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Bioverativ Therapeutics Inc. [2023] APO 64 (14 December 2023)

Last Updated: 14 December 2023


IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Bioverativ Therapeutics Inc. [2023] APO 64

Patent Application: 2022228110

Title: Factor IX polypeptide formulations

Patent Applicant: Bioverativ Therapeutics Inc

Delegate: Felix White

Decision Date: 14 December 2023

Hearing Date: 13 September 2023, by videoconference

Catchwords: PATENTS – extension of time – request for extension of time under s223(2)(a) to file a divisional application – error or omission – erroneous understanding of eligibility for patent term extension – whether error prevented formation of intention to carry out relevant act – whether error frustrated existing strategic intention – determination of strategic intention – request refused

Representation: Katrina Crooks & Daniel Sieveking, Spruson & Ferguson

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE


Patent Application: 2022228110

Title: Factor IX polypeptide formulations

Patent Applicant: Bioverativ Therapeutics Inc.

Date of Decision: 14 December 2023

DECISION

The provisions of section 223(2)(a) cannot be enlivened as I cannot conclude on the basis of the evidence presented that but for a causative error, a divisional application would have been filed by the required time. There is no need to consider discretionary factors. I refuse the request for extension of time.

REASONS FOR DECISION

  1. This decision relates to a request for an extension of time (“the request”) under section 223(2)(a) of the Patents Act 1990 (“The Act”)[1] for claiming divisional status from Australian patent application 2019208273 (“the ‘273 application”).

History

  1. The ‘273 application was accepted on 10 September 2021 and this acceptance was advertised on 30 September 2021. Pursuant to Reg 6A.1, any divisional application must have been filed by 30 December 2021.
  2. Australian patent application 2022228110 (“The present application”) was filed on 6 September 2022 in the name of Bioverativ Therapeutics Inc (“Bioverativ” or “The Applicant”), accompanied by a request for a 9 month extension of time for claiming divisional status from the ‘273 application.
  3. A first declaration from Mr James Velema (“Velema #1”) in support of the s223 request was filed on 14 November 2022.
  4. In this first declaration, Mr Velema, a registered US patent attorney, stated that he is responsible for the worldwide management of Bioverativ’s patent portfolio, including the ‘273 application which relates to pharmaceutical formulations marketed and sold under the drug name ALPROLIX®.[2] Inter alia, claims 1 and 2 of the ‘273 application are respectively directed to the two highest dosage forms (3000 IU and 4000 IU) of ALPROLIX® registered in Australia.[3] According to Mr Velema, “Bioverativ’s position is that all relevant subject matter relating to products and therapies for which regulatory approval is being sought, or has been obtained, should be suitably claimed and that possible extensions of patent term should be sought when available.”[4] He had an “understanding at the time of acceptance that the patent issuing on AU ‘273 would be eligible for an extension of term based on the regulatory approval of ALPROLIX® in Australia.”[5]
  5. The grant of the ‘273 application was reported to Mr Velema by the Applicant’s Australian patent attorneys (Spruson & Ferguson), and being aware that the deadline for seeking extension of term was six months after the date of grant,[6] Mr Velema sought further information about procedures for this at the end of June 2022, approximately one month before the extension of term deadline (but approximately six months after the deadline for filing a divisional application).[7]
  6. After requesting further information from Bioverativ (via Mr Velema) about the products on which the extension of term would be based, Spruson & Ferguson advised Mr Velema that an application for extension of term for ‘273 based on ALPROLIX® would likely be rejected because the earliest approved good falling within the scope of the granted claims (ALPROLIX® 3000 IU) had an approval date less than five years after the date of patent.[8]
  7. However, Spruson & Ferguson also advised Mr Velema at the same time that the registration of the 4000 IU formulation would satisfy the timing requirements for patent term extension eligibility with respect to the ‘273 application.[9]
  8. According to Mr Velema’s evidence, ALPROLIX® formulations of 250-3000 IU had been registered on the Australian Register of Therapeutic Goods (ARTG) on 1 May 2014, and a 4000 IU formulation had been registered on 16 January 2020.[10] The date of patent of the ‘273 application was 14 March 2014.
  9. Mr Velema then came to a realisation that his understanding that AU’273 would be eligible for patent term extension had been incorrect, and came to an awareness “that a divisional application should be filed in order to pursue claims directed to the 4000 IU dosage only, so that a resultant patent might satisfy the timing requirements for an extension of patent term and ultimately provide maximal patent coverage for ALPROLIX®.”[11]
  10. Upon then being instructed to carry out a broader review of the Applicant’s patent portfolio relating to ALPROLIX®, Spruson & Ferguson advised Mr Velema of the provisions for seeking an extension of time for filing a divisional application, following which Mr Velema issued instructions for the filing of the present application and the instant extension of time request.[12]
  11. Mr Velema concluded his first declaration by confirming “it was my client’s intention to obtain patent protection in Australia whenever possible that suitably covers their commercial products that have received regulatory approval, and for that subject matter to be afforded the longest possible patent term available.”[13]
  12. In a letter dated 8 December 2022, a delegate of the Commissioner indicated that further information was needed before the request could be accepted. In particular, the delegate suggested that Mr Velema had made a choice between filing an extension of term from the ‘273 patent and seeking an extension of time to file a divisional application. The delegate formed an opinion that the intention to file the divisional application did not materialise until 3 August 2022,[14] and stated that the present case aligned with the situation in Amicus Therapeutics, Inc. [2020] APO 4 (“Amicus”) in that the filing a divisional application may have been an alternative strategy that appeared with the benefit of hindsight, but s223(2)(a) is not a general power of extension to enable such “mercurial” changes in strategy.
  13. A second declaration from Mr Velema (“Velema #2”) was duly filed on 8 February 2023.
  14. The second declaration stressed that Bioverativ’s intention had been to “obtain extensions of patent term for all relevant subject matter where available”[15] and to take “all actions” to maximise patent coverage and term.[16] It further stressed that the error which led to the failure to form the intention to file a divisional application was Mr Velema’s incorrect understanding and belief that the ‘273 patent would be eligible for patent term extension based on the regulatory approval of ALPROLIX® in Australia,[17] and there had never been any “intent not to file any required divisional application”.[18]
  15. Mr Velema clarified that he had not believed there was any choice between filing an extension of term and a divisional application. Rather, based on the advice received from Spruson & Ferguson, he understood that filing an application for extension of term from the ‘273 patent “was not viable”.[19]
  16. Mr Velema reiterated that because his intention to seek extension of patent term was contingent on grant of the ‘273 patent, he did not seek advice on the requirements of Australian law until after said grant, i.e. after the relevant date for filing the divisional application,[20] and that there was “no doubt” he would have instructed filing of the divisional application had he “been timely aware of the requirements of Australian patent law applicable to these facts”.[21]
  17. In a second letter dated 16 February 2023, the delegate appeared to accept that Bioverativ had an “overarching aspiration to have maximum patent coverage and term” but also seemed to consider that Mr Velema had been “keeping himself in the dark” in terms of how to achieve that objective, and therefore did not consider that s223(2)(a) could be enlivened. The delegate considered that the appropriate correction for Mr Velema’s failure to appreciate the timing and claim scope requirements of Australian law for extension of term would have been to amend the claims of the ‘273 application rather than necessarily contemplate filing a divisional application. The delegate also questioned whether any application for extension of term based on the 4000 IU ALPROLIX® approval would have been successful for other reasons.
  18. The delegate concluded that s223(2)(a) could not be enlivened, at least on the basis of the information provided thus far.
  19. A third declaration from Mr Velema (“Velema #3”) was duly filed on 17 March 2023 which sought to address the issues raised in the delegate’s second letter.[22] To this end, I note that much of the third (and indeed the second) declaration appears to be legal analysis and argument rather than provision of additional facts.
  20. In particular, Mr Velema declared that the claims in the ‘273 application contained valuable protection for the 3000 IU dosage form and deletion of those claims by amendment would not have been the most logical option. Rather, he stated that the filing of an additional divisional application would have been the “logical” intention.[23]
  21. Mr Velema clarified that he had some understanding of the provisions for extension of term, but this understanding was incomplete. In particular, he knew the timing for filing the patent term extension application, but had no further knowledge of timing and claim scope requirements, and specifically he did not understand that any term extension of the ‘273 application would be calculated based on the earlier approval of the 3000 IU dosage form and not the later approval of the 4000 IU dosage form.[24] He again stated that due to this incomplete understanding, he failed to form the intention to file a further divisional application by the relevant date,[25] and had he been timely aware of the requirements, there is no doubt in his mind that he would have instructed Spruson & Ferguson to file a further divisional application prior to the 30 December 2021 deadline.[26]
  22. In a third letter dated 27 March 2023, the delegate was still of the opinion that there was “never any intention to file a divisional application after the acceptance of ... AU201920873”, concluding instead that the present extension of time request had been filed “to make up for [an] identified missed opportunity” and expressed an intention to refuse the request.
  23. I do note that in the above correspondence, the delegate made a number of comments relating to what Bioverativ’s options, and chances of success, for establishing patent term extensions may have been. For the avoidance of doubt, in my consideration these factors have no bearing whatsoever on whether or not there was an error that led to a divisional application not being filed in time. However I can appreciate that the delegate may have been trying to establish what Bioverativ’s strategy would have been, consistent with the delegate’s knowledge of the s70 provisions and the available facts, in the absence of unambiguous evidence as to Bioverativ’s intentions at the time actually were.
  24. On 24 April 2023, the Applicant requested to be heard on the matter. A summary of the Applicant’s submissions (“AS”) was filed on 30 August 2023, and the matter was heard on 13 September 2023 by videoconference. I thank the Applicant and their representatives for their assistance during the hearing. I will address their key submissions in my consideration below.

Extensions of Time

  1. The Act provides, in section 223, a mechanism that gives the Commissioner the discretionary power to extend the time for doing certain acts.
  2. The subsection relied on by the Applicant in this case is 223(2) which relates to errors, omissions, or circumstances beyond the control of the person concerned.
    (2) Where, because of:

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

    agent or attorney; or

    (b) circumstances beyond the control of the person concerned;

    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.

  1. As noted above this is a discretionary power. However, before the Commissioner can choose to exercise his discretion, a number of statutory criteria must be met:
  2. The request is for an extension of time for claiming divisional status. It is a well established practice of the Commissioner that filing a divisional application is a “relevant act that is required to be done within a certain time” and therefore extensions of time are available.

The meaning of “error”

  1. The meaning of “error or omission” was considered by Jenkinson J in Kimberly-Clark Limited v the Commissioner of Patents and Minnesota Mining and Manufacturing Company [1988] FCA 421 (“Kimberly-Clark”). This decision related to the corresponding provisions of the Patents Act 1952, regarding the then s160(2) which used the same language as s223(2) presently in force.
  2. Jenkinson J noted the second reading of the Bill introducing the then s160:
    The committee considered representations that through pressure of business in offices of patent attorneys, errors do occur that result in acts that ought to be done not being done. It recommended that an error or omission on the part of an applicant, or of his agent or attorney be made an additional ground for extending the time for the doing of an act. Clause 29 restates section 160 to give effect to this recommendation.

  3. Jenkinson J considered errors could include those resulting from faulty reflection, as well as accidental slips and inadvertences, and cautioned against giving a restricted definition to “error or omission”, particularly because “some errors of judgment by agents and attorneys may be as bizarre and as little to be anticipated as lapses of memory and accidental slips”[27]
  4. His Honour did accept, however, that not every mistaken judgment can be treated as an “error or omission” in the context of this section.
  5. As elegantly put by the Commissioner’s delegate in correspondence leading up to the Amicus decision:
    ... if I were to accept that Mr Alegria simply not making any enquiry for any reason (and not as usual practice) is an error, then I would have to accept that operating in ignorance of the law is an error. In my opinion that would mean that every judgement by “the person concerned” which is later shown to have been mistaken would be an “error or omission”. It is difficult to see how such circumstances would not reduce s223(2)(a) to “a mere general power of extension” (contrary to Jenkinson J in Kimberly-Clark Ltd v. Commissioner and Minnesota Mining and Manufacturing Co (No 3) [1988] FCA 421; 13 IPR 569), which would, to be successful in gaining one, simply require no questions being asked of anyone.[28]

  1. The criterion Jenkinson J provided for distinguishing an error is “obviousness in error”.[29] I understand this to mean that although errors are not limited by the type of act, they must immediately and obviously be recognised as such.
  2. Although his Honour did not go further into elucidating what makes something “obviously” an error, I understand this to mean that it must be very plain, on the face of the facts of the case, that the mental state or action of the applicant or their agent was contrary to an established fact or intention (respectively).
  3. This is consistent with the Macquarie Dictionary definition of “error” as, inter alia,
    1. deviation from accuracy or correctness; a mistake, as in action, speech, etc.

    2. belief in something untrue, the holding of mistaken opinions

Both of which necessarily require the presence of an established fact or intended course of action.

  1. I note at this point that the established intention I am referring to above does not necessarily have to be the intention to do the relevant act itself. It is well established that, in the words of the AAT in Apotex “there will be, as in this case and in Kimberly-Clarke, exceptional circumstances where no specific intention [to do the relevant act] has been formed. In this case, as in Kimberly-Clarke, the relevant error precluded the forming of the specific intention.”[30] In those circumstances, however, there was an overarching intention for a course of action that, but for the error, would have resulted in the formation of the specific intention to do the relevant act.
  2. The Applicant submitted that the present case is in fact one of those exceptional circumstances in which an error prevented the formation of the intention to file the divisional application. In order for this submission to be accepted, therefore, I must be satisfied there was an overarching intention that, but for an alleged error, would have necessarily resulted in the filing of a divisional application by the required date.
  3. It is worthwhile at this point to conduct a brief review of the circumstances of the most similar cases referred to here.
  4. Although both Apotex and Kimberly-Clarke related to extensions of time to file oppositions, the Applicant also drew attention to Lundbeck,[31] in which an extension of time to file an application for extension of patent term was granted after the patentee’s flawed understanding initially led to the extension application being filed for the wrong pharmaceutical substance. The Applicant submitted that the situation in Lundbeck was on all fours with the present case, since the Applicant’s strategic objectives in this case also related to obtaining patent term extension, and the asserted error in this case is also said to be a flawed understanding of the Australian requirements for patent term extension.
  5. I am not convinced that the situation in Lundbeck is on all fours with the present case. The relevant act in Lundbeck was the filing of the request for patent term extension itself. In the present case, although the strategic goal also involves obtaining patent term extension, the relevant act under consideration is a separate act – the filing of a divisional application.
  6. It is notable that Kimberly-Clarke, Apotex, and Lundbeck were all situations where the relevant court or tribunal found an obvious error[32] which precluded the possibility of forming the intention to carry out the relevant act, in the face of an evidenced, overarching, strategic intention to do the same kind of act.
  7. As mentioned above, both Kimberly-Clarke and Apotex concerned extensions of time for filing a notice of opposition. The relevant deadline is based on the publication of notice of acceptance of a third party patent application, and in both cases the error caused the notice of acceptance to be unreported or otherwise missed (in Kimberly-Clarke, a specific instruction to keep overseas agents informed of the acceptance of the third party application was not followed by the Australian agent, and in Apotex a contracted patent search misclassified the third party application which caused it to be left off a watch list). In both cases there was an evidenced strategic intention to carry out the same type of act as the extension was sought for, although the errors by the agents concerned caused the deadline (Kimberly-Clarke) or the identity of the opposed application (Apotex) to not come to the attention of the person concerned, thereby frustrating the ability to perform the act on time.
  8. In Lundbeck, there was a clearly evidenced strategic intention to obtain patent term extension for the pharmaceutical substance (+)escitalopram. The patentee in that case had formed a clear view[33] that the earliest registration for (+)escitalopram falling within the scope of the patent in question was for the drug Lexapro, and not the drug Cipramil. After the patentee’s application for extension of term based on Lexapro was found to be unsuccessful, it became objectively clear that the patentee’s understanding with respect to Cipramil had in fact been erroneous, and that but for that erroneous understanding, the patentee’s strategic objective would have resulted in an application for patent term extension based on Cipramil instead.
  9. The Applicant also made submissions distinguishing the present case from the decision of the Commissioner’s delegate in Amicus. In Amicus, the person concerned only became aware of the possibility of performing the relevant act (claiming the grace period under s24 of the Act) after a discussion with an Australian patent attorney after the relevant date had passed. Indeed, in Amicus there did not seem to be any evidence of any intentions prior to the relevant date at all, and certainly not any demonstrated intent for any overarching course of action.
  10. The Applicant submitted that, in contrast to Amicus where there had been no apparent intention to do anything at all at the relevant time, Bioverativ had had an intention to obtain patent term extensions for ALPROLIX®, if available, and filing the divisional application is something that Mr Velema asserts that he would have done had he been properly aware of the state of Australian law at the relevant date.[34]

The evidence

  1. The question of whether or not an error occurred is a question of evidence, and the standard for judging the evidence is the balance of probabilities.[35]
  2. The evidence must show that an error occurred and that the error was causative for the act not being done.
  3. Evidence of a pre-existing intention to do the act can often be sufficient to infer that some (even unspecified) causative error had occurred.[36]
  4. However in the present, exceptional, circumstances where no intention to do the act had been formed prior to the relevant date, I must be satisfied that the factors discussed at paragraph 43 above apply. That is:

Nature of the error

  1. What was the alleged causative error? The Applicant submits[37] that it was “Mr Velema’s incorrect understanding that the ’273 application would be entitled to an extension of term since its claims encompassed products which had been registered on the ARTG”.
  2. The types of errors contemplated by Jenkinson J in Kimberly-Clark all had the characteristics of being actions. I understand that such actions do not necessarily have to be physical actions, but can include mental ones such as ill-reasoned decisions. However, as set out in paragraph 36 above an “understanding” or “belief” can become a causative error within the meaning of s223(2) if it is contradicted by an established fact.
  3. Mr Velema received legal advice, which forced him to reevaluate his understanding, from Spruson & Ferguson after the relevant date.[38] I concur with that advice, that an application for patent term extension based on the ‘273 application as accepted would receive no extension of term. Therefore I can accept that Mr Velema’s understanding and belief was in error.

Overarching course of action

  1. What was Bioverativ’s overarching strategic objective? Was it, as Mr Velema stated at the end of his last declaration, “to have maximum patent coverage and term for their products and therapies”? Or was it merely “that possible extensions of patent term should be sought when available” as was originally stated in Mr Velema’s first declaration? Or was it something different altogether? In this case I have no direct evidence from an employee of Bioverativ itself - although Mr Velema was “responsible for worldwide management of the portfolio of patent applications arising from PCT/US2014/029010”[39] there is no direct evidence on what the terms of reference of this management were.
  2. I have difficulty accepting that “maximizing patent coverage” can be an overarching strategic objective which could be frustrated by error. Such a strategic appetite would always be hungry for more coverage, and if it can never be satisfied it seems equally difficult to say that it can be meaningfully frustrated.
  3. Furthermore, Bioverativ’s actions do not appear consistent with “maximising patent coverage”: although there were specific granted claims to the 3000 IU and 4000 IU formulations of ALPROLIX®, there were no corresponding claims to the 250, 500, 1000 and 2000 IU formulations which had also been approved by the TGA. Indeed, no truly “maximal” patent strategy could ever contemplate terminating prosecution without filing additional divisional applications.
  4. Although it is of course possible that the 3000 IU and 4000 IU formulations were the only ones of commercial interest to Bioverativ, and it is possible that Bioverativ’s objective could have been to “maximize patent coverage on the 3000 IU and 4000 IU formulations equally”, there is no specific evidence that this was the case before the relevant date.
  5. On the other hand, I find that Mr Velema’s actions of taking steps towards applying for patent term extension by the deadline of 6 months from grant to be more consistent with “seeking patent term extensions when available”.
  6. I am therefore satisfied on the balance of probabilities that Bioverativ’s overarching strategic objective was to seek, or in other words attempt to obtain, patent term extensions for ALPROLIX® when available. Against this background, the question then is whether but for an error or omission, a divisional application would necessarily have been filed from the ‘273 application.
  7. I stress here that I do not find it plausible that Bioverativ’s intention could have been to “succeed in obtaining patent term extension”. While this may well have been an aspiration, it is something outside of Bioverativ’s control. Notwithstanding the impediment identified by Spruson & Ferguson, it is entirely possible that any extension of term application filed from ‘273 may have been unsuccessful for other reasons. I note that in all relevant authorities discussed in the case, the relevant act or strategic objective has been limited to something under the parties' control: file an appropriate opposition or patent term extension rather than necessarily succeed in the endeavour.[40]

Did the error frustrate the overarching course of action?

  1. I cannot conclude that Mr Velema’s erroneous belief frustrated Bioverativ’s strategic objective of seeking patent term extensions where available.
  2. Specifically, this erroneous belief did not impact Bioverativ’s ability to try to obtain an extension of term, which was still available up until 6 months from grant. Furthermore it is quite possible that if Mr Velema’s understanding had been correct, i.e. if he had understood the ‘273 application would not be entitled to extension of term, the only effect would have been that Mr Velema would not have made enquiries about the term extension process in the first place.
  3. It therefore does not follow that “but for” this erroneous belief, a divisional application would have inevitably been filed by the relevant date. Critically, the additional information that a patent specific to the 4000 IU formulation would be entitled to patent term extension was not passed on by Spruson & Ferguson until after the relevant date. There is no suggestion in the evidence that there was any error involved in the timing of that correspondence.
  4. The only scenario where a divisional application would have been necessary to Bioverativ’s strategic objectives, is one in which those objectives were specifically to obtain patent claims specific to the 3000 IU formulation as well as filing an extension of term on the 4000 IU formulation. Although this objective could potentially be inferred from the “logic” found at paragraph 6 of Velema #3, that paragraph strikes me as a legal argument prepared well after the relevant date. On the balance of probabilities, I cannot infer such precise objectives from the available evidence relating to Bioverativ’s intentions at the relevant date.
  5. While I do not necessarily doubt the sincerity of Mr Velema’s belief that he had been entrusted with maximising Bioverativ’s IP assets, I have found no clear evidence that Bioverativ was (or should have been) unsatisfied with its patent position as of 30 December 2021. I can appreciate that, much like Mr Velema’s hindsight revelation mentioned at paragraph 22 above, Bioverativ may have improved its strategic position had it filed a divisional application. But that, to me, would be exactly the ex post facto change of strategy that was cautioned against in Amicus.
  6. Finally, and congruent with the sentiment expressed in Amicus at 28 and 34, the idea that Mr Velema would have no doubt made the appropriate instructions had he been aware of the relevant requirements at the relevant time[41] could well, if accepted, become some kind of shibboleth that any petitioner could invoke with impunity at any time regardless of the circumstances. This would contradict the injunction that s223 cannot simply become a general power of extension.

Conclusion

  1. Although I am satisfied that Mr Velema had an erroneous understanding of the Australian patent term extension provisions, the evidence available to me does not support the conclusion that this was a causative error, but for which in a divisional application would have been filed by 30 December 2021 The provisions of s223(2)(a) therefore cannot be enlivened. Consideration of the exercise of discretion is therefore moot. I refuse the request for extension of time.

Felix White

Delegate of the Commissioner of Patents

[1] Any reference to legislation herein refers to this Act, or the associated Patents Regulations 1991
[2] Velema #1 at 2 and 5
[3] Velema #1 at 7
[4] Velema #1 at 4
[5] Velema #1 at 7
[6] Cf Velema #3 at 8
[7] Velema #1 at 9
[8] Velema #1 at 14
[9] Velema #1 at 14
[10] Velema #1 at 12
[11] Velema #1 at 15
[12] Velema #1 at 16-17
[13] Velema #1 at 18
[14] The date of a videoconference between Mr Velema and Spruson and Ferguson, cf Velema #1 at 16
[15] Velema #2 at 8
[16] Velema #2 at 15-16
[17] Velema #2 at 9
[18] Velema #2 at 15
[19] Velema #2 at 11-12
[20] Velema #2 at 14
[21] Velema #2 at 17
[22] Velema #3 at 4
[23] Velema #3 at 6
[24] Velema #3 at 9-10
[25] Velema #3 at 11
[26] Velema #3 at 12
[27] Kimberly-Clark at 9
[28] Cited at paragraph 28 of the Amicus decision
[29] Kimberly-Clark at 10
[30] Apotex Pty Limited and Commissioner of Patents and Les Laboratoires Servier (Party Joined) [2008] AATA 226 (“Apotex”) at 21
[31] The Applicant referred to two decisions: Aspen Pharma Pty Ltd and Others and Commissioner of Patents and H Lundbeck A/S [2012] AATA 851 (“Lundbeck AATA”) and its appeal Aspen Pharma Pty Ltd v H Lundbeck A/S [2013] FCAFC 129 (“Lundbeck FCAFC”). A further appeal of this case to the High Court was not relied upon as it was not directed to the nature of the error.
[32] Indeed, the errors in those cases were all so obvious that there was little discussion in the respective decisions as to whether they were indeed “errors”.
[33] The following evidence of Mr Petersen for Lundbeck was accepted by the AAT and the Full Federal Court: “[11] As a chemist and patent attorney it is and always has been my view that Cipramil does not fall within the scope of the claims of the Lexapro patent. This view is shared by Lundbeck. [on this basis], I and Lundbeck did not contemplate applying to extend the term of the Lexapro Patent on the basis of the marketing approval of Cipramil.” Lundbeck AATA at 57
[34] Velema #3 at 12
[35] Cf Generic Partners Pty Ltd v Neurim Pharmaceuticals Ltd.  [2022] APO 2  at 28
[36] Cf Canva Pty Ltd [2021] APO 35 at 27-30
[37] AS at 24
[38] Velema #1 at 14
[39] Velema #1 at 2
[40] I note that it is the practice of the Commissioner to grant extensions of time for successfully gaining acceptance under s142(2)(e). However in that situation the relevant act is one done by the Commissioner and as such is not comparable to the present case.
[41] Velema #3 at 12

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