Dan Boehnen is a patent attorney and founding partner of the Chicago-based law firm of McDonnell, Boehnen. His legal efforts reach into a number of fields, including biotechnology, pharmaceuticals, computing, and chemicals. Among his current clients is RNAi drug development firm Sirna Therapeutics. RNAi News recently spoke to Boehnen on his views about the rapidly changing sector.
How did you first get interested in RNAi?
I have been working with a company that was known as Ribozyme Pharmaceuticals for a number of years and … less than a year ago that company decided to change its focus and they decided to commit their resources to RNAi.
That company is, of course, Sirna. Given your close relationship with a major RNAi player, what’s your take on the IP situation in the RNAi space?
I think that it remains a very early-stage technology where the patent rights are continuing to sort themselves out. Six months ago we had probably five or six institutions that seemed to have a claim on seminal rights, as well as another four or five companies that wanted to position themselves to be involved with those seminal rights. Now all of that has narrowed itself down to perhaps about two or three companies that claim to have those seminal rights, [two of which being] Alnylam and Sirna Therapeutics, both of whom have worldwide exclusive rights — and the right to grant sublicenses — under the basic Tuschl patents.
How do you see it all shaking out?
So much of it is going to depend on the kinds of … individual experiences and developments that are made from here. We don’t know yet which are going to be the specific therapies … or uses of RNAi that are going to come to market first. That, clearly, is going to be a very important factor in what goes and what doesn’t go…
What would be one piece of advice you would give to someone working in the RNAi space?
That’s a huge question, of course. I think that the most common mistake that non-patent lawyers make is the belief that if they can get their own patent on something they’re doing, that means that they don’t infringe anyone else’s patent and they don’t need a license [to other patents.] That is a very common mistake, but it is a dead wrong mistake. The flip side is equally important. Even though somebody may have fundamental rights that you might need to conduct your own R&D program, that should not in any way diminish the value of discoveries you make … There’s lots of room for improvement patents here.
Can you think of any important court rulings or changes in the law that people should be aware of?
I don’t know if there’s any one thing that’s so spe- cific to RNAi, but I think that … it’s clear that over the last 10 years, the Federal Circuit Court of Appeals has been trying to find ways of making patent protection more predictable and clearer, so that when third parties look at a patent they can better understand the scope of whether they need to have a license or not have a license.
The principal way the court of appeals has tried to do that is by tightening the connection between what has to be described in the text of the application and what has to be included in the words of the claims. That’s not to say that broad patents cannot still be granted, but, generally speaking, as a trend … [it] is in the direction of trying to have a closer connection between what’s claimed in the patent and what’s described in the patent.
Is that to say courts are looking for more supporting data of the claims that are being made?
That’s one aspect of it. But it’s everything that’s being disclosed in the body of the application. There’s a lot of different ways that you describe things in the body of a patent application; some of it’s data, some of it doesn’t have to be data, but the general trend is that the court wants you, in the body of the application, to describe as specifically as possible what your invention is. Then, when you get to the claims, to narrowly define those in relation to what was described.