Every Paragraph IV certification is a potential trial. But this simple fact is often ignored until just before trial, when the attorneys rush to figure out how to present the case. The most effective and efficiently runs case, however, is one in which every aspect of the case—from beginning to end—revolves around a case story. Without a compelling story firmly in mind early, discovery can become unfocused and inefficient. Having a compelling story early can streamline and target your discovery. It also can lead to an early and favorable settlement.
A while ago, we handled a Paragraph IV challenge on a transdermal nitroglycerin patch. In this patch, the nitroglycerin was dissolved in the adhesive. The adhesive was then spread on the patch. In use, the patch was stuck to the skin and the drug moved out of the adhesive into the skin. The patent covered a solvent-based adhesive.
Our client used a water-based adhesive, which we argued was non-infringing. Early in the case, the judge asked for a tutorial for each side to teach the court about the technology in the case. Although not standard practice in all federal courts, these tutorials are common in many.
The branded company explained to the court that the choice of an adhesive in the patch was no different than the choice of wall paint. He explained that for paints you had a choice of latex (water-based) or oil (solvent-based) paints. He argued that the two different adhesive for patches were equivalent just as the two different types of paints were.
We argued that the use of one adhesive or another was not a simple design choice. In fact, the choice of an adhesive for nitroglycerin patches could have explosively different consequences, literally! We explained that to make the patch, the nitroglycerin first is dissolved in the adhesive. Farther down the production line, however, the adhesive evaporates, carrying nitroglycerin with it into the exhaust ducts. There, the solvent can condense and form drops of nitroglycerin. Those drops are highly sensitive to vibration and can explode. As a result, elaborate measures had to be taken to handle the solvent-based adhesive exhaust so it would not explode.
To reinforce how dangerous nitroglycerin is, we described a nitroglycerin-producing plant for the judge. In the plant, all of the nitroglycerin production takes place underground in bunkers and all of the mixing is done robotically. All of the raw ingredients are carried into the bunkers by automated trains. The control center, where people are, is located a significant distance from the actual mixing bunker and is, itself, underground in a bunker. All these precautions are taken because nitroglycerin is a highly powerful and destructive explosive and it is particularly hard to use and manipulate.
We explained to the judge that the use of a water-based adhesivet produced no fumes and, therefore, there was no opportunity for an explosion. No elaborate measures were needed to handle any potentially explosive condensation. Quite literally, there was an explosive difference between the two processes!
While the “explosive” distinction may see corny, it was a story backed with solid facts and it was extremely easy to remember. It also was compelling. It had such an impact on the judge that the judge referred to it often. Needless to say, the plaintiff only needed to hear the judge repeating our story a few times before it settled the case.
So what’s the moral of this story? Spend time early in your case developing a strong and compelling story and then use that story to drive your discovery. Do not wait until the end of discovery or just prior to trial to develop your story. By then, it may be too late.
If you are currently involved in a Paragraph IV case, ask your attorneys to tell you the story of the case in a short, succinct and compelling way. If they cannot do this, you are likely paying for an inefficiently run case and may be wasting an opportunity for an early and favorable settlement.