European Patent Office Says Pfizer's Method of Use Patent for ED Invalid
- This decision makes it clear that Pfizer is not entitled to exclusivity in the field of erectile dysfunction (ED).
- Lilly ICOS is pleased, but not surprised, with the decision. Lilly ICOS was confident - as were the other companies that opposed the method of use claims - that this particular patent was invalid. This decision is consistent with the decision of the UK court in November last year, which also held that the UK designation of the same patent was invalid.
- This decision leaves unaffected Pfizer's compound patent, which covers sildenafil.
Lilly ICOS recently submitted applications with the U.S. Food and Drug Administration (FDA) and European Agency for the Evaluation of Medicinal Products (EMEA) requesting marketing approval of CialisTM (IC351) for the treatment of ED.
About Lilly ICOS
Lilly ICOS LLC, a joint venture between ICOS Corporation (NASDAQ: ICOS) and Eli Lilly and Company (NYSE: LLY), is developing Cialis (IC351), which is currently under investigation for the treatment of sexual dysfunction.
Eli Lilly and Company, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world’s most urgent medical needs.
ICOS Corporation is a product-driven company that has expertise in both protein-based and small molecule therapeutics. ICOS, located in Bothell, Wash., combines capabilities in molecular, cellular and structural biology, high throughput drug screening, medicinal chemistry and genomics to develop highly innovative products with significant commercial potential. The company applies its integrated approach to specific target areas where it has expertise. ICOS believes this strategy increases the chances of successfully developing commercial products. ICOS' disease targets include sexual dysfunction, sepsis, pulmonary hypertension and other cardiovascular diseases.
This contains forward-looking statements about the potential of the investigational compound Cialis (IC351) in treating male erectile dysfunction that reflect management's current beliefs. However, as with any pharmaceutical under development, there are risks and uncertainties in the process of development and regulatory review. There are no guarantees that future clinical trials will confirm the preliminary results reported in this release or that the product will receive regulatory approvals or prove to be commercially successful. In addition, new pharmaceutical products can face risks of intellectual property claims and product litigation. For further discussion of these and other risks and uncertainties, see the U.S. Securities and Exchange Commission filings of ICOS and Lilly.