By Memorandum Opinion entered by The Honorable Gregory M. Sleet in the consolidated patent infringement action, Aventis Pharma S.A., et al. v. Hospira, Inc., C.A. No 07-721-GMS and Aventis Pharma S.A., et al. v. Apotex, Inc., C.A. No. 08-496-GMS (D.Del., September 27, 2010), the Court concluded, among other things, that (1) claims 2 and 10 of the ‘561 patent are invalid due to indefiniteness; (2) all asserted claims of the patents-in-suit are invalid due to obviousness; and (3) the asserted claims are unenforceable due to inequitable conduct. Id. at 2. The Court made its ruling following a seven day bench trial and post-trial submissions by the parties.
A complete copy of the Memorandum Opinion is attached.
A patent claim satisfies the definiteness requirement of 35 U.S.C. § 112 if a person of ordinary skill in the art would understand the bounds of the claim when read in light of the specification. See 35 U.S.C. § 112 (2000). Paragraph 2 of 35 U.S.C. § 112 requires that the specification conclude with one or more claims “particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.” Id. Significantly, “[a] claim is considered indefinite if it does not reasonably apprise those skilled in the art of its scope.” Id. at 20 (quoting Microprocessor Enhancement Corp. v. Texas Instruments Inc., 520 F.3d 1367, 1374 (Fed. Cir. 2008)).
With respect to its conclusion that claims 2 and 10 of the ‘561 patent are invalid due to indefiniteness, the Court agreed with defendants, Hospira and Apotex, that claims 2 and 10 of the ‘561 patent are indefinite because they impermissibly mix two categories of patentable subject matter. Id. at 20. Specifically, defendants asserted that claims 2 and 10 of the ‘561 patent, both of which are composition claims, “impermissibly include a process limitation: ‘whereby said composition is used to form’ (claim 2), and ‘whereby said therapeutic composition forms or is used to form’ (claim 10). Id. at 20.
After analyzing the claims at issue and the Federal Circuit’s holdings in IPXL Holdings, L.L.C. v. Amazon.com, Inc., 430 F.3d 1377, 1383-84 (Fed. Cir. 2005) (when a claim impermissibly mixes two or more classes of patentable subject matter, the claim is indefinite) and Microprocessor Enhancement Corp., 520 F.3d at 1375 (clarifying scope of IPXL Holdings opinion), the Court found that claims 2 and 10 of the ‘561 patent “fall squarely within the category of indefinite claims discussed in IPXL Holdings, even as that holding was limited by Microprocessor Enhancement Corp.” Id. at 23. The Court followed the Federal Circuit’s reasoning in IPXL Holdings that noted, “when two separate statutory classes of invention are impermissibly mixed, a manufacturer or seller of the claim apparatus would not know from the claim whether it might also be liable for contributory infringement because a buyer or user of the apparatus later performs the claimed method of using the apparatus.” Id. at 23 (citing IPXL Holdings, 430 F.3d at 1384. The Court concluded that same reasoning applied to claims 2 and 10 of the ‘561 patent, because they are mixed subject matter claims and it is not clear from those claims when they would be infringed. Id. at 22.