Bristol-Myers Squibb Company appeals from the decision of the United States District Court for the District of New Jersey granting the motion by Ben Venue Laboratories, Inc., Bedford Laboratories, Boehringer Ingelheim Corporation, Im-munex Corporation, IVAX Corporation, Zenith Goldline Pharmaceuticals, Inc., Marsam Pharmaceuticals, Inc., Schein Pharmaceutical, Inc., and Mylan Pharmaceuticals, Inc. (collectively, “the defendants”) for summary judgment that claims 1-3 and 6 of U.S. Patent 5,641,803 and claims 1, 2, 5, 6, 8 and 9 of U.S. Patent 5,670,537 are invalid for anticipation. Bristol-Myers Squibb Co. v. Boehringer Ingelheim Corp.,
Because the district court did not err in holding claims 1-3 and 6 of the '803 patent and claims 1, 2, 5 and 8 of the '537 patent invalid, we affirm the court’s judgment as to those claims. The district court erred in holding claims 6 and 9 of the '537 patent invalid, however. We therefore vacate the court’s grant of summary judgment with respect to those two claims.
BACKGROUND
Bristol-Myers Squibb Co. (“Bristol”) is the assignee of the '803 and '537 patents, which relate to a three-hour administration of the antitumor drug paclitaxel.
1. A method for reducing. hematologic toxicity in a cancer patient undergoing [tjaxol treatment comprising parenterally administering to said patient an anti-neoplastically effective amount of about 185-175 mg/m2 taxol over a period of about three hours.
’803 patent, col. 16, 11. 13-18 (emphasis added). The '537 patent is also directed to three-hour paclitaxel administration and additionally requires premedication, as shown in representative claims 1 and 5 below:
1. A method for treating a patient suffering from a taxol-sensitive tumor comprising
(i) pbemedicating said patient with a medicament that reduces or eliminates hypersensitivity reactions, and
(ii) parenterally administering to said patient about 135-175 mg/m2 taxol over about three hours.
*1372 5. A method for treating a cancer patient to effect regression of a taxol-sensi-tive tumor, said method being associated with reduced hematologic toxicity, said method comprising:
(i) premedicating said patient with a medicament that reduces or eliminates hypersensitivity reactions; and
(ii) parenterally administering to said patient about 135-175 mg/m2 taxol over about 3 hours.
’537 patent, col. 15,11. 45-51; col. 16,11. 21-27 (emphasis added).
Claims 2 and 8 of the '537 patent differ from claims 1 and 5, respectively, only in the dosage amount, which is “about 135 mg/m2 taxol.” Id. at col. 16,11. 5-6; 11. 41-42. Claims 6 and 9 of the '537 patent are directed to the same particular premedi-cants; claim 6 depends from claim 5 and claim 9 depends from claim 8. Claim 6 is reproduced below as representative of claims 6 and 9:
6. The method of claim 5 wherein the step of premedicating said patient comprises the administration of a medicament selected from the group consisting of steroids, antihistamines, H2 receptor antagonists, and combinations thereof.
’537 patent, col. 16, 11. 28-32 (emphasis added).
The defendants filed Abbreviated New Drug Applications (“ANDAs”) seeking approval to market paclitaxel prior to the patents’ expiration, alleging that' the patents were invalid over, inter alia, an article by Kris in which Kris treated patients with three-hour infusions of paclitaxel within the claimed dosage ranges but observed no antitumor response. Mark G. Kris, et al., Phase I Trial of Taxol Given as a 3-Hour Infusion Every 21 Days, 70 Cancer Treatment Reports 605-07 (1986) {“Kris ”). Patients treated with more than 190 mg/m2 of paclitaxel, an amount greater than the claimed range of 135-175 mg/ m2, showed treatment-limiting hypersensitivity reactions. In his concluding remarks, Kris commented:
Hypersensitivity reactions constitute a severe and unpredictable treatment-limiting toxicity for the present cremophor-containing formulation of taxol given on this schedule. Further studies are needed to see if pretreatment regimens, alternative schedules ... or a reformulated preparation will permit the safe administration of this compound.
Id. at 607. (emphasis added). Kris did not employ the suggested pretreatment regimens in that study.
Bristol sued for infringement based on the defendants’ ANDAs under 35 U.S.C.A. § 271(e)(2) (West Supp.2000); the defendants moved for summary judgment that the patents were invalid for anticipation under 35 U.S.C. § 102(b) (1994) and obviousness under 35 U.S.C. § 103 (Supp. IV 1998).
Following a Markman hearing, the district court construed the claims. Bristol-Myers Squibb Co. v. Immunex Corp.,
In Bristol II, the court granted the defendants’ motion for summary judgment that the claims at issue were invalid, holding that Kris anticipated most of the claims in the '803 and '537 patents. Bristol II,
Although the court did not consider the preamble language of reducing toxicity levels and tumor regression to be limiting, the court determined that even if these claim terms were limiting, the claims would have been inherently anticipated because reducing toxicity and tumor regression were necessary consequences of practicing the method steps of Kris. íd. at 442. However, the court denied the defendants’ motion for summary judgment that the claims were obvious over Kris and other references because it found a genuine factual dispute as to whether Kris would have led a person of ordinary skill in the art to have had a reasonable expectation of success from following his treatment regimens. Bristol then disclaimed claims 4 and 5 of the '803 patent and claims 3, 4, 7, and 10 of the '537 patent in a stipulation under Fed.R.Civ.P. 54(b) to obtain a final judgment. Bristol appeals from the court’s claim construction and invalidity judgment. We have jurisdiction of this appeal pursuant to 28 U.S.C. § 1295(a)(1) (1994).
DISCUSSION
Claim construction is an issue of law, Markman v. Westview Instruments, Inc.,
Summary judgment is appropriate when there is no genuine issue of material fact and the moving party is entitled to judgment as a matter of law. Fed. R.Civ.P. 56(c); Anderson v. Liberty Lobby, Inc.,
A. Claim Construction
Bristol argues that the district court erred by not giving effect to the preamble “for reducing hematologic toxicity” and the expression “an antineoplastically effective amount” in the '803 claims. In particular, Bristol asserts that “an antineoplastically effective amount” is limiting because it was added by amendment to distinguish over Kris, who observed no antitumor efficacy. Similarly, Bristol argues that the court improperly read out the phrase “[a] method for treating a cancer patient to effect regression of a taxol-sensitive tumor, said method being associated with reduced hematologic toxicity” from claims 5, 6, 8, and 9 of the '537 patent, asserting that this expression is the only difference between claims 1 and 5 and therefore must be given effect under the doctrine of claim differentiation. Finally, Bristol argues that these expressions are limitations because they distinguish the new use of the process over the prior art, which did not show usefulness for treating cancer in three-hour pa-clitaxel infusions.
The defendants respond that the expressions “reduced hematologic toxicity” and “antineoplastically effective amount” in the '803 patent claims merely state the intended result of those claims and are non-limiting. Furthermore, the defendants point out that “antineoplastically effective amount” was not required by the examiner to distinguish over the prior art because Bristol voluntarily added the phrase to the claims after the examiner had found them allowable. The defendants also assert that the preamble language of the '537 claims, “to effect regression of a taxol-sensitive tumor, said method being associated with reduced hematologic toxicity,” only states an intended result of that claimed method. Moreover, the defendants assert that the doctrine of claim differentiation does not apply to distinguish the scope of claim 5, which recites that expression, from claim 1, which does not, because both claims are independent. The defendants also argue that Bristol’s claim construction arguments violate the rule of consistency, which requires courts to construe claims consistently for both validity and infringement. Finally, the defendants respond to Bristol’s argument that the asserted claim limita
We first address the preamble language of the claims in the '803 patent, “for reducing hematologic toxicity.” We discern no error in the district court’s interpretation of that language as non-limiting, and merely expressing a purpose of reducing hematologic toxicity relative to the toxicity experienced by a patient undergoing a twenty-four-hour infusion. The steps of the three-hour infusion method are performed in the same way regardless whether or not the patient experiences a reduction in hematologic toxicity, and the language of the claim itself strongly suggests the independence of the preamble from the body of the claim. See, e.g., In re Hirao,
We reach the same conclusion with respect to the expression “an antineoplas-tically effective amount,” also in the '803 claims. That expression of intended result essentially duplicates the dosage amounts recited in the claims that are also described in the specification as “antineoplas-tically effective.” '803 patent, col. 5, 11. 40-44 (“It has also been surprisingly discovered that lower taxol dosages, such as about 135 mg/m2 can be administered via infusions lasting about 3-hours to about 28-hours, and still be antineoplastically effective.”). The express dosage amounts are material claim limitations; the statement of the intended result of administering those amounts does not change those amounts or otherwise limit the claim.
We also agree with the defendants that the amendment adding “antineoplastically effective amount” was voluntarily made after the examiner had already indicated to Bristol that the claims were allowable. See Supplemental Response for Application No. 08/544,594 (Jan. 10, 1997). These unsolicited assertions of patentability made during prosecution do not create a material claim limitation where we have determined that the language does not create one. Indeed, for purposes of infringement, Bristol apparently does not see this expression as requiring efficacy; Bristol stated its view in response to requests for admission that the claims of each patent would be infringed without a showing of an objective response in every patient. Bristol cannot have an expression be limiting in this context and non-limiting in another. W.L. Gore Assocs., Inc. v. Garlock, Inc.,
We next construe the expression “[a] method for treating a cancer patient
We are also unpersuaded by Bristol’s argument that this expression must be given effect under the doctrine of claim differentiation to distinguish between claims 1 and 5 and claims 2 and 8. The doctrine only creates a presumption that each claim in a patent has a different scope; it is not a “hard and fast” rule of construction. Comark Communications, Inc. v. Harris Corp.,
Finally, we address Bristol’s argument that new uses of old processes are patentable, that we should treat the expressions of efficacy as limitations because they distinguish the new use of the process over the prior art, and that claims should be read to preserve their validity. Bristol is correct that new uses of known processes may be patentable. See 35 U.S.C. § 101 (1994) (“Whoever invents or discovers any new and useful process ... may obtain a patent therefor.”); 35 U.S.C. § 100(b) (1994) (“The term ‘process’ means process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.”). However, the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by Kris. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent. In re May,
In May, one of our predecessor courts held that claims to the method of effecting analgesic activity without producing physical dependency by administering a genus of non-addictive analgesic compounds were anticipated by a disclosure of a species of that genus that was used as an analgesic. In re May,
B. Anticipation
Bristol argues that Kris cannot anticipate the claims because Kris is a failed experiment and therefore that it does not describe the claimed invention for purposes of 35 U.S.C. § 102(b). Although acknowledging that we have found anticipation by references that disparage the claims at issue, Bristol asserts that the Supreme Court held in United States v. Adams,
The defendants respond that a negative reference that discloses each limitation of a claimed invention describes that invention for purposes of 35 U.S.C. § 102(b) even if it disparages that invention. The defendants distinguish United States v. Adams, arguing that the allegedly anticipatory disclosure in that case was different from the claimed invention as well as inoperative. The defendants take issue with Bristol’s characterization of Kris as a “failed experiment,” stating that Kris was only a Phase I trial under Food and Drug Administration (“FDA”) procedures in which searching for efficacy was not his goal. The defendants also assert that Kris enabled the pretreatment limitations of the '537 patent and that the court properly relied on extrinsic evidence, such as Bristol’s statements made during prosecution. The defendants cite several additional references that demonstrate the enablement of Kris’s suggestion to premedicate. Finally, the defendants argue that claims 6 and 9 are anticipated by Kris’s suggestion to premedicate because they recite only drugs commonly used for premedication, and that the claims alternatively would have been obvious under 35 U.S.C. § 103.
1. '803 Patent
We conclude that the district court did not err in granting summary judgment of invalidity on the basis of anticipation of claims 1-3 and 6 of the '803
We are not persuaded by Bristol’s argument that Kris cannot anticipate under the rationale of United States v. Adams because it is a failed experiment. In Adams, the Court stated that “[a]n inoperable invention or one which fails to achieve its intended result does not negative novelty.” Adams,
2. '537 Patent
We also conclude that the district court did not err in granting summary judgment of invalidity on the basis of anticipation of claims 1, 2, 5 and 8' of the '537 patent, which are similar to the '803 claims but include the additional limitation of “premedicating said patient with a medicament that reduces or eliminates hypersensitivity reaction.” Bristol correctly asserts that Kris’s suggestion of premedication is primarily directed to patients receiving higher doses who experienced hypersensitivity reactions, and that Kris did not actually employ premedication. Nevertheless, Kris did not confine his pretreatment suggestion only to patients given higher doses; rather, he stated that “hypersensitivity reactions constitute a severe and unpredictable treatment-limiting toxicity for the present cremophor-containing formulation of taxol given
Enablement of an anticipatory reference may be demonstrated by a later reference. In Donohue, we accepted the use of a later reference, Lincoln, to show enablement of an earlier anticipatory reference, Nomura. Id. at 532,
The district court relied on Bristol’s “admission” made during prosecution that the claimed invention was drawn to “a novel method for administering taxol to patients that have been pretreated with conventional medication for minimizing hypersensitivity reactions” for its conclusion that premedication was conventional, and thus Kris would have enabled someone to premedicate patients. Bristol II,
Nevertheless, the defendants assert that several additional references show enablement of Kris for pretreatment prior to August 3, 1991, the critical date for purposes of anticipation. For example, Weiss et al, Hypersensitivity Reactions from Taxol, J. Clinical Oncology, Vol. 8, No. 7, 1263-68 (July 1990), discloses pretreating patients before giving them paelitaxel. Similarly, Rowinsky et al., Taxol: A Novel Investigational Antimierotubule Agent, J. Nat’l Cancer Institute, Vol. 82, No. 15, 1247-1259 (1990), reports giving prophylactic “anti-allergic” regimens consisting of steroids and H2-histamine antagonists before six-hour paelitaxel infusions to patients. We agree with the defendants that
Bristol has asserted that its inventors achieved success, where Kris had assertedly failed, and that the patent system is supposed to encourage and reward success. Moreover, Bristol and its inventors persevered despite the discouraging tone of Kris’s paper. We appreciate the point. However, one cannot obtain a valid patent on a known use of a known process that has been described in the literature more than one year prior to the date of one’s invention. Such processes are old, regardless of the relative success of the prior and later participants. We are not in a position to evaluate what other incentives and rewards Bristol and its inventors may have been subject to and benefited from. We can only apply the law to the facts in light of the decision of the district court. We are pleased that Bristol and its inventors persevered, but can only affirm the district court’s decision of invalidity.
We do agree with Bristol, however, that the district court erred by granting summary judgment of anticipation of claims 6 and 9 of the '537 patent. Kris discloses only the use of premedicants generally, not the specific classes of premedicants in those claims: steroids, antihistamines, and H2-receptor antagonists. Anticipation requires a showing that each limitation of a claim is found in a single reference, Donohue,
The record in this case does not establish whether the general class of premedi-cants that are suitable to prophylactically treat hypersensitivity reactions before administration of a cancer drug such as pa-clitaxel is small enough such that Kris’s disclosure of premedicants effectively described the specific classes of premedi-cants in claims 6 and 9. The district court relied on Bristol’s statement during prosecution concerning pretreatment as “conventional medication for minimizing hypersensitivity reactions” in its determination that Kris’s general disclosure of premedi-cants anticipated the specific ones recited in claims 6 and 9. Bristol II,
Finally, we decline the invitation by the defendants to hold these claims invalid in
CONCLUSION
Because the district court did not err in determining that claims 1-3 and 6 of the '803 patent and claims 1, 2, 5, and 8 of the '537 patent are invalid for anticipation, we affirm the court’s grant of summary judgment as to those claims. However, we vacate its grant of summary judgment with respect to claims 6 and 9 of the '587 patent. We therefore
AFFIRM-IN-PART, VACATE-IN-PART, and REMAND.
Notes
. Paclitaxel is the generic name of the anticancer agent derived from the Pacific Yew tree. Taxol® is the registered trademark for Bristol’s anticancer drug, which includes pa-clitaxel as its active ingredient.
. An "antineoplastic drug” is an agent "that is antagonistic to the growth of a neoplasm,”