AstraZeneca's shares soared 9 percent on Tuesday after a US judge ruled that the patent for Crestor (rosuvastatin) is valid and enforceable. The ruling stems from a patent infringement case the company filed against several generic drugmakers that had sought to market a version of the statin prior to the expiration of one of its key patents.
The generic drug manufacturers, which include Teva, Novartis' Sandoz unit, Mylan, Par Pharmaceutical, Apotex, Aurobindo Pharma and Sun Pharmaceuticals, challenged the validity of the Crestor patent, arguing that its invention was obvious and that the patent was unenforceable because the original patent applicants withheld certain information from the Patent and Trademark Office.
Judge Joseph Farnan of the District Court in Delaware ruled in favour of AstraZeneca on the key points of the case, noting that "after evaluating the extensive arguments of the parties and the evidence adduced at trial, the court concludes that defendants have not demonstrated by clear and convincing evidence that the ... patent is invalid as obvious." He also noted that AstraZeneca provided compelling evidence that "significant work was needed" to develop Crestor and said that Apotex may be held liable for infringing the drug's patent.
Bernstein analyst Tim Anderson commented that the ruling, while expected, nonetheless "removes an overhang" of what could have been a "devastating" loss. Crestor had $4.5 billion in sales last year.
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