- Merck's efforts to protect five patents on Cubicin (daptomycin for injection) in the U.S. Court of Appeals failed, with only one patent upheld. This clears the way for generic competition. The validated patent expires on June 15, 2016, while the four invalidated were initially slated to expire in 2019 and 2020.
- Cubicin is an antibiotic used to treat antibiotic-resistant skin and blood-borne infections. Last year, it generated a little more than $1 billion in revenue. The drug has brought in about $874 million in 2015 sales to date.
- On December 8, Merck agreed to buy Cubist Pharmaceuticals for roughly $9.5 billion (including $1.1 billion in assumed debt). The biggest part of the deal was the acquisition of Cubicin.
Here's the backstory: On December 9, 2014—the day after Merck announced its intentions to buy Cubist Pharmaceuticals, a judge in a federal court invalidated four of the five patents on Cubicin, Cubist's top-selling product.
This initial rulling was perceived as a major setback for Merck because generic competition was not expected for at least three years. Based on the latest ruling, generic competitors will be able to move into the market by next June. Hospira (now owned by Pfizer) is already preparing to launch its generic version of daptomycin upon patent expiration.
The patents that were invalidated cover dosing and purity levels. Merck is not giving up trying to defend its patents, stating it "is considering next steps, which may include further review at the Federal Circuit or Supreme Court."