Apotex, Inc. v. Cephalon, Inc.

Case Name: Apotex, Inc. v. Cephalon, Inc., Case No. 06-2768, 2012 U.S. Dist. LEXIS 43479 (E.D. Pa. March 28, 2012) (Goldberg, J.). (Variable and unreliable results on Canadian generic product, which has different specifications from ANDA product, led Court to find non-infringement.).

Drug Product and Patent(s)-in0Suit: Provigil® (modafinil); U.S. Reexam Pat. No. 37,516 ("the '516 patent")

Nature of the Case and Issue(s) Presented: Apotex's invalidity and unenforceability claims were bifurcated from its non-infringement claim.  After a bench trial on those claims the Court concluded that the '516 patent was both invalid and unenforceable.  A second bench trial, on Apotex's noninfringement claim, is the subject of this opinion.  In this case, Cephalon argued that Apotex's ANDA product infringed the asserted claims of the '516 patent, which are directed to a composition having modafinil of a certain particle size.  Cephalon alleged that Apotex's ANDA infringed the composition claims of the '516 patent even though Apotex was not manufacturing a product made according to the ANDA.

Cephalon argued that Apotex's proposed manufacturing process would include a milling step that would reduce the particle size of modafinil in the generic product to within the claimed scope.  Additionally, Cephalon tested Apotex's generic product sold in Canada.  Cephalon asserted that its tests of the Canadian product showed that Apotex will manufacture a generic that will fall within the claim scope of the '516 patent.

Apotex rebutted Cephalon's claim by arguing that its ANDA specifically addresses the issue of infringement by requiring most of the particles of modafinil in its proposed product to be greater than the limit included in the '516 patent.  Though Apotex admitted that its milling process may result in reduction of particle size, it argued there was no evidence to support Cephalon's allegation that milling resulted in a particle size the patent covered.  Lastly, Apotex argued that its Canadian generic was made according to a different specification, and that Cephalon's testing methods were unreliable.

Why Apotex Prevailed: The issue before the Court was whether the Court could consider additional evidence outside the ANDA when determining infringement.  Based on Federal Circuit precedent, the Court determined that the infringement analysis must begin with the ANDA, and can only consider additional outside evidence if the ANDA does not directly address the issue of infringement.  In the present case, the Court determined that Apotex's ANDA did not address directly all of the facts relevant to infringement, and therefore, it would consider whether the evidence offered by Cephalon demonstrates that, as a result of the milling step, the drug likely to be produced  pursuant to Apotex's ANDA would infringe the particle size limitation in Cephalon's '516 patent.

In analyzing Cephalon's testing of Apotex's Canadian generic, the Court rejected Apotex's criticisms of Cephalon's sample preparation, largely because of the Court's concern that Apotex's expert was biased.  Nevertheless, the Court found the large variance in Cephalon's particle-size measurements demonstrated that the Canadian product did not infringe the '516 patent.  The Court also found that Cephalon's testing of the Canadian generic was not indicative of the product that Apotex would release in the U.S. because there was no evidence that Apotex intended to release a product in the U.S. that was identical to the Canadian product.  Thus, the Court found that Cephalon had not shown infringement by a preponderance of the evidence.