Indianapolis-based pharmaceutical manufacturer Eli Lilly and Company has had to weather a variety of foreign and domestic intellectual property controversies in recent weeks. After reconciling a trade secrets dispute involving a Chinese business partner earlier in the month, the firm must now defend the validity of a patent covering its second-best-selling drug.
Lilly currently benefits from a unique method-of-use patent that accompanies the active ingredient patent it holds over its proprietary lung cancer drug, Alimta. According to The Indianapolis Star, the treatment generated $2.6 billion in sales last year - more than 10 percent of Lilly's total 2012 revenue. However, a challenge filed by several generic drugmakers threatens to strip Alimta of as many as five years of market exclusivity.
The case hinges on whether or not the method-of-use described in Lilly's patent constitutes novel innovation, according to the news outlet. While plaintiffs argue that anyone reasonably educated in nutritional sciences could have come up with the idea to supplement Alimta with vitamin B12 and folic acid, Lilly contends that the treatment plan was considered counterintuitive at the time, and even derided as "crazy" by one medical expert.
Lilly has grown all too familiar with patent cliffs in recent years, according to Reuters, with its schizophrenia treatment Zyprexa losing market exclusivity in 2011 and its flagship antidepressant Cymbalta scheduled to come off patent in December. But as one investment expert told the news source, there is little legal precedent to suggest who the court may side with in this latest dispute.