Tiotropium bromide - USA

Claim Construction (District of New Jersey): Apr. 16 2020

[BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. et al v. LUPIN ATLANTIS HOLDINGS SA et al;

Case : 3:2018cv12663]

This case arises out of an action for patent infringement instituted by Boehringer against Lupin. Boehringer manufactures and sells SPIRIVA® HandiHaler® (“product” or “inhaler”) for the purpose of treating bronchospasm associated with chronic obstructive pulmonary disease (“COPD”). US 7,694,676 patent is at issue, entitled “Dry Powder Inhaler.” The first claim term at issue appears in the preamble of the ’676 Patent, which states the patent is directed to “[a]n inhaler for inhaling powdered pharmaceutical compositions from capsules.” The second claim term at issue appears in Claims 1 and 13 of the ’676 patent and specifies the location of the gripping aid as “disposed proximate to an edge of the mouthpiece and proximate to the actuating member when the mouthpiece is closed.”

Claim 1. An inhaler for inhaling powdered pharmaceutical compositions from capsules, comprising: a lower part, a plate which can be latched to the lower part and with which the lower part can be closed off, and a capsule holder for receiving the capsules, this holder being adapted to be lowered into the lower part, a mouthpiece latchable to the plate, a lid which covers the mouthpiece in a closed position and latches it by means of a closure element, the lower part, the plate, the mouthpiece and the lid being hinged together by means of a single joint, and an actuating member which can be moved out a resting position and thereby interacts with at least one pin which can be made to pierce the capsule holder, wherein: the mouthpiece has a gripping aid by means of which the mouthpiece can be flipped open, away to the side, the gripping aid disposed proximate to an edge of the mouthpiece and proximate to the actuating member when the mouthpiece is closed the actuating member is constructed as a double function actuating member by means of which, in a first actuation, the closure element can be released from the lower part in order to swivel the lid, and with which, in a second actuation, the capsule is pierced, the actuating member including a recess to receive and engage the closure element when the lid covers the mouthpiece in the closed position.

Claim 13. An inhaler for inhaling powdered pharmaceutical compositions from capsules, comprising; a lower part, a plate which can be latched to the lower part and with which the lower part can be closed off, and a capsule holder for receiving the capsules, this holder being adapted to be lowered into the lower part, a mouthpiece latchable to the plate, a lid which covers the mouthpiece in a closed position and latches it by means of a closure elemental the lower part, the plate, the mouthpiece and the lid being hinged together by means of a single joint, and an actuating member which can be moved out a resting position and thereby interacts with at least one pin which can be made to pierce the capsule holder, wherein the mouthpiece has a gripping aid by means of which the mouthpiece can be flipped open, away to the side, the gripping aid disposed proximate to an edge of the mouthpiece and proximate to the actuating member when the mouthpiece is closed, the actuating member including a recess to receive and engage the closure element when the lid covers the mouthpiece in the closed position.

The chart below sets forth the parties’ proposed constructions.

Claim Language	Asserted Claims	Boehringer Construction	Lupin Construction
“inhaler for powdered pharmaceutical compositions from capsules”	’676 Claims 1, 13	Preamble term is limiting, does not require further construction	Preamble term is not Limiting. If it is limiting, should be construed as “inhalation device”
“gripping aid disposed proximate to an edge of the mouthpiece and proximate to the actuating member when the mouthpiece is closed”	’676 Claims 1, 13	“gripping aid located close to an edge of the mouthpiece and close to the actuating member when the mouthpiece is closed”	“gripping aid disposed next to or immediately before/after an edge of the mouthpiece and next to or immediately before/after the actuating member when the mouthpiece is closed”

Construction of Disputed Terms:

A. The Meaning of “inhaler for inhaling powdered pharmaceutical compositions from capsules”

Court’s construction: Court finds the preamble term, “inhaler for inhaling powdered pharmaceutical compositions from capsules” is limiting.

B. The Meaning of “proximate to”

Court’s construction: Court construes “proximate” to have its plain and ordinary meaning, which is “near or close to.”