By James DeGiulio --
Lilly's Patent for Strattera Found Invalid, Lilly Appeals to Federal Circuit
Teva Pharmaceuticals USA, Mylan Pharmaceuticals, and Apotex successfully argued that Eli Lilly's patent for the ADHD drug Strattera (U.S. Patent No. 5,658,590) lacked utility, thus invalidating the '590 patent and opening the door for generic versions of the drug. Responding immediately, Lilly appealed the decision to the Federal Circuit and moved for a temporary injunction to prevent generic market entry until the decision on appeal.
On August 9, 2007, Lilly brought suit against Actavis in the U.S. District Court for the District of New Jersey for infringement of the '590 patent (see "Court Report," August 19, 2007). One month later, Lilly amended its complaint, including Glenmark, Sun, Sandoz, Mylan, Teva, Apotex, Aurobindo, Synthon, and Zydus as defendants. In the months that followed, Lilly settled with Zydus, Glenmark, Synthon, Teva, and Actavis. On December 29, 2009, Judge Dennis Cavanaugh determined the remaining defendants had induced infringement of the '590 patent by filing ANDAs for generic versions of Strattera. The judge declined to grant summary judgment motions to either side at that time, saving questions on the patent's validity for trial.
On August 12, Judge Cavanaugh found that Lilly's 1995 application for the '590 patent had not included test results required to prove the drug's utility. Although Lilly completed clinical trials on the product after submitting its application, the invalidity inquiry demands that the Court consider utility at the time of filing. Judge Cavanaugh noted that at the time of filing, a person of skill in the art would not have recognized the drug's efficacy without the test results. The judge rejected the defendants' obviousness and inequitable conduct arguments, but invalidated the '590 patent for lack of utility. The '590 patent had been set to expire in November 2016.
Acting quickly, Lilly filed a motion on August 16 seeking a temporary injunction barring the seven remaining defendants in the infringement suit from launching generic versions of Strattera while the Federal Circuit decides Lilly's appeal of the invalidity ruling.
Judge Cavanaugh's invalidity order can be found here, and Lilly's motion for temporary injunction can be found here.
Daiichi, Apotex Reach Settlement In Evoxac Patent Suit
Daiichi Sankyo has reached a settlement and licensing agreement with Apotex in its patent infringement suit over Daiichi's dry mouth drug Evoxac, thus paving the way for Apotex to market a generic version of the drug in 2012.
The suit originated in June 2009 when Daiichi sued Apotex in the U.S. District Court for the District of Delaware in response to an ANDA covering a generic version of Evoxac (see "Court Report," July 5, 2009). In response, Apotex argued that its product would not infringe Daiichi's U.S. Patent No. 5,340,821 and that the patent was invalid. The parties filed a stipulation of dismissal in March 2010, and Judge Jerome Simandle dismissed the case without prejudice three days later.
According to a Daiichi spokesperson, the August 5 agreement resolves the parties' dispute and the settlement ends the case. Under the agreement, Apotex's license will allow it to launch its generic cevimeline hydrochloride product in late 2012.
Arbitration Award to Roche and Gen-Probe Approved in HPV License Suit with Qiagen
The 2009 arbitration proceeding that granted significant attorneys' fees to Roche and Gen-Probe was affirmed in federal court, thus confirming that Roche did not violate a cross-licensing agreement with Qiagen over the development of an exclusive test for diagnosing human papillomavirus.
In December 2006, Qiagen (then Digene) alleged before the International Centre for Dispute Resolution (ICDR) that Roche had breached its cross-licensing agreement when it entered into a supply deal with Gen-Probe for designing sequences for HPV detection kits. Qiagen argued that only end-user products could be provided, not the oligo probe products. Gen-Probe intervened in the dispute, and the ICDR concluded in March 2009 that Roche was allowed to provide Gen-Probe with the oligo probes under the licensing agreement. The panel awarded attorneys' fees of $3.2 million for Roche and $3 million for Gen-Probe. In August 2009, Qiagen filed a petition in New York state court seeking to vacate or modify the final award, while Roche and Gen-Probe filed petitions in the U.S. District Court for the Southern District of New York to get the award confirmed. The cases were subsequently consolidated in the Southern District.
On August 11, Judge Pauley affirmed the 2009 arbitration award in favor of Roche and Gen-Probe in its entirety, including awards of attorneys' fees. Judge Pauley approved Gen-Probe's intervention and rejected Qiagen's assertions that the panel exceeded its powers by awarding Roche and Gen-Probe attorneys' fees. The judge simultaneously denied a motion to vacate by Qiagen, which had accused Roche of breaching the licensing agreement when it entered into the supply deal with Gen-Probe.
Judge Pauley's order can be found here.
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