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BRISTOL-MEYERS SQUIBB CO. v. DANBURY PHARMACAL

June 30, 1993

BRISTOL-MEYERS SQUIBB COMPANY and MEAD JOHNSON & COMPANY, Plaintiffs,
v.
DANBURY PHARMACAL, INC., Defendant.


MARTIN, JR.


The opinion of the court was delivered by: JOHN S. MARTIN, JR.

JOHN S. MARTIN, JR., District Judge:

 The '763 patent was issued on January 8, 1980 and claimed a new use of the drug "buspirone" to treat neurotic anxiety in human patients. Buspirone had previously been developed by plaintiffs and had been patented under two separate patents, U.S. Patent Nos. 3,717,634 (the "'634 patent") and 3,976,776 (the "'776 patent"), which had been applied for in a single application originally filed on November 24, 1969 and which were issued on February 20, 1973 and August 24, 1976 respectively. Defendant claims that the '634 and '776 patents *fn1" anticipated, or disclosed, the new use sought to be patented in the '763 patent, and that the use in the '763 patent was therefore non-novel and not properly the subject of a patent.

 The claims in the '763 patent application were initially rejected by the patent examiner pursuant to 35 U.S.C. § 103 because they were obvious from the '776 and '634 patents, as well as from certain studies which were referenced in those patents. The examiner noted, "Tranquilizers have traditionally been used to treat anxiety conditions. The claimed used [sic] is for an anxiety problem." However, after plaintiffs argued that the examiner had oversimplified the usage of the term "tranquilizers," the claims were allowed.

 Discussion

 Summary judgment is proper when there is no genuine issue of material fact and, based upon facts not in dispute, the moving party is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322-23, 106 S. Ct. 2548, 91 L. Ed. 2d 265 (1986). The court's role on a motion for summary judgment is not to decide disputed issues of fact but only to determine whether there is a genuine issue to be tried. Rattner v. Netburn, 930 F.2d 204, 209 (2d Cir. 1991). Moreover, the court must resolve all ambiguities and draw all factual inferences in favor of the nonmoving party. Rattner, 930 F.2d at 209 (citing Anderson v. Liberty Lobby Inc., 477 U.S. 242, 255, 106 S. Ct. 2505, 91 L. Ed. 2d 202 (1986)). The validity of a patent, and specifically whether the patent was anticipated, can be the subject of summary judgment when appropriate. Scripps Clinic & Research Found. v. Genentech, Inc., 927 F.2d 1565, 1576 (Fed. Cir. 1991).

 A patent holder is entitled to a presumption of validity, 35 U.S.C. § 282, which may only be defeated by clear and convincing evidence, Bausch & Lomb, Inc. v. Barnes-Hind/Hydrocurve, Inc., 796 F.2d 443, 446 (Fed. Cir. 1986), cert. denied, 484 U.S. 823, 98 L. Ed. 2d 47, 108 S. Ct. 85 (1987). Moreover, where the patent examiner had the same evidence before him as does the instant court, "the burden on the party asserting invalidity is more difficult to meet." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1467 (Fed. Cir. 1990); Barnes-Hind, 796 F.2d at 447. Of course, on summary judgment, it must be established that there is no genuine issue of material fact as to the validity of the patent. See supra.

 Anticipation, or prior disclosure of the invention, will prevent a patent from being issued because it renders the invention non-novel. "A party asserting that a patent claim is anticipated under 35 U.S.C. § 102 'must demonstrate, among other things, identity of invention.'" Minnesota Mining & Mfg. Co. v. Johnson & Johnson Orthopaedics, Inc., 976 F.2d 1559, 1565 (Fed. Cir. 1992) (quoting Kalman v. Kimberly-Clark Corp., 713 F.2d 760, 771 (Fed. Cir. 1983), cert. denied, 465 U.S. 1026, 79 L. Ed. 2d 687, 104 S. Ct. 1284 (1984), overruled in part on other grounds, SRI Int'l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1125 (Fed. Cir. 1985) (en banc)).

  "Invalidity for anticipation requires that all of the elements and limitations of the claim are found within a single prior art reference. There must be no difference between the claimed invention and the reference disclosure, as viewed by a person of ordinary skill in the field of the invention." Scripps, 927 F.2d at 1576 (citations omitted). Furthermore, the reference disclosure must be evaluated from the standpoint of one of ordinary skill at the time of the disclosure. Studiengesellschaft Kohle, m.b. H. v. Dart Indus., Inc., 726 F.2d 724, 726 (Fed. Cir. 1984). Where the prior art reference is in a patent, it is not necessary that the reference "teach" the claim sought to be invalidated; "it is only necessary that the claims under attack, as construed by the court, 'read on' something disclosed in the reference, i.e., all limitations of the claim are found in the reference, or 'fully met' by it." Kalman, 713 F.2d at 772.

 Although "a finding of anticipation requires that all aspects of the claimed invention were already described in a single reference," Scripps, 927 F.2d at 1576, "it is sometimes appropriate to consider extrinsic evidence to explain the disclosure of a reference. . . . The role of extrinsic evidence is to educate the decision maker as to what the reference meant to persons of ordinary skill in the field of the invention, not to fill in gaps in the reference." Id.; see Studiengesellschaft, 726 F.2d at 727.

 The '776 patent summarized the invention as follows:

 
The present invention relates to azaspirodecanedione and azaspiroundecanedione derivatives as hereinabove described . . . . In U.S. Pat. No. 3,398,151 reference is also made to derivatives of azaspirodecanediones and azaspiroundecanediones which have a number of pharmacological activities including tranquilizing action. In the instant case, it has been discovered that N-(heteroarcyclic)piperazine alkyl derivatives of azaspirodecanediones and azaspiroundecanediones are highly active and specific tranquilizing agents and in addition also exhibit anti-emetic properties. Present compounds are improved tranquilizing agents compared to azaspirodecanediones and azaspiroundecanediones of U.S. pat. No. 3,398,151, in that tranquilizing activity is more potent and specific.
 
With respect to side effects such as sedative and alpha-adrenergic blockade which are exhibited by a number of prominent tranquilizing agents the present compounds are unique in that such an adverse reaction is substantially diminished or practically nonexistent. By way of illustration, [one of the buspirone compounds] has only about 1/400th. ...

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