In an amended complaint, filed on February 16, 2005, Tercica and Genentech challenged Insmed’s right to commercialize SomatoKine and added allegations of infringement of an additional patent.
Insmed asserts that all alleged activities fall within the statutory safe harbor provided by the Clinical Trial Exemption. This exemption prevents patent infringements from being filed against activities reasonably related to obtaining FDA approval of a product, such as when the product is still being tested in clinical trials.
Insmed further asserts that Tercica and Genentech have failed to state a claim for the requested relief, have not sued the proper party, have failed to name all the proper plaintiffs and have failed to establish the existence of a sufficiently real and substantial controversy. Insmed seeks immediate dismissal or summary judgment against the allegation on these grounds.
Dr Geoffrey Allan, Insmed’s president and CEO, commented, “We believe that this litigation is clearly an attempt to interfere with our ongoing business activities designed to bring IGF-I therapy to patients with medical need. We continue to maintain our belief that we do not infringe any valid patent claims and do not believe that Tercica will succeed in their efforts to prevent our proprietary IGF-I therapy, SomatoKine from reaching patients with orphan diseases.”