Pharma Blog Watch

Caraco Wins on a Ratio (Patent Docs)
In his post, Donald Zuhn discusses a recent patent suit between Ortho-McNeil and Caraco Pharmaceutical over Ortho's patent for Ultracet (tramadol HCl/acetaminophen). The patent covers formulations containing the active ingredients in a certain ratio. Caraco had filed an abbreviated new drug application (ANDA) for a generic version of the drug.

"The threshold issue in this case involves the proper construction of the term 'about 1:5.' Before the District Court, Ortho argued that 'about 1:5' means 'approximately 1:5, and … encompasses a range of ratios of at least 1:3.6 to 1:7.1,' and Caraco countered that the term means 'approximately 1:5, subject perhaps to minor measuring errors of, say, 5 or 10 percent'," he writes. "Based on its construction of the term 'about 1:5,' the District Court concluded that the composition described in Caraco's ANDA did not literally infringe [on] the '691 patent."