Addressing the issue of whether defendant’s abbreviated new drug application (ANDA) formulation would infringe plaintiff’s method patents under a theory of joint direct infringement, Circuit Judge Bryson sitting in the US District Court for the District of Delaware denied plaintiff’s motion for summary judgment. Pernix Ireland Pain DAC v. Alvogen Malta Operations Ltd., Civil Action No. 16-139-WCB, 2018 (D. Del., May 15, 2018) (Bryson, J). 

Pernix filed a motion for summary judgment of infringement of its method patents based on Alvogen’s filing of an ANDA with the US Food and Drug Administration (FDA) seeking authorization to sell hydrocodone bitartrate extended release capsules as generic versions of Pernix’s formulation, sold under the name Zohydro.

During claim construction, the court rejected Pernix’s argument that the term “administering” should include the acts of prescribing or dispensing by a physician or health care provider, and issued a construction that “administering” meant “delivering into the body.” In the context of this construction, Pernix filed an infringement contention based on a theory of joint direct infringement by the physician and the patient. Specifically, Pernix contended that a physician and patient jointly infringe the method claims when the physician prescribes and directs a hepatically impaired patient to take extended release hydrocodone bitartrate, and the patient takes the drug as directed.

The court cited to established Federal Circuit precedent that “joint direct infringement of a claimed method occurs if the physician ‘directs or controls’ the patient so that the patient’s acts are attributable to the physician.” Eli Lilly & Co. v. Teva Parenteral Meds., Inc., Case No. 845 F.3d 1357, 1364 (Fed. Cir., 2017). In particular, the court noted that the requisite degree of direction and control occurs if the physician “conditions participation in an activity or receipt of a benefit” on the patient’s performance of one or more steps of the claimed method, and the physician “establishes the manner or timing of that performance.”

The court found that “[a]lthough it is clear that a physician gives instructions to a patient as to dosing levels and practices, the extent to which those instructions constitute ‘direction and control’ of the patient’s infringing conduct turns on factual questions.” Pernix argued that no issue of material fact existed regarding a physician’s direction and control. Specifically, Pernix cited to the fact that hydrocodone is a controlled substance, and physicians enter into agreements with their patients requiring the patients to take the drug as prescribed, and thus exercise control and direction over the patients’ conduct in that regard. Pernix also cited to the deposition testimony of Alvogen’s infringement expert that physicians establish the timing and manner in which the patients administer the drug.

Alvogen countered that Pernix’s evidence did not show that physicians necessarily control and direct patients, because there is no evidence that physicians “condition” on the patient’s administering the drug as prescribed. In addition, Alvogen argued that physicians have no means of verifying that instructions are followed.

The court found that Pernix’s evidence was insufficient to show that there was not an issue of material fact, stating that “[w]hile Pernix’s evidence could support a finding that physicians exercise direction and control over the self-administration of hydrocodone extended release formulations by patients, the evidence on that issue is not so compelling as to justify the entry of summary judgment in Pernix’s favor.”

Practice Note: Alvogen was able to provide expert testimony that countered the evidence proffered by Pernix. This expert testimony was enough to show that the facts regarding joint  direct infringement were disputable, thus demonstrating the value of expert testimony at the summary judgment stage.