Copernicus has exclusive, worldwide licenses to ten U.S. patents issued to Case Western Reserve University, two U.S. patents issued to Copernicus, and six pending U.S. patent applications that provide strong support for the commercialization of its technologies. Over 30 non-US patents extend protection throughout world markets.

Nine issued U.S. patents cover Copernicus' delivery technologies, and six applications are pending. The foundational patents for DNA nanoparticles (U.S. Nos. 5,844,107, 5,877,302, 6,008,336 and 6,077,835) include claims for methods and compositions of matter involving any nucleic acid mixed with any polycation (peptides, lipids, liposomes, etc.) provided that the resulting complex has a charge ratio of essentially 1:1 and is less than twice its minimum size (with mass calculated as a condensed sphere). This provision extends coverage to any complex containing up to eight molecules of nucleic acid. The 6,077,835 patent specifically extends coverage for therapeutic uses of DNA nanoparticles. The 6,506,890 patent covers new formulation methods developed and owned by Copernicus. 6,281,005 covers automated devices that may be used for complex production, and this patent, which is useful for scale-up manufacturing, is owned by Copernicus. Additional applications cover formulation methods, compositions, and new targeting systems. Five pending applications (divisionals of Lyophilizable and Enhanced Compacted Nucleic Acids) are assigned to Copernicus, and cover compositions and formulation methods pertinent to the CF and other indications.

Nine issued U.S. patents protect Copernicus' targeting technologies. U.S. patent numbers 5,844,107 and 5,877,302 contain methods and composition of matter claims that broadly cover the targeting of nucleic acids to cell-specific receptors, including (but not limited to) hepatocytes via the asialoglycoprotein protein receptor, and to macrophages and dendritic cells via the mannose receptor. One issued patent contains therapeutic use claims for these targeting systems (6,077,835). Another issued patent (U.S. 5,972,900) contains methods, use, and composition claims for the targeting of nucleic acids to gut and lung epithelial cells via the polymeric immunoglobulin receptor (pIgR). Two issued patents (U.S. 5,972,901 and 6,200,801) contain methods, use and composition claims for the targeting of nucleic acids via the serpin enzyme complex receptor. Three issued (6,072,041, 6,287,817 and 6,261,787) patents cover Copernicus' pIgR-targeted fusion proteins and small molecule fusion products.

As discussed above, the nucleic acid nanoparticle technology is covered by numerous issued and pending applications. Claim categories cover formulation methods, compositions of matter, methods for use in humans, and manufacturing and scale-up activities. Composition of matter claims represent nearly half of issued and pending claims. Copernicus enjoys current proprietary protection and the pending applications will prolong protection for compositions under development.