Eli Lilly and Company v. Teva Parenteral Medicines, Inc. et al.

Docket No. 2015-2067

January 12, 2017

Brief Summary: DC decision finding of direct infringement by physicians and induced infringement (§ 271(b)) by Teva as well as no obviousness affirmed.

Summary: Teva et al. (“Teva”) appealed DC finding of direct infringement by physicians and induced infringement (§ 271(b)) by Teva as well as no invalidity of Lillys US 7,772,209 relating to methods for administering the chemotherapy drug pemetrexed (marketed as ALIMTA®) following pretreatment with “an effective amount of folic acid” and “an effective amount of a methylmalonic acid lowering agent…selected from the group consisting of vitamin B12…” (independent claim 1). Independent claim 12 requires pre-adminstration of “between about 350 [micrograms] and about 1000 [micrograms] of folic acid” and “about 500 [micrograms] and about 1500 [micrograms] of vitamin B12”. In front of the DC, Lilly and Teva agreed the proposed labeling of Teva’s generic product would be materially the same as the ALIMTA® product labeling” including “instructions regarding the administration of folic acid” which the DC “found would be performed by the patients but attributable to physicians”. The FC panel opinion explained that under Akamai V (FC 2015, en banc, cert. denied 2016) “[w]here, as here, 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.” And “[t]he performance of method steps is only attributable to a single entity in two types of circumstances: when that entity ‘directs or controls’ others’ performance [pursued here], or when the actors ‘form a joint enterprise’” (not pursued here). Further, “‘directing or controlling’…includes circumstances in which an actor: (1) ‘conditions participation in an activity or receipt of a benefit’ upon others’ performance of one or more steps of a patented method, and (2) ‘establishes the manner or timing of that performance.’” The FC panel agreed with the DC that in this case “physicians ‘condition’ pemetrexed treatment on the administration of folic acid” (e.g., product labeling repeatedly states that physicians should “‘[i]nstruct patients’ to take folic acid” before pemetrexed treatment; “physicians cross the line from merely guiding or instructing…to conditioning”; “conditioning” does not require “legal oblibations of technical prerequisites”) and that, therefore, the “conditioning” prong of the analysis is met. It also found the second prong (“establishing the manner or timing of performance”) was also met based on, e.g., the dosing instructions of the product labeling and expert testimony that “‘it’s the doctor’ who ‘decides’” what dose will be taken by the patient. Thus, the FC panel agreed with the DC that the “underlying direct infringement” required to show induced infringement was present (noting that this holding “does not assume that patient action is attributable to a prescribing physician solely because they have a physician-patient relationship”).

It also explained, however, that “[t]he mere existence of direct infringement by physicians…is not sufficient for inducement” (Takeda, FC 2015) and that Lilly had to show “specific intent and action to induce infringement” (and not “[m]ere knowledge of the acts alleged to constitute infringement” (DSU Med., FC 2006). Teva argued that their “product labeling does not induce” the direct infringement. The FC panel explained, however, that the instructions on the label may be enough for the court to “infer…an affirmative intent to infringe the patent” (e.g., “[t]he label must encourage, recommend or promote infringement”) and “[d]epending 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” (AstraZeneca, FC 2010; “‘vague’ instructions that require one to ‘look outside the label to understand the alleged implicit encouragement’ do not, without more, induce infringement” (Takeda)). Here, the FC panel concluded that the product labeling that Defendants seek would inevitably lead some physicians to infringe” which “establishes the requisite intent for inducement”, and found the DC did not clearly err in its decision.

The DC also held “vitamin B12” was not indefinite before the Supreme Court’s Nautilus decision (US 2014) which rejected the FC’s “not amenable to construction or insolubly ambiguous” standard and instead found the “reasonable certainty” standard to be correct. The parties did not dispute that “vitamin B12” can “refer either to cyanocobalamin or, more broadly, to a class of compounds including pharmaceutical derivatives of cyanocobalamine” and that “the ‘209 patent uses the term both ways.” The FC panel found “no clear error in the [DC’s] acceptance of the understanding that ‘vitamin B12,’…in a medical context, refers to cyanocobalamin” and that that context was relevant to the disputed claims (e.g., “if ‘vitamin B12’ were to refer to a class of compounds, then claim 2 would be the same scope as claim 1” (doctrine of claim differentiation (AK Steel, FC 2003)). And it was not persuaded by the argument that “if ‘vitamin B12’ means ‘cyanocobalamin,’ then claim 1 recites a Markush group…that lists the same compound twice” (“Although we have in some instances interpreted claims to avoid redundancy, ‘the rule is not inflexible.’” Power Mosfet, FC 2004). The prosecution history was not found to “detract from, and [to be] consistent with, the other intrinsic evidence.”. The DC decision on this point was therefore affirmed.

The FC panel also found that the DC’s determination of no obviousness to be correct (e.g., “no evidence for a relationship of vitamin B12 and pemetrexed toxicity” and therefore no motivation “to administer vitamin B12 to patietns to addresss pemetrexed toxicity…Defendants fail to point to evidence that, even if folic acid supplementation were known to improve the effects of pemetrexed treatment, a skilled artisan would have thought the same of vitamin B12.”) The DC decision of no obviousness in view of the prior art was therefore affirmed. It also affirmed the DC decision of no obviousness-type double patenting “[f]or the same reasons”.

This entry was posted in Claim Differentiation, Indefiniteness, Inducement to Infringe, Infringement, Obviousness. Bookmark the permalink.

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