Failing to Find Sufficient Facts Pleading Sham Litigation or Unreasonably Listing Patents in Orange Book, District of Massachusetts Grants Eli Lilly’s Motion to Dismiss in In re Lantus

Abiel Garcia
Gibson Dunn & Crutcher LLP

On January 10, 2018, U.S. District Judge Gail Dein granted Sanofi’s motion to dismiss the plaintiffs’ amended complaint.  The plaintiffs, who are purchasers of insulin glargine products Lantus and Lantus SoloSTAR, alleged that Sanofi improperly extended its monopoly for Lantus and Lantus SoloSTAR by improperly listing six patents in the FDA Orange Book and by pursuing, and then settling, sham litigation against Eli Lilly and Company (Lilly).  In re Lantus Direct Purchaser Antitrust Litig., No. 16-12652-JGD, 2018 WL 355372 at*1 (D. Mass. January 10, 2018).  Judge Dein found that the plaintiffs failed to allege sufficient facts to support a finding of antitrust liability against Sanofi for listing its patents in the Orange Book unreasonably or for engaging in sham litigation with the Lilly.  Id.

Background

Sanofi holds the “formulation” patents covering preparations of insulin and the patents that cover the injector pens for said insulin.  Sanofi’s patents were listed in the FDA’s Orange Book, which is intended to put other drug manufacturers on notice of any relevant patents that should be addressed in any new drug applications (NDA) filings.  The plaintiffs contended that the listing of six patents that covered the injector pens were part of a scheme to maintain and extend Sanofi’s monopoly power with respect to its Lantus and Lantus SoloSTAR.  Id. at *2.  In Sanofi’s motion to dismiss, Sanofi focused on one patent covering the injector pen, the ‘864 patent, arguing that if Sanofi prevailed with respect to the ‘864 patent, then the entire complaint must be dismissed due to the inability of plaintiffs to establish any damages.  Id.

In 2013, Lilly sough FDA approval for its own insulin-glargine product and notified Sanofi of the relationship between Lilly’s product and Sanofi’s patents listed in the Orange Book for Lantus and Lantus SoloSTAR.  In its notification to Sanofi, Lilly stated that all patents, except one, were invalid, unenforceable, and/or would not be infringed by the commercial manufacture, use, or sale of the Lilly product.  Sanofi responded with a suit alleging infringement of four patents, including the ‘864 injector pen patent.  Due to the lawsuit, an automatic stay on FDA approval of any Lilly product was triggered.  The plaintiffs alleged that the litigation instigated by Sanofi was a sham—brought without any basis—and for the exclusive reason of extending Sanofi’s monopoly in the Lantus and Lantus SoloSTAR markets.  Id.

Sanofi’s Patents Were Reasonably Submitted to the Orange Book

Turning to how patents get listed in the Orange Book, the courts looked to regulation 21 C.F.R. section 314.53(b)(1), which describes the patents that must be listed when filing an NDA.  Regulation 21 C.F.R. Section 314.53(b)(1) provides that applicants need to list “patent[s] that claim [] the drug or a method of using the drug . . . [which] consist of drug substance (active ingredient) patents drug product (formulation and composition) patents, and method-of-use patents.”  Id. at *4.  The section also provides that patents which describe process or packaging should not be submitted to the FDA.  Id.  The court then described the confusion around which patents, outside of the active ingredient and composition patents, must be listed on the Orange Book, as there was some confusion surrounding the FDA’s requirements.  The court boiled down the issue to whether the ‘864 injector pen patent was just a packaging patent and did not need to be included in the Orange Book or if the ‘864 patent was required to be listed in the Orange Book.

In analyzing the listing of the ‘864 patent in the Orange Book, the court stated that the FDA is required by law to publish information provided by the applicant.  Id. at *8.  Quoting United Food and In re Lipitor Antitrust, the court determined that the FDA did not independently determine whether a particular drug product actually tracked to a particular patent claim and that the Orange Book listing was simply a statutory obligation.  Id. at *8 (citing United Food and Comm. Workers Unions &Employers Midwest Health Benefits Fund v. Novartis Pharm Corp., No. 15–cv–12732, 2017 WL 2837002, at *5 (D. Mass. June 30, 2017); ” In re Lipitor Antitrust Litig., MDL No. 2332, 2013 WL 4780496, at *21 (D.N.J. Sept. 5, 2013).  Nevertheless, the court still found that improperly listing a patent in the Orange Book may subject the patent holder to antitrust liability, unless the applicant had a reasonable basis for the submission.  Id. at *8.  The plaintiffs alleged that it was obvious that the ‘864 patent should not have been listed in the Orange Book since it was just a packaging change, but the court disagreed, finding that the record demonstrated the Lantus SoloSTAR product was approved as a drug delivery system.  Id. at *9.  The language used—“drug delivery system”—would require more analysis.  Id. at *9.

After reviewing Orange Book submission protocol, the court turned to analyze the FDA’s statements regarding what kind of patents should be listed in the Orange Book and the exact language used in the FDA’s approval letter for Lantus SoloSTAR,.  The plaintiffs argument basically relied solely on the FDA’s response to comments on the 2003 proposed rule 21 C.F.R. § 314.53.  Those comments stated that key to determining whether a patent should be submitted to the Orange Book is whether the patent claims the finished dosage form of the approved drug product, which the ‘864 did not.  Id. at *9.  While the court gave deference to the FDA’s language, the court still found that the plaintiffs did not plead sufficient facts to establish the listing in the Orange Book to be unreasonable or objectively baseless.  Id.  The court’s holding was additionally supported by the fact that Sanofi’s interpretation of the FDA’s language and requirements to submit patents to the Orange Book were similar to interpretations by other pharmaceutical companies including AstraZeneca and GlaxoSmithKline.  The court chose not to make any determinations as to the correct interpretation of the FDA requirement, but stated that it was “clear from [the] requests that the issue whether the ‘864 patent should have been listed is an open question in the industry.” Id. at *11.

The Sham Litigation Claim

The court then turned to the sham litigation claim alleged by the direct purchasers.  Id.at *11.  Allegedly Sanofi sought to wrongfully extend its exclusionary period by commencing and maintaining sham litigation against Lilly in order to delay the introduction of competing products, according to the direct purchasers.  Yet, according to the court, the moment that Lilly filed its Paragraph IV Certification in its NDA, Sanofi had a statutory right to sue under the Hatch-Waxman Act.  Id.  And while a patent holder was not obligated to bring patent infringement litigation upon notification of a Paragraph IV Certification, the court stated, it could bring such litigation, and in doing so, would be generally protected under the First Amendment per the Noerr-Pennington doctrine.  Id. 

After walking through the basics of the Noerr-Pennington doctrine, the court explained that the plaintiffs needed to establish that Sanofi had no reasonable basis to believe that its patent claims were valid or that they were infringed.  Id. at *12.  Reviewing the complaint, the court found that “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 or any claims in the two vial formulation patents, the plaintiffs have offered no facts in support of these conclusions.”  Id. at *12.  The court, disregarding the conclusory allegations of fact and law, found that the allegations in the complaint were insufficient to show that the underlying lawsuit lacked any reasonable merit.  Id. at *12. 

Additional evidence was cited by the court to support the holding that the lawsuit was not objectively baseless.  Additional facts that supported the court’s finding included: 1) Sanofi enforcing patents that had never been invalidated or found unenforceable,

2) Sanofi seeking to protect the ‘864 patent in the face of a Paragraph IV Certification, 3) Sanofi participating in claim construction disputes that addressed the challenged patents, and 4) the litigation between Sanofi and Lilly being heavily contested.  Id. at *13.  All of these facts weighed in favor of finding that the litigation was not a sham or objectively baseless.  Since the court found that the Orange Book listings and the underlying litigation were not a sham, the court found that the plaintiffs failed to show any casual connection between the antitrust violation and the actual damages suffered, thereby dismissing the rest of the complaint.  Id. at *14