Eli Lilly ($LLY) just scored billions in additional sales. A federal judge decreed that an unusual patent on Lilly's cancer drug Alimta is valid. And that means the company keeps its Alimta exclusivity till 2022. At more than $2.7 billion in 2013 sales, about $1.2 billion in the U.S., 5 extra years of exclusivity promise a big boost at a crucial time.
Israel-based Teva Pharmaceutical Industries ($TEVA) had tried to buck that 2022 patent, which covers Alimta's use in combination with two B vitamins. Without those supplements, Alimta (pemetrexed) can cause potentially fatal side effects, so figuring out a remedy was important for the company--and not an easy task, Lilly contends. Teva, however, maintains that adding B vitamins to the Alimta regimen was simply a logical conclusion.
U.S. District Judge Tanya Walton Pratt didn't buy Teva's argument. In her decision, Pratt writes that using folic acid and B-12 to prevent Alimta side effects wasn't an obvious technique, despite some early-stage studies that suggested the vitamins could solve the problem. Correct doses of vitamins and Alimta were key to minimize side effects without interfering with the drug's ability to fight cancer, and that balance wasn't obvious, the judge determined.
Lilly SVP and General Counsel Michael Harrington said the company is "pleased" with Pratt's ruling. "The significant scientific research that Lilly performed in support of the vitamin dosage regimen patent deserves intellectual property protection," Harrington said in a statement. The company is expecting Teva to appeal, however, analysts say.
"Pleased" is an understatement. Alimta is Lilly's second-best-selling drug, behind the $5 billion antidepressant Cymbalta--and Cymbalta lost patent protection in December. With more than its share of pipeline setbacks in recent years, the company has fewer new meds on the market than it had hoped to have by now. And with generics already hacking away at Cymbalta sales, Lilly needs Alimta more than ever.
Lilly does have some promising new products in the offing, including the diabetes drug dulaglutide, which won backing from European regulators earlier this month. But launching those drugs will take time; indeed, the FDA recently refused to approve dulaglutide because of problems at the plant where it would be manufactured. So, Lilly will need to lean on Alimta and its other older products till the new ones can take hold.
To keep its lock on overseas Alimta sales, the company is defending similar method patents, with a trial set for early April in the U.K. Rulings there and in Germany could happen this quarter, ISI Group analyst Mark Schoenebaum figures. There's also an E.U. Patent Office trial.
The U.S. win could mean an extra half-billion in 2017 sales, Schoenebaum says, and $600 million in 2019. Winning in the E.U. would add up to $175 million per year from 2016 to 2019, he said.
- read the Lilly statement
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