Patent Report

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Contact: Gary Cox
Partner/Associate: Gary Cox

1 July 2004

The Board of Directors
Revenir Limited
Level 2, Troika House
129 Melville Parade
COMO WA 6152

Dear Sirs

Patent Attorneys’ Report
This report has been prepared on behalf of Revenir Limited (hereinafter ‘Revenir’).

Background
Wray & Associates is a firm of patent and trademark attorneys specializing in the law and practice relating to intellectual property. The firm was established in 1920 and has a long history in servicing the intellectual property needs of both Australian and overseas clients.

Each of our partners is a Fellow of the Institute of Patent and Trade Mark Attorneys of Australia. Our professional staff are divided into departments by technology areas, each department being overseen by a partner or associate of the firm. The firm’s structure presently contains departments dedicated to the chemical/pharmaceutical, biotechnology, computer/electronic, mechanical engineering and the physics/general mechanical technology areas. Each of our professional staff members holds a tertiary qualification in the technology field in which they practice.

Intellectual property may be regarded as a collective term for a group of rights that provide varying degrees of exclusivity in relation to products, processes, names, designs and drawings in industry, science or commerce. Patent rights constitute an important component of intellectual property, and provide protection for new, non-obvious and useful inventions for a limited period. Patents may be granted in respect of new or improved products, compositions and processes in almost all areas of current scientific, commercial and industrial activities, including pharmaceuticals.

The Patent Process
Patent rights are essentially national rather than trans-national and a patent must be obtained in each country where protection of an invention is required. A fundamental requirement of the patent system is that the invention be ‘new’ at the time of lodging a patent application. Newness in this sense is judged in relation to what was publicly known or used at the date of the application. Another requirement is for a distinct inventive advance over what was previously known. This means that valid patent protection cannot be obtained for trivial or obvious developments.

Pursuant to the Paris Convention, the filing of an initial patent application in, for example, Australia establishes a priority date for the invention in Australia and all other countries that are a party to this Convention, including countries such as the United States, Canada, New Zealand, Europe and Japan.

The usual steps towards obtaining a patent in Australia and other countries in respect of an invention begin by filing of an application accompanied by a provisional specification. The filing of a provisional application establishes the priority date in respect of the invention disclosed in the provisional specification.

Within twelve months from the date of the filing of the provisional application, a complete application must be lodged otherwise the provisional application ceases to exist. At this time, in order to obtain protection in other countries, the applicant may file separate national patent applications in each of the countries in which protection is required. Alternatively, the applicant may file a single International application under the provisions of the Patent Cooperation Treaty (generally referred to as a ‘PCT’ application or an ‘International’ application) in which it is possible to designate countries or regions in which protection is required. The International application itself does not mature into a worldwide patent, but at the end of the international phase, steps can be taken to file the application into any or all of the countries or regions designated in the original International application.

Regional patent applications, such as a European regional application, may also be filed. A European application may designate any or all countries that are a party to the European Patent Convention. A European patent application may also be extended to certain other jurisdictions including those that are not full signatories to the European Patent Convention. The European patent application is processed centrally and in a single language and, if ultimately successful, can mature into a granted European patent. The term ‘European patent’ actually constitutes a bundle of national patent rights, each of which can be enforced separately through national Courts.
In Australia and most other countries, patent rights may be kept in force for a period of 20 years from the date of filing of the complete application on which the patent is granted, and while the patent is in force the owner has the exclusive right to exploit the invention.
The Licensed Patents and Patent Applications

For the purposes of the present prospectus, Revenir has requested that Wray & Associates summarise the status of patents and patent applications in which it has indicated that it is interested. Those patents and patent applications are set out in Schedule 2. The information on which we have based our searches was provided to us in the form of a summary, a copy of which forms Schedule I. Further information regarding the applications located during our search was provided by the attorneys responsible for prosecution of the patent applications. Those applications for which we obtained information from third parties regarding the status of the applications are marked accordingly.

The patents and patent applications set out in Schedule 2 are currently in force, although they are subject to the payment of periodic (mainly annual) fees in order to maintain them in force. In most countries, a patent application is subjected to examination for novelty (and obviousness) before a patent is granted. There can be no assurance that each of the patent applications set out in Schedule 2 will result in the grant of a patent, or that the scope of protection provided by any granted patent will be identical to the scope of the application as originally filed. Furthermore, the scope of protection provided by a granted patent in one jurisdiction may differ from that provided by a granted patent in another jurisdiction, due to differences in examination and scope of available protection.

It should be noted, the grant of a patent does not guarantee validity of that patent since it may be revoked on the grounds of invalidity at any time during its life. If none of the claims of a granted patent are valid then the patent is unenforceable. For example, relevant prior disclosures may be discovered that were not raised during examination, which may limit the scope of patent protection sought, perhaps to a very narrow field.

It should also be noted that the granting of a patent does not guarantee that the patentee has freedom to operate the invention claimed in the patent. It may be that working of a patented invention is prevented by the existence of another patent or a patent application which still needs to mature to a patent and which has an earlier priority date.

Patent Search
We were instructed to identify the current members and status of the patent families identified in Schedule I. A summary of the identified patents and patent applications is included as Schedule 2. The results presented in our summary are derived from computer searches conducted on various International patent databases and from further information provided by the attorneys responsible for prosecution of the patent applications. Those applications for which we obtained information from third parties regarding the status of the applications are marked accordingly.

The patents and patent applications identified in Schedule 2 can be divided into six broad inventions. Those families are discussed below.

Patent Family 1 – Absorption Enhancers [Axcess I]
This family is directed to a composition of an enteric capsule containing a mixture of (a) an active principal and (b) a hydrophilic aromatic alcohol absorption enhancer. The absorption enhancer may be used in the manufacture of compositions wherein the presence of the absorption enhancer enhances the absorption of the active principal across the wall of the intestine.
This patent family comprises two pending patent applications in Europe and the United States of America, the details of which are set out in Schedule 2.

Patent Family 2 – [Axcess II]
The content of this patent application is currently unknown to us as the application has only recently been filed and has not been published.
According to the information provided in Schedule I, this family comprises an International application, filed on 15 April 2004 and claiming priority from a British patent application. The International application has not been published and accordingly cannot be accessed by third parties at this time.

Patent Family 3 – [Axcess III]
The content of this patent application is currently unknown to us as the application has only recently been filed and has not been published.
According to the information provided in Schedule I, this family comprises an International application, filed on 15 April 2004 and claiming priority from a British patent application. The International application has not been published and accordingly cannot be accessed by third parties at this time.

Patent Family 4 – Immunogenic Compositions [Vaxcine I]
This family is directed to immunogenic preparations and compositions comprising immunogens distributed in a hydrophobic solvent in which they would not normally be soluble. The compositions may be single phase (thus free from any hydrophilic phase) and be suitable for freeze-drying etc, or may be two-phase, with the immunogen distributed in the hydrophobic phase.

This family comprises the patent and patent applications set out in Schedule 2. Chinese and Japanese applications are currently under examination. Schedule 1 identifies a European patent. We have confirmed the existence of this patent but have been unable to determine which European countries the patent has been validated in. The European patent will not have any legal effect in countries where it has not been validated.

Patent Family 5 – Pharmaceutical Compositions Containing a Bile Salt and a Buffer for Increased Bioavailability of an Active Compound [Vaxcine II]
This family is directed to compositions containing an active ingredient, bile salts and a buffer that will adjust the pH of the gut to 7.5 to 9.0. The bile salt improves the permeability of the active ingredient across the gut wall, and the pH adjustment improves the ability of the bile salt to increase permeability and reduces the toxic side effects of bile salts.

This family comprises the patents and patent applications set out in Schedule 2. A granted patent exists in the United States of America and a Japanese application is currently under examination.

Patent Family 6 – Epitopes Formed by Non-Covalent Association of Conjugates [Mozaic]
This family is directed to compositions for interacting with ligands, wherein the compositions comprise a non-covalent association of different conjugates. The conjugates comprise a head group and a hydrophobic tail group. The tail groups of the conjugates form a hydrophobic aggregate within which the individual conjugates can move around, so that on exposure to a ligand, at least two of the head groups are appropriately positioned to interact with the ligand more strongly than any of the individual heads groups alone.

This family comprises the patents and patent applications set out in Schedule 2. The Australian patent application has been accepted and is awaiting grant, the opposition period ends on 29 October 2004. A Chinese application is currently under examination. Examination has also been requested on applications in Canada, Europe, Brazil, Israel, and the United States of America. A Japanese application has also been filed.

Independence
Neither Wray & Associates nor any of its partners has any entitlement to any shares in Revenir, or has any interest in the promotion of Revenir. Wray & Associates will be paid its usual professional fee for the preparation of this report based on commercial rates. It has no other interests in the promotion of Revenir.
The total extent of the service that we have provided to Revenir up until the preparation of this report is a to review the six patent families they have presented to us.

Yours sincerely

WRAY & ASSOCIATES
Gary Cox