Company: TVRD
Filing Date: 2025-02-14
Form Type: S-4/A
Source: 0001104659-25-013053
Chunk: 441

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: S-4/A
Chunk 441
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 U.S. patents with claims to oral formulations of difelikefalin that are not currently under development have been granted and are expected to expire no earlier than September 13, 2039. Related U.S. and foreign applications, if granted, would also be expected to expire no earlier than September 13, 2039. Cara also relies on trade secrets and careful monitoring of its proprietary information to protect aspects of its business that are not amenable to, or that Cara does not consider appropriate for, patent protection.

Cara’s success will depend significantly on its ability to obtain and maintain patent and other proprietary protection for commercially important technology, inventions and know-how related to its business, defend and enforce its patents, maintain its licenses to use intellectual property owned by third parties, preserve the confidentiality of its trade secrets and operate without infringing valid and enforceable patents and other proprietary rights of third parties. Cara also relies on know-how, and continuing technological innovation to develop, strengthen, and maintain its proprietary position in the field of chronic pruritus.

A third party may hold intellectual property, including patent rights, which are important or necessary to the development of Cara’s products. It may be necessary for Cara to use the patented or proprietary technology of third parties to commercialize its products, in which case Cara would be required to obtain a license from these third parties on commercially reasonable terms, or its business could be harmed, possibly materially. If Cara were not able to obtain a license or were not able to obtain a license on commercially reasonable terms, its business could be harmed, possibly materially.

The patent positions of biopharmaceutical companies like Cara are generally uncertain and involve complex legal, scientific and factual questions. In addition, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and the patent’s scope can be modified after issuance by later judicial decisions. Consequently, Cara does not know whether its product candidates will be adequately protectable or remain protected by enforceable patents. Cara cannot predict whether the patent applications Cara is currently pursuing will issue as patents in any particular jurisdiction or whether the claims of any issued patents will provide sufficient proprietary protection from competitors. Any patents that Cara holds may be challenged, circumvented or invalidated by third parties.

Because patent applications in the United States and certain other jurisdictions are maintained in secrecy for up to 18 months, and since publication of discoveries in the scientific or patent literature often lags behind actual discoveries, Cara cannot be certain of its entitlement to the inventions covered by pending patent applications. Moreover,