Opinion
CASE No. CV 00-09589 MRP
January 10, 2002
MEMORANDUM OF DECISION RE: Defendants' Renewed Motion for Partial Summary Judgment of Invalidity
I. INTRODUCTION
Defendants Baker Norton Pharmaceuticals, Inc., Zenith Goidline Pharmaceuticals, Inc., and IVAX Corp. (hereinafter "IVAX") filed this motion on May 10, 2001. The Court vacated the motion pending a ruling on claim construction and issued its order regarding partial claim construction on August 28, 2001. Defendants then renewed this summary judgment motion on October 29, 2001.
Defendants' Renewed Motion for Partial Summary Judgment of Invalidity of U.S. Patent No. 6,096,331 ("the `331 patent") came before the Court for hearing on December 3, 2001. The Court heard oral argument and took the matter under submission. Having considered the papers filed in support of and in opposition to the motion, the arguments of counsel, and the record in this case, the Court GRANTS Defendants' motion as to claims 31, 36, 39, 41 and 42.
II. LEGAL STANDARD
In this Motion, IVAX requests summary adjudication that the asserted claims of the `331 patent (claims 31, 36, 39, 41 and 42) are invalid as anticipated by certain prior art. Summary judgment is proper where no genuine issue of fact exists and the moving party is entitled to judgment as a matter of law. See Kegel Co., Inc. v. AMF Bowling, Inc., 127 F.3d 1420, 1424 (Fed. Cir. 1997). In a summary judgment motion, the evidence should be viewed in the light most favorable to the party opposing the motion, and all doubts resolved in its favor. See Karlin Tech. Corp. v. Surgical Dynamics, Inc., 177 F.3d 968, 970 (Fed. Cir. 1999). Because this is a motion for summary judgment of invalidity, the Court views the evidence in light of the clear and convincing burden that would inhere at trial. See National Presto Indus., Inc. v. West Bend Co., 76 F.3d 1185, 1189 (Fed. Cir. 1996).
III. DISCUSSION
A. The Pre-1993 References
IVAX argues that a number of prior art references anticipate the asserted claims of the `331 patent.
ABI's argument that these references are not properly authenticated is without merit. IVAX has included affidavits from librarians in its Reply brief to this motion that cover each of the references at issue. See IVAX Reply Br., at 7-12. Further, at least the published articles from periodicals are self-authenticating under Federal Rule of Evidence 902(6). ABI has produced no evidence that any of the documents are not authentic.
Independent claim 31 is directed to "A unit dosage form comprising a vessel containing a sufficient quantity of taxane to allow systemic administration at a dose in the range of about 30 mg/m2 to about 1000 mg/m2 over an administration period of less than 3 hours." Claim 41 is identical to claim 31, except it narrows the dosage to a range between 80 mg/m2 and 700 mg/m2.
Independent claim 36 is similar to claim 31, but requires only a "taxane-containing formulation suitable for delivery of a dose in the range of about 30 mg/m2 to about 1000 mg/in2 with an administration period of less than 3 hours." Dependent claim 42 simply narrows the range to between 80 mg/m2 and 700 mg/in2. Finally, independent claim 39 requires "[a] pharmaceutically acceptable formulation of taxane comprising in the range of about 30 mg/in2 to about 1000 mg/in2 of taxane, wherein said formulation is useful for the reduction of serum testosterone levels in a subject."
A patent claim is invalid if "[t]he invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States." 35 U.S.C. § 102 (b). A prior art reference anticipates a claim if each and every claim limitation is disclosed in a single prior art reference. See Helifix Ltd. v. BlokLok Ltd., 208 F.3d 1339, 1346 (Fed. Cir. 2000).
IVAX first argues that claims 31, 36, 41 and 42 are anticipated by three clinical trials conducted in the late 1980s. O'Connell, which was published in 1985, discloses administering Taxol over periods of two to three hours at 100, 135 and 160 mg/in2, which is within the range of all four claims. If a prior art references teaches even a single point within a claimed range, the claim is invalid. See Titanium Metals Corp. v. Banner, 778 F.2d 775 (Fed. Cir. 1985) Similarly, Longnecker discloses administering Taxol at a dose of 135 mg/in2 over one hour, and Donehower et al describe administering Taxol at doses of 90 and 135 mg/m2 over a period of one hour. These references meet the dosage and time limitations of the claims.
Although it appears, that ABI is not currently claiming infringement of claims 36 and 42, the Court finds that IVAX has a reasonable apprehension of suit on these claims, and that they are therefore a proper subject of this motion. IVAX included these claims in its Local Rule 7.14.1 statement, and asserted as an undisputed fact that it had a reasonable apprehension of suit on these claims. ABI did not contest this in its response. Therefore, the Court finds that a reasonable apprehension of suit existed and continues to exist, even if ABI elects not to press these claims at the present time.
ABI does not contest that these references disclose the dosages and time periods noted above. Rather, it argues that the "vessel" or "formulation" limitations are missing in these references, because the references do not explicitly mention them. The Court does not find this argument persuasive because some kind of vessel is necessarily required to contain the formulations.
There is no dispute regarding the fact that the references do not teach containing the dosage of Taxol in a single vessel. However, beyond this bald assertion, ABI has made no assertion that anyone has ever administered Taxol in any way other than via a single vessel. ABI suggests that using multiple vessels is possible, but provides no evidence that anything other than a single vessel was ever used. At the claim construction hearing, ABI demonstrated Taxol administration using a single vessel. IVAX has also presented substantial evidence that those skilled in the art of administering Taxol use a single container, typically an IV bag or bottle. In the absence of any evidence from ABI that contradicts IVAX's substantial evidence that a single container is used by those skilled in the art of administering Taxol, this Court must find for IVAX.
There is also considerable support for the proposition that, in an open ended claim, "a vessel" is not restricted to "a single vessel." See KCJ Corp. v. Kinetic Concepts, Inc., 223 F.3d 1351, 1356 (Fed. Cir. 2000.) ("under the general rules of claim construction, this court presumes the customary meaning of `a' — one or more.") ABI does not dispute that, in this case, "a vessel" can mean "one or more vessels," and the Court finds nothing in the written description or prosecution history to indicate otherwise.
In either case, there is no serious dispute regarding the anticipation of claims 31, 36, 41 and 42 by these references. Each and every limitation has been met by at least the three references described above.
The Pre-1997 References
1. The effective filing date of the asserted claims
IVAX argues that the claims at issue are not entitled to a filing date earlier than September 9, 1997, because the original written description does not support the claims at issue in this case, which were added in a continuation-in-part application but which seek priority back to the February 22, 1993 parent application. According to IVAX, the written description in the parent is silent about each and every element of the claims. If the written description fails to notify one skilled in the art that the inventor was in possession of each claimed limitation, the later-added claim is not supported by that description. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (1998). There is no dispute that the September 9, 1997 application does provide support for the claims at issue here.
ABI has raised a genuine factual dispute regarding written description support for the dosage ranges claimed. ABI's expert notes that dosage ranges for test animals are disclosed in the written description, and that means of translating those ranges into human dosages are known in the art. Although IVAX disputes ABI's explanation, the Court finds it raises an issue that would preclude summary judgment on that issue. This is irrelevant, however, because there is no support for the time limitation.
ABI does not dispute that the written description is silent regarding the time limitation (less than three hours) in Claims 31, 36, 41 and 42. Further, it does not dispute that the written description is silent regarding Claim 39's requirement that the formulation reduce the serum testosterone levels in a subject. Because there is no dispute that the written description provides no support for these limitations, the priority date of all claims at issue is September 9, 1997.
2. The pre-1997 references
IVAX lists three references which anticipate the dosage range and time period in the asserted claims which ABI does not dispute. ThePhysician's Desk Reference from 1995 discloses a dose of 135-175 mg/in2 Taxol over a period of three hours. A European Patent Application EPO 584,001, corresponding to Bristol's U.S. Patent No. 5, 641, 803 ("the `803 patent"), published in 1994, describes administering Taxol in 135 and 175 mg/in2 doses over three hours. And a clinical trial published by Eisenhauer, et al discloses the administration of Taxol of 135 and 175 mg/m2 over three hours.
The relevant claims in the `331 patent disclose a formulation "suitable for delivery . . . with an administration period of less than three hours." Although there is a difference between three hours and less than three hours, the wording of the claims renders the minor distinction irrelevant here. A formula suitable for administration over three hours would undoubtedly also be suitable for administration over 2 hours and 59 minutes. This, combined with the other limitations discussed above, constitutes clear and convincing evidence, without serious dispute, of anticipation as to claims 31, 36, 41 and 42.
Bristol's sale of Taxol also anticipates these claims, because the label indicates that it should be administered over three hours in dosages between 135 and 175 mg/in2. Bristol began selling Taxol with this label in the early 1990s, before the earliest filing date asserted in this action. ABI argues that the product does not anticipate, because the Bristol vials contain 30 mg, while the claims at issue only encompass container sizes ranging between 33 mg and 3,000 mg.
The claims are directed to "a vessel containing a sufficient quantity of taxane to allow systemic administration at a dose" in the specified ranges. ABI ignores the fact that Bristol's 30 mg vial is not such a vessel, because the 30 mg vial must first be diluted in an IV bag — the latter being the "vessel" required by the claims. Further, 30 mg is not a sufficient quantity of taxane to allow systemic administration — vials must be combined for administration. Further, in 1996 Bristol began selling vials of 100 and 300 mg, so' that under ABI's later filing date, these sales also anticipate claims 31, 36, 41 and 42.
Humans have a surface area ranging from 1.1m2 and 3.0 m2. See IVAX's Corrected Reply Br. At 3 (citing ABI's Mentlik Decl., Exh. E pp 7). Therefore, a standard dose of 135 mg/in2 would be 148.5 mg, or three vials, for the smallest person, and 435 mg for the largest. See id. Even the lowest claimed dose of 30 mg/in2 would require combination and dilution of two or three vials, because it would occupy a range of 33 mg for the smallest person, and 90 mg for the largest.
Finally, ABI has admitted that Bristol's Taxol formulation, which was in the prior art even before ABI's asserted 1993 priority date, causes a reduction in serum testosterone levels. See Dr. Soon-Shiong declaration, exhibit CC to IVAX's Claim Construction Reply Br. (Stating that Bristol's package insert discloses such a reduction) ABI's argument that certain Taxol vials come in 30 mg sizes does not account for the well-established and undisputed method of administering Taxol to patients via a single IV bag or bottle, in which those vials are diluted and combined.
For the reasons above, the Court hereby GRANTS summary judgment of invalidity as to all the claims asserted.
IT IS SO ORDERED.