Intellectual Property
Inovio's leadership has produced a dominant intellectual property and patent estate
Inovio Biomedical Corporation, through its operating subsidiary, Genetronics Inc., maintains a broad-based patent portfolio (both original and in-licensed) that includes approximately 280 US and foreign counterpart patents, all of which collectively include claims to methods and/or devices for clinical use in the electroporation medical arts. Specifically, patented subject matter, as well as subject matter pending in the US and foreign patent offices, includes method and device claims for delivering medically important substances to the interior of cells in various body tissues such as a patient's muscle, skin, and other organs, by electroporation.
The company's patents encompass five broad, medically relevant "indication" categories including gene therapy/delivery (including vaccination with expressible vectors), oncology, vascular administration (e.g. by catheter), transdermal administration (including delivery of substances for cancer, gene therapy, and cosmetic applications), and ex vivo administration (e.g. by electroporation of cells outside the body and introducing the created cells to the patient). The company also has significant patent protection in the delivery of genes to plants that may be useful in the production of improved food crops such as rice and corn.
Gene therapy/delivery enjoys a broad scope of patent protection such as found in US patent number 5,273,525, which includes claims to an apparatus for implanting macromolecules (e.g. DNA, RNAi, and pharmaceutical compounds) into selected tissues of a patient and methods of implanting macromolecules into living cells of a patient by electroporation. US patent number 6,763,264, with claims to methods of delivering expression vectors and molecules, and US patent number 6,697,669, with claims to methods of in vivo electroporation of skin and muscle, provide broad-based coverage to the company. Additionally, other of the company's patents protect the company's proprietary methodology of electroporation wherein the electroporation process is carried out using "opposed-paired" electric field pulsing. Such patents include, but are not limited to, US patent numbers 6,241,701, 6,120,493, 6,233,482, and 5,702,359. It is important to understand that patents with claims directed to apparatuses and methods for the electroporation of any tissues are broadly applicable to many applications including intramuscular, intradermal and intratumoral applications.
The company also has a number of issued US and foreign patents claiming a widely used gene regulation technology called the GeneSwitch® that permits control of gene expression from DNA sequences via a small molecule drug that can be administered orally. For example, US patents 5,364,791 and 6,599,698 claim various aspects of this unique regulation system that may be used in gene therapy products. In addition to electroporation technology for gene delivery, the company has also acquired a group of patents claiming the delivery of DNA using polymers (e.g., 6,040,295 and 6,514,947) and lipids (e.g., 6,387,395 and 6,235,310) that are useful in the development of certain DNA vaccines where reduced levels of gene expression are adequate.
With respect to oncology, US patent number 6,569,149 provides broad claim coverage directed to a method for the application of electric fields to a tissue of a patient having a "cell proliferation disorder" for the purpose of introducing molecules into cells of the tissue to treat the cell proliferation disorder. Such method comprises providing an array of multiple opposed pairs of electrodes connected to a generator, wherein at least two pairs of electrodes are activated simultaneously after being placed in such tissue along with the substance being electroporated, and then applying an electric pulse.
With respect to vascular, transdermal, and ex vivo applications of electroporation technology, the company's patent portfolio is also vibrant. US patent 5,704,908 includes claims directed to an electroporation balloon catheter. Additionally, US patent 6,342,247 is directed to methods of increasing vasodilation, an important indication in maintaining blood flow in certain patients with vessel occlusion problems. US patents 6,697,669, 6,654,636, 5,810,762, and 5,439,440 provide claims to transdermal application of electric fields to surface tissues, while US patents 6,027,488, 6,746,441, 6,800,484, and 6,150,148 include claims to electroporation of cells in vitro. Such electroporated cells could be used either in laboratory settings or for introduction into patient blood stream or other tissues.
The currently issued patents provide a monopoly base for the claimed subject matter for the various indications to at least the year 2017 and numerous claims will be in force to between 2018 and 2020.