PTAB

IPR2018-01680

Mylan Pharmaceuticals Inc v. Sanofi Aventis Deutschland GmbH

Key Events

Petition

petition

Title: Pen-Type Injector
Brief Description: The ’844 patent relates to a drug delivery device, specifically a pen-type injector for the self-administration of medicine such as insulin. The invention focuses on the internal mechanical components that 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, a prior art patent for a medication delivery pen, disclosed every element of independent claim 21 and dependent claims 22-29. Giambattista’s device was shown to include the six core components recited in claim 21: a housing (body 18), a dose indicator (dose knob 20), a piston rod (leadscrew 26), a driving member (driver 24), a sleeve (dosing ring 22/adaptor 28), and a piston rod holder (bulkhead 44 with aperture 46). Petitioner further asserted that Giambattista’s disclosure of a clutch mechanism (dosing ring 22) and an audible clicker (ratchet arms 96 and ribs 80) anticipated the limitations of the dependent claims.
- Key Aspects: This ground asserted that Giambattista’s components performed the same functions and had the same structural relationships as those claimed in the ’844 patent, constituting a complete anticipation of nine of the ten challenged claims.

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 asserted that to the extent Giambattista’s clicker mechanism was found not to explicitly teach that each audible click corresponds to a specific unit dose of medicament, Steenfeldt-Jensen supplied this teaching. Steenfeldt-Jensen disclosed a similar injection syringe with a clicker mechanism (radial protrusion 87 and recesses 81) where the spacing of the recesses was explicitly designed so that "one click corresponds to a chosen change of the set dose, e.g. one unit or a half unit." Petitioner argued this rendered the limitations of claims 24, 25, and 29 obvious.
- Motivation to Combine: A POSITA would combine Giambattista with Steenfeldt-Jensen’s teachings to improve the functionality and user-friendliness of the injection pen. Providing clear, unit-based audible and tactile feedback was a well-known design goal for such devices to ensure accurate dosing by patients.
- Expectation of Success: A POSITA would have had a high expectation of success, as implementing a clicker with evenly spaced detents to correspond to unit doses was a simple mechanical modification involving known principles.

Prior Art Relied Upon: Giambattista (Patent 6,932,794) and Klitgaard (Patent 6,582,404).
Core Argument for this Ground:
- Prior Art Mapping: Building on the argument that Giambattista taught all limitations of claim 21, this ground addressed the additional limitation in claim 30: "a nut that tracks each set dose of medicament delivered." Klitgaard was cited for its express disclosure of a dose-limiting mechanism featuring a nut member (32) that tracks the total sum of injected doses. Klitgaard's nut prevents a user from setting a dose that exceeds the remaining medication 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 critical safety and convenience feature. Klitgaard explicitly stated that such a limiting device is "convenient" and prevents setting an impossible dose, directly addressing a known problem in the field.
- Expectation of Success: A POSITA would have had a reasonable expectation of success in incorporating the nut, as the components in both references shared a similar concentric-sleeve arrangement, making the integration of Klitgaard's tracking nut into Giambattista's device straightforward.

"the piston rod and the driving member are configured to rotate relative to one another during dose dispensing": Petitioner noted that the Patent Owner, in related litigation, construed this with its plain and ordinary meaning, described as "the piston rod rotates while the driving member does not rotate, the driving member rotates while the piston rod does not rotate, or both rotate at different rates and/or directions." This construction was central to the prosecution history and the obviousness arguments.
"clutch," "clicker," and "holder": Petitioner argued that if the Board were to construe these terms as means-plus-function limitations, the structures disclosed in the specification (e.g., component 60 for "clutch," component 50 for "clicker," component 16 for "holder") correspond to structures that were well-known in the prior art, such as in Giambattista.

Lack of Written Description Support for Priority Date: Petitioner dedicated a significant portion of its argument to assert that claims 21-30 are not entitled to a priority date earlier than their filing date of May 17, 2016. The argument centered on the limitation of a "piston rod comprising either an internal or an external fourth thread." Petitioner contended that all priority documents uniformly and repeatedly described only a piston rod with external threads engaging internal threads of other components. The introduction of claim language covering an internally threaded piston rod was alleged to be new matter lacking written description support in the priority applications, thereby making post-2003 prior art like Giambattista applicable.

Petitioner requests institution of an inter partes review and cancellation of claims 21-30 of the ’844 patent as unpatentable.