Hospira suffers setback as two patents invalidated
A US district court has invalidated two patents owned by American pharmaceutical firm Hospira, in a victory for German healthcare company Fresenius Kabi.
The decision was issued by the US District Court for the Northern District of Illinois, Eastern Division on Monday, December 17.
Hospira brought proceedings against Fresenius in January 2016, initially accusing the German company of infringing four of its patents (US numbers 8,242,158; 8,338,470; 8,455,527; and 8,648,106). A second suit was filed in January 2017 citing infringement of a fifth patent (US number 9,616,049).
Hospira subsequently dropped most of the claims, asserting only claim 6 of the ‘106 patent and claim 8 of the ‘049 patent.
The patents cover a ‘dexmedetomidine premix formulation’ and ‘methods of treatment using a dexmedetomidine premix formulation’. Dexmedetomidine is the active component in Hospira’s Precedex Premix and Precedex Concentrate products, which are both used as a short-term sedative in intensive care settings.
The dispute arose in December 2015 when Fresenius informed Hospira that it intended to produce a generic dexmedetomidine product.
Precedex Concentrate must be diluted before use. Hospira obtained the patents-in-suit for a ready-to-use diluted version, Precedex Premix.
Fresenius disputed the validity of the patents, arguing that the dilution formula would be obvious to person of ordinary skill in the art.
According to the ruling, the guidelines for use on the label of Precedex Concentrate disclosed the formula used to make Precedex Premix. Fresenius cited this as prior art in arguing against the validity of the ‘106 and ‘049 patents.
The court invalidated the patents as obvious on the grounds that a person of ordinary skill in the art would, in combination with this previously disclosed information, be able to devise the diluted product with a reasonable expectation of success.
Hospira is a subsidiary of American pharmaceutical company Pfizer. A spokesperson for Pfizer said that “we are disappointed by the ruling and plan to appeal”.
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