In re Fenofibrate Patent Litig.

4.71/1 does not fall “between 5/1 and 15/1,” particularly when the range was limited during prosecution to avoid prior art.

April 17, 2013

GENERICally Speaking

Case Name: In re Fenofibrate Patent Litig., Case No. 11 MDL 2241, 2013 U.S. Dist. LEXIS 21165 (S.D.N.Y. Jan. 4, 2013) (Rakoff, J.)

Drug Product and Patent(s)-in-Suit: Antara® (fenofibrate); U.S. Patent Nos. 7,101,574 (“the ’574 patent”) and 7,863,331 (“the ’331 patent”)

Nature of the Case and Issue(s) Presented: In a prior Order, the district court granted Mylan’s motion for summary judgment of non-infringement. The disputed claim element required a particular ratio of fenofibrate to binding cellulose derivative of “between 5/1 and 15/1.” The district court found that Mylan’s proposed product had an undisputed ratio of 4.71/1, falling outside the claim limitation. Lupin sought a preliminary injunction to preclude Mylan from introducing its generic product to the market. Lupin argued that the district court erred because it relied on cases that were factually opposite of the present case. In particular, Lupin argued that it would show on appeal that the claimed range would include Mylan’s proposed generic product because a person of ordinary skill would have rounded the ratio to the first integer. The district court denied Lupin’s motion for a preliminary injunction.

Why Mylan Prevailed: The court held thatLupin could not show a likelihood of success on the merits. In particular, the district court noted that Lupin merely asserted the arguments it presented in opposition to summary judgment in its motion for preliminary injunction. The district court noted that there were factual differences between the present case and the cited cases, but those differences did not change the common sense patent law basics that the word “between” means “in the time, space or interval that separates.” Moreover, Lupin failed to recognize that the ratios limitation were added to distinguish the invention from the prior art. This limited the scope of the claim and Lupin could not reclaim substance that it gave up in prosecution.

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