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Rule 11 of the Federal Rules of Civil Procedure requires that a plaintiff, before filing a complaint, make “an inquiry reasonable under the circumstances” to ensure that “the allegations and other factual contentions have evidentiary support.” Fed. R. Civ. P. 11(b)(3). A plaintiff’s failure to conduct an appropriate pre-filing inquiry in compliance with this rule can result in the court’s imposition of Rule 11 sanctions. How this rule should be applied in process-patent suits in which a confidential accused process is not accessible to the plaintiff/ patentee prior to commencing suit has caused some confusion. Several cases in the U.S. Court of Appeals for the Federal Circuit recently have addressed the issue. These cases involve patents on confidential processes by which pharmaceutical products are manufactured. Unlike infringement of a patent claiming the chemical composition of a pharmaceutical product, which can be determined by testing samples of the suspected products to determine their chemical compositions, infringement of a process patent, or “synthetic pathway,” is often difficult, if not impossible, to determine by reverse engineering methods. Although traces of various intermediate chemicals in the final products may give clues as to the procedures that were employed in their manufacture, if the final products are so pure that no traces of the intermediate chemicals, or markers, can be detected, the final products of different synthetic pathways may be indistinguishable from one another. When this is the case, a prefiling determination of infringement depends on the suspected infringer’s voluntary disclosure of the confidential process. CAMBRIDGE One of the first cases to examine the Rule 11 prefiling inquiry requirement in this context was Cambridge Products Ltd. v. Penn Nutrients Inc.,962 F.2d 1048 (Fed. Cir. 1992). In that case, plaintiff Cambridge, the owner of the process patent for a methylrosaniline chloride-based mold inhibitor, was unable to determine whether a chemical product of Penn, one of its competitors, infringed its patent. After attempting to reverse-engineer the product, Cambridge determined that the product could have been produced by the patented method. However, the results of the testing were inconclusive as to whether the drug was actually manufactured by the patented process. At that point, to take advantage of the discovery process to determine whether infringement occurred, Cambridge brought suit against the suspected infringer. Discovery allowed Cambridge access to the synthetic pathway used by Penn. After examining the pathway, Cambridge moved for voluntary dismissal of the action within two weeks of the trial date. The defendant Penn responded with a motion for attorney fees under 35 U.S.C. � 285 and Rule 11, claiming that Cambridge failed to conduct a reasonable inquiry into the possible infringement before filing its complaint. Penn argued that Cambridge’s attorney, in signing the complaint, answers to interrogatories and plaintiff’s substantive response to Penn’s motion for attorney fees, could not reasonably have believed Cambridge’s infringement allegations to be true at the time they were submitted. Although Cambridge performed an independent chemical analysis of its allegedly infringing product, Penn based this allegation, in the Federal Circuit’s words, on the fact that Cambridge “did not make any attempt to determine the method by which the 6BA liquid was made before the complaint was filed and that a simple phone call to Penn would have revealed that the method was not the same.” Cambridge, 962 F.2d at 1050. Despite this argument, the Federal Circuit upheld the district court’s denial of attorney fees, holding that Cambridge’s chemical analysis constituted a reasonable prefiling inquiry and that acquiring any further information would have required the aid of discovery. Thus, it was not necessary for Cambridge to attempt to acquire the evidence directly from Penn. ROHM AND HAAS The Federal Circuit again examined the applicability of Rule 11 sanctions in the context of a process-patent infringement suit in Rohm and Haas Co. v. Brotech Corp., 127 F.3d 1089 (Fed. Cir. 1997 ). Rohm and Haasinvolved two patents issued to plaintiff R&H in 1983 for both the product of macroreticular copolymer beads and the process for manufacturing them. The process was complex, involving various intermediate steps in the production of the resulting beads. R&H asserted that part of defendant Brotech’s process infringed several claims in R&H’s patents. Unlike Cambridge, this case went to trial. The district court determined that Brotech did not infringe R&H’s patents. Similar to the defendant in Cambridge, defendant Brotech moved for attorney fees, claiming that R&H had made a baseless charge of infringement and then withdrew the charge shortly before trial. On appeal, the Federal Circuit affirmed the district court’s denial of sanctions, holding that the trial court properly denied Brotech’s request for sanctions based on the trial court’s ruling that R&H’s initial claim of infringement was not unreasonable in light of the available information at the time of filing and the trial court’s finding that R&H had responded to Brotech’s discovery requests in a timely and complete manner. Rohm and Haas, 127 F.3d at 1093. HOFFMANN-LA ROCHE One of the most recent cases to address the application of Rule 11 to process-patent infringement suits is Hoffmann-La Roche Inc. v. Invamed Inc., 213 F.3d 1359 (Fed. Cir. 2000). Plaintiff Syntex manufactures the drug ticlopidine hydrochloride, which it sold under the TICLID brand. Co-plaintiff Roche was the exclusive distributor of the TICLID brand. Defendant Torpharm Inc., a manufacturer of generic drugs, filed an Abbreviated New Drug Application under 21 U.S.C. � 355(j) (� 505(j) of the Federal Food, Drug, and Cosmetic Act) with the Food and Drug Administration to produce the ticlopidine hydrochloride drug. The case involved several patents owned by Syntex and directed to claiming a process for the manufacture of ticlopidine hydrochloride. Although Syntex’s “Orange Book” patent corresponding to the approved TICLID product had expired, the process patents asserted by Roche/Syntex in the amended complaint had not yet expired. Roche/Syntex, believing that Torpharm’s production of the drug infringed these process patents, attempted to determine the exact synthetic pathway used by Torpharm. Roche/Syntex’s efforts included the chemical testing of a sample of the drug obtained directly from Torpharm, as well as a request to Torpharm for its synthetic pathway, which Roche offered could be produced under a confidentiality agreement. The chemical testing was inconclusive as to the process employed by Torpharm, and the request for the pathway was denied. Seeing no other means of obtaining the information, Roche/Syntex then filed suit against Torpharm and moved for expedited discovery to determine the synthetic pathway Torpharm used. Pursuant to an agreement between the parties, Torpharm ultimately disclosed the synthetic pathway, which revealed that the process employed by Torpharm did not infringe Syntex’s patents. Roche/ Syntex voluntarily dismissed their infringement suit. After Roche/ Syntex dismissed their case, Torpharm made a motion for sanctions and attorney fees, arguing, inter alia, that Roche/Syntex had failed to conduct a reasonable pre-filing inquiry in accordance with Rule 11. The Federal Circuit noted that Roche/Syntex had engaged in every prefiling effort available to obtain the synthetic pathway used by Torpharm. It rejected Torpharm’s assertion that Roche/Syntex either should have set out facts showing infringement or not filed at all. Finding that Roche/Syntex had taken all reasonable measures to obtain the pathway prior to filing, the Federal Circuit affirmed the district court’s denial of Torpharm’s motion for sanctions and attorney fees. The Federal Circuit held that “if Torpharm initially had told them, under a confidentiality agreement, the process used to manufacture the drug — as it subsequently did — it could have avoided this litigation and the expenses incurred in defending it.” Hoffmann-La Roche, 213 F.3d at 1363. It seems from these three cases that, to avoid Rule 11 sanctions, the prefiling inquiries of plaintiffs in process-patent infringement suits need not be conclusive. What characteristics of such plaintiffs’ prefiling inquiries are required to avoid Rule 11 sanctions is less clear. In Cambridge, the plaintiff avoided sanctions without even attempting to obtain the necessary evidence directly from the accused infringer. After noting that Cambridge found the chemical composition to be consistent with the patented process, the Federal Circuit absolved Cambridge of any further responsibility: “Without the aid of discovery, any further information was not practicably obtainable. Thus, Cambridge met the Rule 11 standard for filing and maintaining its case.” Cambridge, 962 F.2d at 1050. In Hoffmann-La Roche, the Federal Circuit used the fact that Roche/Syntex’s inquiry was more extensive than Cambridge’s inquiry — which the same court had held to be reasonable — to conclude that Roche/Syntex’s inquiry was reasonable. Although the court mentioned Roche/Syntex’s attempt to obtain the necessary evidence directly from the accused infringer, whether this was a determining factor in the court’s denial of attorney fees is unclear. This ruling does not seem to impose any duty on plaintiffs to request evidence directly from potential defendants. However, it does indicate that doing so makes the Federal Circuit’s denial of Rule 11 sanctions more likely. Tony V. Pezzano is a partner in the New York-based law firm of Morgan & Finnegan, LLP. Kristopher M. Dawes assisted in the preparation of this article.

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