like defendants' in this case. We see no reason to conclude that Congress intended to prohibit all product development and testing work (potentially infringing conduct) which was inspired, in part, by a hope that it would someday lead to profitable sales. Again, if a party were to lose the exemption every time a business purpose was detectable in its otherwise infringing activities, the exemption would virtually never be available and thus would fail to achieve Congress' objective.
For all these reasons, Congress sensibly chose words in the exemption that would lead courts to focus not on "purposes" or motives, but on "uses," and not on collateral activities, but only on the kinds of conduct which, absent the exemption, would constitute infringement. In the context of this understanding, we have struggled with the question of what analytical significance, if any, to ascribe to the "effects" of the otherwise infringing "uses" by defendant of the patented material. Because we believe that Congress contemplated a strictly objective test (to determine whether the exemption attaches), and because we believe that Congress did not intend the availability of the exemption to turn on findings about a party's "purposes" or "motives," we believe that we should consider "effects" only to the extent that doing so is helpful in identifying what the actual uses have been, and not, obviously, to shed light on the designs or ambitions or goals ("purposes") that might have underlay those uses. Moreover, since what we are examining is actual, otherwise infringing uses, not purposes and not collateral activity, we conclude that the only kinds of "effects" to which it might be appropriate to ascribe appreciable significance in this analysis are those that are immediate and direct. We will concern ourselves little, if at all, with effects that are indirect, or in which the causal chain has several links. We will ignore altogether effects that are speculative or remote.
Thus, our inquiry is relatively straightforward. We focus only on those acts by Ventritex which would be deemed "infringing" but for § 271(e)(1) and in which Ventritex actually has engaged (as opposed to the acts in which the company might engage in the future). With respect to those actual acts, we do not ask what underlying motives might have inspired them or what indirect, ripple effects (e.g., long range consequential benefits) they might bring. Instead, we simply ask: are these actual uses "solely . . . reasonably related to the development and submission of information" to the FDA. If so, the exemption protects Ventritex. But if there are any actual, non-de minimis uses that are not reasonably related to generating data for the FDA, the exemption will not protect Ventritex.
We infer that the phrase "reasonably related" (to development of information for the FDA) as used in § 271(e)(1) reflects Congress' acknowledgement that it will not always be clear to parties setting out to seek FDA approval for their new product exactly which kinds of information, and in what quantities, it will take to win that agency's approval. Thus, Congress used this phrase to communicate its intention that the courts give parties some latitude in making judgments about the nature and extent of the otherwise infringing activities they would engage in as they sought to develop information to satisfy the FDA. Contrary to the suggestion seemingly made by plaintiff, we do not believe that Congress intended a party to lose the exemption simply because it turns out, after the fact, that some of that party's otherwise infringing "uses" either failed to generate information in which the FDA was interested or generated more information than turned out to be necessary to secure FDA approval. Instead, with respect to this aspect of the test we should ask: would it have been reasonable, objectively, for a party in defendant's situation to believe that there was a decent prospect that the "use" in question would contribute (relatively directly) to the generation of kinds of information that was likely to be relevant in the processes by which the FDA would decide whether to approve the product? If the answer is yes, it should not matter that other reasonable persons might have concluded that FDA approval could be secured even without the information in question.
3. Standards Applicable to Ruling on These Motions
As we noted in the introduction, we are treating the parties' cross motions as motions for partial summary judgment. Thus, we apply standards developed under Federal Rule of Civil Procedure 56. In so doing we resolve all reasonable doubts about whether any material issue can be viewed as genuinely in dispute in favor of the party against whom the motion is made.
In the specific setting of the motions directed toward the availability of the exemption under § 271(e)(1), we first ask: Absent the exemption, which alleged uses by Ventritex would be deemed "infringing"? In connection with this first inquiry, we ascertain whether there are genuine disputes about whether in fact Ventritex engaged in any of the uses that we believe, as a matter of law, could constitute "infringements" but for the exemption. If there are genuine disputes about whether Ventritex engaged in any such uses, we will assume, for purposes of ruling on these motions, that Ventritex in fact engaged in those uses.
Our next task will be to determine whether there is a genuine factual dispute about whether any of Ventritex's otherwise infringing and non de-minimis uses of its product are not reasonably related to securing FDA approval. If any such factual matters are genuinely in dispute, we may not grant summary judgment in defendant's favor.
In earlier papers plaintiff identified a number of activities which it claims constitute uses of the Cadence that are not reasonably related to generating data for the FDA. These activities include:
1. Using data gathered from the testing of the Cadence to obtain import approval from foreign governments;
2. Authorizing the publication of articles describing features of the Cadence;