Post-Grant Claim Amendments: Amending Within the Bounds of the Original Scope of Protection
Juno Pharmaceuticals Pty Ltd v Janssen Pharmaceutica NV [2024] APO 48 (4 December 2024)
This case related to Australian patent 2008340101, which was granted on 3 December 2015 and for which Janssen Pharmaceutical NV (“Janssen”) is the owner. The subject matter of the patent concerned dosing regimens for administration of long acting injectable paliperidone palmitate formulations.
The patentee sought leave to amend the specification, the amendments of which were advertised on 15 June 2023 for opposition purposes.
The opponent, Juno Pharmaceuticals Pty Ltd, filed a notice of opposition on 15 August 2023 to oppose the amendments sought by the Patentee. Specifically, the scope of the amended claims would no longer fall within the same scope of the pre-amended claims. Furthermore, it was also argued that the amendments proposed were not fairly based on the matters as described in the specification (section 40(3)).
Relevant Law
The provisions “pre-Raising the Bar” apply in this case, since the request for examination of the patent was filed before 15 April 2013.
i) Section 102(1)
Section 102(1) of the Patents Act 1990 (“the Act”), states that “an amendment of a complete specification is not allowable if, as a result of the amendment, the specification would claim matter not in substance disclosed in the specification as filed.”
It is well-established that the test for section 102(1) is very similar to that used to assess fair basis, except that an assessment under section 102(1) is on the specification as filed, including the claims, whereas the test for fair basis is made with reference to the description of the specification only. The approach for assessing fair basis as approved by the High Court in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [2004] HCA 58 was set out in the case of Rehm Pty Ltd v Websters Security Systems (international) Pty Ltd (1998) 81 ALR 79 at 95:
“the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification”.
For the requirement for a real and reasonably clear disclosure of the claims to be satisfied, the claims must not, as a result of the amendment, be inconsistent with what is disclosed in the specification as filed.
ii) Section 102(1)(a)
To assess whether an amendment would result in a claim that does not in substance fall within the scope of the claims of the specification before it was amended, one must assess whether the amendment make something an infringement that would not have been an infringement prior to the amendment (Bristol-Myers Squibb Company v Apotex Pty Ltd [2010] FCA 814 at [40]). The test therefore looks into the scope of exploitation of the invention claimed before and after the amendment. The term “exploit” encompassing the activities of making, hiring, selling or otherwise disposing of the product, offering to make, sell or otherwise dispose of it, use or import it, or keep it for the purposes of doing any of those things, or in the case of a method or process, to do any of those acts in respect of a product resulting from such use.
iii) Section 102(2)(b)
The provisions under Section 102(2)(b) relate to whether the amendments result in claims that are not clearly, succinctly and are not fairly based on the matter as described in the specification (section 40(3)). The test for assessing fair basis has already been discussed under item (i) above (Section 102(1)).
The Amendments
The amendments opposed in the case concern (i) amendments to the loading dose range and (ii) new method of treatment claims.
i) Amending the Loading Dose Range
The amendments to the loading dose ranges in claim 1 are reproduced below for convenience:
“a first loading dose of from about 100mg-eq. to about 150 mg-eq. of paliperidone” and “a second loading dose of from about 100mg-eq. to about 150 mg-eq. of paliperidone.”
It was contended by the opponent that prior to amendment, the claim would have been understood to include administration of a first and second loading dose of at least (not less than) 100 mg eq. and up to, but no more than 150 mg eq. After amendment, the opponent contends that the scope of the claim now includes doses above and below 150 and 100 mg eq., respectively. Thus, the amendments have broadened the scope of the claims, when compared with the scope prior to the amendments.
In their counter-argument, the patentee contended that the claim scope prior to amendment, defines a range of doses extending from a lower limit of “about 100 mg eq” to an upper limit of “about 150 mg eq” wherein the term “about” is understood to mean “approximately”. Therefore, the doses claimed prior to amendment are to an extent greater than and less than the specified values. If the term “about” was to be interpreted otherwise, it would make inclusion of such a term redundant in the claim.
The delegate considered that to address this question would involve construing the specification to see how the term “about” is defined. Whilst it was not apparent that there was any specific technical meaning given to the term “about” within the specification, ultimately, the delegate considered that the patentee’s interpretations were more appropriate in the context. This was because there was considered no reason as to why the term “about” should be used to mean something different when used in the context of the claims defining ranges. The delegate referred to the case of Pharmacia LLC v Juno Pharmaceuticals Pty Ltd [2022] FCAFC 167 at [54], wherein the Full Court stated that with respect to amendments, an unchallenged finding by the primary judge, means that the word “about” must be understood to extend the ranges set out in the various claims. To opt for the interpretation as suggested by the opponent would provide different meanings to the term “about” throughout the claim set of the patent, such that in some contexts it would be completely redundant, thereby providing an “unnatural” construction of the claims.
The delegate then considered whether the amendment which changed the first loading dose to the upper limit of the range disclosed prior to the amendment and which also changed the second loading dose to the lower limit of the range as previously disclosed in the claim, whilst retaining the original maintenance dose range is within the scope of the original claims.
It was held that the first and second loading doses of about 150 mg eq. and about 100 mg eq., respectively, are within the scope of the original ranges. Thus, the proposed amendments were narrowing in nature and are consistent with the disclosures in the specification. In other words, the amendments did not lack fair basis.
The opponent further argued that in relation to some of the other claims (6 and 7), for which amendments were also made thereto, there was no disclosure of a first loading dose of about 100 mg eq. for administration to a renally impaired patient. Instead, the specification only disclosed a lower loading dose of 75 mg eq. Thus, these claims were not in substance disclosed by the specification, or there was at least absence of a real and reasonable clear disclosure of this feature.
The delegate noted that the amendment to claim 6 involved changing this claim to become an independent claim, whereas previously it was dependent on claim 5 prior to the amendments. Claim 5 recited a first loading dose of about 100 mg eq. of paliperidone. Amending claim 6 to become a new independent claim involved replacing the statement of dependency with a preamble in the claim to which it was appended. This meant that the feature of the administration of a first loading dose of about 100 mg eq. of paliperidone to a renally impaired patient is not newly introduced by the amendment.
With respect to claim 7, the maintenance dose schedule is the same as claim 5 prior to the amendments. Claim 5 prior to amendment defined a first loading dose of from about 75 mg eq. That is, about 75 mg eq was stated to be the lower limit, while no upper limit was specified. The delegate considered that given claim 6, which followed directly therefrom claim 5, defines a first loading dose of about 100 mg eq, which was originally appended to claim 5, a skilled person, in the context of the claim set would have understood a first loading dose of about 100 mg eq to be within the scope of the first loading dose, defined in claim 5, prior to amendment. Therefore, it cannot be concluded that the claims prior to amendment did not encompass or clearly define a dosage regimen for administering paliperidone to renally impaired psychiatric patients, which includes a first loading dose of about 100 mg eq. of paliperidone. This means that the opposition grounds concerning amendments to the loading dose range therefore failed.
ii) Addition of Method of Treatment Claims
The second opposition grounds concerning amendments to add new method of treatment claims, which focused on the question of whether the amendment has the effect of making something an infringement that would not previously have been an infringement, was subsequently assessed. The opponent’s submissions contended that prior to the amendments, dosage regimen claims (“use of paliperidone palmitate in a dosage regimen…”) were disclosed, which is not a method of treatment. By introducing method of treatment claims, the Applicant is expanding the range of infringing acts, because dosing regimens merely provide a list of recommended instructions (or information) from the manufacturer for administering a drug. This contrasts with a method of treatment claim which otherwise may involve administration of a drug according to a schedule, the schedule of which does not itself treat the patient.
The delegate disagreed with the opponent, stating that the dosage regimen claims define “use of paliperidone palmitate in a dosage regimen according to [the preceding claim] for treating a [patient]. It was further noted that the preceding claim defined the regimen as being “for administering paliperidone palmitate, outlining steps for administering paliperidone palmitate to a patient.” In light of this, the delegate considered that the sensible construction of the dosage regimen claims would be that they are use or method claims for treating a patient by administering paliperidone palmitate. The new method of treatment claims therefore in substance fall within the scope of the claims prior to amendment. In other words, the amendment to include these method of treatment claims was not found to make anything an infringement that was not otherwise an infringement prior to amendment.
The opposition was thereby unsuccessful and costs were awarded against the opponent.
Key Points
This case highlights the importance of claim construction in defining the scope of patent protection. It offers hope to Applicants who may be seeking to narrow a specified claimed range, as the delegate in this case advocated for a common sense approach to interpreting the term “about” as used in the context of the claims defining ranges.
Furthermore, the case demonstrates that dosage regimen claims may be used to provide basis for method of treatment claims, provided there is sufficient detail on, for example, the steps that may be taken for administering a dosage to a patient. Amendments seeking to add method of treatment claims in light of such dosage regimen claims would therefore not change the original scope of protection for these dosage regimen claims.
For advice on patent claim amendments, feel free to contact the patent team at MBIP.
