NEWS
Novartis seeks injunction against proposed Zometa generic
Novartis has sued drug company BPI Labs for alleged patent
infringement aſter it requested
permission to market a generic version of Novartis’s bone cancer drug Zometa (zoledronic acid). Te Swiss pharmaceutical company filed the
case on February 9 at the US District Court for the Middle District of Florida, Tampa Division. It came in response to BPI’s Abbreviated New Drug Application (ANDA) at the US Food and Drug Administration (FDA). Wyoming-based BPI has sought approval
to make and sell a generic version of the drug before Novartis’s patent covering it—US number 8,324,189—expires in 2025. Zometa, which is used to treat cancer that has
spread to the bones, was approved by the FDA in 2001. According to the complaint, Novartis has
already filed several other patent infringement lawsuits, at the US District Court for the District of New Jersey, which concern alleged infringement
of the ‘189 patent. One is an action against pharma company Wockhardt USA. Te patent, called “use of zoledronate for the
manufacture of a medicament for the treatment of bone metabolism diseases”, covers the method of administration for Zometa. It is the only patent listed for Zometa in the Orange Book. BPI previously argued in its notice letter
to Novartis that the ‘189 patent is invalid and unenforceable. Novartis has asked for a judgment that the patent is valid and enforceable, that it has been infringed by BPI’s submission of the ANDA, and for an order providing that the FDA will not approve BPI’s ANDA before the ‘189 patent expires. Te Swiss company has also asked for a
permanent injunction stopping BPI from selling the proposed generic product in the US. Novartis did not respond to a request
for comment. BPI could not be reached for comment.
patent suit
Bayer’s animal health division has filed for a declaratory judgment
that SHP Chemical has
infringed three patents covering a range of products that control fleas affecting cats and dogs. Te German chemical and pharmaceutical
company filed the lawsuit on February 6 at the US District Court for the District of Nevada. In October 2013, according to the suit, SHP informed Bayer that
Environmental Protection Agency
it had applied to the US (EPA) to
register a similar product, formulated with the active ingredient imidacloprid. Te EPA is a US government body that protects
human health and the environment, and plays a role in regulating flea and tick products for animals. Imidacloprid is an insecticide used in Bayer’s
Advantage II for Cats and Dogs, Advantage Multi for Cats and Dogs, and K9 Advantix II for Dogs products. Bayer has cited the three patents it owns
covering uses and formulations of imidacloprid to treat cats and dogs with fleas. According to the complaint, the only
EPA-approved use of imidacloprid in animal-related products involves the control of parasitic insects by topical application, which is covered by Bayer’s US patent 6,232,328. Bayer argued that SHP’s proposed
product will infringe one or more of its patents, which cover the three cited products. Te company said it had asked SHP repeatedly for
6 Life Sciences Intellectual Property Review Volume 2, Issue 2
assurance that its proposed product would not infringe the three patents, but it did not receive any. Bayer claimed that a letter from its counsel
asking SHP to “identify any basis it has to believe that it is not infringing, inducing infringement, or contributing to infringement” did yield a response shortly aſter it was sent, in October 2013, but that SHP did not clarify its position. “SHP are not willing to reveal in writing any
basis for the belief that they are not infringing, inducing infringement or contributing to the infringement of any Bayer patent,” according to Bayer's complaint. Bayer also claimed that another letter it sent
to SHP later in October 2013, again asking for clarification, was not responded to. Bayer has asked for a declaration that
the
proposed sale of SHP’s product would infringe the three patents, and a preliminary and permanent injunction stopping SHP from infringing the patents. Te German company has also asked that if the product is commercialised it receives damages, which will either be compensation for lost profits or a “reasonable royalty”. SHP’s product has not yet
been finally approved. Bayer did not respond to a request for comment. SHP could not be reached for comment.
www.lifesciencesipreview.com
ERMOLAEV ALEXANDER /
SHUTTERSTOCK.COM
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