5.7.6.1 Insertion or alteration of s6(c) information - deposit requirements

Also in this Chapter:

• 5.7.6.2 Amendment or Correction of Sequence Listings

Key Legislation:

Patents Act:

• s6(c)-(d) Deposit requirements
• s40(2)(a) Specifications  
• s41 Specifications: micro-organisms
• s104 Amendments by applicants and patentees  
• s223 Extensions of time

Patents Regulations:

• reg 1.5 Deposit requirements: prescribed period
• reg 3.25 Request for Commissioner's certification authorising release of sample of a micro-organism
• reg 3.29(1) Notification that a deposit requirement has ceased to be satisfied
• reg 3.30 Prescribed period: deposit requirements taken to be satisfied
• reg 10.2(8)-(9) Commissioner to consider and deal with requests for leave to amend
• reg 10.2C(3) Amendments not allowable for other documents
• reg 10.6(1)-(2) Time for allowance of amendments​​​​​​​​​​​​​​

Related Chapters:

• ​​​​​​​5.6.7.2 Clear and Complete Enough Disclosure
• 5.6.7.6 Clear disclosure of Micro-organisms

On this page

• Overview
• Sections 104 and 223 - Insertion of Section 6(c) Information​​​​​​​
  • When is an Extension of Time Under Section 223 Required?
  • When is an Extension of Time Under Section 223 Not Required?
  • Examination Practice;
• Article 34 Amendments Concerning Section 6(c) Information;
• Amendment Procedure When a Request for Certification for Release is Pending;
• Amendment Procedure When Deposit Requirements Cease to be Satisfied

Overview

An amendment of the specification under s104 to include any or all of the information referred to in s6(c) (that is, the name of the prescribed depositary institution and/or the file, accession or registration number of the deposit) can be made at any time before the end of the prescribed period. In general, the prescribed period ends immediately before the day on which the specification becomes open to public inspection (OPI), or immediately before acceptance, whichever is earlier.

Any amendment of the specification to include s6(c) information after the end of the prescribed period will not achieve compliance with the deposit requirements, unless the applicant also obtains an extension of time under s223, such that the amendment can occur within the extended time period.

Sections 104 and 223 - Insertion of Section 6(c) Information

When is an Extension of Time Under Section 223 Required?

An extension of time under s223 to include s6(c) information is only required if:

• the deposit is required to satisfy the requirements of s40(2)(a) (i.e. clear enough and complete enough disclosure); and
• the specification has not included that information since the end of the prescribed period.

The specification has not included the information relating to the deposit if the relevant information was:

• absent
  
  i.e. no information relating to the deposit was previously disclosed in the specification;

OR

• incomplete
  
  i.e. information relating to the deposit was previously present, but that information was incomplete, e.g. the file, accession or registration number was omitted;

OR

• incorrect and a hindrance
  
  i.e. information relating to the deposit was previously present, but that information was incorrect (e.g. the deposit number was wrong), and the incorrect information would have hindered a person seeking access to the deposit.​​​​​​​

Note that if incorrect information relating to the deposit was previously present, but the error would not have hindered a person seeking access to the deposit (for example, if the file, accession, or registration number contains an obvious mistake), then the specification “has included” the s6(c) information.

When is an Extension of Time Under Section 223 Not Required?

An extension of time under s223 to include s6(c) information is not required if:

• the deposit information is not required for the purposes of s41, i.e. the deposit is not necessary to satisfy the requirements of s40(2)(a);

OR

• the deposit information was present, and any incorrect information would not have hindered a person seeking access to the deposit;

OR

• the deposit information was present, and an amendment has the effect of replacing (or supplementing) that information with information relating to a different deposit of the same micro-organism, e.g. a new or transferred deposit.​​​​​​​

Note: If the deposit requirements had ceased to be satisfied before filing the request to amend, the provisions of s41(4) and reg 3.30 apply.

Examination Practice

Where a s104 amendment is proposed to include s6(c) information in the specification, examiners should process the amendment regardless of whether an application under s223 has been made. The allowability of the amendment is not dependent upon whether an extension of time has been granted.  If the s223 request is refused, the applicant will not be able to rely on the deposit for the purposes of s40(2).

The processing of s104 amendments to insert s6(c) information differs from the processing of other s104 amendments.  Thus:

• A s104 amendment to insert s6(c) information is processed and allowed separately from other proposed amendments, without requiring the remainder of the specification to be in order for acceptance.
• Consequently, the amendment is allowed forthwith (reg 10.6(1)) and allowance is advertised as soon as possible
• Other amendments are allowed immediately before acceptance (reg 10.6(2)).

Examiners should therefore advise applicants that to facilitate correct processing, amendments to insert s6(c) information should be proposed as items separate from those proposing to amend other matters.

Applications under s223 are processed by Patent Oppositions.  If the case file contains an application under s223 which has not been granted, examiners should initially consult a supervising examiner. The supervising examiner will determine whether the application has been processed and arrange for any action by Patent Oppositions that may be required.

If the s223 extension of time to include s6(c) information has not been granted, or has been refused, examiners must disregard the deposit for the purposes of s40 and s41, and consider whether the claimed matter involving a micro-organism has been otherwise disclosed in the specification in a clear enough and complete enough manner.

Where the only outstanding matter is a s40 deficiency due to the fact that an extension of time to insert s6(c) information has not yet been allowed, the application cannot be accepted.  A report to this effect should therefore be issued.

Article 34 Amendments Concerning Section 6(c) Information

Section 6(c) information can be inserted into the description of a PCT application under Article 34 (see Article 34 Amendments). These amendments are taken to have been made on the date when they were filed (Rule 66.3). If this date is on or after the OPI date of the application, examiners must report that:

• although the deposit details were inserted under Article 34, and these details are taken to have been inserted into the specification, they were inserted outside the period prescribed under reg 1.5; and
• the deposit details cannot be relied on for the purposes of s40, unless an extension of time under s223 is granted.

Amendment Procedure When a Request for Certification for Release is Pending

Under reg 3.25(1), a person may request that the Commissioner grant a certification authorising the release of a sample of a micro-organism. When such a request is pending, and the applicant or patentee files a request to amend the specification for the purpose of inserting s6(c) information (i.e. the name of the prescribed depositary institution and/or the file, accession or registration number of the deposit), the person who made the reg 3.25(1) request should be sent:

• a copy of the amendment request and the statement of proposed amendments (reg 10.2(8)); together with
• a covering letter advising that should the person wish to be heard on the matter, they have 21 days from the date of the letter to notify the Commissioner.  

Before allowing an amendment, examiners should bring the matter to the attention of the Supervising Examiner CHEM 1, so that any issues affecting the request for release under reg 3.25(1) can be considered.

Amendment Procedure When Deposit Requirements Cease to be Satisfied

A person other than the applicant or patentee may file a notice under reg 3.29(1) notifying the Commissioner that the deposit requirements of s6(c) or s6(d) have ceased to be satisfied. Where the applicant or patentee subsequently files a request to amend the specification for the purpose of inserting s6(c) information (i.e. the name of the prescribed depositary institution and/or the file, accession or registration number of the deposit), the person who filed the notice should be sent:

• a copy of the amendment request and the statement of proposed amendments (reg 10.2(9)); together with
• a covering letter advising that should the person wish to be heard on the matter, they have 21 days from the date of the letter to notify the Commissioner.  

Before allowing an amendment, examiners should bring the matter to the attention of the Supervising Examiner CHEM 1, so that any issues affecting the reg 3.29(1) notification can be considered.