The Court of Appeal for Federal Circuit (CAFC) today affirmed an order by the District Court for the Northern District of West Virginia on litigation cost to innovator Daiichi under 28 USC 1920 and federal rule of civil procedure 54 (d).
The cost are related to following disputed patent listed in Orange Book for Levofloxacin (Levaquin) 250, 500, and 750mg tablets:
US5053407 (Assignee: Daiichi, Date of Grant: October 1, 1991, Expiry: June 20, 2011): which covers S(-)-9-Fluoro-3-methyl-10 -(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxa zine-6-carboxylic acid (Levofloxacin) as product
Mylan countered that the '407 patent was invalid and unenforceable. District Court for the Northern District of West Virginia opined that Mylan failed to establish ‘407 patent’s invalidity by clear and convincing evidence and upheld patent and awarded litigation cost against Mylan.
Daiichi calculated its costs as $2.2 million, but the district court in August 2008, reduced those costs by 40% to $1.33 million . The major portion of the calculated fees was w.r.t translation cost of about $1 million . On appeal, the CAFC affirmed these costs.
Mylan objected on a number of grounds, and argued for an apportionment of costs based on the fact that a portion of the discovery in the instant case had been conducted jointly with related action against another generic player Teva Pharma in the District Court for the District of New Jersey.
The ‘407 patent has been challenged by generic companies like Teva and Mylan on patent invalidation grounds. Further, generic player Lupin challenged the patent term extension of 810 days granted by USPTO under section 35 USC 156. In May 2009, Court denied summary judgment to Lupin and upheld the patent term extension.
It is pertinent to mention here that this is a second patent litigation, wherein, generic giant Mylan has to pay litigation cost. Earlier in Pioglitazone litigation, court has awarded attorney cost of $11.4 million from Mylan in favor of innovator Takeda for filing paragraph IV certification against product patent (generic player Alphapharm fined $5.4 million as attorney cost in the said case).
Levofloxacin which is an enantiomer of Ofloxacin has better physicochemical features and better efficacy in comparison to Oflaxacin. Due to it's better pharamceutical attributes and sale figures, the generic players has tried for early generic erosion, however, due to strong patent portfolio of innovator early generic erosion has not succeeded.
Opinion of court Here
Link to related news:
1) Patent Docs review Here
2) PatentlyO review Here
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