Eli Lilly and Company v. Teva Parenteral Medicines
845 F.3d 1357
| Fed. Cir. | 2017Background
- Eli Lilly owns U.S. Patent No. 7,772,209, which claims methods of administering pemetrexed after pretreatment with folic acid and vitamin B12 to reduce toxicity. The asserted claims require patient administration of folic acid and physician administration of vitamin B12 and pemetrexed.
- Defendants filed ANDAs seeking to market generic pemetrexed and provided Paragraph IV certifications; Lilly sued under 35 U.S.C. § 271(e)(2). The district court held separate bench trials on invalidity and infringement.
- Because claim steps are split between physicians (prescribe/administer B12 and pemetrexed) and patients (self-administer folic acid), Lilly’s infringement theory depended on divided-infringement law.
- After the Supreme Court’s Limelight decision, the case was remanded; the district court applied this court’s en banc Akamai decision (Akamai V) and found physicians’ acts attributable to them (direction/control), and that defendants would induce infringement via proposed labeling.
- The district court also held the claims definite ("vitamin B12" construed to mean cyanocobalamin), not obvious (including as to vitamin B12 use and claimed doses/schedules), and not invalid for obviousness-type double patenting over an earlier Eli Lilly patent. The Federal Circuit affirmed.
Issues
| Issue | Plaintiff's Argument (Lilly) | Defendant's Argument (Defendants) | Held |
|---|---|---|---|
| Whether divided infringement (direct infringement) exists when patients perform a claimed step | Physicians direct or control patients: labeling conditions pemetrexed treatment on folic acid and prescribes dose/timing, so patient acts are attributable to physicians under Akamai V | Labeling is mere guidance; patients choose dose/form/timing and physicians do not legally force compliance, so direction/control not shown | Court: physicians meet Akamai V two‑prong test (condition benefit and establish manner/timing); direct infringement attributable to physicians affirmed |
| Whether defendants’ proposed labeling induces infringement (specific intent) | Labeling unambiguously instructs physicians to require folic acid in the claimed manner; seeking FDA approval of that label supports an inference of intent to induce physicians to practice claim steps | Lilly failed to prove what physicians do generally; compliance and additional measures (pill counts, diaries) show label alone insufficient to induce | Court: label teaches infringing use and supports inference defendants had specific intent; inducement affirmed |
| Whether the claim term "vitamin B12" is indefinite | In context of medical supplementation claims, a POSA would understand "vitamin B12" to mean cyanocobalamin; prosecution and claim structure support that meaning | Term is used variably in the specification (class vs. specific compound), so scope is not reasonably certain under Nautilus | Court: no clear error in district court’s factual finding; term is definite and construed to mean cyanocobalamin |
| Obviousness of using vitamin B12 pretreatment and claimed doses/schedules with pemetrexed | Prior art and biochemical links would have motivated a POSA to use B12 and routine choice of dosing makes claims obvious | Prior art did not disclose B12 pretreatment with antifolates in cancer; Niyikiza abstracts did not link MMA (B12 deficiency marker) to toxicity; no reasonable expectation of success | Court: Defendants failed to prove by clear and convincing evidence obviousness as to B12 use or claimed dosing/schedules; nonobviousness affirmed |
| Obviousness‑type double patenting over earlier Eli Lilly patent ('974) | Asserted claims are obvious variants of claim 20 of the '974 patent | Lilly: asserted claims add pemetrexed, patient administration, vitamin B12, and narrower folic acid ranges — patentably distinct | Court: differences (esp. absence of B12 in '974 and other limitations) render claims patentably distinct; no double patenting invalidity |
Key Cases Cited
- Akamai Technologies, Inc. v. Limelight Networks, Inc., 797 F.3d 1020 (Fed. Cir. 2015) (en banc) (per curiam) (tests for attributing others’ acts to a single actor in divided‑infringement contexts)
- Limelight Networks, Inc. v. Akamai Techs., Inc., 134 S. Ct. 2111 (2014) (Supreme Court) (inducement requires underlying direct infringement)
- Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120 (2014) (clarified indefiniteness standard: reasonable certainty)
- Takeda Pharm. USA, Inc. v. West‑Ward Pharm. Corp., 785 F.3d 625 (Fed. Cir. 2015) (label instructions must teach an infringing use to infer intent to induce)
- DSU Medical Corp. v. JMS Co., 471 F.3d 1293 (Fed. Cir. 2006) (inducement requires knowledge/intent)
- AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042 (Fed. Cir. 2010) (label‑based inducement: some users ignoring warnings is irrelevant)
- KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) (flexible obviousness inquiry)