District Court Dismisses Wyeth Lanham Act Case Concerning Generic PROTONIX, But Leaves the Door Open for Further Litigation

By Kurt R. Karst –      

The U.S. District Court for the Eastern District of Michigan (Southern Division) recently dismissed without prejudice a Complaint filed by Wyeth and granted a Motion to Dismiss filed by Sun Pharmaceutical Industries, Ltd. and Caraco Pharmaceutical Laboratories, Ltd. (“Sun”) in a Lanham Act case concerning the identification of a “polymorph” in the labeling of Sun’s generic PROTONIX (pantoprazole sodium) Delayed-Release Tablets.  PROTONIX contains pantoprazole sodium sesquihydrate as the active ingredient.  Wyeth alleged that “[d]espite expressly representing to the public that they are selling pantoprazole sodium sesquihydrate tablets, Sun and Caraco are actually selling tablets containing a different polymorphic form of pantoprazole sodium, pantoprazole sodium monohydrate,” and that “[b]y selling pantoprazole sodium monohydrate tablets labeled as containing pantoprazole sodium sesquihydrate as the active ingredient, Sun is making a literally false statement regarding the active ingredient of its pharmaceutical product, in violation of the Lanham Act” (emphasis in original), as well as in violation of the Michigan Consumer Protection Act (Mich. Comp. Law § 445.901).

By way of background, FDA has explained in guidance – “ANDAs: Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information” – that polymorphs are different crystalline and amorphous forms as well as solvate and hydrate forms of the same chemical compound.  Polymorphs of a compound share the same chemical formula and molecular structure, but can have different properties, including melting point, stability, dissolution, and bioavailability.  It is FDA’s longstanding policy that active ingredient “sameness” for ANDA approval purposes is not affected by different polymorphs.  Indeed, the Orange Book Preface states that “[a]nhydrous and hydrated entities, as well as different polymorphs, are considered pharmaceutical equivalents and must meet the same standards and, where necessary . . . their equivalence is supported by appropriate bioavailability/bioequivalence studies.”  For example, FDA has approved generic versions of HYTRIN (terazosin HCL) in an anhydrous form, whereas the innovator product is in a dihydrate form.  FDA has also approved generic versions of ZITHROMAX (azithromycin) in a monohydrate form, whereas the innovator product is in a dihydrate form.  In that case, Pfizer submitted citizen petitions to FDA (here and here) challenging the accuracy of generic ZITHROMAX labeling related to polymorph identification. (FDA has not substantively responded to either petition.)

Sun argued that the complaint should be dismissed, primarily because FDA has the exclusive jurisdiction to determine the appropriate language in drug product labeling.  That argument is that Wyeth sought to inappropriately use the Lanham Act as a vehicle to privately enforce the FDC Act.  As we previously reported, many courts have ruled – including the Seventh Circuit’s recent decision in Schering-Plough Healthcare Products, Inc., v. Schwarz Pharma, Inc., 586 F.3d 500 (7th Cir., 2009) (Hyman, Phelps & McNamara, P.C. represented Schwarz Pharma, Inc. and Kremers Urban, LLC in that case) – that this is not a legitimate use of the Lanham Act.  Sun also argued that Wyeth failed to state a Lanham Act claim “because they fail to plead a necessary element of a false advertising claim – that the deception had a material effect on purchasing decisions because the allegedly false statements are in the package insert, which is not seen by the consumer until after purchase,” and that Wyeth failed to state an unfair competition claim under Michigan law. 

Explaining that “the Court finds that this is a matter that is better left to the FDA’s expertise,” the court ruled that for Wyeth to make a successful claim under the Lanham Act, the FDA must first make a finding under the FDC Act that the ingredient in Sun’s generic PROTONIX is not sesquihydrate.  Moreover, the court commented that:

Plaintiff has not identified, nor has the Court uncovered, a single instance in which a federal court has permitted the manufacturer of a pioneer drug to challenge generic-equivalency representations under the Lanham Act when the defending party markets a FDA-approved, Orange Book-listed generic version of the pioneer drug.

Although the court found that Wyeth “jumped the gun” by suing Sun before FDA addressed the polymorph labeling issue, the court, in dismissing the complaint without prejudice, commented that “[i]f the FDA confirms Plaintiff’s suspicions, however, Plaintiff may be able to sustain its Lanham Act claims.”  So, depending on the outcome of an FDA investigation, there might be more to come on this.