Talk about a one-two punch.

First, the U.S. Patent Office rejects its claims to a potentially lucrative patent that was the focus of a closely watched US Supreme Court decision last month. Known as the Cabilly or 415 patent, it covers methods of making certain antibodies and was issued to Genentech in 2001.

Medimmune, which licenses the patent, sued Genentech, claiming the patent was invalid because it was based on methods already covered in another patent with an earlier expiration date. The patent is the basis for a $1 billion drug sold by Medimmune. Big royalties are at stake.

Here’s a little background: The Supreme Court ruled Medimmune could pursue its claim that it doesn’t owe Genentech any royalties. Genentech had argued it couldn’t pursue a lawsuit because it was still paying royalties for the patent. Many companies support Genentech because they fear the decision could embolden licensees to challenge existing patents.

In a brief statement, Genentech said it would fight on. What choice does they do have? The appeals process, the company estimates, could take a year or two.

Then, the FDA says it wants a Black Box warning for Xolair, which is used to treat patients with asthma related to allergies, because it may cause anaphylaxis. Can’t say that. Never mind. This is what can happen: trouble breathing, chest tightness, dizziness, fainting, itching and hives, and swelling of the mouth and throat. Med Guides should also be given to patients.

The FDA notes that anaphylaxis was reported during clinical trials and discussed in the initial product labeling. The cases were reported at a frequency of approximately one in a thousand patients, or 0.1 percent. But reports kept coming in, some of which may have been life threatening, and there’s also the possibility of delayed onset.

Who says the pharmaceutical business isn’t risky?

[tags]Black Box, FDA, Genentech, MedImmune, Patents, Xolair[/tags]