A recent decision from the Delaware District Court held that the composition of matter patent for the drug Baraclude was invalid as obvious. This opinion has drawn immediate attention because it is the first time that a lead compound obviousness challenge has succeeded in a district court since KSR v. Teleflex issued. What this means for inside counsel depends on which side of the aisle you are on, but regardless this decision may provide the beachhead for obviousness attacks where none existed before. For generic pharmaceutical companies, the ruling may affect pre-filing decisions, such as which patents to attack listed with the Orange Book and concomitant certifications, may take on a sizeable shift, and change the landscape for at-risk launches. Patent prosecutors should also heed the court’s decision when drafting claims.
With this in mind, this column examines several key questions: What underlying facts and factors were crucial to the Delaware district court’s decision that the patent for Baraclude would have been obvious? What are the potential points of attack for Bristol-Myers Squibb (BMS) to overturn this decision on appeal? Does this ruling suggest that composition of matter patents will be more susceptible to obviousness challenges in the future? We conclude with practice points that can be gleaned from this case.