Eli Lilly is celebrating a decision by a US court that backs the company’s patents on the blockbuster antipsychotic Zyprexa.
The Court of Appeals for the Federal Circuit in Washington DC affirmed a ruling from April 2005 which protects Lilly’s Zyprexa patent until 2011. The firm's chief executive Sidney Laurel claimed that the ruling is a victory for innovative drugmakers, saying that it "not only affirms the validity of our patent, but upholds patent law that helps enable the significant investments required to develop the next generation of revolutionary medicines for the patients who need them."
The original case involved a challenge by generic drugmakers Zenith Goldline Pharmaceuticals, owned by IVAX Corp (now part of Novartis), India's Dr Reddy's Laboratories and the US arm of Israel's Teva Pharmaceutical Industries. The firms claimed that the Zyprexa’s patent was no longer was valid because discovery its molecular structure was obvious and that a previous Lilly patent had covered it.
The news of the ruling is a considerable boost to Lilly and Zyprexa which is a massive earner for the firm, bringing in $1.12 billion in the third quarter of 2006 alone. The decision is especially welcome given the adverse publicity surrounding the drug of late, notably through a spate that has been played out on the pages of the New York Times which published leaked documents that questioned the firm’s marketing practices, among other things, regarding the blockbuster.
FDA OKs expanded use of Byetta
Meantime, Lilly and partner Amylin Pharmaceuticals have been celebrating the news that the US Food and Drug Administration has approved the diabetes drug Byetta (exenatide) as an add-on therapy to improve blood sugar control in people with type II diabetes who have not achieved adequate control on a thiazolidinedione.
Byetta is already approved for treatment of patients with type 2 diabetes who are unsuccessful at controlling their blood sugar levels despite using the commonly prescribed oral medications metformin, a sulfonylurea, or a thiazolidinedione. Total sales of the product in the third quarter of 2006 were $126.4 million, a 28% increase year-on-year, despite only being launched in June 2005.