Intellectual Property and Patents

Novogen Patent Coverage

Novogen's pioneering science over two decades has led to the discovery that naturally occurring Isoflavones, plant cell bio-regulators, can prevent the onset of human degenerative diseases. With the knowledge that fundamental cell mechanisms in plants and humans differ little, Novogen's key discoveries; that Isoflavones are the most powerful plant bio-regulators; and that they can, and do, play a critical role in human cell function; has preceded two streams of scientific development.

1. The creation of Isoflavone-based, over-the-counter, clinically proven products to address men’s and women’s health issues like menopause and prostate problems.
2. The synthesis of isoflavoniods into pharmaceutical drugs for the treatment of major degenerative diseases like cancer, cardiovascular and inflammatory disorders.

Novogen's scientific discoveries have led to patent applications and patent approvals around the world. Patents supporting Novogen's consumer brands have been granted in USA, Europe, Canada and Australia. Currently 27 have been issued and 25 are pending. Details of Novogen' consumer patents are listed below:

Novogen believes the protection of Intellectual Property is a fundamental step in the development of high quality nutritional supplements with standardised active ingredients that are clinically supported for the benefit of consumers, health care professionals and retailers. Novogen patents cover soy and red clover isoflavones. The soy isoflavone component of the Novogen patent portfolio has been licensed to a major USA soy manufacturer.

Novogen Limited licensed the soy isoflavone patent to DuPont Protein Technologies in November 1997. DuPont Protein Technologies had the worldwide rights (excluding Australia and New Zealand) to Novogen’s patents relating to soy applications and soy isoflavone technology. Under the licence agreement, Novogen received initial consideration of A$15.7 million. The licence also required DuPont Protein Technologies to make regular milestone payments and to pay royalties on sales of its products covered by the Novogen patents. In June 2003 Novogen Limited licensee The Solae Company (formally known as DuPont Protein Technologies International Inc.) filed a patent infringement suit against Archer Daniel Midland Company and Amerifit Nutrition Inc. The lawsuit asserted that ADM's Novasoy ® isoflavone products and the Estroven® health supplement products marketed by Amerifit infringed certain patent rights of The Solae Company. Novogen's recently granted US patent which covers the use of certain isoflavones for the treatment of menopausal symptoms, forms part of the patent portfolio available to Solae. Solae sought court orders that ADM and Amerifit stop selling and making the products claimed to infringe the patents and to seek damages. The inclusion of Novogen's US patent in the action by Solae confirmed the commercial utility of Novogen's expanding intellectual property portfolio. In February 2005 the Novogen Patent License to Solae was transferred to ADM. The Novogen licence to ADM is worldwide, other than for Australia and New Zealand. The transfer of the licence coincided with the settlement of litigation initiated by Solae against ADM, and was facilitated by Novogen's consent to the transfer. ADM assumed the rights and obligations formerly held by Solae, including royalty and milestone payments under the Novogen licence. ADM is one of the world's largest processors of soybeans, and has over 26,000 employees, more than 250 processing plants and net sales for the fiscal year ended June 30, 2004 of over $US 36 billion. The transfer of the Novogen patent licence and certain other business of Solae to ADM consolidates ADM's position as one of the world leaders in the soy industry.

Red Clover Isoflavones
Novogen has retained global patent rights to its red clover-based isoflavone technologies. Novogen is focused on the protection of its Intellectual Property rights in all countries and territories where the company's patents have been issued

Results and Outcomes of Novogen Patent Actions

USA

• January 2005 Novogen reaches settlement with General Nutrition Corporation (GNC) on isoflavone patent infringement case for an undisclosed amount and terms. The lawsuit alleged that certain menopause products sold under the GNC brand infringed one of Novogen's US patents (US Patent No. 6,562,380). In addition to an undisclosed monetary settlement GNC has agreed to reinstate the sale of Promensil, through GNC's retail outlets. GNC is a retailer of health food supplements in the US with 4800 retail outlets and 1300 franchise stores.
• December 2005 Novogen and NBTY, Inc., (US$1.9b turnover company) satisfactorily settle Patent Infringement Case. Novogen alleged that NBTY infringed one of Novogen's US patents. Settlement included financial and production commitments from NBTY.
• June 2006 Novogen and Natural Alternatives International (US$100m turnover company) (NAI) satisfactorily settle Patent Infringement Case. Novogen alleged that NAI infringed one of Novogen's US patents. Settlement included financial and production commitments from NAI.
• June 2007 Novogen settled satisfactorily the legal action it had taken against Chattem, Inc., (US$300m turnover company). The lawsuit alleged that certain menopause products sold by Chattem infringed Novogen's patent for health supplements containing isoflavones.

• August 2005 Novogen reached settlement with Jamieson Laboratories on Isoflavone patent infringements. The lawsuit filed against Jamieson alleged that health supplement product, Menoflavon, which is sold in Canada under the Jamieson brand, infringed one of the patents in Novogen's patent portfolio covering the use of isoflavones in health supplements. The settlement was reached through a licence agreement with Melbrosin International, the manufacturer of Menoflavon. The licence agreement grants Melbrosin the rights to sub-licence the rights for health supplements containing isoflavones from red clover in Canada.
• August 2005 Novogen and WN Pharmaceuticals and Holista Health settled a Patent Infringement Case. Novogen alleged that both companies infringed Novogen's Canada patent. Settlement included financial and production commitments from WN Pharmaceuticals.
• October 2005 Novogen and Swiss Herbal Remedies Limited settled a Patent Infringement Case. Novogen alleged that Swiss Herbal infringed Novogen's Canada patent. Settlement included financial and production commitments from Swiss Herbal.
• May 2006 Novogen and Genuine Health Limited settled a Patent Infringement Case. Novogen alleged that Genuine Health infringed Novogen's Canadian patent. Settlement included financial and production commitments from Genuine Health.
• January 2007 Novogen has settled for an undisclosed amount and terms, its allegations of patent infringement against Sante Naturelle A.G. Ltee. Novogen had alleged that certain menopause products sold by Sante Naturelle infringed Novogen's Canadian patent for health supplements containing isoflavones. In addition to an undisclosed monetary settlement Sante Naturelle entered into a licencing agreement with Novogen. This agreement granted Sante Naturelle a licence under Canadian Patent No.2136233 and enabled Sante Naturelle to continue to manufacture and sell certain menopause supplements containing isoflavones derived from sources other than soy or red clover.

• March 2005 Novogen and Melbrosin International reached agreement on a patent licence for Melbrosin's menopause products Menoflavon, Melbrosia and Menovital. The licence agreement granted Melbrosin the rights for health supplements containing isoflavones from red clover in Europe. Melbrosin's rights and obligations include royalty and milestone payments under the Novogen licence.
• January 2006 Novogen Limited announced that it had sought an injunction in the Netherlands against a red clover menopause product seeking to immediately enforce its phytoestrogen extracts patent. The injunction was not allowed. Novogen will appeal and seek the immediate enforcement of its granted patent. Novogen believes there are very strong grounds for a successful appeal of the injunction and to activate the prompt enforcement of the patent.
• June 2006 Austrian Court upheld Novogen's Patent for red clover isoflavones. Vienna Commercial Court found that Novogen's isoflavone invention and patent is novel and inventive. The Court found APOtrend's menopause product Vitalady infringed Novogen's patent and the provisional injunction against Vitalady was upheld. APOtrend is required to retract all infringing Vitalady products from retail, wholesale and any other channels of sale.
• June 2008 Novogen signs Spanish patent licence with Laboratorios Cassen-Fleet. Novogen is the registered owner of the European Patent "Use of isoflavone phyto-oestrogen extract of soy or clover" (EPO 656786 B1). Laboratorios Cassen-Fleet the Spanish affiliate of the US multinational healthcare company Fleet Laboratories recently acquired the red clover isoflavone based menopause product Fitogyn from Laboratorios Gynes S A. In conjunction with the product acquisition Laboratorios Casen-Fleet and Novogen have agreed on confidential terms for a Patent Licence Agreement.

Australia

• June 2005 Novogen Limited received the grant of three health supplement patents in Australia. The patents cover tablets or capsules containing any two of the four main isoflavones, biochanin, formononetin, daidzein and genistein, all of which have been associated with a range of health benefits including management of menopause symptoms, improved cardiovascular and bone health and improved prostate function in men.
• July 2005 Blackmores took up a Licence to the Novogen Australian patent. Blackmores' rights and obligations include royalty and milestone payments under the Novogen licence.