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UPDATE Merck V INTELLECTUAL PROPERTY A PUBLICATION OF THE INTELLECTUAL PROPERTY GROUP OF DORSEY & WHITNEY LLP UPDATE Merck v. Integra: Safe Harbor in Uncharted Waters? On June 13, 2005, the Supreme processes that the same surface Merck infringed Integra’s patents and Court of the United States decided receptor controls is the blood vessel that § 271(e)(1) did not exempt Merck Merck KGaA (“Merck”) v. Integra growth. In theory, blocking such a from infringing the RGD peptide Lifesciences I, Ltd. (“Integra”), 545 U.S. receptor could halt tumor growth by patents. Merck appealed to the United ___ (2005). The central issue in the depriving the tumor of the blood supply States Court of Appeals for the Federal case concerned the safe harbor needed to grow. The Scripps researcher Circuit asserting, among other things, provision in 35 U.S.C. § 271(e)(1). This found that some RGD peptides could be error in the District Court’s interpretation section creates a “safe harbor” that used to effectively block the cell receptor. of § 271(e)(1). allows the generic companies to Therefore, these peptides were In 2003, the Federal Circuit concurred conduct research on patented drugs in potentially valuable for the inhibition of with the District Court’s interpretation advance of patent expiration so long as solid tumor growth, with potential and affirmed the § 271(e)(1) aspect of the experiments are “reasonably related” applications to cancer and many other the decision. The Federal Circuit held to securing regulatory approval. Without diseases. that the express objective of § 271(e)(1), a patent holder would get a Recognizing the importance of § 271(e)(1) is to facilitate the entry of de facto patent term extension because Scripps’ discovery, Merck entered into safe and effective generic drugs into the generic companies could not start an agreement with Scripps to identify the market immediately upon patent the testing required for the FDA possible drug candidates. The expiration. The Federal Circuit’s position approval until the patent expired, thus agreement set forth a 3-year timetable was that it is not in the interest of FDA giving the patent holder an extension of in which in vivo and in vitro testing of to hunt for drugs that may or may not the patent monopoly. RGD peptides would occur in year one, undergo clinical testing for regulatory Section 271(e)(1) provides, in culminating with the submission of an approval. The Federal Circuit viewed pertinent part, that “it shall not be an act investigational new drug (“IND”) Merck’s early work as “only general of infringement to make, use, or sell a application to FDA in year three. biomedical research,” particularly the patented invention...solely for uses Several RGD peptides were identified development of a number of lead reasonably related to the development as potential candidates. In vivo and in candidates simultaneously, only one of and submission of information under a vitro experiments were performed to which was ultimately selected. Thus, it Federal law which regulates the assess their specificity, efficacy, and stated that Merck’s activities were not manufacture, use, or sale of drugs.” The toxicity. Eventually, this research led to “reasonably related” to generating data crux of the Merck case involved the the discovery of a promising cancer for regulatory approval, and were not term “reasonably related.” Specifically, drug, RGD Peptide 121974. exempt from infringement liability. the issue was how far back in the drug Integra offered Merck a license to the The Federal Circuit did not provide development process the competitor RGD peptide patents. After a lengthy any bright-line rule as to when exactly can perform otherwise-infringing negotiation, Merck declined. the safe harbor provision applies. It experiments without incurring liability for Subsequently, Integra sued Merck and noted that the provision does not cover patent infringement.1 Scripps for patent infringement. Among all stages of the drug development Integra owns a series of patents other defenses, Merck contended that simply because some of the drugs will related to particular peptides (“RGD the experiments in question were need regulatory approval some day. The peptides”), which bind certain cell surface protected under the safe harbor best guidance provided by the Federal receptors with high affinity. Working provision in § 271(e)(1). Circuit is that the provision does not independently of Integra, a scientist at cover exploratory research that may Following a jury trial in 1999, the the Scripps Research Institute (“Scripps”) rationally form only a predicate for United States District Court for the discovered that one of the cellular future clinical testing, which seems to Southern District of California held that INTELLECTUAL PROPERTY UPDATE | Volume 5, Number 2 1 WWW.DORSEY.COM suggest at a minimum drawing a line at be relevant to an IND or NDA. ‘reasonably related’ to the process of the commencement of clinical trials. Specifically, it contended that such developing information for submission Thus, many commentators view the exemption is not limited to clinical of any federal law regulating the Federal Circuit’s position as excluding research, and that the exemption applies manufacture, use, or distribution of work done for preclinical trials. when a researcher progresses beyond drugs.” (emphasis in original). basic research and begins efforts to Merck subsequently petitioned the The Court pointed out two particular develop a particular drug. Supreme Court for certiorari. Merck situations where the exemption may be argued that the safe harbor provision in In its unanimous decision, the Court broad enough to protect the use of § 271(e)(1) covers preclinical in vivo sided with Merck, setting aside the patented compounds. First, and in vitro studies, which encompass a Federal Circuit’s holding and recognizing that scientific testing is a wide range of animal and test-tube remanding the case for further process of trial and error even at the research that is submitted to FDA in proceedings. Citing its previous late stages of drug development, the connection with both an IND filing and decision in Eli Lilly, the Court made it Court held that § 271(e)(1) covers the the ultimate new drug application clear from the outset that based on the experimentation on drugs that (“NDA”) filing. It also contended that statutory text, “§ 271(e)(1)’s ultimately are not the subject of an the Federal Circuit erred in narrowly exemption from infringement extends FDA submission. Section 271(e)(1) interpreting the provision, and stated to all uses of patented inventions that should be properly construed to allow that the undisputed evidence confirmed are reasonably related to the room for experimentation and failure that the accused experiments were development and submission of any en route to regulatory approval. As directed at producing data “reasonably information under the FDCA,” (emphasis long as the drug company has a related” to an IND application. in original) and that “[t]his necessarily reasonable belief that the patented includes preclinical studies of patented compound may work, its use is Integra’s brief addressed only compounds that are appropriate for protected under the safe harbor procedural matters, and was virtually submission to the FDA in the regulatory provision. Second, noting the silent with respect to the interpretation of process.” It rejected the suggestion uncertainties associated with the and protection under § 271(e)(1). from the Federal Circuit’s opinion that decision as to what research to include Integra argued that the District Court’s § 271(e)(1) is “limited to research in an IND or NDA, the Court ruled that jury instruction applied the correct legal conducted in clinical trials.” (emphasis the use of patented compounds in standard, and that legally sufficient in original). The Court held that experiments not ultimately submitted to evidence supported the verdict that § 271(e)(1) applies to preclinical in vitro FDA does not, standing alone, Merck failed to carry its burden of proof and in vivo studies intended to obtain constitute infringement. Citing the under the FDA exemption. information on the pharmacological, amicus brief for the United States, the Close to twenty amicus briefs were toxicological, pharmacokinetic, and Court concurred with the government filed in connection with the Merck case. biological qualities of the drug in that such use is protected under Merck’s position was supported by the animals. Citing the amicus brief for the § 271(e)(1) so long as the drugmaker United States Government (the Attorney United States, the Court ruled that reasonably believes that the General’s and Solicitor General’s offices), § 271(e)(1) also applies to preclinical experiments will produce information the AARP, several pharmaceutical efficacy studies as part of the risk- relevant to an IND or NDA submission. companies such as Eli Lilly, Wyeth, and benefit assessment of the proposed What does this holding mean? In its Pfizer, and several biologics companies clinical trial. Countering the argument discussion, the Court broadly interpreted such as Genentech and Biogen. Integra’s presented by Integra, the Court the § 271(e)(1) safe harbor provision case was supported by Applera, Isis, suggested that safety-related with a narrow focus on the use of Invitrogen, Vaccinex, and WARF, all of experiments, even if conducted not in “patented compounds.” Is a “patented which were concerned with the effect of compliance with FDA regulations, are compound” one that could be the the holding on “research tool” patents. protected under § 271(e)(1) as well. subject of an FDA application, or is it Of particular interest is the amicus The Court proceeded to reject the broader than that? The only brief for the United States.2 The United Federal Circuit’s narrow construction of conceivable scenario suggested by the States government argued that the FDA § 271(e)(1) as applicable only to the Court where § 271(e)(1) does not apply exemption protects all activities that are activities necessary to seek approval of is where the basic research is being undertaken in the course of attempting a generic drug.
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