The Hatch-Waxman safe harbor provision permits some otherwise-infringing uses of patented inventions in activities related to the development and submission of information under federal laws that regulate drugs. The exact scope of what is permitted has been the subject of controversy and litigation. In 2005 the United States Supreme Court addressed this issue in the case of Merck KGaA v. Integra Lifesciences I, Ltd. Focusing on the broad language of the safe harbor provision and the realities of drug development and the FDA approval process, the Court settled upon a broad interpretation of the safe harbor that includes new drug development activities, among other things. The Court held that the safe harbor provides a wide berth for the use of patented drugs and potential drugs in research that would be appropriate to submit to the FDA to seek product approval. But while the safe harbor post-Integra is broad, the decision is consistent with limits on both the types of activities permitted and the types of patented inventions that may be used within the safe harbor. These limits remain somewhat vague after the decision and will have to be delineated by future courts.