Pharmaceutical Patents Review

The Pharmaceutical Patents Review Draft Report is now available from the Draft Report page.

Written responses to the Draft Report are due by 5pm on 30 April 2013. For more information, please see the Providing a Written Response to the Draft Report page.

Once an extension of term has been granted, should a pharmaceutical patent owner’s exclusive rights extend to manufacture for export and sale in other countries?

The owner of a patent has the exclusive right of exploitation. As might be expected, sale of patented products and products made using patented processes is included in the definition of ‘exploit’ in Schedule 1 of the Patents Act 1990 (Cth), but it extends to manufacture, use and other activities. Thus, anyone making a patented product or using a patented process in Australia without the patent owner’s permission risks liability for infringement – even if they export the product without any intention of ever selling it domestically.

Generic pharmaceutical manufacturers in Australia may be significantly disadvantaged by this requirement during the pharmaceutical patent extension period if equivalent patents have already expired in other jurisdictions. The Productivity Commission considered this issue in 2003 (Evaluation of the Pharmaceutical Industry Investment Program: Research Report), concluding at 8.10 that:

Overall, there is a compelling economic case to allow generic drug manufacturers in Australia to export to countries where patents have expired during the period of patent extension granted in Australia.

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Do the requirements for an extension of term for pharmaceutical patents make sense and are they applied correctly? This post will take a closer look at the requirement for the patent to disclose a ‘pharmaceutical substance per se’ that is included on the Australian Register of Therapeutic Goods (ARTG).

According to the Patents Act 1990, the patent must disclose either a pharmaceutical substance per se or a pharmaceutical substance when produced by recombinant DNA technology. So while patents that claim a process for producing a pharmaceutical wouldn’t usually be eligible for an extension, in the case of biologics it may be the best or only way to precisely describe the substance. The explanatory memorandum of the bill introducing the extension of term provisions says that “claims to pharmaceutical substances per se would usually be restricted to new and inventive substances.” It clarifies this by saying that extensions would not be available for claims to new processes of making, or new uses for, known pharmaceutical substances.

A consequence of these exclusions is that where a known substance is found to be useful in treating a different condition, it is unlikely to be eligible for an extension of term.
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The Panel is happy to consider publishing guest posts to the blog. Please see the Guest Post Policy for more information.

Review Secretariat

This is a guest post from Hazel Moir. Hazel’s submission can be viewed here.

I am concerned to read that the absymally low height of the inventive step will not be a primary focus of this review.

It is the very low “inventiveness” requirement for a patent that allows so many evergreening patents to accumulate.

Indeed outside the patent world, the inventiveness standard would be labelled ‘trivial difference” not inventiveness.
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One of the issues in the terms of reference concerns the extension of a pharmaceutical patent for up to 5 years. There appear to be a number of matters of interest in this part of the review.  The first is whether or not pharmaceutical patents ought to be able to be extended. This right does not apply in all countries.  It derives from the length of time it takes to get government regulatory approval for pharmaceuticals, a process which is not applicable to the commercialisation of other patents.  Another matter is the length of the extension.  In some jurisdictions it is longer, in others it is shorter.
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Welcome to the Pharmaceutical Patents Review blog.

Today we released the Review’s Background and Suggested Issues Paper.
It suggests issues that we are interested in learning more about.

We will use this blog to explore those issues with you, or other issues with the pharmaceutical patent system that you think should be discussed in this Review.

We also look forward to receiving submissions. The details about providing submissions are in the Paper at pages i and ii.

Terry Moore
Pharmaceutical Patents Review Secretariat