Over the course of 30 years, Princeton University professor Dr. Edward Taylor discovered and helped develop the drug today known as Alimta (Pemetrexed). This was the first drug to treat malignant pleural mesothelioma. It was an arduous journey that almost did not succeed when the drug was implicated in deaths while in clinical trials. Eli Lilly, had to conduct extensive research to uncover that folic acid and vitamin B12 supplementation significantly reduce the side effects of the antimetabolite Alimta. The drug was approved in 2004 in combination with cisplatin for malignant pleural mesothelioma. Its indication was expanded in 2008 to non-small cell lung cancer.
Currently, Alimta’s patent protection will expire in 2016, which means generic drug companies cannot saturate the market until this date. When this occurs, the price of Alimta will significantly decrease. Eli Lilly is fighting an ongoing case with the FDA to extend the patent life of the drug to 2022, due to their research in discovering the need for patients to supplement the drug with folic acid and Vitamin B12. This would be done with its “method of use” patent for Alimta. This would keep generics from including the use of nutrients in the label, which in this case would keep the FDA from approving generic forms of Alimta due to the safety risk.
It is true that the FDA would not have approved this drug had Eli Lilly not discovered people must take folic acid and B12 with take the drug to avoid horrible side effects. Yet, Teva Pharmaceuticals is arguing that you cannot patent vitamins, even if they need to be taken in tandem with medicines.
Princeton has licensed the drug to Eli Lilly for, “single digit royalties,” according to Eli Lilly’s SEC Filings, but Dr. Taylor told me that Princeton receives 5% of the total revenue. In 2012, the drug had global revenue of 3.5B, which means Princeton took in 175M from the drug. The drug has already paid for the new chemistry building. Thus, this decision is especially intriguing to me because it could potentially cost Princeton 1.2B in revenue from the drug sales from 2016 to 2022.
To put this in perspective, this would be about 7% of Princeton’s current endowment. Also, 1.2B is more than the entire endowments for the university of Florida, Kansas, Nebraska, and even Georgetown.
Could Teva’s attack for Alimta to maintain its loss of patent in 2016 be about more than money? Or is it just a coincidence that Teva’s former CEO Shlomo Yanai went to Harvard business school and their board member Elon Kohlberg is on the faculty at Harvard’s business school?