Guest Post by Ted Sichelman, University of San Diego School of Law
As any diligent reader of Patently-O would know, the Federal Circuit is considering en banc whether to retain the written description requirement—and, if so, in what form—in the pending case, Ariad Pharmaceuticals v. Eli Lilly & Co.
Lilly, which was found liable in the district court, argues in its en banc brief that the Federal Circuit should retain a strong and independent written description requirement. In the event Lilly’s arguments are successful—and Ariad’s patent is invalidated—Lilly stands to save roughly $250 million (in present value) of potential damages and likely settlement payments. (For an explanation of the calculation, click here.)
Yet, in another case pending at the Federal Circuit, Lilly v. Teva, Lilly—as the patentee—is on the other side of the fence on the written description issue. Specifically, Lilly appealed a finding that some of its patents are invalid for lack of written description. If Lilly wins this appeal, assuming infringement holds up, it stands to gain roughly $750 million (in present value) in on-going profits from the sale of its blockbuster osteoporosis drug Evista. (Ironically, Evista is one of the accused infringing drugs in Ariad.)
Thus, in simple dollar terms—focusing on Lilly’s pending patent cases at the Federal Circuit—Lilly has more money to gain by losing the Ariad appeal than winning it. Presumably, Lilly has other financial interests motivating its position in Ariad. For instance, Lilly has been subject to more than several accusations of infringement over the years and its financial wherewithal to engage in intensive R & D may make its patents relatively immune to written description attacks.
But, even so, Lilly might not care as much as the usual appellant if it loses the Ariad case. To be fair to Lilly and its lawyers, I have not seen any evidence showing that they have not vigorously argued their case. Nevertheless, Lilly’s large financial interest in Teva is concerning, especially given that Ariad could be one of the most important Federal Circuit decisions in recent years.
So when I read Lilly’s en banc brief to the Federal Circuit in Ariad, I was surprised that Lilly did not disclose its position in Teva. And it seems very unlikely that Lilly’s lawyers in Ariad were unaware of the issue in Teva, since at least three of them are working on both cases. Moreover, the district court in Teva mentioned the pending Ariad case in its final order, noting that it was bound by existing precedent to apply an independent written description requirement.
The Federal Circuit has a rule that requires litigants to disclose certain information about other pending cases. The applicable rule, Fed. Cir. R. 47.5, reads in relevant part:
Each principal brief must contain a statement of related cases indicating: …. (b) … any case known to counsel to be pending in this or any other court that will directly affect or be directly affected by this court’s decision in the pending appeal. If there are many related cases, they may be described generally, but the title and case number must be given for any case known to be pending in the Supreme Court, this court, or any other circuit court of appeals.
In my view, one could read the rule such that Lilly should have disclosed the Teva case in its Ariad brief. Unfortunately, the scope of this rule is sufficiently ambiguous to be construed otherwise. In particular, it is unclear whether “related cases” in the preamble of Rule 47.5 is, so to speak, a “limitation”—namely, does a case qualifying under Rule 47.5(b) need to be a “related case” in addition to meeting the requirements stated in that sub-section, or does that sub-section fully define the kinds of “related cases” that need to be disclosed? Arguably, the latter is the better reading, but it does not seem compelled by the language of the rule. Moreover, it is unclear exactly what “directly affect or be directly affected by this court’s decision” means. Since the rule contemplates that there may be “many related cases,” arguably this clause should be read broadly, but again, such an interpretation does not seem mandated by the rule.
What does seem clear, though, is that the roughly $750 million Lilly potentially has to gain in Teva from losing the Ariad case is important information that any Federal Circuit judge would want to know when reading Lilly’s briefs and listening to its arguments. As such, the Federal Circuit should clarify the scope of Rule 47.5—like it has done in a few cases (here and here)—or explicitly revise the rule to ensure that parties are clearly required to disclose cases like Lilly v. Teva.
For example, the Federal Circuit could—similar to DC Circuit Local Rule 28(a)(1)(C)—define a “related case” as including “any pending case involving at least one of the same parties and the same or similar issues.” Such a definition would capture cases like Lilly v. Teva, but would not overly burden litigants. With this sort of rule in place, potentially contrary interests of parties in other cases—particularly those worth large sums—would be appropriately unveiled on appeal.
Ted Sichelman is an Assistant Professor at the University of San Diego School of Law, where he teaches patent law and other intellectual property courses. He has neither represented nor has any financial interest (other than from market index funds) in Ariad Pharmaceuticals, Eli Lilly, or Teva.