Jury Rules Amgen's Patents Valid in PCSK9 Battle

Amgen today won its patent suit against rival Regeneron in the battle over the costly cholesterol drugs, the PCSK9 inhibitors. Trading on Regeneron was temporarily halted on the news, which came midday.

The maker of Repatha (evolocumab) sued Regeneron in October 2014, and the case went to a Delaware jury that today ruled in Amgen’s favor over 2 patent claims. Regeneron and its marketing partner, Sanofi, vowed immediately to appeal to keep Praluent (alirocumab) on the market. The appeals process is lengthy, and Regeneron emphasized in a statement that there is no change in availability for the drug.

“This is a complex area of law and science, and we believe the facts and controlling law support our position,” said Joseph LaRosa, Regeneron’s general counsel. “We look forward to taking our case to the Federal Circuit Court of Appeals, the US appellate court that hears all biopharmaceutical patent appeals.”

Amgen's

Robert A. Bradway

Amgen

Amgen waited until midafternoon to release a statement: "We are thankful that the jury weighed the evidence carefully and recognized the validity of patents on Repatha, our innovative biologic molecule that reduces LDL cholesterol," said , chairman and CEO at .

It’s the latest twist in a battle over the huge market for a breakthrough class of drugs, which have been shown in clinical trials to reduce low-density lipoprotein (LDL) cholesterol levels by 60%. Amgen’s forecasts for the class have reached $150 billion, and an independent estimate of US sales for the 2 drugs for 2016 was $1.2 billion.

In late 2014, Regeneron had been behind Amgen on the regulatory calendar, but it jumped ahead of Amgen by purchasing a $67.5 million priority-review voucher that allowed it to gain FDA approval in July, one month ahead of Repatha.

The judge set a date of March 23-24, 2016, for a hearing on Amgen’s request for a permanent injunction, which could conceivably pull Praluent from the market. Some experts believe a more likely outcome is for Regeneron to be forced to pay Amgen royalties on sales.

Both drugs hit the market at just above $14,000 a year, after FDA limited both labels to smaller groups of patients than can obtain the drug in Europe. Of note, the drug makers did not win broad approval for physicians to prescribe PCKS9 inhibitors to patients who have not exhausted options at the highest doses of statins or who don’t want to take statins. A new study on the issue of stain intolerance and PCSK9 inhibitors scheduled to be presented at the upcoming meeting of the American College of Cardiology in Chicago, to be held April 2-4, 2016.

The meeting will come a little more than 2 years after Amgen’s splash at the ACC meeting in Washington, DC, when attendees packed a session to hear data on evolocumab. The injectable proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor was shown to dramatically reduce LDL cholesterol, to levels never before seen.

Right now, the FDA label and payer utilization protocols have limited PCSK9 inhibitors to the highest-risk groups of patients—those who have been unable to achieve lower levels of low-density lipoprotein (LDL) cholesterol on high doses of statins, as well as patients who have genetic conditions that result in abnormally high levels of cholesterol. It is unclear yet what the effect of today’s ruling will have on the efforts pharmacy benefit managers (PBMs) have put in place to keep PCKS9 inhibitors from upending health plan and employer benefits budgets.

Representatives from leading PBMs decried the pricing of the drug class and took advantage of the presence of both drugs entering the market at the same time. Express Scripts subjected both drugs to a rigorous formulary review and negotiated discounts, while CVS Health opted to only put Repatha on formulary.

Analyst Mark Schoenbaum of Evercore ISI wrote in an email to clients that an appeal could take a year to 18 months. He reminded clients that such appeals are fact based, without new arguments, “so the bar is relatively high.”