The University of Oxford announces it has commenced Ph II trials of adalimumab as a treatment for patients with COVID-19. The trial will enrol up to 750 patients from community care settings throughout the UK and is funded by the COVID-19 Therapeutics Accelerator, an initiative set up by Wellcome and Mastercard. The trial will assess Hyrimoz® (biosimilar adalimumab), developed by Sandoz.
Centus Biotherapeutics announces it has received EC marketing authorisation for Equidacent® (biosimilar bevacizumab). Equidacent® has been exclusively licensed to Fujifilm Kyowa Kirin Biologics on a worldwide basis.
The Alliance of Community Health Plans (ACHP) released a new report ‘Health Care 2030: ACHP’s Roadmap to Reform’ which calls for nonpartisan and practical changes to the American healthcare system. Among these proposed changes, ACHP has called for reforms to IP laws which are used to block the launch of biosimilar drugs, the promotion of FDA approval and clinical adoption of more biosimilars.
Significant biosimilar activities this week include
21 Sep 20 | EU | Alexion announced it has received a positive opinion from the EU’s CHMP for a new 100mg/mL formulation of Ultomiris® (ravulizumab). The new formulation requires an infusion time of 0.4 hours to 1.3 hours depending on body weight, which is less than half of the required infusion time for the current 10mg/mL formulation.
22 Sep 20 | Alvotech announced an expansion of its strategic partnership with DKSH to commercialise six new biosimilar product candidates for Asian markets, including Taiwan, Korea, Hong Kong, Philippines, Vietnam, Thailand, Cambodia, Myanmar, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan. These biosimilar candidates’ brand values are estimated around US$1.5 billion in annual sales in the Asia Pacific region, according to IQVIA data.. The biosimilar candidates will address multiple therapeutic areas and represent an estimated (combined) US$1.5 billion in annual sales in the Asia Pacific region.
24 Sep 20 | Accord Healthcare launched Zercepac® (biosimilar trastuzumab) in the UK. Zercepac® is indicated for HER2-positive early breast cancer, HER2-positive metastatic breast cancer and previously untreated HER2-positive metastatic gastric cancer and is available in a 150mg single-dose vial.
24 Sep 20 | The International Generic and Biosimilar Medicines Association (IGBA) released a new policy paper which calls for the streamlining of biosimilar regulatory requirements, and renewed efforts in informing and educating healthcare community stakeholders.
25 Sep 20 | JP | Alexion announced it has received approval in Japan for an additional indication of Ultomiris® (ravulizumab). Ultomiris® is now also indicated for atypical hemolytic uremic syndrome in adults and children.
Innovent announces its ph III trial of Byvasda® (proposed bevacizumab biosimilar) in combination with Tyvyt® (sintilimab) met its primary endpoints of progression-free survival and overall survival. Innovent reported that the safety profile of both products was consistent with previously reported studies, and no new safety signals were identified.
Accord Healthcare launches Zercepac® (biosimilar trastuzumab) in the UK. Zercepac® is indicated for HER2-positive early breast cancer, HER2-positive metastatic breast cancer and previously untreated HER2-positive metastatic gastric cancer and is available in a 150mg single-dose vial.
The International Generic and Biosimilar Medicines Association (IGBA) released a new policy paper which calls for the streamlining of biosimilar regulatory requirements, and renewed efforts in informing and educating healthcare community stakeholders.
The Australian Government announced it has joined the COVAX facility, committing an initial $123.2 million for the ability to purchase vaccines when they become available. The COVAX facility is a collaboration between Gavi, the Coalition for Epidemic Preparedness Innovations, the WHO and other organisations and aims to ensure equitable access to COVID-19 vaccines.
Alvotech announces an expansion of its strategic partnership with DKSH to commercialise six new biosimilar product candidates for Asian markets, including Taiwan, Korea, Hong Kong, Philippines, Vietnam, Thailand, Cambodia, Myanmar, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan. These biosimilar candidates’ brand values are estimated around US$1.5 billion in annual sales in the Asia Pacific region, according to IQVIA data.. The biosimilar candidates will address multiple therapeutic areas and represent an estimated (combined) US$1.5 billion in annual sales in the Asia Pacific region.
Alvotech announced an expansion of its strategic partnership with DKSH to commercialise six new biosimilar product candidates for Asian markets, including Taiwan, Korea, Hong Kong, Philippines, Vietnam, Thailand, Cambodia, Myanmar, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan. These biosimilar candidates’ brand values are estimated around US$1.5 billion in annual sales in the Asia Pacific region, according to IQVIA data. The biosimilar candidates will address multiple therapeutic areas and represent an estimated (combined) US$1.5 billion in annual sales in the Asia Pacific region.
Significant biosimilar activities this week include
14 Sep 20 | Novartis announced the results of Ph III trials of Beovu® (brolucizumab) in diabetic macular edema. Novartis announced the trial met its primary and key secondary endpoints, demonstrating non-inferiority of Beovu® versus aflibercept at year one.
14 Sep 20 | US | Republican Congressman Glenn Grothman introduced a bill to waive interchangeability requirements for FDA approved insulin products. If passed, this bill would allow for insulin products to be automatically substituted at the pharmacy counter at the patient and physician’s discretion.
15 Sep 20 | CA | Merck announced Health Canada has approved Brenzys® (biosimilar etanercept) for four new indications:
adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy
pediatric patients ages 4 to 17 years with chronic severe PsO who are candidates for systemic therapy or phototherapy
reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis and improving physical function in adult patients with psoriatic arthritis (PsA)
reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 to 17 years
15 Sep 20 | Samsung Bioepis announced the results of Ph III trials of Aybintio® (biosimilar bevacizumab) reinforce the equivalent clinical efficacy between Aybintio® and the reference product. The results will be presented for the first time at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
15 Sep 20 | EU | Mylan announced the European Commission has approved the proposed merger between Mylan and Pfizer’s Upjohn. Following approvals in Australia and New Zealand, clearance is only pending in the US. Mylan announced that they expect the transaction will be closed in Q4 2020. The merger NewCo now know as “Viatris” will provide expanded reach for (Mylan) biosimilars including trastuzumab (Ogivri®), bevacizumab (Abevmy®), pegfilgrastim (Fulphila®), and insulin glargine (Semglee®) together with pipeline products including biosimilars to abatacept and aflibercept.
17 Sep 20 | Lotus Pharma announced it has signed a commercialisation agreement with Chong Kun Dang for Nesbell® (biosimilar darbepoetin-alpha). Under the agreement, Chong Kun Dang will supply Lotus with Nesbell® for sale in Taiwan, Vietnam and Thailand pending the success of clinical trials in those countries.
17 Sep 20 | The Centre for Biosimilars reported that data presented at the ESMO Virtual Congress by PrestigeBiopharma demonstrates positive findings for Ph I trials of HD201 (proposed trastuzumab biosimilar). HD201 is current under review by the EMA.
SBS News reported the Australian Government has committed $6 million to the research and development of three potential COVID-19 vaccines. The University of Melbourne will receive $3 million for the development of two vaccines, and the University of Sydney will receive $3 million to commence clinical trials of a novel DNA-based COVID-19 vaccine.
Regenxbio announces it has commenced dosing in Ph II trials comparing RGX-314 to monthly ranibizumab injections. RGX-314 is being developed as a novel, one-time subretinal treatment for wet AMD and diabetic retinopathy.
The Australian Patent Office, in Ono Pharmaceutical Co., Ltd. et al [2020] APO 43, has emphatically confirmed that a patent term extension (PTE) request must be based on the first regulatory approval of a product
covered by the claims, even if it is a competitor product. This decision has critical practical implications for patentees of pharmaceutical patents that intersect the breadth of the claims and the timing of PTE requests.
Background
Under Australian law, patents that cover pharmaceutical inventions are eligible for an extension of term of up to five years.
The legal requirements for obtaining a pharmaceutical PTE as stated in the Australian Patents Act 1990 are:
The patent must relate to a pharmaceutical substance per se or a pharmaceutical substance when produced by recombinant DNA technology. The substance must be disclosed in the specification and must fall within the scope of the claims.
The substance must be included on the Australian Register of Therapeutic Goods (ARTG) before the 20-year term of the patent expires and the entry must be current at the time of the application for an extension.
At least five years must have elapsed between the effective filing date of the patent application and the first inclusion of the pharmaceutical on the ARTG.
Further, an application for a PTE must be lodged within six months from the later of the following dates:
the date the patent was granted; or
the date of first regulatory approval of a product containing or consisting of a pharmaceutical substance covered by the claims of the patent.
The patent-in-suit
Australian Patent No. 2011203119 covers antibodies that bind the immune checkpoint inhibitor PD-1 and includes claims directed to game-changing, blockbuster cancer drugs OPDIVO and KEYTRUDA. Regulatory approval for OPDIVO and KEYTRUDA in Australia was obtained on 11 January 2016 and 16 April 2015, respectively. The patentee, Ono Pharmaceutical, believed that because there were two alternate interpretations of the PTE provisions in the Patents Act, they should pursue a “double-barreled” PTE request – one based on their own product OPDIVO and the other based on KEYTRUDA, a Merck Sharp & Dohme product. Notably, the PTE requests were filed on 11 July 2016, which meant the KEYTRUDA PTE request was filed outside of the six-month deadline from the relevant regulatory approval date, and therefore required an accompanying application for an extension of time in which to make the PTE request.
This Patent Office decision relates to consideration of the OPDIVO PTE request.
The issues and considerations
In the first instance, the Patent Office issued a deficiency notice for the OPDIVO PTE request, noting that KEYTRUDA, which fell within the scope of the claims, was the product having the first regulatory approval date. The patentee requested to be heard on this issue.
The patentee submitted that the PTE request should be based on OPDIVO because the purpose of the PTE provisions is to restore the time lost to patentees prior to gaining pharmaceutical marketing approval, and to compensate the patentee for the additional time, expense and difficulty in developing and commercialising a “new drug”. The patentee submitted that OPDIVO was such a new drug. The patentee also submitted that it was “manifestly absurd or unreasonable” for a PTE to be based on a competitor product.
The Patent Office disagreed, stating that “the scheme of the Act does not limit consideration to only those substances developed by the patentee and this position is not manifestly unreasonable”.
The Delegate of the Commissioner of Patents referred to a previous Patent Office decision, G.D. Searle LLC [2008] APO 31 (the Searle decision) which found that an application for a PTE must be made on the basis of the earliest first inclusion in the ARTG of goods containing, or consisting of, a pharmaceutical substance which in substance falls within the scope of the claims, irrespective of the sponsor of the goods. However, the patentee challenged the correctness of the Searle decision – in particular, the “earliest first regulatory approval date”. Ultimately, the patentee’s submissions were not persuasive. In coming to his decision, the Delegate noted that the purpose of the PTE provisions is to encourage the development of new drugs, and that if the claims cover a third party’s drug, the patentee’s drug is “effectively the same substance”. Therefore, the patentee’s position, if successful, would lead to extensions based on “old drugs” being granted, which would not incentivise the development of new drugs but rather new PTEs. For these reasons, the Delegate found that the drug with the earliest regulatory approval date containing, or consisting of, the substance covered by the claims of the patent was KEYTRUDA. As such, the PTE request based on OPDIVO was refused.
Crucial practical implications for patentees, generics and biosimilars manufacturers
This decision has crucial practical implications for patentees of pharmaceutical patents, particularly in relation to the breadth of the claims and the timing of PTE requests. It is essential that patentees are aware of all the pharmaceutical substances covered by their claims and the relevant regulatory approval dates of these pharmaceutical substances. It is also critical that the review of issues relating to the PTE be undertaken well before the PTE deadline to allow for appropriate amendment of the claims if necessary in order to exclude (generally by a narrow proviso) products that might jeopardise the request. This will ensure that PTE requests are based on the relevant pharmaceutical substance and that the PTE request is filed within the required time.
This decision is equally important for other stakeholders such as generics and biosimilars manufacturers, who should always ensure that term extension on relevant competitor patents are based on the first regulatory approval of a product covered by the claims.
Concluding remarks
For Ono Pharmaceutical to obtain an extension of term they can either appeal this decision or, alternatively, rely their KEYTRUDA PTE request and the accompanying application for an extension of time in which to make the PTE request. Whether this second option is successful will largely depend on the allowability of their extension of time request, and Pearce IP will keep you promptly informed in this regard.
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.
Jacinta is a trusted and recognised leader in biotech/pharma patenting, identified as an "IP Star" by the highly regarded Managing Intellectual Property Journal (MIP) for her expertise.
She is a registered patent attorney with 20 years' experience serving clients in the biotechnology, pharmaceutical and biopharmaceutical industries.
The Centre for Biosimilars reports that data presented at the ESMO Virtual Congress by PrestigeBiopharma demonstrates positive findings for Ph I trials of HD201 (proposed bevacizumab biosimilar). HD201 is current under review by the EMA.
Lotus Pharma announces it has signed a commercialisation agreement with Chong Kun Dang for Nesbell® (biosimilar darbepoetin-alpha). Under the agreement, Chong Kun Dang will supply Lotus with Nesbell® for sale in Taiwan, Vietnam and Thailand pending the success of clinical trials in those countries.
Merck announced Health Canada has approved Brenzys® (biosimilar etanercept) for four new indications:
adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy
pediatric patients ages 4 to 17 years with chronic severe PsO who are candidates for systemic therapy or phototherapy
reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis and improving physical function in adult patients with psoriatic arthritis (PsA)
reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 to 17 years
Significant biosimilar activities this week include
08 Sep 20 | The Centre for Biosimilarsreports a new study published in Diabetes Spectrum suggests FDA biosimilar naming requirements and switching restrictions cause patients to perceive biosimilars as less similar to reference products. The authors linked the requirement for a biosimilar product to use a four letter suffix and restrictions on pharmacy interchangeability to a diminished interest in biosimilars among patients.
10 Sep 20 | AU | Australia’s Competition and Consumer Commission (ACCC) announced it would not oppose the proposed merger between Mylan NV and Pfizer’s Upjohn Inc division. Mylan and Upjohn have undertaken to divest three off-patent products (atorvastatin, latanoprost and latanoprost/timolol) in response to competition concerns raised by the ACCC. Aspen has been approved by the ACCC as the purchaser for these products.
10 Sep 20 | Regenxbio announced it has commenced dosing in Ph II trials comparing RGX-314 to monthly ranibizumab injections. RGX-314 is being developed as a novel, one-time subretinal treatment for wet AMD and diabetic retinopathy.
10 Sep 20 | a new study presented at the Congress of Clinical Rheumatology East indicates that ustekinumab is safe and efficacious in young and elderly patients with psoriatic arthritis. Researchers reported that there were no clinically meaningful differences in the effectiveness and safety in PsA patients 60 years or older compared with those younger than 60.
10 Sep 20 | Neurology Advisor reported a new study indicates that natalizumab may be more effective than fingolimod or BRACETD in reducing relapses in patients with relapsing-remitting multiple sclerosis.
AstraZeneca announced it has resumed clinical trials in the UK and Brazil following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so.
A new study presented at the Congress of Clinical Rheumatology East indicates that ustekinumab is safe and efficacious in young and elderly patients with psoriatic arthritis. Researchers reported that there were no clinically meaningful differences in the effectiveness and safety in PsA patients 60 years or older compared with those younger than 60.
Neurology Advisor reported a new study indicates that natalizumab may be more effective than fingolimod or BRACETD in reducing relapses in patients with relapsing-remitting multiple sclerosis.
AstraZeneca announced it has voluntarily paused Ph III trials of AZD1222 to investigate a potentially unexplained illness in one of the trials. AZ said it will expedite the review of the single event to minimise any impact to the trial timeline.
TheCentre for Biosimilars reports a new study published in Diabetes Spectrum suggests FDA biosimilar naming requirements and switching restrictions cause patients to perceive biosimilars as less similar to reference products. The authors linked the requirement for a biosimilar product to use a four letter suffix and restrictions on pharmacy interchangeability to a diminished interest in biosimilars among patients.
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