Classen Immunotherapies, Inc. v. Elan Pharm., Inc., Civ. No.: RDB-04-3521

• Decision Date: 27 September 2016
• Docket Number: Civ. No.: RDB-04-3521
• Citation: 210 F.Supp.3d 772
• Parties: CLASSEN IMMUNOTHERAPIES, INC., Plaintiff, v. ELAN PHARMACEUTICALS, INC., Defendants.
• Court: U.S. District Court — District of Maryland

210 F.Supp.3d 772

CLASSEN IMMUNOTHERAPIES, INC., Plaintiff,

v.ELAN PHARMACEUTICALS, INC., Defendants.

Civ. No.: RDB-04-3521

United States District Court, D. Maryland.

Signed September 27, 2016

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

James B. Monroe, Justin James Hasford, Paul William Browning, Samhitha C. Muralidhar, William L. Strauss, Finnegan Henderson Farabow Garrett and Dunner LLP, Washington, DC, for Defendants.

MEMORANDUM OPINION

Richard D. Bennett, United States District Judge

This case is again before this court on remand from the United States Court of Appeals for the Federal Circuit. (ECF No. 231.)¹ Currently pending is defendant Elan Pharmaceuticals, Inc.'s ("Elan" or "Defendant") Motion for Summary Judgment of Non-Infringement ("Elan's Motion") (ECF No. 249). Plaintiff Classen Immunotherapies, Inc. ("Classen" or "Plaintiff") has filed an Opposition to Elan's Motion ("Classen's Opposition") (ECF No. 250), and Elan has filed a Reply to Classen's Opposition ("Elan's Reply") (ECF No. 251). The Court conducted a hearing on the parties' submissions on September 22, 2016. (ECF No. 252.) For the reasons set forth below, Elan's Motion is GRANTED.

FACTUAL AND PROCEDURAL BACKGROUND

The pertinent factual and procedural history of this case was set forth by the Federal Circuit in its decision remanding this case to this Court. Classen Immunotherapies, Inc. v. Elan Pharm., Inc. , 786 F.3d 892, 894–95 (Fed. Cir. 2015).

"Classen owns the '472 patent, which is directed to a method for accessing and analyzing data on a commercially available drug to identify a new use of that drug, and then commercializing that new use. Classen sued Elan in 2004, alleging that Elan infringed the '472 patent when it studied the effect of food on the bioavailability of Skelaxin, used the clinical data to identify a new use of the drug, and commercialized the new use. Classen, 466 F.Supp.2d at 624. Elan moved for summary judgment of noninfringement. The district court granted the motion in 2006, finding Elan protected by the safe harbor provision of § 271(e)(1)² because Elan submitted its clinical data to the FDA with its citizen petition and sNDA, and thus its activities were "reasonably related to the submission of information" under the Federal Food, Drug, and Cosmetic Act ("FDCA"). Id. at 625.

"The lawsuit was then stayed pending an ex parte reexamination of the '472 patent, during which the PTO cancelled 107 of the 137 originally issued claims. Of the remaining claims, only claims 36, 42, 48–50, 59, 73–76, 84, 131, and 135 were asserted against Elan. Prior to issuing the reexamination certificate, the PTO Examiner stated, as reasons for patentability, that the "prior art of record fails to teach or fairly suggest the limitation of ‘a manufacturer or distributor of the product must inform consumers, users or individuals responsible for the user, physicians or prescribers about at least one new adverse event associated with exposure to or use of the product.’ "

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"After the reexamination certificate issued in 2010, Classen filed a motion in the district court seeking to lift the stay and to vacate the 2006 summary judgment. Classen argued that our decision in Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011) warranted reconsideration of the summary judgment because we held in Biogen that certain post-approval routine submissions to the FDA are outside the safe harbor of § 271(e)(1). In response, the district court lifted the stay but denied reconsideration of its 2006 decision. The court concluded that Elan was protected by the safe harbor under both Biogen and our subsequent decision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012). The court reasoned that unlike Biogen, where the post-approval submissions were routine, Elan's submissions to the FDA were "not routine" because they were necessary to update the Skelaxin product label and to change the FDA-approval process for generic versions of Skelaxin. Classen, 981 F.Supp.2d at 421–22.

"On the parties' joint motion, the district court entered final judgment of noninfringement under Rule 54(b) of the Federal Rules of Civil Procedure."

Classen , 786 F.3d at 895–96.

On May 13, 2015, the Federal Circuit vacated and remanded Judge Quarles' 2012 judgment of non-infringement in favor of Elan. (ECF No. 232.) In its opinion remanding this case to this Court, the Federal Circuit concluded that "the district court correctly decided that § 271(e)(1) exempts Elan's activities reasonably relating to developing clinical data on its approved drug Skelaxin ® ("Skelaxin") and submitting that information to the Food and Drug Administration ("FDA") in a citizen petition and a supplemental new drug application ("sNDA")." Classen , 786 F.3d at 894. However, the court also found that because Judge Quarles' opinion did not address Plaintiff's "assert[ion] that certain activities that occurred after the FDA submissions infringed the '472 patent and that those activities are not exempt under the safe harbor of § 271(e)(1)," remand was appropriate. Id. Accordingly, the sole question now before this court is whether Elan's "post-submission activities constituted infringement of the '472 patent or whether they were exempt under the safe harbor." Id. at 898–99.

This case was transferred to the undersigned on January 22, 2016 following Judge Quarles' retirement from the bench. A new Scheduling Order (ECF No. 248) was issued, and, consistent with that Order, Elan filed its now-pending Motion on March 31, 2016. (ECF No. 249.) The Court conducted a hearing on September 22, 2016, and the matter is fully ripe for the Court's resolution. (ECF No. 252.)

STANDARD OF REVIEW

Rule 56 of the Federal Rules of Civil Procedure provides that a 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." Fed. R. Civ. P. 56(c). A material fact is one that "might affect the outcome of the suit under the governing law." Libertarian Party of Va. v. Judd , 718 F.3d 308, 313 (4th Cir. 2013) (quoting Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). Thus, summary judgment is proper "only when no ‘reasonable jury could return a verdict for the nonmoving party.’ " Monon Corp. v. Stoughton Trailers, Inc. , 239 F.3d 1253, 1257 (Fed. Cir. 2001) (quoting Anderson , 477 U.S. at 255, 106 S.Ct. 2505 )). When considering a motion for summary judgment, a judge's function is limited to determining whether sufficient evidence exists on a claimed factual dispute to warrant submission of the matter to a jury for resolution at trial. Anderson , 477 U.S. at 249, 106 S.Ct. 2505.

In undertaking this inquiry, this Court must consider the facts and all reasonable inferences in the light most favorable to the nonmoving party. Libertarian Party of Va. , 718 F.3d at 312 ; see also Scott v. Harris , 550 U.S. 372, 378, 127 S.Ct. 1769, 167 L.Ed.2d 686 (2007). However, this Court must also abide by its affirmative obligation to prevent factually unsupported claims and defenses from going to trial. Drewitt v. Pratt , 999 F.2d 774, 778–79 (4th Cir. 1993). If the evidence presented by the nonmoving party is merely colorable, or is not significantly probative, summary judgment must be granted. Anderson , 477 U.S. at 249–50, 106 S.Ct. 2505. On the other hand, a party opposing summary judgment must "do more than simply show that there is some metaphysical doubt as to the material facts." Matsushita Elec. Indus. Co. v. Zenith Radio Corp. , 475 U.S. 574, 586, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986) ; see also In re Apex Express Corp. , 190 F.3d 624, 633 (4th Cir. 1999). As this Court has previously explained, a "party cannot create a genuine dispute of material fact through mere speculation or compilation of inferences." Shin v. Shalala, 166 F.Supp.2d 373, 375 (D. Md. 2001) (citations omitted).

DISCUSSION

I. No Additional Discovery Is Required

At oral argument, the parties conceded that no additional factual discovery is required in order for the Court to rule on Elan's Motion. Specifically, counsel for Plaintiff indicated that now is the time to apply the law to the facts of this case. Counsel for Defendant agreed that no further discovery was needed and that the court could rule on the pending motion for summary judgment.

Although Classen argues that "the complex facts in this matter are not fully presentable to the Court in a comprehensive and understandable manner" and that "[t]he fact that the issues were remanded to the trial court clearly indicates that they are not ripe for summary determination but require a full, fair and comprehensive factual hearing, i.e., a trial on the merits" these arguments do not indicate what purpose additional discovery would serve. (ECF No. 250 at 7-8)(emphasis in original.)

II. The Federal Circuit's Guidance

In its decision remanding this case to this Court, the Federal Circuit offered the following guidance with respect to Plaintiff's claims:

"To assist the district court in its analysis of infringement, if the court reaches that issue on remand, we make the following observations of the record. Filing a patent application is generally not an infringement of a patent. It is not the making, using, offering to sell, selling, or importing of an invention. It is the act of approaching an agency of the government in order to obtain a limited privilege and to fulfill a public goal of making knowledge of an invention available to the public. It is not commercializing an invention, which requires introducing an invention into commerce, or making preparations to do so. Moreover, infringing a multi-step method claim requires carrying out all the steps of the claim. As filing a patent application is not commercializing an invention, a method claim requiring commercialization, as claim 36 does, is likely not infringed by

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