MSD targets Apotex in Nasonex infringement action

Merck Sharp & Dohme (MSD) has sued Apotex at the US District Court for the District of New Jersey for allegedly infringing a patent covering hay fever nasal spray Nasonex (mometasone furoate).

MSD’s patent, US number 6,127,353, covers a process for making mometasone furoate and its pharmaceutical compositions.

The patent has already been the subject of litigation between the two companies at the same court.

In 2009, Apotex filed an Abbreviated New Drug Application (ANDA) at the US Food and Drug Administration (FDA) seeking approval to make and sell a generic version of Nasonex before the ‘353 patent’s October 2017 expiry date.

MSD sued Apotex in response to the ANDA later that year, accusing it of infringing the ‘353 patent. The case was tried in 2012.

The judge found that the ‘353 patent was valid, but could not determine whether it had been infringed by Apotex as the company had supplied MSD with one sample of its proposed generic product, rather than a selection from different batches.

Since that case Apotex has launched its generic mometasone furoate product in Canada and Australia.

According to MSD, the generic products marketed in those countries, which contain the patented active ingredient, differ from the sample it was given in the previous litigation.

MSD wrote to Apotex in December last year asking for confirmation that it had not modified the generic product and on whether it was planning to launch in the US since the result of the previous case, but did not receive a reply.

The latest case was filed as MSD suspects that Apotex is planning to launch a product that differs from the one tested in the previous litigation and that the new product would infringe the ‘353 patent.

In its complaint, filed last Thursday (April 2), MSD asked for a judgment that Apotex has infringed the ‘353 patent, and for a permanent injunction stopping Apotex from making or selling a product that includes the therapeutic composition covered by the ‘353 patent.

It also asked that the FDA does not approve any proposed generic until after the patent expires.

Nasonex is one of the biggest selling drugs in the US, generating sales of just under $1.1 billion in 2014.

Apotex did not respond to a request for comment.