Court Dismisses Mylan Pharmaceuticals Lawsuit Over Lipitor Generic ANDAs On Standing and Ripeness Grounds

May 10, 2011   

On May, 2, 2011, the United States District Court for the District of Columbia granted the FDAs Motion to Dismiss a lawsuit brought by Mylan Pharmaceuticals (“Mylan”) seeking injunctive and declaratory relief for alleged violations of the Administrative Procedure Act (“APA”) by the FDA in the approval process of several Abbreviated New Drug Applications (“ANDA”) for the brand-name drug Lipitor. A copy of the Courts decision can be read here.

The decision contains a helpful and educational summary of the FDA approval process for generic drugs. As explained within the opinion, once a brand-name or “pioneer drug” has received approval, manufacturers of generic versions of these drugs may seek approval of the FDA to market their generic versions by filing an ANDA.

Within the ANDA, a generic drug manufacturer must demonstrate that the generic is the “bioequivalent” of the pioneer drug, i.e. the new generic drug can be expected to have the same therapeutic effect as the pioneer drug when administered to patients. Additionally, for each “Orange Book” patent of the pioneer drug that is implicated by the generic drug, the generic manufacturer must certify as to whether the proposed generic would infringe on that patent. If an ANDA applicant seeks to market its generic drug prior to the expiration of the patents for the brand name drug, it must make a “paragraph IV” certification stating “such patent is invalid or will not be infringed by the manufacture, use, or sale, of the new drug. . . .” 21 U.S.C. § 355(j)(2(A)(vii)(IV).

However, once a generic drug manufacturer has filed an ANDA with a paragraph IV certification, it has by law infringed on the underlying patents and the brand-name drug manufacturer may bring a patent infringement suit. As a result, challenging patents can be costly for generic manufacturers. To encourage the production of generic drugs, federal law provides the first generic drug manufacturer who files an ANDA containing a paragraph IV certification, whose ANDA is ultimately approved by the FDA, a 180 day exclusivity period in which it may manufacture its generic version free from competition from other generic manufacturers. 21 U.S.C. § 355(j)(5)(B)(iv).

The Mylan case stems from competing ANDAs for the production of a generic equivalent of Lipitor. Plaintiff, Mylan Pharmaceuticals, through its subsidiary Matrix labs, filed an ANDA for its generic of Lipitor two years ago and, at the time of the suit, the FDA was still evaluating its application for approval. Mylan argued that its generic should be eligible for approval and marketing by June 28, 2011 when the exclusivity on Lipitor patents begin to expire.
In this case, Mylan also alleged that a competitor, Ranbaxy Laboratories, Ltd. (“Ranbaxy”), whose own ANDA for a generic equivalent of Lipitor was filed nine years prior to the suit, was the first generic manufacturer to file an ANDA with a paragraph IV certification for Lipitor, therefore making Ranbaxy eligible for the 180 exclusivity period should its product become approved. Mylan further alleged that Lipitors manufacturer Pfizer and Ranbaxy reached a patent infringement settlement that prohibits the production of a generic equivalent by Ranbaxy until November 2011.

As a result of this settlement, and the additional 180 exclusivity period that Ranbaxy would be entitled to should its ANDA be approved, Mylan would be unable to market is product until May 2012. Mylan further argued that Ranbaxy should be stripped of its 180 day exclusivity period for violations of the FDA application integrity policy (“AIP”). The AIP was developed by the FDA to ensure validity of data submissions called into question by the agency’s discovery of wrongful acts such as fraud, untrue statements of material fact, bribery, and illegal gratuities and to withdraw approval of, or refuse to approve, applications containing fraudulent data. More information on the FDAs AIP can be found on the FDAs website here.

The case addressed whether drug manufacturers can sue the FDA and force the agency to take action on pending ANDAs filed by their competitors. Mylan brought its action against the FDA alleging two counts: 1) the FDA violated the APA by unreasonably or unlawfully delaying a determination that Ranbaxy violated the integrity policy; and 2) the FDAs failure to approve Mylans ANDA on the basis of Ranbaxys 180 exclusivity violated the APA because it is arbitrary and capricious. In response, the FDA Filed a Motion to Dismiss for lack of subject matter jurisdiction.

In rejecting Mylans arguments and granting the FDAs Motion to Dismiss, the Court focused on standing and ripeness, two basic requirements lawsuits. Put simply, standing is the right of a person to bring a case. In order to establish standing, a plaintiff must demonstrate: 1) that it has suffered an injury in fact, which is an actual or imminent invasion of a legally protected, concrete and particularized injury; 2) causation, i.e. the alleged injury must have been caused by the defendants conduct at issue; and 3) redressability, i.e. the court can provide a remedy to rectify the injury. Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-561 (1992).

In determining that Mylan lacked standing, the Court found that because Mylans ANDA had yet to be approved it faced no imminent injury from the FDAs possible approval Ranbaxys ANDA and 180 day exclusivity period. Further, the Court found that no case within the D.C. Circuit has ever granted standing to a drug manufacturer who was a subsequent ANDA filer and who has not yet received FDA approval to compel the FDA to take action on a competitors ANDA.

Additionally, the Court went on to find that even if Mylan could assert an imminent injury, it still lacked standing because its injury could not be redressed by the relief it requested. As stated above, Mylans own ANDA has not yet been approved by the FDA. Therefore, even if the Court granted the relief Mylan requested, denying Ranbaxys ANDA and extinguishing its 180 day exclusivity period, Mylan could be no more certain that its own generic could begin being marketed in June 2011.

The Court went on to hold that even if Mylan could establish standing to sue the FDA, the case must still be dismissed because it was not ripe. The ripeness concept is closely related to the idea of standing to sue. In order to determine whether a controversy is ripe, the court must “evaluate both the fitness of the issues for judicial decision and the hardship to the parties of withholding court consideration.” Texas v. United States, 523 U.S. 296, 301 (1998).

Here, the Court found that the case was not ripe for two reasons. First, because Mylans own ANDA had not yet received approval from the FDA, factual uncertainty remained. As stated by the Court, “a claim is not ripe for adjudication if it rests upon contingent future events that may not occur as anticipated.” Further, the Court found that because the FDA has not yet acted, there was no final agency action, which is a required element for review under the APA. Finally, the Court found that any hardship Mylan might suffer by a delayed exclusivity determination was hypothetical because Mylans ANDA has not yet been approved. However, the Court did note that “nothing prevents Mylan from seeking judicial recourse if and when the FDA renders a final exclusivity decision that is not to Mylans liking.”

This decision places Mylan in a very difficult position. We will monitor this case as it makes its way to the D.C. Circuit Court of Appeals and will report when and if this decision is upheld on appeal. For more information regarding the ANDA generic drug approval process or for any questions regarding how your company can maintain FDA regulatory compliance, please contact us at