By Brandon Owen
In the Drug Price Competition and Patent Term Restoration Act of 1984, Congress provided an exception to the general rule that it is generally considered patent infringement to make, use, offer to sell or sell any patented invention. This exception included actions that were “reasonably related” to the development and submission of information under a Federal law which regulated the manufacture, use or sale of drugs.
The definition of what can be “reasonably related” was further clarified by the Supreme Court in Merck v. Integra, 545 U.S. (2005). In this decision, the Supreme Court considered the Federal Food, Drug and Cosmetic Act (FDCA), a Federal law that regulates the manufacture, use or sale of drugs. The FDCA requires a pharmaceutical manufacturer to submit research data to the FDA at two stages of drug development. First, before conducting human clinical trials, the manufacturer must submit an investigational new drug application (IND). The IND must describe preclinical tests (including tests on animals) of the drug adequate to justify the human clinical tests. Second, before marketing a new drug, a manufacturer must submit a new drug application (NDA), containing full reports of investigations which have been made to show whether or not the drug is safe for use and whether the drug is effective in use. The NDA must include all clinical studies, as well as preclinical studies, related to a drug’s efficacy, toxicity, and pharmacological properties.
The Supreme Court determined that using patented inventions in preclinical testing is exempted from infringement, even if the results are not ultimately included in a submission to the FDA (i.e., in an IND or NDA). The Supreme Court explained that the exemption from infringement extends to all uses of patented inventions that are reasonably related to the development and submission of “any information” under the FDCA. The Supreme Court noted that scientific testing is a process of “trial and error” and that the statute “provides a wide berth for use of patented drugs in activities related to the federal regulatory process.”
For further information contact Brandon Owen at bowen@kmclaw.com.