Indianapolis, Indiana – Patent lawyers for Eli Lilly and Company (“Lilly”) of Indianapolis, Indiana are in trial again this week in the Southern District of Indiana pursuing patent-infringement allegations against five generic-drug challengers, including AAP Pharmaceuticals of Schaumberg, Illinois and Pliva Hrvatksa of Croatia. At issue is Lilly’s patent on the use of Alimta in conjunction with specific vitamins; patents for the two Alimta treatments, both with and without the supplemental therapy, have been issued by the U.S. Patent Office.
Lilly sells the drug Alimta to treat various types of lung cancer, including mesothelioma. However, certain side effects were troublesome, including treatment-related hematologic and gastrointestinal toxicity. Deaths among some patients were attributed to treatment with Alimta. In response to this concern, Lilly took the unusual step of mandating supplementation of the Alimta protocol with two vitamins, folic acid and vitamin B12. The patentability of that idea is the focus of a patent challenge by five makers of generic drugs.
Patent-infringement litigation between brand-name manufacturers and generic-drug makers is common. In a typical lawsuit, a company which wishes to sell a generic version of a brand-name drug, usually a widely used drug, will try to invalidate the patent on the drug, in the hopes that it could then offer the same drug in generic form.
This litigation is different from traditional patent litigation. The original patent on Alimta, administered as a stand-alone treatment, protects only Alimta’s active ingredient. That patent will expire in 2017. However, the focus of the current litigation is on the combination treatment which involves both Alimta and the vitamin regimen. The patent on the method of administration, if upheld, would expire in 2022.
The generic challengers contend in part that the patent on the combined therapy is invalid, arguing that someone knowledgeable about both nutrition and medicine could have easily concluded that supplementation with B12 and folate might alleviate certain side effects of Alimta.
Lilly, in contrast, argues that the vitamin regimen was not only counterintuitive when it was proposed, it was called “crazy” a leading cancer doctor before testing showed its benefits.
The case, which is before Judge Tanya Walton Pratt, began last Monday and is expected to continue another week.
Lilly is facing a significant patent cliff. Its patent for a former top product, the antipsychotic Zyprexa – which once generated $5 billion in annual revenues – expired in 2011. Its current top-selling drug, the antidepressant Cymbalta, will lose patent protection this year. The patent on blockbuster Evista, a breast cancer drug, will expire in early 2014.
Alimta is currently Lilly’s second-best-selling drug. It generated $2.6 billion in sales last year, or about 11 percent of total Lilly’s revenue. Since it was launched in 2004, Alimta has generated $12 billion in total sales for Lilly through 2012.
Under patent law, a court can deem a patent invalid if its claims are “obvious” and anticipated by previous research. In this case, the court will weigh the merits of the separate “method-of-use” patent on the administration of Alimta with B12 and folic acid.
If successful in defending this patent, intellectual-property law will grant market exclusivity to Lilly until 2022, allowing it to exclude generic manufacturers and, thus, to charge the higher brand-name price for Alimta therapy. If the patent is not upheld in this litigation, Lilly will lose the five additional years of exclusivity that the second patent would have afforded.