Court Rejects FDA on Ferring's Prepopik Exclusivity

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By Dana A. Elfin

Sept. 12 — The FDA likely will award a full five years of marketing exclusivity to Ferring Pharmaceuticals Inc.'s colon cleansing drug Prepopik following a recent court ruling ( Ferring Pharm., Inc. v. Burwell, 2016 BL 294111, D.D.C., No. 15-cv-0802, 9/8/16 ).

Judge Rudolph Contreras of the U.S. District Court for the District of Columbia Sept. 8 said the agency acted arbitrarily when it denied Ferring's request for new chemical entity (NCE) exclusivity for Prepopik.

Contreras said the Food and Drug Administration's prior policy on NCE exclusivity rights was arbitrary and capricious. He ordered the FDA to reconsider its decision denying NCE exclusivity to Prepopik.

Not only does the ruling mean that the agency likely will grant Prepopik (sodium picosulfate, magnesium oxide, anhydrous citric acid) five years of marketing exclusivity, but also it likely will affect exclusivity rights for Gilead Sciences Inc.'s Stribild and Bayer HealthCare Pharmaceutical Inc.'s Natazia.

Like Prepopik, Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir), an AIDS drug, and Natazia (estradiol valerate and estradiol valerate/dienogest), an oral contraceptive, contain at least one active ingredient that hadn't previously been approved by the FDA. Under the FDA's prior policy of awarding new chemical entity exclusivity rights based on the order in which drug applications were approved, the FDA denied NCE exclusivity to all three drugs.

Old Policy Changed

Before October 2014, the FDA interpreted the five-year exclusivity provision as saying that only drug products containing no previously approved drug substances were eligible for exclusivity.

In October 2014, the FDA issued a guidance that extended the five-year NCE exclusivity to new combination drugs that contain previously approved drug substances as long as they also contain a drug substance that hasn't been approved.

However, the FDA said its new interpretation didn't apply to combination drugs like Prepopik that were approved before the guidance was published.

Prepopik Approved in 2012

Prepopik, a fixed-dose combination drug product, is intended for cleansing the colon in preparation for colonoscopy in adults. It contains three active ingredients: sodium picosulfate, magnesium oxide, and anhydrous citric acid.

The FDA had approved magnesium oxide and anhydrous citric acid but hadn't yet approved the third ingredient, sodium picosulfate, a stimulant laxative.

Because sodium picosulfate constituted a new drug substance, Ferring sought five-year NCE exclusivity for Prepopik when it submitted its new drug application (NDA) to the agency.

The FDA approved Ferring's NDA for Prepopik in 2012, but only awarded Ferring three-year exclusivity because magnesium oxide and anhydrous citric acid had been approved.

Ferring challenged the decision in a citizen petition with the FDA, which the FDA denied in February 2014, along with similar petitions filed by Gilead on Stribild and Bayer on Natazia.

Ferring Sues

In 2015, Ferring sued the agency in federal court, challenging its NCE policy as arbitrary and capricious.

Contreras's latest decision finding the FDA's prior NCE policy arbitrary and capricious is a reversal of his position just six months ago. In March, he upheld the FDA's pre-2014 policy as a reasonable interpretation of the exclusivity provision.

The judge said that he changed his position because Ferring had subsequently provided the court with several specific examples of how the FDA, under its prior policy, had treated similar cases differently.

“[U]nder the FDA’s prior interpretation, certain drug substances lost out on a five-year period of marketing exclusivity solely because they had been first approved as part of a fixed-combination drug product,” Contreras wrote.

The FDA failed to provide a legitimate reason that justified its denial of NCE marketing exclusivity to certain drug substances.

“The relevant point is that certain drug substances received a five-year period of marketing exclusivity—in which later fixed-combination drug products that included those drug substances were able to share,” he said, but other drug substances were denied the same marketing exclusivity period because a fixed-combination drug product was approved first. Therefore, the FDA's prior interpretation was arbitrary and capricious, Contreras said.

“Consequently, the Court finds that there is good reason to correct a clear error in its prior opinion, that Ferring would be harmed by the Court's failure to do so, and that Ferring's motion for summary judgment should have been granted.”

Saving Face?

“The FDA probably saw this coming a long time ago,” Terry G. Mahn, an attorney with Fish & Richardson P.C. in Washington, who is an expert in patent and exclusivity matters, told Bloomberg BNA Sept. 9. “It made no sense in the beginning but, once they made policy, the agency was fully invested and there was no clean way out.”

“It is probably better for the court to order the policy arbitrary than for FDA to try to undo things,” Mahn said. “Now it gets to say ‘the court is making us do this.' ”

Ferring was contacted for comment on the decision but wasn't available for comment.

Ferring has global headquarters in Switzerland and its main base of U.S. operations is in Parsippany, N.J.

To contact the reporter on this story: Dana A. Elfin in Washington at

To contact the editor responsible for this story: Brian Broderick at

For More Information

A copy of the opinion is at

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