Monday, May 19, 2014

Watson, Lupin and Others End Suit against Cephalon over Nuvigil Patents

Case Filed: Apr 29, 2013

Case Closed: May 12, 2014

Origin Case: 1:10-cv-00210

Case Summary:
Frazer, Pennsylvania-based pharmaceutical company, Cephalon filed complaint against Watson concerning U.S. patents covering a prescription drug Nuvigil (armodafinil) used to treat excessive sleepiness with sleep apnea/hypopnea syndrome, narcolepsy and shift work sleep disorder. Cephalon France and Teva Sante SAS were also plaintiffs in this case.

The patents in suit are:
  •        US7132570 entitled ‘Acetamide derivative having defined particle size,’ issued to Jan 15, 2002 and expiring* by Oct 06, 2014
  •        RE37516 entitled ‘Method for the production of crystalline forms and crystalline forms of optical enantiomers of modafinil,’ issued to Nov 07, 2006 and expiring* by Dec 20, 2022
The patents are assigned to Cephalon and the patents describe processes for obtaining crystalline forms of the enantiomers of modafinil and pharmaceutical compositions comprising modafinil as particles of defined size.

As in Complaint:
The case was lodged against Watson in Delaware District Court in 2010 as a response to its filing an abbreviated new drug application (ANDA) no. 200-156 with FDA seeking approval to manufacture generic copies of Cephalon’s armodafinil products before the expiration of the patents. Once ANDA is approved by the FDA, Watson intended to commercialize the product. By submitting ANDA, Watson infringed the patents-in-suit. Watson also alleged that the claims of the patents-in-suit are invalid, unenforceable or not infringed.

Nuvigil (armodafinil)
Cephalon is the current holder+ of the new drug application (NDA) no. 21-875 for the use of Nuvigil tablets in 50, 100, 200, 250 mg dosage strengths (source: Patent Marker), which was approved by FDA in June 2007. According to the company, Nuvigil is an improved version of Provigil and was launched in the U.S. in Jun 2009.

District Court Trial:
Cephalon had also filed a few cases against other pharmaceutical companies including Lupin, Sandoz and Apotex asserting Nuvigil (armodafinil) and the cases were consolidated. As a result of bench trial, the court issued a memorandum and order on Mar 30, 2013. Accordingly, judgment was entered in favor of the plaintiffs against the defendants, ordering the effective date of any approval of the ANDA(s) as not earlier than the expiration of the patents-in-suit.

Appeal Court:
Watson, Lupin, Sandoz and Apotex filed a notice of appeal to the federal circuit challenging the district court’s judgment. Recently, Lupin filed a motion to dismiss the appeal. With no opposition filed by the parties, appeal court granted the motion and dismissed the case. Each party will bear its own costs.

See 2013-1361 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

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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.

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

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