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.)
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, 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.)
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
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.)
In its decision remanding this case to this Court, the Federal Circuit offered the following guidance with respect to Plaintiff's claims:
Classen, 786 F.3d at 898-99 (emphasis added).
While Plaintiff interprets the Federal Circuit's use of the term "generally" to indicate that exceptions may apply to these general rules, this argument — unsupported by authority — is unpersuasive. (ECF No. 250 at 8.) Moreover, when this issue was raised during the hearing, counsel for Plaintiff was unable to indicate why the Federal Circuit's guidance should not govern this Court's analysis.
Elan argues that summary judgment is appropriate because its allegedly infringing activities are protected by 35 U.S.C. § 271(e)(1)'s safe harbor provision.
In its Opposition, Classen argues that Elan's post-submission activities — that is, submission of clinical data to the FDA — are aimed at commercialization and thus, in Classen's view, fall outside of the safe harbor of § 271(e)(1). (ECF No. 250 at 2-4, 14-17.) The allegedly infringing activities are: (1) "reanalyzing the clinical data to identify patentable information and filing patent applications;" and (2) "making and selling Skelaxin with the revised label that contained the information derived from the clinical study." Classen, 786 F.3d at 897-98.
Following the Federal Circuit's guidance, it is clear that Elan's alleged "reanalyzing the clinical data to identify patentable information and filing patent applications," and "making and selling Skelaxin with the revised label that contained the information derived from the clinical study" fall squarely within the safe harbor of § 271(e)(1). This conclusion is also consistent with the decision of this Court in Classen Immunotherapies, Inc. v. Shionogi, Inc., 993 F.Supp.2d 569, 578 (D. Md. 2014), aff'd, 586 Fed.Appx. 585 (Fed. Cir. 2014). In Shionogi, Judge Titus of this Court rejected Classen's nearly identical argument to that raised here, stating:
Shionogi, 993 F.Supp.2d at 578 (internal citations omitted) (emphasis added). Notably, Shionogi involved the same Plaintiff alleging a nearly identical legal theory.
This Court's conclusion that Elan's post-submission activities fit within the scope of § 271(e)(1)'s safe harbor is further supported by Telectronics Pacing Sys. v. Ventritex, Inc., 982 F.2d 1520, 1523-24 (Fed. Cir. 1992). As the Federal Circuit explained, Telectronics stands for the proposition that "the subsequent disclosure or use of information obtained from an exempt clinical study, even for purposes other than regulatory approval, does not repeal that exemption of the clinical study, provided that the subsequent disclosure or use is itself not an act of infringement of the asserted claims." Classen, 786 F.3d at 898 (emphasis in original) (citing Telectronics, 982 F.2d at 1523-24). On this basis, the defendant in Telectronics remained within the safe harbor when it "present[ed] clinical trial data at a cardiology conference, report[ed] clinical trial progress to investors, analysts and journalists, and describe[ed] clinical trial results in a private fund-raising memorandum." Id. The alleged acts of commercialization by Elan — the filing of patent applications based on the reanalyzed clinical data and the sale of Skelaxin with the revised label containing information derived from the clinical trial — appear, contrary to Classen's argument, far less "commercial" in nature than those activities deemed protected in Telectronics. Accordingly, these activities remain within the scope of § 271(e)(1)'s safe harbor, and Elan is entitled to summary judgment.
Even if Classen's claims were not barred as a matter of law, Classen still fails to
Here, with discovery long complete and this case having worn on for nearly twelve years, Classen has produced no evidence of Elan's alleged reanalysis of the data for commercial purposes so as to raise a genuine issue of material fact regarding Elan's infringement. Attached to Classen's Opposition brief are copies of Classen's and Elan's patents at issue in this case (ECF Nos. 250-1, 250-5), materials related to Dr. Classen's November 2001 presentation (ECF No. 250-2), Elan's 2001 Clinical Study Report (ECF No. 250-6), Elan's 2001 Citizen's Petition to the FDA (ECF No. 250-7), and portions of the deposition transcripts of Nancy Santilli (ECF No. 250-3) and Steve Cartt (ECF No. 250-4). While the deposition excerpts may support the inference that Ms. Santilli, Mr. Cartt, and other Elan employees attended Dr. Classen's presentation, met with Dr. Classen, and even explored the possibility of entering into a business relationship with him, these materials say nothing of Elan's alleged reanalysis of clinical study data and commercialization of that data. See ECF Nos. 250-3, 250-4. Thus, even if Classen's allegations were not barred as a matter of law on account of § 271(e)(1)'s safe harbor, Classen has failed to show that there exists a genuine issue of material fact with respect to a key element of its allegations.
For the foregoing reasons, this 27th day of September, 2016, Elan Pharmaceuticals, Inc.'s Motion for Summary Judgment as to Non-Infringement (ECF No. 249) is GRANTED.
A separate Order follows.