Federal Circuit Temporarily Enjoins Sandoz and Upsher-Smith from Selling Generic Oxandrin

In a dramatic turn of events in Savient Pharma's patent litigation against Sandoz and Upsher-Smith, late this afternoon the Court of Appeals for the Federal Circuit granted Savient's emergency appeal and temporarily enjoined Sandoz and Upsher-Smith from marketing their generic versions of Oxandrin (oxandrolone).  The Federal Circuit's order came just before a district court's Temporary Restraining Order was set to expire.

On December 1st, the FDA denied two Savient citizen petitions relating to Oxandrin and granted final approval to Sandoz and Upsher-Smith's ANDAs for generic oxandrolone tablets.  On December 4th, Savient sued Sandoz and Upsher-Smith in the District of New Jersey, alleging infringement of five method of use patents relating to oxandrolone.  At the same time, Savient moved for a TRO and preliminary injunction.  The next day, Judge Peter G. Sheridan granted Savient's request for temporary relief, ordering Sandoz and Upsher-Smith to stop efforts to market their generic products and ordering Savient to ensure that Watson Labs would not launch an authorized generic of Oxandrin.  In the next two days, both parties submitted briefs, and on December 8th Judge Sheridan reversed course and ordered the temporary restraints to be lifted as of 5:00 p.m. today.  He also granted permission for Savient to appeal to the Federal Circuit.

Unfortunately, neither Judge Sheridan's opinion lifting the TRO nor the Federal Circuit's order are publicly available at this time.  However, a declaration submitted by Sandoz and a reply brief filed by Savient reveal several interesting facts.  Apparently, at the time Sandoz and Upsher-Smith filed their ANDAs, the Orange Book did not contain any patent information for Oxandrin.  Accordingly, they filed with Paragraph I certifications.  Later, Savient listed its method of use patents, but Savient late-listed four of the patents and therefore Sandoz and Upsher-Smith were not required to certify to those patents.  Savient timely listed the fifth patent, U.S. Patent No. 6,828,313, but Sandoz and Upsher-Smith carved out from their ANDAs the indication claimed in that patent and informed the FDA accordingly.  The defendants later carved out the indications claimed in Savient's other patents.

It appears that Sandoz and Upsher-Smith are currently approved to market generic oxandrin only for two very specific indications:  (1) to offset protein catabolism associated with prolonged administration of corticosteroids and (2) for the relief of bone pain accompanying osteoporosis.  Meanwhile, Barr Labs recently filed an ANDA to sell Oxandrin for all approved uses (and Savient responded by suing for patent infringement).  The primary indication for Oxandrin is the promotion of weight gain following extensive surgery, chronic infection, or severe trauma.  Oxandrin has annual sales of approximately $60 million.

RELATED READING:

• Savient press releases
• Savient citizen petitions:  2005P-0383 and 2004P-0074
• Sandoz approval letter
• Upsher-Smith approval letter
• Barr Labs press release