AKAO 2017 Annual Report

23 consider any of our additional patents or patent applications are material at this time and it is unclear what, if any, patent protection we will have for the ultimate products we choose to move forward through development. Plazomicin (Aminoglycoside) The patent portfolio for plazomicin is based upon an Achaogen-owned patent family that includes patents and patent applications directed to plazomicin and structural analogs thereof, pharmaceutical compositions containing plazomicin or analogs thereof, and methods of using plazomicin or analogs thereof in the treatment of bacterial infections. As of January 31, 2018, this patent family included four U.S. patents (U.S. Patent No. 8,383,596, issued February 26, 2013; U.S. Patent No. 8,822,424, issued September 2, 2014; U.S. Patent No 9,266,919, issued February 23, 2016; and, U.S. Patent No. 9,688,711, issued June 27, 2017 which we refer to herein as the ‘596, ‘424, ‘919 and ‘711 patents, respectively), and corresponding foreign patents and patent applications. As of January 31, 2018, we had corresponding granted patent or patents in Australia, Canada, China, Eurasia, Europe (with country- specific validations), India, Israel, Japan, Korea, Mexico and Taiwan. In addition, as of January 31, 2018, we had corresponding patent applications pending in Brazil, Europe, and the US. We expect any U.S. and foreign patents in this patent family to expire in November 2028, excluding any available extensions or adjustments. Note, the U.S. Patent and Trademark Office (“USPTO”) has determined that the ‘596 patent is entitled to 923 days of patent term adjustment. Assuming that plazomicin achieves regulatory approval and depending upon the date of any such approval, the term of a US patent could be extended up to the lesser of (i) up to five additional years or (ii) no more than fourteen years from plazomicin’s approval date, under the provisions of the Drug Price Competition and Patent Term Restoration Act of 1984, also referred to as the Hatch-Waxman Act. Plazomicin could also qualify for pediatric exclusivity, which can be obtained during the approval process or after approval, and effectively delays the approval of a generic application until six months after the expiration of any patent or other exclusivity that would otherwise delay approval, thus providing an additional six months without generic competition. In order to qualify for pediatric exclusivity, the FDA must make a written request for pediatric studies, the application holder must agree to the request and complete the studies within the required timeframe, and the studies must be accepted by the FDA based on a determination that the studies fairly respond to the request. Patent term extension and supplementary protection certificates also may be available in certain foreign countries upon regulatory approval. Additional intellectual property, including patent protection, may protect plazomicin in areas including but not limited to method of use, manufacturing, and platform technologies. Additional Patent Positions Our C-Scape program was created at Achaogen and we are pursuing intellectual property relating to this program. C-Scape was granted QIDP designation by the FDA which provides incentives for the development of new antibiotics, including priority review and extension by an additional five years of any non-patent market exclusivity the product may be awarded upon approval. Currently, C-Scape is not covered by any issued patents but we are pursuing patent positions in connection with various aspects of our program. Trade Secrets In addition to patents, we rely on trade secrets and know-how to develop and maintain our competitive position. We seek to protect our proprietary data and processes, in part, by confidentiality agreements and invention assignment agreements with our employees, consultants, scientific advisors, contractors, and partners. These agreements are designed to protect our proprietary information. We also seek to preserve the integrity and confidentiality of our data, trade secrets and know-how by maintaining physical security of our premises and physical and electronic security of our information technology systems. Trade secrets and know-how can be difficult to protect. Consequently, we anticipate that trade secrets and know-how will, over time, be disseminated within the industry through independent development, the publication of journal articles, and the movement of personnel skilled in the art from academic to industry scientific positions. Government Regulation and Product Approval Government authorities in the United States, at the federal, state and local level, and in other countries extensively regulate, among other things, the research, development, testing, manufacture, including any