J U N E 2 0 0 2 Last The Federal Circuit month at Month at a Glance NO RELIEF FOR INNOVATOR DRUG LATE CLAIM TO INVENTION COSTS PARTY COMPANIES WHEN GENERIC IN INTERFERENCE COMPETITORS FAIL TO COMPLY WITH 35 U.S.C. § 135(b) presents a threshold issue FDA REQUIREMENTS that should be addressed by the Board at Sufficiency of Paragraph IV certification must the preliminary stage of an interference be raised initially before the FDA and there- before proceeding on the merits. Berman v. after in a judicial review proceeding brought Housey , No. 01-1311 (Fed. Cir. May 29, under the APA. Minnesota Mining and Mfg. 2002) . . . . . . . . . . . . . . . . . . . . . . . . . . .7 Co. v. Barr Labs., Inc. , No. 01-1369 (Fed. Cir. May 1, 2002) . . . . . . . . . . . . . . . . . . .1 ASSUMPTIONS ABOUT PROPERTIES OF PRIOR ART STRUCTURE FAIL TO PROVE SALE OF REPLACEMENT PART DOES NOT INHERENCY LEAD TO INFRINGING RECONSTRUCTION Inherency requires that a limitation must Activity “akin to repair” does not infringe if be necessarily present in a reference and a the part in question is readily replaceable. person of ordinary skill in the art would Husky Injection Molding Sys. Ltd. v. R&D recognize its presence. Crown Operations Tool & Eng’g Co. , No. 01-1346 (Fed. Cir. Int’l, Ltd. v. Solutia Inc. , No. 01-1144 May 17, 2002) . . . . . . . . . . . . . . . . . . . . .2 (Fed. Cir. May 13, 2002) . . . . . . . . . . . . . .7 COURT AFFIRMS HOLDING OF INFRINGE- LICENSE DEFENSE DOES NOT DENY MENT AS A DISCOVERY SANCTION FEDERAL COURT JURISDICTION To hold otherwise would be to disarm the Jurisdiction in the federal courts for patent- Washington, DC court of its important power to police its infringement cases is not lost simply because 202-408-4000 proceedings to ensure transparency and pre- the most efficient approach at trial may dictability and to discourage mischievous be to address the license defense first. conduct by litigants. Transclean Corp. v. Pixton v. B&B Plastics, Inc. , No. 01-1012 Palo Alto 650-849-6600 Bridgewood Servs., Inc. , No. 01-1268 (Fed. Cir. May 29, 2002) . . . . . . . . . . . . . .8 (Fed. Cir. May 21, 2002) . . . . . . . . . . . . . .3 CLAIMED “MEMBER” IS NOT LIMITED Atlanta USE RECITED IN CLAIM PREAMBLE ONLY TO DISCLOSED EMBODIMENT 404-653-6400 FOUND NOT LIMITING Pointing to the preferred embodiment in the Preamble is not limiting where patentee specification or prosecution history is insuffi- defines structurally complete invention in cient to overcome the heavy presumption Cambridge claim body and uses preamble only to state that a claim term carries its ordinary and 617-452-1600 purpose or intended use for invention. customary meaning. CCS Fitness, Inc. v. Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Brunswick Corp. , No. 01-1139 (Fed. Cir. Inc. , No. 01-1324 (Fed. Cir. May 8, May 3, 2002) . . . . . . . . . . . . . . . . . . . . . .9 Tokyo 2002) . . . . . . . . . . . . . . . . . . . . . . . . . . .4 011-813-3431-6943 DRAWINGS SHOWING CLAIMED COURT BROADENS CLAIM SCOPE AND FEATURES MEET WRITTEN-DESCRIPTION REMANDS Brussels 011-322-646-0353 REQUIREMENT An assertion of infringement against a prod- Claims may be no broader than the support- uct, standing alone, is not an admission of ing disclosure. Cooper Cameron Corp. v. invalidity if the product is prior art. Beckson Kvaerner Oilfield Prods., Inc. , No. 01-1383 Marine, Inc. v. NFM, Inc. , No. 01-1301 EDITED BY VINCE KOVALICK (Fed. Cir. May 14, 2002) . . . . . . . . . . . . . .6 (Fed. Cir. May 31, 2002) . . . . . . . . . . . . .10 This publication brings you a synopsis of patent cases decided last month by the United States Court of Appeals for the Federal Circuit based on slip opinions received from the court. You can review and download the full text of each opinion by visiting our website at www.finnegan.com
L A S T M O N T H A T T H E F E D E R A L C I R C U I T No Relief for Innovator Drug Barr’s refusal to provide a detailed statement of its factual and legal bases of noninfringe- Companies When Generic ment was merely an improper attempt to Competitors Fail to Comply with obtain a judgment of noninfringement FDA Requirements designed to trigger a 180-day marketing exclusivity period promised to a third party, Gregory A. Chopskie Alphapharm Pty. Ltd. (“Alphapharm”). The district court refused to dismiss the case and [Judges: Dyk (author), Gajarsa, and Michel] granted Barr’s motion for SJ. On appeal, 3M argued that the district In Minnesota Mining & Manufacturing Co. court should have dismissed the suit without v. Barr Laboratories, Inc ., No. 01-1369 (Fed. prejudice for lack of subject matter jurisdiction Cir. May 1, 2002), the Federal Circuit affirmed because after the filing of the infringement a district court’s refusal to dismiss the suit and suit, 3M agreed that no infringement had grant of SJ of noninfringement. occurred. Barr argued that 3M could not Minnesota Mining & Manufacturing escape an adverse judgment by voluntary dis- Company (“3M”) charged Barr Laboratories, missal and, even if dismissed, the suit should Inc. (“Barr”) with infringement of U.S. Patent be dismissed with prejudice, thus triggering No. 4,642,384 (“the ‘384 patent”) by Barr’s Alphapharm’s exclusivity period. 3M argued page 01 filing of an Abbreviated New Drug Application that the district court was obligated to use its (“ANDA”) seeking FDA approval to market a inherent power to sanction Barr’s failure to generic version of 3M’s heart medication comply with the statutory notice requirement. Tambocor ™ . Under the Hatch-Waxman The Federal Circuit held that, although 3M amendments (“the Hatch Waxman Act” or might well be correct that a case or controver- “the Act”) to the Federal Food, Drug, and sy ceased to exist in the course of litigation, Cosmetic Act (“FFDCA”), the ‘384 patent was the party’s dispute over the form of the dis- listed in the FDA publication known as the missal alone was sufficient to create subject Orange Book. That listing in the Orange Book matter jurisdiction. Moreover, the Federal required Barr to “certify” to the ‘384 patent. Circuit held that the district court had not Barr filed a “Paragraph IV” certification, con- abused its discretion in refusing to dismiss the tending that its ANDA did not infringe the suit without prejudice. With respect to Barr’s ‘384 patent. Under the Hatch-Waxman Act, alleged violation of the statutory notice the filing of a Paragraph IV certification requirement, the Federal Circuit agreed that required Barr to provide 3M with notice of its 3M’s claim of Barr’s violation was not insub- noninfringement certification, including a stantial, but held that 3M was impermissibly detailed statement of the factual and legal attempting to assert a private right of action basis of Barr’s opinion that the ‘384 patent under the FFDCA. According to the Federal was not infringed. Although Barr had provid- Circuit, the FFDCA proscribes all private rights ed notice of its Paragraph IV filing, 3M con- of action for alleged failures to comply with tended that Barr refused to provide the the FFDCA, and, thus, the district court could required detailed statement supporting its not decide the issue of Barr’s compliance with noninfringement opinion. Accordingly, 3M the statutory notice requirement. filed suit. In a concurring opinion, Judge Gajarsa After 3M filed suit, Barr disclosed the emphasized what he perceived as the Court’s detailed basis of its opinion that it did not inconsistency in holding that the district court infringe 3M’s patent and immediately moved had not abused its discretion in finding Barr’s for SJ of noninfringement. 3M sought to dis- notice adequate and also that the sufficiency miss the suit without prejudice, arguing that of the notice could not be considered under L L P . F I N N E G A N H E N D E R S O N F A R A B O W G A R R E T T D U N N E R
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