Bayer has suffered a major blow with the news that a US court has ruled that the patent on the firm’s blockbuster oral contraceptive Yasmin is invalid, leaving the way open for Barr Pharmaceuticals to sell its generic version of the drug.
The ruling, by Judge Peter Sheridan for the District of New Jersey, stated that the 531 patent at issue was invalid because it was obvious. This decision could signal the end of a legal battle that began when Barr filed its Abbreviated New Drug application containing a paragraph IV certification for a copycat version of Yasmin (drospirenone and ethinyl estradiol) with the US Food and Drug Administration in January 2005.
Barr’s ANDA was met by a patent infringement lawsuit in April of the same year filed by Schering AG (which was acquired by Bayer in June 2006) and its US subsidiary Berlex. The ruling was certainly feared by Bayer which is facing up to generic competition for the hypertension treatment Adalat (nifedipine) and the antibiotic Cipro/Ciprobay (ciprofloxacin) and at last week’s spring press conference in Leverkusen, chairman Werner Wenning said that Yasmin was the most important patent case the firm was dealing with.
Source: PharmaTimes
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