Case 1:14-cv-00113-RGA-MPT Document 278-4 Filed 09/25/15 Page 1 of 17 PageID #: 9438
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 14-113-RGA-MPT
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`SANOFI-AVENTIS U.S. LLC, SANOFI-
`AVENTIS DEUTSCHLAND GMBH,
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`Plaintiffs,
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`v.
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`ELI LILLY AND COMPANY,
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`Defendant.
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`PRETRIAL ORDER EXHIBIT 4:
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`SANOFI’S STATEMENT OF ISSUES OF LAW
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`Case 1:14-cv-00113-RGA-MPT Document 278-4 Filed 09/25/15 Page 2 of 17 PageID #: 9439
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`TABLE OF CONTENTS
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`Page
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`I.
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`Infringement .............................................................................................................................. 1
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`A. Literal Infringement ............................................................................................................ 2
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`B. Infringement under the Doctrine of Equivalents ................................................................ 3
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`II. Validity ..................................................................................................................................... 4
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`A. Obviousness ........................................................................................................................ 5
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`a. Objective Indicia of Non-Obviousness ......................................................................... 8
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`B. Written Description ........................................................................................................... 10
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`C. Prosecution Laches ........................................................................................................... 13
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`Case 1:14-cv-00113-RGA-MPT Document 278-4 Filed 09/25/15 Page 3 of 17 PageID #: 9440
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`Pursuant to L.R. 16.3(c)(5), Plaintiffs provide the following statement of issues of law
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`that remain to be litigated.
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`I.
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`INFRINGEMENT
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`1.
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`Under the Hatch-Waxman Act, it is a statutory act of patent infringement to file a
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`New Drug Application (“NDA”) under Section 505(b)(2) of the Federal Food, Drug, and
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`Cosmetic Act, 21 U.S.C. § 355(b)(2), for the purpose of obtaining approval to engage in the
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`commercial manufacture, use, or sale of a patented drug or method of use. 35 U.S.C.
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`§ 271(e)(2)(A). “When a patentee seeks to block FDA approval of an NDA under 35 U.S.C. §
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`271(e)(2)(A), the infringement inquiry focuses on the hypothetical infringement that would occur
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`if the defendant’s NDA were approved and the defendant began to make and sell the drug.”
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`Novartis Corp. v. Ben Venue Labs., Inc., 271 F.3d 1043, 1047 (Fed. Cir. 2001) (citing Glaxo,
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`Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1569 (Fed.Cir.1997)); accord Novartis Pharms. Corp. v.
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`Par Pharm., Inc., 48 F. Supp. 3d 733, at 738 (D. Del. 2014) (Andrews, J.,) (“Under 35 U.S.C. §
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`271(e)(2)(A), a court must determine whether, if the drug were approved based upon the ANDA,
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`the manufacture, use, or sale of that drug would infringe the patent in the conventional sense.”
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`(internal annotations omitted)). The patentee “has the burden of proving infringement by a
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`preponderance of the evidence.” Novartis Pharms., 48 F. Supp. 3d at 738. The infringement
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`inquiry is “based on consideration of all the relevant evidence, including the [NDA] filing, other
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`materials submitted by the accused infringer to the FDA, and other evidence provided by the
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`parties.” Abbott Labs. v. TorPharm, Inc., 300 F.3d 1367, 1373 (Fed. Cir. 2002).
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`2.
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`The first step in determining infringement is to construe the asserted claims, a
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`matter of law decided by courts. Markman v. Westview Instruments, Inc., 517 U.S. 370, 389-91
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`(1996). “When construing the claims of a patent, a court considers the literal language of a
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`Case 1:14-cv-00113-RGA-MPT Document 278-4 Filed 09/25/15 Page 4 of 17 PageID #: 9441
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`claim, the specification and the prosecution history.” Wyeth v. Impax Labs., Inc., 526 F. Supp.
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`2d 474, 477 (D. Del. 2007) (citing Markman, 52 F.3d 967, 979 (Fed. Cir. 1995) aff’d, 517 U.S.
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`370 (1996). It is a “well-established principle that a court may not import limitations from the
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`written description into the claims.” Laitram Corp. v. NEC Corp., 163 F.3d 1342, 1347 (Fed.
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`Cir. 1998); accord, Pfizer, Inc. v. Ranbaxy Labs. Ltd., 457 F.3d 1284, 1290 (Fed. Cir. 2006)
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`(refusing to limit a claimed class of pharmaceutical compounds to the specific chemical structure
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`depicted in the specification); Wyeth, 526 F. Supp. 2d at 479-80 (refusing to limit the general
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`claim term, “extended release formulation,” to the specific ingredients listed in the specification).
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`Also, “the presence of a dependent claim that adds a particular limitation gives rise to a
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`presumption that the limitation in question is not present in the independent claim.” Phillips v.
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`AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005)
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`3.
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`Furthermore, “expert testimony inconsistent with the Court’s claim construction is
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`unreliable and unhelpful to the finder of fact.” Personalized User Model, L.L.P. v. Google Inc.,
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`No. CV 09-525-LPS, 2014 WL 807736, at *2 (D. Del. Feb. 27, 2014); see also LP Matthews
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`LLC v. Bath & Body Works, Inc., 458 F. Supp. 2d 198, 210 (D. Del. 2006).
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`A.
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`4.
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`Literal Infringement
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`“The application of a patent claim to an accused product is a fact-specific inquiry.
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`Literal infringement is present only when each and every element set forth in the patent claims is
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`found in the accused product. . . . Infringement can be shown by any method of analysis that is
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`probative of the fact of infringement, and, in some cases, circumstantial evidence may be
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`sufficient.” Novartis Pharms., 48 F. Supp. 3d at 738-39 (internal citations omitted).
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`5.
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`A product infringes a claim when it meets each claim element during normal
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`operation. See, e.g., CIF Licensing, LLC v. Agere Sys. Inc., 727 F. Supp. 2d 337, 347 (D. Del.
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`2010) (“For purposes of conducting an infringement analysis, the Federal Circuit distinguishes
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`between usual or reasonable uses of a device on one hand, and uses which are unusual, or merely
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`possible, on the other hand.”). “[I]nfringement is not avoided merely because a non-infringing
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`mode of operation is possible.” Z4 Techs., Inc. v. Microsoft Corp., 507 F.3d 1340, 1350 (Fed.
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`Cir. 2007). A product can meet a claim element for the presence of a specific compound even
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`when a very small quantity of the compound is present in the product. SmithKline Beecham
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`Corp. v. Apotex Corp., 403 F.3d 1331, 1339–41 (Fed. Cir. 2005) (finding that the asserted claim
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`was not limited to commercially significant amounts of paroxetine hydrochloride hemihydrate
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`and affirming the district court’s finding of infringement based on the trace amounts of
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`paroxetine hydrochloride hemihydrate in the accused product). “[T]he statute leaves no leeway
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`to excuse infringement because the infringer only infringed a little.” Embrex, Inc. v. Serv. Eng’g
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`Corp., 216 F.3d 1343, 1352–53 (Fed. Cir. 2000) (Rader, J., concurring); accord Organic Seed
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`Growers & Trade Ass’n v. Monsanto Co., 718 F.3d 1350, 1356 (Fed. Cir. 2013) (summarizing
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`Judge Rader’s concurrence in Embrex and other cases “reject[ing] the proposition that patent
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`claims should be construed to avoid reading on ‘trace amounts’ of a patented compound”).
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`6.
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`Because direct patent infringement is a strict liability offense, the defendant’s
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`alleged desire to avoid infringing is irrelevant. See Commil USA, LLC v. Cisco Systems, Inc.,
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`135 S. Ct. 1920, 1926 (2015). Accordingly, an accused product that meets every limitation of an
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`asserted claim infringes even if the defendant did not intend for every limitation to be present.
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`See, e.g., Novartis Pharm. Corp. v. Par Pharm., Inc., 48 F. Supp. 3d 733, 740 (D. Del. 2014)
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`(Andrews, J.) (finding that an ANDA product infringed where the infringing element entered the
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`product in small amounts as an impurity introduced by an upstream supplier).
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`B.
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`7.
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`Infringement under the Doctrine of Equivalents
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`The doctrine of equivalents prohibits one from “avoiding infringement liability by
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`making only ‘insubstantial changes and substitutions . . . which, though adding nothing, would
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`be enough to take the copied matter outside the claim, and hence outside the reach of law.”
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`Siemens Med. Solutions USA, Inc. v. Saint-Gobain Ceramics & Plastics, Inc., 637 F.3d 1269,
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`1279 (Fed. Cir. 2011) (quoting Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605,
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`607 (1950)).
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`8.
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`A “product or process that does not literally infringe upon the express terms of a
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`patent claim may nonetheless be found to infringe if there is ‘equivalence’ between the elements
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`of the accused product or process and the claimed elements of the patented invention.” Warner-
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`Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 21 (1997). The doctrine of equivalents
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`must be applied to the “individual elements of the claim, not to the invention as a whole.” Id. at
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`29.
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`9.
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`“An element is equivalent if the differences between the element and the claim
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`limitation are ‘insubstantial.’ One test used to determine “insubstantiality” is whether the
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`element performs substantially the same function in substantially the same way to obtain
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`substantially the same result as the claim limitation.” Intellectual Ventures I, LLC v. Motorola
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`Mobility, LLC, 13 F. Supp. 3d 369, 382 (D. Del. 2014).
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`II.
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`VALIDITY
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`10.
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`Patent claims issued by the United States Patent and Trademark Office “shall be
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`presumed valid. Each claim of a patent (whether an independent, dependent, or multiple
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`dependent form) shall be presumed valid independently of the validity of other claims;
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`dependent or multiple dependent claims shall be presumed valid even though dependent upon an
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`invalid claim. The burden of establishing invalidity of a patent or any claim thereof shall rest on
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`the party asserting such invalidity.” 35 U.S.C. § 282; see also Rosco, Inc. v. Mirror Lite Co.,
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`304 F.3d 1373, 1379 (Fed. Cir. 2002) (“When determining the validity of the claims of a patent,
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`each claim must be separately considered.”).
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`11.
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`The presumption that an issued patent claim is valid can be overturned only with
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`clear and convincing evidence of invalidity. Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S. --, 131
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`S. Ct. 2238, 2245-46 (2011). “Although the standard of proof does not depart from that of clear
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`and convincing evidence, a party challenging validity shoulders an enhanced burden if the
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`invalidity argument relies on the same prior art considered during examination by the [PTO].”
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`Creative Compounds, LLC v. Starmark Labs., 651 F.3d 1303, 1313 (Fed. Cir. 2011) (quoting
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`Tokai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1367 (Fed. Cir. 2011)).
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`When no prior art other than that which was considered by the PTO examiner is
`relied on by the attacker, he has the added burden of overcoming the deference
`that is due to a qualified government agency presumed to have properly done its
`job, which includes one or more examiners who are assumed to have some
`expertise in interpreting the references and to be familiar from their work with the
`level of skill in the art and whose duty it is to issue only valid patents.
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`Intellectual Ventures I, LLC v. Motorola Mobility, LLC, 13 F. Supp. 3d 369, 384 (D. Del. 2014).
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`A.
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`Obviousness
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`12.
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`Obviousness is a question of law based on underlying issues of fact. KSR Int’l
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`Co. v. Teleflex Inc., 550 U.S. 398, 427 (2007). The Court has summarized the obviousness
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`inquiry as follows:
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`The presumption that all patents are valid is the starting point for any obviousness
`determination. 35 U.S.C. § 282 (2012). Under § 103(a), a patent may not be
`obtained . . . if the differences between the subject matter sought to be patented
`and the prior art are such that the subject matter as a whole would have been
`obvious at the time the invention was made to a person having ordinary skill in
`the art.” Id. § 103(a). Obviousness is a question of law that depends on the
`following factual inquiries: (1) the scope and content of the prior art; (2) the
`differences between the claims and the prior art; (3) the level of ordinary skill in
`the relevant art; and (4) any objective considerations such as commercial success,
`long felt but unsolved need, and the failure of others.
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`Novartis Pharms., 48 F. Supp. 3d at 752.
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`13.
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`In determining the scope and content of the prior art, the prior art must be
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`considered “as a whole.” In re Hedges, 783 F.2d 1038, 1041 (Fed. Cir. 1986); Ortho-McNeil
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`Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358, 1364 (Fed. Cir. 2008). “It is impermissible
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`within the framework of section 103 to pick and choose from any one reference only so much of
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`it as will support a given position, to the exclusion of other parts necessary to the full
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`appreciation of what such reference fairly suggests to one of ordinary skill in the art.” In re
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`Hedges, 783 F.2d at 1041.
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`14.
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`Obviousness “requires more than a mere showing that the prior art includes
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`separate references covering each separate limitation in a claim under examination.” Unigene
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`Labs., Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011). To protect against the
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`“distortion caused by hindsight bias,” there must be “a reason that would have prompted a person
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`of ordinary skill in the relevant field to combine the elements in the way the claimed new
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`invention does.” KSR Int’l Co., 550 U.S. at 418, 421; see also id. at 421 (“A factfinder should be
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`aware, of course, of the distortion caused by hindsight bias and must be cautious of arguments
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`reliant upon ex post reasoning.”); Novartis Pharms., 48 F. Supp. 3d at 752 (“A party seeking to
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`invalidate a patent claim “must show that a PHOSITA would be motivated to combine the
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`claimed combinations with a reasonable expectation of success.”). This motivation to combine
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`must be demonstrated by clear and convincing evidence. In re Cyclobenzaprine Hydrochloride
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`Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1068-69 (Fed. Cir. 2012).
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`15. When two references provide conflicting teachings, “such conflicting teachings
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`cannot reasonably be viewed as suggesting their combination.” Karsten Mfg. Corp. v. Cleveland
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`Golf Co., 242 F.3d 1376, 1385 (Fed. Cir. 2001). Similarly, an “inference of nonobviousness is
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`especially strong where the prior art’s teachings undermine the very reason being proffered as to
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`why a person of ordinary skill would have combined the known elements.” Allergan, Inc. v.
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`Sandoz, — F.3d— , 2015 WL 4639308, at *9 (Fed. Cir. Aug. 4, 2015) (quoting DePuy Spine,
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`Case 1:14-cv-00113-RGA-MPT Document 278-4 Filed 09/25/15 Page 9 of 17 PageID #: 9446
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`Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1326 (Fed. Cir. 2009). “A reference may
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`be said to teach away when a person of ordinary skill, upon reading the reference, would be
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`discouraged from following the path set out in the reference, or would be led in a direction
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`divergent from the path that was taken by the applicant.” DePuy Spine, 567 F.3d 1314, 1326
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`(Fed. Cir. 2009).
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`16.
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`“The inventor’s own path itself never leads to a conclusion of obviousness; that is
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`hindsight. What matters is the path that the person of ordinary skill in the art would have
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`followed, as evidenced by the pertinent prior art.” Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d
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`1280, 1296 (Fed. Cir. 2012) (citing 35 U.S.C. § 103(a) (“Patentability shall not be negatived [sic,
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`negated] by the manner in which the invention was made.”)); accord Life Techs., Inc. v. Clontech
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`Labs., Inc., 224 F.3d 1320, 1326 (Fed. Cir. 2000) (“That the inventors were ultimately successful
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`is irrelevant to whether one of ordinary skill in the art, at the time the invention was made, would
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`have reasonably expected success.”).
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`17.
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`“Evidence of obviousness, especially when that evidence is proffered in support
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`of an obvious-to-try theory, is insufficient unless it indicates that the possible options skilled
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`artisans would have encountered were finite, small, or easily traversed, and that skilled artisans
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`would have had a reason to select the route that produced the claimed invention.” Novartis
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`Pharms., 48 F. Supp. 3d at 752-53 (internal quotations omitted); accord St. Jude Medical, Inc. v.
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`Access Closure, Inc., 729 F.3d 1369, 1381 (Fed. Cir. 2013) (holding that combination of
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`references did not render claims obvious because “[o]ne of ordinary skill in the art at the time of
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`the invention would have viewed the [two devices] as substitutes to achieve the same . . .
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`objective, not as complementary devices to achieve the . . . benefit of [the] claimed invention.”).
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`18.
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`For an accused infringer “to establish obviousness, it is insufficient to allege a
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`general motivation to discover an undefined solution that could take many possible forms.” In re
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`Armodafinil, 939 F. Supp. 2d 497, 500 (D. Del. 2013). This is because “knowledge of a problem
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`and motivation to solve it are entirely different from motivation to combine particular references
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`to reach the particular claimed method.” Id. (quoting Innogenetics, N.V. v. Abbott Labs., 512
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`F.3d 1362, 1373-74 (Fed. Cir. 2008)).
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`[T]he Federal Circuit has clarified that obvious to try is also not obvious when a
`skilled artisan would have to: (1) vary all parameters or try each of numerous
`possible choices until one possibly arrived at a successful result, where the prior
`art gave either no indication of which parameters were critical or no direction as
`to which of many possible choices is likely to be successful; or (2) explore new
`technology or general approach that seemed to be a promising field of
`experimentation, where the prior art gave only general guidance as to the
`particular form of the claimed invention or how to achieve it.
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`Id. at 502 (internal quotation marks omitted).
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`a.
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`Objective Indicia of Non-Obviousness
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`19.
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`Objective indicia, such as commercial success, praise by the industry, and long-
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`felt but unmet need, can serve as probative evidence of nonobviousness. KSR Int’l Co., 550 U.S.
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`at 406. The Federal Circuit “has emphasized that consideration of the objective indicia is part of
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`the whole obviousness analysis, not just an afterthought. . . .” Leo Pharm. Prods., Ltd. v. Rea,
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`726 F.3d 1346, 1357 (Fed. Cir. 2013). Objective indicia “are not just a cumulative or
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`confirmatory part of the obviousness calculus but constitute independent evidence of
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`nonobviousness [and] can be the most probative evidence of nonobviousness in the record, and
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`enables the court to avert the trap of hindsight.” Id. at 1358.
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`20.
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`A patentee may argue objective indicia of non-obviousness, but is not obligated to
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`do so, because objective indicia of non-obviousness are not a requirement of patentability.
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`Therefore “[s]uch evidence, if present, would weigh in favor of non-obviousness, although the
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`lack of such evidence does not weight in favor of obviousness.” Miles Labs., Inc. v. Shandon
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`Inc., 997 F.2d 870, 878 (Fed. Cir. 1993); see also Custom Accessories, Inc. v. Jeffrey-Allan
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`Indus., Inc., 807 F.2d 955, 960 (Fed. Cir. 1986) (“the absence of objective evidence does not
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`preclude a holding of nonobviousness because such evidence is not a requirement of
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`patentability. . . . [T]he absence of objective evidence ‘is a neutral factor’”).
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`21.
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`Objective indicia of non-obviousness may be demonstrated based upon a
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`commercial embodiment having more than the claimed features, provided that there is a
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`sufficient nexus between the objective indicia and the claimed features. ArcelorMittal France v.
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`AK Steel Corp., 700 F.3d 1314, 1325-26 (Fed. Cir. 2012).
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`22.
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`In considering objective indicia of non-obviousness, “[i]t is not necessary that the
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`patented invention be solely responsible for the commercial success” to establish that there is a
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`nexus.” Continental Can Co. USA, Inc. v. Monsanto Co., 948 F.2d 1264, 1273 (Fed. Cir. 1991)
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`(emphasis added); see also Ecolochem, Inc. v. S. California Edison Co., 227 F.3d 1361, 1378
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`(Fed. Cir. 2000). “A requirement for proof of the negative of all imaginable contributing factors
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`would be unfairly burdensome, and contrary to the ordinary rules of evidence.” Demaco Corp. v.
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`F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1394 (Fed. Cir. 1988).
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`23.
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`“When a patentee can demonstrate commercial success, usually shown by
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`significant sales in a relevant market, and that the successful product is the invention disclosed
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`and claimed in the patent, it is presumed that the commercial success is due to the patented
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`invention.” J.T. Eaton & Co. v. Atl. Paste & Glue Co., 106 F.3d 1563, 1571 (Fed. Cir. 1997).
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`24.
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`“If a patentee makes the requisite showing of nexus between commercial success
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`and the patented invention, the burden shifts to the challenger to prove that the commercial
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`success is instead due to other factors extraneous to the patented invention, such as advertising or
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`superior workmanship.” J.T. Eaton & Co. v. Atl. Paste & Glue Co., 106 F.3d 1563, 1571 (Fed.
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`Cir. 1997).
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`B. Written Description
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`25.
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`A patent’s compliance with the written description requirement is a factual inquiry
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`undertaken from the objective standpoint of a person of ordinary skill in the art. Invitrogen Corp.
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`v. Clontech Labs., Inc., 429 F.3d 1052, 1072 (Fed. Cir. 2005); Streck Inc. v. Research &
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`Diagnostic Sys., Inc., 665 F.3d 1269, 1285 (Fed. Cir. 2012).
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`26.
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`A patent claim “need not provide in haec verba support for the claimed subject
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`matter at issue” to satisfy the written description requirement. Lampi Corp. v. American Power
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`Prods, Inc., 228 F.3d 1365, 1378 (Fed. Cir. 2000) (citing Fujikawa v. Wattanasin, 93 F.3d 1559,
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`1570 (Fed. Cir. 1996)). Rather, the written description requirement is satisfied if “the disclosure
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`of the application relied upon reasonably conveys to those skilled in the art that the inventor had
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`possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly &
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`Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010); see also Streck, 665 F.3d at 1285; Vas-Cath Inc. v.
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`Mahurkar, 935 F.2d 1555, 1563-34 (Fed. Cir. 1991).
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`27.
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`The claims included in a patent application are part of the specification for
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`purposes of satisfying the written description requirement. Crown Packaging Tech., Inc. v. Ball
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`Metal Beverage Container Corp., 635 F.3d 1373, 1380 (Fed. Cir. 2011). In many instances,
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`disclosure of the issued claims in the original application will satisfy the written description
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`requirement for those claims. Id. This is especially true when the issued claims are claims
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`directed to compositions of matter, rather than to a functionally-defined genus. Id.
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`28.
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`An inventor need not have actually reduced to practice all embodiments of the
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`claimed invention to satisfy the written description requirement. Streck, 665 F.3d at 1286.
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`29.
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`“[T]he level of detail required to satisfy the written description requirement varies
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`depending on the nature and scope of the claims and on the complexity and predictability of the
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`relevant technology. For generic claims, we have set forth a number of factors for evaluating the
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`adequacy of the disclosure, including the existing knowledge in the particular field, the extent and
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`content of the prior art, the maturity of the science or technology, and the predictability of the
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`aspect at issue.” Ariad Pharm., Inc., 598 F.3d at 1351 (internal citations and quotation marks
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`omitted); see also Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1368 (Fed. Cir. 2006) (“The
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`written description requirement states that the patentee must describe the invention. . . . . [T]he
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`forced recitation of known sequences in patent disclosures would only add unnecessary bulk to
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`the specification.”).
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`30.
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`“The disclosure of a species may be sufficient written description support for a
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`later claimed genus including that species.” Bilstad v. Wakalopulos, 386 F.3d 1116, 1124 (Fed.
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`Cir. 2004). The “mechanical world” is “a fairly predictable field.” Id. at 1126.
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`31.
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`The written description requirement does not require that the specification
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`“describe every conceivable and possible future embodiment of his invention.” Cordis Corp. v.
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`Medtronic AVE, Inc., 339 F.3d 1352, 1365 (Fed. Cir. 2003) (internal quotation omitted).
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`32.
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`The written description may contain a broad description of a claim without
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`describing all the species that fall within that broad claim. Utter v. Hiraga, 845 F.2d 993, 998
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`(Fed. Cir. 1988), superseded on other grounds, Kubota v. Shibuya, 999 F.2d 517 (Fed. Cir. 1993).
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`A patentee may rely on information that is well known in the art for purposes of meeting the
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`written description requirement. Boston Sci. Corp. v. Johnson & Johnson, 647 F.3d 1353, 1366
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`(Fed. Cir. 2011); S3 Inc. v. nVidia Corp., 259 F.3d 1364, 1371 (Fed. Cir. 2001).
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`33.
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`“A claim will not be invalidated on section 112 grounds simply because the
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`embodiments of the specification do not contain examples explicitly covering the full scope of the
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`claim language.” LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1345 (Fed. Cir.
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`2005); see also Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1371 (Fed. Cir.
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`2009) (“[A] patent claim is not necessarily invalid for lack of written description just because it
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`is broader than the specific examples disclosed.”).
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`34.
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`Under section 112, “[o]pen-ended claims are not inherently improper . . . . They
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`may be supported if there is an inherent, albeit not precisely known, . . . limit and the
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`specification enables one of skill in the art to approach that limit. Andersen Corp. v. Fiber
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`Composites LLC, 474 F.3d 1361, 1376-77 (Fed. Cir. 2007) (quoting Scripps Clinic & Research
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`Found. v. Genentech, Inc., 927 F.2d 1565, 1572 (Fed. Cir. 1991).
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`35.
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`The written description need not disclose features or structures that are not
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`covered by the claims. Spine Solutions, Inc. v. Medtronic Sofamor Danek USA, Inc., 620 F.3d
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`1305, 1313 (Fed. Cir. 2010); see also Crown Packaging Tech., Inc. v. Ball Metal Beverage
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`Container Corp., 635 F.3d 1373, 1383 (Fed. Cir. 2011) (stating that “[a] patentee need only
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`describe the product as claimed, and need not describe an unclaimed method of making the
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`claimed product”) (internal quotation omitted).
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`36.
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`The statement that a claim element “is selected from” a list of particular
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`embodiments may limit a claim to the listed embodiments if it appears in a patent claim, but does
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`not have the same limiting effect when it appears in a patent specification. Abbott Labs. v. Andrx
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`Pharms, Inc., 473 F.3d 1196, 1208-11 (Fed. Cir. 2007). Under the doctrine of claim
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`differentiation, a claim element in an independent claim should be construed to encompass more
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`than the specific embodiments of that claim element as set forth in a dependent claim. Id. at
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`1209.
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`C.
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`37.
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`Prosecution Laches
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`Lilly carries the burden to prove prosecution laches. To meet that burden, Lilly
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`must first show an “‘unreasonable and unexplained delay in prosecution’ that constitutes an
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`egregious misuse of the statutory patent system under the totality of the circumstances.” Cancer
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`Research Tech. Ltd. v. Barr Labs., Inc., 625 F.3d 724, 728-29 (Fed. Cir. 2010), denying en banc
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`reh’g, 637 F.3d 1293 (Fed. Cir. 2011), cert. denied, 132 S. Ct. 499 (2011).
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`38.
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`The Federal Circuit has emphasized that “[t]he doctrine should be applied only in
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`egregious cases of misuse of the statutory patent system” and also elaborated on legitimate uses
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`of the patent system. Symbol Techs., Inc. v. Lemelson Med., Educ. & Research Found., 422 F.3d
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`1378, 1385 (Fed. Cir.), amended on reh’g in part sub nom. Symbol Techs., Inc. v. Lemelson
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`Med., Educ. & Research Found., LP, 429 F.3d 1051 (Fed. Cir. 2005). These legitimate uses
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`include filing a divisional application considered by the PTO to be a separate and distinct
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`invention, adding “subject matter in order to attempt to support broader claims as the
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`development of an invention progresses,” and “refil[ing] an application even in the absence of
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`any of these reasons, provided that such refiling is not unduly successive or repetitive.” Id. at
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`1385.
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`39.
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`District courts have also elaborated on circumstances that do not constitute an
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`unreasonable or unexplained delay that is an egregious misuse of the patent system. “[A]
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`continuation application containing new claims is appropriate when, for example, an applicant
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`seeks to claim a different embodiment of an invention disclosed in the common specification or
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`to rewrite claims with a different scope.” Holmes Grp., Inc. v. RPS Prods., Inc., No. CIV. A. 03-
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`40146-FDS, 2010 WL 7867756, at *9 (D. Mass. June 25, 2010) (citations omitted).
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`40.
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`Prosecution of other patent applications based on the original application is a
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`reasonable excuse for delay. Stambler v. RSA Sec., Inc., 243 F. Supp. 2d 74, 76 n. 3 (D. Del.
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`2003) (C.J. Robinson) (holding that a delay of over three years in filing the divisional
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`applications following the PTO’s original restriction requirement was not unreasonable).
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`41.
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`“[T]he mere passage of time from a patent application filing to the issuance of the
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`patent is insufficient in and of itself to constitute improper delay.” Koninklijke Philips Elecs.
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`N.V. v. Cinram Int’l, Inc., No. CIV.A. 08-0515, 2012 WL 4074419, at *8 (S.D.N.Y. Aug. 23,
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`2012) (citations omitted).
`
`42.
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`“‘[T]here is nothing improper, illegal, or inequitable in filing a patent application
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`for the purpose of obtaining a right to exclude a known competitor’s product from the
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`marketplace.’” Ormco Corp. v. Align Tech., Inc., 647 F. Supp. 2d 1200, 1207 (C.D. Cal. 2009)
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`(citing Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867, 874 (Fed. Cir. 1988));
`
`see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 669 F. Supp. 2d 756 (E.D. Tex. 2009) (“It
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`is not unusual or improper to draft claims to cover a competitor’s product, as long as there is a
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`basis in the pending application.”), rev’d on other grounds, 636 F.3d 1341 (Fed. Cir. 2011).
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`43.
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`Lilly must also prove that it suffered prejudice to establish prosecution laches.
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`Cancer Research Tech., 625 F.3d at 729. This includes proof that it experienced harm because
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`of the alleged delay. Id. at 731; see also Ormco, 647 F. Supp. 2d at 1207 (“[T]here has been an
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`insufficient showing of prejudice . . . . [Defendant] has failed to set forth evidence indicating that
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`[it] would have done anything differently if it had been faced with the asserted claims of the
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`[asserted] patent sooner.”).
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`44.
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`There are conflicting cases from the District of Delaware regarding the proper
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`burden of proof for prosecution laches. Compare Novo Nordisk Pharms., Inc. v. Bio-Tech. Gen.
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