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Update on NCE case...from DC Attorney's present at

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Biobillionair Member Level  Tuesday, 03/17/15 11:05:09 PM
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Update on NCE case...from DC Attorney's present at hearing I presume: My take...the FDA is really screwed! Amarin was able to tie Investor Law Suit and Anchor Rescindment into this case...

FDA allowed this can of worms to be opened and it's been baking in the sun for 3 long years...This should move alone nicely with the Senate HELP Committee meeting topic next week.

Law360, Washington (March 17, 2015, 8:00 PM ET) -- The U.S. Food and Drug Administration improperly reversed course on how it defined an active ingredient when it denied market exclusivity to Amarin Pharmaceuticals Ireland Ltd.’s drug Vascepa, the company argued on Tuesday, asking a D.C. federal judge to grant that exclusivity.

The Irish biopharmaceutical company urged the judge to rule that the FDA should have granted market exclusivity for its “pioneer drug” at the summary judgment hearing, saying that its drug is a novel invention.

The FDA denied its application for market exclusivity based on the fact that Vascepa’s active ingredient is an “active moiety” in the mixture for another approved drug, GlaxoSmithKline PLC’s Lovaza, according to court documents. Christopher N. Sipes of Covington & Burling LLP, an attorney for Amarin, said that went against the intent of the Hatch-Waxman Act that established the exclusivity, as well as more than two decades of agency precedent

“There is no separate authority for the idea that active ingredient means active moiety, except for the FDA’s fiat in this case,” Sipes said.

As part of the drug’s application for market exclusivity, the agency separated the different parts of Lovaza, which was an undifferentiated fish oil mixture, including icosapent ethyl, the active ingredient in Vascepa, and said in its 2014 ruling that the drug was not eligible.

Sipes said that the agency allowed drugs that contained components from previously approved mixtures through at least 2009 and if it had planned on reversing course on that rule, it should have followed the normal notice-and-comment process.

“That [reversal] creates a level of uncertainty Congress did not intend when it created the incentive provision,” Sipes said.

In addition, he said that the agency was inconsistent within the case itself, because agency officials required the company to conduct clinical trials for the ingredient in the drug in 2008 and 2009 as though it were a new drug, and not derivative of an existing one.

Vascepa was granted a more limited, three-year market exclusivity, but Sipes said that the FDA’s decision has already caused irreparable harm, because five Abbreviated New Drug Applications have already been filed for generic versions of Vascepa, as well as accompanying patent litigation.

He said that the injunction cannot at this point take those costs back, but it can give the company more time to plan, as well as the incentive to continue developing new drugs, which Congress intended in the statute.

That reasoning would undermine the regulatory structure that the FDA has built, according to Ann Frances Entwistle, an attorney for the FDA. She said that the agency should be given deference to interpret the phrase "active ingredient" in different parts of the statute, as it applies in ambiguous contexts.

“Congress’ intention there was to reward the creation of something novel, a new molecule,” Entwistle said. “Not merely the salt or ester, or in this case the more pure version, of a previous drug.”

The agency always evaluates the components of a drug when it is approving an undifferentiated mixture, she said, and should be able to deny an application when a new drug comes out that is a derived version of an old one.

“Inherently you have to, in a mixture, identify what ion or molecule is responsible for that effect,” she said.

Entwistle said that the agency should be allowed to interpret the provision of the Hatch-Waxman Act, and its own regulations, to say that it covers the components of a previously undifferentiated mixture drug’s single active ingredient, even though the statute does not specifically state that.

However, District Judge Randolph Moss questioned how the agency could reason that the phrase “active ingredient” could have different meanings in different sections of the act. He pointed to a portion of the statute that referred to drugs with multiple separate active ingredients applying for generic approval.

Judge Moss asked how that could square with the agency’s interpretation of its ability to parse components of a mixture after approving the whole thing as a single active ingredient.

“It seems as though there is not the difference in meaning you propose,” he said. “Congress itself tied ‘active ingredient’ to the approval process in the sentence we are talking about.”

The case is not the first battle that Amarin has had with the FDA over Vascepa, with the company also fighting the agency over its refusal to expand the use of the drug to sign off on clinical trial results meant to support its expanded use. As a result of that fight, Amarin shareholders have sued the company, arguing that it misled them into believing it would win approval for wider use of the drug.

Amarin is represented by Christopher N. Sipes, Benjamin C. Block and Matthew J. Berns of Covington & Burling LLP.

The FDA is represented by Ann Frances Entwistle, Gerald Cooper Kell, Andrew E. Clark and Cindy Jane Cho of the U.S. Department of Justice.

The case is Amarin Pharmaceuticals Ireland Ltd. v. Food and Drug Administration et al., case number 1:14-cv-00324, in the U.S. District Court for the District of Columbia.


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