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]	Title
US5837284 Celgene	Nov 17, 1998	Dec 04, 2015	Delivery of multiple doses of medications
US6635284 Celgene	Oct 21, 2003	Dec 04, 2015	Delivery of multiple doses of medications
US5908850 Celgene	Jun 01, 1999	Dec 04, 2015	Method of treating attention deficit disorders with d-threo methylphenidate
US6355656 Celgene	Mar 12, 2002	Dec 04, 2015	Phenidate drug formulations having diminished abuse potential
US6528530 Celgene	Mar 04, 2003	Dec 04, 2015	Phenidate drug formulations having diminished abuse potential
US7431944 Celgene	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:

Defendant	Case Number	Date Filed	Status
Actavis	2:11-cv-06519 2:11-cv-02162	11/04/2011 04/15/2011	Dismissal without prejudice
Par Pharmaceutical	2:11-cv-03094	05/27/2011	Dismissal without prejudice

Note: Table information sourced from Maxval Litigation Database.

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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.