Legal: Going to Court

So the patent on one of your company's top-selling drugs has been challenged. If this is your first go-round with patent litigation, you're probably hearing horror stories about the cost and unpredictability of litigation. If you are a repeat player, then you may wonder if this next foray into court will turn into a quixotic journey to rival the last one. Either way, you are in for a stomach-churning ride. Much of what happens will be out of your immediate control.

Jonathan Singer

But there is one important thing that you can choose: where to litigate the case. Absent jurisdictional concerns—a real problem in some cases—you can generally file your patent lawsuit wherever you like. Your choice can affect the outcome of your case. You may rue or celebrate it when the verdict comes in.

So, what should you do? Your lawyers will tell you tales about this judge and that one. They can speak with seeming authority about the types of patents that hold up (or get knocked down) in pharmaceutical cases. You will probably just stare back at them and wonder whether they know what they're talking about. I know. I've been on the receiving end of those stares.

What your lawyers forget: You are a data person. You want to know what actually happens in these different venues. You want to see trends in the reported verdicts. You wouldn't make an important decision about a new product without the best information available. So why make a critical decision about where to file a lawsuit without hard data? No good reason. But more often than not, that's what happens.

No more. We examined cases available online that reached a judgment or verdict from 2002 to 2006 in three of the most popular venues for generic drug litigation—the Northern District of Illinois, the Southern District of New York, and the District of New Jersey—as well as the District of Delaware, which has more recently become popular. Is there one place that offers a discernable advantage to patent holders? Another that favors generic applicants? Or is this all nonsense, since each fact-intensive case is unique?

Trial results in light orange boxes Summary judgment results in dark orange boxes

It turns out that the District of Delaware stands out as the best place for branded drug manufacturers to litigate (see table).

Over the five years studied, six generic drug cases have reached a verdict in Delaware—all in favor of branded manufacturers. And while our sample size may be too small to draw firm conclusions, there were no reported summary judgments in favor of generics in Delaware from 2002 to 2006.

These data surprise even hardcore patent junkies. A landmark study of patent litigation, by Federal Circuit Judge Kimberly Moore, suggested that Delaware was actually worse than average for patentees, which may be true. But when it comes to pharmaceutical cases, Delaware appears to be the host with the most. Of course, it's possible that only strong cases were brought in Delaware, where the trial calendar is quick and the judicial willingness to try cases is high. Nonetheless, it seems clear that if you are a patentee with a good case, you will get a fair shake in Delaware. And that is saying a lot.

Consider the flipside. Where are the venues that give branded manufacturers consistent problems? Hello New Jersey and Illinois. Over the past five years, courts have granted summary judgment to generic drug makers in six cases in New Jersey and four in Illinois. Two verdicts in Illinois also went in favor of generic manufacturers. If you are a branded manufacturer and have an option, these are two jurisdictions to avoid.

One final point. If possible, don't file your case in a forum that has not seen significant drug litigation. If you think you're going to get a home-court advantage by litigating in your backyard, even if your backyard normally has lots of patent litigation, forget it. As the table demonstrates, filing in a court that does not see much drug litigation is a recipe for defeat.

Of course, there is no magic formula for choosing where to litigate. The intuition of a great lawyer can trump almost any data set. But as Mark Twain once said, "Get your facts first. Then you can distort them as you please."

Sidebar Headline Is associate vice president of leadership and management development at Sanofi Aventis. As president of the Society of Phamaceutical and Biotech Trainers (SPBT), he also serves on the editorial advisory board of Pharmaceutical Representative magazine lication). Prior to joininers (SPBT), he also Advanstar publication). Prior to joininers (SPBT), he also serves on the editorial advisory serves on the editorial advisory board of Pharmaceutical Representative magazine (an Advanstar publication). Prior to joininers (SPB, he also serves on the editorial advisory serves on the editorial advisory board of Pharmaceutical Representative magazine (an Advanstar publicarial advisory board of Pharmaceutical Representative magazine (an Advanstar publication). Prior to joininers (SPBT), he also serves on the editorial advisory board of Pharmaceutical Representative magazine (an Advanstar publication). Prior to joininers (SPBT), he also serves on the editorial advisory board of Pharmaceutical Representative magazine (an Advanstar publication). Prior to joining Aventis, Rauschkolb was the senior director of the University of Pfizer, Hospital and Specialty Representative Training.

Jonathan Singer is a principal in the Minneapolis office of Fish & Richardson. He can be reached at singer@fr.com