Acura Strikes Sandoz with Patent-Suit

On Thursday, November 01, 2012, Acura Pharmaceuticals (plaintiff) recorded a suit against Sandoz (defendant) for patent infringement in the U.S. District Court of Delaware (case no. 1:12-cv-01373). 

Acura Pharmaceuticals is engaged in research, development and manufacture of pharmaceutical products for the treatment of severe pain using its Aversion technology. The company's portfolio of pipeline products includes opioid analgesics such as Acurox, Acuracet and Vycavert tablets. Sandoz develops, manufactures and markets generic drugs as well as pharmaceutical and biotechnological active ingredients.

The patent US7510726 involved in suit is currently assigned[i] to Acura (source: MaxVal’s Assignment Database). The patent entitled Methods and compositions for deterring abuse of opioid containing dosage forms was issued on March 31, 2009 and expires[ii] on November 26, 2023. 

Pfizer and partner Acura received US Food and Drug Administration (FDA) approval for  New Drug Application[iii] (NDA) no. 20-2080 for Oxecta® (formerly known as Acurox) (source: Patent Marker) on June 17, 2011.  Oxecta became a part of Pfizer’s portfolio following its acquisition of King Pharmaceuticals. Oxecta was developed under an agreement for the licensing, development, and commercialization of immediate release (IR) pain medicines utilizing Acura's Aversion (abuse-deterrent) technology. The abuse-deterrent technology has been designed to discourage opioid abuse and misuse through common ways of tampering. 

Oxecta is used in the treatment of chronic pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). Oxecta 5 and 7.5 mg as shown in fig.1 have a high potential for abuse. The drug is currently accepted for medical use with severe restrictions. Defendant with the Abbreviated New Drug Application (ANDA) no. 20-4155 also seeks FDA approval to market Sandoz’s Oxycodone HCl Tablets that is covered by the ‘726 patent.

Fig. 1 Oxecta 5 mg and 7.5 mg 

Plaintiff has filed suit against 3 other companies for the same patent. The case details are listed below:

Company	Case No.	Date Filed	Status
Impax Laboratories	1:12-cv-01371	10/31/2012	Pending
Par Pharmaceutical	1:12-cv-01372	10/31/2012	Pending
Watson Pharmaceutical	1:12-cv-01374	10/31/2012	Pending

For more details, visit Maxval-IP and subscribe to our Litigation Alerts.

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[i] MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.

[ii] 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.

[iii] Patent Marker provides an online environment for patentees can virtually mark products and search for patent related information.