Intellectual Property

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SquareX has a strong intellectual property position. We have the following patents issued or pending in the United States and other countries.

The active ingredient of SquareX’s lead candidate, squaric acid dibutyl ester (SADBE), is not available as an FDA-approved product. SquareX is positioned to be the first company to receive FDA approval for SADBE and expects to retain patent exclusivity until at least 2036.

In addition to method of medical treatment patents and a composition of matter patent, SquareX has pending patent applications for devices and kits that will make up our commercial product. 

U.S. Patent 10,245,314. 

This patent has claims covering a method of medical treatment of using SADBE to prevent herpes labialis outbreaks (cold sores) by application to the arm, rather than to the lip or to a lesion. This covers the use of our SQX770 drug for our indication of preventing herpes labialis outbreaks. It will expire in 2036, with extensions of time available for time spent in FDA review. SquareX has at least 15 years of patent term remaining. 

U.S. Patent No. 10,940,197. 

This patent has claims covering a method of medical treatment of using SADBE or compounds similar to SADBE to prevent herpes labialis outbreaks by application any place on the body other than a lesion. This will prevent a competitor from using a similar compound that acts by the same mechanism of action as our SQX770 drug. It will expire in 2036, with extensions of time available for time spent in FDA review. SquareX has at least 15 years of patent term remaining. 

Foreign patents

Foreign patents in the same patent family as the U.S. 10,245,314 and U.S. 10,940,197 patents with similar claims are issued in Japan, allowed for issue in Europe and Canada, and pending patent applications in India, China, South Korea, and Australia. These will all expire in 2036. 

U.S. Patent No. 9,205,065 

This patent covers a method of medical treatment using SADBE and similar topical contact sensitizers to treat or prevent any type of herpes simplex (HSV) infection (both HSV-1 and HSV-2) in any location (both oral and genital herpes) to prevent or reduce the frequency of future outbreaks by application to a herpes lesion. The key limitation is that they require local application on a lesion, unlike the U.S. Patent Nos. 10,245,314 and 10,940,197 described above. This patent will expire in 2028, with extensions of time possible for time in clinical trials.   

U.S. Patent No. 10,744,084 

This patent has claims directed to a pharmaceutical composition comprising SADBE dissolved in DMSO, which is our SQX770 formulation. This is a composition of matter patent covering our SQX770 drug. This patent will expire in 2028, with extension of time available for time in clinical trials. 

Issued Korean patent No. 10-1352238 

This issued patent has claims similar to the U.S. 9,205,065 and U.S. 10,744,084 patents. It will expire in 2028. 

International Patent Application No. PCT/US18/50358. 

Publication No. WO2020055382 

This international patent application has claims directed to methods of medical treatment to use SADBE and related topical contact sensitizers to treat molluscum contagiosum and fungal or yeast infections. Molluscum contagiosum is a contagious viral disease of the skin that produces raised bumps or papules on the skin on any area of the body. The bumps are usually not painful but can itch. The symptoms usually last for 6 to 12 months and can last for years. It is a fairly common disease and there are no good treatments. Fungal and yeast infections of the skin or mucous membranes, such as vaginal yeast infections, are extremely common.  SADBE would act by improving immune response to the fungus or yeast. A U.S. national patent application has been filed by Squarex. If it issues as a U.S. patent, it would expire in 2038. 

Pending U.S. and International Patent Application for Device and Kit 

We have a pending U.S. and international patent application that is not yet published that has claims directed to a dermal patch delivery system and to a kit containing a dermal patch with a vial with liquid SQX770 solution, which will be our commercial approved product if issued as a patent it would expire in 2040 or 2041.