Bristol-Myers Squibb Co. v. Pharmachemie B.V.

• Citation: 361 F.3d 1343
• Decision Date: 17 March 2004
• Docket Number: No. 03-1077.,03-1077.
• Parties: BRISTOL-MYERS SQUIBB COMPANY, Plaintiff-Appellee, and Research Corporation Technologies, Inc., Plaintiff-Appellee, v. PHARMACHEMIE B.V., Defendant-Appellant.
• Court: United States Courts of Appeals. United States Court of Appeals for the Federal Circuit

361 F.3d 1343

BRISTOL-MYERS SQUIBB COMPANY, Plaintiff-Appellee, and Research Corporation Technologies, Inc., Plaintiff-Appellee, v. PHARMACHEMIE B.V., Defendant-Appellant.

No. 03-1077.

United States Court of Appeals, Federal Circuit.

March 17, 2004.

Rehearing En Banc Denied April 21, 2004.

David T. Pritikin, Sidley, Austin, Brown & Wood, of Chicago, Illinois, argued for both plaintiffs-appellees. With him on the brief were Constantine L. Trela, Jr., Lisa A. Schneider, and Marc A. Cavan; and Eugenia S. Hansen, Sidley Austin Brown & Wood, of Dallas, Texas. On the brief for plaintiff-appellee Bristol-Myers Squibb Company, was Robert L. Baechtold, Fitzpatrick, Cella, Harper & Scinto, of New York, New York.

Francis C. Lynch, Palmer & Dodge, LLP of Boston, Massachusetts, argued for defendant-appellant. With him on the brief was Laurie S. Gill.

Before NEWMAN, MICHEL, and BRYSON, Circuit Judges.

BRYSON, Circuit Judge.

The question in this patent case is whether the patent in suit is invalid for double patenting. The district court held on summary judgment that an earlier patent, which stemmed from the same application as the patent in suit, could not be used as a reference against the patent in suit for double patenting purposes. Bristol-Myers Squibb Co. v. Pharmachemie, B.V., No. 01-3751(MLC) (D.N.J. July 29, 2002). Because we disagree with a key conclusion on which the district court's summary judgment was based, we vacate the district court's judgment and remand the case to the district court for further proceedings.

I

A

Research Corporation Technologies, Inc., is the owner of U.S. Patent No. 4,657,927 ("the '927 patent"), and Bristol-Myers Squibb Co. is the exclusive licensee under that patent. The patent claims (1) methods for treating malignant tumors with certain platinum coordination compounds and (2) compositions containing those compounds in amounts sufficient to cause regression of those tumors. Appellant Pharmachemie, B.V., filed an Abbreviated New Drug Application ("ANDA") with the Food and Drug Administration, seeking FDA approval to market a cancer-treating drug covered by the '927 patent. Research Corporation Technologies, Inc., and Bristol-Myers Squibb Co. (collectively "Bristol-Myers") brought suit charging Pharmachemie with patent infringement under 35 U.S.C. § 271(e)(2). As a defense, Pharmachemie asserted that the '927 patent was invalid for obviousness-type double patenting over U.S. Patent No. 4,140,707 ("the '707 patent"), which was issued in 1979 and expired in 1998.

B

The double patenting issue in this case turns on whether Bristol-Myers is entitled to invoke section 121 of the Patent Act, 35 U.S.C. § 121, as a defense against the claim of double patenting. That issue in turn depends on an interpretation of the prosecution history of the '707 and '927 patents.

The '927 patent can be traced to an application filed with the Patent and Trademark Office in 1972. That application, Serial No. 260,989 ("the '989 application"), disclosed and claimed compounds corresponding generally to the compounds that were ultimately claimed in the '707 patent. In addition, the '989 application claimed methods of treatment and compositions corresponding to the claims that were ultimately included in the '927 patent.

In the course of the prosecution of the '989 application, the examiners imposed two restriction requirements. The first, imposed in 1973, required that the applicants elect either the compound claims, classified in art class 260, or the method of treatment and composition claims, classified in art class 424. In addition, the 1973 restriction requirement directed the applicants to elect "a single disclosed species for examination on the merits." As a result of the 1973 restriction requirement, the applicants elected the compound claims and withdrew the non-elected method of use and composition claims from further consideration at that time. The examiner then rejected the elected compound claims on the basis of lack of utility.

In 1974, a different examiner issued a second restriction requirement on the '989 application. That restriction requirement identified four different compound groups within the compounds claimed in the application as constituting independent and distinct inventions. The four groups were: (1) "Organometallic platinum compound[s] classified in class 260, subclass 429"; (2) "Platinum compounds containing `heterocyclic amines' or [']heterocyclic substituents' classified in class 260, subclass 270R and many various subclasses"; (3) "Compounds of the above type with 2-valent platinum and no L moiety"; and (4) "Compounds with 4-valent platinum containing various `anionic' ligands." In addition, the examiner expressly stated that the 1973 restriction requirement segregating the compound claims from the method of use and composition claims was maintained. The applicants did not file a divisional application in response to either of the restriction requirements, but instead appealed the final rejection of the claims to the PTO Board of Appeals.

In 1977, while that appeal was pending, the applicants filed a continuation application Serial No. 778,955 ("the '955 application"), and abandoned the '989 application. The '955 application presented all of the original claims of the '989 application for examination. A new examiner examined the '955 application "for restriction only" and imposed a new restriction requirement. The 1977 restriction requirement differed from the 1973 and 1974 requirements that had been imposed in connection with the '989 application. The 1977 restriction requirement mandated that the claims be separated into four groups, but unlike the 1973 restriction requirement, it did not segregate the compound claims from the method of use and composition claims. Instead, the first two of the four groups set forth in the restriction requirement referred to art groups that included methods of use and compositions as well as compounds. The first group consisted of "[o]rganometallic platinum compound[s] classified in class 260, subclass 429 [compounds] and class 424, subclass 287 [methods of use and compositions]." The second group consisted of "[p]latinum compounds containing `heterocyclic amines' or [']heterocyclic substituents' classified in Class 260, subclasses 270R and many various subclasses [compounds], and Class 424 subclass 245 [compositions and methods of use]." The third group set forth in the 1977 restriction requirement consisted of "[c]ompounds of the above type with 2-valent platinum and no L moiety." The fourth group consisted of "[c]ompounds with 4-valent platinum containing various `anionic' ligands."

The applicants responded to the 1977 restriction requirement by electing four claims, which corresponded to the claims that were ultimately included in the '707 patent that issued two years later. Before that patent issued, however, the applicants filed a divisional application, Serial No. 902,706 ("the '706 divisional application"). After a preliminary amendment, the '706 divisional application included 16 claims, denominated claims 5-20. Claims 5-13 were cancelled shortly thereafter. The remaining claims, in slightly rewritten form, claimed the non-elected compound groups and the methods of use and compositions originally claimed in both the '989 and the '955 applications. Following the filing of the '706 divisional application, the '707 patent issued, containing the four compound claims that had been elected from the '955 application.

The examiner issued a restriction requirement with respect to the '706 divisional application. The office action began with the statement "Restriction has been required ... between the following inventions," after which the examiner divided the claims into three groups: claim 14, "which is drawn to Platinum (II) complexes classified in Class 260, subclass 270R"; claim 15, "which is directed to platinum (IV) complexes classified in Class 260, subclass 429R"; and claims 16-20, "which are drafted to composition and method [sic] classified in Class 424, subclass 245, 287." In the same office action, the examiner then set forth a second, four-way restriction requirement, which replicated the four-way restriction requirement that had earlier been imposed on the claims of the '955 application. The applicants responded to that office action by asserting that the two restriction requirements seemed to be "somewhat in conflict" in that "any invention elected in accordance with the requirements [of the first] would necessarily involve election of one or more of the groups set forth [in the second]." In an effort to comply with the requirements, however, the applicants elected claim 14 of the '706 divisional application.

In 1983, after further unsuccessful appellate proceedings, the applicants filed another divisional application, which again consisted of the original 1972 application. In preliminary amendments, the applicants canceled the 13 original claims and added, as claims 14-19, the claims that had been claims 15-20 of the '706 divisional application. Another examiner was assigned to the application and another restriction requirement was issued. This time, the examiner divided the claims into two groups, one consisting of claim 14, "drawn to platinum IV complexes, classified in Class 260, subclass 239E," and the other consisting of claims 15-19, "drawn to methods of use and compositions, classified in Class 424, subclass 245." In 1987, that application matured into the '927 patent. The four claims of the '927 patent corresponded generally to four of the method of use and composition claims of the 1983 divisional application.

C

The district court noted that the question whether section 121 of the Patent Act is available to Bristol-Myers depends on whether the applicants were required by a restriction requirement to prosecute the claims that ultimately became part of the '927 patent separately from the claims that...