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Novo Nordisk Inc. v. Teva Pharmaceuticals USA, Inc.

United States District Court, D. Delaware

June 26, 2018

NOVO NORDISK INC. and NOVO NORDISKA/S, Plaintiffs,
v.
TEVA PHARMACEUTICALS USA, INC., Defendant.

          REPORT AND RECOMMENDATION

          MARY PAT THVNGE CHIEF U.S. MAGISTRATE JUDGE

         I. INTRODUCTION

         On March 3, 2017, Novo Nordisk, Inc. and Novo Nordisk A/S (collectively, "Novo Nordisk" or "plaintiffs"), brought this action against Defendant Teva Pharmaceuticals USA, Inc. ("Teva" or "defendant") alleging infringement of U.S. Patent Nos. 6, 268, 343 ("the '343 patent"); 8, 114, 833 ("the '833 patent"); 8, 846, 618 ("the '618 patent"); 9, 265, 893 ("the '893 patent"); and RE4I, 956 ("the '956 patent").[1] Presently, the parties dispute claim terms from the '833, '893 and '956 patents.[2]

         A Markman hearing was held on May 17, 2018. The court recommends that the district court construe the disputed claim terms as is set forth below.

         II. CLAIM CONSTRUCTION

         A. '833 Patent

         1. "About:"[3] when used in connection with pH, means " or - 0.1 pH units from [the stated number]."[4]

         2. "Replacing the isotonicity agent previously utilized in said formulation with propylene glycol, ";[5] "the propylene glycol-containing formulation relative to that observed for the formulation containing the previously utilized isotonicity agent, "[6] and "the isotonicity agent to be replaced by propylene glycol:"[7] "Having a first formulation that utilized an isotonicity agent other than propylene glycol and having a second formulation wherein the isotonicity agent used in the first formulation is substituted or replaced with propylene glycol[.]"[8] Independent claim 23 of the '833 patent recites:

23. A method for reducing deposits on production equipment during production of a GLP-1 agonist formulation, said method comprising replacing the isotonicity agent previously utilized in said formulation with propylene glycol at a concentration of between 1-100 mg/ml, and wherein said GLP-1 agonist formulation comprises a disodium phosphate dihydrate buffer.[9]

         Claims 23-31 are process claims.[10] The specification is clear that, for the intended application, propylene glycol is superior to mannitol and related substances, because "mannitol results in clogging of injection devices[.]"[11] Moreover, in describing various embodiments, the specification explains, for example, that "during production of a peptide formulation, [] the method comprises replacing the isotonicity agent previously utilized in said formulation with propylene glycol[.]"[12]

         The claimed process requires that "during production of a ... formulation[, ]"[13]there is an "isotonicity agent [that was] previously utilized in said formulation[, ]"[14] that is replaced "with propylene glycol[.]"[15] The specification does not discuss (or claim) a process for removing the previously used isotonicity agent from the formulation and then replacing the isotonicity agent with propylene glycol.[16] In fact, the parties agree that the formulation containing propylene glycol is separate and distinct from the formulation in which another isotonicity agent was "previously utilized[.]"[17] Therefore, in order for the method to comprise "replacing the isotonicity agent previously utilized in said formulation with propylene glycol[, ]"[18] there must be a separate prior formulation containing this other isotonicity agent.[19]

         B. '893 Patent

         3. "Driving part:"[20]"a part that transfers force from the push button."[21] Claim 1 recites:

1. A push button connection for an injection device comprising:
a push button mountable on a driving part being rotatable relatively to the push button and which push button further comprises a bore with a bottom surface and which bore surrounds a protrusion on the driving part which protrusion has a top surface and wherein a pivot bearing is formed between the bottom surface and the top surface, wherein when a user presses on the push button the force is directed toward the driving part and wherein the driving part rotates relative to the push button.[22]

         In the context of this "push button connection[, ]"[23] when "the user pushes the push button 10[, ]"[24] this action "moves the driving part 20 axially forward in the injection device."[25] "During this forward movement of the driving part 20 it also rotates."[26] Thus, the "driving part" transfers force from the push button.

         4. Meanwhile, defendant's proposal of "component with a protrusion that inserts into the push button that is used to transfer axial force from the push button to the injector[, ]"[27] is not supported by the specification. First, the court agrees with plaintiff that defendant's proposed "component with a protrusion" is redundant with limitations present in the claim.[28] Second, as to defendant's proposed "transfer axial force" limitation, defendant argues that, in view of Figure 2, "the only force that the driving part transfers from the push button is an axial force."[29] The specification says otherwise:

When the user applies an injection force A at the peripheral area of the push button 10, a vertical reaction force B will appear at the pivot point 22, 18, at the same time a radial force C will occur at the upper radial bearing 13, 23. Since the upper radial bearing 13, 23 are located at the top part 23 having the smaller diameter, the resulting torque is relatively small. Further, a radial force D will occur at the lower radial bearing 14, 25, however due to the distance between the upper radial bearing 13, 23 and the lower radial bearing 14, 25, the force resulting on the lower radial bearing 14, 25 is relatively small.[30]

         Although these forces are relatively small, the "force pair" of "C" and "D" in Figure 2 is something the inventors sought to minimize.[31] Nonetheless, the specification recognizes that "the offset applied push button forces[]" result in a "bending force" applied to the protrusion of the driving part.[32] Therefore, to limit the driving part to solely transmitting axial forces would read the Figure 2 embodiment, which is discussed extensively in the specification, from the claim.

         5. "Pivot bearing:"[33] "a bearing that supports an end of a rotating shaft subject to an axial load."[34] The specification does not define the structure of "pivot bearing" and instead provides functional descriptions of the structure. For example, the specification explains:

When a user pushes on the injection button, the force applied is directed to the forward movement of the driving part, however, since the push button and the driving part rotate relatively to each other a friction between these rotating parts will occur. The user therefore also has to apply a force large enough to overcome this friction. One way of minimizing the force a user must apply in order to perform an injection is therefore to minimize this friction. By forming a pivot bearing between the two parts, the surface area of interaction between the two objects can be minimized and the radius of the resulting friction force can be kept at a minimum.[35]

         In this description, the "pivot bearing" somehow minimizes "the surface area of interaction" and, therefore, keeps "the resulting friction force ... at a minimum."[36]Confusingly, the specification describes an embodiment in which a "pivot bearing" is formed with a "pivot" element in the bearing, [37] which seems to suggest a meaning of "pivot bearing" that deviates from the plain meaning.[38] However, other than this preferred embodiment nothing else in the intrinsic record[39] suggests that the applicant intended a different definition.[40] The definitions proposed by the parties share two common elements: (1) a definition of the bearing, including its shape, and (2) a reference to friction reduction.[41] The court addresses these two components of the definition in sequence.

         6. First, the bearing surface can take any number of shapes. The specification does not describe these shapes, and claim 1 does not limit the pivot bearing to a specific shape.[42] The court, therefore, turns to extrinsic evidence.[43]A textbook on the subject of statics explains that "[p]ivot and collar bearings are commonly used in machines to support an (IMAGE OMITTED) axial load on a rotating shaft[, ]"[44] which is depicted in an accompanying figure.[45] In comparison to collar bearings, which support an axial load in the middle of a rotating shaft, it is plain that pivot bearings support an end of the rotating shaft.[46] The textbooks and journal articles provided by the parties refer to the rotating shaft as the "pivot" and the surface supporting the shaft as the bearing.[47] In claim 1, the pivot bearing is formed from the "top surface" of the "protrusion on the driving part" and the "bottom surface" of the "bore" in the "push button."[48] Therefore, the court concludes that the pivot bearing in the "push button connection" consists of a pivot, which is the "protrusion on the driving part" (which rotates) and a receiving bearing, which is the "bore" in the "push button" (which does not rotate).[49] Thus, the extrinsic evidence suggests a definition of pivot bearing as a bearing[50] that supports an end of a rotating shaft subject to an axial load.

         7. Second, with respect to reducing friction, the specification explains that the reason for using a pivot bearing between the "push button" and the "driving part" is to minimize the friction between these two parts so that, in the injection device, "the force a user must apply [to the push button] in order to perform an injection" is as small as possible.[51] Both parties seek to translate the stated design objective of minimizing friction into a definitional requirement that the pivot bearing "reduce[s]" friction.[52] The court notes that bearings reduce friction between moving parts, and an inclusion of friction reduction in the definition of "bearing" is redundant. Moreover, it is unclear what the reference point is for friction reduction as proposed by the parties. For example, the specification is clear that, in comparison with designs in the prior art, [53] the pivot bearing itself is the design choice that minimizes the friction between these two parts, because. "the radius of the resulting friction force can be kept at a minimum."[54] According to the extrinsic evidence, "in the case of a pivot bearing" with a flat end, the moment (turning force) required to overcome the static friction in the bearing is directly proportional to the axial force and the radius[55] of the bearing.[56] Therefore, minimizing the radius (and hence the diameter) of the "protrusion" of the "driving part" minimizes "the radius of the resulting friction force," which, in turn, minimizes friction between the "push button" and the "driving part." Claim 1 recites a limitation that includes a pivot bearing, and the specification explains that, in this "injection device" application, a pivot bearing is superior to other design choices, because in comparison to those other designs it reduces the amount of force required to inject the medication. However, were the court to employ the term "bearing" in the definition of "pivot bearing," nothing in the intrinsic record[57] suggests that the proposed reductions in friction would further distinguish a "pivot bearing" from any other bearing. Therefore, the court defines pivot bearing as a bearing that supports an end of a rotating shaft subject to an axial load.

         8. "Radial bearing:"[58] "a bearing that supports a load on a shaft that is perpendicular to the axis of rotation."[59] Claim 2 recites "[a] push button connection according to claim 1, in which at least one radial bearing between the push button and the driving part is provided.[60] The specification discusses, but does not define, the radial bearing term.[61] For example, the specification states: "[i]n order to secure the fit between the push button and the driving part and on the same time direct forces applied on the periphery of the push button to the driving part at least one radial bearing between the push button and the protrusion is formed."[62] As with the "pivot bearing" term, the court declines to engage in defining "radial bearing" according to "reducing" friction objectives associated with bearings and instead uses the term "bearing" in its construction.[63]

         9. According to the extrinsic evidence, "[a] bearing can [] be classified as a radial bearing or a thrust bearing, depending on whether the bearing load is in the radial or axial direction, respectively, of the shaft."[64] "The load on the shaft can be divided into radial and axial components. . . . [and] the radial load component is in the direction normal [or perpendicular] to the shaft axis."[65] "Certain bearings . . . can support radial as well as thrust forces. [But c]ertain other bearings . . . are applied only for radial loads."[66] Therefore, the court defines radial bearing according to the plain meaning as a bearing that supports a load on a shaft that is perpendicular to the axis of rotation.

         C. '956 Patent

         10. Claims 1 and 2 of the '956 patent recite:

1. A limiting mechanism that prevents setting of a dose that exceeds the injectable amount of liquid left in a cartridge of an injection device wherein a dose is set by rotating a dose setting member relative to a driver and away from a fixed stop in the injection device, and the dose is injected by pressing an injection button which rotates back the dose setting member which during this rotation carries the driver with it to rotate this driver which moves the piston rod forward, wherein the driver is provided with a track having a length which is related to the total injectable amount of medicament in the cartridge and which track is engaged by a track follower coupled to the dose setting member to follow rotation of this dose setting member and wherein the driver is disk shaped and the track has a spiral shape which is engaged by the track follower which is flexibly coupled to the dose setting member so that the track follower can be moved radially when it follows the track of the driver element.
2. A limiting mechanism that prevents setting of a dose that exceeds the amount of liquid left in a cartridge of an injection device wherein a dose is set by rotating a dose setting member relative to a driver and away from a fixed stop in the injection device, and the dose is injected by rotating back the dose setting member which during this rotation carries the driver with it to rotate this driver which moves the piston rod forward, wherein the driver is provided with a track having a length which is related to the total amount of medicament in the cartridge and which track is engaged by a track follower coupled to the dose setting member to follow rotation of this dose setting member and wherein the driver is cylindrical and the track has a helical shape which is engaged by the track follower which is coupled to the dose setting member so that the track follower can be moved rotationally when it follows the track of the driver element.[67]

         11. "Driver:"[68] "a part that transfers force from the injection button."[69] The specification explains that:

An object of the invention is to provide a limiting mechanism which prevents setting of a dose that exceeds the amount of liquid left in a cartridge of an injection device of the geared type wherein a dose is set by rotating a dose setting member relative to a driver and away from a fixed stop in the injection device, and the dose is injected by rotating back the dose setting member which during this rotation carries the driver element with it to rotate this driver element which moves the piston rod forward.[70]

         Therefore, the driver moves the piston rod forward to inject the medication. In the two embodiments disclosed, this process is initiated "when the injection button is pressed[.]"[71]

         12. "Track:"[72] "a path along which a part moves."[73] Claim 1 describes that "the driver is provided with a track . . . which track is engaged by a track follower. . . [which] can be moved radially when it follows the track of the driver element."[74] In claim 2, "the driver is provided with a track . . . which track is engaged by a track follower. . . [which] can be moved rotationally when it follows the track of the driver element"[75] Claim 5 recites an "assembly [that] comprises: (a) a helical track . . . and (b) a follower that engages the helical track; wherein the follower moves along the helical track[.]"[76]

         13. "Track follower:"[77] "a part that moves along a path."[78] As discussed above in relation to the "track" term, it is apparent in claims 1, 2, and 5, that the "track follower" moves along the track, which the court has defined as "a path along which a part moves."[79]

         14. "Track having a length:"[80] "the length of the track that the track follower can move along."[81] Claim 1 states that "the driver is provided with a track having a length which is related to the total injectable amount of medicament in the cartridge[.]"[82]The motion of the track follower along the track is critical to setting the dosage, and if there is insufficient medication in the cartridge, the dosage cannot be set.[83] Moreover, during prosecution, the applicant argued that "[a]s the follower moves along the track . . . only during dose setting, it acts as a summation machine for the set and injected doses. Thus, the length which the follower can move along the track (or the track along the follower) defines the volume of the drug that remains in the pen syringe that is available to be injected."[84]

         ORDER: THE COURT'S CLAIM CONSTRUCTION

         At Wilmington this 25th day of June, 2018, having heard oral argument, having reviewed the papers submitted with the parties' proposed claim constructions, and having considered all of the parties' arguments (whether or not explicitly discussed herein);

         IT IS ORDERED that the disputed claim language of U.S. Patent Nos. 8, 114, 833 ("the '833 patent"); 9, 265, 893 ("the '893 patent"); and RE4I, 956 ("the '956 patent") shall be construed consistent with the tenets of claim construction set forth by the United States Court of Appeals for ...


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