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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.

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.

 

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.

 

Pearce IP BioBlast® for the week ending 27 September 2024

Aflibercept

23 September 2024 | Positive 52-Week, Ph 3 Results for Celltrion’s Aflibercept Biosimilar

On 23 September 2024, Celltrion announced that it presented the 52-week results of its Phase 3 trial of Eydenzelt™ (CT-P42), biosimilar to Regeneron’s Eylea® (aflibercept), at the European Society of Retina Specialists (EURETINA) conference… Read more here.

23 September 2024 | US | US Court Refuses Preliminary Injunction Regarding Amgen’s Aflibercept Biosimilar

On 23 September 2024, the United States District Court for the Northern District of West Virginia denied Regeneron’s motion for a preliminary injunction against Amgen seeking to prevent it from launching Pavblu™… Read more here.


Bimekizumab

23 September 2024 | US | New Indication Alert: FDA Approves Bimzelx® for Three New Indications

On 23 September 2024, UCB announced that its Bimzelx® (bimekizumab-bkzx) has received FDA approval for active psoriatic arthritis, active non-radiographic axial spondyloarthritis with objective signs of inflammation and active ankylosing spondylitis… Read more here.


Dupilumab

27 September 2024 | US | CN | New Indication Alert: Sanofi and Regeneron’s Dupixent® Approved in US and China for COPD

On 27 September 2024, Sanofi and Regeneron announced that Dupixent® (dupilumab) has been approved in the US as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD)… Read more here.


Isatuximab

20 September 2024 | US | New Indication Alert: FDA Approves Sanofi’s Sarclisa® for Multiple Myeloma

On 20 September 2024, Sanofi announced that the US FDA has approved Sarclisa® (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone as a first line treatment option… Read more here.


Lebrikizumab

25 September 2024 | Data Shows Sustained Efficacy of Eli Lilly’s Ebglyss™ (Lebrikizumab) for Atopic Dermatitis

On 25 September 2024, Eli Lilly published three-year data for its atopic dermatitis treatment, Ebglyss™ (lebrikizumab-lbkz).  The results, presented at the European Academy of Dermatology and Venereology (EADV)… Read more here.


Pembrolizumab

25 September 2024 | JP | New Indication Alert: MSD’s Keytruda® Approved in Japan for NSCLC and Urothelial Carcinoma

On 25 September 2024, MSD announced that Japan’s Ministry of Health, Labour and Welfare approved its Keytruda® (pembrolizumab) in combination with chemotherapy as a neoadjuvant treatment, then continued as monotherapy… Read more here.


Talquetamab

27 September 2024 | AU | Latest Australian Approvals Include Janssen’s Talvey® (Talquetamab) Plus Infliximab and Adalimumab Biosimilars

On 27 September 2024, the Australian Therapeutic Goods Administration (TGA) approved Pfizer’s Ixifi™, biosimilar to Janssen’s Remicade® (infliximab), in 100mg powder for injection vial… Read more here.


Ustekinumab

27 September 2024 | EU | US |  Approval Alert: Formycon/Fresenius’ Ustekinumab Biosimilar Approved in US and Europe

On 27 September 2024, Formycon and Fresenius Kabi announced that Otulfi®/FYB202, biosimilar to Janssen’s Stelara® (ustekinumab), has received approval from both the European Commission and the US FDA… Read more here.

26 September 2024 | UK | Janssen Refused Leave to Appeal UK Court Decision Revoking Stelara® (Ustekinumab) UC Patent

In a short decision published on 26 September 2024, Justice Meade of the High Court of Justice of England and Wales has refused Janssen leave to appeal from a decision that the UK counterpart of Janssen’s European Patent… Read more here.


Ustekinumab | Adalimumab

25 September 2024 | Biocon Presents New Data on Ustekinumab and Adalimumab Biosimilars

On 25 September 2024, Biocon Biologics Ltd announced new data on its adalimumab and ustekinumab biosimilars, presented at the 2024 European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam… Read more here.


Vedolizumab

25 September 2024 | Alvotech’s Vedolizumab Biosimilar Enters the Clinic in Ph 3 Trial

On 25 September 2024, Alvotech announced commencement of a Phase 3 clinical trial for AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab), in moderate to severe ulcerative colitis… Read more here.


Zolbetuximab

20 September 2024 | EU | KR | Approval Alert: Astellas’ Vyloy™ (Zolbetuximab) Approved for Gastric Cancer in Europe and Korea

On 20 September 2024, Astellas Pharma announced that the European Commission has approved Vyloy™ (zolbetuximab) in combination with fluoropyrimidine- and platinum-containing chemotherapy… Read more here.

 

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.

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

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: Sanofi and Regeneron’s Dupixent® Approved in US and China for COPD

On 27 September 2024, Sanofi and Regeneron announced that Dupixent® (dupilumab) has been approved in the US as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.  On the same date, the companies announced that China’s National Medical Products Administration (NMPA) has approved Dupixent® for the same indication.

This follows the UK approval of Dupixent® as an add-on maintenance treatment for COPD earlier this month.

In July 2024, Dupixent® received European approval as an add-on maintenance treatment for adults with uncontrolled COPD, the first approval of Dupixent® for COPD anywhere in the world.  In the same month, Sanofi reported that Q2 2024 Dupixent® sales grew by 29.2% to over €3.3B.

Latest Australian Approvals Include Janssen’s Talvey® (Talquetamab) Plus Infliximab and Adalimumab Biosimilars

On 27 September 2024, the Australian Therapeutic Goods Administration (TGA) approved Pfizer’s Ixifi™, biosimilar to Janssen’s Remicade® (infliximab), in 100mg powder for injection vial for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn’s disease, refractory fistulising Crohn’s disease and ulcerative colitis.

This is the second approval for a Pfizer-sponsored infliximab biosimilar, with Inflectra® having been the first infliximab biosimilar approved in Australia in November 2015.

On 26 September 2024, the TGA provisionally approved Janssen’s Talvey® (talquetamab) in 2mg/ml and 40mg/ml solutions for injection vial for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least four prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.  Talvey® was granted accelerated approval in the US by the FDA in August 2023.

Also on 26 September 2024, Celltrion’s Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), received Australian approval for a lower dose of 20mg/0.2ml solution for injection pre-filled syringe.  Yuflyma® has previously been approved in Australia in 40mg/0.4ml (March 2022) and 80mg/0.8ml (30 June 2023) forms and was PBS listed in March 2023 (40mg/0.4ml).

Approval Alert: Formycon/Fresenius’ Ustekinumab Biosimilar Approved in US and Europe

On 27 September 2024, Formycon and Fresenius Kabi announced that Otulfi®/FYB202, biosimilar to Janssen’s Stelara® (ustekinumab), has received approval from both the European Commission and the US FDA.  The European approval is for moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis and active psoriatic arthritis, while the US approval is for the same indications with the addition of ulcerative colitis.

Otulfi®/FYB202 is being commercialised in the US and most of Europe by Fresenius Kabi, under a global licence agreement entered into between Formycon and Fresenius in February 2023.  Under the agreement, Fresenius has exclusive commercialisation rights to the ustekinumab biosimilar in key global markets, while Formycon retains semi-exclusive commercialisation rights in Germany, parts of the MENA region and Latin America.

In March 2024 Formycon and Fresenius announced they reached a settlement with J&J/Janssen regarding the commercialisation of FYB202 in Europe and Canada.  This followed a US settlement in August 2023, enabling US launch of FYB202 “no later than 15 April 2024”.

Ustekinumab biosimilars previously approved in Europe are Samsung Bioepis’ Eksunbi™ (September 2024), Celltrion’s SteQeyma®/CT-P47 (August 2024), Amgen’s Wezenla™ (June 2024), Sandoz/Samsung Bioepis’ Pyzchiva®/SB17 (April 2024, launched July 2024), and Alvotech/Stada’s Uzpruvo® (January 2024, launched July 2024).  Bio-Thera’s MAA for BAT2206 (ustekinumab) was accepted by the EMA in July 2024.

In the US, approved ustekinumab biosimilars are Samsung Bioepis’ Pyzchiva®/SB17 (July 2024), Alvotech/Teva’s Selarsdi™ (April 2024) and Amgen’s Wezlana® (October 2023).  Further approvals and are anticipated in light of J&J/Janssen’s ustekinumab settlements with Biocon (BLA for Bmab 1200 accepted May 2024, US launch dated no later than 22 February 2025), Accord BioPharma (BLA for DMB-3115 accepted January 2024, US launch date no later than 15 May 2025) and Celltrion (application submitted with the FDA for CT-P43 in June 2023, US launch date of 7 March 2025).

Pfizer Etanercept Battle Continues: A Lesson in Discovery and Case Management Principles

 

Date of decision: 18 June 2024
Body:  Federal Court
Adjudicator: Justice Burley

Highlight

On 18 June 2024, Justice Burley delivered a decision regarding documentary discovery in the long running dispute between Pfizer (Pfizer Ireland Pharmaceuticals and Pfizer Australia) and four of its competitors over AU2005280034 for the “Production of polypeptides” (the Pfizer Patent).  Justice Burley’s decision illustrates clearly the Federal Court’s strict approach to confining discovery only to the production of documents that are directly relevant to the issues in dispute. Following this strict approach, his Honour declined to order discovery of Pfizer’s research & development documents, warning that the relevance of the patentee’s research & development documents to a lack of inventive step ground will vary from case to case. His Honour did however order the production of documents in a second category given its direct relevance to the pleaded lack of best method case. His Honour also took the opportunity to comment on the parties’ case management, criticising what he described as the “poorly focussed, scattergun approach” to lack of inventive step, and requiring the parties to reduce the scope of the currently pleaded case which at the time of Justice Burley’s decision involved over 80 combinations of common general knowledge and prior art documents.

Background

In the proceedings, Pfizer has alleged that Organon (Organon LLC and Organon Pharma), Samsung Bioepis (Samsung Bioepis Co. Ltd and Samsung Bioepis Australia), MSD (Merck Sharp Dohme Corp and Merck Sharp Dohme Australia) and two Arrow companies (the Respondents) infringe the Pfizer Patent in their manufacture of etanercept, a biologic used in the treatment of autoimmune diseases. Pfizer manufactures and sells etanercept under the brand name ENBREL®. The Respondents have cross-claimed alleging that the Pfizer Patent is invalid on numerous grounds including want of novelty, lack of inventive step, inutility and failure to disclose the best method.

The proceedings are not far advanced, despite Pfizer commencing the proceedings in May 2022. Pleadings have closed but no affidavit evidence has been filed. Affidavit evidence in chief is due to be filed in December 2024, with answer affidavit evidence due in April 2025. The proceeding has then been listed for a three week hearing in September to October 2025.

Key Issues

In advance of filing any affidavit evidence, the Respondents sought discovery in two categories, summarised as follows:

  1. Category One: documents recording the research and development on the claimed invention between August 2002 and August 2004. The Respondents argued that Category One documents were relevant to both the lack of inventive step and inutility grounds.
  2. Category Two: all documents created or dated before the filing date of the patent concerning the production of etanercept or “TNFR-Ig” as described in Example 16 of the Pfizer Patent. The Respondents argued that Category Two documents were relevant to the lack of best method ground.

Outcome

Category One

Justice Burley did not order discovery in Category One for two key reasons.

First, the Federal Court Rules require that documents be “directly relevant to the issues raised by the pleadings or in the affidavits” to be discoverable. Lack of inventive step is an objective test which requires the Court to consider whether a person skilled in the art would have found the invention to be obvious “…which is a remove from the steps taken by the inventors themselves”. So, the patentee’s research and development documents, while relevant to the question of inventive step, are of secondary significance only. The Respondents’ inventive step pleading emphasised the secondary significance of the research and development documents, giving “no inkling that [the inventor’s own path to the invention was] relevant at all”.

Second, section 37M of the Federal Court of Australia Act 1976 (Cth) “requires the court to be astute to the quick, inexpensive, and efficient disposition of cases”. The Judge considered that the Category One documents could be viewed as “an exercise in fishing”. While there was no evidence that discovery of these documents would be oppressive, additional work would be required by Pfizer to locate and produce the documents, by the Respondents to review and assess the documents and by the Court, all of which would add to the cost of the proceedings.

Justice Burley also did not consider that the inutility ground supported discovery of Category One documents. His Honour, however, indicated that he would order Category One discovery if Pfizer ultimately file affidavit evidence from the inventors.

In considering the Category One discovery, Justice Burley made some initial observations on the Respondents’ lack of inventive step case which relies on the common general knowledge considered alone or alternatively in combination with multiple prior art documents considered separately or in combination. The combinations and permutations of the prior art add up to over 80 variations of common general knowledge and prior art documents. Justice Burley expressed his dissatisfaction with the Respondents’ approach on inventive step, noting that “[g]iven the number of permutations and items of prior art pleaded, it may be said that the lack of inventive step case takes something of a poorly focussed, scattergun approach”. In response, the Respondents have undertaken to streamline their lack of inventive step case in the coming months.

Category Two

Justice Burley ordered discovery in Category Two (in a slightly amended and narrower form than sought by the Respondents) as the category is directly relevant to the Respondents’ lack of best method pleading. The Respondents expressly plead that the best method is set out in Example 16, but that Example 16 omits certain information which may be inferred to be known to the patent applicant at the time of filing the patent application. His Honour also considered that the Respondent’s pleaded case was to some extent supported by the evidence of Dr Denis Drapeau, one of the co-inventors, whose declaration was annexed to an affidavit filed by Pfizer in response to the Respondents’ discovery application.

Implications

Justice Burley’s decision is a timely reminder of the Federal Court’s strict approach on discovery applications. Discovery will only be ordered for documents directly relevant to the issues in dispute.

His Honour’s decision is also a timely reminder that the Court seeks to conduct proceedings in accordance with section 37M of the Federal Court of Australia Act 1976 (Cth) which “…requires the court to be astute to the quick, inexpensive, and efficient disposition of cases”. The Court looks to the parties to run cases in as streamlined and as cost-effective manner as possible. His Honour took the opportunity to comment on the parties’ case management, criticising what he described as the “poorly focussed, scattergun approach” to lack of inventive step, and requiring the parties to reduce the scope of the currently pleaded inventive step case.

 

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.

Janssen Refused Leave to Appeal UK Court Decision Revoking Stelara® (Ustekinumab) UC Patent

In a short decision published on 26 September 2024, Justice Meade of the High Court of Justice of England and Wales has refused Janssen leave to appeal from a decision that the UK counterpart of Janssen’s European Patent No. EP 3883606, relating to the use of ustekinumab for treating ulcerative colitis, is invalid.

The matter involves litigation brought by Samsung Bioepis seeking to invalidate the Janssen patent on the grounds of novelty and obviousness.  Janssen counter-claimed against Samsung Bioepis for patent infringement.  On 30 July 2024, Justice Meade issued a decision in Samsung Bioepis’ favour, holding that the Janssen patent is invalid for obviousness in light of a slide presentation entitled “Safety and efficacy of Ustekinumab Induction Therapy in Patients with Moderate to Severe UC: Results from the Phase 3 UNIFI Study” delivered at the October 2018 American College of Gastroenterology conference.

Justice Meade’s ruling against Janssen’s application for leave to appeal his decision is another resounding success for Samsung Bioepis.  Justice Meade stated that the key argument on which Janssen relied to seek leave to appeal had “no prospect of success” and it was “not legitimate to raise it at this stage.  If it was to have been taken, it could and should have been taken at trial”.

The matter will now return to court for Justice Meade to deal with costs and other consequential matters.

Samsung Bioepis’ ustekinumab biosimilar (SB17) was approved in Europe in April 2024 as Pyzchiva®. Pyzchiva® will be commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.

Data Shows Sustained Efficacy of Eli Lilly’s Ebglyss™ (Lebrikizumab) for Atopic Dermatitis

On 25 September 2024, Eli Lilly published three-year data for its atopic dermatitis treatment, Ebglyss™ (lebrikizumab-lbkz).  The results, presented at the European Academy of Dermatology and Venereology (EADV), reportedly show that more than 80% of adults and adolescents with moderate-to-severe atopic dermatitis who responded to Ebglyss™ at week 16 and continued treatment for up to three years experienced sustained skin clearance with monthly maintenance dosing.  The results are also reported to show that nearly 87% of patients did not require high-potency topical corticosteroids or systemic treatments during the study period.

Earlier this month, the US FDA approved Ebglyss™ for adults and children 12 years and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled despite treatment with topical prescription therapies.

New Indication Alert: MSD’s Keytruda® Approved in Japan for NSCLC and Urothelial Carcinoma

On 25 September 2024, MSD announced that Japan’s Ministry of Health, Labour and Welfare approved its Keytruda® (pembrolizumab) in combination with chemotherapy as a neoadjuvant treatment, then continued as monotherapy, for patients with non-small cell lung carcinoma (NSCLC).  This NSCLC indication approval is based on results from the Phase 3 KEYNOTE-671 trial and follows approvals for the same indication in the EU (March 2024) and US (October 2023).

On the same date, MSD announced that Keytruda® has also been approved in Japan as monotherapy for patients with radically unresectable urothelial carcinoma who are not eligible for any platinum-containing chemotherapy and, in combination with Astellas’ Padcev® (enfortumab verdotin-ejfv), for first-line treatment of radically unresectable urothelial carcinoma.  These approvals were based on results of the Phase 2 KEYNOTE-052 and Phase 3 KEYNOTE-A39 trials, respectively.

The Padcev®/Keytruda® combination was approved in Europe earlier this month as first-line treatment for unresectable or metastatic urothelial cancer and in the US in December 2023 for the same indication.  Padcev®, an antibody drug conjugate, is co-developed by Astellas and Pfizer under a global development and commercialisation collaboration.

Biocon Presents New Data on Ustekinumab and Adalimumab Biosimilars

On 25 September 2024, Biocon Biologics Ltd announced new data on its adalimumab and ustekinumab biosimilars, presented at the 2024 European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam.

The first set of data is results from a Phase 3 study comparing the efficacy, safety, immunogenicity, and pharmacokinetics of Biocon’s Bmab 1200 (bUstekinumab), with Janssen’s Stelara® (ustekinumab) in adult patients with moderate to severe chronic plaque psoriasis.  The results are said to show biosimilarity between Bmab 1200 and Stelara®.

In May 2024, Biocon announced that the FDA accepted its BLA for Bmab 1200 for review under the 351(k) pathway.  In February 2024, Biocon entered a settlement agreement with Janssen enabling it to launch Bmab 1200 in the US in February 2025.  A second patent settlement and licence agreement was entered between Biocon and Janssen in August 2024, allowing Biocon to commercialise Bmab 1200 in Europe, the UK, Canada and Japan.  Biocon has submitted regulatory applications in each of these jurisdictions.

The second set of data is results from a Phase 3 study evaluating repeated switches between Biocon’s Hulio® (adalimumab-fkhp, 40mg/0.8ml) and AbbVie’s high-concentration Humira® (adalimumab, 40mg/0.4ml) in patients with moderate to severe chronic plaque psoriasis.  This data reportedly shows interchangeability between the two products.  Biocon says it has submitted the data to the FDA to support an interchangeable designation for its adalimumab biosimilar.

Biocon’s Hulio® (adalimumab-fkhp) was first approved in Europe in 2018 and in the US in 2020.

Alvotech’s Vedolizumab Biosimilar Enters the Clinic in Ph 3 Trial

On 25 September 2024, Alvotech announced commencement of a Phase 3 clinical trial for AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab), in moderate to severe ulcerative colitis.

In August 2024, Intas Pharmaceutical received approval from India’s Central Drug Standard Control Organisation (CDSCO) to conduct a Phase 3 clinical study of its vedolizumab biosimilar, INTP53.  In February 2024, Polpharma Biologics announced that its PB016 (vedolizumab) demonstrated pharmacokinetic and pharmacodynamic equivalence to Entyvio®.

Takeda obtained FDA approval of Entyvio® (vedolizumab) for ulcerative colitis in September 2023, and more recently (in April 2024) has received FDA approval for subcutaneous administration of Entyvio®.

Show Me the Money!

Australian Mud:

Date of decision: 1 May 2024
Body:  Federal Court of Australia
Adjudicator: Justice Besanko

Vald:

Date of decision: 28 June 2024
Body:  Federal Court of Australia
Adjudicator: Justice Downes

The Federal Court has continued its run of decisions on contested costs orders.  The cost of litigating patent disputes in the Federal Court is high.  To maximise the costs recovered, parties are issuing Notices of Offer (pursuant to the Federal Court Rules) and Calderbank letters.  These are designed to put the other party at risk of an indemnity costs order should they reject the offer and the first party ultimately receive a more favourable judgment.  Indemnity costs orders enable a successful party to claw back up to 100% of their legal costs, whereas a party/party costs order typically only provides a successful party with around 60% of their actual legal costs.  So, significant sums of money can be at stake as a result of an effective or ineffective Notice of Offer or Caldberank letter.

Here, we discuss the outcome of the contested costs orders in the long-running litigation between:

  1. Australian Mud Company Pty Ltd (Australian Mud) and Reflex Instruments Asia Pacific Pty Ltd (Reflex) against Globaltech Corporation Pty Ltd and Globaltech Pty Ltd (together, Globaltech) regarding a type of core sample orientation tool for use in mapping cores drilled in mining operations; and
  2. Vald Pty Ltd and KangTech Pty Ltd regarding an apparatus for use in assessing the strength of a knee flexor muscle of a person.

Australian Mud and Reflex v Globaltech

Australian Mud and Reflex sought an order for the two Globaltech companies to pay their costs on a party/party basis from 26 March 2019 to 22 February 2023, and then on an indemnity basis from 22 February 2023 onwards.  Australian Mud and Reflex submitted that an indemnity costs order from this date onwards was appropriate as they had achieved a more favourable outcome than that set out in their Notice of Offer which Globaltech had rejected.  So, the issue for the Judge was whether Australian Mud and Reflex had in fact achieved a more favourable outcome from the litigation.

In the Notice of Offer, Australian Mud and Reflex offered a full and final resolution of their monetary claim if the two Globaltech companies paid them $7,100,000.  Rejecting the Notice of Offer, the two Globaltech companies were ultimately ordered to jointly pay an amount lower than $7,100,000 (the Joint Amount), with one of the Globaltech companies separately ordered to pay another sum of money (Separate Amount).  The Joint and Separate Amounts totalled more than $7,100,000.

Globaltech argued that the offer was made jointly to both Globaltech companies, and so, the relevant amount was the amount both companies were ordered to pay. On that approach, it was clear that the outcome was not more favourable than the terms of the offer.

The Judge disagreed with Globaltech, holding that there should be an order that Globaltech pay indemnity costs as claimed by Australian Mud and Reflex. In the Judge’s opinion:

  1. the Globaltech companies were closely related parties; one was the operating company and the other had no assets or employees; and
  2. those in the Globaltech Group who considered the offer would not have placed any weight on the difference between the two companies. Instead, they would have considered the offer from the point of view of the amount of the offer.

Vald v KangaTech

The starting position on costs was that the Judge considered that Vald should be the beneficiary of a costs order in its favour.  The Judge had held in an earlier decision that the Vald patent was valid and infringed by the original but not the modified KangaTech products.  See here for our report on the Judge’s earlier decision on liability.  KangaTech, however, argued that it should receive an indemnity costs order following a Notice of Offer and Calderbank Letter (the Offers).

The Judge disagreed, finding that an indemnity costs order was not appropriate because:

  1. The Offers did not include any agreement by KangaTech to submit to an inquiry as to whether additional damages ought to be awarded, and if so, in what amount. Vald had ultimately obtained such an order in the proceedings.
  2. The Offers did not include an undertaking in the same terms as the general injunctive relief, or an offer to consent to any declarations. Vald had sought this relief in its Amended Originating Application and was ultimately awarded this relief in the proceedings.

So, in the Judge’s opinion, Vald did not obtain a judgment that was less favourable than the terms of the Offers.  Her Honour also did not consider that Vald had acted unreasonably in continuing its claim, particularly given that the central issue of the interpretation (construction) to be given to the Vald Patent remained unresolved and as KangaTech had made only limited admissions as to infringement at the time of the Offers.

Conclusion

The outcomes of these contested costs orders underscore the significant financial implications of effective Notices of Offer and Calderbank letters in patent litigation.  In Australian Mud and Reflex v. Globaltech, the Judge ruled in favour of indemnity costs for Australian Mud and Reflex, emphasising the joint nature of the offer and the relationship between the Globaltech companies.  Conversely, in Vald v. KangaTech, the Judge denied indemnity costs to KangaTech due to the inadequacies in their offers, highlighting the importance of comprehensive and inclusive settlement proposals.  These cases illustrate the critical role of strategic cost management in high-stakes legal disputes.

 

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.

Pearce IP’s Founder & CEO is a Finalist for the Lawyers Weekly Women in Law “Executive of The Year” 2024

We are thrilled to share that Pearce IP’s Founder and CEO, Naomi Pearce, a Finalist in the Lawyers Weekly Women in Law Awards 2024 “Executive of Year. 

Now in its 13th year, the Women in Law Awards celebrates the best and brightest women in the legal field, recognising their dedication to their clients and their contributions to advancing the legal profession to new heights of excellence. 

Naomi was the Lawyers Weekly Women in Law Partner of the Year (SME Law) in 2021, and we are delighted to see her shortlisted for the “Executive of the Year” in 2024, with the winner to be announced on 23 October 2024. 

Pearce IP’s Executive, Deputy CEO and Head of Talent, Adele Chadwick, says:

Naomi epitomises excellence, in her client relationships, employee engagement and as a leader who demonstrates this core value of Pearce IP each and every dayWe are so inspired by Naomi, her achievements and her vision for Pearce IPHer consistent push to be at the forefront of leading-edge employee policy, client initiatives and strategic growth provide her team with insight and motivation to excel in every aspect of their role.  Congratulations Naomi! 

Pearce IP’s Executive Lawyer, Helen Macpherson, says:

The Pearce IP team is incredibly proud to see Naomi nominated again for this award.  Her nomination is a tribute to her inspiring and fearless leadership of the firm, unique contribution to the profession and first-class work with clients

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.

 

Pearce IP BioBlast® for the week ending 20 September 2024

Aflibercept

19 September 2024 | EU | Sandoz & Samsung Bioepis/Biogen Aflibercept Biosimilars Recommended in Europe

At its September meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Sandoz’s and Samsung Bioepis/Biogen’s biosimilars to Regeneron’s Eylea® (aflibercept)… Read more here.


Amivantamab

19 September 2024 | US | New Indication Alert: J&J’s Rybrevant® Combination US-Approved for NSCLC

On 19 September 2024, Johnson & Johnson (J&J) announced that it received FDA approval for Rybrevant® (amivantamab-vmjw) in combination with standard of care chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients… Read more here.


Belantamab mafodotin

17 September 2024 | JP | GSK’s NDA for Blenrep® Combinations Accepted in Japan

On 17 September 2024, GlaxoSmithKline (GSK) announced that Japan’s Ministry of Health has accepted for review a new drug application for Blenrep® (belantamab mafodotin) in combination with BorDex (bortezomib plus dexamethasone)… Read more here.


Benralizumab

18 September 2024 | US | New Indication Alert: AstraZeneca’s Fasenra® FDA-Approved for EGPA

On 18 September 2024, AstraZeneca announced that its Fasenra® (benralizumab) has been approved by the FDA for eosinophilic granulomatosis with polyangiitis (EGPA).  The approval was based on positive results from a Phase 3 trial (MANDARA)… Read more here.


Dupilumab

12 September 2024 | UK | New Indication Alert: Sanofi and Regeneron’s Dupixent® Approved in UK for COPD

On 12 September 2024, PM Live reported that Sanofi and Regeneron’s Dupixent® (dupilumab) has been approved by the UK Medicines Healthcare products Regulatory Agency (MHRA) as an add-on maintenance treatment… Read more here.


Lebrikizumab

13 September 2024 | US | Approval Alert: FDA Approves Eli Lilly’s Ebglyss® for Eczema

On 13 September 2024, Eli Lilly announced that its Ebglyss® (lebrikizumab-lbkz) received FDA approval for adults and children 12 years and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled… Read more here.


Marstacimab | Serplulimab

19 September 2024 | EU | CHMP Positive Opinions for 3 New Biologics and Extended Indications for 5 in EU

At its September 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three new biologics, each of which was designated as an orphan medicine during development… Read more here.


Patritumab deruxtecan

17 September 2024 | Daiichi/MSD Ph 3 Trial Shows Patritumab Deruxtecan Improves Progression-Free Survival in NSCLC

On 17 September 2024, Daiichi Sankyo and MSD announced positive results from a Phase 3 trial of their antibody drug conjugate, patritumab deruxtecan (HER3-DXd).  In the trial (HERTENA-Lung02), patritumab deruxtecan showed… Read more here.


Pembrolizumab

18 September 2024 | US | New Indication Alert: MSD’s Keytruda® Plus Chemo FDA-Approved for MPM

On 18 September 2024, Merck (known as MSD outside the US and Canada) announced that Keytruda® (pembrolizumab) has been approved by the FDA, in combination with pemetrexed and platinum chemotherapy… Read more here.


Semaglutide

19 September 2024 | EU | EMA’s CHMP Recommends Expanded Wegovy® Label for Obesity-Related HFpEF

On 19 September 2024, Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for a label expansion for Novo Nordisk’s Wegovy® (semaglutide 2.4mg)… Read more here.

10 September 2024 | Iconovo Commences Development of Intranasal Semaglutide

On 10 September 2024, Swedish CDMO, Iconovo, announced that it has commenced developing an intranasally inhaled form of semaglutide for treatment of obesity.  The product will reportedly use an improved form… Read more here.


Trastuzumab

18 September 2024 | US | Accord BioPharma Receives FDA Approval for Second Strength of its Biosimilar Trastuzumab

On 18 September 2024, Accord BioPharma announced that the FDA has approved a 420mg strength of its Hercessi™ (trastuzumab-strf), biosimilar to Roche’s Herceptin®, for HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma… Read more here.


Ustekinumab

17 September 2024 | Formycon to Present Clinical Data on FYB202 (Ustekinumab) Later This Month

Formycon has announced that it will present study data for Fymskina (FYB202), biosimilar to Janssen’s Stelara® (ustekinumab), at the 2024 European Academy of Dermatology and Venerology Congress (25 to 28 September in Amsterdam)… Read more here.

 

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.

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

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.

 

Positive 52-Week, Ph 3 Results for Celltrion’s Aflibercept Biosimilar

On 23 September 2024, Celltrion announced that it presented the 52-week results of its Phase 3 trial of Eydenzelt™ (CT-P42), biosimilar to Regeneron’s Eylea® (aflibercept), at the European Society of Retina Specialists (EURETINA) conference held from 19-22 September in Barcelona.

Celltrion reports that the Phase 3 trial showed that Eydenzelt™ has comparable efficacy and safety to Eylea® over 52 weeks in patients with diabetic macula oedema (DME).

Eydenzelt™ was approved in Korea in May 2024.  Celltrion sought EU marketing authorisation for CT-P42 in November 2023 and filed an NDA with the FDA in June 2023.

In November 2023 and May 2024, Regeneron commenced US BPCIA proceedings against Celltrion in the US District Court (Northern District of West Virginia), alleging infringement of 38 and 25 patents respectively relating to aflibercept.  These proceedings are ongoing.

US Court Refuses Preliminary Injunction Regarding Amgen’s Aflibercept Biosimilar

On 23 September 2024, the United States District Court for the Northern District of West Virginia denied Regeneron’s motion for a preliminary injunction against Amgen seeking to prevent it from launching Pavblu™, biosimilar to Regeneron’s Eylea® (aflibercept), in the US.  The order is currently under seal.

On the same date, Regeneron filed an appeal from the preliminary injunction determination.

The proceeding against Amgen is part of consolidated, multi-district BPCIA litigation brought by Regeneron regarding aflibercept biosimilars against each of Amgen (aBLA for ABP 938/Pavblu™ accepted by FDA in October 2023 and approved in August 2024), Samsung Bioepis (2 actions; Opuviz™/SB15 approved May 2024), Biocon (Yesafili™ approved May 2024), Formycon (Ahzantive®/FYB203 approved June 2024), Celltrion (2 actions, aBLA for CT-P42 submitted to FDA in June 2023) and Sandoz (Enzeevu™ approved August 2024).

The Court’s refusal to grant a preliminary injunction against Amgen differs from decisions of the same Court to grant preliminary injunctions against Samsung Bioepis (14 June 2024), Formycon (21 June 2024) and Celltrion (June-July 2024), and a permanent injunction against Biocon (11 June 2024), based on findings of infringement of Regeneron’s US patent 11,084,865 (ophthalmic formulations of a VEGF antagonist).

Samsung Bioepis, Formycon and Celltrion lodged appeals from the preliminary injunction orders (on 14 June 2024, 25 June 2024, and 10 July 2024, respectively).  Biocon filed a Notice of Appeal from the permanent injunction order on 21 June 2024.  Those appeals are all pending.

New Indication Alert: FDA Approves Bimzelx® for Three New Indications

On 23 September 2024, UCB announced that its Bimzelx® (bimekizumab-bkzx) has received FDA approval for active psoriatic arthritis, active non-radiographic axial spondyloarthritis with objective signs of inflammation and active ankylosing spondylitis.  UCB reports that Bimzelx® is the first approved treatment for these three indications that is designed to selectively inhibit two key cytokines driving inflammatory processes – IL-17A and IL-17F.

This follows US approval of Bimzelx® in October 2023 for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

In April 2024, Australia’s PBAC recommended Bimzelx® for listing on the PBS for severe psoriatic arthritis.  Bimzelx® is also potentially in line for PBS-listing for psoriatic arthritis and ankylosing spondylitis, having previously been listed for chronic plaque psoriasis.

In March 2024, the EU’s Committee for Medicinal Products for Human Use (CHMP) recommended an indication extension for Bimzelx® for the treatment of hidradenitis suppurativa.  Bimzelx® was first approved in the EU in August 2021 for moderate to severe plaque psoriasis.

New Indication Alert: FDA Approves Sanofi’s Sarclisa® for Multiple Myeloma

On 20 September 2024, Sanofi announced that the US FDA has approved Sarclisa® (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT).  This approval is the third indication for Sarclisa® in the US and the first indication in newly diagnosed patients.

Sarclisa® has previously been approved in over 50 countries (in combination with pomalidomide and dexamethasone) for treatment of relapsed refractory MM (RRMM) who have received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor and who progressed on last therapy.  Sarclisa® has also been approved (in combination with carfilzomib and dexamethasone), including in the US for the treatment of patients with RRMM who have received 1–3 prior lines of therapy and in the EU for patients with MM who have received at least one prior therapy.

Approval Alert: Astellas’ Vyloy™ (Zolbetuximab) Approved for Gastric Cancer in Europe and Korea

On 20 September 2024, Astellas Pharma announced that the European Commission has approved Vyloy™ (zolbetuximab) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are claudin (CLDN) 18.2 positive.  European approval of Vyloy™ follows its recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use in July this year.

The Korea Biomedical Review has also recently reported that Vyloy™ has been approved for the same indication in Korea.

Vyloy™ is said to be the first therapy worldwide to target Claudin 18.2, a protein expressed in the stomach, and has previously been approved in the UK (August 2024),  Japan (March 2024) and China (August 2023).

New Indication Alert: J&J’s Rybrevant® Combination US-Approved for NSCLC

On 19 September 2024, Johnson & Johnson (J&J) announced that it received FDA approval for Rybrevant® (amivantamab-vmjw) in combination with standard of care chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor exon 19 deletions or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.

The approval is based on results from the Phase 3 MARIPOSA-2 (NCT04988295) study which showed that Rybrevant® plus chemotherapy reduced the risk of disease progression or death by 52 percent vs. chemotherapy alone.

In July 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended an indication extension for Rybrevant® for the same indication.

Rybrevant® will be considered for PBS listing by Australia’s PBAC for the NSCLC indication at its November 2024 meeting.

CHMP Positive Opinions for 3 New Biologics and Extended Indications for 5 in EU

At its September 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three new biologics, each of which was designated as an orphan medicine during development, and recommended indication extensions for five.

The new biologics are AbbVie’s antibody drug conjugate Elahere® (mirvetusimab soravtansine) for treatment of adults with ovarian, fallopian tube or primary peritoneal cancer (which received FDA approval in March 2024); Pfizer’s Hympavzi® (marstacimab) for bleeding episodes in patients aged 12 years and older with sever haemophilia A or B; and Henlius/Intas’ Hetronifly® (serplulimab) for first‑line treatment of adult patients with extensive‑stage small cell lung cancer (ES‑SCLC).

Hetronifly® (serplulimab) will reportedly be commercialised by Intas through its subsidiary, Accord Healthcare, across more than 30 countries in Europe.  Serplulimab has previously been launched as HANSIZHUANG in China, Indonesia, Cambodia and Thailand.

The five recommended indication expansions for biologics are:

In addition, two aflibercept biosimilars received positive opinions at CHMP’s September 2024 meeting, as reported here.

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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