In Andrulis Pharmaceuticals Corp. v. Celgene Corporation, C.A. No. 13-1644-RGA (D. Del. Apr. 10, 2014), Judge Richard G. Andrews considered defendant’s motion to dismiss plaintiff’s direct and induced infringement claims for failure to state a claim. As to direct infringement, plaintiff alleged both “undivided” direct infringement and joint infringement. Id. at 1.
Judge Andrews dismissed plaintiff’s undivided direct infringement claim, which alleged that plaintiff itself directly “administers the patented method.” Id. at 1-2. Plaintiff argued that dismissal was inappropriate because the pleading “complies with Form 18.” Judge Andrews explained, however, that compliance with Form 18 is “not limited to whether the form was simply parroted.” Id. Rather, Judge Andrews found that “notice and facial plausibility,” were required, which were both found to be lacking with respect to the undivided direct infringement claim. Id. Additionally, in response to plaintiff’s argument that “dismissal would require construing the claims, which is inappropriate at the pleadings phase,” Judge Andrews acknowledged in a footnote that “I am always hesitant to engage in claim construction without a Markman hearing.” Id. at 2 n.1. In this case, however, Judge Andrews found occasion to note that “the claim at issue is a method claim that cannot possibly be read to make direct infringers out of anyone other than the medical personnel who treat patients.” Id.
Judge Andrews next considered plaintiff’s joint direct infringement claim, which alleged that “physicians administer the patented method under [defendant’s] direction and control.” Id. at 2. Finding these claims to survive the motion to dismiss, Judge Andrews explained that plaintiff “has pled more than enough factual allegations describing the relationship between prescribing doctors and Celgene” that would plausibly support the inference that defendant “direct or controls” the “doctors’ performance of the claimed method.” Id. at 3.
Judge Andrews also found plaintiff’s induced infringement claim to survive the motion to dismiss. Id. at 3-4. Defendant argued that “disseminating publications about an unapproved use of a product does not serve as evidence of intent that the product be used for that unapproved use because the FDA guidelines allow for dissemination of these materials.” Id. Judge Andrews found, however, that “[j]ust because the FDA labels materials as ‘non-promotional’ does not mean that doctors do not view these materials as promoting off-label uses.” Id. at 4. Accordingly, as Judge Andrews explained, “[t]he fact that [defendant] was aware of the patent and disseminated materials which it knew might be viewed as promoting that use is sufficient at this stage.” Id.