Harmonization is key to biotech innovation – clarity

Harmonization Across Nations Can Improve Biotechnology Innovation

Harmonization of patent laws advances goals of incentivizing and enabling innovation, especially in the areas of potentially lifesaving, life-altering technologies. For instance, in August 2011, then-Director Kappos outlined the importance of patent law harmonization:

“Harmonization—the alignment of laws and procedures among intellectual property (IP) systems to ensure consistency and clarity of rights for the world’s innovators—is a prerequisite to maximizing the development and dissemination of innovation and thereby improving quality of life for all the world’s people.”

David J. Kappos, The Time Is Now, Landslide 16-17 (July/Aug. 2011).

The America Invents Act (AIA) was another effort to harmonize U.S. patent law with the law of other nations. As the USPTO stated: “The [AIA] paves the way for greater patent harmonization-the alignment of laws and procedures among intellectual property systems to ensure consistency and clarity of rights for the world’s innovators.” U.S. Patent and Trademark Office, Harmonization: The Time is Now (last modified Oct. 31, 2019).

Before the AIA, the “IP5” was advancing harmonization efforts. Founded in 2007, the IP5 includes the European Patent Office (EPO), U.S. Patent and Trademark Office (USPTO), the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), and the National Intellectual Property Administration of the People’s Republic of China (CNIPA), the five largest patent offices in the world.

Even earlier, the biotechnology industry was identified as an area where global harmonization efforts are important considerations. See, e.g., National Research Council, Global Dimensions of Intellectual Property Rights in Science and Technology 319 (1993).