The company Novocell (merged from Cythera, BresaGen, and Novocell) has been strategically developing an IP portfolio covering numerous aspects of treating diabetes.
Having IP on endoderm, as well as encapsulation technologies, the company recently was issued the current patent covering generation of insulin producing cells from embryonic stem cells.
The first independent claim covers: "A method for producing insulin, said method comprising the steps of:
(a) contacting human embryonic stem (hES) cells in vitro with a first medium comprising activin A, thereby activating a TGF-.beta. receptor family member;
(b) culturing in vitro the hES-derived cells of step (a) in a second medium lacking activin A, thereby generating PDX-1 positive pancreatic endoderm cells;
(c) transplanting the PDX-1 positive pancreatic endoderm cells of step (b) into a mammalian subject; and
(d) maturing the PDX-1 positive pancreatic endoderm cells of step (c) in vivo, thereby obtaining insulin secreting cells, wherein the insulin secreting cells secrete insulin in response to glucose stimulation.
Generation of insulin producing cells has been performed by other methods, however the key question, which Novocell seems to have answered, is whether the cells produce enough insulin to be physiologically relevant. For example, it has been reported that bone marrow mesenchymal stem cells, treated with a 4 step protocol can generate insulin. Additionally, transfection with PDX-1 of mesenchymal stem cells can also generate insulin producing cells.
The question with other approaches is scalability and physiological relavance. These seem to be addressed in Novocell's current patent.
In addition to scientific strength, one can tell that much time has gone into this incredibly broad specification which covers 394 variations of the protocol for generation of islets.
Congratulations Novocell (and IP Director Dr. Liz Bui) on another masterpiece !!!