Exasperated at Teva Pharmaceutical Industries Ltd.’s latest attempt to block approval of ANDAs for generic Copaxone (glatiramer), FDA told a district court that it should decline Teva’s “remarkable invitation” to determine whether an application should be approved before the agency decides to do so.

In a May 12 filing, FDA asked the court to toss Teva’s suit against the agency, which seeks a temporary restraining order and preliminary injunction preventing FDA from approving ANDAs of the multiple sclerosis drug that do not meet Teva’s conditions for approval. The conditions are specified in a Dec. 5 citizen petition to FDA. The agency’s rejection of the petition triggered Teva’s May 8 complaint.

“Teva’s request that this court decide whether an abbreviated new drug application (“ANDA”) may be approved in the first instance without first meeting Teva’s additional ‘conditions’ for approval – conditions above and beyond what Congress has set forth in the statute – is absolutely unprecedented, extrastatutory, and extrajudicial,” the filing states.

FDA said it is not aware of any instance in which a court has overturned an FDA decision approving a generic drug on scientific grounds. And it says Teva has not cited any case in which a court has blocked generic approval before it has occurred.

The U.S. District Court for the District of Columbia held a hearing on Teva’s motion for a temporary restraining order on May 9 and denied the motion. A hearing on its motion for a preliminary injunction is to be held May 14.

FDA Refutes Teva’s “Illusion Of Harm”

Patents covering Copaxone 20 mg/mL expire on May 24. A patent covering the manufacturing process for glatiramer, patent No. 5,800,808, expires on Sept. 1, 2015, but the U.S. Court of Appeals for the Federal Circuit ruled that it is invalid. The Supreme Court is to review the Federal Circuit decision in its next term, which begins in October.

The high court denied Teva’s request to stay the Federal Circuit’s ruling until it issues a decision. Sandoz International GMBHand Mylan NV had argued that a stay would in essence decide the case since the patent would likely expire around the time the court issues a ruling ([A#14140414006]).

Copaxone had U.S. sales of more than $3 billion in 2013. Teva contends that it will suffer irreparable harm without an injunction to stop ANDA approvals. Teva says that FDA’s sovereign immunity bars an award of monetary damages and thus it could not be made whole if it ultimately prevails on the merits of the case.

FDA replied that Teva’s projected losses are significantly less than what the company predicts. The agency cites Teva’s December 2013 statement to investors in which it said it expected net revenue loss due to generic competition from June 1, 2014 to the end of 2014 would be approximately $546 million for 2014. FDA said that this projected loss is insignificant given Teva earned more than $24 billion in sales in 2013.

“Further diminishing the illusion of harm, Teva has been vigorously converting users of the Copaxone dosage form at issue in this case to the new 40 mg/mL dosage form, for which Teva has listed patents that do not expire until 2030,” the agency states.

FDA approved the 40 mg/vial dosage in January Also see "Copaxone Reduces Its Dosing Schedule, But Can It Shrink The Competition?" - Pink Sheet, 31 January, 2014..

Teva Cites FDA’s “Gamesmanship” In Citizen Petition Denials

FDA said Teva has filed six citizen petitions over the last six years demanding that FDA not approve any generic competitor’s product without requiring a full set of clinical trials. The agency said that each time it told Teva that it could not issue a substantive response without completing the scientific analysis necessary to make the approval decision.

But Teva argues that FDA’s denial of its petition “without comment” on the merits reflects a “tactical decision” not to deny the relief requested in the petition until the agency approves one or more pending generic drug applications.

“Unless this court acts now, then, FDA’s gamesmanship will preclude Teva from obtaining meaningful judicial review before FDA allows these putative generic products to overwhelm the market,” Teva’s complaint states.

Teva also contends that extensive testing has been conducted on generic versions of Copaxone being sold overseas which demonstrate significant differences between Copaxone and the generics in physicochemical, immunogenic and genetic measures. The company says patients have reported serious adverse reactions with the generics, including MS relapses within weeks or months of exposure.

Sandoz, Momenta Note “Highly Innovative Science” In Their ANDA

Teva says gene expression analysis of the generics “revealed astonishing batch-to-batch inconsistency within putative generic versions,” including Natco Pharma Ltd.’s Glatimer, which is marketed in India and Ukraine.

Natco is Mylan’s manufacturing partner. In a filing opposing Teva’s motion for a preliminary injunction, Mylan states that the material Teva tested did not include glatiramer submitted for FDA approval.

In a separate filing in the case,Sandoz and its partner Momenta Pharmaceuticals Inc. point to the data they have provided FDA to support their glatiramer generic.

“Teva has not been privy to the thorough, highly innovative science submitted to the FDA in Sandoz/Momenta’s ANDA, and so it is not yet aware of the advanced methodologies Sandoz and Momenta employ to characterize both Copaxone and their generic glatiramer acetate for purposes of establishing ‘sameness’ under Hatch-Waxman. Nor is Teva privy to recent requests for information by FDA or the specific data that Sandoz and Momenta have developed to address gene expression and immunogenicity questions raised in the most recent citizen petitions,” their filing states.

Teva’s Copaxone Suit Is “Absolutely Unprecedented,” FDA Says

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