Intellectual Property

Clinuvel Pharmaceuticals has the worldwide licence to intellectual property covering the use of analogues of -MSH invented by scientists at the University of Arizona. In total there are 34 patents in the licence's patent schedule. The patents contain within their scope the use of numerous analogues of -MSH for the induction of melanogenesis, in particular afamelanotide (CUV1647). Expiry dates for the allowed claims for the analogues range from September 2006 until October 2015 in the various jurisdictions.

In addition to the licensed patents, Clinuvel Pharmaceuticals has filed three full international patent applications under the Patent Cooperation Treaty (PCT) since September 2005. Currently, Clinuvel is filing additional patents under the same scheme.

The first patent application was filed on 23 November 2004 and contained within its scope the use of numerous analogues of  -MSH for the induction of melanogenesis in subjects who do not normally respond to -MSH due to genetic variations of the receptors on the melanin-producing cells, melanocytes.

The second patent was filed on 11 February 2005 and contained within its scope the use of numerous analogues of -MSH for the induction of melanogenesis using any sustained release dosage that results in a low controlled level of drug in the blood for at least a period of twenty four hours.

The third patent was filed on 7 October 2005 and contained within its scope the use of numerous analogues of -MSH for the induction of melanogenesis using a unique topically applied formulation.

Typically, granting of patents under the PCT can take up to five years in each of the individual countries covered under the treaty.

In the major marketing jurisdictions around the world, in order to protect originator pharmaceutical companies from generic pharmaceutical companies following approval of their new drug, a period of data exclusivity is established. This basically affords market exclusivity for a period of 5 years in the US and Australia/New Zealand and 6-10 years (plus a further 1 to 3 years for the generic registration process) in Europe irrespective of the originator pharmaceutical company's patent position.

Together with its extensive data on afamelanotide (CUV1647) and clinical trials, Clinuvel is in a strong position to capitalise on afamelanotide (CUV1647).