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Biosimilars Deals 2021

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast updates below.

Merck and Pfizer pneumococcal conjugate vaccine settlement prolongs uncertainty regarding Australian product claims

Recently, Merck Sharp & Dohme (MSD) (known as Merck & Co., Inc. in the US and Canada) announced a settlement and licence agreement with Pfizer Inc. in relation to MSD’s pneumococcal conjugate vaccine (PCV) products, including VAXNEUVANCETM (Pneumococcal 15-valent Conjugate Vaccine).

In Australia, the Merck and Pfizer pneumococcal conjugate vaccine matter was considered by the Federal Court in Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477  (the Merck decision). Relevantly, the Merck decision included findings in relation to the validity of claims using the term “comprises” that sent a collective shiver down the spines of Australian patent applicants and their attorneys responsible for patent prosecution.

The claims in question defined a multivalent immunogenic composition comprising polysaccharide-protein conjugates, wherein each of the conjugates comprises a capsular polysaccharide from 13 different serotypes.  The Court construed the term “comprises” in the inclusive sense, which meant that the claims were found to encompass compositions with polysaccharide-protein conjugates from the 13 serotypes, as defined in the claims, as well as other polysaccharide-protein conjugates.  This was a significant issue for MSD because their vaccine product, having polysaccharide-protein conjugates prepared from 15 different serotypes, was found to infringe the claims in question.  However, the Court also found that because the technical contribution of the specification related only to the 13 serotypes defined in the claims, it did not provide support for additional polysaccharide-protein conjugates covered by the full scope of the claims.  For this reason, the claims were found to be invalid (at [551] and [552]).

The concern for Australian patent applicants was articulated by Wyeth who stated in their submissions that finding the claims invalid for lack of support was “contrary to patent law, because every product claim using the words ‘comprising’ or ‘including’ is liable to be revoked for lack of support” (at [555]).  However, the Court rejected this view by asserting that, “Whether other claims are invalid will depend on the particular language they use, and the scope of the disclosure in the relevant specification” (at [555]).

It is hardly surprising that Australian applicants, take little comfort from the Court’s view.  Most product claims use the words, “comprising”, “comprises” or “including” and, therefore, according to the Federal Court, these claims cover products having the defined components as well as any other components, including components that are not described in the description of the specification.  This arguably supports Wyeth’s view that many granted Australian product claims could be invalidated for lack of support.

The Merck decision at first instance was appealed and heard by the Full Court of the Federal Court in May 2021.  As the appeal decision was pending when the settlement between MSD and Pfizer was announced, no Full Court decision will be issued.  This leaves many Australian applicants uncertain in relation to the strength of their product claims.  Importantly, from a practical perspective, it means that Australian patent attorneys should consider including claims directed to products that are limited to components described or enabled by the specification.

It is highly likely that this issue will be raised in future litigation and Pearce IP will keep you promptly advised of relevant outcomes.

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.

Kate Legge

Kate Legge

Special Counsel, Lawyer

Kate is an experienced IP and patent lawyer, providing IP leadership for pharmaceutical product development and commercialisation in global markets – from initial scoping through to post-launch.

She has developed and implemented global IP strategies over more than 15 years at multi-national pharmaceutical companies. She is an Australian qualified and registered legal practitioner, and has a Master’s degree in IP Law and a BSc in biochemistry.

Pearce IP BioBlast®: w/e 01 October 2021

27 Sep 21 | Hikma Pharmaceuticals announced that it will acquire Custopharm for an initial cash consideration of USD $375 million with a further USD $50 million in contingent consideration payable upon the achievement of certain commercial milestones.

27 Sep 21 | CN | JW Therapeutics announced that China’s NMPA has approved the IND for a clinical trial of BCMA-targeted Chimeric Antigen Receptor (CAR) T cell JWCAR129 in treating relapsed or refractory multiple myeloma.

27 Sep 21 | JP | AbbVie, Eisai Co and EA Pharma announced Humira® (adalimumab) has received additional approvals in Japan for its high-dose regimen in adults with ulcerative colitis and in a new regimen in paediatric patients.

27 Sep 21 | A new study published in Annals of Internal Medicine reported that a live virus Varicella-Zoster vaccine in immunosuppressed patients receiving biologic therapies may be a reasonable option if no alternative vaccine is available.

28 Sep 21 | US | Eli Lilly announced that the FDA has approved Erbitux® (cetuximab) in combination with Braftovi® (encorafenib) for the treatment of metastatic colorectal cancer with a BRAF V600E mutation.

29 Sep 21 | US | The US House Judiciary Committee voted in favour of the Preserve Access to Affordable Generics and Biosimilars Act. If passed, this act would allow the FTC to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connected with the sale of a drug or biological product.

30 Sep 21 | EU | Xbrane Pharma and STADA announced that the MAA for Xlucane™ (proposed biosimilar ranibizumab) has been submitted to the EMA.

01 Oct 21 | US, KR | Korea Biomedical Review reported that Celltrion has submitted an application for CT-P16 (proposed biosimilar bevacizumab) in the US and Korea.

01 Oct 21 | US | Coherus Biosciences announced that the FDA has accepted for review the BLA for CHS-201 (proposed biosimilar ranibizumab).

Celltrion submits MAA to EMA for regdanvimab

Celltrion announced that it has submitted a Marketing Authorisation Application to the EMA seeking approval of regdanvimab for the treatment of COVID-19 in adults who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID-19.

Coherus Biosciences announces positive results from study of Udencya® (biosimilar pegfilgrastim) administered via an on-body injector device

Coherus Biosciences announced positive results from a randomised, open-label, crossover study assessing the pharmacokinetic and pharmacodynamic bioequivalence of Udencya® (biosimilar pegfilgrastim) administered via an on-body injector device compared to the currently marketed Udencya® pre-filled syringe. Coherus plans to submit its application to the FDA in 2022 and expects to launch directly post approval.

Taking a position on patent infringement – position statements where multiple products accused

Surefoot IP Holdings Pty Ltd v All Footings Solutions Pty Ltd [2021] FCA 1181

Date: 30 September 2021
Court:  Federal Court of Australia
Judge: Rofe J

Background

The patentee (Surefoot) alleged that seven of the respondents’ (All Footings) products infringe Australian Patent 2012276281 (Patent), which relates to ‘footing plates’ to be placed at the base of posts, poles or upright beams to secure them in position. All Footings’ seven impugned footing plates differ in their features, most significantly in that six of the footing plates are square and one is circular.

Key Issues

At the first directions hearing, Surefoot was ordered to serve particulars of infringement. It subsequently filed a position statement on infringement (PSI). PSIs are described in the Federal Court Intellectual Property Practice Note, and are intended to concisely state the facts and matters relied upon in support of infringement allegations, including by reference to the particular integers of any claim alleged to have been infringed. In this case, Surefoot’s PSI addressed one of All Footings’ products by way of example, only briefly addressing relevant differences between it and the other six products.

All Footings disputed the adequacy of the PSI, submitting that the PSI should address each footing plate individually to indicate how differences between the products were relevant to the integers of the claims. They further submitted that it was unclear from the PSI how three of the integers of the claims were satisfied by the exemplified product; in simple terms, how one part of the product “originated” from another part, how one part of the product was connected to and supported another part, and how one part of the product was “offset” from another part. All Footings therefore sought amendment of the PSI.

Surefoot submitted that All Footings were fully informed of the infringement case based on the PSI and that each of the alleged deficiencies in the PSI resulted from the parties’ differing views on construction, which would be resolved at trial.

Outcome

Regarding All Footings’ first submission, Rofe J held that, insofar as the six square footing plates were concerned, it was sufficient to use an example footing plate as the basis for identifying the features said to correspond to the claim integers. However, it was not sufficient in the case of the seventh, circular footing plate. This was because several of the claim integers referred to “edges” (plural), and there was room for confusion as to how Surefoot construed these integers to read onto the product features. Surefoot was ordered to amend its PSI to address the circular footing plate specifically.

As to All Footings’ second submission, Rofe J applied established case law that the purpose of a PSI is to clarify the patentee’s construction of the integers of each asserted claim, not to justify or explain that construction. In each case, Surefoot’s construction of the relevant integer was clear from the PSI. All Footings were seeking an explanation or justification of that construction, which is a matter for trial. Surefoot was not required to amend its PSI to include such explanation or justification.

Implications

The judgment provides useful clarification on the use of a PSI and the level of detail required on points of construction. In the case of multiple allegedly infringing products, the PSI must adequately cover all features of each product to the extent that they materially differ from each other, but examples can be used where there are no such differences.

The judgment also highlights in a more general sense the utility of a PSI to force the patentee to adopt a specific construction of its claims and infringement position early on. By insisting that this is done precisely, a respondent can not only determine its response on infringement but also seek to prevent ‘slippage’ in construction arguments, particularly as an invalidity case takes shape.

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.

Pearce IP BioBlast®: w/e 24 September 2021

18 Sep 21 | Merck announced that the first results from Ph III trials of Keytruda® (pembrolizumab) showed a statistically significant and clinically meaningful improvement in recurrence-free survival compared to placebo in patients with resected high-risk stage II melanoma.

18 Sep 21 | KR | Celltrion announced that South Korea’s MFDS has approved regdanvimab for the extended use in elderly patients aged 50 years and over, or with at least one underlying medical condition with mild symptoms of COVID-19, and in adults patients with moderate symptoms of COVID-19.

20 Sep 21 | US | Samsung Bioepis and Biogen announced that the FDA has approved Byooviz® (biosimilar ranibizumab) for the treatment of neovascular (wet) age-related macular degeneration, macular edema and myopic choroidal neovascularisation.

20 Sep 21 | US | AbbVie announced it has submitted the regulatory application for Skyrizi® (risankizumab) for the treatment of patients 16 years and older with moderate to severe Crohn’s Disease.

20 Sep 21 | 180 Life Sciences and Celltrion announced that they have entered into a Memorandum of Understanding for the supply of an anti-TNF biosimilar drug to be used for new indications with significant unmet medical needs.

23 Sep 21 | Business Standard reported that Aurobindo Pharma (through the subsidiary CuraTeQ Biologics) has submitted a Marketing Authorisation Application to the EMA for BP14 (proposed biosimilar pegfilgrastim).

23 Sep 21 | PharmGene Science and Access Bio announced that they have signed a Memorandum of Understanding for the joint development and commercialisation of a biosimilar mRNA COVID-19 vaccine.

23 Sep 21 | Merck announced that it has entered into a global settlement and license agreement with Pfizer resolving the ongoing dispute relating to Merck’s pneumoccocal conjugate vaccine products.

Wrinkle for supplier of Botox ‘alternative’ as Court finds trade mark infringed, Australian Consumer Law breached

The Full Federal Court has held a supplier of cosmetic products (Self Care) liable to Allergan for infringing its BOTOX trade mark and for misleading or deceptive conduct.  In doing so, the Court reached novel conclusions as to circumstances in which the comparative advertising defence will not apply to what is ostensibly comparative advertising.

Background 

Allergan supplies the well-known Botox anti-wrinkle injections to consumers in Australia under trade marks including a BOTOX word mark, which is registered in class 3 and includes anti-wrinkle creams. Self Care sold anti-wrinkle creams in Australia using the marks “Protox” and “Inhibox”.  The Inhibox cream was marketed as an “instant Botox® alternative”.

At first instance, Justice Stewart dismissed Allergan’s case that the “Protox” and “instant Botox® alternative” marks infringed the BOTOX word mark, as well as all but one of Allergan’s Australian Consumer Law allegations.  Allergan appealed.

Trade mark infringement

Stewart J had found that most consumers on seeing an anti-wrinkle cream called Protox would immediately have been reminded of BOTOX, but that the two words were sufficiently distinct so as not to be confused with one another.  The Court explained that the correct question was whether the Protox mark would confuse consumers as to whether Protox came from the same source as Botox, not whether consumers would confuse the two marks.  It found that some consumers were likely to have wondered whether PROTOX was an alternative product offered by the suppliers of BOTOX, perhaps targeted to those who did not like injections or who wanted the convenience of a home treatment, or to improve or prolong the results of BOTOX.  The Court therefore considered there was a real risk of confusion as to source and that “Protox” was deceptively similar to BOTOX.

In reaching this conclusion, the Court noted the finding of Stewart J that ”Protox” had in fact been chosen because it would remind consumers of BOTOX, and that there was an intention to capitalise on BOTOX’s reputation.  Although the Court did not go so far as to find an intention to cause confusion, it noted the “rule” in Australian Woollen Mills that where a mark is adopted for appropriating the reputation of a rival, it should be presumed to be fit for that purpose.

Concluding that the “instant Botox® alternative” statement also infringed, the Court held that:

  • the statement was not being used in a purely descriptive way, and was used prominently in the advertising relative to “Inhibox”, which indicated that it had been used as a trade mark;
  • although the use of two descriptive words around Botox® made the mark less similar to BOTOX, that was not enough to avoid the real risk that consumers would wonder whether the product had a common origin with Botox;
  • none of Self Care’s defences could apply to the statement because the fact that it could cause consumers to wonder whether the product came from the same source as Botox precluded the statement merely indicating the intended purpose or characteristics of the product or its use in comparative advertising; and
  • the comparative advertising defence additionally did not apply because the words “instant” and “alternative” had not been used to compare the Inhibox and Botox products, but to leverage off Botox’s reputation, and this subjective intention was inconsistent with the application of the comparative advertising defence.
Misleading or deceptive conduct

Marketing Inhibox as an “alternative” to Botox constituted a representation that Inhibox was as effective as Botox at treating wrinkles.  Allergan did not significantly challenge Stewart J’s decision that it was not misleading or deceptive to assert that Inhibox reduced the appearance of wrinkles to a similar extent as Botox.  However, Allergan disputed Self Care’s grounds for asserting that Inhibox’s anti-wrinkle effects were as long-lasting as those of Botox.  Self Care had no evidence to support this assertion.  It followed that Inhibox was not a true alternative to Botox and Self Care’s representation to this effect was misleading or deceptive.

Analysis

The most significant legal development in this judgment may be the reasoning behind the Court’s decision that the statement “instant Botox® alternative” infringed the BOTOX trade mark.

The Court appeared convinced that the statement was not a genuine comparison of the attributes of competing products, but rather had been used as a trade mark.  The brevity of the statement and its prominence relative to other trade marks on the packaging or in advertisements were key to this conclusion.  Furthermore, the Court’s conclusion was that where ostensible comparative advertising could cause consumers to wonder whether the product being advertised comes from the same source as the rival product, the comparative advertising defence will not apply.

To date, there have been few cases in Australia on the comparative advertising defence to trade mark infringement, leaving would-be advertisers with little guidance in this area.  Where the topic has arisen, there has often been a focus on the accuracy of the comparisons made, rather than the question of whether use of the competitor’s mark was use as a trade mark or was likely to cause consumers to wonder whether there was a connection, given that the purpose of comparative advertising is generally, at least in part, to provide a favourable comparison with the competitor’s product.

However in light of the Court’s decision in this case, advertisers would be well advised to take considerable care when using a rival’s mark in any context. In particular, those wishing to market their product in Australia as having improved or comparable attributes to an existing product should ensure that comparisons are of sufficient length to be meaningful comparisons of attributes and that the comparison is not so prominent as to potentially be considered to be acting as a trade mark.

It further appears that the subjective motivation of the advertiser is potentially relevant to the issue, notwithstanding that the comparative advertising defence does not include a ‘good faith’ element.  Accordingly, discovery of documents relevant to the advertiser’s intention may be part of comparative advertising trade mark disputes going forward.

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.

Kate Legge

Kate Legge

Special Counsel, Lawyer

Kate is an experienced IP and patent lawyer, providing IP leadership for pharmaceutical product development and commercialisation in global markets – from initial scoping through to post-launch.

She has developed and implemented global IP strategies over more than 15 years at multi-national pharmaceutical companies. She is an Australian qualified and registered legal practitioner, and has a Master’s degree in IP Law and a BSc in biochemistry.