Ruling Threatens Mylan's Benicar Exclusivity

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By Dana A. Elfin

Jan. 11 — Generic drugmaker Apotex Inc. won a court ruling that potentially threatens rival drugmaker Mylan Pharmaceuticals Inc.'s period of exclusivity on a generic version of the high blood pressure treatment Benicar.

Because Mylan was the first to file a challenge to Daiichi Sankyo Inc.'s patents on Benicar (olmesartan medoxomil), it was eligible for the very valuable six months of market exclusivity on generic versions.

But a Jan. 8 ruling from Judge Sharon Johnson Coleman of the U.S. District Court for the Northern District of Illinois could force Mylan to instead share the generic Benicar market with Apotex. Like Mylan, Apotex also filed an abbreviated new drug application with the Food and Drug Administration seeking to market generic equivalents of Benicar.

In her opinion, Coleman ruled that Apotex had the right to sue for a declaration that its proposed generic versions of Benicar and Benicar HCT didn't infringe a patent on the drug that Daiichi had disclaimed and agreed not to enforce.

Both Mylan, which intervened in the case, and Daiichi had argued that Apotex didn't have standing to ask for a ruling on a disclaimed patent. They also argued that it lacked standing because Apotex hadn't even secured tentative regulatory approval for its proposed generic Benicar products.

But Coleman disagreed.

“Tentative approval, or even a strong likelihood of approval by the FDA, are not prerequisites for the resolution of this action,” Coleman said in her opinion.

“All that is required to constitute an injury and establish redressability is showing that a patent's listing constitutes an independent barrier to entry into the drug market and that a judicial decision can remove that barrier; there is no need to show that it is the only remaining barrier to entry,” she wrote.

Daiichi's disclaimed patent, U.S. Patent No. 6,878,703, is still listed in the FDA's Orange Book, even though Daiichi has said it won't enforce it. Officially titled Approved Drug Products with Therapeutic Equivalence Evaluations, the Orange Book lists patents that brand-name companies claim cover their drug products.

“Here, the ‘703 patent's listing in the Orange Book constitutes an independent barrier to the drug market for both of Apotex's ANDAs that may be removed through a favorable decision from this Court,” the opinion said. “Because Apotex has filed ANDA's containing Paragraph IV disclaimers [Paragraph IVs are certifications challenging the patent] with respect to Patent ‘703, it has standing to ask this Court to determine whether its ANDAs would infringe upon that patent which, although disclaimed, nonetheless serves as a barrier to entry into the marketplace by virtue of its continued Orange Book listing.”

The judge concluded that Apotex didn't infringe the ‘703 patent. “Non-infringement of the ‘703 patent follows as a matter of law from the fact that it has been formally disclaimed.”

Active Ingredient Patent Expires in October

Because Mylan's Benicar ANDAs were found to have infringed the other Daiichi patent listed in the Orange Book, U.S. Patent No. 5,616,599, Mylan must wait until after that patent expires to enter the market.

The ‘599 patent, which covers the active ingredient in Benicar, expires Oct. 25.

Under the Hatch-Waxman Act, if a subsequent ANDA filer obtains a final judgment of invalidity or noninfringement with respect to the ‘703 patent, Mylan must begin to market its generic within 75 days or it forfeits its market exclusivity.

If Mylan winds up forfeiting its exclusivity, Apotex could also go to market with its generic after the patent expires, assuming it secures regulatory approval from the FDA.

In a brief filed in the case, Apotex said it hopes to get secure final judgment of noninfringement on the ‘703 patent by Aug. 11. It said it intends to seek a mandate from the U.S. Court of Appeals for the Federal Circuit confirming Coleman's ruling.

The firms of Husch Blackwell in Chicago and Hahn Loeser & Parks, LLP, Chicago, represented Apotex.

The firms of Fitzpatrick Cella Harper & Scinto, New York, and Howard & Howard in Chicago, represented Daiichi Sankyo.

The firms of Perkins Coie LLP in Washington, Chicago and Madison, Wis., represented intervenor defendant Mylan Pharmaceuticals.

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

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