In two decisions issued under the same name (Ferring B.V. v. Watson Laboratories, Inc.), the Federal Circuit upheld the validity of the Orange Book-listed patents for Lysteda®, but found that they were not infringed by either Apotex’s or Watson’s Abbreviated New Drug Applications (ANDAs). In this article, I focus on the decision relating to the Apotex ANDAs, and the Federal Circuit’s discussion of the patentee’s burden when an ANDA does not answer the infringement question. (You can read my article on the non-obviousness analysis here.)

The Patents at Issue

The patents at issue were Ferring’s U.S. 7,947,739; U.S. 8,022,106, and U.S. 8,273,795, which are listed in the Orange Book for Lysteda®, Ferring’s tranexamic acid product for the treatment of heavy menstrual bleeding. As summarized by the Federal Circuit, the claims are directed to “oral dosage forms or formulations and methods of treating menorrhagia and require three elements: (1) about 650 mg of tranexamic acid; (2) a so-called modified release material that comprises either about 10% to about 35% or about 5% to about 50% by weight of the formulation; and (3) a specified dissolution release rate of the tranexamic acid in water as measured by a particular United States Pharmacopeia (“USP”) method.”

Non-Infringement by the Apotex ANDAs

The district court found that the original Apotex ANDA infringed the Lysteda® patents, because the dissolution rate information did not preclude infringement. On the other hand, the district court found that the amended Apotex ANDA did not infringe, because it specified a dissolution rate that falls outside of the dissolution rates recited in the claims.

In an opinion authored by Judge Dyk and joined by Judges Lourie and Reyna, the Federal Circuit found that Ferring had not shown infringement by either ANDA.

With regard to the first ANDA, the Federal Circuit provided this guidance:

When an ANDA is silent with respect to infringement, as is the 2010 ANDA, the correct analysis is under Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1570 (Fed. Cir. 1997), not Sunovion [Pharmaceuticals, Inc. v. Teva Pharmaceuticals, Inc., 731 F.3d 1271 (Fed. Cir. 2013),]. …. [Under Glaxo], “[t]he relevant inquiry is whether the patentee has proven by a preponderance of the evidence that the alleged infringer will likely market an infringing product. What is likely to be sold, or, preferably, what will be sold, will ultimately determine whether infringement exists.”…. For the patent-holder to prove that a Glaxo-type ANDA is infringing, it must rely on evidence that the ANDA applicant “would likely sell an infringing composition pursuant to an approved ANDA.”

Noting that Ferring’s own expert had testified that “none of the tablets produced by Apotex in discovery was infringing,” the Federal Circuit found that Ferring had not established infringement by the original ANDA.

With regard to the second ANDA, the district court had found that the specification that “each unit dissolved NLT [i.e., not less than] 75% by weight tranexamic acid] in 45 minutes” precluded infringement of the Lysteda® patents, which recited that “less than about 70 percent by weight tranexamic acid be dissolved at 45 minutes.” Ferring challenged this decision on appeal based on claim construction, and the meaning of the qualifier “about”. The Federal Circuit rejected Ferring’s claim construction arguments, and affirmed the district court’s decision that the second ANDA did not infringe the Lysteda® patents.

Two Paradigms for Infringement by an ANDA

As outlined in this decision, there are two different paradigms for establishing infringement by an ANDA.

• Under Sunovion, “when an ANDA specification defines a compound such that it meets the limitations of the asserted claims,” the ANDA infringes.
• Under Glaxo, “[w]hen an ANDA is silent with respect to infringement,” then the patentee must prove that the product that “is likely to be sold” infringes.

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