Mari /
24 April 2017Americas

Momenta and Sandoz seek to dismiss competition claims

Momenta Pharmaceuticals and Sandoz have filed a motion to dismiss competition allegations made by Amphastar Pharmaceuticals.

This case concerns enoxaparin, a drug which is used primarily to treat deep vein thrombosis.

The memorandum, filed on Thursday, April 20, at the US District Court for the District of Massachusetts, follows a complaint filed by Amphastar in September 2015.

According to the filing, in order to sell a generic version of enoxaparin, a pharmaceutical company must submit an Abbreviated New Drug Application (ANDA) to the Food and Drug Administration (FDA) demonstrating that the applicant’s product is structurally the same as branded Lovenox (enoxaparin).

Enoxaparin was first sold in the US by Sanofi under the brand name Lovenox.

The filing added: “Among other things, the ANDA applicant must describe its manufacturing process and the quality control procedures that it will use to confirm that the enoxaparin in each batch of commercial product has the requisite structural characteristics.”

Momenta scientists had developed a procedure to determine whether a given batch of enoxaparin has the “requisite structural features”.

In 2003, Momenta filed a patent application on the procedure. It was later approved and is now US patent number 7,575,886.

In the same year, Momenta and Sandoz entered into a licence agreement in order to develop and sell generic enoxaparin in the US.

In August 2005, Sandoz filed an ANDA seeking FDA approval to sell generic enoxaparin. This was approved by the FDA in 2010.

Amphastar also filed an ANDA to sell generic enoxaparin, in 2003, but this was only approved in 2011.

Shortly after the FDA approved Amphastar’s generic, Momenta and Sandoz filed a patent infringement complaint alleging that Amphastar’s quality-control process infringed the ‘886 patent.

Amphastar then asserted two defences, accusing Momenta and Sandoz of failing to disclose the ‘886 patent application to the US Pharmacopeial Convention (USP), a scientific non-profit organisation that sets standards for the identity, strength, quality, and purity of medicines.

Amphastar further alleged that Momenta and Sandoz wrongfully enforced that patent in Momenta v Amphastar.

In the memorandum, Momenta and Sandoz claimed that Amphastar’s allegations should be dismissed because it failed to “allege facts sufficient to support a plausible inference that the USP’s adoption method caused its alleged antitrust injury”.

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Momenta and Sandoz also asked the court to dismiss the case on the grounds that Amphastar did not identify an actionable restraint of trade.

The companies said: “Amphastar and other manufacturers are free to use alternative procedures to confirm that their generic enoxaparin has the requisite structural characteristics. Thus, there is no ‘lock-in’ effect and no antitrust violation.”

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