Form 424B3 Roivant Sciences Ltd.
and future products and product candidates, or their use, provided such pending patent applications result in issued patents. Our ability to develop and commercialize our current and future products and product candidates may be adversely affected in the jurisdictions where these patents are issued.
The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent, and the prosecution history of the patent. Our interpretation of the relevance or scope of a patent or pending application may be incorrect, which may adversely impact our ability to commercialize our products or, if approved, our product candidates. We may incorrectly determine that our products or product candidates are not covered by a third-party patent or incorrectly predict whether a third-party’s pending application will issue claims of relevant scope. Our determination of the expiration date of any U.S. or foreign patent that we consider relevant may be incorrect and we may incorrectly conclude that a third-party patent is invalid or unenforceable. Our failure to properly identify and interpret relevant patents may adversely impact our ability to develop and commercialize our current and future products and, if approved, product candidates.
If we fail to identify and correctly interpret the relevant patents, we may be subject to claims of infringement. We cannot guarantee that we will be able to successfully settle or resolve such infringement claims. If we fail in such litigation, in addition to being obligated to pay damages, we may be temporarily or permanently prohibited from marketing any of our products or, if approved, product candidates, which are considered infringing. We may, where possible, also be required to redesign products or product candidates so as to no longer infringe the intellectual property rights of third parties. Any of these events, even if we were to ultimately prevail, could require us to divert significant financial and management resources that we would otherwise be able to devote to our business.
We may be involved in lawsuits to protect or enforce our patents, our licensors’ patents, or our other intellectual property rights, which could be costly, lengthy, and unsuccessful.
Competitors may infringe, misappropriate or otherwise violate our patents, our licensors’ patents or our other intellectual property rights. To combat infringement or unauthorized use, we may be required to file and pursue legal actions against one or more third parties, which can be costly and time-consuming, even if ultimately successful. For example, in February 2022, Roivant’s subsidiary, Genevant Sciences, and Arbutus Biopharma Corporation filed a lawsuit in the United States District Court for the District of Delaware against Moderna, Inc. and an affiliate seeking damages for infringement of U.S. Patent Nos. 8,058,069, 8,492,359. , 8,822,668, 9,364,435, 9,504,651 and 11,141,378 in the manufacture and sale of MRNA-1273, Moderna’s vaccine for COVID-19[feminine] (the “Moderna Action”). Additionally, in March 2022, Acuitas Therapeutics Inc. filed a lawsuit in the United States District Court for the Southern District of New York against Genevant Sciences and Arbutus Biopharma Corporation seeking declaratory judgment that US patents 8,058 069, 8492359, 8822668, 9006417, 9364435, 9404127, 9504651, 9518272 and 11141378 are not infringed by the manufacture, use, offer for sale, the sale or import into the United States of the COMIRNATY, Pfizer and BioNTech vaccine for COVID-19[feminine] and are otherwise invalid (the “Acuitas Action”).
In an infringement proceeding, a court may decide that one of our or our licensors’ patents is invalid or unenforceable, or may refuse to restrain the other party from using the technology in cause on the grounds that our patents do not cover the technology in question. question. The standards used by courts to interpret patents are not always applied in a predictable or consistent manner and may change, particularly as new technologies develop. Accordingly, we cannot predict with certainty the degree of protection, if any, that will be accorded to our patents if we attempt to enforce them and they are challenged in court and whether such proceedings, including the ‘Moderna action and Acuitas action, finally be successfully resolved. In addition, even if we are successful against an infringer in a U.S. district court, there is always the risk that the infringer will appeal and the district court judgment will be overturned by the court of appeals and/or an adverse decision is rendered by the Court of Appeal regarding the validity or enforceability of our patents. An adverse outcome in litigation or defense proceedings could put one or more of our patents at risk of being invalidated or narrowly construed in a manner insufficient to achieve our business objectives, or could put our patent applications at risk not to be delivered. The filing of a complaint against a