In Brief: Novo Nordisk v. Sanofi-Aventis

Posted on | June 2, 2008 | 4 Comments

2008-1225 Novo Nordisk v. Sanofi-Aventis
D/NJ 07-CV-3206
Judge Mary L. Cooper

Briefing is done in Novo’s appeal of the district court’s denial of its motion for a preliminary injunction.  Oral argument is scheduled for Thursday, 10 July 2008, courtroom 201.

Novo accused Sanofi’s SoloStar® disposable insulin delivery "pen" of
infringing 7,241,278, which is generally directed to an medication
injection device that requires less force to inject the medication and
prevents the user from dialing up a dose that exceeds the amount left
in the cartridge.  Claim 1 states:

1. A drug delivery device comprising:

a piston rod having at least one threaded portion (4);

a
dose dial sleeve (17) threadedly engaged with a portion of the device
and having a scale indicative of dose sizes and wherein the dose dial
sleeve is rotatable during a dose setting operation so that it can be
rotated to a position where a predetermined dose is indicated on the
scale;

a drive sleeve (20) for driving the piston rod; and

a
clutch (21), which is comprised of one or more components (33, 32),
that releasably couples the dose dial sleeve (17) and the drive sleeve
(20); and wherein:

(i) during the
dose setting operation the dose dial sleeve (17) and the drive sleeve
(20) are coupled by the clutch so that they rotate together; and

(ii)
during injecting of medication from the device, the dose dial sleeve
(17) is decoupled from the drive sleeve (20) and so that it rotates
back to an original pre-dose setting position upon completion of the
injection but the drive sleeve (20) does not rotate during injecting of
medication but instead moves in a longitudinal direction toward an
injecting end of the device.

Judge Cooper found that there was a "substantial question of
non-infringement" based on Sanofi’s argument that the claims required a “gearbox” and a “non-rotating piston rod” because that was the
"invention."  This was the only preliminary injunction factor addressed by the court and its sole stated basis for denying the injunciton.

Summary of Argument from plaintiff/appellant Novo Nordisk.  Sullivan & Cromwell, New York, NY (David B. Tulchin, Marc De Leeuw, James T. Williams) on brief.  Novo’s primary appeals brief is here, its reply brief here. 

It is black-letter law that a proper claim construction must focus on the language of the claims themselves. Thus, there is a “heavy presumption” that the ordinary meaning of the claim terms will control, which can only be overcome if the patentee demonstrated “an express intent to impart a novel meaning to claim terms” by acting as his own “lexicographer” or characterizing the invention in the patent or prosecution history with words that represent a “clear disavowal of claim scope.”  Nothing of that sort took place here.

The terms of the asserted claims are clear and unambiguous, and do not even refer to a “gearbox” or a “non-rotating piston rod.” The claim language itself, and use of the term “gear box” in unasserted Claims 2 and 4, make clear that those limitations are inappropriate. The trial court ignored the claim language entirely, and failed even to identify a single claim term that is susceptible of clarification by the limitations it imported.

The district court committed “one of the cardinal sins of patent law” by “reading a limitation from the written description into the claims.” The references to a “gearbox” and “non-rotating piston rod” in the specification pertain to the preferred embodiments, not the invention as a whole. Certainly nothing in the specification overcomes the “heavy presumption” that the ordinary meaning controls or demonstrates “an express intent to impart a novel meaning to claim terms” or represents a “clear disavowal of claim scope.”

The prosecution history also strongly supports an ordinary meaning construction. Sanofi stated that in 2007 Novo “abandon[ed]” claims with a “gearbox” requirement in prosecuting the patent, and the PTO’s Notice of Allowance makes no reference at all to “gearbox” or “nonrotating piston rod” limitations. Instead, the Examiner recognized that the clutch was an invention in its own right.

The doctrine of claim differentiation also contradicts the trial court’s view. Under the district court’s construction, Claim 2 and Claim 1 would in substance be identical.

The facts here even more strongly support an ordinary meaning construction than those in Saunders Group, Inc. v. Comfortrac, Inc., 492 F.3d 1326 (Fed. Cir. 2007). As in that case, Novo here amended its claims to remove the limitations at issue from some but not all of the claims. And the supposedly “restrictive language” in the specification does not come close to imposing any limitation on the clear words of the claims.

Summary of Argument from defendant/appellee Sanofi-Aventis.  McDonnell Boehnen Hulbert & Berghoff LLP, Chicago, IL (Paul H. Berghoff, David M. Frischkorn, Curt J. Whitenack, Eric R. Moran) on brief.  Sanofi’s appellate brief is here.

Novo’s intrinsic evidence mandates that its claims, and specifically the terms "dose setting" and "injecting," be construed to require a gearbox. Indeed, Novo’s specification proclaims a sole objective requiring a gearbox, expressly defines the invention as requiring a gearbox, and repeatedly emphasizes that the invention requires a gearbox. Novo’s prosecution history also confirms the gearbox requirement. Further, at the same time Novo’s specification characterizes the invention as requiring a gearbox, it disclaims threading. For similar reasons, Novo’s intrinsic evidence also mandates that these claim terms be interpreted as requiring a non-rotatable piston rod.

Novo now seeks a claim construction that does not include a gearbox or a non-rotatable piston rod and would thus allow the claims to read on disclaimed threaded devices such as the SoloStar device. In support, Novo asserts that the invention is actually a clutch and that the gearbox is merely a feature of preferred embodiments. Novo’s specification is dominated by the gearbox, however, and never refers to a clutch as the invention. Further, unlike a gearbox, a clutch does not establish a gearing between the drive sleeve and the piston rod that provides a mechanical advantage, as required by Novo’s patent. Accordingly, Novo’s proposed construction contravenes this Court’s mandate that claims be read in light of the intrinsic evidence.

A. SciMed, Alloc, and Honeywell Control

This case is strikingly similar to SciMed, Alloc, and Honeywell. In those cases, this Court used aspects of the intrinsic evidence such as characterizations of the invention and criticisms of the prior art to establish that the "very nature of the invention" led to the inescapable conclusion that claims must include a required limitation. Here, as in those cases, there are a number of clear indications that the invention requires a gearbox and a nonrotatable piston rod, including Novo’s disclaimer of any claim scope encompassing threaded injection devices such as the SoloStar device.

B. Novo’s Intrinsic Evidence Mandates That Novo’s Claims Be
Construed To Require a Gearbox

Consistent with Novo’s intrinsic evidence, the claim terms "dose setting" and "injecting," as well as corresponding terms in other claims, must each be construed to require a gearbox.

Novo’s patent repeatedly characterizes the invention as an injection device requiring a gearbox. For example, Novo’s specification states that the sole "objective of the invention" is "to provide an injection device" in which a "direct gearing" is established. Novo’s specification describes only one device capable of meeting this objective—an injection device requiring a gearbox.

Novo’s patent also clearly defines the invention by stating: an "injection device is according to the invention characterised in that a gearbox is provided." Additionally, Novo’s entire specification, including five figures each depicting a gearbox, repeatedly emphasizes that the invention requires a gearbox. Novo’s prosecution history further confirms that the invention requires a gearbox.

Critically, Novo was fully aware of threading when characterizing the invention as requiring a gearbox. In fact, Novo’s patent explicitly disclaims such threading by criticizing it as disadvantageous and then emphasizing that the invention overcomes these disadvantages.

Novo now contends that the invention is really a clutch mechanism that reduces injection force. Novo’s specification, however, never suggests that the invention is a clutch, which is a completely different component that performs a completely different function than a gearbox. Instead, from beginning to end, Novo’s specification focuses overwhelmingly on the gearbox.

Novo also contends that its characterizations and disclaimers in the intrinsic evidence are mere descriptions of a preferred embodiment. Novo’s intrinsic evidence, however, never contemplates that the invention is anything other than an injection device with a gearbox.

Novo’s other attempts to dispute the proper claim construction are unpersuasive. First, to the extent they are required, Novo’s claims clearly have textual "hooks," including the terms "dose setting" and "injecting."

Second, claim differentiation is not applicable. Here, the claims to which Novo points have a different scope, so the presumption of claim differentiation does not attach. Even if it did, however, Novo’s intrinsic evidence requiring a gearbox more than rebuts any such presumption. Moreover, if given credence, Novo’s claim differentiation arguments would allow Novo to evade the clear disclaimers in its specification merely by adding dependent claims during prosecution.

Third, the Saunders case on which Novo relies so heavily is inapplicable due to a number of key differences from the present case.

C. Novo’s Intrinsic Evidence Mandates That Novo’s Claims Be
Construed To Require a Non-Rotatable Piston Rod

Along with the gearbox requirement, Novo’s specification also characterizes the invention as requiring a non-rotatable piston rod. As with a gearbox, every injection device disclosed in Novo’s detailed description includes a non-rotatable piston rod. The requirement that the piston rod not rotate flows from the required gearbox, is consistent with the sole objective of the invention, and mandates that all claims require a non-rotatable piston rod.

Based on the foregoing, the district court properly construed Novo’s claims in accordance with Novo’s specification. That construction, and the subsequent denial of Novo’s preliminary injunction motion, should be affirmed.

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