PTAB

IPR2019-01022

Pfizer Inc v. Sanofi Aventis Deutschland

Key Events

Petition

petition

Title: Pen-Type Injector
Brief Description: The ’844 patent describes a pen-type drug delivery device for self-administration of medicine, such as insulin. The technology involves a mechanical assembly of threaded components, including a housing, dose indicator, driving member, sleeve, and piston rod, which interact to allow a user to set and dispense a precise dose.

Prior Art Relied Upon: Giambattista (Patent 6,932,794).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that Giambattista discloses every element of independent claim 21 and dependent claims 22-29. Giambattista’s medication delivery pen allegedly includes all six key components: a housing (body 18 and cartridge holder 14), a dose indicator (dose knob 20), a driving member (driver 24), a sleeve (dosing ring adaptor 28 and dosing ring 22), a piston rod (leadscrew 26), and a piston rod holder (bulkhead 44 with aperture 46). Petitioner asserted these components are arranged and function as claimed, including the relative rotational and axial movements during dose setting and dispensing. For dependent claims, Giambattista's dosing ring assembly (22, 28) was argued to meet the "clutch" limitation, and its ratchet arms (96) interacting with longitudinal ribs (80) meet the "clicker" limitation for providing audible and tactile feedback.

Prior Art Relied Upon: Giambattista (Patent 6,932,794) and Steenfeldt-Jensen (Patent 6,235,004).
Core Argument for this Ground:
- Prior Art Mapping: This ground was presented as an alternative to anticipation. To the extent Giambattista's clicking mechanism was found not to explicitly teach that each click corresponds to a specific "unit dose" of medicament as required by claims 24, 25, and 29, Petitioner argued that Steenfeldt-Jensen supplied this teaching. Steenfeldt-Jensen describes a similar injector pen with a clicking mechanism where depressions are "appropriately made so that a dose of one unit is set" for each click.
- Motivation to Combine: A POSITA would combine Steenfeldt-Jensen's unit-dose feedback mechanism with Giambattista's device to improve its precision, safety, and user-friendliness. Providing clear, incremental dose feedback was a well-known and desirable feature in such devices.
- Expectation of Success: A POSITA would have a high expectation of success because implementing this feature was a matter of routine calibration. It involved calculating the axial translation of Giambattista's leadscrew for each click and adjusting the spacing of the ratchet mechanism's ribs to correspond to a desired unit dose volume.

Prior Art Relied Upon: Giambattista (Patent 6,932,794) and Klitgaard (Patent 6,582,404).
Core Argument for this Ground:
- Prior Art Mapping: Claim 30 adds the limitation of a "nut that tracks each set dose of medicament delivered." Petitioner asserted that while Giambattista anticipates the base device of claim 21, Klitgaard explicitly teaches a dose-tracking nut for this exact purpose. Klitgaard discloses a "nut member 32" that tracks the total sum of set and injected doses to prevent a user from setting a dose that exceeds the medication remaining in the cartridge.
- Motivation to Combine: A POSITA would be motivated to incorporate Klitgaard’s dose-tracking nut into Giambattista’s pen to add a significant safety feature. Klitgaard expressly states this mechanism makes it "impossible to set a dose that exceeds the amount of medicament which is left in the cartridge," a clear benefit that would have been desirable to implement in any similar injection pen.
- Expectation of Success: Success was reasonably expected because the components in Giambattista (concentric dose knob, sleeve, and driver) provide the necessary concentric arrangement and relative movement that Klitgaard identifies as the foundation for applying its tracking nut.

"the piston rod and the driving member are configured to rotate relative to one another during dose dispensing": Petitioner adopted the Patent Owner's proposed construction from related litigation, which describes this limitation as meaning the piston rod rotates while the driving member does not, the driving member rotates while the piston rod does not, or both rotate at different rates or in different directions. This limitation was added during prosecution to secure allowance.
Means-Plus-Function Terms: Petitioner argued that should the terms "clutch," "clicker," and "holder" be construed as means-plus-function limitations, the prior art still discloses the claimed functions and corresponding structures.
- "clutch": The function is coupling/decoupling components during dose setting. Petitioner identified Giambattista's dosing ring (22) and adaptor (28) as the corresponding structure.
- "clicker": The function is providing audible clicks during dose setting/cancelling. Petitioner pointed to Giambattista's ratchet arms (96) and longitudinal ribs (80) as the corresponding structure.
- "holder": The function is preventing piston rod rotation during dose setting while permitting axial traversal during dispensing. Petitioner identified Giambattista's bulkhead (44) and its shaped aperture (46) as the corresponding structure.

Lack of Written Description Support for Priority Claim: Petitioner contended that claims 21-30 are not entitled to a priority date earlier than May 17, 2016. The claims recite a "piston rod comprising either an internal or an external fourth thread." Petitioner argued that the priority applications only disclose a piston rod with external threads engaging a driving member with internal threads. The introduction of the internally-threaded piston rod option was alleged to be new matter, breaking the priority chain and making Giambattista (2005) available as prior art under pre-AIA §102.

Petitioner requested institution of an inter partes review and cancellation of claims 21-30 of Patent 9,526,844 as unpatentable.