Dennis Crouch's excellent patent law blog has a post summarizing some of the briefs submitted thus far in Merck KGaA v. Integra Lifesciences I, Ltd., the first patent case before the Supreme Court since Festo three years ago. The brief I helped to write is featured, along with a brief signed by one of my former professors.
The case highlights what can go wrong when the people who write patent laws and decide patent cases do so without becoming educated in how science is actually done in research labs. The statutory safe harbor may have been intended only to protect studies aimed at approval of generic drugs, but the wording Congress chose reaches a far wider range of drug and medical device research. To fix that problem, the Federal Circuit applied a test that strains the statutory language and reflects that court's poor understanding of the regulatory process for new drugs. Now the Supreme Court will interpret the statute, and if Congress is unhappy with the resulting scope of the safe harbor, it can step in and fix the language. It may be slow, but it does represent the process working as it is supposed to.