Abraxis Bioscience v. Navinta, No. 2009-1539 (Fed. Cir. 2010)
In 2006, Navinta filed an ANDA for a generic version of Naropin (ropivacaine), a drug indicated for use in surgical anasthesia and acute pain management. At the time, there was only one patent listed for ropivacaine in the Orange Book, U.S. Patent No. 4,870,086, which claims an optically pure isomer of ropivacaine hydrochloride monohydrate. Navinta's ANDA included a paragraph IV certification to the '086 patent.
Shortly after receiving Navinta's notice of paragraph IV certification to the '086 patent, Abraxis sued Navinta under 35 USC 271(e)(2), alleging infringement not only of the '086 patent, but also of U.S. Patent Nos. 5,670,524 and 5,834,489 (the "method patents"), which are directed to methods of using low concentrations of ropivacaine for the treatment of pain. Although the '524 and '489 patents issued years earlier, they were not listed in the Orange Book at the time Navinta filed its ANDA.
Navinta filed a motion to dismiss Abraxis's claims regarding the method patents, arguing that because the method patents were not listed in the Orange Book, Navinta did not file paragraph IV certifications on them, and therefore there was no basis for suit under section 271(e)(2). The district court, however, denied Navinta's motion to dismiss, concluding that suit under 271(e)(2) was proper notwithstanding that the method patents weren't listed in the Orange Book.
Navinta appealed this ruling to the Federal Circuit, arguing that jurisdiction under section 271(e)(2) is proper only when an ANDA filer has made a paragraph IV certification, and citing several cases from the Supreme Court and Federal Circuit that allegedly "held that section 271(e)(2) requires a paragraph IV certification." In response, Abraxis argued that the alleged "holdings" cited by Navinta were actually mere dicta, and that neither the Supreme Court nor Federal Circuit has ever directly answered whether a paragraph IV certification is a prerequisite to suit under 271(e)(2).
Some number of months after the district court denied Navinta's motion to dismiss for lack of jurisdiction under section 271(e)(2), Navinta filed a second motion to dismiss, this time alleging that Abraxis lacked standing to sue because, due to a break in the chain of title, Abraxis did not own the patents-in-suit at the time that it filed the Complaint. The district court, however, again denied Navinta's motion, finding that although there was a break in the chain of title to the patents, the "intent" of the various assigning entities was sufficient to imply a nunc pro tunc assignment based on the relationship between the corporate entities. Having denied Navinta's second motion to dismiss, the case proceeded to trial.
Last August, after a seven-day bench trial, the district court issued its opinion on the merits. The court found direct and indirect infringement of the '086 composition patent, and indirect infringement of the '524 and '489 method patents. Pursuant to its findings of infringement of the method patents, the district court ordered that the effective date of approval of Navinta's ANDA product be no earlier than September 14, 2014, the expiration date of the method patents.
The district court's findings that Navinta would induce infringement of the method patents are the most interesting, because while the method patents are limited to the use of a low concentration of ropivacaine for the treatment of acute pain, Navinta had amended its ANDA not to seek approval of the low concentration of ropivacaine and, pursuant to section viii, had "carved out" the acute pain indication from its proposed ANDA product labeling. The district court, however, concluded that Navinta "knows or should know that practicioners will use its ANDA products at diluted concentrations for pain management." Furthermore, despite Navinta's section viii labeling carve-out, the district court concluded:
Navinta's Package Insert Labeling is sufficient to establish Navinta's encouragement of direct infringement of the '524 and '489 patents: (1) Navinta's Labeling specifically encourages infringement by including multiple references to use of the ANDA Products in labor and delivery, which is an acute pain management application that is only FDA-approved at [low] concentrations and by epidural administration; (2) Navinta's Labeling specifically encourages infringement by including statements referring practicioners to medical practice texts and references, which would instruct practicioners to use ropivacaine at concentrations of 0.2% or below for pain management; (3) Navinta's Labeling specifically encourages infringement by encouraging the use of the ANDA Products at the lowest possible concentrations for pain management issues.
Navinta appealed these findings. Navinta argued in its appeal brief that the district court erred "because there was insufficient evidence that Navinta will actively encourage infringement or that Navinta possesses specific intent to encourage infringement," as required under the Federal Circuit's en banc decision in DSU Medical v. JMS. Navinta argued: "In holding Navinta responsible for uses of its ANDA product that are not mentioned or suggested in its labeling, the district court converted indirect infringement into a strict liability offense where Navinta was held responsible for possible downstream uses that it did nothing to encourage." In support, Navinta cited the Federal Circuit's two off-label use decisions of 2003: Warner-Lambert v. Apotex and Allergan v. Alcon. In those cases, the Federal Circuit concluded that the ANDA filers were not liable for inducement of infringement of patents claiming off-label uses.
On Tuesday, the Federal Circuit issued its decision on the appeal. Unfortunately, however, it based its decision on the least interesting of the three issues that Navinta appealed. The Federal Circuit concluded that due to a break in the chain of title, Abraxis did not own the patents-in-suit when it filed the Complaint, and Abraxis therefore lacked standing. Accordingly, the Federal Circuit reversed and vacated the district court's denial of Abraxis's second motion to dismiss, and remanded with instructions for the district court to dismiss Abraxis's complaint without prejudice.
In all likelihood, Abraxis will refile its Complaint against Navinta in the district court, the district court will quickly issue a final judgment on the merits of the infringement claims, Navinta will appeal again and the case will be back at the Federal Circuit. There is, therefore, still hope that the Federal Circuit will weigh in on the interesting issues in this case.
FEDERAL CIRCUIT APPEAL BREIFS:
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