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Soft Close, Hard Lessons: Full Court Reinforces Purposive Construction of Patent Claims and the Disclosure Requirements for Divisional Patents

 

Date of decision: 17 July 2024
Body:  Full Court of the Federal Court of Australia
Adjudicators: Yates, Charlesworth and Rofe JJ

Background

This is an appeal from the first instance decision of Justice Burley in TCT Group Pty Ltd v Polaris IP Pty Ltd [2022] FCA 1493.  The decision at first instance involved two innovation patents, AU2020100485 (the 485 Patent) and AU2020102918 (the 918 Patent), which relate to hinges for soft-closing glass panelled doors.  Both patents are divisionals, and so claim priority from parent application 2017201858 (the Parent) filed three years earlier.  This appeal concerned only the 918 Patent, owned by Polaris IP Pty Ltd (Polaris).  Glass Hardware Australia Pty Ltd (Glass Hardware), the appellant, is the exclusive licensee.  TCT Group Pty Ltd and Astral Hardware Pty Ltd (collectively TCT Group) marketed and sold hinges under the “Orion” brand in Australia before the divisional application for the 918 Patent was filed.

The primary judge, Justice Burley, found the 918 Patent infringed but held that:

  1. The 918 Patent was not entitled to claim priority from the Parent because the Parent did not disclose the invention claimed in the 918 Patent in a manner that was clear enough and complete enough for the invention to be performed by a person skilled in the relevant art (PSA).  As a result, the 918 Patent claims were anticipated by the sale of the Orion hinges; and
  1. The specification of the 918 Patent also failed for insufficiency because it did not disclose the invention claimed in the 918 Patent in a manner that was clear enough and complete enough for the invention to be performed by a PSA.

On appeal, Glass Hardware raised three grounds:

  1. The proper construction of the invention disclosed in the Parent and the 918 Patent.
  1. Whether the 918 Patent claims disclose a “relevant range” requiring embodiments to be enabled across the scope of the range.
  1. If a relevant range exists, whether a PSA can make other embodiments without undue burden.

Glass Hardware needed to succeed on all grounds.  As grounds two and three depended on ground one, failure on ground one would resolve the appeal.

Key Issues

Person Skilled in the Art

The parties agreed that the PSA was a “person engaged in, or who has experience in, the design of mechanical devices and, in particular, in respect of hinges used in domestic and commercial applications”.  The experts called by the parties met this description (Mr Hunter for TCT Group and Mr Richardson for Glass Hardware).

Primary Judge’s Findings

Justice Burley construed claim 1 of the 918 Patent without limiting the dampener’s orientation or how it affects dampening upon closure of the hinge.  His Honour held that the disputed integer, “striking surface to cooperate with the dampener”, encompassed a striking surface which interacted both directly and indirectly with the dampener to achieve the dampening effect.  The Full Court summarised Justice Burley’s view as follows:

…the dampener must have a longitudinal axis disposed between, and substantially parallel with, planes defined by opposing faces of the first panel and be at least partially housed within the first insert component of the first leaf assembly.

Justice Burley observed that the Orion hinges were “actuated by a combination of interactions between several sliding surfaces external to the dampeners themselves”.  On Justice Burley’s construction of claim 1, this indirect interaction between the dampener and the striking surface fell within the scope of the claim.

However, TCT Group argued that claim 1 of the 918 Patent was broader than the invention disclosed in the Parent (and the 918 Patent specification), which did not include dampeners functioning without direct contact.  Justice Burley agreed.  The Full Court summarised Justice Burley’s conclusion as follows:

…the specification of the Parent describes the invention by reference not only to the “co-planarity feature” but also by the limitation that the dampener comes into contact with the second leaf assembly, with the dampener arranged so that it is orthogonal or substantially orthogonal [i.e at right angles]  to the hinge axis”

(emphasis added)

Justice Burley held that the requirement for the dampener to be oriented at right angles to the hinge axis addressed a problem arising from lateral forces applied to the dampener at other angles.  Expert evidence indicated that changing the dampener angle would require a fundamental redesign and determining its feasibility would require a prototype to be built and tested.  His Honour considered that this “left gaps in its teaching that must be filled by imaginative design work”.

Justice Burley also rejected Glass Hardware’s submission that the word “dampener” in the Parent meant a  “dampener mechanism” for three reasons:

  1. A dampener is a component recognised in the field, which the expert evidence described as a component where a piston moves within a cylinder, its motion restricted by factors like friction or pressure.
  1. The specification supported the view that a PSA would understand a dampener to mean a specific component.  The figures also depicted the dampener as a component, cooperating with a dampener body and dampener pin.
  1. Cross-examination of Mr Hunter revealed that he agreed that the ‘sliding cam’ could be regarded as a component of the “dampener mechanism”.

As a result, Justice Burley concluded that the 918 Patent was not entitled to claim priority from the Parent because the Parent did not disclose the invention claimed in the 918 Patent in a manner that was clear enough and complete enough for the invention to be performed by a PSA; and that the specification of the 918 Patent failed for insufficiency because it did not disclose the invention claimed in the 918 Patent in a manner that was clear enough and complete enough for the invention to be performed by a PSA.

Appeal submissions

Glass Hardware challenged Justice Burley’s decision on several fronts.

On the question of construction, Glass Hardware submitted that his Honour employed an “over-meticulous verbal analysis”, and argued for a more purposive construction with a “generous measure of common sense” such that the dampener mechanism in the Parent could function through both direct contact and indirect contact via an intermediate component.  Glass Hardware contended that “coming into contact with” (in the Parent) shouldn’t exclude indirect contact, and that it was materially equivalent to the 918 Patent’s phrasing of “a striking surface to cooperate with the dampener”.  Glass Hardware also took issue with the narrow interpretation of ‘dampener’, arguing it should include broader mechanisms achieving a dampening action.

Regarding sufficiency, Glass Hardware:

(i) Disputed the application of the “relevant range” concept described in Regeneron Pharmaceuticals Inc v Kymab Ltd [2020] RPC 22.  Justice Burley found that “the angle of the dampener relative to the second leaf assembly is unlimited”, such that the 918 Patent claimed a range of dampener axis orientations from 0° to 360°.  In Regeneron, the relevant claim was to a range of types of transgenic mouse, however, the PSA could only make some of the types of mice within that range.  Glass Hardware sought to distinguish Regeneron on the basis that the claims of the 918 Patent employed a descriptive or functional language which “may well cover a variety of things”, and therefore did not evoke the notion of a “relevant range”;

(ii) Distinguished Jusand Nominees Pty Ltd v Rattlejack Innovations Pty Ltd (2023) 176 IPR 336, in which the Full Bench of the Federal Court had found that the range of materials that could be used was part of the invention’s ‘essence’ or ‘core’.  Glass Hardware submitted that the innovative step in the 918 Patent related to the transmission of dampening forces within the same plane as the panel; and

(iii) Argued that a single example of a preferred embodiment of the invention could meet the disclosure requirement.  In support, Glass Hardware cited the Explanatory Memorandum to the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) (the Explanatory Memorandum), which states:

A specification that provides a single example of the invention may satisfy the requirements, but only where the skilled person can extend the teaching of the specification to produce the invention across the full width of the claims, without undue burden, or the need for further invention.

In response, TCT Group submitted that the wider context of the Explanatory Memorandum provides further direction as to this requirement as follows:

However, it is expected to be more likely that, where the claims are broad, the specification will need to give a number of examples or describe alternative embodiments or variations extending over the full scope of the claims. This ensures that the monopoly extends only to that which could reasonably be said to be disclosed and no further.

Consideration

The Full Court emphasised that the 918 Patent would only be entitled to the Parent’s priority date if it clearly and completely disclosed the 918 Patent claims such that a PSA could perform the invention.

In their analysis, the Full Court noted that Glass Hardware did not challenge the primary judge’s construction of the “cooperate” integer in claim 1 of the 918 Patent (that it was not limited to direct contact between the dampener and the striking surface).  The Full Court observed that “cooperate” was only found in the Summary of the 918 Patent describing the “first aspect” of the invention, but was not found in the Parent.

Applying a purposive construction, the Full Court agreed with Justice Burley’s observation that the language of the Parent was “unambiguous” and required the dampener to be oriented at right angles to the hinge axis and make direct contact with the second leaf assembly.

Relying on a joint expert report, the Full Court also agreed that “dampener” meant a component of a dampener mechanism.  The Full Court observed that a “dampener” had a generally accepted definition and emphasised that this was not an instance where the patentee was attempting to describe a previously non-existent concept.  This was consistent with the description in the Parent which showed the “dampener” as a component and not as an entire mechanism itself.

The Full Court also addressed Glass Hardware’s argument that Justice Burley applied inconsistent reasoning by construing “coming into contact” to exclude indirect contact, yet construed “orthogonal” to mean more or less at right angles per Catnic Components Ltd v Hill and Smith Ltd [1982] RPC 183.  The Full Court observed that minor variations to the orthogonality (a few degrees either side) would not materially affect the invention’s function, whereas including indirect contact would fundamentally change how it worked.

In their concluding remarks, the Full Court stressed that while purposive construction and common sense are vital in patent construction, they cannot displace or override the clear ordinary meaning of words chosen by the patentee.  They affirmed that Justice Burley had correctly given effect to the plain language without resorting to an “overly meticulous verbal analysis or purely literal construction”.  The Full Court’s final message was clear:

Calling in aid a combination of purposive construction, together with the application of common sense, does not enable words deliberately chosen by the patentee to be broadened beyond their ordinary English meaning to expand the scope of the monopoly claimed (to what the patentee may have intended) in order to catch a creative alleged infringer, whilst maintaining priority from the earlier specification.

Outcome

The Full Court substantially agreed with Justice Burley’s decision, finding that:

  1. The 918 Patent was not entitled to claim priority from the Parent because the Parent did not disclose the invention claimed in the 918 Patent in a manner that was clear enough and complete enough for the invention to be performed by a PSA; and
  1. The specification of the 918 Patent also failed for insufficiency because it did not disclose the invention claimed in the 918 Patent in a manner that was clear enough and complete enough for the invention to be performed by a PSA.

The Full Court dismissed the appeal with costs.

Implications

The Full Court’s decision emphasises that:

  1. Unlike many other countries, Australia does not have a doctrine of equivalents.  While purposive construction and common sense are integral to patent construction, they cannot broaden the scope of the monopoly claimed by expanding or overriding the clear and ordinary meaning of words deliberately chosen by the patentee.
  1. Technical terms will be construed in light of their meaning as understood by a PSA.  If a technical term is to be given a different meaning, then the specification will need to provide a clear definition of that term as it is to be understood in the context of the patent.
  1. To rely on a parent application’s priority date, the invention claimed in the divisional application must be clearly and completely disclosed in the parent.  Patentees should be cautious about using different terminology in divisional applications from that used in the parent application, and avoid broader language that may extend beyond the scope of the parent.  Similarly, the invention claimed in the patent must be enabled by the disclosure in the specification, that is, the specification must disclose the claimed invention in a manner that is clear enough and complete enough for the invention to be performed by a PSA.

 

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

 

Naomi Pearce

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.

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation – Australia)

Helen has over 25 years’ experience as an intellectual property specialist and is recognised as an industry leader. Helen advises on all forms of intellectual property including patents, plant breeder’s rights, trade marks, copyright and confidential information.

Helen is a member of the Intellectual Property Committee of the Law Council of Australia, as well as a member of the Intellectual Property Society of Australia and New Zealand.

Nathan Kan

Nathan Kan

Graduate (Law)

Nathan is a Graduate (Law) focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.

Nathan is passionate about the intersection of law and science.  Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.

 

Pearce IP supports 2024 “International Day of the Girl Child” by taking action against human trafficking

On 11 October 2024, the UN’s “International Day of the Girl Child” highlights the inequities faced by 1.1 billion girls worldwide. Pearce IP proudly supports this important day through the charity A21, whose mission is to end modern day slavery, including human trafficking.

According to a 2022 report from the International Labour Organisation:

  • 49.6 million people are currently enslaved worldwide (or 6.4 out of every 1,000 people);
  • 54% of slavery victims are women and children;
  • In Australia alone, 41,000 people are trapped in modern slavery.

Pearce IP’s Deputy CEO and Head of Talent, Adele Chadwick, shares a powerful message:

“We are so incredibly lucky that our girls enjoy the opportunity to be children and have access to health care, security and education. For so many others this is far from their reality.

 

We have an opportunity to support and shine a light on A21 in their tireless work to end modern day slavery and in turn improve the lives of girls across the globe. I encourage you to take 2 minutes to read some of their stories which are both frightening yet filled with hope for a better future.

 

To every little girl – we see you.”

A21 works tirelessly to fight for freedom through education and awareness programs, operating National Human Trafficking Hotlines, and providing legal assistance to survivors. The organisation’s Child Advocacy Centers provide care for exploited children, while their Freedom Centers help restore survivors to independence. A21’s programs have seen incredible success, as demonstrated in the 2023 Freedom Report.

This year the team at Pearce IP are donating to A21 via payroll deductions, with Pearce IP matching every dollar donated.

Pearce IP invites everyone to join us in supporting A21’s vital mission. Donations help fund their life-saving programs, but if you’re unable to contribute financially, there are still other ways to get involved. Visit A21’s website to learn more about the issue or join the Walk for Freedom on 19 October 2024 to raise awareness and stand in solidarity with the millions affected by slavery.

Together, we can help shape a future where every girl is free.

Samsung Bioepis Publishes Seventh Biosimilar Market Report: Tocilizumab Biosimilars Enter the US Market; Adalimumab Biosimilar US Market Share at 22%

On 10 October 2024, Samsung Bioepis released its quarterly US Biosimilar Market Report.  The report has been published every quarter since April 2023 and details average sales price information for US launched biosimilars and market share and price trends.

The Q4 2024 edition reports that, as of September 2024, the FDA has approved 61 biosimilars across 17 unique biological molecules, 41 of which have launched in the US market.  There were four new biosimilars approved by the FDA in the last quarter: Samsung Bioepis’ Epysqli™/SB12 (Soliris®, eculizumab), Amgen’s Pavblu™/ABP 938 and Sandoz’s Enzeevu™ (Eylea®, aflibercept) and Formycon/Fresenius Kabi’s Otulfi™ (Stelara®, ustekinumab).

The report tracks the impact of US biosimilars and finds that the US adalimumab biosimilar market share reached 22% as of August 2024, largely driven by the uptake of biosimilars through private label brands.  It also reports that two tocilizumab biosimilars (vial formulation only) entered the US market in Q2 2024, Biogen/Bio-Thera’s Tofidence® and Fresenius Kabi’s Tyenne®, at Wholesale Acquisition Cost discounts of -16% (US$2,200) and -26% (US$1,960) respectively, compared to Roche’s Actemra® (US$2,656).

Samsung Bioepis cites data reporting that, from 2015-2023, total US biosimilar savings are US$36billion, with a third of those savings occurring in 2023.

Pharmac Broadens Funding for Eli Lilly/Merck KgGA’s Erbitux® (Cetuximab)

New Zealand’s drug-funding body, Pharmac, has announced that Eli Lilly/Merck KgGa’s Erbitux® (cetuximab) will now be funded for left-sided, RAS and BRAF wild-type, metastatic colorectal cancer.  Minor amendments have also been made to eligibility criteria for currently funded head and neck cancer indications.

Pharmac is still assessing whether funding should also be extended to BRAF-mutated metastatic colorectal cancer and has invited a funding application to be made for cetuximab in combination with encorafenib.  This funding application would require a submission for Medsafe approval of encorafenib which is not yet approved in New Zealand, unlike in the US where this combination therapy has been approved.

New Indication Alert: J&J Applies for Expanded US and EU Indications of Darzalex® Quadruplet Regimen for Multiple Myeloma

On 10 October 2024, Johnson & Johnson (J&J) announced that it submitted a Type II variation application to the EMA seeking an indication extension for Darzalex® (daratumumab) subcutaneous formulation in combination with bortezomib, lenalidomide and dexamethasone for adult patients with newly diagnosed multiple myeloma (NDMM) for whom autologous stem cell transplant (ASCT) is deferred or who are ineligible for ASCT.

This followed the 2 October 2024 announcement that J&J has submitted a supplemental Biologics License Application to the US FDA for approval of Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in the same combination and for the same indication.

In July 2024, the combination regimen was approved by the FDA for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.  In March 2024, J&J submitted an application to the European Medicines Agency for Darzalex® (daratumumab) for an indication extension for the treatment of transplant-eligible patients newly diagnosed with multiple myeloma.

EMA Accepts Alvotech/STADA’s MAA for Biosimilar Denosumab

On 10 October 2024, STADA announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).

Under an agreement with Alvotech entered in June 2024, STADA has semi-exclusive rights to commercialise the Alvotech-developed AVT03 in Europe, Switzerland and the UK, and exclusive rights in certain Central Asian and Middle Eastern countries.

Sandoz’s Jubbonti® and Wyost® were the first denosumab biosimilars to be approved in Europe in May 2024.  The EMA accepted MAAs for denosumab biosimilars of Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), Shanghai Henlius Biotech/Organon (HLX14, May 2024), and Teva (October 2024)

Denosumab biosimilars have also been approved in the US (Sandoz’s Jubbonti® and Wyost®, March 2024), Canada (Sandoz’s Jubbonti®, February 2024 and Wyost®, March 2024), China (Boan Biotech’s Byoubei® (November 2022) and Boluojia® (May 2024) and Mabwell’s Mailishu® (March 2023) and Maiweijian™ (April 2024)).

Ono’s Opdivo® Combination Therapy Approved in Taiwan for Urothelial Carcinoma

On 9 October 2024, Ono Pharma Taiwan received additional approval of Opdivo® (nivolumab) intravenous infusion in combination with cisplatin and gemcitabine, from the Taiwan Food and Drug Administration, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.

This combination treatment has previously been approved in the US.

In 2011, Ono granted BMS commercialisation rights for Opdivo® excluding in Japan, South Korea and Taiwan, where Ono retains all rights.  In July 2014, Ono and BMS agreed to expand their collaboration agreement to jointly develop and commercialise multiple immunotherapies as single agent and combination regimens for cancer in Japan, South Korea and Taiwan.

Biogen Receives FDA Breakthrough Therapy Designation for Felzartamab for Treatment of AMR

On 9 October 2024, Biogen announced that its felzartamab received FDA Breakthrough Therapy Designation (BTD) for the treatment of late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients.  Felzartamab is an investigational anti-CD38 monoclonal antibody and is said to be a potential first-in-class therapeutic candidate for a range of rare immune-mediated indications.

Nanjing Leads Biolabs Achieves Breakthrough Therapy Designation for LBL-024 in China

On 9 October 2024, Nanjing Leads Biolabs announced that China’s Center for Drug Evaluation of National Medical Products Administration granted Breakthrough Therapy Designation to LBL-024, an anti-PD-L1/4-1BB bispecific antibody, for the treatment of patients with advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) who have progressed after receiving two or more lines of chemotherapy.

According to Nanjing Leads Biolabs, clinical data shows that LBL-024 monotherapy has more than doubled both the Objective Response Rate and Overall Survival compared to existing treatments for this disease.

Bio-Thera Solutions and Gedeon Richter Seal Ustekinumab Biosimilar Commercialisation Deal

On 9 October 2024, Bio-Thera Solutions and Gedeon Richter announced that they have entered into an exclusive commercialisation and license agreement for BAT2206, biosimilar to Janssen’s Stelara® (ustekinumab).  Pursuant to the agreement, Bio-Thera continues to be responsible for the development, manufacturing, and supply of BAT2206, with Gedeon Richter having exclusive rights to commercialise the product in the European Union, the UK, Switzerland and selected other countries.  Bio-Thera is set to receive an upfront payment of US$8.5 million, plus development and commercial milestones of up to US$101.5 million, subject to the fulfillment of certain conditions.

On 24 July 2024, Bio-Thera Solutions announced that the FDA BLA and EMA MAA for its BAT2206 have both been accepted.  BAT2206 is the first biosimilar to Janssen’s Stelara® developed by a Chinese company to be submitted to the FDA or EMA for approval.

Bio-Thera’s BLA for BAT2206 is also currently under review by the China National Medicinal Product Administration.

Keytruda®/Padcev® Combination Therapy for Bladder Cancer Approved in UK

On 8 October 2024,  MSD’s Keytruda® (pembrolizumab) and Astellas/Pfizer’s Padcev® (enfortumab vedotin) were approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as a first-line combination treatment for unresectable or metastatic urothelial carcinoma (UC) in adults who are eligible for platinum-containing chemotherapy.

This follows approval of this combination therapy for the same indication in Europe on 3 September 2024.  Enfortumab vedotin, an antibody drug conjugate, is being co-developed by Astellas and Pfizer under a global development and commercialisation collaboration.

Bayer’s High Dose Eylea® (Aflibercept) PFS Approved in Australia

On 8 October 2024, Australia’s Therapeutic Goods Administration (TGA) approved Bayer’s Eylea® (aflibercept) 8mg pre-filled syringe (PFS), “OcuClick”, for nAMD and diabetic macular oedema (DME).

This follows approval of high dose Eylea® PFS (OcuClick) in Europe last month.

Eylea® 8mg was jointly developed by Bayer and Regeneron.  Regeneron holds the exclusive rights to both low and high dose Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

High dose Eylea® for intravitreal injection has previously been approved for nAMD and DME in Australia (June 2024), the EU (January 2024), Japan (January 2024), and the UK (January 2024).  Eylea® HD was approved for nAMD, DME and diabetic retinopathy in the US (August 2023).

Teva’s Biosimilar Denosumab Applications Accepted in US and EU

On 8 October 2024, Teva Pharmaceuticals announced that the US FDA and European Medicines Agency (EMA) accepted Biologics Licence and Marketing Authorisation Applications, respectively, for its TVB-009P, biosimilar to Amgen’s Prolia® (denosumab).  Both applications cover all approved indications of Prolia®, including osteoporosis in postmenopausal women with a high risk of fracture.  The approval decisions of the FDA and EMA are expected in the second half of 2025.

Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in the US in March 2024.  Following the April 2024 resolution of US BPCI litigation, commenced by Amgen against Sandoz in May 2023, Jubbonti® and Wyost® are expected to launch in the US from 31 May 2025.  No other denosumab biosimilars are currently approved in the US, although Fresenius Kabi’s BLA for its denosumab biosimilar was accepted by the FDA in May 2024.

Sandoz’s Jubbonti® and Wyost® have also been approved in Europe (May 2024).  The EMA has accepted MAAs for denosumab biosimilars of Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024) and Shanghai Henlius Biotech/Organon (HLX14, May 2024).

Novo Nordisk Settles US Patent Dispute Regarding Semaglutide Patent with Mylan/Natco, Dr Reddy’s, Apotex and Sun Pharma

From 4-8 October 2024, Novo Nordisk and each of Mylan Pharmaceuticals (a subsidiary of Viatris), Dr Reddy’s, Apotex and Sun Pharma filed joint motions notifying the US Patent Trial and Appeal Board (PTAB) that they had settled their dispute regarding the validity of Novo Nordisk’s US patent no. 10,335,462.  The patent covers specific dosages of semaglutide used to treat type 2 diabetes.

Mylan had filed a petition for inter partes review (IPR) challenging the validity of the ‘462 patent on 16 March 2023 and the IPR proceeding was instituted on 4 October 2023 (IPR2023-00724).  IPRs instituted based on petitions filed by Dr Reddy’s, Apotex and Sun Pharma in relation to the ‘462 patent were subsequently joined to the Mylan IPR proceeding.  The joint motions recently filed by the parties now request termination of the IPR proceedings.

On 7 October 2024, Natco Pharma, Mylan’s partner in relation to the development of generic Ozempic® products, announced in a regulatory update that Mylan and Novo Nordisk “have reached a settlement of the U.S. patent litigation related to generic Ozempic® (Semaglutide)” and confirmed that the terms of that settlement are confidential.

We have previously reported on Novo Nordisk’s litigation against Sun Pharma and Mylan for US patent infringement, as well as legal action taken to prevent sale of counterfeit versions of Ozempic®.  Novo Nordisk’s annual report for 2023 notes that Ozempic® generated US$14 billion in sales, with sales projected to reach about US$18 billing in 2024, whereas Wegovy® sales are about a third of that achieved by Ozempic®.

Notably, on 8 October 2024, scientists from Novo Nordisk published a peer-reviewed study that highlighted significant differences between its branded products and various copied versions.  The Danish pharmaceutical company tested 16 injectable formulations of semaglutide, the active ingredient in its Ozempic® and Wegovy®.  These included copy products obtained from a range of sources, such as compounding pharmacies, telehealth providers, and medical spas.  The article concludes that copied products are inferior, and may give rise to safety concerns, hence the need for regulatory intervention.

Insert Appeal, Pull Lever, Repeat: Aristocrat Deals itself another Hand in Ongoing Dispute over Electronic Gaming Machine Patents

 

Date of decision: 30 August 2024
Body:  Federal Court of Australia
Adjudicator: Justice O’Bryan

In a recent Federal Court decision, Justice O’Bryan has granted Aristocrat Technology Australia Pty Ltd (Aristocrat) leave to appeal against Justice Burley’s decision on remittal from March 2024.  This latest development adds another chapter to the long-running saga concerning the patentability of Aristocrat’s electronic gaming machine technology.

The case, which has already seen multiple hearings in the Federal Court, a Full Court appeal, and an equally divided High Court Decision, centres on whether Aristocrat’s innovation patents claim a manner of manufacture within the meaning of s 18(1A)(a) of the Patents Act 1990 (Cth) (the Act).

Background and Procedural History

The Commissioner of Patents initially revoked four of Aristocrat’s innovation patents, finding that the relevant claims were not to a manner of manufacture.  These patents, all related to gaming systems and methods, were:

Aristocrat appealed to the Federal Court, where Justice Burley allowed the appeal, setting aside the Commissioner’s decision.  The Commissioner then successfully appealed to the Full Court, which delivered two judgments (a joint and a separate judgment).  Notably, the parties agreed that if claim 1 of the 967 patent is a manner of manufacture, then so too were the rest of the claims in all of the patents in suit.  The Full Court ultimately found that claim 1 of the 967 patent was not a patentable invention.

Aristocrat’s subsequent appeal to the High Court resulted in a 3:3 split decision.  As per s 23(2)(a) of the Judiciary Act 1903 (Cth) (Judiciary Act), this equally divided opinion affirmed the Full Court’s decision, remitting the proceedings back to the primary judge.

On remittal to the Federal Court, Justice Burley dismissed Aristocrat’s appeal from the original decision of the Commissioner, applying the Full Court’s reasoning to the residual claims.

Following this, Aristocrat sought leave to appeal under s 158(2) of the Act, raising two principal issues:

  1. Whether the primary judge erred in applying s 23(2)(a) of the Judiciary Act, specifically in applying the Full Court’s reasoning rather than the reasoning in the High Court’s split decision.
  1. Whether the primary judge ought to have found that the invention claimed in the residual claims is a manner of manufacture.

Parties’ Submissions

In seeking leave to appeal, Aristocrat presented three main arguments.  Aristocrat contended that the primary judgment’s finality in determining their innovation patents’ non-grant could cause substantial injustice.  Aristocrat also contended that their appeal grounds were arguable, pointing to the disagreement among High Court judges with parts of the Full Court’s reasoning (albeit three ultimately coming to the same conclusion).  Lastly, Aristocrat emphasised the case’s broader significance for patent law administration and the patentability of computer-implemented inventions.

The Commissioner, opposing leave, countered that the primary judge’s decision was not sufficiently doubtful so as to warrant reconsideration, emphasising that the High Court’s split decision created no binding precedent.  The Commissioner further argued that Aristocrat did not raise issues of general importance.  The Commissioner also argued that refusing leave would not cause substantial injustice given the patents’ expiration and Aristocrat’s pending standard patent applications on the same subject matter.

Consideration

Justice O’Bryan noted that the application for leave was finely balanced.   His Honour agreed that the primary judgment finally determined the non-grant of the patents in suit but observed that this consideration was lessened by:

  1. The parties’ agreement that the patentability of claim 1 of the 967 patent had been finally determined by the Full Court’s decision, and all that remained was determination of the residual claims by the primary judgment.
  1. The expiration of the innovation patents and Aristocrat’s pending standard patent applications covering the same subject matter which remained on foot.

His Honour accepted that Aristocrat’s grounds of appeal were arguable, noting the novel issues concerning the application of s 23(2)(a) of the Judiciary Act, especially in unusual circumstances where the affirmed Full Court decision required a remittal based on its own reasoning, despite both High Court judgments disagreeing with parts of that reasoning.

However, Justice O’Bryan was not fully convinced by Aristocrat’s argument about the wider significance of the case to patent law administration and the patentability of computer-implemented inventions, observing that the case’s unusual circumstances limited its broader applicability.

Despite reservations about granting what could be seen as a “second go” at establishing different principles for adjudicating the manner of manufacture requirement, Justice O’Bryan ultimately granted leave to appeal.  Two factors marginally tipped the balance:

  1. The effect of the primary judgment in finally determining that the innovation patents would not be granted.
  1. The arguable nature of Aristocrat’s grounds of appeal, which raised novel questions about the operation of s 23(2)(a) of the Judiciary Act in unusual circumstances.

Key Takeaways

This decision prolongs the uncertainty surrounding the patentability of computer-implemented inventions in Australia and highlights the contrasting approaches taken at different court levels:

  • Federal Court (Justice Burley): Initially found Aristocrat’s invention to be a manner of manufacture and not a mere scheme
  • Full Court: Unanimously overturned this decision, emphasising the need for an advance in computer technology itself.
  • High Court: Equally divided on the patentability of the Aristocrat gaming technology, but overall critical of the Full Court’s two-step test.

The case now raises novel questions about the application of s 23(2)(a) of the Judiciary Act in cases of equally divided High Court decisions.  According to the currently accepted interpretation of s 23(2)(a) of the Judiciary Act, the Full Court’s approach stands as the prevailing test.

However, the Full Court’s approach remains contentious and may be subject to change.  All eyes now turn to the Full Court and the opportunity it has to provide clarity as to the proper application of the Judiciary Act, and perhaps further to the patentability of computer-implemented inventions in light of the High Court’s reasoning.

 

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

 

Naomi Pearce

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.

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation – Australia)

Helen has over 25 years’ experience as an intellectual property specialist and is recognised as an industry leader. Helen advises on all forms of intellectual property including patents, plant breeder’s rights, trade marks, copyright and confidential information.

Helen is a member of the Intellectual Property Committee of the Law Council of Australia, as well as a member of the Intellectual Property Society of Australia and New Zealand.

Nathan Kan

Nathan Kan

Graduate (Law)

Nathan is a Graduate (Law) focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.

Nathan is passionate about the intersection of law and science.  Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.

 

Amgen Sues Fresenius Kabi in Fourth US BPCIA Action for Infringement of Denosumab Patents

On 4 October 2024, Amgen filed a BPCIA complaint against Fresenius Kabi in the US District Court for the Northern District of Illinois (Eastern Division) asserting infringement of 33 US patents relating to denosumab and methods of its manufacture.

The litigation follows Fresenius Kabi’s submission of an abbreviated Biologic Licence Application (aBLA) to the US FDA seeking approval to manufacture and sell its FKS518, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).  Fresenius’ aBLA for denosumab was accepted for review by the US FDA on 27 May 2024.

Amgen’s complaint against Fresenius Kabi is the fourth BPCIA litigation it has filed in relation to denosumab.  In August 2024, Amgen filed a complaint against Samsung Bioepis (24-cv-08417-CPO-EAP) and, in May 2024, it filed a complaint against Celltrion (24-cv-06497-CPO-EAP), alleging infringement of US patents relating to denosumab.  Those complaints remain pending.  In May 2023, Amgen sued Sandoz in the US over its denosumab biosimilars (Jubbonti® and Wyost®) asserting infringement of 21 denosumab patents.  That dispute was resolved in April 2024, enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025 (or earlier in certain undisclosed circumstances).

Daiichi Sankyo Submits Application for Expanded Indication of Enhertu® in Japan

On 4 October 2024, Daiichi Sankyo announced that it has submitted a supplemental new drug application for Enhertu® (trastuzumab deruxtecan) to Japan’s Ministry of Health, Labour and Welfare.  The application proposes use of Enhertu® in adult patients with HER2 low (IHC 1+ or IHC 2+/ISH-) or ultralow (IHC 0 with membrane staining) unresectable or recurrent breast cancer.

Enhertu® has previously been approved for HER2-low breast cancer in Japan (March 2023), as well as in China (July 2023) and the US (August 2022).  In August 2023, Enhertu® was approved in Japan to treat patients with unresectable advanced or recurrent non-small cell lung cancer (NSCLC) with HER2 (ERBB2) mutations that has progressed after chemotherapy.

Rough Ride: EIS Gets a Tough Massage from LELO

 

Date of decision: 3 July 2024
Body:  Federal Court of Australia
Adjudicator: Justice Downes

Background

The applicant, EIS GmbH (EIS) initiated Federal Court proceedings against the respondents, LELO Oceania Pty LTD and LELOiAB (LELO) (and separately against Calvista Australia Pty Ltd, a distributor of LELO’s products in Australia) alleging infringement of Australian patent 2018200317 (Patent) which relates to a feminine pressure wave massager.  LELO denied infringement and cross-claimed for revocation.  The proceedings have been set down for trial in February 2025.

This decision concerned LELO’s application for an order under r 34.50(2)(b) of the Federal Court Rules 2011 (Cth) (‘Rules’) for:

… leave to rely on the affidavit of Michael Duff affirmed on 6 March 2024 (and annexures “MD-11”, “MD-13” and “MD-14”) as evidence of the conduct and results of experiments performed in Suzhou, China on a Satisfyer Pro 2, Womanizer W100 and Womanizer W500.

Under r 34.50(1)(a), when a party wishes to submit experimental proof as evidence in a proceeding, they must first apply for orders related to the experiment, including orders about the following:

  • the service on other parties of particulars of the experiment and of each fact that the proponent asserts is, will or may be proved by the experiment;
  • any persons who must be permitted to attend the conduct of the experiment;
  • the time when, and the place where, the experiment must be conducted;
  • the means by which the conduct and results of the experiment must be recorded;
  • the time by which any other party (the opponent) must notify the proponent of any grounds on which the opponent will contend that the experiment does not prove a fact that the proponent asserts is, will or may be proved by the experiment.

Under r34.50(2), experimental evidence will only be admissible if the party proposing to file experimental evidence has complied with r 34.50(1), unless the Court otherwise grants leave.

Prior to LELO’s application, EIS had applied to the Court seeking orders to rely on experimental testing of LELO’s allegedly infringing massager.  The purpose of the testing was to measure the volume change in the cavity of the pressure wave massagers during operation to prove that the volume change ratios and pressure fields generated fell within the scope of the Patent claims.  LELO challenged EIS’ Notice of Experiments, arguing that the results of the experiment would not be relevant and raised further concerns regarding the accuracy and reliability of the experimental protocol.  Ultimately, Nicholas J made orders granting leave to EIS to tender experimental evidence at trial, but noting that LELO had reserved its right to argue at trial that EIS’ experimental evidence was neither relevant nor accurate.

The experiments which LELO’s expert, Mr Duff, conducted in his laboratory in Suzhou, China generally followed the same protocol which EIS had used for the conduct of EIS’ experiments, but with some improvements said to increase accuracy.  LELO did not apply to the Court for an order pursuant to r 34.50(1) prior to conducting those experiments, claiming that it was not practical to give such notice to EIS and seek such orders due to the tight Court timetable for the filing of evidence in chief on invalidity.  LELO instead proposed that EIS watch the video it had made of the conduct of Mr Duff’s experiments, and also offered to repeat the experiments at a later time.  EIS declined to watch the video and did not consider that the experiments should be repeated.

Key Issues

The key issue for Justice Downes was whether to grant leave under r 34.50(2) to LELO to rely on the experiments already conducted by Mr Duff. EIS opposed the Court granting leave primarily on the basis that EIS would suffer prejudice both in prosecuting its infringement case and in defending LELO’s cross-claim for invalidity. EIS raised the following key arguments in support of its position:

  1. Contemporaneous records

EIS submitted that the experiments were undertaken by Mr Duff’s team and that there were no contemporaneous records of the conduct and results of the experiments.  Justice Downes observed that EIS had relied upon the affidavit evidence of Mr Payne (who conducted EIS’ experiment) which also did not annex such contemporaneous records.  In any case, her Honour considered that this objection could be dealt with at trial.

  1. Lack of representatives

EIS submitted that it had not been given the opportunity to have its representative attend Mr Duff’s experiments and that the video was “limited to what [Mr Duff’s team] elected to film”.  Justice Downes did not consider this submission to be persuasive as EIS had never requested to view the footage despite being offered nor accepted the invitation by LELO to have the experiments repeated.

  1. Independent expert

EIS submitted that Mr Duff was not an independent expert, but was aligned with and had an interest in LELO succeeding.  Justice Downes declined to determine this issue at this stage of the proceeding,  particularly given that Mr Duff was yet to be cross-examined on his evidence.

  1. Experimental protocol

EIS submitted that Mr Duff’s affidavit did not disclose a clear experimental protocol.  Justice Downes disagreed, observing that Mr Duff’s evidence indicated that he had followed the same protocol as that used for EIS’s experiments, albeit with some identified changes.  In any case, her Honour considered that whether there had been a failure to disclose Mr Duff’s experimental protocol was an issue to be addressed at the trial.

  1. Massagers

EIS raised a number of issues in relation to the massagers that Mr Duff tested in his experiments.  EIS’ key argument was that it was no longer possible to inspect any of these massagers to confirm their authenticity as they had been destroyed during testing.  Her Honour rejected this submission, finding that the massagers were in fact not destroyed and were available for inspection, although not in their original state.  Furthermore, EIS could also inspect undamaged versions of the devices prior to any further experimentation.

  1. Analogous decisions

EIS argued that refusing leave would “accord with previous decisions” of the Federal Court involving analogous facts.  EIS relied on the decisions of Justice Jagot in Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd [2013] FCA 226 and Beadcrete Pty Ltd v Fei Yu trading as Jewels 4 Pools [2012] FCA 1091.  Justice Downes distinguished these cases on the following bases:

  • In Bayer, the applicant brought the application on the first day of the hearing, and did not offer to repeat the experiments; nor was there any indication that the experiments had been video-recorded.
  • In Beadcrete, the party seeking leave did not provide any explanation as to why they failed to seek orders pursuant to r 34.50 before carrying out the experiment. Furthermore, the experiments caused the samples to be destroyed.

Outcome

Justice Downes held that LELO’s application should succeed and made orders granting leave to rely on Mr Duff’s affidavit evidence of the conduct and results of the experiments he performed in Suzhou, China.  Her Honour also ordered EIS to pay LELO’s costs of its application for leave to rely on experimental evidence.

Implications

Justice Downes’ judgment provides guidance to litigants who may wish to rely on the Court’s discretion to grant leave to admit experimental evidence under r 34.50. In particular, her Honour’s judgment illustrates:

  1. The importance of taking reasonable steps to promote transparency and fairness to the opposing party, if a party decides that it wishes to rely on experimental evidence but is not able to comply with r 34.50(1)(a) prior to conducting the experiments.
  1. That steps to document and maintain records of experiments (such as video recording) will be viewed favourably by the Court when considering whether to grant leave. Informing the opposing party of the experimental protocol, remaining substantially consistent with an earlier protocol, and offering to repeat experiments at a later time are also likely support an application under r 34.50(2).
  1. That questions regarding the accuracy, reliability, or credibility of experiments are likely to be deferred to and addressed at trial.

The order that EIS pay LELO’s costs also highlights the monetary cost associated with procedural disputes of this nature.  Cost penalties may arise when objections are not substantiated and the opposing party fails to cooperate or engage with the reasonable efforts of the other party to conduct experiments in a transparent and fair manner, despite not having applied for orders and r 34.50(1).

 

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

 

Naomi Pearce

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.

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation – Australia)

Helen has over 25 years’ experience as an intellectual property specialist and is recognised as an industry leader. Helen advises on all forms of intellectual property including patents, plant breeder’s rights, trade marks, copyright and confidential information.

Helen is a member of the Intellectual Property Committee of the Law Council of Australia, as well as a member of the Intellectual Property Society of Australia and New Zealand.

Nathan Kan

Nathan Kan

Graduate (Law)

Nathan is a Graduate (Law) focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.

Nathan is passionate about the intersection of law and science.  Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.

 

New Indication Alert: FDA Approves BMS’ Opdivo® for Perioperative Treatment of Resectable NSCLC with Chemotherapy and Surgery

On 3 October 2024, BMS announced that the FDA has approved Opdivo® (nivolumab) for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo® as adjuvant treatment after surgery.

The approval is based on results from the CheckMate-77T trial, the company’s second positive Phase 3 randomized trial with an immunotherapy-based combination for the treatment of resectable NSCLC.

This follows the February 2024 FDA acceptance of BMS’ sBLA for neoadjuvant Opdivo® (nivolumab) with chemotherapy followed by surgery + adjuvant Opdivo® in the treatment of resectable stage IIA to IIIB NSCLC and Opdivo®’s listing earlier this year on Australia’s PBS for resectable NSCLC.

Update on MSD Challenges to Johns Hopkins’ Pembrolizumab MOT Patents

On 3 October 2024, the US Patent Trial and Appeal Board (PTAB) instituted inter partes review (IPR) of Johns Hopkins University’s US patent no. 11,643,462 in IPR2024-00648.  MSD filed a petition on 13 March 2024, challenging the validity of the patent, which is directed to a method for treating, with pembrolizumab, cancer patients having a tumour that is microsatellite instability high (MSI-H) or DNA mismatch repair (MMR) deficient.

This followed the institution of eight IPRs in relation to Johns Hopkins University (JHU) patents relating to pembrolizumab on:

In each case, the PTAB determined that MSD had demonstrated there was a “reasonable likelihood that the petition would prevail in showing that at least one challenged claim is unpatentable”.

In November 2022 MSD filed a complaint in the United States District Court (District of Maryland) against JHU seeking declarations of breach of contract, non-infringement and promissory estoppel.  JHU filed a counter-claim on 12 April 2023, including alleging infringement of each of the patents subject to the IPR proceedings referred to above.

The US Court proceeding has been stayed pending the outcome of IPR2024-240.  No trial date has been scheduled.

MSD’s Keytruda® (pembrolizumab) is approved in the US (alone or in combination with other agents) for numerous indications including in relation to endometrial carcinoma, Stage 111-IVA cervical cancer, urothelial carcinoma, gastric/gastroesophageal junction adenocarcinoma, and biliary tract cancer.

Teva/mAbxience Global Licensing Deal for Anti PD-1 Oncology Biosimilar Candidate

On 3 October 2024, Teva Pharmaceuticals and mAbxience (majority owned by Fresenius Kabi) each announced that they have entered into a new global licensing agreement for the development of an unnamed anti PD-1 oncology biosimilar candidate.  Under the agreement, mAbxience will develop the biosimilar, with Teva managing regulatory approvals and commercialisation in multiple markets, including Europe and the US.

The new licensing agreement expands upon an agreement entered into by the two companies in April 2024 in relation to an unnamed oncology biosimilar candidate.

NHS Launches Consultation on Phased Rollout of Obesity Drug Tirzepatide

The UK National Health Service (NHS) launched a consultation on a phased rollout of Eli Lilly’s obesity drug Mounjaro® (tirzepatide), prioritising patients who are most likely to benefit from weight loss.  In a proposal made to National Institute for Health and Care Excellence (Nice), published online on 3 October 2024, a range of new community-based and digital services to administer the injection are being developed, aiming to reach nearly 250,000 people within the first three years. The rollout will be evaluated for cost-effectiveness, with plans to expand over nine years.

NICE is a public body in the UK responsible for providing national guidance and advice to improve health and social care.  Established in 1999, NICE evaluates the effectiveness, safety, and cost-efficiency of health interventions, treatments, and care practices for use in the NHS and other public healthcare systems in England and Wales.

Tirzepatide has been said to be more effective than Novo Nordisk’s semaglutide (Ozempic®/Wegovy®) in significantly reducing body weight in clinical trials.  Until now, Wegovy® has been the only drug authorised for NHS use by NICE in weight management.

Eisai Submits Application for Leqembi® in Saudi Arabia

On 2 October 2024, Eisai reported that it has submitted an application for approval of Leqembi® (lecanemab) in Saudi Arabia for Alzheimer’s disease .

The news follows approval of Leqembi® in the UK for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease in August 2024.  Leqembi® has previously been approved for MCI and mild dementia due to Alzheimer’s disease in the USJapanChinaSouth KoreaHong Kong and Israel, and the UAE, and applications are under review in the European UnionAustralia, Brazil, Canada, India, Russia, Taiwan, Singapore, and Switzerland.

ABL Bio to Conduct Ph 1b/2 Trial for ABL 103 in Combination with MSD’s Keytruda®

On 2 October 2024, South Korea-headquartered ABL Bio announced it has entered a clinical collaboration and supply agreement with MSD to evaluate the bispecific antibody ABL 103 in combination with MSD’s Keytruda® (pembrolizumab) in patients with advanced or metastatic solid tumours.

ABL 103, a bispecific antibody which targets the tumour-associated antigen B7-H4 and the costimulatory receptor 4-1BB, is currently in a phase 1 clinical trial in South Korea.  It will be evaluated with Keytruda® in a Phase 1b/2 clinical trial

On 12 September 2024, MSD’s Keytruda® was approved in Canada as monotherapy for treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumours that have progressed following prior treatment and which have no satisfactory alternative treatment options.

BioBlast® Editor and Contributing Author

Naomi Pearce & Emily Bristow

Naomi Pearce & Emily Bristow

Editor: Naomi Pearce, Executive Lawyer, Patent Attorney & Trade Mark Attorney
Contributing Author: Emily Bristow, Law Graduate

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