Allergan sued for promoting off-label Botox use
An Ontario-based company has sued Allergan for allegedly infringing a method patent that protects the use of cosmetic drug Botox (onabotulinumtoxinA) to treat back pain.
The company, known as “1474971 Ontario” in the court filing, launched the suit at the US District Court for the Northern District of Illinois last Thursday (April 16).
Botox is best known for its cosmetic uses. It is injected into the face to smooth wrinkles by paralysing facial muscles, though it has other medical uses including the treatment of chronic migraine and excessive sweating.
In its court filing, 1474971 accused Allergan of infringing and inducing infringement of its US patent 6,806,251, titled “method of treating pain”, by encouraging physicians to use Botox to treat back pain.
The patent claims a method of treating back pain by injecting Botox into the deep muscles of the spine, a treatment that has not been approved by the US Food and Drug Administration (FDA).
According to the complaint, Allergan, which itself markets Botox in the US,
had been training healthcare professionals to perform this spinal injection of Botox. The plaintiff sent Allergan a letter in June 2011—not threatening infringement but arguing that the company was “falsely claiming ownership of the ‘251 patent in the commercial marketplace”.
1474971 said in the complaint that Allergan has created and financed organisations to promote off-label uses of Botox. It added that Allergan encouraged such use by informing the injectors about how to be reimbursed for “these non-approved uses by third-party payers”.
The plaintiff argued that many of Allergan’s Botox sales derive from uses that have not been approved by the FDA, including those that allegedly infringe its patent.
It has asked for a judgment that the ‘251 patent is valid and has been infringed by Allergan, and for a permanent injunction stopping Allergan from infringing the patent. It also asked for damages, including triple damages “for willful and reckless infringement”.
Allergan’s Botox and neuromodulators unit generated $2.2 billion last year. Botox is available in about 80 countries around the world.
In 2010, Allergan was found guilty of promoting off-label and unapproved use of Botox by the US government, and fined $600 million.
1474971 could not be reached for comment. Allergan did not respond to a request for comment.
