SoftKemo Pharma Corp
[2022] APO 81
•13 December 2022
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
SoftKemo Pharma Corp [2022] APO 81
Patent Application: 2019219792
Title:Bendamustine anionic-cationic cyclopolysaccharide compositions
Patent Applicant: SoftKemo Pharma Corp
Delegate:Dr Scott D. Makin
Decision Date: 13 December 2022
Hearing Date: Written submissions filed on 25 August 2021
Catchwords: PATENTS – examiner’s objections – novelty -
grace period provisions apply – information is disclosed in original application – information in currently cited prior art must be disregarded – section 40 – support – support objection cannot be maintained – usefulness – utility – the claimed invention is useful – the claimed invention has utility
Representation: Patent attorney for the applicant: Halfords IP
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2019219792
Title:Bendamustine anionic-cationic cyclopolysaccharide compositions
Patent Applicant: SoftKemo Pharma Corp
Date of Decision: 13 December 2022
DECISION
The information in D1 (WO 2010/097700 A1) and D2 (WO 2011/103150 A2) must be disregarded in deciding whether the present claims are novel.
The present claims are supported under subsection 40(3).
The present claims meet the usefulness requirement under subsection 18(1)(c).
The current outstanding objections cannot be maintained. The application will be referred back to examination to consider whether further prior art searching is required. The period to gain acceptance is extended to three (3) months from the date of this decision.
REASONS FOR DECISION
Background
Patent application 2019219792 (the application or the present application) was filed by SoftKemo Pharma Corp (the applicant) on 21 August 2019. It is a divisional application of 2017216568 (the parent application) which lapsed on 21 August 2019. The parent application is in turn a divisional application of now granted patent 2011363446 which was a national phase application of PCT/IB2011/003367 (the grandparent application or the grandparent patent). The present application has an earliest claimed priority date of 19 July 2010.
The parent application was the subject of a single examination report issued on 21 August 2018 which raised objections on the grounds that the claims lacked support under subsection 40(3) and that the claims lacked novelty. There was no response to that examination report and the parent application duly lapsed for failure to gain acceptance by 21 August 2019.
Prior to lapsing of the parent application, the applicant filed for a divisional application which forms the basis of the application under consideration here. The present application and the parent application are almost identical except for some minor differences in the description. Two examination reports have been issued on the present application. A first examination report for the present application was issued on 15 June 2020 raising identical grounds of objection to that of the single examination report issued against the parent application. The applicant responded to the first report on 7 June 2021 without proposed amendments. A second examination report was issued on 11 June 2021 maintaining the previous grounds of objection and raising an additional objection that the claimed invention also lacked utility under subsection 18(1)(c).
On 15 June 2021 (the final date for acceptance of the present application), the applicant wrote to the Commissioner requesting to be heard in relation to the outstanding objections. On 14 July 2021, the Commissioner wrote to the applicant indicating that the hearing would be conducted by written submission due to be filed by 25 August 2021. The applicant filed submissions on 25 August 2021 (the applicant’s submissions).
The present application was filed on 21 August 2019 and the amendment of the Patents Act 1990 (the Act) brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 therefore applies to the present application. The standard of proof that applies to the examination of the present application is the balance of probabilities.
Pursuant to regulation 13.4(1)(g), when the Commissioner gives an applicant an opportunity to be heard in relation to an examiner’s objection and issues a written decision, the period for gaining acceptance of the application may be extended until three months from the date the decision is issued or, pursuant to regulation 13.4(3), for a period of longer than three months if the Commissioner is satisfied that acceptance should be postponed. However, this regulation is irrelevant should I refuse the application.
The complete specification as filed
The present application is directed to a composition comprising:
Øbendamustine,
Øa first charge cyclopolysaccharide comprising at least one charged group, and optionally
Øa stabilizing agent which is a second charged cyclopolysaccharide having at least one charged group having a charge opposite to that of the first polysaccharide.
Bendamustine[1] is used in the treatment of certain cancers including leukaemias and some lymphomas. However, owing to bendamustine’s inherent chemical instability in plasma, high or repeated doses are generally required to achieve therapeutic activity and there is deemed to be a need for formulations which will exhibit increased stability.[2] The applicants allege to have found that compositions of bendamustine with certain combinations of charged cyclopolysaccharides lead to increased stability of the active compound and potentially increased anticancer activity.[3]
[1] Bendamustine is the generic name for 4-[5-[bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic acid.
[2] Page 1, lines 14 to 18 of the application.
[3] Page 1, line 14 to page 2, line 2 of the application.
According to the specification, preferred cyclopolysaccharides that can be used in the bendamustine compositions include cyclodextrins, cyclomannins, cycloaltrins, cyclofructans and the like. Cyclodextrins are particularly preferred, especially those comprising between 6 and 8 sugar units. The most preferred are beta-cyclodextrins, which comprise 7 sugar units.[4]
[4] Page 2, line 29 to page 3, line 41 of the application.
The cyclopolysaccharides used in composition with bendamustine are charged, which the applicant defines as being where one or more of the hydroxyl groups on the cyclopolysaccharide is replaced by a charged moiety.[5] Various preferred charged groups (anionic and cationic) which may be on the cyclopolysaccharides of the alleged invention are also defined.[6] Particularly preferred anionic cyclopolysaccharides include sulfobutyl ether beta-cyclodextrin (SBECD) and particularly preferred cationic cyclopolysaccharides include heptakis(6-amino-6-deoxy) beta-cyclodextrin (H6A).[7]
[5] Page 3, line 3 to line 8 of the application.
[6] Page 3, line 13 to line 19 and line 34 to line 38 of the application.
[7] Page 3, line 13 to line 19 and line 39 to line 41 of the application.
The ratio of bendamustine to charged polysaccharides in the composition is also described and according to the applicant can be between about 1:5000 and about 1:5 but is most preferably between about 1:100 and 1:10.[8]
[8] Page 2, line 21 to line 27 of the application.
Component (c), the stabilising agent, of the bendamustine compositions is an optional requirement. I note in reviewing ancestor applications that in the grandparent application the stabilising agent was identified as a mandatory component of the claimed invention. The optional nature of component (c) was introduced in the parent application to the present application.
A general method of preparing stabilised compositions of bendamustine and charged polysaccharides is also provided.[9]
[9] Page 4, line 11 to line 37 of the application.
The Examples
Example 1 in the description[10] of the present application describes preparing aqueous compositions of bendamustine with sodium sulfobutyl ether beta-cyclodextrin (SBECD) and hepatkis(6-amino-6-deoxy)-beta-cyclodextrin hydrochloride (H6A). Various ratios of bendamustine, SBECD and H6A are described. The compositions also comprise mannitol (a simple sugar) as an excipient and were filtered prior to use.
[10] Page 5, line 15 to end page 5 of the application.
Example 2 in the specification[11] outlines the comparison of two compositions from example 1 against two different control compositions. The first control is bendamustine and mannitol in brine (without any cyclopolysaccharides). The second control, called Composition A, consists of bendamustine, SBECD and mannitol in water. Table 1 shows the concentration of bendamustine in rat plasma against time after injection. The results appear to suggest that compositions comprising bendamustine, SBECD and H6A exhibit superior stability compared to bendamustine without any cyclopolysaccharide (control) or bendamustine with only SBECD (composition A).
[11] Page 6, line 1 to page 7, line 15 of the application.
Example 3 in the description[12] summarises a comparison of a composition of bendamustine, SBECD and H6A to a reference composition of bendamustine and an untreated control in treating human breast carcinoma implanted subcutaneously in mice. The data in Table 2 appear to demonstrate that the composition of bendamustine, SBECD and H6A is more efficacious than bendamustine alone with reduced tumour size after 23 days compared to untreated control and reference.
[12] Page 7, line 17 to end page 9 of the application.
The Claims
The specification ends with ten claims as set out in Annex A for reference. Claim 1 is the only independent claim and reads:
A composition comprising:
(a)bendamustine; and
(b)a cyclopolysaccharide having at least one charged group which is an anionic group.
The claim is directed to a composition “comprising” the specified components. There is no definition of the term “comprising” in the specification so the meaning of this term, that is whether it is construed to be exhaustive or non-exhaustive, needs to be determined in accordance with the context of the specification. Given the nature of the examples and the general background of the invention indicates optionally having additional elements in the bendamustine compositions, the term “comprising” must be construed as being non-exhaustive. That is to say, the composition must have components (a) and (b) but may also include further additional components and these additional components are not restricted to, but can include, oppositely charged cyclopolysaccharides.
There is no specific cyclopolysaccharide identified in claim 1, however, it must have at least one anionic (negatively charged) group.
Claims 2-5 define further embodiments of the cyclopolysaccharide of component (b) of the claimed composition, including the type of cyclopolysaccharide and the anionic group attached. Claims 6-9 define further embodiments relating to the ratio of bendamustine to component (b) in the composition. Claim 10 is directed to a freeze-dried embodiment of any of the preceding claims.
The remaining objections
There are objections that remain outstanding and require consideration. These are:
ØThe claims lack support under subsection 40(3);
ØThe claims do not meet the usefulness requirements under subsection 18(1)(c); and
ØThe claims are not novel in view WO 2010/097700 A1 (hereinafter referred to as D1) or WO 2011/103150 A2 (D2).
Before considering the outstanding objections and applicant’s submissions in more detail, I will briefly outline some more details of the prosecution of this application to this point.
The present application was filed on 21 August 2019 as a divisional application of parent application 2017216568. Examination of the present application was requested on 1 November 2019 and a first examination report was issued on 15 June 2020. The objections in that report were identical to those raised in the first report against the parent application. The first objection was made under subsection 40(3) as follows:
“As previously indicated with respect to the parent application AU2017216568, the invention defined by claims 1-10 lacks support under subsection 40(3) because it omits the feature of a second charged cyclopolysaccharide with a charge that is opposite to that of the first, and acts to stabilise the composition.
“In the absence of this feature, the claimed invention is inconsistent with the description because it would appear that the stabilizing agent, the second cyclopolysaccharide, is the crux of the invention…
“This inventive concept seems to be reiterated throughout the description and examples.
There does not appear to be any reasonable disclosure of the invention not comprising the second and oppositely charged cyclopolysaccharide.”
The next objection alleges the invention lacks novelty when compared to either D1[13] or D2[14]. These documents are colloquially known in the Australian context as “whole of contents” citations and can only be used for establishing lack of novelty, not for establishing lack of inventive step, if they have a valid, earlier priority claim and were published on or after the priority date of the claims under consideration. Whole of contents citations must be an Australian patent specification, which includes PCT applications designated for entry into Australian national phase. The novelty objection raised was as follows:
“Claims 1-10 are not novel when compared with either WO2011103150 (D2) or WO2010097700 (D1). Although these were both published on or after the priority date of the present claims, their information has an earlier priority date than the present claims.
“Both discloses [sic] all of the essential features of the present claims, namely compositions comprising bendamustine and cyclopolysaccharides such as cyclodextrin with an anionic charge (see each of the documents in their entirety).”
[13] D1 was published on 2 September 2010, having an earliest claimed priority date of 25 February 2009
[14] D2 was published on 25 August 2011, having an earliest claimed priority date of 18 February 2010
The applicant responded to the first examination report on 7 June 2021 disputing both objections. However, the examiner maintained the objections in the second examination report issued on 11 June 2021 and raised a further, short-form objection on the grounds of utility stating:
“…it would appear that, especially in light of 'Formulation A' versus the control in example 2, that the claims do not define patentable subject matter, as the subject matter is not useful because it fails to fulfil the promised benefit.”
On 15 June 2021, the applicant requested to be heard in relation to the outstanding objections. On 25 August 2021 written submissions were received in support of the applicant’s position. I will expand further on the applicant’s submissions as required, but the main points of the applicant’s submissions are:
Ø The examiner erred in the assessment of the support of the claims because “the specification throughout, in numerous places, makes clear that the invention resides in the combination of bendamustine and the first charged polysaccharide, the second charged polysaccharide being strictly optional”;
Ø The claimed invention is useful because “the Examiner erred in taking a narrow view of the promise of the invention as described” and “is incorrect to conclude…that the second charged cyclopolysaccharide is an essential feature without which the compositions would fail to meet the promise of the invention”; and
Ø The novelty objection should be withdrawn as the information in D1 and D2 should be disregarded for the purposes of deciding whether the claimed invention is novel because the circumstances set out in the grace period provisions under subsection 24(1) of the Act and the relevant Regulations regarding prior disclosure of the invention apply.
Novelty
Should the information in D1 and D2 be disregarded?
For reasons of efficiency, I will first decide whether the information in D1 and D2 must be disregarded in deciding whether the claimed invention is novel. Some of the considerations I will make here are relevant to the other objections.
Subsection 24(1) of the Act and the corresponding regulations provide a grace period of up to 12 months in which to file an application if a prior publication disclosing the applicant’s invention is made either by the applicant or by a third party without consent after deriving information from the nominated person/patentee (or their predecessor).
The applicant is seeking to have D1 and D2 disregarded from the prior art base by claiming benefit under subsection 24(1)(a) for D1 and subsection 24(1)(b) for D2.[15] Several decisions have established that the information in whole of contents documents can be disregarded from the prior art under the grace period provisions of subsection 24(1).[16]
[15] Applicant’s submissions pages 4-5, “Rejection for Lack of Novelty.”
[16] Biogen Idec MA Inc. [2014] APO 25; Rozenberg & Co Pty Ltd. v Velin-Pharma A/S [2017] APO 61, paras [185]-[189]; CNH Industrial Italia S.p.A. [2020] APO 16; Cytec Industries Inc. v Nalco Company [2021] FCA 970, paras [218]-[224]
The information in D1 and D2 was made publicly available before 15 April 2013. Therefore, the grace period provisions of section 24 of the Act and chapter 2 of the regulations as they applied before 15 April 2013 are relevant here (that is, pre-Raising the Bar reforms).[17] While I note the applicant’s submissions refer to the Act and Regulations post-Raising the Bar reforms, because both sets of requirements are intended to operate similarly, except for some clarifying amendments that are not relevant to the present application,[18] the outcome would be the same under either set of requirements.
[17] Section 133(4) of Schedule 6 of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 and subregulation 23.36(4), Item 3 added by the Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 (No 1)
[18] Explanatory Memorandum, Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (Cth), Items 32 and 33: ‘Grace period’, pages 119-120
Subsection 24(1) at the time the information in D1 and D2 was made publicly available provided that:
24 Validity not affected by certain publication or use
(1)For the purpose of deciding whether an invention is novel or involves an inventive step or an innovative step, the person making the decision must disregard:
(a) any information made publicly available, through any publication or use of the invention in the prescribed circumstances, by or with the consent of the nominated person or patentee, or the predecessor in title of the nominated person or patentee; and
(b) any information made publicly available without the consent of the nominated person or patentee, through any publication or use of the invention by another person who derived the information from the nominated person or patentee or from the predecessor in title of the nominated person or patentee;
but only if a patent application for the invention is made within the prescribed period.
At the time D1 and D2 were published, the extent to which a divisional application could benefit from the provisions of subsection 24(1) was governed by regulations 2.3(3)-(4):
2.3 Publication or use: prescribed periods
(3)Subregulation (4) applies:
(a) if an application for a patent is a divisional application:
(i)under section 79B of the Act for an invention disclosed in the specification filed with a previous application for a standard patent (the original application); or
(ii)under section 79C of the Act for an invention disclosed in the specification filed with a previous application for a standard patent (the original application); and
(b) only to information disclosed in the divisional application that was disclosed in the original application.
(4)For determining the prescribed period for subsection 24(1) of the Act, the filing date of the divisional application is taken to be the filing date of the original application.
The Full Court of the Federal Court considered these regulations in Mont Adventure Equipment Pty Ltd v Phoenix Leisure Group Pty Ltd (Mont Adventure Equipment)[19] and confirmed that divisional applications are entitled to the same grace period benefits as the application from which the divisional came insofar as it contains information disclosed in the original application. Bennett and Jagot JJ summarising, respectively, in their separate reasons (emphases added):
“[I] see no reason why a divisional fairly based on a parent and entitled to priority date…should be deprived of the benefit of the grace period if there was a publication or use of the invention within 12 months before the filing date of the parent but not within 12 months before the date of the divisional.
“Regulations 2.3(3) and 2.3(4) are concerned to protect the divisional so far as it contains the same information as the parent. The Regulations leave open the effect of new information in the divisional. That information may, for example, affect the description of the invention or add information to some or all of the claims, such as an additional integer. It is a question of fact whether such additional information results in a new invention so that the purported divisional does not comply with s 79B or s 79C of the Act. If, for example, the additional information is for a new or different invention, so far as claimed in some of the claims, the grace period for s 24 in respect of that information will date back from the filing date of the divisional and not the parent.”[20]
and
“When cll 2.3(3) and (4) of the Regulations are taken into account the person deciding whether an invention is novel or involves an inventive step or an innovative step must also recognise that, insofar as information disclosed in the divisional application was disclosed in the earlier (or parent or original) application, the filing date of the divisional application is taken to be the filing date of the earlier (or parent or original) application.”[21]
[19] [2009] FCAFC 84
[20] Bennnet J at paras.[50]-[51]
[21] Jagot J at para. [80]
Divisional applications, by the terms of section 79B, are applications for inventions disclosed in the specification of the parent application as filed. Section 79B does not specifically state that a divisional application needs to be fairly based on or disclosed clearly enough and completely enough in the parent application (depending on pre- or post-Raising the Bar requirements)—it only requires the invention to be disclosed in the specification. However, as noted by Emmet J in Mont Adventure Equipment,[22] it is assumed there is “in substance…no distinction between the concept of an invention being disclosed in the specification of the Parent Application and a claim for an invention being fairly based on matter disclosed in the Parent Application.” In other words, if a claimed invention in a divisional application is fairly based on its parent, it is considered “disclosed” for the purposes of subsection 79B. It would also, by virtue of the Regulations, gain the same priority entitlement as its parent application.
[22] Emmet J at paras. [10]-[12]
Although pre-Raising the Bar requirements applied in Mont Adventure Equipment, similar considerations would seem to apply to post-Raising the Bar divisional applications regarding there being a clear enough and complete enough disclosure of the claimed invention in its parent and being “disclosed” for the purposes of subsection 79B.
Implicit then, is that if the claims of a divisional application have the same priority entitlement as its parent application, those claims must be directed to information (or an invention) disclosed in its parent and, accordingly, the same grace period provisions could apply to the divisional application as would relate to the parent. It seems, then, that the simplest course of action in determining whether the present claims are directed to information disclosed in the earlier application is to assess whether they are entitled to the same priority date as the grandparent. If the claims share the same priority date, they must be directed to information disclosed in the original application, which means regulations 2.3(3) and 2.3(4) relevant at the time D1 and D2 were published could be engaged.
The situation in the present application appears to be complicated somewhat by the changes made to the consistory statements in the present application (and its parent application) compared to the grandparent patent such that the second, oppositely charged cyclopolysaccharide is now optional, where originally it was indicated throughout the grandparent specification to be a mandatory aspect of the invention. Much of the previous attention and argument in the prosecution of this application to this point has focussed on this issue, particularly regarding whether the claims are supported. On its face, it may seem easy to conclude this potentially indicates a fundamental change to the entire nature of the invention that might result in disclosing and claiming new information. However, determining whether there actually is disclosure or claiming of additional information requires a more rigorous consideration than comparing the consistory statements of ancestor applications.
Once I have determined whether the present claims are directed to information in the original application, I will then decide whether the grace period provisions apply and whether D1 and D2 can be disregarded from the prior art base under subsection 24(1). The applicant’s more detailed submissions[23] vis-à-vis disregarding the information in D1 and D2 will be somewhat irrelevant if the grace period provisions cannot be applied.
[23] Applicant’s submission, pages 4-5, “Rejection for Lack of Novelty”
Are present claims entitled to same priority date as the grandparent application?
As I said earlier, the present application is subject to the amendments to the Act brought about by the Raising the Bar amendments. I also note that the parent and grandparent applications in this chain of divisional applications are also subject to the same requirements. Divisional applications filed post-Raising the Bar amendments and validly made under section 79B of the Act usually obtain priority entitlement from their parent application through regulation 3.13D if the earlier application clearly discloses the invention in the claim, noting that in a chain of divisional applications, priority date is passed from ancestor to ancestor in a stepwise manner through the chain. Subject to regulation 3.12, the priority date is the date the claim would have had if the claim was in the earlier specification and for regulation 3.13D, “clearly disclosed” is taken to mean the invention is disclosed in a manner clear enough and complete enough for the invention to be performed by a person skilled in the art.[24] Therefore, for the present claims to have the same priority date as the grandparent application, there must be sufficient disclosure of the presently claimed invention in the parent application, which in turn must properly derive priority entitlement from the grandparent application.
[24] Subregulation 3.12(4)
The applicant has asserted that the present application has a priority date of 19 July 2010 and [for the purposes of the grace period provisions] an effective filing date of 23 February 2011.[25] As the present application is the third generation in a chain of applications, for this assertion to be correct, it requires that the present claims are directed to an invention disclosed in grandparent patent 2011363446 and that it also shares the same priority entitlement. It also requires that the grandparent patent itself is entitled to claim priority from the earliest priority filing US 61/399,855.
[25] Applicant’s submission, p. 4, second to last paragraph.
While discussion in the applicant’s submission does not appear to extend further than the general assertion above, I note that in response to the first examination report, the applicant states “the matter presently claimed is enabled by the disclosure of the parent application 2017216568, and the grandparent 2011363446 for the same reasons stated above.”[26] The reasons put forth by the applicant are that the present application makes it clear that the presence of a second charged stabilising cyclopolysaccharide agent is optional and that the specification describes the preparation of the composition of the invention by dissolution of bendamustine in an aqueous solution of the first (anionic) cyclopolysaccharide including preferred cyclodextrin concentrations, providing an enabling disclosure.[27]
[26] Response to First Examination Report, dated 07 June 2021, p.1, last para.
[27] Present application, page 4 lines 12-23
The general approach for determining whether an invention is disclosed in a sufficient manner was outlined by Lord Hoffman in Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2005] RPC 9 at [103]:
"The first step is to identify the invention and decide what it claims to enable the skilled man to do. Then one can ask whether the specification enables him to do it."
Following from this, the delegate in CSR Building Products Limited v United States Gypsum Company (CSR)[28] framed the test to determine the sufficiency of disclosure as having the following three steps:
(i)Construe the claims to determine the scope of invention as claimed,
(ii)Construe the description to determine what it discloses to the person skilled in the art, and
(iii)Decide whether the specification provides an enabling disclosure of all the things that fall within the scope of the claims.
[28] [2015] APO 72 (CSR) at [95]
This approach has been noted with apparent approval by the Federal Court.[29]
[29] Cytec Industries Inc. v Nalco Company [2021] FCA 970, para [143].
Therefore, to decide whether the present claims are entitled to the same priority date as the grandparent and to determine whether the disclosure of the earlier application is sufficient, the latter two steps of the CSR test can be reframed:
(ii)Construe the description of the earlier application to determine what it discloses to the person skilled in the art, and
(iii)Decide whether the specification of the earlier application provides an enabling disclosure of all things that fall within the scope of the present claims.
What is the invention as presently claimed?
Above, I stated that claim 1 is directed to a composition comprising:
(a)bendamustine; and
(b)a cyclopolysaccharide having at least one charged group which is an anionic group.
The claims of the present application are of broader scope than the grandparent patent’s claims. As I also stated earlier, the compositions of the present claims are not limited to include only these two components, but the scope is such that the composition may contain any other ingredient. There is no requirement in the present claims that the bendamustine composition additionally comprises a cyclopolysaccharide stabilising agent of opposite charge as per the claims of the granted grandparent application.
What does the specification of the earlier application disclose?
I have reviewed the specifications of the parent application (and the grandparent application). The claims of the present application are identical to those as filed in the parent application and there are minor differences as noted earlier between the description in each of the family members in this chain of divisional applications relating mainly to the consistory statements and the optional or mandatory nature of the stabilising cyclopolysaccharide. Except for those differences, the remainder of the text in all other parts of the family of applications appears to be identical, including general methods of preparing compositions and the specific examples.
While the examples in the parent application are generally directed towards producing and using stabilised compositions comprising bendamustine and two oppositely-charged cyclopolysaccharides to achieved additional stability of bendamustine and improved anti-cancer properties, this does not necessarily mean there is a lack of disclosure on which the present claims could be based.
Firstly, there is a single, specific disclosure in example 2 of a composition within the broad limitations of the present claims. So-called composition A which comprises bendamustine and sulfobutyl ether betacyclodextrin[30] (along with excipients) is clearly encompassed in present claim 1. That specific composition, though, is presented only in the context of a comparative example to demonstrate the beneficial nature of the three-component compositions which have clearly superior stability than composition A.
[30] AU 2017216568, Composition A, Example 2, page 6 to page 8.
Secondly, within the general method of preparing the three-component compositions in the description of the parent application,[31] that method first involves preparing an aqueous solution of the first-charged polysaccharide and then dissolving bendamustine in that solution. That solution, which meets the requirements of the present claims, exists as a standalone intermediate first and it is only after preparing this first solution that the final three-component system is made by adding the second, oppositely charged cyclopolysaccharide into the previously prepared solution of bendamustine and the first cyclopolysaccharide. Notably, this disclosure is present in each of the chain of applications from which the present application claims priority.
Does the relevant earlier specification provide an enabling disclosure of all the things that fall within the scope of the present claims?
[31] AU 2017216568, page 4, line 24 to page 5, line 14.
Taking everything into account, I agree with the applicant’s position that there is an enabling disclosure for the present claims. My reading of the paragraphs relating to the general procedure for preparing the three-component composition accords with the applicant in that the presently claimed compositions are intermediate products in either solution or solid form towards preparing the stabilised three component mixture. I think it clearly indicates that the composition of the present claims is prepared as a separate entity and that by following the general procedure outlined when seeking to make a three-component mixture, the person skilled in the art would inevitably produce compositions meeting the requirements of the present claims.
There is, prima facie, a principle of general application in that disclosure, read in view of the rest of the description, that would allow the person skilled in the art to work the invention over its scope without undue burden and nothing leads me to believe this would not be the case. So, although not specifically identified as a separate invention in the original application, I am satisfied the present claims are sufficiently disclosed in the each of the earlier applications and also in the present application. As a result, the present claims share the same priority entitlement as the grandparent patent.
The actual priority date of the present claims is not specifically relevant to the consideration of whether the information in D1 and D2 can be disregarded. However, for completeness, I conclude that the present claims have a priority date of 19 July 2010. The grandparent application claims priority from US 61/399,855 which was filed on 19 July 2010. Having read this priority document, I am satisfied it provides sufficient disclosure to provide the grandparent application and its claims with a priority of 19 July 2010. The grandparent application is essentially identical to the priority document having largely the same description and identical experimental details in the examples.
Because the present claims share the same priority entitlement as the grandparent patent, they are inevitably directed to information that was disclosed in the original application.
The information in D1 and D2 must be disregarded
All claims are directed to information in the original application. Therefore, regulations 2.3(3) and 2.3(4) as they applied when D1 and D2 were published can be engaged to provide the same grace period provisions that would have been available to the original application. I have reviewed and accept the applicant’s submissions on the circumstances surrounding the publication of D1 and D2.
D1 was clearly filed by the applicant’s predecessor and shares common inventors. Under subsection 24(1)(a), the information in D1 must be disregarded in deciding whether the present claims are novel.
The applicant also submits the information in D2 was made publicly available without consent after information had been derived from the applicant’s predecessor. In considering this matter, I also obtained a copy of the initial documents filed by the applicant’s predecessor in the Eastern District Court of Pennsylvania.[32] Having read that document in view of the applicant’s submission that the parties subsequently entered into a settlement,[33] I am willing to accept, on the balance of probabilities, that D2 was made available without the consent of the applicant or its predecessor in title. Under subsection 24(1)(b), the information in D2 must also be disregarded in deciding whether the present claims are novel.
[32] Supratek Pharma, Inc. v Cephalon, Inc., et al., Civil Action 2:12-CV-00261
[33] Applicant’s submission, page 5, paras 6-7
Accordingly, the outstanding novelty objections over D1 and D2 cannot be maintained.
Support
An objection to lack of support has been maintained over several reports (including in parent application 2017216568) because the claims are alleged to omit the feature of an oppositely charged cyclopolysaccharide stabilising agent which appears necessary to perform the invention—as a result, the claims are said to be inconsistent with description.
In their submission, the applicant refers to several paragraphs in Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477 at [545]-[547] where Burley J outlines some of the basic requirements of sufficiency and support provisions of the Patents Act. I will add to this that Burley J also cites here with apparent approval the Delegate of the Commissioner in CSR,[34] who adopted the approach of Aldous J in Schering Biotech Corp.'s Application [1993] RPC 249 at 252-253 of requiring that the technical contribution to the art must be ascertained and it is that which must justify the breadth of monopoly claimed.
[34] [2015] APO 72 at [114]-[115]
Above I stated that there is sufficient disclosure of the present claims. Where the claims are directed to a discrete product and there is an enabling disclosure that allows the person skilled in the art to make that product across the scope of the claim, it usually follows, in the absence of any special factors to take into account, such as the product being further defined in terms of a property or function, that the product forms part of the applicant’s technical contribution to the art (on the assumption that product is also novel and not obvious).[35] No such special factors define the compositions claimed in the present application. Therefore, the present claims accord with what the applicant appears to have contributed to the art.
[35] Generics (UK) Limited and others v H Lundbeck AS [2009] UKHL 12 [2009] RPC 13 at [95]
While I agree with the examiner that most of the present application seems to be directed to preparing stabilised bendamustine compositions having two, oppositely charged cyclopolysaccharides, I disagree with the view that there is no reasonable disclosure of the present claims. The presently claimed compositions are disclosed as being intermediates towards preparing those stabilised compositions and as a comparative control example in testing. It follows that the claims are consistent with the description and, consequently, I conclude that the claims are supported.
Utility
In the second examination report, the examiner objected that the claims do not meet the usefulness requirements of subsection 18(1)(c). This objection was raised in short form in addition to the support objection and said to follow from the reasons given in relation to the support objection. This objection had not been raised previously. The basis of the objection was that the promise of the invention appears to lie in the compositions of the invention having unexpectedly desirable stability and anticancer activity and “in light of ‘Formulation A” versus the control in example 2, that the claims do not define patentable subject matter…because it fails to fulfil the promised benefit”.
The basic principles of utility have been summarised by the Full Court of the Federal Court in Artcraft Urban Group Pty Ltd v Streetworx Pty Ltd.[36] In essence, an invention has utility if it “does what it is intended by the patentee to do, and the end attained is itself useful”. What the invention is intended to do is to be attained from whole specification and, by following the teaching of the patent, does the claimed invention attain the result promised?
[36] [2016] FCAFC 29 at [120]-[121]
In determining the promise of the invention, the Full Court of Federal Court in ESCO Corporation v Ronneby Road Pty Ltd (ESCO Corporation)[37] also said “the promise for the invention is to be found by, put simply, following the teaching of the Specification to see what result is claimed for the invention. Utility “depends” upon whether the result claimed is attained or produced” and that “it is necessary to identify the “teaching” of the Specification and the relationship between the teaching and the claims”.
[37] [2018] FCAFC 46 at [300] and [291], respectively.
Thus, as the claims in the present application are directed, ultimately, to different (albeit similar) subject matter compared to the grandparent patent, the consideration of usefulness should not be limited to what the promise achieved by the claimed subject matter in the grandparent application may have been without first considering the teaching of the present specification. The present claims are directed to a composition that comprises bendamustine and a cyclopolysaccharide having at least one anionic group and I need to consider what the specification promises (or indeed may not promise) regarding these compositions.
The applicant has submitted that “the Examiner has erred in taking a narrow view of the promise of the invention as described, and in particular has referred to aspects of the invention which are specifically stated as relating to preferred forms of the invention”. The applicant further submits that not all embodiments of the invention must provide the stability afforded by having two oppositely charged cyclopolysaccharides in composition with bendamustine.[38] I agree with the applicant.
[38] Applicant’s submission, page 3, second and third paras.
I do not think that the specification promises unexpected stability nor improved anticancer activity for compositions meeting the minimum requirements of claim 1. Indeed, Composition A in Example 2 of the description suggests overall lower stability than bendamustine alone (the control composition) and significantly lower stability than compositions having bendamustine and both cyclopolysaccharides (compositions 1 and 2). There is also no data presented on the efficacy of composition A in reducing tumour size (Example 3).
I agree with the applicant that the main function of compositions meeting the minimum requirements of claim 1 is as an intermediate composition which is subsequently used to produce bendamustine compositions that are stabilised by adding a second and oppositely charged cyclopolysaccharide. The promise of the invention is to be found, therefore, at page 4, lines 12-28 which outlines their preparation, isolation and use as intermediates. The compositions clearly fulfil that promise and there is no countervailing evidence to suggest otherwise.
I further note, as is also noted by the applicant in their submission, the description states “Embodiments of the composition of the present invention may provide unexpectedly desirable stability in reactive environments…coupled with unexpectedly desirable anticancer activity.”[39] This also clearly indicates not all compositions need the particularly desirable effects to which the promise of the invention had been limited by the Examiner.
[39] Present application, p.1, line 38 to p. 2, line 2.
The claimed subject matter is useful.
Additional Observations
To this point, D1 and D2 have been put forward as the only citations relevant to the novelty of the present claims. As a result of the examiner’s long-held views regarding support for the present claims, it is not immediately apparent to me that a sufficiently rigorous prior art search considering the subject matter I have found to be supported and useful has been conducted. I think it is appropriate that the application is returned to examination to allow an examiner the opportunity to consider the exactitude of searching thus far. If there is no other prior art that needs to be considered, the application should proceed to acceptance.
Conclusion
The information in D1 and D2 must be disregarded in deciding whether the present claims are novel.
The present claims are supported under subsection 40(3).
The present claims meet the usefulness requirement under subsection 18(1)(c).
The current outstanding objections cannot be maintained. Noting my comments above, I will refer the application back to examination to consider whether further prior art searching is required. If it is not required or no other relevant prior art documents are found, the application should proceed to acceptance.
In accordance with the Regulations, the final date for acceptance is three (3) months from the date of this decision.
Dr Scott D. Makin
Delegate of the Commissioner of Patents
ANNEX A
CLAIMS
A composition comprising:
(a) bendamustine; and
(b) a cyclopolysaccharide having at least one charged group which is an anionic group.
The composition of claim 1 wherein the cyclopolysaccharide is cyclodextrin.
The composition of claims 1 or 2 wherein the anionic group is selected from the group consisting of sulphate, sulphonyl, and carbonyl.
The composition of claim 3 wherein component (b) is selected from the group consisting of sulfobutyl ether beta-cyclodextrin, sodium carboxymethylated-beta-cyclodextrin, sodium O-phosphated-beta-cyclodextrin, succinyl-(2-hydroxy)propyl-beta-cyclodextrin, sodium sulfopropylated-beta- cyclodextrin, and sodium O-sulfated-beta-cyclodextrin.
The composition of claim 4 wherein component (b) is sulfobutyl ether beta-cyclodextrin.
The composition of any of claims 1-5 wherein the weight ratio of bendamustine to component (b) is between 1:5000 and 1:5.
The composition of claim 6 wherein the weight ratio of bendamustine to component (b) is between 1:1000 and 1:8.
The composition of claim 7 wherein the weight ratio of bendamustine to component (b) is between 1:500 and 1:10.
The composition of claim 8 wherein the weight ratio of bendamustine to component (b) is between 1:100 and 1:10.
10. The composition of any of claims 1-9 wherein said composition is freeze dried.
0
9
0