Wednesday, April 17, 2013

Patent Litigation Resolved between Medicis and Actavis

On August 2012, Medicis filed a complaint against Actavis for infringing the patent US8236816. The patent is entitled ‘2.times.2.times.2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75 % imiquimod’. The patent was issued in Aug 2012 and expires[i] in Dec 2029. The patent is currently assigned[ii] to Medicis (source: MaxVal’s Assignment Database).

The case was filed against Actavis for filing Abbreviated New Drug Application (ANDA) no. 203-792 and 202-564 for Clindamycin and Tretinoin Gel and Imiquimod Cream, seeking FDA approval to manufacture generic versions of Zyclara® and Ziana®.

Zyclara cream is used to treat actinic keratosis (a condition caused by too much sun exposure) on the face and scalp. Ziana is a gel used to treat severe nodular acne above 12 years.

Now Medicis (a subsidiary of Valeant) and Actavis have reached a settlement agreement. Under the terms of the agreement, Actavis may launch its generic versions of Zyclara® and Ziana® in July 2016 and Jan, 2019.

Actavis stated that Valeant will receive a share of the economics from the generic products sold under the agreements. No other information about the agreement is available at this time. The settlement agreement puts an end to the litigation between the parties.

For more details see 1:12-cv-01091. 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.

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