While Congress may consider legislation to amend the U.S. patent system to address perceived deficiencies, the U.S. Supreme Court also plays a significant role in clarifying vague or ambiguous language in the Patent Act that is often at the heart of disputes between parties involved in patent infringement suits. In the latter half of this decade, the Supreme Court has granted certiorari in nine patent cases, perhaps in recognition of the increasing importance of intellectual property to technological innovation, as well as in order to correct errors in lower courts' interpretation and application of patent law. What follows is a general overview of the facts and outcomes of these recent cases, presented in chronological order starting from the October Term 2004. It is normally an infringement of a patent holder's rights for anyone, without prior authorization, to use, make, offer to sell, or sell any patented invention within the United States. However, there are exceptions to this general rule; for example, a statutory exception codified at 35 U.S.C. § 271(e)(1) provides: "It shall not be an act of [patent] infringement to ... use ... or import into the United States a patented invention ... solely for uses reasonably related to the development and submission of information" under the Federal Food, Drug, and Cosmetic Act. This is a "safe harbor" provision that immunizes parties from liability for their otherwise infringing acts. The factual history of Merck KGaA v. Integra Lifesciences I is as follows. Integra Lifesciences I, Ltd. ("Integra") is an American pharmaceutical company that owns patents related to compounds known as RGD peptides. Merck KGaA ("Merck") is a German pharmaceutical corporation that was interested in developing a drug to control angiogenesis, a process that plays a critical role in the spread of many diseases, including cancerous tumor growth, diabetic retinopathy, and rheumatoid arthritis. Merck conducted experiments using the RGD peptides to determine their efficacy in inhibiting angiogenesis. Integra sued Merck, seeking monetary damages for Merck's alleged infringement of its patented compounds. In defense, Merck asserted, in part, that its actions involving the RGD peptides came within the statutory safe harbor discussed above. At trial, the U.S. District Court for the Southern District of California instructed the jury that, for Merck to prevail on the "safe harbor" defense, it must prove by a preponderance of the evidence that it was objectively reasonable for the company to believe that "there was a decent prospect" that the experiments "would contribute, relatively directly," to the generation of information likely to be relevant to the drug approval regulatory process. The jury found Merck liable for infringing Integra's patents because Merck had failed to show that § 271(e)(1) protected its research activities. In June 2003, a divided panel of the U.S. Court of Appeals for the Federal Circuit ("Federal Circuit") affirmed the district court's determination as to Merck's liability. The panel majority narrowly construed the safe harbor provision as exempting from infringement liability only clinical research activities that contribute "relatively directly" to information submitted to the Food and Drug Administration (FDA) for consideration in the drug approval process. Merck appealed the Federal Circuit's decision to the U.S. Supreme Court. The question presented to the Supreme Court was "whether uses of patented inventions in preclinical research, the results of which are not ultimately included in a submission to the Food and Drug Administration (FDA), are exempted from infringement by 35 U.S.C. § 271(e)(1)." In vacating the Federal Circuit's interpretation of the safe harbor provision, the Supreme Court unanimously ruled that the exemption applies to all uses of patented inventions that are "reasonably related" to the process of developing any information for FDA submission, including preclinical use of patented inventions in the drug research and development process. The Court explained that, under certain conditions, the safe harbor provision is even "sufficiently broad" to protect the use of patented compounds in experiments that are not ultimately submitted to the FDA or drug experiments that are not ultimately the subject of an FDA submission. One of the statutory bars to patentability of an invention is "novelty." For an invention to be considered "novel," it must not be wholly "anticipated" by the so-called "prior art," or public domain materials such as publications and other patents. In early 2000, the food company ConAgra informed companies that sold equipment and/or processes for browning precooked meats that such browning processes may infringe its patent on "A Method for Browning Precooked Whole Muscle Meat Products," and offered those companies the opportunity to license its patent. A competitor, Unitherm, sued ConAgra for a declaratory judgment that the patent was invalid and unenforceable, and that ConAgra had violated federal antitrust laws by attempting to enforce a patent that was obtained by committing fraud on the U.S. Patent and Trademark Office. The U.S. District Court for the Western District of Oklahoma ruled that ConAgra's patent was invalid because of evidence that Unitherm's president had invented the process described in that patent six years before ConAgra had filed its patent application. The court then allowed the antitrust claim to proceed to trial. Before the case was submitted to the jury, ConAgra filed a motion with the court for a judgment as a matter of law, on the grounds that no reasonable jury would have a legally sufficient evidentiary basis to support a verdict in favor of Unitherm on the antitrust issue. The District Court denied the motion, and the jury returned a verdict for Unitherm. ConAgra, however, failed to renew its request for judgment as a matter of law by filing another motion after the verdict, a procedural requirement under Federal Rules of Procedure 50(b), nor did it request a new trial under Federal Rules of Procedure 59. ConAgra appealed to the Federal Circuit, asserting that there was insufficient evidence to sustain the jury's verdict. The Federal Circuit determined that ConAgra's failure to file a postverdict motion did not preclude the company on appeal from raising the challenge to the sufficiency of the evidence on the antitrust claim. The appellate court then proceeded to review the evidence and after concluding it was insufficient, vacated the jury's judgment in favor of Unitherm and remanded the case for a new trial. In a 7-2 decision, the U.S. Supreme Court held that the Federal Circuit was precluded from reviewing the case, and reversed its judgment. The Court explained that a party's failure to file a postverdict motion challenging the sufficiency of the evidence under Rule 50(b) renders an "appellate court without power to direct the District Court to enter judgment contrary to the one it had permitted to stand." Strict compliance with this postverdict motion rule is necessary, according to the Court, because "[d]etermination of whether a new trial should be granted or a judgment entered under Rule 50(b) calls for the judgment in the first instance of the judge who saw and heard the witnesses and has the feel of the case which no appellate printed transcript can impart." Because ConAgra did not file such a motion in the district court, it is not entitled to pursue a new trial on appeal, the Court ruled. This case involved the practice of Trident (a subsidiary of Illinois Tool Works) of selling its patented printing systems (consisting of patented ink jet printheads and patented ink containers) to manufacturers of printers only on the condition that those manufacturers (and their customers) agree to purchase their ink exclusively from Trident, although such ink itself is unpatented. Independent Ink, a competitor manufacturer of ink that could be used in those printheads, sued Trident, alleging that Trident's practice was an illegal tying arrangement and monopolization in violation of federal antitrust laws. Traditionally, for tying to constitute an antitrust violation, the plaintiff must affirmatively establish that the defendant has market power (i.e., control over the market in which his product competes). Independent Ink asserted that Trident "necessarily ha[d] market power in the market for the tying product [printheads] as a matter of law" solely by virtue of its patent on the printhead system. The U.S. District Court for the Central District of California rejected that claim and found that there had been no affirmative evidence of the relevant market nor of Trident's position in it. Thus, the court granted summary judgment in favor of Trident. In January 2005, the Federal Circuit reversed the district court's decision, holding that "a rebuttable presumption of market power arises from the possession of a patent over a tying product." In so ruling, the appellate court emphasized that it had a "duty ... to follow the precedents of the Supreme Court until the Court itself chooses to expressly overrule them." The Supreme Court has held for more than 60 years that where a patented product was the "tying" product, there was a presumption that the existence of a patent monopoly creates sufficient market power to support an antitrust violation. Congress, however, rejected this presumption for purposes of establishing the patent misuse defense when it amended the Patent Act in 1988. Yet neither Congress nor the Supreme Court had decided whether the presumption remained in antitrust jurisprudence when the tying product is patented. In March 2006, the Supreme Court vacated the Federal Circuit's judgment without dissent, holding that "the mere fact that a tying product is patented does not support such a presumption." The Court explained that its reevaluation of its precedents establishing the per se rule was prudent in light of Congress's narrowing of the patent misuse defense, as well as the "vast majority of academic literature" that had extensively criticized the "patent equals market power" presumption.