Alimta, a lung cancer pharmaceutical from Eli Lilly that is quickly rising to $3.5 billion-per-year blockbuster status, has three years until its basic use patent expires. However, if its ancillary method-of-use patent—which requires that it be administered with folic acid and vitamin B12—holds muster in court this year, Lilly may reserve marketing rights until 2022. When patents expire, drug makers lose share to generic manufacturers in a hot minute, and any possibility of extending exclusivity is worth its weight in litigation.
The company is currently under suit regarding the patent from generics manufacturers Teva Pharmaceuticals and APP Pharmaceuticals, and the case will reach federal court this summer. Lilly is likely to argue that it did original research to confirm that folic acid and vitamin B12 supplementation inhibit the nasty side effects of Alimta, and administration of these nutrients is required in its prescripiton. The counter-argument would be that the need for supplementation is too obvious to require a method-of-use patent.
It's an interesting gamble for Lilly—and one it desperately needs to win. Here's the original reporting from Reuters:
In October 2011, the company began facing one of the worst patent cliffs in industry history when its biggest drug, Zyprexa for schizophrenia, began facing generics. Sales of the former $4.5 billion-a-year drug have plunged by two-thirds. The pain worsens in December of 2013, when Lilly's current top seller, the $5 billion-a-year anti-depressant Cymbalta, goes generic, and after cheap versions of its $1 billion Evista osteoporosis drug arrive in early 2014.
A patent on vitamins?
The rub here is that the case bucks against the old adage in the supplement industry that you can't patent natural products. Of course, intellectual property abounds in dietary supplements, but typically it's based on unique manufacturing, extraction, chelation or synthesizing processes, not on the compounds themselves. This is the first method-of-use patent I've seen tying pharmaceuticals to supplements (perhaps there are others?), even if it's to protect the drug, not the nutrient.
It'll be interesting to see whether this decision filters into the practitioner supplement realm, or whether there is opportunity to be had in partnering with drug makers on prescribing complementary nutrition alongside certain pharmaceuticals. This latter idea was actually tried by an Australian supplement company last year—and it resulted in a spectacular failure.
But maybe the Lilly case will have the secondary effect of further uniting U.S. pharma and nutra. One can only hope.