FACT #3: Myotrophin composition rhIGF-I is in the public domain and therefore cannot be patented.
"The Company believes that the composition of rhIGF-I is in the public domain and therefore cannot be patented under a composition-of-matter patent".
"Other companies are developing rhIGF-I (Myotrophin's generic name)as a therapeutic product for diseases other than ALS or peripheral neuropathy, including Genentech, Inc., which is evaluating rhIGF-I in diabetes. "
"There are significant efforts by others, including many large pharmaceutical companies and academic institutions, to develop therapeutic products which may compete with the products being developed by the Company, including Alzheimer's disease and stroke. Some of these products may be at a more advanced stage of development than the Company's products."
"...if the sale of rhIGF-I by third parties is approved for other indications, such products might compete with MYOTROPHIN (rhIGF-I) through "off-label" use, especially if such product is priced below MYOTROPHIN (rhIGF-I)."
" It is not always possible to detect "off-label" sales and therefore enforcement of use patents can be difficult. Furthermore, some jurisdictions outside of the United States restrict the manner in which patents claiming uses of a product may be enforced."
taken from FORM 10-K405 Filed March 13, 1997 sec.gov
So whats the use of getting approval if you can't enforce a patent unless you make it a use patent. Other comapnies like Genetech will be able to undersell the product.
Sell your stock now for a profit before it really tanks!!! |