Patents

We patent the technology, inventions and improvements that we consider important to the development of our business. As of 31 July 2008, we owned or had exclusive rights to 20 issued U.S. and foreign patents and 14 pending U.S. and foreign patent applications. Of these, 11 issued patents and three pending applications relate to Aridol and Bronchitol. The last of these issued patents are due to expire in 2021. One pending application relates to PXS25 and PXS64 and has now entered the national phase and one provisional application relates to PXS4159. The remaining patents and applications relate to other aspects of our technology or other drug discovery programs that have not yet entered a full development program. If available to us, we intend to seek patent term extension for our eligible patents, including under the Hatch-Waxman Act, which provides up to five years of patent extension.

The status of the Company’s patent portfolio is summarised in the following table:

	USA	Europe	Australia	ROW
Patent Family 1 — Aridol and Bronchitol	G	P	G	P/G1
Patent Family 2 — Phosphosugar based anti-inflammatory and/or immunosuppressive drugs	G	G	G	G
Patent Family 3 — Novel phosphosugars and phosphosugar-containing compounds having anti-inflammatory activity	G	n/a	G	n/a
Patent Family 4 — Novel compounds and methods	G	P	P	G/P
Patent Family 5 — Novel pyrans and methods (PXS25)	NP	NP	NP	NP
Patent Family 7 — Novel inhibitors of TNF (PXS2076)	Prov
Patent Family 8 — Novel inhibitors of SSAO/VAP-1 (PXS4159)	Prov

G = granted; P = pending; Prov = provisional; PCT = patent cooperation treaty; NP = national phase ROW = rest of the world including Japan; (1) Aridol granted in Japan

Details of patents and patent applications licensed to, or owned by Pharmaxis Ltd are set out below:

Patent Family 1 - The Use of Inhaled Mannitol

The invention covered by this family of patents and patent applications generally relates to the use of mannitol and other substances in the form of a dispersible dry powder capable of inducing sputum and promoting airway clearance in conditions where clearance of excess mucus would be advantageous. Included is a test of airway function and susceptibility to asthma based on inhaling an effective amount of mannitol or other substance.

This series of patents and patent applications are held in the name of Sydney South West Area Health Service and stem from an initial Australian provisional patent application PM4114 filed 25 February 1994. Subsequently, complete applications were filed via a PCT application (PCT/AU/95/00086; 23-Feb-1995).

Patent Family 2 - Phosphosugar-based anti-inflammatory and/or immunosuppressive drugs

The invention covered by this family of patents and patent applications generally relates to a method for treating inflammatory or immune-mediated conditions in patients by administering a phosphosugar (mainly mannose-6-phosphate and fructose-6-phosphate) as well as oligo- and polyBaccharides that contain such phosphosugars. These agents act as antagonists at mannose phosphate receptors by competitive inhibition of the binding of the natural ligand for these receptors. This treatment targets “delayed hypersensitivity” types of immune reactions and their attendant inflammatory processes, and the patent is directed specifically to the treatment of arthritis, inflammatory diseases of the central nervous system, and the rejection of organ transplants.

This family of patents is owned by The Australian National University (“ANU”) and claims priority to Australian Provisional application P19942/88 filed on 19 August 1988. Subsequently, complete applications were based on a PCT application (PCT/AU89/00350) filed 18 August 1989).

Patent Family 3 - Novel phosphosugars and phosphosugar-containing compounds having anti-inflammatory activity

These patents are for substituted D-mannoside-6-phosphate compounds that have anti-inflammaCory activity and their use in treating inflammatory diseases, particularly cell-mediated inflammatory diseases. The patent discloses use of these compounds to suppress experimental auto2mmune encephalomyelitis in the rat (a model of multiple sclerosis) and two different types of delayed-type hypersensitivity responses in mice. Issued claims in the U.S. patent cover some of these novel phosphosugar compositions and methods of treating cell-mediated inflammation in a human or non-human mammalian patient by administering these compositions.

The above family of patents are held in the name of the ANU and stem from a priority Australian provisional patent application PO 3098/96 filed 18 October 1996.

Patent Family 4 - Novel compounds and methods

This family of patent applications relates generally to novel phosphotetrahydropyran (mannose-6- phosphate derivatives) compounds and their use in treating diseases that are dependent upon T lymphocyte migration. These compounds were shown to inhibit (a) T lymphocyte migration across rat brain endothelial cell layers in vitro; (b) lymphocyte migration into lymphatic and extralymphatic tissues in vivo; and (c) delayed hypersensitivity-type immune responses and development of T cell-mediated autoimmune disease in vivo in animal models. In particular, the present invention relates to the use of the above compounds in the treatment of T lymphocyte mediated inflammatory diseases in animals and man, such as rheumatoid arthritis, multiple sclerosis, etc.

These applications stem from Australian Provisional Patent Application No. PQ8723/00 filed on 11 July 2000. Complete applications were based on a PCT application (PCT/AU01/00831) filed on 11 July 2001.

Patent Family 5 - Novel phosphotetrahydropyrans and methods

The present invention relates generally to novel phosphotetrahydropyran compounds, primarily derivatives of mannose-6-phosphate, and their use in treating diseases or disorders that are mediated at least in part by T lymphocyte emigration from blood to tissues. These compounds are said to be improved inhibitors as compared to the compounds in Patent Family 4. Pharmaceutical compositions containing these compounds are used in methods to treat T lymphocyte mediated inflammatory and autoimmune diseases in animals and man, including rheumatoid arthritis, multiple sclerosis, acute disseminated encephalomyelitis, psoriasis, Crohn’s disease, T cell-mediated dermatitis, stromal keratitis, uveitis, thyroiditis, sialitis or type I diabetes.

These applications stem from U.S. Provisional Patent Application No. 60/471,716 filed on 20 May 2003. Complete applications were based on a PCT application (PCT/US2004/015876) filed on 19 May 2004.

Patent Family 7 - Novel Anti-inflammatory Agents and Uses Thereof

This patent relates to a series of compounds and pharmaceutical compositions comprising novel inhibitors of tumor necrosis factor (TNF). The compounds are useful for the treatment of treat inflammatory conditions, immune disorders and cell proliferative disorders, as well as in pain management, either alone or in combination with known agents for these conditions.

The U.S. provisional application was filed in the name of Pharmaxis Ltd on 28 January 2008 and the non-provisional and/or the international application must be filed by no later than 28 January 2009 in order to claim priority from this provisional application.

Patent Family 8 - Novel Inhibitors of SSAO/VAP-1

This patent relates to a series of compounds and pharmaceutical compositions comprising novel inhibitors of SSAO/VAP-1. The compounds are useful for the treatment of inflammatory conditions, immune disorders and cell proliferative disorders, either alone or in combination with known agents for these conditions.

The U.S. provisional application was filed in the name of Pharmaxis Ltd on 21 November 2007 and the non-provisional and/or the international application must be filed by no later than 21 November 2008 in order to claim priority from this provisional application.