Case: 1:16-cv-00651 Document #: 114-1 Filed: 06/25/18 Page 1 of 2 PageID #:3342
`Case: 1:16—cv—00651 Document #: 114-1 Filed: 06/25/18 Page 1 of 2 PageID #:3342
`
`SECTION I
`
`SECTION I
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`

`

`Case: 1:16-cv-00651 Document #: 114-1 Filed: 06/25/18 Page 2 of 2 PageID #:3343
`
`Joint Statement of the Issues
`
`Hospira asserts claim 6 of U.S. Patent No. 8,648,106 and claim 8 of U.S. Patent No.
`9,616,049 (“Asserted Claims”). Fresenius Kabi (FK) counterclaims as to several other related
`claims in these and related patents for regulatory purposes, as the FDA will request judgments in
`order to clear patent issues where (as here) there are other generic filers. Hospira objects at least
`on the ground of mootness to any further litigation on non-asserted patents and claims.
`
`The claims relate to ready-to-use (“RTU”) compositions of the sedative dexmedetomidine
`in a sealed glass container. The RTU compositions are for administration to a patient without
`dilution or reconstitution. (D.I. 69.) FK stipulated to infringement of the Asserted Claims. (D.I.
`93.) The remaining issue for trial is whether FK can prove by clear and convincing evidence that
`the Asserted Claims are invalid. FK alleges the following invalidity bases:1
`
`• 35 U.S.C. § 102, Anticipation / On-Sale / Offer for Sale: FK alleges that the Investigational
`New Drug Application (IND) prepared by Orion is prior art because it was subject to two
`different commercial sales and offers for sale, and the disclosed product was ready for
`patenting before the priority date. Hospira alleges neither transaction constituted an
`invalidating sale of a claimed RTU dexmedetomidine product. Any alleged sale was not for
`commercial purposes and did not involve a formulation that was ready-for-patenting.
`
`• 35 U.S.C. § 103, Obviousness: FK asserts that the Asserted Claims would have been obvious
`to a skilled artisan under 35 U.S.C. § 103 by January 2012. Hospira asserts that the subject
`matter was not obvious at least because there was no reasonable expectation of success in
`developing the claimed RTU dexmedetomidine formulations. In addition, the success of
`Hospira’s commercial RTU product (Precedex Premix) further indicates non-obviousness. FK
`alleges that any such success lacks nexus to the claimed features.
`
`• 35 U.S.C. § 103, Obviousness Inherency: With respect to the ‘106 patent, FK alleges that
`the claimed stability is an inherent property of the claimed formulation. Hospira alleges that
`the stability is not inherent in the formulations.
`
`• 35 U.S.C. § 112: FK contends that, if the stability limitation of the ‘106 patent is not inherent,
`then the asserted claims are not enabled and indefinite because the patent does not teach how
`to obtain the claimed stability. Hospira responds that the patent adequately describes the
`claimed stability and how to attain it.
`
`• 35 U.S.C. § 102(f)/Inventorship: FK alleges that the named inventors did not invent the
`subject matter of the patents-in-suit. Another company (Orion) and others within Hospira
`conceived of an RTU dexmedetomdine composition in a sealed glass container. Hospira
`responds that the inventors are properly named because they actually developed the claimed
`RTU composition.
`
`
`1 The brief description provides a general overview of the main issues, and is not a waiver of any
`arguments not specifically mentioned herein.
`
`