Mallinckrodt Ends Suit against Amneal over Anti-Inflammatory Drug

Case Filed: Mar 27, 2014

Case Closed: Jul 28, 2014

Court: Delaware District Court

Judge: Richard G. Andrews

Case Summary:

Mallinckrodt, a global specialty pharmaceuticals along with Canada-based, Nuvo Research filed a patent infringement complaint against Amneal, a US-based manufacturer of generic pharmaceuticals, concerning its filing of an abbreviated new drug application (ANDA) with the United States Food and Drug Administration (FDA) seeking approval to market generic version of Mallinckrodt’s pharmaceutical product Pennsaid®, prior to the expiration of three US patents, which cover the use of Pennsaid®. The case has been closed as the plaintiff filed a voluntary dismissal, which was granted by the court.

Patents-in-Suit:

The patents involved in the suit were: US8217078 entitled ‘Treatment of pain with topical diclofenac’ and US8546450 and US8618164 entitled ‘Treatment of pain with topical diclofenac compounds’. The patents were issued by USPTO on Jul 10, 2012, Oct 01, 2013 and Dec 31, 2013, respectively. The patents are scheduled to expire[i] in Jul 10, 2029. Paladin Labs is the current assignee[ii] of the ‘078, ‘450 and ‘164 patents (source: MaxVal’s Assignment Database). The claims of the patents-in-suit cover the method of treating a patient with an oral NSAID and Pennsaid®.

Pennsaid®:

The drug was first developed in Canada by Nuvo as a treatment for the signs and symptoms of osteoarthritis, particularly the knee. Pennsaid® contains the active ingredient diclofenac, a non-steroidal anti-inflammatory drug (NSAID) that is formulated with dimethyl sulfoxide (DMSO).

NDA Holder:

Mallinckrodt licensed Nuvo’s Pennsaid® patents and sought approval from the FDA to market in US. Mallinckrodt is the current holder[iii] of the FDA approved new drug application (NDA) no. 020947 for diclofenac sodium topical solution 1.5%, under the trade name Pennsaid®, in Nov 2009 (source: Patent Marker).

As in Complaint:

Mallinckrodt alleged that Amneal infringed the patents-in-suit by submitting the Amneal ANDA, by which Amneal seeks approval from the FDA to engage in the commercial manufacture, use, offer to sell, sale, or importation of the Amneal Product prior to the expiration of the ‘078, ‘450 and ‘164 patents.

The complaint further stated that approval of the Amneal ANDA is substantially likely to result in the commercial manufacture of a drug product that is marketed and sold for use in a method claimed in the patents-in-suit.

Mallinckrodt wanted the judge to declare the case an exceptional and award them attorneys’ fees in light of Amneal’s conduct.

Other Cases:

Mallinckrodt have filed nearly a dozen cases and in 2013, it entered into an agreement with Amneal to distribute generic version of Suboxone®, a prescription medication indicated for the maintenance treatment of opioid dependence.

See 1:14-cv-00389 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

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[i] 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. 

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

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