IP: Navigating the divide

A closer look at drugs, medical devices, research & patent litigation

Academic and noncommercial basic research has always been an engine for innovation, particularly in the areas of medicine and drugs. The extent to which patents may touch noncommercial research is critically important, whether to spur innovation by offering a reward, or to limit the use of patented technology for basic research under the threat of infringement suits. At the same time, distinctions between noncommercial basic research and commercial development are not so clear. Perhaps surprisingly, applied commercial drug and medical device research has more protection from patent infringement litigation than noncommercial research does. The U.S. Supreme Court is set to touch on the question of the patentability of research-based advancements with its upcoming review of the Myriad decision. For now, patent owners and researchers should look to previous lower court decision and emerging technology transfer best practices for guidance.

What’s protected: different research, different standards

Where to go from here

Until now, the combination of the statutory safe harbor for drug development with popular sentiment in favor of basic, noncommercial research has provided some protection to basic researchers from charges of patent infringement. But as research funding increasingly comes from private sources, and as patents on the materials and methods used in basic research become subject to private control, the relationship of patents to basic research may be changing. For example, in Alzheimer’s Inst. of Am. v. Avid Radiopharmaceuticals and Alzheimer’s Inst. of Am. v. Elan Pharmas, the Alzheimer’s Institute of America (the AIA) sued numerous non-profit research institutions for development and use of mouse lines incorporating a gene that may be associated with Alzheimer’s disease.

Contributing Author

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Jake Holdreith

Jake Holdreith is a partner at Robins, Kaplan, Miller & Ciresi L.L.P. He counsels clients and tries complex lawsuits including intellectual property, regulatory...

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Contributing Author

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Jamie Kurtz

Jamie Kurtz, an attorney at Robins, Miller, Kaplan & Ciresi, focuses her practice on intellectual property litigation, focusing on patent litigation in the area of...

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