By James DeGiulio --
Cordis Stent Found to Infringe Boston Scientific Patent
Boston Scientific Corp. secured a favorable ruling on summary judgment in its patent infringement suit against Cordis Corp. over one of its drug-eluting stents. In 2003, Boston Scientific sued Cordis in the U.S. District Court for the District of Delaware for infringement of U.S. Patent No. 5,922,021, asserting that three sizes of Cordis' Cypher stent infringed the '021 patent. In 2005, a jury agreed and returned a verdict in favor of Boston Scientific. Cordis sought reexamination of the '021 patent in 2009. Three claims of the '021 patent were rejected as obvious, but Boston Scientific was able to overcome this rejection. Cordis filed a second request for reexamination in January 2011, which rejected one claim of the '021 patent as anticipated and obvious. Following this rejection, Cordis asked the District Court to delay trial until the Patent Office finished its reexamination, while Boston Scientific moved for summary judgment of infringement.
On April 13, Judge Sue L. Robinson issued an opinion that denied Cordis' motion to delay the start of a trial, weighing the general factors for staying a trial. Judge Robinson considered the stay improper, since discovery was complete, the trial for damages was set to start May 5, and the reexamination could take many months to complete. Judge Robinson also granted Boston Scientific's motion for summary judgment, finding that the product at issue, Cordis' 2.25 mm Cypher stent, infringes the '012 patent since it has the same architecture as three other sizes of stent that were found to infringe the same claim of the patent in a previous case. Judge Robinson also assigned a favorable date to Boston Scientific for damage calculation. Finally, Judge Robinson denied Cordis' Daubert motion to exclude an expert in royalty calculations from testifying for Boston Scientific. Cordis had previously challenged the expert's methodology, but the favorable damage calculation date assigned to Cordis significantly weakened its challenge.
Mylan, Barr and Anchen Blocked from Introducing Generic Amrix
Cephalon was able to extend an injunction ruling that generic drugmakers cannot release their own versions of Amrix until the Judge issues a ruling on the validity and enforceability of the patents. Cephalon brought six cases against several generic manufacturers to block them from producing generic versions of the extended release drug Amrix after their ANDA filings. These cases were consolidated in the U.S. District Court for the District of Delaware in December 2009. A bench trial was held from September 29 through October 10, 2010, where Barr and Mylan challenged the validity of Cephalon's Amrix 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 were unenforceable due to inequitable conduct. After trial, Cephalon settled with Impax (see "Biotech/Pharma Docket," October 14, 2010). 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 is earlier.
On April 8, Judge Sue L. Robinson issued an order enjoining the generic manufacturers from launching their products until an opinion on the patents is issued in the case. The 30-month automatic stay in this case is set to expire on April 17, and the generics have made it known that they intend to introduce their Amrix drugs to market on April 17, regardless of whether Judge Robinson issues her ruling, as per the stipulation. While Judge Robinson intends to release her opinion on the patents soon, she did not guarantee that the opinion would come down before April 17. Consequently, despite the parties' stipulation, the judge issued an injunction over all defendants in all the cases, keeping all generic Amrix off the market until she issues her ruling.
Galderma, Dermalogix Agree to End Clobex Suit with Paddock
As trial was set to begin, Galderma SA and Dermalogix Partners Inc. reached an agreement with Paddock Labs which ends their patent infringement suit over a generic version of the psoriasis spray Clobex. In 2009, Galderma and Dermalogix brought suit in the U.S. District Court for the Northern District of Texas, alleging infringement of U.S. Patent No. 5,972,920 after Paddock submitted an ANDA seeking approval for a generic clobetasol propionate spray (see "Court Report," January 11, 2011). Both parties moved for summary judgment, with the plaintiffs asking the District Court to rule that the proposed generic infringes the '920 patent and that the patent is not invalid. The judge found that Paddock's proposed spray did infringe the '920 patent as a matter of law. Paddock argued that the '920 patent was unenforceable due to inequitable conduct by the inventors and patent attorney. However, the judge determined that there were genuine issues of material fact with respect to both infringement and inequitable conduct that must be established at trial, which was slated to start Monday.
Judge Terry R. Means signed off on the three companies' stipulation to dismiss the suit with prejudice, leaving each side to pay its own costs and attorneys' fees. The stipulation was silent as to any settlement.
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