Case Filed: Jul 21, 2014
Origin Case: 1:14-cv-00270
In Feb 2014, Antares Pharma, a US-based developer of automatic injection devices filed a complaint alleging infringement of two U.S. patents by defendants Medac Pharma, a subsidiary of German pharmaceutical company, Medac GmbH commercializing hand-powered pre-filled methotrexate syringes. The complaint was filed in the Delaware District Court.
The patents involved in the suit are:
- US8480631 entitled ‘Hazardous agent injection system,’ issued on Jul 09, 2013 and expiring* by Mar 19, 2030
- US6565553 entitled ‘Needle assisted jet injector,’ issued on May 20, 2003 and expiring* by Feb 24, 2019
As in Complaint:
Medac infringed claims of patents-in-suit, in violation of Antares' patent rights, by submitting Medac NDA to the FDA seeking approval to commercially market Medac's MTX product, also referred as MPI-2505, before the expiration date of patents-in-suit. The proposed NDA product indications are the same as those approved for Otrexup™, according to the complaint.
In Oct 2013, the FDA approved NDA no. 204-824 for Otrexup™, which uses Antares' proprietary automatic injection device for which Antares is the current holder± (source: Patent Marker). Otrexup™ is the first and only product approved by the FDA to administer methotrexate subcutaneously (under the skin) to treat rheumatoid arthritis (RA) and psoriasis.
According to court documents, in Sep 2013, Medac submitted NDA application with the FDA for a methotrexate injection product to be sold under the trade name Rasuvo™.
District Court Proceedings:
Antares amended its complaint, adding allegations of infringement of two other reissue patents: RE44846 and RE44847. In May 2014, Becton Dickinson and Company (Becton) filed an intervenor complaint seeking a declaratory judgment that claims of the patents-in-suit are not infringed and alleged that patents-in-suit are invalid. The parties correspondingly filed counterclaims.
Antares filed a motion seeking preliminary injunction over the patents-in-suit. The court denied its motion reasoning that Antares did not succeed in showing that Medac's product infringes claims directed to a jet injector.
Appeal against Order:
An interlocutory appeal was filed by Antares as district court denied its motion seeking preliminary injunction. Antares (appellant) filed a motion to expedite the briefing schedule and oral argument, which the court granted and is currently awaiting Medac’s (appellee) brief response.
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* Expected expiration date. Patent Term Estimator is a free web-based tool that automatically calculates patent terms and expiration dates for U.S. utility patents.
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± Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.