It wasn’t frontpage news when the U.S. Supreme Court handed down its decision on Merck KGaA v. Integra Lifesciences earlier this summer. But among Indiana’s burgeoning life sciences sector, it should have been-n – largely because of the doors it opens (or appears to) for
On June 13, the country’s highest court ruled that a “safe harbor” provision in U.S. law gives life sciences companies more freedom to use patented compounds in pre-clinical research, as long as the companies reasonably believe the research will be relevant to applications to receive Food and Drug Administration (FDAn) approval for a new or improved drug. For discovery-driven companies, both large and small, this means less risk of being successfully sued for patent infringement.
On the other hand, patent-holders everywhere-including those in the industry-may now be thinking twice about how and whether to enforce their intellectual-property rights. While the law’s scope may encourage the creation and expansion of the life sciences indus
try in Indiana, many businesses may find themselves on alternating sides of the safe- harbor provision as both patentholders and researchers using patented compounds.
In Merck v. Integra, the Supreme Court said the statutory safe harbor provision in 35 U.S.C. 271(e)(1) “provides a wide berth for the use of patented drugs in activities related to the federal regulatory process.” This includes preclinical studies relating to drug safety, drug effectiveness, mechanism of action, pharmacokinetics and pharmacology-even if the study results ultimately aren’t the focus of or a part of an FDA submission. The true test for applicability of the safe harbor is whether there is a reasonable basis to believe the research will produce the types of information relevant to FDA submissions.
What, then, is considered a “reasonable basis” for this belief? No one knows for sure. The life sciences industry (and its lawyers) may get some guidance from future court decisions, but for now, the requirements are unclear. The court’s opinion unquestionably re-emphasized the broad boundaries of the law’s safeharbor provision, but many of the practical effects of this decision have yet to unfold.
The newly articulated breadth of the law’s safe harbor will have greater ramifications for certain life-sciences-related
businesses than for others. Companies that spend a vast amount of resources on pharmaceutical development will reap many of the benefits of the decision, because they frequently use patented compounds in FDA-related drug development.
But, moving forward, it is important to understand that Merck v. Integra does not support an automatic “exemption” for every use of patented compounds in research. Furthermore, this case did not decide the extent of a researcher’s ability to use patented compounds as research tools-tools that are necessary to conduct research but are not the focus of that research. That issue affects more technology companies than the safe- harbor provision does. For the answer to that question, however, technology companies will have to wait until the right case comes along.
In the meantime, it appears Indiana’s research-driven life sciences companies have a victory on their hands. With any luck, the Supreme Court’s decision not only will enable Indiana researchers to develop their businesses, but also will allow those scientists to continue finding new treatments that improve the lives of those in Indiana and around the globe.