In re Lantus Direct Purchaser Antitrust Litig.

284 F. Supp. 3d 91
CourtDistrict Court, District of Columbia
DecidedJanuary 10, 2018
DocketCIVIL ACTION NO. 16–12652–JGD
StatusPublished
Cited by2 cases

This text of 284 F. Supp. 3d 91 (In re Lantus Direct Purchaser Antitrust Litig.) is published on Counsel Stack Legal Research, covering District Court, District of Columbia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re Lantus Direct Purchaser Antitrust Litig., 284 F. Supp. 3d 91 (D.D.C. 2018).

Opinion

*108First, the lawsuit must be objectively baseless in the sense that no reasonable litigant could realistically expect success on the merits. If an objective litigant could conclude that the suit is reasonably calculated to elicit a favorable outcome, the suit is immunized under Noerr, and an antitrust claim premised on the sham exception must fail. Only if the challenged litigation is objectively meritless may a court examine the litigant's subjective motivation. Under this second part of our definition of sham, the court should focus on whether the baseless lawsuit conceals an attempt to interfere directly with the business relationships of a competitor....

Prof'l Real Estate Investors, Inc., 508 U.S. at 60, 113 S.Ct. 1920 (internal quotations and emphasis omitted). "Only if the suit is found to be objectively baseless may the court proceed to the second prong of the test." Morton Grove Pharm. v. Par Pharm. Cos., Inc., 2006 WL 850873, at *10 (N.D. Ill. 2006).

Specific to the '864 patent, the plaintiffs make two principal claims in support of their sham litigation argument. First, the plaintiffs claim that Sanofi initiated litigation while knowing that Lilly's KwikPen did not infringe the '864 patent. Second, the plaintiffs contend that Sanofi sued on the '864 patent knowing that the patent should not have been listed in the Orange Book to begin with. As the court has already dismissed the Orange Book listing claim, the plaintiffs' second argument need not be addressed further.

The Facts as Alleged do not Establish that the Lawsuit was "Objectively Baseless"

"A firm that has received a patent from the patent office (and not by fraud ...), and thus enjoys the presumption of validity that attaches to an issued patent ... is entitled to defend the patent's validity in court, to sue alleged infringers, and to settle with them, whatever its private doubts, unless a neutral observer would reasonably think either that the patent was almost certain to be declared invalid, or the defendants were almost certain to be found not to have infringed it, if the suit went to judgment." United Food, 2017 WL 2837002, at *11 (quoting Asahi Glass Co. v. Pentech Pharm., Inc., 289 F.Supp.2d 986, 992-93 (N.D. Ill. 2003) ). Thus, to prevail on its sham litigation claim, the plaintiffs must establish that Sanofi "had no reasonable basis to believe that its patent claims were valid or that they were infringed by [Lilly.]" 800 Adept, Inc. v. Murex Sec., Ltd., 539 F.3d 1354, 1370 (Fed. Cir. 2008), and cases cited. Here, however, the facts as alleged do not show that Lilly was "almost certain to be found not to have infringed" the '864 patent. United Food, 2017 WL 2837002, at *11.

According to the Amended Complaint, prior to bringing suit Sanofi had "[t]he pages of Lilly's § 505(b)(2) application [that] (1) showed the list of ingredients of Lilly's NDA product, and (2) identified the type of injector pen by which the Lilly NDA product would be administered." Am. Compl. ¶ 204. Other than repeatedly stating that the documents showed that Lilly's products "would not infringe any of the claims in the two injector pen patents (the '864 and '044 patents ) or any claims in the two vial formulation patents (the '652 and '930 patents )[,]" the plaintiffs have offered no facts in support of these conclusions. Id. ¶¶ 204, 211-12, 231-33. Since this court must disregard conclusory allegations of fact and law, Schatz, 669 F.3d at 55, the allegations of the Amended Complaint are insufficient to show that the underlying lawsuit lacked any reasonable merit.

*109Other facts also support the conclusion that the lawsuit was not objectively baseless.12 While none of these facts, in and of themselves, establish that the litigation brought by Sanofi was not sham litigation, they all combine to defeat any contention that the litigation was objectively unreasonable when brought. See United Food, 2017 WL 2837002, at *10-13 (finding that plaintiffs fail to sufficiently plead sham litigation after considering multiple factors); AstraZeneca AB v. Mylan Labs., Inc., MDL Docket No. 1291, 2010 WL 2079722, at *4 (S.D.N.Y. May 19, 2010) (finding that suit was not a sham based on an analysis of the extent of the underlying litigation and because a Paragraph IV Certification gave "an objectively reasonable basis to sue.").

As an initial matter, in its litigation with Lilly, Sanofi was enforcing patents that had never been invalidated or found unenforceable against an obvious act of infringement. While this is not a prerequisite to a claim of sham litigation, it is not irrelevant: patents are presumed to be valid, and patent holders are entitled to enforce their rights under their patents, so parties claiming sham litigation must overcome these presumptions. See United Food, 2017 WL 2837002, at *10 ("The Court declines to adopt a bright-line rule requiring that a patent be invalidated or tarnished before a plaintiff can allege a sham litigation claim, but notes that it is difficult to conceive of a scenario in which a sham litigation claim would go forward without the patent having been invalidated or otherwise tarnished."). Moreover, with respect to the '864 patent, as detailed above, there was industry support for the proposition that such patents should be listed in the Orange Book. Thus, the fact that Sanofi sought to protect the '864 patent in the face of a Paragraph IV Certification is not obviously unreasonable.

Moreover, the record in the underlying litigation establishes that Sanofi's contention that the KwikPen infringed on the '864 patent was not objectively baseless. As detailed above, the plaintiffs' assertion that there was no infringement is not supported by any facts in the Amended Complaint. In contrast, the parties in Sanofi I engaged in a claim construction dispute addressing various elements of the '864 patent. If Lilly's KwikPen was completely different, and bore no relationship to the Lantus SoloSTAR (as plaintiffs allege) there would have been no reason for Lilly to have participated in a claims construction exercise.

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Bluebook (online)
284 F. Supp. 3d 91, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-lantus-direct-purchaser-antitrust-litig-dcd-2018.