The ruling "has cast a little bit of a cloud over our patents," says Hans Sauer, associate general counsel of the Biotechnology Industry Organization. "We need all of the certainty we can get. We have less certainty now."
Many so-called incremental improvements "can make a big difference" in medications, says Sauer. Plus, even small changes require a lot of time, money and effort. "There is value to the consumer in making a drug better."
Meanwhile, Ludwig is telling clients and fellow lawyers that they must do more, and earlier, preparation to prove their invention is capable of clearing the "obviousness" hurdle.
For example, they should locate test data and laboratory notebooks that illustrate the difficulty in developing a new and improved drug. They also should compile data that shows how successful the improved product has been. And they should try to show that a product meets a "long-felt need," a legal term that means a problem is addressed that hadn't previously been solved.