284 F. Supp. 3d 91
D.D.C.2018Background
- Sanofi sued Lilly over multiple patents, including the '864 injector-pen patent, after Lilly filed an ANDA with a Paragraph IV certification for an insulin glargine product (Basaglar/KwikPen).
- Plaintiffs allege Sanofi’s suit on the '864 patent was a sham: Sanofi knew Lilly’s KwikPen did not infringe and the '864 patent should not have been Orange Book–listed. The Orange Book listing claim was previously dismissed.
- The Amended Complaint points to portions of Lilly’s §505(b)(2) application as showing noninfringement but offers no nonconclusory facts to support that assertion.
- The underlying litigation (Sanofi I) involved contested claim-construction proceedings and was litigated for over 18 months before a settlement and consent judgment that licensed Lilly and provided royalties to Sanofi.
- The court treated the issued '864 patent as presumptively valid and examined whether the complaint plausibly alleged the suit was objectively baseless under the two-part sham-litigation test.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Sanofi’s suit on the '864 patent was a sham (objectively baseless) | Sanofi knew Lilly’s KwikPen did not infringe and still sued to delay entry | Sanofi had a reasonable basis to sue an issued patent and engaged in bona fide claim construction and litigation | Court: Plaintiffs failed to plead objective baselessness; litigation was not a sham |
| Whether, if objectively baseless, the suit concealed an attempt to interfere with competitor relationships (subjective prong) | Plaintiffs allege anticompetitive motive and harm from delayed entry | Sanofi argues motive irrelevant because suit had reasonable basis; settlement and claim construction show contested dispute | Court: Did not reach subjective prong because objective baselessness not shown |
| Whether the settlement/consent judgment constitutes admission of noninfringement | Plaintiffs claim settlement shows Sanofi admitted no infringement of certain patents | Sanofi points to licensing language and royalties showing a substantive settlement, not an admission | Court: Consent judgment reflected license; plaintiffs’ claim of admission not supported by record |
| Causation for antitrust damages tied to other patents | Plaintiffs say other Sanofi patents caused artificially high prices between Feb 2015–Dec 2016 | Sanofi says the validly asserted '864 patent lawfully delayed entry and severs causation | Court: Dismissed remaining antitrust claims for lack of causation because '864 lawfully barred entry during the alleged harm period |
Key Cases Cited
- Professional Real Estate Investors, Inc. v. Columbia Pictures Indus., Inc., 508 U.S. 49 (sham-litigation test; objective baselessness prerequisite to probing subjective motive)
- Asahi Glass Co. v. Pentech Pharm., Inc., 289 F. Supp. 2d 986 (N.D. Ill. 2003) (discussing presumption of patent validity and threshold for sham claims)
- 800 Adept, Inc. v. Murex Sec., Ltd., 539 F.3d 1354 (Fed. Cir. 2008) (plaintiff must show patent holder had no reasonable basis to believe claims valid or infringed)
- In re Hydrogen Peroxide Antitrust Litig., 552 F.3d 305 (3d Cir. 2008) (antitrust class plaintiffs must prove individual antitrust impact)