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Allowability of post-grant amendments (Section 84(3))

7.26 Post-grant amendments (Section 84(3)):

(3) No amendment of the specification of a patent shall be allowed under section 38(1), 81 or 83 if it —

(a) results in the specification disclosing any additional matter; or
(b) extends the protection conferred by the patent.

7.27 Guidance on the assessment of post-grant amendments have been provided in two recent Singapore High Court decisions: Ship’s Equipment Centre v Fuji Trading [2015] SGHC 159 and Warner Lambert v Novartis [2016] SGHC 106.

7.28 For the determination of condition (a) whether the proposed amendment discloses additional matter, the same test that applies for pre-grant amendments as set down in the UK case Bonzel and Schneider (Europe) AG v Intervention Ltd [1991] RPC 553 applies essentially for post-grant amendments. The Bonzel test was accordingly followed in Ship’s Equipment Centre v Fuji Trading and Warner Lambert v Novartis.

7.29 The proposed amendment was from a method of treatment claim to a Swiss-style claim in Warner Lambert v Novartis. Specifically, the granted claims were directed towards methods of treating pain by administering a therapeutically effective amount of the disclosed compound. The proprietor proposed to amend the granted claims to claims directed to the use of the same compound to prepare a medicament (i.e. the therapeutically effective amount of the disclosed compound) for treating pain. Following the Bonzel test, George Wei J concluded the amendment does not disclose any “added matter”, taking into account the skilled addressee would appreciate that the Swiss-style claims were conceived to protect specific medical indications.

7.30 After considering condition (a), it is then necessary to determine condition (b) whether the proposed amendment extends the protection conferred by the patent. The crux of the inquiry is whether the ambit of the protection conferred by the patent will be extended by the proposed amendment. As such, it is important not to be unnecessarily side-tracked by the change in the category or subject matter of the claims in the patent. For example, it would be permissible to reformulate an apparatus claim by way of amendment to a claim covering only a use of the product, if the result is to cut down the scope of protection. In this sense, the decision as to whether the scope of protection has been extended cannot be decided on a formalistic basis (see Ship’s Equipment Centre v Fuji Trading and Warner Lambert v Novartis).

7.31 A good test is to ask whether something that fell outside the scope of the [granted] claims (properly interpreted) and hence not an infringing act on its own now falls within the [proposed amended] claims such that it becomes an infringing act (“the Infringement Test”) (Terrell on the Law of Patents at para 15-41, Richard Miller et al, Sweet & Maxwell, 17th Ed, 2011). In properly applying the test, a “purposive approach” should first be applied to construing the patent claims. It is then necessary to compare the totality of protection established by the patent before and after the amendment, and not the scope of protection within the wording of each single claim as granted. For example, the extension of the scope of an individual claim per se is not objectionable, if it does not result in the extension of the protection of the patent (see Warner Lambert v Novartis and Ship’s Equipment Centre v Fuji Trading).

7.32 Based on these considerations, George Wei J concluded that the amendment has broadened the scope of protection to include manufacture of a medicament, which represents a shift away from the granted claims directed to the method of treatment, and hence fails condition (b).

“Whilst broadly connected by the same final objective (of treating pain), the granted claims and the amended claims are targeted at different activities — the latter covers the making of the compound for the purposes of administration (to treat pain) whereas the former covers only the follow-on act of administration of the compound to treat pain.”

7.33 Apart from the requirements under Section 84(3), the proposed amendments must also satisfy the requirements under Sections 25(5)(b) and (c) of the Patents Act, i.e., the [amended] claim or claims must be ‘clear and concise’ and ‘supported by the description’. These are the “base-line criteria” that any claim amendments must satisfy as set out in Trek Technology (Singapore) Pte Ltd v FE Global Electronics Pte Ltd and others and other suits [2005] 3 SLR(R) 389, as affirmed in Ship’s Equipment Centre v Fuji Trading and Warner Lambert v Novartis.

7.34 The Registry issued a Circular No. 1/2016 on 30 June 2016 whichtakes effect from its issuance date and applies to all pending and future requests. In addition to the requirements under Section 84(3), it is made clear in the Circular that any post-grant amendments under Section 38 will also be assessed based on the following criteria:

(1) Whether relevant matters are sufficiently disclosed;
(2) Whether there was any unreasonable delay in seeking amendments; and
(3) Whether the patentee has gained an unfair advantage obtained by delaying amendments which are known to be needed.

7.35 As required by criterion (1) of the Circular, any application for post-grant amendment should set out fully the reason(s) for amendments, including the circumstances leading to the amendments and any evidence in support thereof to facilitate the assessment. As such, relevant matters, i.e. the reason(s) for amendments, should be disclosed to the extent that said disclosure would be sufficient for the Examiner to establish a prima facie case of allowability for the proposed amendments. In the situation where the Examiner deems that the evidence in support of the reason(s) for amendment is not sufficient, a request may be made, via the Registry of Patents, for the applicant to provide further evidence.

7.36 Guidance for consideration of criterion (2) Whether there was any unreasonable delay in seeking amendments may be found in Warner Lambert v Novartis [2016] SGHC 106 at 101-104:

“First and foremost, for the delay to be considered undue, the period of the delay need not be long provided that there is no plausible explanation for the delay.” “Second, a delay may not be held against the applicant if it is able to provide a reasonable explanation for the delay.” “Third, the appropriate juncture to question whether the amending party has been guilty of an unreasonable delay is the time it was first made aware of the need to amend.”

7.37 Guidance for consideration of criterion (3), whether the patentee has gained an unfair advantage obtained by delaying amendments which are known to be needed, may also be found in in Warner Lambert v Novartis [2016] SGHC 106 at 117-121.