Bone Care Int'l v. Roxane Labs., No. 09-cv-285 (GMS) (D. Del.)
In an opinion this past Monday, the U.S. District Court for the District of Delaware found in favor of Genzyme and against ANDA applicants Roxane, Sandoz, and Anchen in the paragraph IV litigation concerning HECTOROL (doxercalciferol), Genzyme's drug for the treatment of secondary hyperparathyroidism (SHPT) in patients with end-stage renal disease (ESRD). The court ruled that defendants' ANDA products would induce infringement of claim 7 of U.S. Patent No. 5,602,116; that claim 7 is entitled to a 1988 priority date; and that claim 7 is not invalid as "inoperative" or obvious. This post focuses on the inducement issue.
Claim 7 of the '116 patent is directed to:
A method for lowering or maintaining lowered serum parathyroid hormone [PTH] in patients suffering from hyperparathyroidism secondary to end stage renal disease, comprising: administering to said patients an effective amount of [doxercalciferol] to lower and maintain lowered serum parathyroid hormone levels.
After a Markman hearing, the court construed the term "effective amount of doxercalciferol to lower and maintain lowered serum parathyroid hormone levels" to mean "an amount of doxercalciferol sufficient to lower and maintain lowered blood concentrations of PTH with a lower incidence of hypercalcemia than would result from using calcitriol or alfacalcidol to achieve the same level of PTH suppression."
After concluding that claim 7 would be directly infringed by the defendants' ANDA products (a predicate to finding inducement of infringement), the court addressed whether the defendants have the required intent to induce infringement. The key issue here was whether the defendants intend to induce infringement of claim 7 notwithstanding that their proposed labeling says nothing about the incidence of hypercalcemia resulting from doxercalciferol relative to the incidence resulting from calcitriol or alfacalcidol.
The court began its analysis by stating:
As noted, the "pertinent question" in ANDA cases, with respect to induced infringement, is "whether the proposed label instructs users to perform the patented method," and "promotes" or "encourages" others to practice that method. Here, the court has found, for the reasons stated above, that the defendants' proposed product labels would instruct users to perform each element of the patented method detailed in claim 7. The Federal Circuit has clarified, however, that satisfaction of this element, without more, is insufficient to prove inducement. Instead, the patentee must also present evidence that the defendant "knew or should have known that his actions would induce actual infringement" and "that the induced acts constitute patent infringement."
The court continued:
As noted, in the Hatch-Waxman context, "statements in a package insert that encourage infringing use of drug product are alone sufficient to establish intent to encourage direct infringement" for purposes of induced infringement under 35 USC 271(b). The Federal Circuit has stated, however, that inducement in the ANDA context should not be decided according to the tenets of strict liability action. Instead, a court assessing an inducement claim should determine whether the proposed label "instructs users to perform the patented method" and "teaches an infringing use . . . such that we are willing to infer from those instructions an affirmative intent to infringe the patent." Here, each of these requirements is met.
For these statements of law, the court cited AstraZeneca v. Apotex (Fed. Cir. 2010), DSU Medical v. JMS (Fed. Cir. 2006), and Vita-Mix v. Basic Holdings (Fed. Cir. 2009).
The court thus concluded:
With respect to the specific intent element of inducement, the court concludes that the plaintiffs have sufficiently shown that the defendants "knew or should have known their actions would induce actual infringements." In this case, all defendants filed ANDAs with the FDA seeking approval to market a doxercalciferol product that would be sold accompanied by information instructing physicians and medical professionals to administer doxercalciferol according to the method explained in claim 7 for treating SHPT in patients with ESRD. This FDA-approved indication is the same use set forth in claim 7 of the patent-in-suit . . . .
The court concludes that, based on the clinical trials and literature available, the defendants knew or should have known that doxercalciferol has been shown to lower and maintain lowered PTH levels with a lower incidence of hypercalcemia than would result from using calcitriol or alfacalcidol at the same level of PTH suppression. Thus, the court concludes that the defendants, in submitting their ANDAs, knew or should have known that their proposed products would induce actual infringement of claim 7. The court finds this level of intent sufficient for inducement purposes.
The defendants are certain to appeal the decision to the Federal Circuit.