Classen Immunotherapies, Inc. v. Idec, Civil No. WDQ–04–2607.

• Decision Date: 27 August 2013
• Docket Number: Civil No. WDQ–04–2607.
• Citation: 968 F.Supp.2d 660
• Parties: CLASSEN IMMUNOTHERAPIES, INC., Plaintiff, v. BIOGEN IDEC, et al., Defendants.
• Court: U.S. District Court — District of Maryland

968 F.Supp.2d 660

CLASSEN IMMUNOTHERAPIES, INC., Plaintiff,
v.
BIOGEN IDEC, et al., Defendants.

Civil No. WDQ–04–2607.

United States District Court,
D. Maryland,
Northern Division.

Aug. 27, 2013.

[968 F.Supp.2d 667]

Joseph J. Zito, Zito TLP, Washington, DC, for Plaintiff.

Amanda Page Masselam, David Bryan Bassett, Wilmer Cutler Pickering Hale and Dorr, LLP, Boston, MA, Dino S. Sangiamo, Venable LLP, Henry R. Abrams, Saul Ewing LLP, James P. Ulwick, Kramon and Graham PA, Baltimore, MD, Donald R. Ware, Jeremy A. Younkin, Sarah Burg, Foley Hoag LLP, Boston, MA, Elizabeth A. Brown, Tracy O. Ebanks, Covington and Burling, Michael Allen Jacobs, Morrison and Foerster, LLP, San Francisco, CA, Emily Ayliffe White, George F. Pappas, Jessica L. Parezo, Jeffrey B. Elikan, Kevin B. Collins, Covington and Burling, LLP, George Brian Busey, Laurie A. Hand, Morrison and Foerster, LLP, Washington, DC, Eudokia Evie Spanos, Covington and Burling, LLP, New York, NY, Michelle L. Morin, Covington and Burling, LLP, Redwood Shores, CA, David N. Farsiou, Joseph Lucci, Woodcock Washburn, LLP, Philadelphia, PA, James Walter Parrett, Jr., Morris Nichols Arsht and Tunnell, Mary B. Graham, Morris Nichols, Wilmington, DE, for Defendants.

MEMORANDUM OPINION
WILLIAM D. QUARLES, JR., District Judge.

Classen Immunotherapies, Inc. (“Classen”) sued Biogen Idec (“Biogen”) and GlaxoSmithKline (“GSK”) (collectively the “defendants”) for patent infringement. Pending is claim construction. On June 7, 2013, the Court held a claim construction hearing.

I. Background ¹

Classen is the assignee of John B. Classen, M.D. (“Dr. Classen”) inventor of the patents in suit. Biogen has licensed patents “relating to recombinant hepatitis B virus vaccines.” ECF No. 207 ¶ 6. GSK and its affiliates manufacture and market several vaccines, including ROTARIX, CERVARIX, BOOSTRIX, PEDIARIX, INFANRIX, and ENGERIX–B. ECF No. 211 ¶ 6.

Each of the three patents in suit is entitled “method and composition for an early vaccine to protect against both common infectious diseases and chronic immune mediated disorders or their sequelae.” See ECF Nos. 219–1 to 219–3. According to the abstracts, each discloses “a method of immunization ... provided for substantially preventing or reducing the symptoms of at least one infectious disease and at least one chronic immune mediated disorder.” Id. The patents have the same specification.

The '139 patent has 70 claims, and the '739 patent has 113 claims. Each has two essential steps, (I) screening two or more

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immunizations schedules, and (II) immunizing according to the lower risk schedule. '139 patent col. 52–53; '739 patent col. 52. The '790 patent has 213 claims and three essential steps: (I) considering the association between an immunization schedule and one or more chronic immune mediated disorders, (II) screening one or more potential recipients, and (III) immunizing according to the considerations. '790 patent col. 51.

B. Procedural History

On August 10, 2004, Classen filed suit asserting infringement of the '139, ' 739, and two other patents. ECF No. 1. This Court dismissed Biogen and GSK under 35 U.S.C. § 271(e)(1) and granted summary judgment for the defendants, holding that the '139 and '739 sought to patent unpatentable subject matter, see, e.g., ECF Nos. 76, 151, 152. On December 22, 2008, the Federal Circuit affirmed. ECF No. 157. However, the Supreme Court granted certiorari, vacated, and remanded to the Federal Circuit. The Federal Circuit, over Judge Moore's dissent, affirmed in part, reversed in part, vacated in part, and remanded in part, holding that Biogen and GSK were not entitled to § 271(e)(1) safe harbor and the '139 and '739 were not ineligible for patenting. ECF No. 159. On December 8, 2011, the mandate issued.

On February 3, 2012, Classen filed an amended complaint. ECF No. 172. On May 29, 2012, the Court granted GSK's motion to dismiss contributory and willful infringement claims and denied as to other claims.² ECF No. 195. On August 9, 2012, the Court granted reconsideration but denied dismissal. ECF No. 214. On September 10, 2012, the parties filed the joint claim construction statement and opening briefs. ECF Nos. 219–221. On November 13, 2012, responsive briefs were filed. ECF Nos. 231–232.

On September 12 and 13, 2012, GSK filed requests for inter partes reexamination of the patents in suit at the Patent and Trademark Office (“PTO”). ECF Nos. 234–4 at 6, 234–6 at 5, 234–8 at 5. On October 24, November 19, and November 23, the PTO granted the reexamination requests and issued First Office Actions rejecting all the asserted claims. See ECF Nos. 234–4 to 234–9.

On February 22, 2013, the Court denied the defendants' motion to stay pending reexamination, ordered Classen to serve infringement contentions compliant with Local Rule 804.1.a for 30 claims within 15 days of the claim construction ruling, and granted the defendants' motion for leave to file supplemental invalidity contentions. ECF No. 238.

On April 1, 2013, the defendants requested additional claim construction briefing because of alleged inconsistencies between Classen's representations to the PTO during reexamination and before this Court. ECF No. 241. Classen did not oppose the request. On April 18, 2013, the Court permitted the defendants to redepose Holohan and ordered supplemental briefing. On May 14, 2013, the defendants filed supplemental briefing. ECF No. 244. On May 28, 2013, Classen filed its brief. ECF No. 249.

On June 7, 2013, the Court held a claim construction hearing. Dr. Classen, Thomas V. Holohan, M.D., and Steven N. Goodman, M.D., M.H.S., Ph.D. testified.

II. Analysis

A. Legal Standard

Claim construction is a question of law, to be determined by the Court.

[968 F.Supp.2d 669]

Markman v. Westview Instruments, Inc., 517 U.S. 370, 384, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). Specifically, “[c]laim construction is a matter of resolution of disputed meanings and technical scope, to clarify and when necessary to explain what the patentee covered by the claims, for use in the determination of infringement. It is not an obligatory exercise in redundancy.” ³ Therefore, “district courts are not ... required to construe every limitation present in a patent's asserted claims.” O2 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1362 (Fed.Cir.2008). For instance, terms that are “commonplace” or that “a juror can easily use [ ] in her infringement fact-finding without further direction from the court” need not be construed because they “are neither unfamiliar to the jury, confusing to the jury, nor affected by the specification[ ⁴] or prosecution history[ ⁵].” ⁶

“Although a claim is not to be construed in light of the accused device, it must inevitably be construed in the context of the accused device.” Pulse Med. Instruments, Inc. v. Drug Impairment Detection Servs., Inc., No. DKC 07–1388, 2009 WL 6898404, at *2 (D.Md. Mar. 20, 2009). “It is only after the claims have been construed without reference to the accused device that the claims, as so construed, are applied to the accused device to determine infringement.” SRI Int'l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1118 (Fed.Cir.1985) (en banc) (emphasis in original).

“It is a bedrock principle of patent law that the claims of a patent define the invention to which the patentee is entitled the right to exclude.” ⁷ Thus, when construing a claim, a court should give its words their “ordinary and customary meaning” as would be understood by “a person of ordinary skill in the art in question at the time of the invention.” ⁸

“The claim should be read within the context of the entire patent, including the specification.” Pulse, 2009 WL 6898404, at *2. The specification “is always highly relevant to the claim construction analysis. Usually it is dispositive; it is the single best guide to the meaning of a disputed term.” ⁹ “The specification functions as a dictionary to explain the claimed subject matter and define the terms used in the claims[, but] is to be used only to interpret words or phrases of a patent claim, not to add to, or detract from, the language of the

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claims.” ¹⁰ “In some instances, the ordinary meaning of a claim as understood by a person of skill in the art will be readily apparent from the words themselves and in those situations, general language dictionaries may be of assistance.” Pulse, 2009 WL 6898404, at *2 ( citing Phillips, 415 F.3d at 1314).

“In addition to consulting the specification ... a court should also consider the patent's prosecution history, if it is in evidence.” Phillips, 415 F.3d at 1317 (internal quotation marks omitted). “The prosecution history limits the interpretation of claim terms so as to exclude any interpretation that was disclaimed during prosecution.” ¹¹ “Yet because the prosecution history represents an ongoing negotiation between the PTO and the applicant, rather than the final product of that negotiation, it often lacks the clarity of the specification and thus is less useful for claim construction purposes.” Phillips, 415 F.3d at 1317.

“In most situations, an analysis of the intrinsic evidence alone will resolve any ambiguity in a disputed claim term. In such circumstances, it is improper to rely on extrinsic evidence.” Vitronics, 90 F.3d at 1583. However, extrinsic evidence, including expert and inventor testimony, dictionaries, and learned treatises,

may be helpful to explain scientific principles, the meaning of technical terms, and terms of art that appear in the patent and prosecution history. Extrinsic evidence may demonstrate the state of the prior art at the time of the invention. It is useful to show what was then old, to distinguish what was new, and to aid the court in the construction of the patent.

Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed.Cir.1995) (internal quotation marks omitted), aff'd,517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). “In sum,...