By James DeGiulio --
Cephalon's Amrix Patents Infringed But Invalid in Suit against Mylan and Barr
Two of Cephalon's patents covering the muscle relaxant Amrix drug were found to be infringed by Mylan and Barr, but those same patents were also found to be invalid for obviousness. Cephalon originally brought six cases against several generic manufacturers to block them from producing generic versions of the extended release drug Amrix after the generics filed Abberviated New Drug Applications (ANDAs). These cases were consolidated in the U.S. District Court for the District of Delaware in December 2009, and a bench trial was held from September 29 through October 10, 2010. At trial, Barr and Mylan challenged the validity of Cephalon's patents, arguing that cyclobenzaprine was well known in the art and anyone with ordinary skill could have made an extended release version with minimal effort. They also asserted that the patents-in-suit, U.S. Patent Nos. 7,387,793 and 7,544,372, were unenforceable due to inequitable conduct. After trial, Cephalon settled with Impax. On October 29, Cephalon, Mylan, Barr, and Anchen stipulated that the generic drugmakers would not enter the Amrix market until April 17, 2011, or the date of issuance of an opinion on Cephalon's patents, whichever was earlier. On April 8, Judge Sue L. Robinson blocked Mylan, Barr and Anchen from introducing their generic versions of Amrix until she issued her final ruling (see "Biotech/Pharma Docket," April 14, 2011).
In an opinion issued on May 12, Judge Robinson ruled that the '793 and '372 patents were invalid due to obviousness. The key prior art includes a European patent application that discloses a controlled release micropellet, a U.S. patent that describes a multidose delivery mechanism for a drug similar to cyclobenzaprine, and two articles in the Journal of Clinical Pharmocology that describe scientific studies with cyclobenzaprine. Judge Robinson said that a person of ordinary skill in the art would have been motivated to combine these references to create an extended release version of cyclobenzaprine, and would have had a reasonable expectation of success in doing so. The defendants argued that cyclobenzaprine had been on the market for years and anyone with ordinary skill could have easily made an extended release version. The plaintiffs argued against obviousness by pointing to several secondary considerations: other leading drug companies had failed to create extended release cyclobenzaprine, that there was a long felt need fulfilled by Amrix, and that its commercial success proved the patents' validity. Judge Robinson instead found that Amrix's success was due to an expansive marketing campaign, rather than its patented features, and that the patents were obvious. In the judgment accompanying her opinion, Judge Robinson also determined that Anchen did not infringe the patents-in-suit.
Cephalon Drops Nuvigil Suit Against Teva
Last month, Teva acquired Cephalon for $6.8 billion. Not surprisingly, Cephalon has now dropped Teva from its long list of alleged infringers in its patent suit over narcolepsy drug Nuvigil. The Nuvigil litigation began in December 2009 against Actavis, and in December 2010, Cephalon's case against Teva was consolidated with several other infringement actions over Nuvigil. Other defendants included Apotex, Teva, Mylan, Watson, Lupin, and Sandoz. While Cephalon asserted U.S. Patent No. 7,132,570 in all seven of the consolidated suits, it also alleged that Sandoz and Apotex infringed U.S. Patent Nos. 7,297,346 and RE37,516. Cephalon recently dropped its suit against Actavis in March (see "Biotech/Pharma Docket," March 24, 2011). In April, Teva amended its patent certification to a Paragraph III in its bid for regulatory approval for generic Nuvigil.
On May 11, Judge Gregory M. Sleet signed off on a stipulation and order dismissing the case. The stipulation and order does not act as an adjudication on the merits of any claim or counterclaim, and Teva agreed to cooperate in good faith to provide reasonable discovery for continuing use in Cephalon's litigation against the other defendants.
Breckenridge, Synthon Settle Actos Patent Suit with Takeda
Takeda has reached an agreement with Breckenridge and Synthon Pharmaceuticals, ending the patent dispute over the diabetes drug Actos. In September 2010, Takeda brought suit in the Southern District of New York against Breckenridge and Synthon, claiming that defendants' ANDA infringed U.S. Patent Nos. 5,965,584; 6,329,404; 6,166,043; 6,172,090; 6,211,205; 6,271,243; and 6,303,640. In 2009, Breckenridge and Synthon had signed a distribution and supply agreement on the generic drug product and have been working together, including the settlement of the Paragraph IV litigation.
On May 16, the suit was resolved following an agreement between the parties. Under the terms of the agreement, Takeda granted Breckenridge and Synthon a non-exclusive, royalty-free license to the patents covering the drug, permitting launch of their generic-equivalent formulation of Actos after first-filers of ANDAs with Paragraph IV certifications exhaust their 180-day marketing exclusivity on February 13, 2013, or earlier under certain circumstances, pending regulatory approval.
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