Bayer's birth-control franchise suffered a blow in Europe as patent regulators yanked protection on Yasmin. As the company's second-best-selling drug, Yasmin could now face generic competition later this year, Reuters notes.
The European Patent Office's ruling comes after an appeal from the Novartis generics unit Hexal, which had been fighting Bayer's patent on a procedure that reduces the size of particles containing Yasmin's active ingredient. That micronization patent would have been in force through 2020 thanks to officials' 2006 decision confirming the patent.
Now, Hexal is set to launch copies of Yasmin during the second half of this year, JP Morgan Cazenove analysts told investors after the ruling was announced. The European development comes after Yasmin lost patent protection in the U.S. last year. Sales in the states dropped last year to $1.6 billion.
The silver lining for Bayer, however, is that European pricing on Yasmin is much lower than in the U.S., giving cheaper generics a smaller cost advantage, analysts said. Plus, in most European markets, women pay out-of-pocket for contraceptives, meaning that insurers pushing for less-expensive copycat drugs might have less of an impact. "Although a negative surprise to the market, this event has a very modest impact to our valuation," UniCredit analyst Craig Maxwell told the news service.
- see the Reuters news