Monday, December 17, 2012

Lawsuit Summary - Celgene and Novartis vs. Mylan

Plaintiffs: Celgene and Novartis
Defendant: Mylan Pharma
Case No: 2:12-cv-07590
Date Filed: 07 December 2012
Patents in suit: 

Patent Number
Current Assignee[i]
Issued Date
Expiration Date[ii]

Nov 17, 1998
Dec 04, 2015
Delivery of multiple doses of medications

Oct 21, 2003
Dec 04, 2015
Delivery of multiple doses of medications

Jun 01, 1999
Dec 04, 2015
Method of treating attention deficit disorders with d-threo methylphenidate

Mar 12, 2002
Dec 04, 2015
Phenidate drug formulations having diminished abuse potential

Mar 04, 2003
Dec 04, 2015
Phenidate drug formulations having diminished abuse potential

Oct 07, 2008
Jun 10, 2023
Delivery of multiple doses of medications
Note: Table information sourced from Maxval Assignment Database. Novartis is the exclusive licensee of the above patents in certain fields of use. 

About the parties: 
Celgene Corporation is an American biotechnology company that manufactures drug therapies for cancer and inflammatory disorders. The company's major products include Thalomid, Revlimid and Vidaza. Celgene also receives royalties from Novartis Pharma AG on sales of the entire Ritalin family of drugs that are widely used to treat Attention Deficit Hyperactivity Disorder (ADHD).

Novartis International AG is a pharmaceutical company based in Basel, Switzerland manufacturing drugs. It was renamed to Novartis following an acquisition by Ciba-Geigy.

Mylan Pharmaceuticals is a manufacturer of generic prescription and specialty drugs with facilities for large scale manufacture of active pharmaceutical ingredient (API). Mylan's medicine cabinet holds generic versions of antibiotics, antidepressants, anti-inflammatories, and respiratory agents in a range of delivery forms. The company's customers in more than 150 countries include wholesalers, distributors, retailers, and government agencies.

As in complaint:
Novartis currently holds[iii] an FDA approved New Drug Application (NDA) no. 021802  for extended release capsules that are sold under the trade name Focalin XR® (see Fig. 1) (source: Maxval’s Patent Marker). It is used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients above 6 years. Plaintiffs alleges that the defendant seeks FDA approval with Abbreviated New Drug Application (ANDA) no. 204266 (Mylan’s proposed product) to market a generic version of Focalin XR® that infringes the above patents.  It is believed that that Mylan’s proposed products have the same active ingredients, dosage, etc. of Focalin XR® products.   

Fig. 1

Other Cases filed by plaintiffs:
Celgene and Novartis (plaintiffs) together have filed cases against the following companies:
Case Number
Date Filed
Dismissal without prejudice
Dismissal without prejudice
Note: Table information sourced from Maxval Litigation Database.
If you are interested in knowing more about the cases filed by the plaintiffs, please contact us.
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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 to virtually mark products and search for patent related information.

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