a risk not priced into the market

I have been researching this company and in the process I believe I have come across a risk that isn't priced into the Sirtex share price.

A company called Sirtology Pty Ltd has submitted a proposal to the Australian Medical Services Advisory Committee (MSAC) for them to consider approving Sirtology’s “Y90Spheres”. These “Y90Spheres” are functionally identical to the Sirtex SIR-Spheres. The Sirtology application is currently posted on the MSAC website for public comment. The deadline for public comment is Friday 5 July 2012.

The Sirtology application is item

1242 - yttrium-90 microsphere radioembolisation to embolise the microvasculature of hepatic primary and secondary cancers

at the following URL http://www.msac.gov.au/

What Intellectual Property Protection does Sirtex have in place to stop companies like Sirtology from deploying the same technology as Sirtex? Will they dispute MSAC approval for the Sirtology Pty Ltd knock-off product?

If Sirtology gets approval I would assume there is nothing stopping the big global biotech companies from doing the same thing?