Regulatory Focus™ > News Articles > Mylan Sues FDA, Seeking Earlier Approval for Generic Celebrex

Mylan Sues FDA, Seeking Earlier Approval for Generic Celebrex

Posted 29 April 2014 | By Alexander Gaffney, RAC

Generic pharmaceutical manufacturer Mylan says it plans to sue the US Food and Drug Administration (FDA) after regulators declined to grant 180 days of market exclusivity for its generic version of Pfizer's Celebrex (celecoxib).


Under the 1984 Hatch-Waxman Act, companies are allowed to file for approval for a generic version of a drug once the original product's patent and market-based exclusivity provisions end. To incentivize companies to challenge the validity of patents (a process known as Paragraph IV certification) and otherwise deal with the challenges of bringing a generic drug to market, FDA grants the company which is "first to file" a challenge against a company with the agency 180 days of exclusivity, during which time no other generic competitors are allowed to market their version of the same drug.  The company, we should add, needs to win that challenge as well.

180-day exclusivity is governed under Section 505(j)(5)(B)(iv) of the Federal Food, Drug and Cosmetic Act, which states:

If the [ANDA] contains a [paragraph IV certification] and is for a drug for which a previous application has been submitted under this subsection continuing [sic] such a certification, the application shall be made effective not earlier than one hundred and eighty days after--

(I) the date the Secretary receives notice from the applicant under the previous [ANDA] of the first commercial marketing of the drug under the previous [ANDA], or

(II) the date of a decision of a court in [a patent infringement action] holding the patent which is the subject of the certification to be invalid or not infringed, whichever is earlier.

Even if the applicant is not sued in the course of challenging the patent (Paragraph IV certification), FDA said in a 1998 guidance document that it would still grant the applicant 180 days of market exclusivity.

A Bundle of Patents

However, at issue between Mylan and FDA is how the agency should treat reissued patents for the purposes of 180-day exclusivity.

Patent reissues are done to correct mistakes or errors in the original patent, which can sometimes alter language that causes the patent to cover a broader scope of work and ideas. For a drug-related patent, FDA must be notified of the changed patent within 30 days of the date the patent was reissued.

But as FDA notes, "Neither the FD&C Act nor FDA's regulations directly address the effect of patent reissuance on the approval of a pending ANDA." Lacking statutory guidance, FDA's policy is to treat those patents as any other, and the agency does not consider them to be a "new and distinct patent for purposes of 180-day exclusivity." It instead treats the original and re-issued patent as a "bundle" of patent rights, it said.

FDA said under this "bundle" treatment, this would give rise to a single exclusivity period-not two separate ones.

"Some might take the position that the reissued patent can be the basis for a new period of 180-day exclusivity such that even if one or more first applicants' exclusivity was triggered and exhausted by the court decision on the original patent, one or more first applicants remain eligible for exclusivity based on paragraph IV certifications to the reissued patent," the agency wrote.

FDA said its default position is that even if an original patent is declared invalid, the patent reissue is presumptively valid until a court determines otherwise.

Mylan Sues

Which is an issue for Mylan (and also Actavis), which is fighting to release its generic Celebrex a few months earlier than its competitors in May 2014, instead of December 2014.

In sorting through a patent reissue challenge between Pfizer, Mylan and Teva, FDA determined that Teva was the first generic pharmaceutical manufacturer to file a Paragraph IV certification challenge against the patent, and was thus eligible for market exclusivity.

Mylan, however, said it thought FDA had erred in doing so, contending that the patent reissue was neither timely nor valid, and that two court decisions had validated its claim.

"We believe the FDA has made an unprecedented error in this case which clearly caught all industry participants off guard, as evidenced by some who have already settled with Pfizer for December 2014 launch dates, which is post patent expiry," said Mylan CEO Heather Bresch.

Mylan is now seeking a court order for FDA to grant its generic celecoxib approval on 30 May 2014.

FDA's Explanation of Patent Exclusivity

Mylan Statement

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