It was like the shot heard 'round the world. No, not the Michael Jackson verdict. The news that the Supereme Court had issued its opinion in the matter of Merck Pharmaceuticals v. Integra LifeSciences whipped through the bio world like wildfire. The unanimous decision, written by Justice Scalia, is already being hailed as major support for clinical research that could usher in faster development times for the pharmaceutical companies.
The Court held that:
The use of patented compounds in preclinical studies is protected under Sec. 271(e)(1) at least as long as there is a reasonable basis to believe that the compound tested could be the subject of an FDA submission and the experiments will produce the types of information relevant to an IND or NDA. The statutory text makes clear that Sec. 271(e)(1) provides a wide berth for the use of patented drugs in activities related to the regulatory process ... .
The Court was looking at what line could be drawn, if any, for when research would be considered experimentation that could go toward an FDA submission, and it surprised some by casting a fairly wide sweep. The Court of Appeals below had rested its opinion on the finding that the Merck experiments were not explicitly designed for submission to the FDA, but to find the best drug candidate to test further. The Supreme Court acknowledged that basic research on a compound is not "reasonably related to the development and submission of information to the FDA." However, the exemption in 271(e)(1) for patent infringement does cover, the Court held, experimentation even if the drug does not become part of an FDA submission and use in experiments whose results are not submitted to the FDA. Doing so would confound the purpose of experimentation.
The Court agreed with Merck's attorneys that a bright line could not be drawn at a clinical phase or type of research. Also, the Court took the government's amicus brief into serious consideration and noted that having all possible experiment results was what the FDA most wanted so it could evaluate the particular drug. Thus, there was no real limit on what could eventually be a part of an FDA submission.
The court did not opine as to how the patent infringement exemption affects "research tools,' as Integra did not argue that the compounds at hand were research tools and that the exemption might impinge upon them. That argument is left to another day and another lawsuit.