Proposal to relax patent certificates under the Therapeutic Goods Act 1989

Proposal to relax patent certificates under the Therapeutic Goods Act 1989

The Government has introduced amendments to Parliament to reduce the scope of the application of the earlier amendments relating to patent certificates under the Therapeutic Goods Act.

In August 2004 we reported on amendments to the Therapeutic Goods Act 1989 which introduced a requirement for applicants to lodge a certificate (a Section 26B Certificate) certifying that:

  1. the marketing of the proposed good would not infringe any third party patents; or
  2. it had notified the patentee of the application.

These amendments commenced on 1 January 2005.

Earlier this month the Government introduced amendments to Parliament to reduce the scope of the application of these provisions. Under the proposed amendments a Section 26B Certificate will be required only if:

  1. the applicant is required to submit evidence or information to establish the safety or efficacy of the goods as part of the process of applying for registration or listing; and
  2. in order to satisfy that requirement, the applicant relies (in whole or in part) on evidence or information that another person submitted to the Secretary:
    (a) to establish the safety or efficacy of other therapeutic goods that have already been registered or listed; and
    (b) as part of the process of applying for the registration or listing of those other goods.

The effect of the amendments is to require a Section 26B Certificate to be lodged only where an applicant seeks to rely on data previously submitted by another person as part of that person’s earlier application. A typical example of such a situation is an application to register a generic version of an existing drug.

As a result, originator applicants will, generally, no longer need to lodge a Section 26B Certificate. However, it would seem that a Section 26B Certificate would be required where an originator seeks to register a new presentation of an existing registered product, but where the existing product is registered in the name of a different entity within the originator group. Such situations are likely to be rare.

The provisions will also have less application to complementary medicines as that sector does not generally rely on evidence or information submitted by others. Although applicants for registration or listing of complementary medicines are required to submit evidence or information to establish the safety or efficacy of the goods, this evidence or information is generally bibliographic, or literature based.

The amendments will apply to applications for registration or listing made on or after the amended provisions commence. The amendments are currently before Federal Parliament and have only recently been read for the first time. Accordingly, they are unlikely to be passed into law for some time (if at all). As currently drafted the amendments are specified to commence on a date to be fixed, or not later than 6 months after receiving Royal Assent.

By narrowing the scope of persons required to lodge Section 26B Certificates, the scope of situations where a certificate under section 26D will be required will also be narrowed. Readers will recall that, before commencing proceedings to enforce a patent against a person who lodged a Section 26B Certificate, a patentee must certify under section 26D that the proceedings are to be commenced in good faith, have reasonable prospects of success and will be conducted without unreasonable delay. This amendment should be welcomed by the local biotech industry.