The Federal Circuit Found Direct Infringement Attributable to Physicians Where “No Single Actor Performs All Steps of a Claim”

Can a patient’s action in taking a generic drug be attributable to a physician such that it can support a finding of the physician’s direct patent infringement? According to a recent precedential opinion of the Court of Appeals for the Federal Circuit (the “Federal Circuit”), at least in some circumstances, it is possible.

On January 12, 2017, the Federal Circuit in Eli Lilly and Company v. Teva Parenteral Medicines, No. 2015-2067 (“Eli Lilly”) affirmed a district court’s findings of (1) direct infringement attributable to physicians and (2) Defendants’ liability for inducing physicians’ infringement, even though “no single actor performs all steps of the asserted claims.” The Federal Circuit at the same time affirmed that the asserted claims were not invalid for indefiniteness, obviousness, or obviousness-type double patenting (invalidity issues are not discussed in this blog).

Eli Lilly is a Hatch-Waxman lawsuit in which Eli Lilly asserted U.S. Patent No. 7,772,209 (“the ’209 patent”). The ’209 patent claims methods of administering the chemotherapy drug pemetrexed disodium after pretreatment with folic acid and vitamin B12. Eli Lilly has marked Pemetrexed disodium under the name ALIMTA®. Defendants filed Abbreviated New Drug Applications (“ANDA”) to seek FDA’s approval of generic versions of ALIMTA®. Eli Lilly sued Defendants for liability of inducing infringement. Defendants counterclaimed that the asserted claims of the ’209 patent were invalid and that there was no infringement.

All asserted claims include a step of administering certain amount of folic acid and methylmalonic acid, such as vitamin B12, prior to administering pemetrexed disodium. For example, asserted claim 12 recites:

12. An improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment, wherein the improvement comprises:
a) administration of between about 350 μg and about 1000 μg of folic acid prior to the first administration of pemetrexed disodium;
b) administration of about 500 μg to about 1500 μg of vitamin B12, prior to the first administration of pemetrexed disodium; and
c) administration of pemetrexed disodium.

Both parties agreed that the steps as recited in the asserted claims were divided between physicians and patients, where physicians administer vitamin B12 and pemetrexed and patients self-administer folic acid. Id. at 5.

In light of the Supreme Court’s holding that liability for inducement cannot be found without direct infringement, id. at 6 (citing Limelight Networks, Inc. v. Akamai Techs., Inc. (Akamai III), 134 S. Ct. 2111 (2014)), the Federal Circuit first considered the direct infringement issue. According to the Federal Circuit, where no single actor performs all steps of a method claim, direct infringement only occurs if “the acts of one are attributable to the other such that a single entity is responsible for the infringement.”  Akamai Technologies, Inc. v. Limelight Networks, Inc. (Akamai V), 797 F.3d 1020, 1022 (Fed. Cir. 2015) (en banc) (per curiam), cert. denied, 136 S. Ct. 1661 (2016). The performance of method steps is attributable to a single entity when that entity “directs or controls” others’ performance, or when the actors “form a joint enterprise.” Eli Lilly, at 9 (citing Akamai V).  Since Eli Lilly did not pursue a joint enterprise theory, the Federal Circuit only considered whether physicians direct or control their patients’ administrations of folic acid.

In considering the “direct or control” issue, the Federal Circuit applied the two-prong test set up in Akamai V:

  1. “conditions participation in an activity or receipt of a benefit’ upon others’ performance of one or more steps of a patented method,”
  2. “establishes the manner or timing of that performance.” Id. (citing Akamai V, at 1023).

The Federal Circuit’s determination relied on the evidence of product labeling and Eli Lilly’s expert testimony. Defendants’ proposed generic product labeling was similar to the ALIMTA® product labeling, which specified that physicians should instruct patients to take folic acid and included information about folic acid dosage ranges and schedules. Id. Eli Lilly’s expert testified that taking folic acid was “an absolute requirement” before pemetrexed treatment and a physician would not give the pemetrexed if a patient did not follow his or her instructions to take folic acid. Id. at 12.

With respect to the first prong, the Federal Circuit first agreed that the district court “correctly identified pemetrexed treatment as the benefit to be conditioned” and concluded that the product labeling, combined with the testimony, provided sufficient evidence that physicians condition pemetrexed treatment on folic acid pretreatment.  Id. at 13. According to the Federal Circuit, the record was “replete with evidence that physician[s] delineate the step of folic acid administration that patients must perform if they wish to receive pemetrexed treatment.”  Id. at 12. The Federal Circuit rejected the Defendants’ argument that mere guidance or instruction was insufficient to show “conditioning” under Akamai V, stating “that evidence regarding the critical nature of folic acid pretreatment and physicians’ practices support a finding that physicians cross the line from merely guiding or instructing patients to take folic acid to conditioning pemetrexed treatment on their administration of folic acid.”  Id. at 12. 

With respect to the second prong, the Federal Circuit stated that the product’s Physician Prescription Information instructed physicians not only to tell patients to take folic acid orally, but also informed the dosage range of folic acid and schedules.  Id. at 14. In addition, the expert testified that it is the doctor “who decides how much [folic acid] the patient will take and when the patient takes it.” Id. Accordingly, the district court’s finding that physicians establish the manner and timing of patients’ folic acid intake was not clearly erroneous. Id. at 14-15.

After establishing physicians’ direct infringement, the Federal Circuit went further to find liability for induced infringement. According to the Federal Circuit, the mere existence of direct infringement by physicians was not sufficient for inducement. Id. at 15.  To show inducement, there must be specific intent and action to induce infringement.  Id. According to the Federal Circuit, the product labeling included repeated instructions and warnings regarding the importance of and reasons for folic acid treatment.  The instructions are unambiguous on their face and encourage or recommend infringement of the asserted claims. Id. at 16-18.  Because the product labeling “would inevitably lead some physicians to infringe establishes the requisite intent for inducement,” the district court did not clearly err in finding Defendants’ inducement. Id. at 18.

In sum, the Federal Circuit upheld a district court’s finding of performance of method steps being attributable to physicians, even though steps of the asserted claims were divided between physicians and patients. The Federal Circuit, however, particularly pointed out that the holding did not assume that patient action is attributable to a prescribing physician solely because they have a physician-patient relationship. The Federal Circuit left open for future determination whether other scenarios may also be found to satisfy the “direction or control” requirement.  Id. at 15.

This blog was written by Mae Hong and Andrew Wahba at Miles & Stockbridge.

Opinions and conclusions in this post are solely those of the author unless otherwise indicated. The information contained in this blog is general in nature and is not offered and cannot be considered as legal advice for any particular situation. Any federal tax advice provided in this communication is not intended or written by the author to be used, and cannot be used by the recipient, for the purpose of avoiding penalties which may be imposed on the recipient by the IRS. Please contact the author if you would like to receive written advice in a format which complies with IRS rules and may be relied upon to avoid penalties.