Adams Respiratory Therapeutics, Inc. v. Perrigo Co.

616 F.3d 1283, 2010 WL 3064010
Court of Appeals for the Federal Circuit·Decided October 6, 2010·No. 2010-1246·Published·Cited by 67 cases

Opinion

MOORE, Circuit Judge.

Adams Respiratory Therapeutics, Inc. (Adams) appeals the judgment of the district court that the guaifenesin product described in Perrigo Co.’s (Perrigo’s) Abbreviated New Drug Application (ANDA) would not infringe the asserted claims of U.S. Patent No. 6,372,252 (the '252 patent). Because the court based its judgment of noninfringement on an erroneous claim construction, we vacate and remand.

Background

Guaifenesin is an expectorant used to thin, loosen, and help expel mucus that causes congestion. It was first approved by the Food and Drug Administration (FDA) in 1952. For many years, drug companies sold products containing guaifenesin in both immediate release (IR) and extended release forms without FDA approval. In 1989, the FDA published standards for IR guaifenesin products in Cold, Cough, Allergy, Bronchodilator, and An~ tiasthmatie Drug Products for Over-the-Counter Human Use; Expectorant Drug *1285 Products for Over-the-Counter Human Use; Final Monograph; Final Rule (Monograph). The FDA determined that IR guaifenesin products that complied with the Monograph would be deemed safe and effective. The Monograph did not address the safety and efficacy of extended release guaifenesin products.

In 2000, Adams filed a New Drug Application (NDA) for an extended release guaifenesin product, Mucinex®. Its extended release tablets contain an IR portion of guaifenesin (designed to be quickly released into the stomach) and a sustained release portion. Mucinex® tablets were designed to be taken every twelve hours, while IR guaifenesin tablets must be taken every four hours to maintain their therapeutic effect. Adams established the safety and efficacy of Mucinex® by showing that it was bioequivalent to a standard IR product (Organidin®) that complied with the Monograph. Adams submitted pharmacokinetic data showing that one Mucinex® tablet (1200 mg) produces the same maximum concentration of guaifenesin in the blood (Cmax) as one Organidin® tablet (400 mg) taken every four hours for twelve hours (three tablets total). The FDA approved Adams’ NDA for Mucinex® and ordered all unapproved extended release formulations off the market.

In 2002, Adams obtained the '252 patent concerning extended release formulations of guaifenesin. The preferred embodiment of the '252 patent is Mucinex®. In 2005, a third-party requested that the PTO conduct a reexamination of the '252 patent. During reexamination the PTO rejected claim 24, which claimed an extended release product having a Cmax “equivalent” to the Cmax of an IR product when dosed as described in the claim. The PTO indicated that claim 24 would likely be rejected under 35 U.S.C. § 112, paragraph 1 because the claim term “equivalent” was not defined. See Amendment in Response to Final Office Action in Ex Parte Reexamination and Patent Owner’s Statement of the Interviews, at 21 (Aug. 21, 2006). Adams asserted that “one of ordinary skill in the art would recognize ‘equivalent’ as being the FDA bioequivalence guidelines of 80-125%.” Adams attached an excerpt of the guidelines, U.S. Department of Health and Human Services, Approved Drug Products with Therapeutic Equivalence Evaluations, p. ix-x (19th ed. 1999) (FDA guidelines), which state:

Two formulations whose rate and extent of absorption differ by -20%/+25% or less are generally considered bioequivalent. The use of the-20%/+25% rule is based on a medical decision that, for most drugs, a -20%/+25% difference in the concentration of the active ingredient in blood will not be clinically significant.
For approval of ANDAs, in most cases, the generic manufacturer must show that a 90% confidence interval for the ratio of the mean response (usually AUC and Cmax) of its product to that of the innovator is within the limits of 0.8 to 1.25, using the log transformed data.

Adams also submitted the declaration of Dr. Crooks, which indicated that one of ordinary skill in the art would understand the term equivalent to mean within the FDA bioequivalent range of 80 to 125%. J.A. 635. 1 The Examiner ultimately re *1286 jected various claims, including claim 24, under 35 U.S.C. § 103. The Board reversed, concluding that none of the rejected claims were invalid.

In 2007, Perrigo filed an ANDA seeking to market 600 mg guaifenesin extended-release tablets before the expiration of the '252 patent. Perrigo included in its ANDA a paragraph IV certification (a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV)) asserting that the claims of the '252 patent were invalid or would not be infringed by its product.

Adams sued Perrigo for infringement of the '252 patent under 35 U.S.C. § 271(e)(2)(A), asserting that Perrigo’s ANDA product would infringe claims 26, 33, 34, and 39. After construing the claims (as discussed below), the district court granted summary judgment of non-infringement with respect to all claims. Adams appeals. We have jurisdiction under 28 U.S.C. § 1295(a)(1).

Discussion

This court reviews a grant of summary judgment de novo. Immunocept, L.L.C. v. Fulbright & Jaworski, L.L.P., 504 F.3d 1281, 1286 (Fed.Cir.2007). “Summary judgment is appropriate when there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law.” Id.

We also review claim construction de novo. Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1455-56 (Fed.Cir.1998) (en banc). The words of a claim are generally given their ordinary and customary meaning as understood by a person of ordinary skill in the art when read in the context of the specification and prosecution history. See Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed.Cir.2005) (en banc).

I. Equivalent

The parties dispute the meaning of the term “equivalent” in claim 24, from which asserted claims 26, 33, 34, and 39 depend. Claim 24 recites:

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Adams Respiratory Therapeutics, Inc. v. Perrigo Co., 616 F.3d 1283, 2010 WL 3064010 (Fed. Cir. 2010).

616 F.3d 1283 (Adams Respiratory Therapeutics, Inc. v. Perrigo Co.) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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