Glaxo Group Ltd. v. TorPharm, Inc., 97-1556

• Decision Date: 21 August 1998
• Docket Number: No. 97-1556,97-1556
• Citation: 47 USPQ2d 1836,153 F.3d 1366
• Parties: GLAXO, INC. and Glaxo Group Limited, Plaintiffs-Appellants, v. TORPHARM, INC., Apotex USA, Inc. and Apotex, Inc., Defendants-Appellees.
• Court: U.S. Court of Appeals — Federal Circuit

Page 1366

153 F.3d 1366

47 U.S.P.Q.2d 1836

GLAXO, INC. and Glaxo Group Limited, Plaintiffs-Appellants, v. TORPHARM, INC., Apotex USA, Inc. and Apotex, Inc. Defendants-Appellees.

No. 97-1556.

United States Court of Appeals Federal Circuit.

Aug. 21, 1998.

Rehearing Denied; Suggestion for Rehearing In Banc

Declined Sept. 29, 1998.

Stephen B. Judlowe, Hopgood, Calimafde, Kalil & Judlowe, L.L.P., New York City, argued, for plaintiffs-appellants. With him on the brief were William G. Todd, Scott Lindvall, Adam T. Bernstein and Daniel R. Schechter.

Hugh L. Moore, Lord, Bissell & Brook, Chicago, IL, argued, for defendants-appellees. With him on the brief were Keith D. Parr and Christine J. Siwik. Of counsel was Diane Irene Jennings.

Before PLAGER, Circuit Judge, ARCHER, Senior Circuit Judge, and RADER, Circuit Judge.

PLAGER, Circuit Judge.

This is yet another appeal in the ongoing litigation between the holder of patents on a popular medication, Zantac TM, and a number of generic drug companies who are attempting to sell a generic equivalent of the drug. The original United States patent held by plaintiffs, Glaxo, Inc. and Glaxo Group Limited ("Glaxo"), No. 4,128,658 ("the '658 patent") covering one form of the active ingredient, expired on July 25, 1997. Nevertheless, Glaxo continues to seek to prevent other drug companies from manufacturing and selling a generic version based on two of Glaxo's other United States Patents (Nos. 4,521,431 ("the '431 patent") and 4,672,133 ("the '133 patent")) covering a second form of the active ingredient. In this case, the district court essentially concluded that Glaxo is impermissibly attempting to extend the term of its now expired '658 patent, and granted the defendants, TorPharm, Inc., Apotex USA, Inc., and Apotex Inc. (collectively "TorPharm"), summary judgment of non-infringement of the '431 and '133 patents.

After careful consideration, we conclude that the district court erred in concluding that the defendants were practicing Example 32 of Glaxo's expired '658 patent; and thus the court's resulting conclusion that the defendants are practicing subject matter that was dedicated to the public upon expiration of the '658 patent is not sustainable. Although the defendants-appellees advance several alternative grounds to affirm, none of them will bear the weight placed on them. We are compelled to vacate and remand this case for further proceedings.

BACKGROUND

Glaxo manufactures and sells the highly successful anti-ulcer medication Zantac TM. The active ingredient in Zantac TM is ranitidine hydrochloride (RHCl), an aminoalkyl furan derivative that can occur in at least two distinct crystalline forms. Glaxo's '658 patent, issued in 1978, claimed the class of aminoalkyl furan derivatives having the desired histamine-blocking activity, and specifically claimed RHCl, the lead compound of the class. At the time the patent application was filed, Glaxo did not know that RHCl could occur in more than one crystalline form. Later, Glaxo determined that the form of RHCl obtained by practicing the '658 patent is a polymorph known as "Form 1." The '658 patent covering Form 1 expired on July 25, 1997.

In 1980, a new crystalline polymorph of RHCl called "Form 2" was discovered by Glaxo scientists. Form 2 exhibits two distinct advantages over Form 1. Form 2 can be prepared and isolated using concentrated hydrochloric acid instead of hydrogen chloride gas, which was required to produce Form 1. Secondly, Form 2 possesses better drying and filtration characteristics. Both of these advantages make Form 2 easier to manufacture. The physical properties of the Form 2 polymorph provide such advantages that all of Glaxo's Zantac TM product sold since 1981 has contained Form 2 RHCl.

Glaxo obtained two patents on Form 2: the '431 patent covering the RHCl crystallized as the Form 2 polymorph per se, and the '133 patent covering specific processes for synthesizing Form 2 RHCl. The claims in both of these patents characterize Form 2 RHCl by means of an infra-red ("IR") spectrum having 29 identifiable main peaks. The '431 patent includes a second, dependent claim describing the x-ray powder diffraction pattern of Form 2 RHCl. The '431 patent covering Form 2 will expire in 2002, and the '133 patent covering the process for making Form 2 will expire in 2004. It is these two Form 2 patents that are the subject of the present suit.

This is not the first time Glaxo has appeared before this court defending its patents related to RHCl. In Glaxo Inc. v. Novopharm Ltd., 52 F.3d 1043, 34 U.S.P.Q.2d 1565 (Fed.Cir.1995) ("Novopharm I "), this court affirmed the judgment of the United States District Court for the Eastern District of North Carolina that the claims of the '431 patent were not anticipated by the '658 patent. (For purposes of that litigation the parties had stipulated to infringement by the accused product.) In Glaxo, Inc. v. Novopharm Ltd., 110 F.3d 1562, 42 U.S.P.Q.2d 1257 (Fed.Cir.1997) ("Novopharm II "), we affirmed a judgment of the district court that the '431 patent was not infringed by a different Novopharm product.

Even though we affirmed the district court's judgment in Novopharm II, we disagreed with its claim construction. The district court interpreted the claims of the '431 and '133 patents to be limited to "pure Form 2 RHCl." Id. at 1565, 110 F.3d 1562, 42 U.S.P.Q.2d at 1260. We held that the claims were not so limited. See id. at 1565-66, 110 F.3d 1562, 42 U.S.P.Q.2d at 1260. The constructional issue was not determinative, however, in light of Glaxo's failure to put forward sufficient evidence to prove infringement. See id. at 1566-67, 110 F.3d 1562, 42 U.S.P.Q.2d at 1260-61. We explicitly declined to address the question of whether small amounts of Form 2 RHCl in a mixture containing primarily Form 1 RHCl could infringe the '431 patent. See id. at 1566 n. 1, 110 F.3d 1562, 42 U.S.P.Q.2d at 1260 n. 1.

TorPharm filed an abbreviated new drug application ("ANDA") with the U.S. Food & Drug Administration ("FDA") on June 5, 1995, seeking approval to market a generic version of an anti-ulcer medication containing Form 1 RHCl after the '658 patent expired. On August 14, 1995, Glaxo sued TorPharm in the Northern District of Illinois, essentially alleging under 35 U.S.C. § 271(e) that TorPharm's Form 1 RHCl product contains a small amount of Form 2 and, therefore, is infringing. Glaxo also sought a declaratory judgment that TorPharm infringes the '133 process patent by manufacturing and selling the drug for which TorPharm was seeking approval.

TorPharm filed a motion for summary judgment of non-infringement of the '431 patent. ¹ In a memorandum opinion and order dated May 18, 1997, the district court granted-in-part and denied-in-part TorPharm's summary judgment motion. See Glaxo, Inc. v. TorPharm, Inc., 1997 WL 282742, * 8 (N.D.Ill. May 18, 1997). The court granted TorPharm's motion for summary judgment of non-infringement of claim 2 of Glaxo's '431 patent on the ground that Glaxo failed to produce evidence that TorPharm's product would exhibit the x-ray diffraction pattern contained in claim 2. In addition, the court, citing Novopharm II, concluded that an expert declaration proffered by Glaxo failed to raise a genuine issue of material fact because the expert failed to use the "Debye Scherrer method" to prove infringement, as required by claim 2.

However, the district court denied TorPharm's motion for summary judgment as to claim 1 holding that the testimony of Glaxo's expert created a triable issue of fact as to whether TorPharm's product demonstrated all 29 main IR peaks. See 1997 WL 282742 at * 7. TorPharm's motion for summary judgment as to Glaxo's declaratory judgment action was also denied on the grounds that Glaxo had presented some evidence of infringement by TorPharm's product. Finally, the district court ordered the parties to brief the question left open in Novopharm II, i.e., whether a 0.5% level of Form 2 RHCl in a mixture consisting otherwise of Form 1 RHCl constitutes infringement of the '431 patent. See id. at * 8. The holdings in the May 18 opinion are not on appeal.

After the parties had briefed the issue of whether a small amount of Form 2 is infringing, the district court subsequently issued a memorandum opinion and order, granting TorPharm's motion for summary judgment of non-infringement of the '431 patent. See Glaxo, Inc. v. Torpharm, Inc., 1997 WL 535090, * 8 (N.D.Ill. Aug. 22, 1997). However, the court did not do so based on the so-called de minimis exception. See, e.g., Spray Refrigeration Co. v. Sea Spray Fishing, Inc., 322 F.2d 34, 36 (9th Cir.1963). The court concluded that Glaxo was correct in asserting that the de minimis exception has no application to the case at hand. Glaxo, 1997 WL 535090 at * 4.

Nonetheless, the district court held that summary judgment was in order. In reaching its conclusion on infringement, after considering all the evidence put before it, the district court found that TorPharm was attempting to practice Example 32 of the '658 patent to produce Form 1 RHCl. Id. at * 8. Because Example 32 was dedicated to the public upon expiration of the '658 patent, according to the court, TorPharm's product could not infringe the Form 2 patents without violating the rule against double patenting. The court also construed the asserted claims of the Form 2 patents in light of the prosecution history, again to avoid double patenting problems, to require that an accused product exhibit improved drying and filtration characteristics in order to infringe. In the district court's view, because TorPharm's product did not possess those improved characteristics, it did not infringe. Glaxo appeals the summary judgment of non-infringement. This court has jurisdiction over Glaxo's appeal pursuant to 28 U.S.C. § 1295(a)(1) (1994).

DISCUSSION

We review the grant of summary judgment of non-infringement without deference to the district court....