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An applicant for an Abbreviated New Drug Application cannot be held liable for acts of patent infringement that may arise in preparing the ANDA, the U.S. Court of Appeals for the Federal Circuit held May 12 ( Bayer AG v. Elan Pharmaceutical Research Corp., Fed. Cir., No. 99-1365, 5/12/00). Under the Hatch-Waxman Act, a drug maker can seek expedited approval of a generic version of a drug previously approved by the Food and Drug Administration, as long as the generic version is the “bioequivalent” of the approved or “listed” drug. The applicant pursues the approval by submitting an ANDA and by certifying either: (I) that the listed drug is not patented; (II) that the patent for the listed drug expired; (III) the patent’s expiration date; or (IV) that the patent “is invalid or . . . it will not be infringed by the manufacture, use, or sale of the new drug.” If the applicant certifies the ANDA under Paragraph IV, it must notify the patentee of the certification. If the patentee does not then file suit within 45 days, the FDA can approve the ANDA. If the patentee files suit, the FDA must suspend approval. SPECIFIC SURFACE AREA Bayer AG and Bayer Corp. (collectively “Bayer”) own U.S. Patent No. 5,264,446, which claims a composition and the use of nifedipine crystals of a specific surface area (“SSA”). Nifedipine is a coronary vasodilator that is used to treat conditions such as high blood pressure. The ’446 patent addresses the problem of maintaining both good solubility — absorption of nifedipine into the blood — and high bioavailability — a sustained presence of nifedipine in the blood. Each claim specifies a SSA range for nifedipine. Claim 1 recites the broadest range of 1.0 to 4 m2/g. Elan Pharmaceutical Research Corp. filed an ANDA seeking approval of the generic bioequivalent of Bayer’s “ADALAT CC,” the commercial embodiment of the ’446 patent. Elan certified the ANDA under paragraph IV, stating that the composition would not infringe the ’446 patent because it would only contain nifedipine crystals with a specific surface area of 5 m2/g or greater. Elan also submitted the results of experiments with the precursor to its composition. The precursor batch was referred to as the “biobatch.” DISTRICT COURT DECISION Within 45 days, Bayer filed suit against Elan in the U.S. District Court for the Northern District of Georgia. The court focused on whether Elan’s drug, when placed on the market, would infringe the ’446 patent. Noting that the ANDA specifies that the drug’s SSA will match or exceed 5 m2/g and that Elan’s nifedipine supplier does not sell nifedipine with an SSA below 4.7m2/g, the court held that Bayer had not satisfied its burden to show literal infringement. The district court further held that infringement under the doctrine of equivalents was estopped by the prosecution history, namely, Bayer’s arguments to overcome an obviousness rejection, its claim amendments that changed the range from 1.0 to 6 m2/g to 1.0 to 4 m2/g, and other statements evidencing a clear and unmistakable surrender of subject matter outside the claimed range. The district court granted Elan’s motion for summary judgment of noninfringement and Bayer appealed. LITERAL INFRINGEMENT On appeal, Bayer argued that a genuine issue of material fact existed as to whether Elan’s biobatch had a SSA in the claimed range. Elan, in turn, denied that the biobatch’s SSA fell within the claimed range and also argued that the focus of the infringement inquiry should be on the product that will actually be sold, not on the biobatch. Judge Alvin A. Schall, writing for the Federal Circuit, agreed that the focus should be on the product that will actually be sold. 35 U.S.C. �271(e)(2)(A) of the Hatch-Waxman Act provides that it shall be an act of infringement to submit an ANDA “if the purpose of such a submission is to obtain approval . . . to engage in the commercial manufacture, use, or sale of a drug . . . claimed in a patent.” However, the court said, 35 U.S.C. �271(e)(1) specifically renders an ANDA applicant immune from allegations of infringement for acts necessary in preparing the ANDA. Thus, even if the biobatch fell within the claimed range, that would not be infringement. The relevant inquiry is into the purpose of the ANDA and that inquiry is properly grounded in the ANDA application itself, the court said. The ANDA clearly states that only nifedipine with an SSA exceeding 5 m2/g will be used and that nifedipine “not meeting this specification will not be used for manufacture.” “In short, the only drug Elan can produce upon approval of the ANDA at issue is a drug that does not literally infringe the ’446 patent.” Furthermore, the court added, if any of the statements in Elan’s ANDA are false or if Elan introduced the drug into interstate commerce without complying with the approval requirements, it could be subject to civil and criminal penalties, an injunction, seizure, and debarment from pursuing future ANDAs. The court affirmed the district court’s grant of summary judgment of no literal infringement. �REASONABLE COMPETITOR’ Bayer also challenged the district court’s finding that the prosecution history estopped a finding of infringement under the doctrine of equivalents. Specifically, it contended that the district court erred in failing to address a factual question–who the “reasonable competitor” was and what it would conclude from reviewing the ’446 patent’s prosecution history. Bayer pointed to an uncontroverted declaration by a patent law expert, Professor Karl F. Jorda, that a reasonable competitor would have no basis to conclude that Bayer surrendered a SSA range of 4.0 to 6 m2/g. Whether subject matter was surrendered, the court said, is a matter of law. “One of the public policy principles underlying the doctrine [of prosecution history estoppel] is that �other players in the marketplace are entitled to rely on the record made in the Patent Office in determining the meaning and scope of the patent.’” Like claim scope, prosecution history estoppel is a legal issue, the court held. Thus, testimony as to what a reasonable competitor would conclude cannot bar summary judgment. “Such testimony is only a tool, which the judge can use at his or her discretion, to aid in the legal determination of prosecution history estoppel.” UNMISTAKABLE SURRENDER Bayer also argued that its claim amendments were made in response to the examiner’s rejection under 35 U.S.C. �112(1), not for reasons related to patentability. The court was unmoved. “We need not resolve the question of why Bayer amended its claims and whether its reasons related to patentability because it is clear that, regardless of why it amended its claims, when it did so it unmistakably surrendered coverage to SSAs above 4 m2/g.” In other words, the court said, whether or not they were made to secure allowance of a claim, unmistakable assertions may preclude protection under the doctrine of equivalents. In this case, Bayer made a number of statements and submitted multiple declarations that spoke of the superiority and unexpected results of the narrower 1.0 to 4 m2/g range. The court affirmed the district court’s grant of summary judgment of no infringement under the doctrine of equivalents.

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