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Sandoz Inc. may be be able to launch a generic version of Allergan Plc’s blockbuster glaucoma drug Combigan earlier than expected, following a favorable ruling from the U.S. Court of Appeals for the Federal Circuit.
In a nonprecedential opinion Dec. 22, the appeals court reversed a 2016 district court decision and found Sandoz’s proposed generic copy of Combigan didn’t infringe an Allergan patent on the drug.
Because Sandoz had already won favorable noninfringement rulings at the district court level on two other Allergan patents at issue in the litigation, the latest appeals court decision may pave the way for it to enter the market with its generic earlier than expected. In December 2016, Judge J. Rodney Gilstrap of the U.S. District Court for the Eastern District of Texas ruled Sandoz, the generics unit of Novartis AG, didn’t infringe two other Allergan patents, but the adverse ruling on a third patent, U.S. Patent No. 8,748,425 (the ‘425 patent), blocked Sandoz from selling the product until that patent expires in April 2022.
Now that the appeals court reversed the infringement ruling on the ‘425 patent, it’s possible Sandoz could enter the market before April 2022 once it secures final Food and Drug Administration approval for its abbreviated new drug application.
But Allergan says not so fast. The company plans to file petitions for rehearing of the appeals court decision and also asserted a new Orange Book patent against Sandoz’s generic version of Combigan, the company said in a Dec. 22 statement provided to Bloomberg Law.
The Orange Book is an FDA listing of patents that branded drugmakers claim cover their products and is formally titled “Approved Drug Products with Therapeutic Equivalence Evaluations.”
The current federal district court’s injunction preventing final approval and launch of the Sandoz product isn’t likely to be lifted before the appeals court decides whether to rehear the case, Allergan said.
In addition, because Allergan is suing Sandoz over a different Combigan patent in federal district court in New Jersey and that case has yet to be decided, Allergan said, it doesn’t believe the appeals court ruling will “result in the market formation for a generic Combigan product.”
Sandoz’s abbreviated new drug application didn’t literally infringe the ‘425 patent because the patent didn’t actually claim Combigan, the appeals court said in the opinion.
“The Hatch-Waxman Act provides for a technical infringement upon submission of an ANDA, but only ‘for a drug claimed in a patent,’” Judge Todd M. Hughes wrote for the panel.
“Here, Combigan contains a 0.2% brimonidine tartrate and 0.68% timolol maleate solution, as its FDA-approved label makes clear,” the opinion said. “But claims 1–8 of the ’425 patent expressly recite 0.5% timolol free base, not 0.68% timolol maleate. Therefore, as a matter of law, Combigan is not the `drug claimed in’ the ’425 patent, and Sandoz’s ANDA does not infringe,” Hughes wrote.
Allergan isn’t eager for generic versions of Combigan to come on the market because the franchise is a lucrative one. Allergan has said Combigan is one of the drivers of revenue growth at the company.
Combigan (brimonidine and timolol) is a prescription eye drop designed to lower intraocular pressure in patients with glaucoma and ocular hypertension.
Allergan Plc used to be Actavis Plc but changed its name when it bought Allergan in 2015. In addition to acquiring Combigan in 2015, the company also acquired several other profitable products in the takeover, including Botox and Juvederm.
Sandoz lost an earlier case over different Combigan patents and subsequently modified its ANDA to remove the word “glaucoma” to avoid those patents.
Bloomberg Law contacted both Sandoz and Allergan for comment on the Federal Circuit’s decision, but no one from either company was available to respond.
Allergan Plc is headquartered in Dublin. Novartis AG, which owns Princeton, N.J.-based Sandoz, is based in Basel, Switzerland.
Fish & Richardson PC represented Allergan.
Kirkland & Ellis LLP represented Sandoz.
In addition to Hughes, Judges Kimberly A. Moore and Haldane R. Mayer also heard oral argument in the case.
The case is Allergan Sales, LLC v. Sandoz, Inc. , Fed. Cir., No. 17-1499, nonprecedential 12/22/17 .
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