How Critical is it to Correlate Claim Language with FDA Labeling?
{3 minutes to read} In a new case, Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., the Federal Circuit affirmed the lower court’s decision finding of patent infringement under Akamai. The appeal arose from an Abbreviated New Drug Application (ANDA) litigation describing to take ALIMTA® [pemetrexed sodium] with folic acid and vitamin B12 to reduce side effects.
The patent at issue, U.S. Patent No. 7,772,209, contained two independent claims which recite, inter alia, to administer pemetrexed disodium together with folic acid and a methylmalonic acid.
Teva’s proposed product labeling was based on the ALIMTA®’s label, that is, on the Physician Prescribing Information, which instructed the patients to initiate folic acid once daily, beginning 7 days before the first dose of pemetrexed, followed by folic acid and vitamin B12 supplementation to reduce treatment-related hematologic and gastrointestinal toxicity.
Moreover, the label also instructed the patients to take folic acid and vitamin B12 prior to and during their treatment [with pemetrexed].
The US District Court applied the“Akamai” decision and found Teva liable for induced infringement based on direct infringement by physicians. The District Court held that the performance of all steps of the asserted claims would be attributable to the physicians.
As in many ANDA cases, the defendant’s liability is based on induced infringement. However, under the Supreme Court’s decision of Limelight Networks, Inc. v. Akamai Techs., Inc., “liability for inducement of infringement cannot be found without direct infringement.” Thus, the question on appeal was whether the defendant’s sale of a generic version would cause direct infringement of the patent. The Federal Circuit agreed with the District Court that it would.
The Federal Circuit applied the two-pronged test of Akamai.
Does a single actor:
(1) condition participation in an activity or receipt of a benefit upon another’s performance of one or more steps of a patented method; and
(2) establish the manner or timing of that performance?
The First Prong
The Federal Circuit agreed that the label specified that the administration of folic acid was a “requirement for premedication” to “reduce the treatment-related toxicity of pemetrexed.”
The Second Prong
The Federal Circuit noted that the label instructed physicians to tell the patients to take folic acid at specific doses and at a specific schedule.
Thus, the Federal Court held that Teva was infringing.
In conclusion, for a patentee it is very important to try to correlate the claim language with FDA labeling. Please contact me to discuss or if you have questions or comments.
Silvia Salvadori, PhD
(212) 897-1938