As many readers will have recognized, I was speaking yesterday about the suit between Merck KGaA and Integra. This one has been going on for nearly ten years now, and is a bit of a mess, but here comes the short version:
In the early 1980s, researchers at the Burnham Institute in La Jolla discovered the so-called "RGD peptides", named for the single-letter amino acid sequences they share. These bind to cell-surface receptors called integrins, which are important in a variety of processes that involve cell adhesion. Blood clotting, wound healing, bone growth, and the invasiveness of some cancer cells all have integrin components. The Burnham group formed a company, Telios, and licensed their patents to it. (Later on, Integra bought the rights from Telios, which is where they enter the picture.)
Merck (Darmstadt) and several other companies also became interested in integrins. In the mid-1980s, Merck collaborated with a group at Scripps (also, as fate would have it, in La Jolla), who showed the potential of blocking some integrin subtypes as a method for inhibiting angiogenesis in tumors. (Yep, anti-angiogenic therapies have been in the works for that long.)
Burnham sued, claiming that use of three key RGD peptides by Merck and Scripps violated their patents. (Licensing discussions had fallen though.) Merck fought back by claiming that their work came under a "safe harbor" provision of patent law, by which companies can do research needed for FDA approval of a drug even if that work actually infringes other patents. A District Court jury awarded Integra $5 million in 2000, later reduced, and Merck appealed. The Federal Circuit Court didn't buy Merck's reasoning, either, and ruled that the safe harbor language wasn't meant to extend that far back into early drug discovery and lead identification. (A longer discussion of that ruling can be found here.)
Merck appealed again, and the Supreme Court agreed to hear the case. That's unusual; most patent disuputes don't make it past the Federal Circuit. But the court seems to think that the safe harbor language is both ill-defined and important enough to deserve their attention, and I think that they're right. Merck (and several other drug firms who've filed friend-of-the-court briefs) argue that if the safe harbor provision is defined that narrowly, then big swaths of drug research are going to have to either come to a halt while patents are hashed out, or it'll just up and move to some country that doesn't respect the IP.
Meanwhile, Integra (and other companies who've lined up with them) say that if the law were interpreted according to Merck, then there would be no incentive to companies to search for and patent new research tools. After all, if you could claim the FDA exemption for anything that might end up leading to a drug - that is, anything that might lead to someone making some money - then what's the point?
Oral arguments took place on April 20th. I'm going to bet that the decision will split hairs in such a way as to not shake things up too drastically (as the court did in the Festo patent law case), but I'm glad I'm not betting with the kind of money that Merck and Integra are.