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Eli Lilly & Co. v. Teva Parenteral Meds., Inc. - 845 F.3d 1357 (Fed. Cir. 2017)

Rule:

The intent for inducement must be with respect to the actions of an underlying direct infringer. The United States Court of Appeals for the Federal Circuit has not required evidence regarding the general prevalence of the induced activity. When an alleged inducement relies on a drug label's instructions, the question is not just whether those instructions describe the infringing mode, but whether the instructions teach an infringing use such that the Federal Circuit is willing to infer from those instructions an affirmative intent to infringe the patent. A label must encourage, recommend, or promote infringement. For purposes of inducement, it is irrelevant that some users may ignore the warnings in a proposed label. Depending on the clarity of the instructions, the decision to continue seeking FDA approval of those instructions may be sufficient evidence of specific intent to induce infringement. The Federal Circuit held in AstraZeneca LP v. Apotex, Inc. that a label that instructed users to follow the instructions in an infringing manner was sufficient even though some users would not follow the instructions. That was true even though the product in question had substantial noninfringing uses. Conversely, "vague" instructions that require one to look outside a label to understand the alleged implicit encouragement do not, without more, induce infringement.

Facts:

Eli Lilly & Co. (Lilly) was the owner of the ‘209 patent issued in 2010. The patent involved methods of administering the chemotherapy drug pemetrexed disodium (pemetrexed) after pretreatment with two common vitamins—folic acid and vitamin B12. Lilly marketed pemetrexed under the brand name ALIMTA®, and the drug was used to treat certain types of lung cancer and mesothelioma. Around 2008-2009, Teva Parenteral Medicines, Inc., APP Pharmaceuticals LLC, Pliva Hrvatska D.O.O., Teva Pharmaceuticals USA, Inc., and Barr Laboratories, Inc. (collectively, Defendants) notified Lilly that they had submitted Abbreviated New Drug Applications (ANDAs) seeking approval by the Food and Drug Administration (FDA) to market generic versions of ALIMTA®. After the '209 patent issued, Defendants sent Lilly additional notices regarding their ANDAs, including notices that they had filed Paragraph IV certifications under 21 U.S.C. § 355(j)(2)(A)(vii)(IV), declaring that the '209 patent was invalid, unenforceable, or would not be infringed. Thereafter, Lilly brought action against the defendants alleging that the Defendants infringed the ‘209 patent. According to Eli Lilly, the Defendants’ generic drugs would be administered with folic acid and vitamin B12 pretreatments and, thus, result in infringement of the ‘209 patent. Defendants raised noninfringement and invalidity defenses. The United States District Court for the Southern District of Indiana held two bench trials, one on infringement and one on invalidity. The district court found that no single actor performed all steps of the asserted claims because the actions of both physicians and patients were required. Nonetheless, the court found direct infringement attributable to physicians and held Defendants liable for inducing that infringement. The court also determined that the asserted claims were valid for indefiniteness, obviousness, or obviousness-type double patenting.

Issue:

Were the defendants liable for inducing that infringement?

Answer:

Yes.

Conclusion:

In previous jurisprudence, the Court held 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 was responsible for the infringement. The Court agreed with the district court’s determination that the factual circumstances of the case supported a finding of direct infringement by physicians. According to the district court’s determination, which the Court upheld, the act of taking folic acid in the manner recited by the asserted claims was a critical and necessary step to reduce the life-threatening toxicities caused by pemetrexed. It was further found that physicians would prescribe an exact dose of folic acid and direct that it be ingested daily. Case law held that directing or controlling others' performance included circumstances in which an actor conditions participation in an activity or receipt of a benefit" upon others' performance of one or more steps of a patented method, and establishes the manner or timing of that performance. The Court held that based on the records of the case, the performance of all the steps of the asserted claims would be attributable to the physicians. Thus, the defendants can be held liable for directly infringing the ‘209 patent.

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