Issue 204 | May 25, 2004
Bristol-Myers Squibb Co. and Research Corp. Tech. v. Pharmachemie B.V.

In Bristol-Myers Squibb Co. and Research Corp. Tech. v. Pharmachemie B.V., No. 03-1077 (Fed. Cir. March 17, 2004), the federal circuit reversed a district court decision holding that an earlier-issued patent stemming from the same application as the �7 patent-in-suit could not be used as a reference against the �7 patent for double patenting purposes.

Bristol-Meyers Squibb (揃MS�) is the exclusive licensee under Research Corp. Tech抯 �7 patent, directed to methods for treating malignant tumors with platinum coordination compounds and compositions containing those compounds. The �7 patent issued from application Ser. No. 260,989 (搾989 application) filed in 1972. Pharmachemie sought approval of a generic version of a drug covered by the �7 patent, alleging that the �7 patent was invalid for obviousness-type double patenting over U.S. patent No. 4,140,707, which issued from the same application as the �7 patent. Because an original 1973 restriction requirement was held to be in effect and to have required the applicants to pursue the method of use and composition claims in separate applications, the district court held that �1 barred Pharmachemie抯 assertion of double patenting. Pharmachemie abandoned its other defenses and the court entered a final judgment of infringement.

On appeal, the federal circuit held that BMS was entitled to invoke �1 protection against the use of the �7 patent as a reference against the �7 patent only if the �7 patent抯 divisional application was filed as a result of the restriction requirement and was consistent with that restriction requirement. Reversing the district court, the federal circuit agreed with Pharmachemie that the �9 application抯 restriction requirement of 1973 was not in effect at the time of the filing of the �7 patent抯 divisional application.

The federal circuit first concluded that the restriction requirement issued in the �5 application was different from the ones issues in the �9 application. Because an applicant 慶ould have complied with the restriction requirement of the �5 application in a way that would have been contrary to the 1973 restriction requirement,� the examiner made clear that the 1973 restriction requirement in the �9 application did not carry over to the '955 application. BMS argued that the four-way restriction requirement of the �5 application incorporated the two-way restriction issued in 1973, but the federal circuit disagreed, stating that there was no evidence that the PTO intended one of the restrictions to carry forward, but not the other. Nor had the applicant proceeded under an assumption that the �9 restriction requirement continued in effect. Because the district court抯 order was based on its finding that the 1973 restriction requirement continued in effect, the federal circuit reversed and remanded for further proceedings.

In a lengthy dissent, Judge Newman stated that a restriction requirement was an administrative procedure that is discretionary with the PTO, reviewable, if at all, under the Administrative Procedure Act. Accordingly, the appropriate standard of review should be one of deference to the PTO, not de novo (as used by the majority). Thus, 搒hould there be any imperfections in the agency's interpretations or applications of the regulations with respect to the examiner's theory of restriction or compliance by the applicant, they are not grounds of invalidity.�/p>

To view the full decision visit http://www.aplf.org/mailer/Issue204.doc

To discuss this topic further, please feel free to contact the author Michael R. Dzwonczyk, (mdzwonczyk@sughrue.com), at Sughrue Mion, PLLC in Washington DC., USA.

The information contained in this email is provided for informational purposes only and does not represent legal advice. Neither the APLF nor the author intends to create an attorney client relationship by providing this information to you through this message.

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