The move by Hospira is the second challenge to Cubicin in three years under the Hatch-Waxman Act, a 28-year-old US law that encourages makers of generic drugs to contest patents on proprietary medicines so consumers can get cheaper versions sooner. Companies selling brand-name treatments contend they need longer exclusivity periods to recoup their costly investments on therapies, such as antibiotics, that fill important medical needs.
Cubist said it will file its suit within the 45-day response period allowed under the law. After that, the FDA is required to impose a 30-month stay before acting on Hospira’s application.
Shares of Cubist dropped 50 cents to $40.34 yesterday, a 1.2 percent decline on the Nasdaq stock exchange.
“We knew this challenge was a possibility,’’ said Cubist chief executive Michael W. Bonney. “It’s indicative of the fact that we have a very competitive product. We’ve been down this road before, and we’re well prepared to defend our patents.’’
The new patent skirmish, which could portend years of legal battles between the two companies, comes 10 months after Cubist settled long-running patent litigation with Israeli generic drug giant Teva Pharmaceutical Industries Ltd. Under that settlement, Cubist granted Teva a license to sell generic daptomycin in the United States starting in 2017 or 2018.
In exchange, Teva agreed to buy its US supply of daptomycin from Cubist, giving the Lexington company a revenue stream after its top-selling drug comes off patent later in the decade. Meanwhile, Cubist is developing new products, including antibiotics, to become more diversified by the time its Cubicin patents expire.
“Cubicin is doing well commercially, so the key for Cubist is going to be the pipeline,’’ said biotechnology analyst Howard Liang, managing director at health care investment bank Leerink Swann in Boston.
