ELI LILLY AND CO. v. TEVA PARENTERAL MEDICINES, INC., No. 2015-2067 (Fed. Cir. January 12, 2017) (precedential).  On appeal from S.D. Ind. Before Prost, Newman, and Dyk.

Procedural Posture: Plaintiff Eli Lily filed a Hatch-Waxman lawsuit against a group of generic pharmaceutical companies, including Teva, to prevent Defendants from making and selling a generic version of a chemotherapy drug that allegedly infringed U.S. Patent No. 7,772,209.  Upon holding two bench trials, one on infringement and one on invalidity, the district court determined that (1) Defendants were liable for inducing infringement performed directly by physicians and (2) the asserted claims were not invalid for, inter alia, indefiniteness, obviousness, or obviousness-type double patenting. The district court found that no single actor performs all steps of the asserted claims, but found induced infringement under Akamai Technologies, Inc. v. Limelight Networks, Inc. (Akamai V), 797 F.3d 1020, 1022 (Fed. Cir. 2015) (en banc). The CAFC affirmed the district court’s decisions, both with respect to induced infringement and no invalidity of the asserted claims.

• Induced Infringement:

• Direct Infringement: The CAFC agreed with the district court’s application of the intervening Akamai V decision, which broadened the circumstances in which others’ acts may be attributed to a single actor to support direct infringement liability in cases of divided infringement. Specifically, they stated that where no single actor performs all steps of a method claim, direct infringement only occurs if the acts of one are attributable to the other such that a single entity is responsible for the infringement. Further, the CAFC cited Akamai V as imparting that the performance of method steps is attributable to a single entity in two circumstances: when i) that entity directs or controls others’ performance or ii) the actors form a joint enterprise. The Plaintiff did not pursue “joint enterprise” induced infringement, but did present the “direct or control” theory. The CAFC applied the two-prong “direct or control” test of Akamai V, under which an actor must: (1) condition participation in an activity or receipt of a benefit upon others’ performance and (2) establish the manner or timing of that performance. The CAFC noted that the parties had agreed that Defendants’ product labeling would consist of the Physician Prescribing Information and Patient Information. Both documents include instructions regarding the administration of folic acid — the step that the district court found would be performed by patients but attributable to physicians — prior to a chemotherapy (pemetrexed) performed by physicians. The CAFC reasoned that a reduction in pemetrexed toxicities is relevant only if pemetrexed treatment is administered, and it provides a reason why physicians would condition the receipt of pemetrexed treatment on folic acid administration. The CAFC concluded that physicians delineate the step of folic acid administration that patients must perform if they wish to receive pemetrexed treatment. The CAFC further clarified that conditioning does not necessarily require double-checking another’s performance or making threats.

• Specific Intent and Action to Induce: The CAFC stated that when alleged inducement relies on a drug label’s instructions, the question is whether the instructions teach an infringing use such that those instructions imply an affirmative intent to infringe the patent. According to the CAFC, the label must encourage, recommend, or promote infringement. The CAFC noted that the decision to continue seeking FDA approval of those instructions may be sufficient evidence of specific intent to induce infringement. The CAFC found specific intent for inducement based on the evidence showing that the product labeling includes repeated instructions and warnings regarding the importance of and reasons for folic acid treatment, such instructions being directed at physicians.

• Indefiniteness: The CAFC applied the Nautilus standard that a patent is invalid for indefiniteness if its claims, read in light of the specification and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention. Plaintiff argued that a claim limitation, “vitamin B12,” means “cyanocobalamin” specifically. Defendants argued that it is not clear that this meaning trumps another possible meaning – a class of compounds including pharmaceutical derivatives of cyanocobalamin – and that this ambiguity renders “vitamin B12” indefinite. The CAFC held that adopting the prior interpretation – cyanocobalamin – would produce redundancy between claim 1 and claim 2, which recites “methylmalonic acid lowering agents.” The CAFC found such redundancy acceptable based on MPEP § 2173.05(h)(I). On the other hand, the CAFC stated that selecting the meaning “a class of compounds including pharmaceutical derivatives of cyanocobalamin” would violate the doctrine of claim differentiation, because claim 2 would have the same scope as claim 1. The CAFC reasoned that because such interpretation would be impermissible, the only viable interpretation was the correct one: “vitamin B12” means “cyanocobalamin.” The existence of only one permissible choice rendered the claim not indefinite, according to the CAFC.

• Obviousness: The CAFC held that there was no reversible error, agreeing with the district court that a skilled artisan would not have been motivated to use vitamin B12 pretreatment with pemetrexed, let alone use the appropriate doses and schedules of such vitamin B12 pretreatment. The CAFC identified uncertainty whether to proscribe vitamin B12 or a folic acid supplementation to treat elevated homocysteine levels known in the prior art. The CAFC explained that such elevated levels may indicate deficiency in either one of the two vitamins. The CAFC established a missing link between B12 deficiency and pemetrexed toxicity and added that credible evidence was available that a skilled artisan would have even considered vitamin B12 to be a problem for the pemetrexed toxicity and not a remedy. Accordingly, the CAFC found the asserted claims non-obvious in view of the prior art.