Andrulis v. Celgene: District Court Dismisses Undivided Direct Infringement Claim But Permits Joint Direct Infringement Claim to Proceed

by Jeffer Mangels Butler & Mitchell LLP

Plaintiff Andrulis Pharmaceuticals Corp. ("Andrulis") filed a patent infringement action against Celgene Corporation ("Celgene") alleging direct, induced, and contributory infringement. Celgene filed a motion to dismiss arguing that the complaint failed to state a claim.

After Andrulis voluntarily dismissed the contributory infringement claim, the district court analyzed the claims for direct and induced infringement. For direct infringement, Andrulis alleged two factually distinct theories. "The first is that Celgene itself directly infringes the claims because it administers the patented method, which Andrulis refers to as the undivided direct infringement claim. The second is that Celgene is a joint infringer because physicians administer the patented method under Celgene's direction and control, which Andrulis refers to as the joint direct infringement claim."

The district court concluded that the undivided direct infringement theory failed to state a claim. "Andrulis alleges that Celgene itself administers the patented method because authorization is required from Celgene before a prescription will be filled. Andrulis contends that dismissal is inappropriate because the pleading complies with Form 18 and that any such dismissal would require construing the claims, which is inappropriate at the pleadings phase. While Andrulis is correct inasmuch as complying with Form 18 is the appropriate inquiry, the analysis is not limited to whether the form was simply parroted." The district court concluded that "[e]ven assuming that Celgene administers thalidomide via authorizing prescriptions, there is no plausible basis to infer that Celgene administers thalidomide in combination with an alkylating agent, as required by the claim. I therefore dismiss the undivided direct infringement claim."

On the join direct infringement claim, however, the district court found that Andrulis had stated a claim. "Celgene argues that the complaint does not allege facts to support a plausible inference that Celgene "directs or controls" doctors' performance of the claimed method. Essentially, Celgene asserts that the allegations do not support a finding that prescribing doctors are agents of Celgene. I disagree. Andrulis has pled more than enough factual allegations describing the relationship between prescribing doctors and Celgene. Andrulis has alleged that Celgene exerts a high degree of control over the prescribing of thalidomide. Andrulis has also alleged that Celgene directs doctors to prescribe thalidomide in concert with alkylating agents by promoting off label uses of thalidomide. Given the number of factual allegations, I find that there is a plausible inference that Celgene "directs or controls" doctors' performance of the claimed method."

The district court also concluded that the induced indirect infringement claim should survive the motion to dismiss. "The factual allegations for this claim are largely the same as the "direction" prong of the joint infringement claim. Celgene argues 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. . . . Just because the FDA labels materials as "non-promotional" does not mean that doctors do not view these materials as promoting off-label uses. Additionally, Andrulis has plausibly alleged that Celgene was aware of the patent. This allegation must also be taken into account in the overall "context." The fact that Celgene was aware of the patent and disseminated materials which it knew might be viewed as promoting that use is sufficient at this stage."

Andrulis Pharmaceuticals Corp. v. Celgene Corporation, Case No. 13-1644-RGA (D. Del. Apr. 11, 2014)

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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