In a nonprecedential decision, the Court of Appeals for the Federal Circuit looked at the issue of whether there is an Article III case or controversy between a patentee drug company and a generic drug company in the context of the Hatch-Waxman Act.  Merck v. Apotex (07-1362).

Merck had sued Apotex for patent infringement when Apotex filed an Abbreviated New Drug Application (“ANDA”) with the FDA for a generic version of FOSAMAX®, which is used to treat and prevent osteoporosis.

Apotex cried patent invalidity and noninfringement.  So, Merck granted Apotex a covenant not to sue for infringement of all patents-in-suit and moved to dismiss all claims and counterclaims on the grounds that the case no longer presented an Article III case or controversy.

Unsatisfied, Apotex tried to amend its counterclaims to add a claim for a violation of the Sherman Antitrust Act, 15 U.S.C. § 2.  The district court said no.

Merck listed ten patents in the FDA’s Orange Book, including US Pat. Nos. 4,621,077; 5,358,941; 5,681,590; 5,849,726; 6,008,207; 6,090,410; 6,194,004; 5,994,329;2 6,015,801; and 6,225,294.  The ’077 patent covers alendronate sodium, the active ingredient.  Six of the listed patents cover various formulations for tablets.  The remaining three are directed to dosing schedules.

Merck’s ’077 patent expired on August 6, 2007.  However, Merck obtained an additional six-month period of regulatory exclusivity from the FDA in exchange for Merck’s submission of certain pediatric studies pursuant to 21 U.S.C. § 355a.  As a result, no generic drug company could obtain FDA approval for alendronate sodium until February 6, 2008.

Merck’s nine remaining Orange-Book-listed patents expire on dates ranging from 2012 to 2018.  Merck also obtained an additional six-month period of regulatory exclusivity beyond the patent terms of each of these remaining patents under 21 U.S.C. § 355a.

When Apotex filed an ANDA with the FDA to obtain approval for a generic version of FOSAMAX®, Apotex filed a Paragraph III certification stating that Apotex would not market its generic drug until six months after the expiration of the ’077 patent.  For Merck’s nine other Orange-Book-listed patents for FOSAMAX®, Apotex filed a Paragraph IV certification stating that the patents were invalid or not infringed by Apotex’s generic drug.  Merck promptly sued Apotex.

In its decision dismissing the case for lack of Article III jurisdiction, the district court found that Apotex’s alleged injury-in-fact—namely, delayed entry into the market— is not fairly traceable to any actions taken by Merck.  Moreover, the district court found that Merck’s grant of a covenant not to sue Apotex eliminated the controversy between the parties.

However, depending on the circumstances, a justiciable Article III controversy may continue to exist between a patentee drug company and a Paragraph IV ANDA filer in the context of the Hatch-Waxman Act even after the patentee drug company has granted the Paragraph IV ANDA filer a covenant not to sue.

In finding no case, the CAFC stated:

This case, however, has been rendered moot by two factual developments that were brought to this court’s attention after oral argument.  First, the FDA decided to treat the thirty-month stay on Apotex’s ANDA as dissolved once the district court dismissed this case.  Second, the first Paragraph IV filer (i.e., Teva) triggered its 180-day exclusivity period under 21 U.S.C. § 355(j)(5)(B)(iv) (2000) by marketing its generic drug on or about February 6, 2008.  As a result, Apotex no longer suffers a delay in entering the market under either the thirty-month stay provision or the 180-day exclusivity provision that is traceable to Merck and redressible by a court judgment

In the end, Apotex’s noninfringement and invalidity counterclaims were just plain moot.

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  1. PR,

    Thanks for your note. You’re correct, it’s Fosamax (the Fed Cir opinion had it as Fosomax and I copied their error). Interestingly, a Google search shows 199,000 hits with Fosomax.

    Also, this note would have been earlier but I wrote up the review and then got busy and forgot to post it. I posted it this week figuring that was better than deleting it.


  2. Thanks for posting the story, Stephen.