Efinaconazole - USA

Claim Construction (District of New Jersey): May 07, 2020

[VALEANT PHARMACEUTICALS NORTH AMERICA LLC et al v. ZYDUS PHARMACEUTICALS (USA) INC. et al.;

Case : 3:2018cv13635]

This case arises out of an action for infringement of Plaintiffs’ patents1 by Defendants’ filing of an Abbreviated New Drug Application (“ANDA”) seeking U.S. Food and Drug Administration (“FDA”) approval to market a generic version of Plaintiffs’ product Jublia®—an efinaconazole topical solution, 10%. The parties dispute the proper construction of a single term, “nail,” used in eight of the nine patents-in-suit.

Claim Language	Asserted Claims	Plaintiffs’ Proposed Construction	Defendants’ Proposed Construction
“nail”	’494 patent claim 1; ’978 patent claims 1, 2, 21, 41; ’009 patent claim 1; ’272 patent claim 1; ’698 patent claims 2, 11; ’955 patent claims 1, 12, 14; ’444 patent claims 2, 9; ’394 patent claim 11	“nail plate”	Plain and ordinary meaning, i.e., “nail unit”

The parties did not dispute that “nail unit” has an ordinary meaning which includes, among other components, the nail plate and nail bed. The nail plate is a rigid outer portion, and the nail bed is the dermis directly beneath the nail plate. However, the present issue is whether the term “nail” as asserted in the patents-in suit refers to merely the nail plate or encompasses the entire nail unit—inclusive of the nail plate, nail bed, and other structures.

Plaintiffs first contend “nail” means “nail plate” because the claims consistently use the phrase “treatment of a disorder of the nail or nail bed”. Plaintiffs argued the use of the word “or” indicates the “nail” is distinct from the “nail bed.” Because the nail bed is part of the nail unit, Defendants’ proposed construction would render the phrase “or nail bed” superfluous and redundant. Defendants contended that their construction would not make “or nail bed” superfluous because a person of ordinary skill in the art (“POSA”) would understand a topical fungal treatment such as Jublia® could be applied to either: 1) the nail unit in its entirety; or 2) the nail bed after removal of the nail plate. Defendants also contended the use of “nail” above should be construed as “nail unit” because the nail unit is primarily composed of hard keratin. Court, however, said that the specifications supports Plaintiff’s construction as it reads:

"The nail plate is thick, hard, and dense, and represents a formidable barrier to drug penetration. Although nail material is similar in various ways to the stratum corneum of the skin, the nail is composed primarily of hard keratin which is highly disulfidelinked and is approximately 100-fold thicker than stratum corneum."