RISK FACTORS 4 new patents or to enforce our existing in-licensed patents and apply prior to expiration of relevant patents or otherwise failing any patents that we might obtain in the future. In particular, there to satisfy applicable requirements. Moreover, the applicable time have been recent proposals for additional changes to the patent period or the scope of patent protection afforded could be less laws of the United States and other countries that, if adopted, than we request. If we are unable to obtain patent term extension could impact our ability to obtain patent protection for our or the term of any such extension is less than we request, our proprietary technology or our ability to enforce our proprietary competitors may obtain approval of competing products following technology. Depending on future actions by the U.S. Congress, our patent expiration, and our revenue could be reduced, possibly the U.S. courts, the USPTO and the relevant law-making bodies materially. in other countries, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability In the European Union, one or more of the in-licensed European to obtain new patents or to enforce our existing patents and Union patents, or any patents that issue from our European patents that we might obtain in the future. Europe’s planned Union patent applications, may be eligible for limited patent term Unified Patent Court, currently working towards early 2018 as a extension if a Supplementary Protection Certificate, or SPC, is target date to come into existence and begin its operations, may available under Regulation (EC) No 469/2009. Further protection particularly present uncertainties for our ability to protect and may also be available by means of a Paediatric Extension to such an enforce our patent rights against competitors in Europe. While SPC. Alternatively, our licensors we may be able to extend their de that new court is being implemented to provide more certainty facto exclusive rights by means of trial data exclusivity protection. and efficiency to patent enforcement throughout Europe, it will In any case, failure to obtain, or lack of eligibility for, such protection also provide our competitors with a new forum to use to centrally may al low our competitors may obtain approval of competing revoke our European patents. It will be several years before we products following our patent expiration, and our revenue could will understand the scope of patent rights that will be recognized be reduced, possibly materially to the extent that we, and/or our and the strength of patent remedies that will be provided by that licensors have no effective period of market exclusivity. court. We will have the right to opt our patents out of that system Our trademarks and trade names may not be adequately protected over the first seven years of the court, but doing so may preclude and we may not be able to build name recognition in our markets us from realizing the benefits of the new unified court. of interest. Upon the expiration of any of our in-licensed U.S. and European The validity of our registered trademark for “GenSight” patents, or any patents issuing from our patent applications, in France could be chal lenged by third parties. Likewise, our we may not receive the benefit of patent term extension or data pending Community Trade Mark application for “GenSight,” exclusivity for our product candidates in the United States and the and any subsequent trademark applications we make, are not European Union. guaranteed to become registered. For example, a trademark Depending upon the timing, duration and specifics of any application may be subject to an opposition proceeding in the marketing approval by the FDA of our product candidates, one USPTO, the Office for Harmonization in the Internal Market or more of our U.S. or European patents that we in-license or that or corresponding other trademark offices, which could result may issue from our patent applications may be eligible for limited in the total or partial refusal of the trademark application. Our patent term extension. Community Trademark application for “GenSight” is currently the subject of opposition proceedings. See Section 20.5, “Legal and In the United States, one or more of the in-licensed U.S. patents, Arbitration Proceedings” of this Registration Document. Even if or any patent that issues from our U.S. patent application, may we are successful in registering “GenSight” or other trademarks or be eligible for patent term extension under the Drug Price trade names, such trademarks or trade names may be challenged, Competition and Patent Term Restoration Act of 1984, or Hatch- infringed, circumvented or declared generic or determined to Waxman Amendments. The Hatch-Waxman Amendments permit be infringing other marks. We may not be able to protect our a patent extension term of up to five years as compensation rights to our trademark and trade name, which we need to build for patent term lost during the FDA regulatory review process. name recognition among potential partners or customers in our A patent term extension cannot extend the remaining term of markets of interest. At times, competitors may adopt trade names a patent beyond a total of 14 years from the date of product or trademarks similar to ours, thereby impeding our ability to build approval, only one patent may be extended and only those claims brand identity and possibly leading to market confusion. Over the covering the approved drug, a method for using it or a method long term, if we are unable to establish name recognition based for manufacturing it may be extended. However, we may not be on our trademarks and trade names, then we may not be able to granted an extension because of, for example, failing to exercise compete effectively and our business may be adversely affected. due diligence during the testing phase or regulatory review Our efforts to enforce or protect our proprietary rights related process, failing to apply within applicable deadlines, failing to to trademarks, domain names or copyrights may be ineffective 52 – GENSIGHT BIOLOGICS – 2017 Registration Document