Bayer Loses Round in Yasmin Patent Dispute

     (CN) – Drug maker Bayer failed to convince the Federal Circuit that its patent for the birth-control pill Yasmin is valid. The court ruled that the patent claims would be obvious to someone in the pharmaceutical industry.




     The three-judge appellate panel upheld the district court’s ruling for Barr Laboratories, which wants to sell a generic version of Yasmin.
     Barr claimed that Bayer’s patent claims were obvious. At trial, the parties agreed that certain forms and doses of the main ingredient, drospirenone, were commonly used as contraceptives.
     Bayer said its Yasmin patent went a step farther by micronizing the active ingredient, a process that increases the drug’s ability to dissolve in the stomach. The drug maker said this increased the amount of the drug absorbed into the blood stream, or “bioavailability.”
     And the patent allegedly introduced micronized drospirenone that didn’t need a special coating for protection against stomach acids.
     These characteristics differentiated its patent claims from prior art, Bayer argued.
     It also pointed out that its patented pill defied the results of an existing study, which predicted that micronized drospirenone would “degrade even more rapidly” in stomach acid.
     But the district court and the Federal Circuit said a person of ordinary skill in the pharmaceutical industry “would be alerted to the study’s shortcomings” and would end up using either a normal pill or a coated pill.
     “This is a finite number of identified, predictable solutions,” Judge Mayer wrote.
     Judge Newman dissented, saying the patent claims can’t be considered obvious if they weren’t obvious to the experienced researchers.
     “The court discounts the testimony of the scientists themselves, ignores the knowledge concerning this product and its instability in acid, ignores the textbook teachings, and finds that this unlikely process obviously should have been tried,” Newman wrote.
     “That is not the law of obviousness.”

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