Biosimilars Deals 2021

Grunenthal GmbH [2026] APO 9 (16 March 2026)

Introduction

On 9 February 2024, AU Pharma Pty Ltd filed a request for re-examination of the granted claims of Grunenthal’s AU2008241013 patent relating to titration methods of tapentadol.  Tapentadol is a centrally acting analgesic known to be effective for the treatment of moderate to severe acute or chronic pain.

In Australia, re-examination is an ex-parte procedure, and as such, once AU Pharma submitted its request and supporting documents, it played no further role in the matter.  The initial re-examination request resulted in a first adverse re-examination report issuing on 26 March 2024, with a further 4 adverse re-examination reports issuing before the Commissioner advised that he intended to revoke the patent and Grunenthal requested to be heard on the matter on 20 June 2025.

Following the hearing, the Commissioner’s Delegate has determined that the majority of the claims (including claim 1) lacked novelty and inventive step in light of prior art clinical trial information.  The Delegate did, however, find claims 7 and 39 to be novel and inventive, and provided Grunenthal with a two-month deadline within which to file claim amendments based on the allowable subject matter.

Interestingly, on 17 April 2026, AU Pharma withdrew its re-examination request on the newly introduced claims, stating that AU Pharma no longer requested the Commissioner to re-examine or revoke any of the newly introduced claims of Grunenthal’s patent.

Background

The object of Grunenthal’s invention in the AU2008241013 patent was stated to be “…to improve the tolerability of tapentadol in the treatment of pain, preferably chronic pain, particularly to reduce the frequency of somnolence; one of the most frequent reported adverse events, as well as other adverse events, without diminishing the efficacy of the compound and the patient compliance”.

The invention involved initiating a treatment at low doses and successively increasing the dose according to a titration regimen.  The tolerability of tapentadol was said to be surprisingly improved by administering tapentadol according to the recited titration regimen.

Claim 1 defined the invention as follows:

Use of tapentadol for the manufacture of a medicament comprising

– a first dose of tapentadol of 50 mg ± 5% or 100 mg ± 5% to be taken twice daily (bid),

– a second dose of tapentadol to be taken twice daily (bid), wherein the second dose is calculated by increasing said first dose by 50 mg to 100 mg ± 5% or 150 mg ± 5%, respectively, and

– a third dose of tapentadol to be taken twice daily (bid), wherein the third dose is calculated by increasing said second dose by 50 mg to 150 mg ± 5% or 200 mg ± 5%, respectively

for the treatment of pain with a lower incidence of somnolence in a subject,

wherein the first dose is administered during a first administration interval of at least 1 to 3 days, the second dose is administered during a second administration interval of at least 3 to 11 days following said first administration interval, and the third dose is administered during a third administration interval of at least 3 to 14 days following said second administration interval.

Key Issues and Consideration

The key issues in consideration were novelty and inventive step.

The only prior art document under consideration was the clinical trial record, D2,  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: “A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain”, ClinicalTrials.gov [online], NCT00361504, version 1 April 2007.  Grunenthal argued that D2 did not anticipate the claimed invention or render the claimed invention obvious on the basis that there was no teaching or suggestion in D2 of lowering the incidence of somnolence in a subject.

The Delegate, however, concluded that D2 anticipated the majority of the claims (including claim 1) on the basis that the dosage regimen of tapentadol described in D2 was generally intended to reduce the incidence of side effects.  The primary and secondary outcomes of D2 included incidence of adverse events in general, changes in laboratory measures, results of physical examinations, pain intensity and patient global impression of change over one year.  While somnolence was not explicitly listed as a specific side effect to be monitored, it would nevertheless inevitably have been captured in “incidence of adverse events”.

At [57] the Delegate stated:

“there is no requirement that D2 explicitly hypothesise or test for a lower level of somnolence to provide clear and unmistakable directions to the method of claim 1. ……….the steps set out in D2 can only be carried out in a way that would fall within the scope of claim 1, including with respect to generating a lower level of somnolence.  Therefore, I must conclude that the result of treating pain with a lower level of somnolence is an inevitable result of D2.  As such it is not required to be explicitly stated that achieving a lower level of the specific side effect of somnolence is the goal for there to be anticipation of the Swiss style claims or method claims.”

In reaching this conclusion, the Delegate relied on the Full Federal Court decision in Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd [2020] FCAFC 116 in which the Full Court stated at [104]:

“We do not accept that a documentary disclosure containing a hypothesis cannot be an anticipatory disclosure that deprives an invention of novelty.  In such a case the question, simply put, remains: what does the prior document disclose? The occasion on which, or the context in which, a particular documentary disclosure is made may well inform the interpretation of the document’s content.  But if, as a matter of interpretation, the document nonetheless discloses that which is later claimed as an invention, that disclosure will anticipate the invention and deprive it of novelty.”

The Delegate then went on to find that the claims which lacked novelty also lacked an inventive step on the basis that there was nothing inventive about carrying out methods and treatments that had already been disclosed.

Outcome and Implications

Accordingly, the majority of the claims (including claim 1) were found to lack novelty and inventive step.  The Delegate, however, did find certain claims to be allowable and provided Grunenthal with an opportunity to file claim amendments based on the allowable subject matter.

The Delegate’s decision illustrates the power of a re-examination request when there is strong prior art which can be cited against the patent.  This decision is also yet another example of prior art clinical trial information being found to anticipate the claimed invention, despite the clinical trial information not providing any scientific proof or substantiation of the results.

About Pearce IP

Pearce IP is a specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

Teva Pharma Australia Pty Ltd & Bayer Australia Limited v Cipla Limited [2026] APO 7

Introduction

Cipla has defeated Teva’s and Bayer’s oppositions to its application for an extension of time in which to pay the renewal fee on AU2003244799 for a combination of azelastine and steroids (the Cipla Patent). This combination is used in the hay fever medication Dymista®, distributed by Alphapharm/Viatris in Australia.  The Delegate’s decision provides a textbook application of the principles underpinning an application for an extension of time, with Cipla providing sufficient evidence to prove the likely errors which caused the failure to pay the renewal fee and why the Delegate should exercise his discretion to grant the requested extension of time.  Following the decision, the Cipla Patent has been reinstated as granted on the Australian Patents Register.

We will watch with interest what happens next with the Cipla Patent.  The Cipla Patent, which contains only formulation, use and method claims, is in its extended term, having been extended before the recent Full Federal Court Otsuka Pharmaceutical Co Lt v Sun Pharma ANZ Pty Ltd decision  in which the Full Court held that only patents with API claims were eligible for extension under the Australian pharmaceutical patent term extension regime.  The Full Court Otsuka decision is now the subject of a High Court appeal.

Background

The relevant background facts were as follows:

Key Issues

The Delegate was required to determine whether an extension of time application should be granted under section 223(2)(a) of the Patents Act. Section 223(2)(a) provides that:

“(2) Where, because of:

(a) an error or omission by the person concerned or by his or her agent or attorney; or

(b)…

a relevant act that is required to be done within a certain time is not, or cannot be, done within that time, the Commissioner may, on application made by the person concerned in accordance with the regulations, extend the time for doing the act.” (emphasis added)

Accordingly, the Delegate was required to determine whether:

• Cipla’s evidence proved that it had an intention to pay the renewal fees within the prescribed time and that an error or omission had contributed to its failure to do so.  Importantly, the failure to pay the renewal fee could not be the error or omission.

Previous cases had interpreted the term “error or omission” broadly to encompass accidental slips, inadvertences and errors caused by faulty reflection; an unexpected failure to exercise due diligence and/or a flaw in mental function in carrying out an intention; and a breakdown in procedure in effecting an intention.

• Cipla had given full and frank disclosure in its evidence of the relevant circumstances, justifying the exercise of the Delegate’s discretion in Cipla’s favour.  Relevantly, in Kimberly-Clark Ltd v Commissioner of Patents (No 3) (1988) 13 IPR 569 at 583-584 [17], the Court had stated that:

‘In order to make out the “proper case … justifying an extension” … an applicant would … have to go beyond a disclosure of the processes by which an agent’s errors came to be committed and would have to expose frankly, inter alia, all the conduct, knowledge, beliefs and mental processes of the applicant … relevant to an understanding of the way the failure to do the act or take the step occurred, or relevant to an evaluation of the reasonableness of that conduct.’

Consideration

The Delegate was satisfied that the evidence proved that Cipla had always intended to maintain the Cipla Patent and that the evidence clearly established a breakdown in procedure.  The Delegate went on to state that while there were a number of times that this breakdown could have been identified (but, somewhat surprisingly, was compounded by another error), he was satisfied that some causal error occurred resulting in the failure to pay the renewal fee within the prescribed time.

The Delegate then turned to the question of whether he should exercise his discretion in Cipla’s favour to grant the extension of time.  In answering the question of discretion, the Delegate considered the following factors:

• Whether a proper case had been made out justifying an extension.

The Delegate concluded that Cipla had fulfilled its obligation to provide an adequate basis upon which its moral claim to an indulgence may be assessed, because it had disclosed Cipla’s state of mind, the circumstances surrounding the various errors, and the relevant internal AAT processes.

• Whether there had been undue delay in seeking an extension of time.

Teva and Bayer argued that there had been a 6-month delay between the receipt of the ceasing letter of 3 January 2024 by Griffith Hack and the filing of the s223 request.  The Delegate did not consider this “delay” to be unreasonable or unnecessary in the circumstances of the case.  Griffith Hack had delayed sending the letter to AAT, and AAT had had not considered the letter immediately upon receipt.They mistakenly believed that the patent had expired.  Indeed, Cipla had filed its extension of time application the day after it had become aware of the patent ceasing.

• The interests of the parties in refusing or granting an extension.

The Delegate considered the interests of the parties to be “offsetting”.  While Cipla’s and Meda’s interests resided in the restoration of the patent monopoly, Teva’s and Bayer’s interests resided with the refusal of an extension of time as such an extension would impede their ability to produce and supply their own equivalent products within Australia.  However, to the extent that Teva or Bayer might already have taken steps to exploit the patented invention in Australia, the compensatory provisions contained in s223(9) were available to mitigate any resulting prejudice.

• The public interest.

The Delegate considered that, on balance, the public interest was neutral to the grant of the extension.  While there was a public interest in certainty as to the status of a patent and the accuracy of the Register, there was also a broad public interest in promotion of innovation through the reward of patent rights and the extension of these patent rights pursuant to the pharmaceutical patent term extension regime.

Outcome

The Delegate was satisfied that, on balance, Cipla always had an intention to maintain the Cipla Patent, some causal error occurred thwarting the patentee’s intention to maintain the patent, and that, as a result of the error, the relevant act was not done in time. The Delegate was also satisfied that he should exercise his discretion in Cipla’s favour to grant the extension of time.  Given this decision, the Delegate awarded costs against Teva and Bayer.

About Pearce IP

Pearce IP is a specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.