Practice note: what to do with medical use claims when employing the foreign route of prosecution in Singapore

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Up until 1 January 2020, the Foreign Route was an available patent prosecution option of a Singapore application having a local or international filing date prior to 1 January 2020, or of a Singapore divisional application filed prior to 1 January 2020. As the deadline for electing the Foreign Route is 54 months from the earliest priority date of a convention application or a PCT national phase entry application, or 54 months from the actual date of filing of a divisional application, there are therefore applications that are currently pending that still have the Foreign Route available as a prosecution option, at least up until 30 June 2024.

As discussed in a previous news update, there are various challenges when employing the Foreign Route. One such challenge commonly encountered in pharmaceutical and life science applications concerns claims directed to methods of treatment (MOT), which are excluded from patentability in Singapore(i.e. point (5) in the previous news update). Although such MOT claims may be amended to the Swiss-style second medical use format to overcome the unpatentable subject matter issue, such an amendment must also meet the “claim relatedness” requirement of the Foreign Route (i.e. the first point (2) in the previous news update). The following are some guidelines clarifying when such MOT claims present in the foreign application/patent used as a basis for grant under the Foreign Route may be amended to the Swiss-style second medical use format and still meet the “claim relatedness” requirement, and when such amendment is not possible:

Claims of foreign application/patentCan the foreign application / patent be used as basis under the Foreign Route?Notes
Scenario 1
When all of the claims in the foreign application/patent (e.g. Australia or United States of America) are MOT claims
No
  • The MOT claims are unpatentable subject matter.
  • The MOT claims cannot be amended to their Swiss-style second medical use equivalents, which are construed as “purpose limited process” claims that define a method of preparing a pharmaceutical which is intended for a particular treatment, and are not considered to be related to the MOT claims which include treatment steps.
  • Therefore, the “claim relatedness” requirement would not be met.
Scenario 2
When all of the claims in the foreign application/patent
(e.g. EP) are “purpose limited product” claims, including:
(i) “compound X for use as a medicament”
(ii) “compound X for use in therapy” 
(iii) “compound X for use in the treatment of disease Y”
No
  • The claims in the foreign application/patent (e.g. the EP application/patent) were examined (and allowed/granted) as second medical use claims – where the claims are only anticipated when the use of compound X for the specific purpose of treating disease Y is disclosed in the prior art.In contrast, the identical claims in the Singapore application are construed differently as first medical use claims during examination – where the claims are anticipated by any prior medical use of compound X.
  • Therefore, employing the Foreign Route based on claims of such a foreign application/patent is not allowed, regardless of whether compound X is novel or not.
  • The claims also cannot be amended to the Swiss-style second medical use equivalents which are construed as “purpose limited process” claims, and would not be considered related to the “purpose limited product” claims.
  • Therefore, the “claim relatedness” requirement would not be met.
Scenario 3
When a claim to a compound X per se is present, in addition to MOT claims (e.g. from corresponding AU/US application/patent) or “purpose limited product” claims (e.g. from corresponding EP application/patent)
Yes
  • The MOT claims or “purpose limited product” claims directed to compound X may be amended to their Swiss-style second medical use equivalents because the amended claims would be considered to be “related” to the compound X per se claim.
  • Therefore, the “claim relatedness” requirement would be met.
  • However, the Swiss-style claims must nevertheless also fulfil the requirements of “added matter” (i.e. point (7) of the previous news update) and support (i.e. the first point (1) of the previous news update), since both are grounds for examination under the Foreign Route.

In view of the above, if an Applicant intends to employ the Foreign Route, it is important to ensure that the foreign application/patent it intends to use for the Foreign Route has a compound per se claim and/or claims already in the Swiss-style second medical use format present. Otherwise, if the claims of the foreign application/patent fall into Scenario 1 or Scenario 2 above, then it would not be possible to use that foreign application/patent for the Foreign Route in Singapore.

If you have any questions regarding the Foreign Route option for your patent application in Singapore, please don’t hesitate to contact us.

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