GI Innovation said it obtained a substance patent of GI-101, its key immunotherapy candidate, in the U.S.
On Monday, the company said it registered the GI-101 patent with a wide range of rights without amino sequence restrictions in the U.S. which accounts for 60 percent of the global biopharmaceutical market. The patent will help the company strongly influence the commercialization of the product in the U.S., it said.
GI Innovation said the patent was on the combination of CD80, Fc domain, and IL-2, which are the essential components of GI-101. The patent also includes CD80’s fragment and IL-2 variant, offering a broad scope of intellectual property rights.
The patent is not limited to the “amino acid sequence,” which makes it difficult for other rivals to evade the patent. In addition, the broad scope of rights includes not only GI-101 monotherapy development but the development of combination therapy with other anticancer drugs such as Keytruda and targeted therapy. So, all the business areas using GI-101 will be protected by the patent, GI Innovation said.
Usually, the U.S. Patent and Trademark Office (USPTO)’s review of a biopharmaceutical product takes about two years because USPTO evaluates the novelty and progress of the drug after the restriction requirement.
However, this time, it only took four months for GI Innovation to obtain the patent because USPTO recognized the novelty and progress of GI-101 immediately after the restriction requirement, the company said.
With the patent, GI Innovation will be able to block competitors’ patent evasion designs and secure a competitive edge when signing a licensing-out deal, the company added.
GI Innovation has completed GI-101 patent applications for substance/use, combined with an immune checkpoint inhibitor, an anticancer agent, radiation, variants, and the drug form.