Tuesday, April 22, 2014

Noven Settles Lidoderm® Patent Challenge

Case Filed: Jun 29, 2012

Case Closed: Apr 17, 2014

Court: Delaware District Court

Judge: Gregory M. Sleet

Case Summary:

Endo, Chadds Ford, Pennsylvania-based pharmaceutical company filed an infringement suit against Noven Pharmaceuticals over a patent covering the drug, Lidoderm®, lidocaine-containing patch for the relief of pain associated with post-herpetic neuralgia (PHN). Teikoku, a Japanese pharmaceutical company is also a plaintiff in the case. The suit was filed as a result of Noven filing ANDA with FDA to obtain approval to manufacture and commercialize a generic version of Lidoderm.

The patent at issue was: US5827529 entitled ‘External preparation for application to the skin containing lidocaine’, issued on Oct 27, 1998 and expires[i] by Oct 27, 2015. Teikoku is the current assignee[ii] of the patent (source: MaxVal’s Assignment Database). Endo is the exclusive licensee of the '529 patent in the relevant field of use and has the exclusive right to market and sell the Lidoderm® in the United States.

In 1999, the United States Food and Drug Administration (FDA) approved Hind Health Care New Drug Application (NDA) no. 020612 for the Lidoderm®, an adhesive patch product that contains lidocaine in the amount of 5%. Teikoku currently holds[iii] the ownership of Lidoderm (source: Patent Marker), effective Jun 1999.

Lidoderm is a local anesthetic (numbing medication) and works by blocking nerve signals. It is used to relieve post-shingles pain. According to Drugs.com, the Q3 2013, sales data of Lidoderm was $319,224 with 1,373 units sold.

According to the complaint, in 2012, Endo and Teikoku received letters notifying that Noven had submitted ANDA No. 20-3265 seeking approval to manufacture, use, or sell generic lidocaine patches 5% and the letter claimed its ANDA would not infringe any claim of the '529 patent and that the '529 patent is invalid.

Endo sought a court order barring FDA approval until the expiration of the '529 patent and costs and expenses.

The parties entered into a ‘Settlement and License Agreement’ dated April 15, 2014. According to the agreement, the parties will settle all outstanding patent litigation related to Noven’s lidocaine topical patch 5% product and will allow Noven to launch its generic Lidoderm® product on or after March 1, 2015, if the product is approved by the FDA. The agreement also provides for an earlier launch under certain circumstances. Other terms of the settlement were not disclosed.

Pursuant to the agreement, joint stipulation of dismissal was filed by Noven, considering which the Court granted the stipulation and ordered dismissal without prejudice and costs.

See 1:12-cv-00831 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.

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