Eli Lilly expects no clarity on Alimta monopoly till 2014

Eli Lilly's ($LLY) fight to extend Alimta exclusivity will drag into next year. As Reuters reports, a patent trial may have wrapped up last week, but both sides plan to file additional briefs through mid-December. At stake: 5 additional years of exclusivity on the blockbuster lung cancer treatment.

It's an unusual argument, so the post-trial submissions may be welcome for Judge Tanya Walton Pratt. Alimta's compound patent is set to expire in 2017, but Lilly has a method patent on Alimta's dosing in combination with vitamins necessary to prevent debilitating side effects. That patent doesn't expire until 2022.

Would-be Alimta imitators Teva Pharmaceutical Industries ($TEVA) and Fresenius have challenged that patent, saying that the Alimta-plus-B-vitamins combo is an obvious fix for the side effects that cropped up in Alimta trials. Lilly claims that's not so, and that it spent considerable time testing various dosage combinations to come up with the patented regimen.

Alimta is Lilly's second-best seller. It brought in $2.59 billion last year, and with $1.286 billion in sales for the first half of this year, it's on track to beat that in 2013, if only slightly. With its new Alzheimer's imaging agent Amyvid hitting reimbursement obstacles, the looming loss of Cymbalta's patent and more than a few pipeline setbacks, Lilly could really use more time to prepare for a fast erosion in Alimta sales.

Indeed, with analysts looking for Alimta to hit $3 billion in sales, that means Lilly could add $15 billion to its sales over those additional 5 years. Without the additional exclusivity, Alimta sales are expected to slide to $2 billion in 2018, and further after that.

- see the Reuters news

Special Reports: Alimta - Top 20 Orphan Drugs by 2018 | Alimta - Top 10 Best-Selling Cancer Drugs

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