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Obviousness upheld against Bayer in Yasmin case

By Lawrence B. Ebert, Esq.

In a 2-1 vote, obviousness (found in D NJ) was upheld by the CAFC.

The dissent of Judge Newman:

With all respect to my colleagues, I do not share their view that it would have been
obvious to do that which was indisputably unobvious to the experienced formulation
scientists whose assignment was to formulate the known product drospirenone. The
evidence showed, without contradiction, that it was known that micronized drospirenone
rapidly degraded at the acidity of stomach acid. The evidence showed, without
contradiction, that the Bayer scientists working in this field believed that the product
required an enteric coating in order to prevent degradation in the stomach, upon ingestion
as an oral contraceptive. Yet my colleagues, employing their own expertise, hold that since
the scientists working in this field turned out to be mistaken, it would have been obvious
that it was not necessary to take steps to prevent acid degradation. 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. That is not the law of obviousness.

The issue of hindsight arose:

The statutory criterion is whether the invention would have been obvious to persons
of ordinary skill at the time of the invention, not whether it is sufficiently simple to appear
obvious to judges after the discovery is finally made, despite the years of contrary belief
among the scientists charged with the project. At the time that the Bayer scientists were
attempting to formulate drospirenone as an oral contraceptive, the textbook teaching was
that micronizing acid-sensitive products would accelerate their acid-induced degradation.

Lawyers on the losing side: Peter B. Bensinger, Jr., Bartlit Beck Herman Palenchar & Scott LLP, of Chicago,
Illinois, argued for plaintiffs-appellants. With him on the brief was Lawrence D. Rosenberg,
Jones Day, of Washington, DC.

Full post as published by IPBiz on August 05, 2009 (boomark / email).