Johns Hopkins Univ. v. 454 Life Scis. Corp.

183 F.Supp.3d 563

Johns Hopkins University, Plaintiff,

v.454 Life Sciences Corporation, Defendant.

C.A. No. 13-1853-LPS

United States District Court, D. Delaware.

Signed May 2, 2016

Karen L. Pascale, James L. Higgins, Young Conaway Stargatt & Taylor LLP, Wilmington, DE, Robert F. Altherr, Jr., Joseph M. Skerpon, Christopher B. Roth, Banner & Witcoff, LTD., Washington, DC, Attorneys for Plaintiff Johns Hopkins University.

Kelly E. Farnan, Selena E. Molina, Richards, Layton & Finger, P.A., Wilmington, DE, R. Danny Huntington, Sharon E. Crane, Seth E. Cockrum, Rothwell, Figg, Ernst & Manbeck, P.C., Washington, DC, Attorneys for Defendant 454 Life Sciences Corporation.

MEMORANDUM OPINION

STARK, United States District Judge:

Pending before the Court are partial motions for summary judgment filed by Johns Hopkins University ("JHU" or "Plaintiff") and 454 Life Sciences Corporation ("454" or "Defendant"). JHU filed this action pursuant to 35 U.S.C. § 146 on November 6, 2013 to review the Decision and Final Judgment of the Board of Patent Appeals and Interferences ("the Board") in Interference No. 105,857 ("the Interference"). (See D.I. 1 at 1, 8) JHU is the junior party in the Interference and 454 is the senior party. (See id. ) The interfering applications are U.S. Patent Application Nos. 12/361,690 (D.I. 39 Ex. 1) (JHU's " '690 application") and 13/33,240 (D.I. 39 Ex. 5) (454's " '240 application"). The Interference involves a single count ("Count")¹ with the interfering subject matter represented by claim 1 of JHU's '690 application and claim 52 of Defendant's '240 application. (See D.I. 44 at 1; D.I. 45 at 1)

Claim 1 of the '690 application is representative and recites the following:

A method for analyzing nucleic acid sequences comprising:

(a) generating a plurality of molecules of a fragment of deoxyribonucleic acid;

(b) delivering the plurality of molecules of the fragment of deoxyribonucleic acid into aqueous microreactors in a water-in-oil emulsion such that a plurality of aqueous microreactors comprise a single molecule of the fragment of deoxyribonucleic acid, a single bead capable of hybridizing the fragment of deoxyribonucleic acid, and reagents necessary to perform deoxyribonucleic acid amplification;

(c) amplifying the fragment of deoxyribonucleic acid in the microreactors to form amplified copies of said fragment of deoxyribonucleic acid bound to beads in the microreactors;

(d) determining presence of amplified copies of said fragment of deoxyribonucleic acid bound to a bead.

(D.I. 44 at 2-3)

The Court held a claim construction hearing on June 9, 2015 and issued a memorandum opinion on claim construction. (D.I. 56) Thereafter, the parties filed summary judgment motions, completing briefing on them on February 16, 2016. (See D.I. 69, 71, 76, 78, 81, 83) JHU moves for partial summary judgment that JHU's priority date with respect to the Count is no later than June 5, 2003 and that three of 454's U.S. Patent Applications—Nos. 60/456,592 ("'592 application"), 60/465,071 ("'071 application"), and 13/033,240 ("'240 application") —fail to provide adequate written description or enablement for the Count, as required by 35 U.S.C. § 112. (D.I. 68) ("JHU's Motion") 454 moves for partial summary judgment that 454's priority date with respect to the Count is April 23, 2003, the filing date of 454's '071 application. (D.I. 70) ("454's Motion") The Court held a hearing on the parties' summary judgment motions on March 1, 2016. (See Transcript (D.I. 90) ("Tr."))

For the reasons discussed below, the Court will grant in part and deny in part JHU's Motion and deny 454's Motion.

I. LEGAL STANDARDS

A. Summary Judgment

Pursuant to Rule 56(a) of the Federal Rules of Civil Procedure, "[t]he court shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." The moving party bears the burden of demonstrating the absence of a genuine issue of material fact. See Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp. , 475 U.S. 574, 585–86, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). An assertion that a fact cannot be—or, alternatively, is—genuinely disputed must be supported either by citing to "particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits or declarations, stipulations (including those made for purposes of the motion only), admissions, interrogatory answers, or other materials," or by "showing that the materials cited do not establish the absence or presence of a genuine dispute, or that an adverse party cannot produce admissible evidence to support the fact." Fed. R. Civ. P. 56(c)(1)(A) & (B). If the moving party has carried its burden, the nonmovant must then "come forward with specific facts showing that there is a genuine issue for trial." Matsushita , 475 U.S. at 587, 106 S.Ct. 1348 (internal quotation marks omitted). The Court will "draw all reasonable inferences in favor of the nonmoving part, and it may not make credibility determinations or weigh the evidence." Reeves v. Sanderson Plumbing Prods., Inc. , 530 U.S. 133, 150, 120 S.Ct. 2097, 147 L.Ed.2d 105 (2000).

To defeat a motion for summary judgment, the nonmoving party must "do more than simply show that there is some metaphysical doubt as to the material facts." Matsushita , 475 U.S. at 586, 106 S.Ct. 1348 ; see also Podobnik v. U.S. Postal Serv. , 409 F.3d 584, 594 (3d Cir.2005) (stating party opposing summary judgment "must present more than just bare assertions, conclusory allegations or suspicions to show the existence of a genuine issue") (internal quotation marks omitted). The "mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment;" a factual dispute is genuine only where "the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 247–48, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986)."If the evidence is merely colorable, or is not significantly probative, summary judgment may be granted." Id. at 249–50, 106 S.Ct. 2505 (internal citations omitted); see also Celotex Corp. v. Catrett , 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986) (stating entry of summary judgment is mandated "against a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial"). Thus, the "mere existence of a scintilla of evidence" in support of the nonmoving party's position is insufficient to defeat a motion for summary judgment; there must be "evidence on which the jury could reasonably find" for the nonmoving party. Anderson , 477 U.S. at 252, 106 S.Ct. 2505.

B. Patent Validity Under 35 U.S.C. § 112

Paragraph 1 of 35 U.S.C. § 112 states in pertinent part:

The specification shall contain a written description of the invention and of the manner and process of making and using it, in such full, clear, concise and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same ....²

The statute sets out separate requirements for written description and enablement. See Ariad Pharm., Inc. v. Eli Lilly & Co. , 598 F.3d 1336, 1344 (Fed.Cir.2010) (holding that written description and enablement requirements are separate). These requirements "often rise and fall together." Id. at 1352. The parties agree that, in a case brought under § 146 arising from an interference, invalidity under § 112 must be proved by a preponderance of the evidence. (See Tr. at 31-32, 45) The Court agrees that a preponderance of the evidence standard applies. See Brui n ing v. Hirose , 1998 WL 690851, at *3–5 (Fed.Cir. Sept. 29, 1998).

1. Written Description

Whether a specification satisfies the written description requirement is a question of fact. See GlaxoSmithKline LLC v. Banner Pharmacaps, Inc. , 744 F.3d 725, 729 (Fed.Cir.2014) ; see also Alcon, Inc. v. Teva Pharms. USA, Inc. , 664 F.Supp.2d 443, 468 (D.Del.2009) ("Satisfaction of the written description requirement is a fact-based inquiry, depending on ‘the nature of the claimed invention and the knowledge of one skilled in the art at the time an invention is made and a patent application is filed.’ ") (quoting Carnegie Mellon Univ. v. Hoffmann – La Roche Inc. , 541 F.3d 1115, 1122 (Fed.Cir.2008) ). Despite being a question of fact, the issue of invalidity for lack of written description is amenable to summary judgment. See, e.g., Carnegie Mellon , 541 F.3d at 1126–28 (affirming summary judgment of invalidity for lack of written description); see also Helicos Biosciences Corp. v. Illumina, Inc ., 888 F.Supp.2d 519, 530–31 (D.Del.2012) ("While compliance with the written description requirement is a question of fact, the issue is ‘amenable to summary judgment in cases where no reasonable fact finder could return a verdict for the non-moving party.’ ") (quoting PowerOasis, Inc. v. T – Mobile USA, Inc ., 522 F.3d 1299, 1307 (Fed.Cir.2008) ).

To comply with the written description requirement, a patent's specification "must clearly allow persons of ordinary skill in the art to recognize that the inventor invented what is claimed." Ariad , 598 F.3d at 1351 (internal brackets and quotation marks omitted). "[T]he test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Id. "[T]he hallmark of written description is disclosure. Thus, ‘possession as shown in the disclosure’ is a more complete formulation" of the written description requirement. Id. "[T]he test requires an objective inquiry into the four comers of the specification from the perspective of a person of ordinary skill in the art." Id....