Generic Drug Draws Preliminary Injunction
A Preliminary Injunction in A Patent Case
In patent litigation, you don’t often see a preliminary injunction barring a defendant’s activity. But a recent case heard by the U.S. Court of Appeals for the Federal Circuit, AstraZeneca LP v. Apotex, Inc., shows that it’s possible to obtain such an injunction.
AstraZeneca LP v. Apotex, Inc.
In 2000, the Food and Drug Administration (FDA) approved AstraZeneca’s application for an asthma drug administered via an inhaler. The drug is covered by two patents. The label that accompanies AstraZeneca’s drug indicates that it may be administered once or twice daily, but the patents describe once-daily treatment. The label states that the drug is available in three strengths and provides a table of recommended starting doses. It repeatedly advises patients to “titrate down” to the lowest effective dose to avoid any adverse effects from excessive use.
Apotex sought FDA approval to manufacture and sell a generic version of the drug for twice-daily use. Its proposed label, with certain exceptions, was identical to AstraZeneca’s label — including the FDA-mandated downward-titration language.
AstraZeneca Seeks Preliminary Injunction
The day after the FDA approved Apotex’s application, AstraZeneca sought a preliminary injunction barring Apotex from launching its version of the drug. AstraZeneca argued that the downward-titration language effectively instructed consumers to take the drug once-daily and, therefore, would induce infringement of its patent claims. The district court issued the injunction, and Apotex appealed.
Sticking to The Label
For a patentee to obtain a preliminary injunction, it must establish that it’s likely to prove its infringement claim in court and that it’s likely to suffer irreparable harm in the absence of an injunction. Apotex contended that, when a product has substantial noninfringing uses (such as twice-daily administration), intent to induce infringement can’t be inferred — even when the alleged inducer has actual knowledge that some users of its product may be infringing the patent.
The Federal Circuit agreed with Apotex. But it noted that a court could find a defendant liable for inducement when the patentee can demonstrate statements or actions by the defendant that were intended to promote infringement.
Both the district and the appellate courts held that evidence of such statements or actions existed in this case. They found that Apotex had the requisite intent to induce infringement because it included instructions in its proposed label that would cause at least some users to infringe the patent claims. Further, despite being aware of the infringement problem the proposed label posed, Apotex proceeded with its plans to distribute its generic drug.
Apotex argued that the titration language in its label constituted a warning and that warnings don’t influence how a drug is used. It also asserted that the warning was just a general recommendation applicable to any drug dosing regimen. The Federal Circuit disagreed, explaining that “the pertinent question is whether the proposed label instructs users to perform the patented method.” And, here, the language would inevitably lead some consumers to use the patented method.
Breathing Easier
In light of the irreparable harm that would otherwise result — including layoffs and loss of goodwill — the Federal Circuit affirmed the granting of the preliminary injunction against Apotex. Although cases such as this are rare, the circumstances of this one are important for patent holders to bear in mind.
About the patent law firm:
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