Adams Respiratory v. Perrigo (CAFC 20101246) precedential

After construing the claims (as discussed below), the district court granted summary judgment of noninfringement with respect to all claims. Adams appeals.

First, construction of the claim term "equivalent."

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, 145556 (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).

The parties dispute the meaning of the term "equivalent" in claim 24, from which asserted claims 26, 33, 34, and 39 depend.

The district court construed "equivalent" as "within 80% to 125% of the value with which it is being compared, at a 90% confidence interval." Adams, Civ. No. 1:07-CV-993, D.I. 176 at 36 (W.D. Mich. July 24, 2009) (Claim Construction Order). The court based its construction on Adams' statements during reexamination, concluding that "Adams explicitly stated during reexamination that 'equivalent' meant 'the FDA bioequivalence guidelines.'" Id.

On appeal, Adams challenges the requirement of a 90% confidence interval. It notes that the specification does not require or even mention any confidence interval. Adams argues that during reexamination, it expressly, consistently, and repeatedly defined equivalent to mean within the 80 to 125% range, but it never included in that definition a 90% confidence interval. It asserts that the 90% requirement makes sense in the context of drug approval, where the FDA is concerned with safety and consistency. But in the context of proving infringement, Adams argues that it must simply show that it is more likely than not that Perrigo's ANDA, if approved, would permit Perrigo to market a product that infringes the '252 patent.

We construe "equivalent" to require a C_max that is 80% to 125% of the value to which it is being compared. Contrary to Perrigo's assertion, Adams did not define equivalent as meeting all of the requirements of the FDA's bioequivalence guidelines. When Adams referred to the FDA guidelines in the context of defining the term equivalent, it referred specifically to the 80 to 125% range... Adams never adopted or even mentioned the 90% confidence interval. The range and the confidence interval are independent concepts. The range reflects "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." FDA Guidelines at ix. On the other hand, the 90% confidence interval reflects the FDA's concern that a generic drug consistently match the performance of the branded drug. See id. at x. Patent infringement does not require bioequivalence, and Adams did not import the 90% confidence interval into its claim. Requiring a 90% confidence interval would inappropriately raise the bar for establishing infringement. Adams must show that it is more likely than not that Perrigo's ANDA product will have a C_max within the 80 to 125% range.

Then the issue of infringement. As with claim construction, the district court put up a higher bar than legally correct, requiring a "two-way crossover study" that Adams did not do, "and thus the court concluded that it could not establish infringement literally or under the doctrine of equivalents."

Adams asserts that it raised a genuine issue of material fact on infringement, sufficient to preclude summary judgment. Adams argues that there is no absolute bar against comparing an accused product to a commercial embodiment of the claimed invention. It asserts that where the commercial product meets the claim limitations, a comparison to that product may be used to establish infringement, citing Glaxo Wellcome, Inc. v. Andrx Pharmaceuticals, Inc., 344 F.3d 1226, 1234 (Fed. Cir. 2003), and Glaxo Group Ltd. v. Torpharm, 153 F.3d 1366, 1373 (Fed. Cir. 1998).

We agree. Our case law does not contain a blanket prohibition against comparing the accused product to a commercial embodiment.

Perrigo has not explained why, as a factual matter, Adams' evidence necessarily fails to establish infringement under the correct construction of equivalent.

Therefore, Adams has raised a genuine issue of material fact on infringement under the proper construction of the term equivalent, sufficient to preclude summary judgment.

Adams' construction--requiring release and availability for absorption--covers the preferred embodiment. Perrigo's construction--requiring both release and actual absorption--excludes the preferred embodiment and essentially all guaifenesin formulations, as the specification explains that absorption occurs in the intestinal tract. A claim construction that excludes the preferred embodiment "is rarely, if ever, correct and would require highly persuasive evidentiary support." Vitronics Corp. v. Conceptronic Inc., 90 F.3d 1576, 1583-84 (Fed. Cir. 1996). We therefore agree with the district court...

The district court got "bioavailable" right.

The district court correctly construed the term "immediate release form which becomes fully bioavailable in the subject's stomach" to mean "a form intended to rapidly release in the stomach substantially all of the active pharmaceutical ingredient for absorption." Perrigo and Adams each proposed a reasonable construction of the term bioavailable in the abstract. Adams' construction is consistent with the use of this term in the specification; Perrigo's is not. Claim terms are not construed in a vacuum divorced from the specification. Although the specification never expressly defines bioavailable, it uses the term when describing the availability of the drug for absorption, not the actual absorption.

In the finale was whether doctrine of equivalents could "could apply to claims requiring a specific numeric range," as Adams argued.

We previously determined that the doctrine of equivalents may apply to claims containing specific numeric ranges. See Philips, 505 F.3d at 1378 (concluding that "resort to the doctrine of equivalents is not foreclosed with respect to the claimed concentration range"); Abbott, 287 F.3d at 1107-08 ("The fact that a claim recites numeric ranges does not, by itself, preclude Abbott from relying on the doctrine of equivalents."); Jeneric/Pentron, Inc. v. Dillon Co., 205 F.3d 1377, 1383 (Fed. Cir. 2000) (noting that "the district court will have the opportunity to adjudicate fully the merits of infringement under the doctrine of equivalents" of a claim to composition comprising specific weight percentages of various oxides).

The fact that the claim does not contain words of approximation (i.e., "about at least 3500 hr*ng/mL") does not affect the analysis--"terms like 'approximately' serve only to expand the scope of literal infringement, not to enable application of the doctrine of equivalents." Philips, 505 F.3d at 1379. The proper inquiry is whether the accused value is insubstantially different from the claimed value.

Vacated and remanded.