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Biotech / Medical : Introgen Therapeutics -- Ignore unavailable to you. Want to Upgrade?

To: Jibacoa who wrote (326)	6/2/2005 5:27:42 PM
From: tuck	Read Replies (1) \| Respond to of 802

I believe I can save you the trouble. They covered this in this year's 10-K: >>We compete with pharmaceutical and biotechnology companies, including Canji, Inc. and Genvec, Inc., which are pursuing forms of treatment similar to ours for the diseases ADVEXIN therapy and our other product candidates target. We are aware Canji, with its parent Schering-Plough, has in the past been involved in research and/or development of adenoviral p53 products and has numerous patents and patent applications relating to adenoviral p53 therapy. We understand Schering-Plough has stopped its adenoviral p53 clinical trials, and it is unknown whether these parties are continuing their adenoviral p53 research and/or development efforts. We are also aware a Chinese pharmaceutical company, SiBioNo GeneTech, Inc., has recently announced it has received regulatory approval from the Chinese drug regulatory agency to market an adenoviral p53 product only in China. We control an issued Chinese patent covering adenoviral p53, and a number of pending Chinese applications directed to p53 therapy and adenoviral production. We do not at present know whether SiBioNo’s adenoviral p53 product is covered by patent protection or whether it infringes our Chinese patent or pending applications. We understand enforcement of patents in China is unpredictable and we do not know if monetary damages could be recovered from SiBioNo GeneTech if its product infringes our patent or patent applications. Patent enforcement and respect of international patent standards, rules and laws have not historically been a key characteristic of the Chinese government and patent system. Further, geopolitical developments, including trade and tariff disputes between the government of China and the United States Department of Commerce could add additional uncertainty to any effort to enforce patents, recover damages, if any, or engage in the sales and marketing of patented or non-patented products in China.<< China's piracy policy will probably be especially effective wrt to things that save lives (as opposed to software). Obviously, it's uncertain whether or not SiBioNo has pirated this in a strictly legal sense, but it seems unlikely INGN will pursue them, regardless. A joint effort might be interesting; maybe they can do offshore manufacturing there for peanuts. Cheers, Tuck

To: Jibacoa who wrote (326)	6/3/2005 1:52:35 AM
From: tuck	Respond to of 802

>>AUSTIN, Texas, June 2 /PRNewswire-FirstCall/ -- Introgen Therapeutics, Inc. (Nasdaq: INGN - News) announced today that it was successful in winning the decision regarding its opposition of European Patent 0 390 323 before the European Patent Office (EPO) in which all claims directed to therapeutic applications of the p53 gene, the active component of Introgen's ADVEXIN® molecular therapy, were finally revoked by the EPO's Technical Board of Appeals. The patent -- entitled Detection of Loss of the Wild-Type p53 Gene - - and licensed to Schering-Plough Corporation, was directed both to diagnosis of p53 gene mutations and to therapeutic applications of the p53 gene. In today's decision, all claims of the patent that purported to cover therapeutic applications of the p53 gene were finally revoked on the basis of insufficiency of the patent disclosure, affirming an earlier decision by the opposition division of the EPO. This is Introgen's third successful outcome over a period of years in oppositions involving European p53 gene patents controlled by or licensed to Schering-Plough. Dr. David L. Parker, Introgen's vice president for Intellectual Property said, "This is a very important win for Introgen on the European patent front as this was the last of the three patents we had identified and targeted for revocation several years ago. In light of today's decision, we do not now see any patent impediment to commercialization of ADVEXIN therapy in Europe." While some diagnostic applications of the p53 gene remain in dispute, the therapeutic claims of this patent can never be reintroduced, according to the EPO proceedings. Diagnostic applications of the p53 gene are not part of Introgen's commercialization plans. Treatments with Introgen's therapies are not dependent on p53 diagnosis. Introgen has previously reported favorable results of oppositions against this European patent. An opposition is an administrative proceeding conducted by the European patent office for challenging the validity, and requesting patent revocation, of issued European patents. To date, Introgen controls 29 issued patents and has a large number of pending patents in the United States and in commercially important foreign countries relating to its ADVEXIN therapy. In addition some patents address adenoviral p53 compositions, production, purification and use in the treatment of cancer. Importantly, some of Introgen's patents that are directed to adenoviral processing, purification and formulation are not limited in scope to Ad-p53 and cover generally commercial scale production and formulation of any adenovirus product.<< snip This may not really mean that much. As noted in my previous post, it would appear Schering-Plough has halted development in this area. Not sure why; perhaps INGN had a lead, this IP issue that they kept losing, or they just didn't like the odds of success. Wouldn't expect much movement on this news, but every little bit helps. Cheers, Tuck