15 March, 2011
Spruson

Key changes relating to the Pharmaceutical/Life Sciences areas: Intellectual Property Laws Amendment (Raising the Bar) Bill 2011

Key changes relating to the Pharmaceutical/Life Sciences areas: Intellectual Property Laws Amendment (Raising the Bar) Bill 2011

1. TRANSITIONAL PROVISIONS

The proposed transitional provisions are those which will govern the manner in which the new laws are applied. The transitional provisions of most concern are those set out in Schedule 1 item 39(1) and Schedule 6 item 132(7). As currently proposed, the new provisions increase the requirements for an application to meet the sufficiency, support, utility and inventive step standards, yet will apply to all applications for which an examination report has not issued prior to commencement of the new legislation. This means that applications filed prior to commencement of the new legislation, and even those upon which an examination request has been filed, will be subject to the new provisions unless an examination report has issued by commencement. Since the date upon which an examination report issues is not in the applicant's control, the publication of this draft legislation now must cause considerable concern to many applicants who have already filed their applications.

In effect this amounts to changing the rules after the game has started. In our opinion the new provisions should only apply to applications filed on or after the date of commencement of the legislation as that provides an applicant with confidence that their application will be judged against a known set of standards rather than against a new set of standards which, by definition, raise the bar of patentability. In the past, amendments to patentability requirements have only applied to applications filed following commencement of the provisions implementing those requirements.

2. UTILITY

Utility is defined for the first time in the draft legislation, as a "specific, substantial and credible use for the invention" and the provisions require that use to be disclosed in the specification.

The words come from USPTO Guidelines for assessing utility in relation to biotech related inventions, and particularly nucleic acid sequences. The intent of the AU Patent Office is that the words will have the same meaning as applied by the US Courts and USPTO. We understand that there have been a couple of US decisions which have attempted to clarify the meanings of the three terms, but we would submit that it is unnecessary to incorporate the requirement into our Patents Act.

3. SUFFICIENCY

An enablement requirement is now recited in that both Provisional and Complete specifications must be "clear enough and complete enough" for a skilled person to perform the invention.

The amended provisions adopt language that is similar to s 14 (3) of the UK patents legislation, which has been interpreted as imposing the requirement of enablement across the full scope of the claim. The wording is also similar to art 83 of the European Patent Convention, which has also been interpreted as requiring full claim scope enablement. The intention is that s 40 (2) (a) be given, as close as is practicable, the same effect as the corresponding provisions of UK legislation, the European Patent Convention and the Patent Cooperation Treaty.

The Explanatory Memorandum states that a specification that provides a single example of the invention may satisfy the requirements. But only where the skilled person could reasonably expect that the teaching in relation to the single example could be extended to produce the invention across the full scope of the claim, without undue burden, or the need for further invention.

However, it is expected to be more likely that, where the claims are broad, the specification will need to give a number of examples or describe alternative embodiments or variations extending over the full scope of the claims. This ensures that the monopoly extends only to that which could reasonably be said to be disclosed and no further.

Most importantly, after an application is filed it may not be possible to amend it to include additional disclosure which may be necessary to meet the new sufficiency requirements. Therefore it is important that the transitional provisions are amended accordingly.

4. OMNIBUS CLAIMS

These are narrow claims which strictly claim an invention by reference to specific examples or Figures in the specification. Although narrow, they have to date served a useful purpose. Under the proposed legislation, they will not be allowed in applications not examined by commencement, as effected by the proposed transitional provisions. Unfortunately unless there is strong submissions by users, we will not be able to retain omnibus claims. Further, The transitional provisions should be amended such that the new provisions should only apply to cases filed after commencement.

5. REGULATORY EXEMPTION/SPRINGBOARDING

The present AU Patents Act already provides an existing infringement exemption for acts occurring within Australia relating to solely obtaining regulatory approval (either within or outside Australia) of pharmaceuticals, when those acts would otherwise have constituted patent infringement.

The provisions propose a broader infringement exemption for acts required to obtain regulatory approval, within or outside Australia, in that exemption will apply to all technologies for which regulatory approval must be obtained prior to release, such as veterinary and agricultural products, medical and electrical devices. As with the existing pharmaceutical exemption provisions, the exempted "use" must be "solely" for obtaining regulatory approval.

Under the current exemption, for the purposes of obtaining regulatory approval of a generic pharmaceutical product, a generic company can, for example, use any patented starting material, process or equipment or patented indication etc.

This exemption would apply to acts carried out after commencement of the section.

There is some thought that a qualification should be placed on both the existing and proposed exemptions to the effect that they only apply where use of a patented invention could not be reasonably avoided in carrying out the activity required for regulatory approval. However, it should also be considered that innovators can equally utilise these provisions, particularly when conducting comparative trials. 


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