Risks Related to Our Intellectual Property
We may not be able to obtain and enforce patent rights or other intellectual property rights that cover our product candidates and that are of sufficient
breadth to prevent third parties from competing against us.
Our success with respect to our product candidates will depend in part on our ability
to obtain and maintain patent protection in the United States and abroad, to preserve our trade secrets, and to prevent third parties from infringing upon our proprietary rights. Our patents and patent applications, however, may not be sufficient to
provide protection for GPS, NeuVax or our other products and product candidates against commercial competition. The four peptide components of GPS are
WT1-A1,
WT1-427
long,
WT1-331
long, and
WT1-122A1
long. We have an exclusive license to United States and foreign patents relating to these peptides from MSK, for all therapeutic and
diagnostic uses. Under the license, we have an issued patent covering the composition of matter of the
WT1-A1
peptide in the United States, issued patents covering composition of matter and methods of use in
Australia, Switzerland, Germany, Spain, France, Great Britain, and Italy, and an issued Canadian patent covering the composition of matter and method of use. The U.S. patent on the
WT1-A1
peptide (U.S. Patent
No. 7,488,718) will expire on March 22, 2026, including patent term adjustment, and the foreign patents will expire on November 30, 2024, absent patent term extension.
We have licensed, issued patents covering the composition of matter of the
WT1-427
long peptide, and methods of use,
in the United States, Australia, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, and Canada. The United States composition of matter patent on the
WT1-427
long peptide (U.S. Patent
No. 8,765,687) will expire on October 26, 2031, including patent term adjustment. The United States method of use patent (U.S. Patent No. 9,233,149) will expire on October 17, 2026, absent patent term extension, and covers
treating a subject with a
WT1-expressing
cancer, reducing an incidence of a
WT1-expressing
cancer, or its relapse, and inducing the formation and proliferation of a
cytotoxic T lymphocyte specific for a
WT1-expressing
cancer. The foreign patents will expire on October 17, 2026, absent patent term extension.
We have licensed, issued patents covering the composition of matter of the
WT1-331
long peptide, and methods of use,
in the United States, Australia, Switzerland, Germany, Spain, France, Great Britain, Ireland, and Italy. The United States composition of matter patent on the
WT1-331
long peptide (U.S. Patent
No. 8,765,687) will expire on October 26, 2031, including patent term adjustment. The United States method of use patent (U.S. Patent No. 9,233,149) will expire on October 17, 2026, absent patent term extension, and covers
treating a subject with a
WT1-expressing
cancer, reducing an incidence of a
WT1-expressing
cancer, or its relapse, and inducing the formation and proliferation of a
cytotoxic T lymphocyte specific for a
WT1-expressing
cancer. The foreign patents will expire on October 17, 2026, absent patent term extension.
We have a licensed, issued United States patent covering the composition of matter of the
WT1-1221A1
long peptide, and
issued patents covering the composition of matter and methods of use, in Austria, Belgium, Switzerland, Germany, Spain, Finland, France, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Romania, and Turkey. The United States composition
of matter patent on the
WT1-1221A1
long peptide (U.S. Patent No. 9,265,816) will expire on February 20, 2033, including patent term adjustment. The European patents will expire on April 10,
2027, absent patent term extension, and cover the composition of matter and use of the peptide for the preparation of a medicament for treating a
WT1-expressing
cancer or for reducing an incidence of a
WT1-expressing
cancer or its relapse in a subject.
We are pursuing additional patent protection through pending patent
applications for compositions of matter and methods of use for the
WT1-331
long peptide and
WT1-122A1
long peptide in Canada, and method of use for the
WT1-122A1
long peptide in the United States. Although we are pursuing additional patent protection for these peptide components through pending patent applications, we may not be able to obtain additional patent
protection that would provide us with a significant commercial advantage. The active peptide found in NeuVax, the E75 peptide, has been known and studied for many years. We have one issued U.S. patent, US 6,514,942, covering the composition of
matter of the E75 peptide, which expired in
mid-2015,
prior to any potential commercialization of NeuVax. We do not have and will not be able to obtain any composition of matter patent
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