as MIP Patent stars for...
BioBlast w/e 12 May 23
11 MAY 2023| EU | Celltrion to supply Vegzelma® (bevacizumab) in Italy and Belgium Korea Biomed has reported that Celltrion Healthcare has won bids to supply Vegzelma®,...
BioBlast w/e 05 May 23
04 MAY 2023 | CN | Boan Biotech commences phase III clinical trials for Prolia®/Xgeva® (denosumab) biosimilar Luye Pharma announced that it has enrolled its first subject in an...
BioBlast w/e 28 Apr 23
28 April 2023 | US | FDA advisory committee supports approval of Merck’s Lynparza® (olaparib) combination for first line treatment of prostate cancer Merck announced that the...
BioBlast w/e 21 Apr 23
20 April 2023 | CA | New indication alert: Health Canada issues notice of compliance for Regeneron/Sanofi’s Dupixent® (dupilumab) in children > 6 months Sanofi and Regeneron...
BioBlast f/e 14 Apr 23
Significant biosimilar activities this fortnight include: 13 April 2023 | US | Alvotech CRL provided to FDA regarding high concentration buffer free biosimilar adalimumab 12...
Webinar | Pharmaceutical Patent Term Extensions The Good, The Bad and the Ugly
Webinar | Pharmaceutical Patent Term Extensions The Good, The Bad and the Ugly
BioBlast w/e 31 Mar 23: Humira® AU price reduction | EMA recommends Samsung’s EPYSQLI™ eculizumab | US Supreme Court hears Amgen v Sanofi | Eli Lilly $1B mAb manufacture investment in Ireland | Daiichi Enhertu® JP approval | Coya and Dr. Reddy’s ww development agreement … and more!
Significant biosimilar activities this week include:01 April 2023 | AU | Humira® 24.39% PBS price drop 30 March 2023 | EU | EMA CHMP gives nod to Samsung Bioepis’ Epysqli™...
High Court finds no wrinkles in PROTOX and INHIBOX brands
Self Care IP Holdings Pty Ltd & Anor v Allergan Australia Pty Ltd & Anor The High Court recently handed down its decision in Self Care IP Holdings Pty Ltd & Anor v...
BioBlast w/e 24 Mar 23: IPRs re Regeneron aflibercept patents | NMPA approves Xgeva® (denosumab) | FDA approves Hyrimoz® (adalimumab) | and more…
Significant biosimilar activities this week include: 22 March 2023 | US | PTAB institutes Celltrion and Samsung IPRs re Regeneron’s key aflibercept patents 21 March 2023 | CN |...
BioBlast w/e 17 Mar 23: Alvotech ustekinumab | Samsung Bioepis’ ustekinumab | Humira® US Medicare Rebates | Apotex aflibercept IPR | J&J US$25M Remicade® settlement | Lantus® price cut | Samsung Biologics US$1.5B plant … and more
Significant biosimilar activities this week include: 01 March 2023 | CA | Study finds nonmedical switching policy did not negatively impact patients A new study published in...
Nailed It – the Full Federal Court upholds purposive construction of fuel cell claims
A central tenet of patent interpretation under Australian law is that the specification should be a given a purposive construction rather than a purely literal one. While this...
BioBlast w/e 10 Mar 23: MiGenTra African developed Humira biosim | USD$400M Sandoz biosim facility | Celltrion fourth aflibercept IPR | Celltrion Remsima SC® | Coherus Udenyca® US approval | Genentech sues Biogen & Millennium for Cabilly royalties | Jannsen Amgen Stelara® dispute …
Significant biosimilar activities this week include: 09 March 2023 | EU | Sandoz signs MOU for USD$400M biologics facility Novartis announced that Sandoz signed an MOU to build...
International Women’s Day | Eliza Jane Saunders on women in law
March 8 is International Women’s Day, a day where we together recognise the unique challenges women face around the world and seek to advance gender equality and the rights of...
BioBlast w/e 03 March 23: BioBlast w/e 03 March 23: Enzene adalimumab launch | Biocon CRL | Celltrion & GeneMedicine trastuzumab deal | Alvotech 2022 results | Celltrion & Samsung Bioepis seek to join Mylan aflibercept IPR | Pfizer/Samsung Biologics manufacturing agreement | Janssen ustekinemab proceedings against Amgen | Celltrion founder returns | Biogen CA ranibizumab biosimilar approved
Significant biosimilar activities this week include: 28 February 2023 | IN | Enzene Biosciences begins supply of Humira® (adalimumab) biosimilar in India Biospectrum...
BioBlast w/e 24 Feb 23: Abbvie in hot water over Humira® pricing, Celltrion’s Yuflyma® delays explained, Merck/Moderna mRNA vaccine/ Keytruda treatment, French Court overturns Novartis/Roche €444M cartel fine, Amgen’s Amjevita® savings, Genetech new biologics facility, Regeneron new aflibercept product, Amgen’s Bekemv® eculizumab
Significant biosimilar activities this week include: 22 February 2023 | EU | AbbVie sued by Dutch group over Humira® pricing The Financial Times has reported that the Dutch...
Pearce IP welcomes Donna Meredith (Patent & Trade Mark Attorney) and Sian Hope (Lawyer)
Pearce IP proudly welcomed Donna Meredith (Patent & Trade Mark Attorney) and Sian Hope (Lawyer) this month. Both Donna and Sian have incredible pedigree and experience at...
BioBlast w/e 17 Feb 2023: Takeda’s vedolizumab trials, Organon’s financial results, Biora’s PGN-OB1 trials, Fresenius Kabi’s pegfilgrastim, Henlius’ trastuzumab, Coherus/Junshi Biosciences’ toripalimab trials, Similis Bio/Novel 351K biosimilars partnership, Biocon bevacizumab FDA Complete Response Letter
Significant biosimilar activities this week include: 18 Feb 23 | Takeda publishes results of Ph III trials of vedolizumab in preventing intestinal acute graft-versus-host disease...
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