Luye Pharma announced its marketing authorisation application for LY01008 (proposed bevacizumab biosimilar) has been accepted by China’s National Medical Products Administration.
Huons Lab and PanGen Biotech to develop biosimilar denosumab
Huons Lab announced it has reached an agreement with PanGen Biotech for the development of biosimilar denosumab. Under the agreement, Huons Lab will gain access to PanGen Biotech’s cell line manufacturing and purification technology.
Pearce IP BioBlast®: w/e 16 April 2021
13 April 2021 | Purple Biotech announced it presented further preclinical data supporting the mechanism of action of NT219 at the American Association of Cancer Research 2021 Annual Meeting. NT219 is being developed as a treatment for recurrent and/or metastatic solid tumors and squamous cell carcinoma of the head and neck cancer.
13 April 2021 | NKMax and Merck KGaA announced an expansion of its clinical trial and supply agreement to include a Ph I/IIa trial of SNK01 in combination with Erbitux® (cetuximab) in patients with locally advanced or metastatic non-small cell lung cancer.
14 April 2021 | US | Two bills aimed at lowering the cost of prescriptions were passed by the House of Representatives. As we previously reported, the Advancing Education on Biosimilars Act and Ensuring Innovation Act were introduced to the Senate in March 2021.
15 April 2021 | CN | Shanghai Henlius Biotech announced China’s NMPA has approved its investigational new drug (IND) application of its HLX26 (recombinant anti-LAG-3 human monoclonal antibody) for treatment of solid tumors and lymphomas. Currently, there are no LAG-3 targeted products on the market.
15 April 2021 | RU | Prestige Biopharma and Pharmapark announced they have reached an agreement for the commercialisation of Prestige Biopharma’s proposed bevacizumab biosimilar in the Russian Federation.
Prestige Biopharma and Pharmapark reach biosimilar bevacizumab deal
Prestige Biopharma and Pharmapark announced they have reached an agreement for the commercialisation of Prestige Biopharma’s proposed bevacizumab biosimilar in the Russian Federation.
NMPA approves Henlius’ IND application for HLX26
Shanghai Henlius Biotech announced China’s NMPA has approved its investigational new drug (IND) application of its HLX26 (recombinant anti-LAG-3 human monoclonal antibody) for treatment of solid tumors and lymphomas. Currently, there are no LAG-3 targeted products on the market.
New York state benefits from biosimilar preference initiative
The Centre for Biosimilars reported a poster presented at AMCP 2021 shows a New York state Medicaid biosimilar preference initiative was successful in increasing biosimilar use in 2019. Biosimilar substitution is not permitted at the pharmacy level in New York, and provider prescriptions are required. The switching program was supported by months of biosimilar promotion and education among plan beneficiaries who were receiving originator biologics.
House of Representatives passes new biosimilar legislation
Two bills aimed at lowering the cost of prescriptions were passed by the House of Representatives. As we previously reported, the Advancing Education on Biosimilars Act and Ensuring Innovation Act were introduced to the Senate in March 2021.
NKMax and Merck KGaA expand clinical trial and supply agreement
NKMax and Merck KGaA announced an expansion of its clinical trial and supply agreement to include a Ph I/IIa trial of SNK01 in combination with Erbitux® (cetuximab) in patients with locally advanced or metastatic non-small cell lung cancer.
Purple Biotech presents further preclinical data for NT219
Purple Biotech announced it presented further preclinical data supporting the mechanism of action of NT219 at the American Association of Cancer Research 2021 Annual Meeting. NT219 is being developed as a treatment for recurrent and/or metastatic solid tumors and squamous cell carcinoma of the head and neck cancer.
Pearce IP BioBlast®: w/e 09 April 2021
06 April 2021 | PlantForm announced it has reached a collaborative research and development agreement with Bio-Manguinhos/Fiocruz to develop a biosimilar pembrolizumab for the Brazilian market.
06 April 2021 | US | The FDA approved a new dosage regimen for Erbitux® (cetuximab) for patients with K-RAS wild-type, EGFR-expressing metastatic colorectal cancer or squamous cell carcinoma of the head and neck. The new dosage regimen allows for fortnightly dosing.
07 April 2021 | CA | British Columbia expanded its biosimilars switching program to include adalimumab, and expanded coverage of etanercept. BC announced that almost 6,000 patients currently treated with Humira® will be switched to either Amgevita® (Amgen), Hadlima® (Merck/Samsung), Hulio® (Mylan), Hyrimoz® (Sandoz) or Idacio® (Fresenius Kabi) over a 6 month period. New and existing plaque psoriasis patients currently being treated by Enbrel® will also be transitioned to Brenzys® (Samsung Bioepis/Merck) or Erelzi® (Sandoz) over the same period.
07 April 2021 | Biogen announced the EC has granted marketing authorisation for Tysabri® (natalizumab) in a subcutaneous presentation. Tysabri® SC is approved for the treatment of relapsing-remitting multiple sclerosis.
08 April 2021 | Biogen announced it has reached an agreement with Bio-Thera for the development, manufacture and commercialisation of BAT1806 (proposed tocilizumab biosimilar). Under the agreement, Biogen will gain exclusive rights to BAT1806 in all countries excluding China.
08 April 2021 | Alteogen announced it has completed Ph I trials of its proposed aflibercept biosimilar ALT-L9. Alteogen reported that the trial confirmed the safety and efficacy of ALT-L9 were similar to that of Eylea®.
Alteogen completes Ph I trials of proposed aflibercept biosimilar
Alteogen announced it has completed Ph I trials of its proposed aflibercept biosimilar ALT-L9. Alteogen reported that the trial confirmed the safety and efficacy of ALT-L9 were similar to that of Eylea®.
Biogen reaches agreement with Bio-Thera for tocilizumab biosimilar
Biogen announced it has reached an agreement with Bio-Thera for the development, manufacture and commercialisation of BAT1806 (proposed tocilizumab biosimilar). Under the agreement, Biogen will gain exclusive rights to BAT1806 in all countries excluding China.
EU grants marketing authorisation for Tysabri® SC (natalizumab)
Biogen announced the EC has granted marketing authorisation for Tysabri® (natalizumab) in a subcutaneous presentation. Tysabri® SC is approved for the treatment of relapsing-remitting multiple sclerosis.
BC expands its biosimilars switching program
British Columbia expanded its biosimilars switching program to include adalimumab, and expanded coverage of etanercept. BC announced that almost 6,000 patients currently treated with Humira® will be switched to either Amgevita® (Amgen), Hadlima® (Merck/Samsung), Hulio® (Mylan), Hyrimoz® (Sandoz) or Idacio® (Fresenius Kabi) over a 6 month period. New and existing plaque psoriasis patients currently being treated by Enbrel® will also be transitioned to Brenzys® (Samsung Bioepis/Merck) or Erelzi® (Sandoz) over the same period.
Pearce IP BioBlast®: w/e 02 April 2021
29 March 2021 | Samsung Bioepis announced on 29 March 2021 that it has launched Hadlima®, its 50mg/mL biosimilar adalimumab in Australia and Canada. Australia’s PBAC previously confirmed that Hadlima® would be PBS listed from 01 April 2021.
30 March 2021 | STADA launched Oyavas® (biosimilar bevacizumab) in the Netherlands and Germany. Oyavas® is indicated for carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.
31 March 2021 | Celltrion received a positive CHMP opinion for Remsima® subcut (subcutaneous infliximab). Remsima® SC was recommended for the direct use without IV loading in patients with rheumatoid arthritis.
31 March 2021 | A new AbbVie study published in the NEJM reports a 30mg dose of upadacitinib is superior to adalimumab in DMARD-refractory psoriatic arthritis (PsA). The percentage of patients with PsA who achieved an ACR20 response at week 12 was 78.5% of patients treated with 30 mg upadacitinib, compared to 65% of patients treated with adalimumab.
FDA approves new dosage regimen for Erbitux® (cetuximab)
The FDA approved a new dosage regimen for Erbitux® (cetuximab) for patients with K-RAS wild-type, EGFR-expressing metastatic colorectal cancer or squamous cell carcinoma of the head and neck. The new dosage regimen allows for fortnightly dosing.
PlantForm announces deal with Bio-Manguinhos/Fiocruz
PlantForm announced it has reached a collaborative research and development agreement with Bio-Manguinhos/Fiocruz to develop a biosimilar pembrolizumab for the Brazilian market.
New AbbVie study reports upadacitinib is superior to adalimumab
A new AbbVie study published in the NEJM reports a 30mg dose of upadacitinib is superior to adalimumab in DMARD-refractory psoriatic arthritis (PsA). The percentage of patients with PsA who achieved an ACR20 response at week 12 was 78.5% of patients treated with 30 mg upadacitinib, compared to 65% of patients treated with adalimumab.
Celltrion received a positive CHMP opinion for Remsima® subcut (subcutaneous infliximab)
Celltrion received a positive CHMP opinion for Remsima® subcut (subcutaneous infliximab). Remsima® SC was recommended for the direct use without IV loading in patients with rheumatoid arthritis.
STADA launches Oyavas® (biosimilar bevacizumab) in the Netherlands and Germany
STADA launched Oyavas® (biosimilar bevacizumab) in the Netherlands and Germany. Oyavas® is indicated for carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.
Samsung Bioepis launches Hadlima® (biosimilar adalimumab) in Australia and Canada
Samsung Bioepis announced on 29 March 2021 that it has launched Hadlima®, its 50mg/mL biosimilar adalimumab in Australia and Canada. Australia’s PBAC previously confirmed that Hadlima® would be PBS listed from 01 April 2021.
Pearce IP BioBlast®: w/e 26 March 2021
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 shown equivalent efficacy to Herceptin®, and demonstrated a comparable safety profile.
25 March 2021 | Alvotech has disputed AbbVie’s claim filed in the Northern District of Illinois last week relating to AbbVie’s allegations of wrongdoing in the development of Alvotech’s biosimilar adalimumab product. Alvotech notes “AbbVie waited over three years from the purported date of the alleged wrongdoing to file its case, doing so after the ex-AbbVie employee had already left Alvotech and without naming the ex-AbbVie employee as a defendant”, suggesting that these latest accusations may be part of AbbVie’s broader strategy to delay biosimilar competition.
25 March 2021 | mAbxience announced it will install an ABEC 4,000L CSR bioreactor at its site in Leon, Spain. The system is expected to be installed within months, and will boost mAbxience’s biosimilar and CDMO manufacturing capacity.
25 March 2021 | JP | Korea Biomedical Review reported that LG Chem has received approval from Japan’s Health Ministry for its biosimilar adalimumab. The product will be commercialised by Mochida Pharmaceuticals.
26 March 2021 | AU | A number of changes have been made to the PBS listings of adalimumab in Australia. From 1 April:
- The Amgen, Merck/Samsung, Sandoz and Fresenius 50mg/ml products will be PBS listed and A flagged against the 50mg/ml Humira formulations for all approved indications; and
- Humira 100mg/ml 20mg and 40mg products will be listed and A flagged against the 50mg/ml Humira formulations, and the 50mg/ml Humira product will be phased out over 12 months but cannot be prescribed after 1 April (ie the pharmacies will honour scripts written prior to 1 April).
- Humira 100mg/ml 80mg syringe and pen products will be PBS listed but will not be A flagged as they are not considered equivalent to the “original” Humira formulation/product.
Alvotech denies AbbVie’s claims of trade secret piracy
Alvotech has disputed AbbVie’s claim filed in the Northern District of Illinois last week relating to AbbVie’s allegations of wrongdoing in the development of Alvotech’s biosimilar adalimumab product. Alvotech notes “AbbVie waited over three years from the purported date of the alleged wrongdoing to file its case, doing so after the ex-AbbVie employee had already left Alvotech and without naming the ex-AbbVie employee as a defendant”, suggesting that these latest accusations may be part of AbbVie’s broader strategy to delay biosimilar competition.
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 relation to the blockbuster antidepressant medication, Lexapro®[2] (Lundbeck decision). In that appeal, the High Court will consider whether Lundbeck Australia (LA), the exclusive licensee in Australia of AU 623144, (the Patent), has standing to sue under Section 79 of the Patents Act 1990 (the Act) in relation to acts of infringement during the extended term of the Patent.
Exclusive licensee’s rights in relation to unextended patents
In Australia, only a patentee or exclusive licensee has standing to sue for infringement (see our recent article here)[3] giving rise to significant implications for patent enforcement where the licence is not exclusive.
The Lundbeck decision did not disrupt the prevailing case law in relation to the standing of the exclusive licensee to sue during the original patent term, but provides useful insight into the nature of an exclusive licence. Part 2 of this two-part blog to be published next week will discuss in depth the nature of exclusive patent licences.
Exclusive licensee’s rights in relation to extended patents
It is most common for patent term extensions to be granted during the original term of a standard patent, that is, before the expiry of the original 20-year term (pre-expiry extension). Where there is a pre-expiry extension, an exclusive licensee may start proceedings for acts of infringement committed at any time during the standard term of the patent and during the extended term of the patent.[4]
In the case of post-expiry extensions, section 79 of the Act provides that once the extension of term is granted, “the patentee … has the same rights to start proceedings” in respect of acts occurring after the expiration of the original term of the patent. In the Lundbeck decision, the Full Court considered the effect of s79 of the Act on the standing of an exclusive licensee for the first time. The Full Court held that, based on the plain language of s79, an exclusive licensee does not have the right to start proceedings because s79 only refers to the patentee’s right to start proceedings.
Patent term extensions granted after the expiry of the original term (post-expiry extension) are rare. Lundbeck’s fact scenario was extremely unusual in that the patent term extension was granted after the ultimate expiry of the extended term of the Patent, and – importantly – after the time in which all infringing acts took place.
If there is a local exclusive licensee and an offshore patentee that does not trade in Australia, the fact that the local exclusive licensee has no standing to sue in a post-expiry extension scenario will present a problem with recovering damages for infringement. This is because the offshore patentee may not suffer any significant (direct) damage as a consequence of the infringement.
Although post expiry extensions are rare, the approach of the Full Court to s79 of the Act is significant, and where a late application for extension of term undergoes opposition, the grant of the extension may well occur after the expiry of the original term of the patent. The Lundbeck decision undercuts the commercial reason for extending a patent term, which is to extend the time in which damages can be recovered for any infringement. Industry will be keenly watching the direction of the High Court on these issus.
In the meantime, the important message for patent licensees taking part in infringement proceedings are:
- Patent licences must be exclusive in order for the licensee to have standing to sue, and the ability to recover damages (particularly important for local sponsors of patented products where the patentee is offshore and does not trade locally);
- To be exclusive, a licence must be granted directly by the patentee and should include all rights to exploit the patented invention;
- Any rights that the patentee wishes to reserve should be licensed back from the exclusive licensee, preferably in a separate, subsequent agreement;
- Once executed, an exclusive licence should be recorded on the Register of Patents, at least prior to commencing any action;
- Patents for products which receive regulatory approval late in the standard patent term run the risk that a request for extension of term will be granted post expiry, and patentees and exclusive licensees should be aware that damages recovery in that case may be problematic.
Pearce IP has extensive expertise in managing patent litigation involving local exclusive licensees and offshore patentees, and a strong track record in advising clients in relation to strategies for extension of patent term. If you would like to discuss your patent strategies, please contact us.
[1] Sandoz Pty Ltd v H Lundbeck A/S [2020] FCAFC 133
[2] H. Lundbeck A-S & Anor v Sandoz Pty Ltd; CNS Pharma Pty Ltd v Sandoz Pty Ltd [2021] HCATrans 13 (11 February 2021)
[3] Ibid, s 120(1)
[4] Section 78, which deals with infringement during the extended term of patents having a pre expiry extension, refers to “the exclusive rights of the patentee” with no indication that these rights cannot be assigned. Section 78 also limits what constitutes infringement during the extended term.
Naomi Pearce
CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)
Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.
Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.
Product specific reports based on extracts from our BioBlast® database
aflibercept | Eylea® | Regeneron
bevacizumab | Avastin® | Roche/Genentech
cetuximab | Erbitux® | BMS/Merck
darbepoetin | Aranesp® | Amgen
denosumab | Prolia®/Xgeva® | Amgen
dupilumab | Dupixent® | Sanofi-Aventis
eculizumab | Soliris® | Alexion
filgrastim (GCSF) | Neupogen® | Amgen
golimumab | Simponi® | Janssen
guselkumab | Tremfya® | Janssen
infliximab | Remicade® | Johnson & Johnson
ixekizumab | Taltz® | Eli Lilly
natalizumab | Tysabri® | Biogen/Elan
omalizumab | Xolair® | Genentech / Novartis
pegfilgrastim | Neulasta® | Amgen
pembrolizumab | Keytruda® | Merck
ranibizumab | Lucentis® | Genentech
regdanvimab | Regkirona® | Celltrion
risankizumab | Skyrizi® | AbbVie
rituximab | Rituxan®/MabThera® | Genentech/Biogen
secukinumab | Cosentyx® | Novartis
tocilizumab | Actemra® | Roche
trastuzumab | Herceptin® | Roche/Genentech
BioBlast® Editor and Contributing Author
Naomi Pearce, Chantal Savage & Faran Shahzad
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