Biotechnology discoveries are made through a complex and lengthy process, often using well-established and validated research methods. But does the routine use of the tools of molecular biology mean that these discoveries aren’t inventions? On April 3, 2009, a U.S. Federal Circuit of Appeals decision (In Re Kubin, read here; read BIO’s amicus filing here) distorts the definition of what a patentable discovery is for the biotechnology industry, but may have a wider impact on all discoveries granted patents in the United States.
The decision logically conflicts with a long history of court decisions, and leaves one asking a simple question: Why?
Researchers pursue discoveries using existing research tools in a process called the scientific method. Researchers hope that by forming a hypothesis, and by testing that hypothesis with tools that have helped previous researchers in their field, their work will eventually lead to a discovery. In all areas of scientific inquiry, the scientific method and research tools are time-tested, reliable, and are not the discoveries themselves. To the U.S. Patent & Trademark Office, the tools and methods are used to make, find, or produce discoveries which are called “patentable inventions.” For example, if you’re a mechanical inventor, and you put together a new machine using known components like screws and bolts in the “prior art” (think of prior art as a master patent database), you can still invent a new, patentable machine. No one would argue that the machine was not new (or “obvious”) because the screws and bolts were already in the prior art. No one would say the new machine (let’s say it combs your hair and reads you romance novels simultaneously) was obvious because other inventors knew how to turn a wrench like you at the time you invented the machine. In other words, no one could correctly claim other inventors would have known to build the same machine just because of the tools or method you used.
In the course of the U.S. Patent & Trademark Office’s existence, the determination of an invention’s improvement over the prior art (called “novelty” and “nonobviousness”) has been made by comparing inventions to previous inventions in its field. Novelty or nonobviousness is not determined by comparing the tools/method used to create the invention to the tools/methods used in the field. At least, not until In Re Kubin. In Re Kubin tells biotechnology inventors that if they work in similar lab setups and use the same starting point, and test their hypotheses the same way with the same lab tools, what they discover is the same thing.
Second, In Re Kubin creates a burden on inventors to show that their invention wasn’t even possible at the time: something was unexpected, something really didn’t go according to plan. But sometimes we discover new things without anything going “wrong”. Biotechnology inventions are often created as a result of using reliable tools/methods in new areas of research to find new discoveries. If taken to its logical conclusion, In Re Kubin would make many biotech inventions that we now think are legitimate inventions obvious because of the used tools or methods in the process of their discovery, and would make it much harder to get a patent for what today are legitimate discoveries and patentable inventions.
Third, we don’t know where Kubin’s reasoning stops. In Kubin, a protein blot on a gel made the later-discovered gene unpatentable because it would have been obvious to any scientist to try routine cloning methods to get to the same result. Sure: “obviously,” many scientists would have wanted to discover that gene, and the tools for doing so apparently existed. But Kubin discovered it first.
Would the Patent Office rather that Kubin hadn’t even tried? What about further discoveries that build upon Kubin’s gene? Are those also unpatentable if they are made with routine research tools and methods? What about a medicine that might one day be developed based on Kubin’s discovery? Is that also just the result of routine experimentation, undeserving of a patent?
Fourth, In Re Kubin may have a damaging impact on information sharing within the scientific community. Inventors will have to protect their tools and methods used in the discovery process. It’s going to stifle information sharing in the scientific community, and will delay solutions yet to be found for today’s health, environmental, and industrial problems.
In Re Kubin is a legal “hindsight” blunder: If an inventor could have guessed (with or without any background knowledge) in a million years that his/her discovery could be made, then it must have been obvious in the prior art at that time.
Hindsight is 20/20… and harmful in determining the patentability of any invention at the time of its discovery.
This post was co-written by Hans Sauer, Associate General Counsel, and Margarita Noriega, Coordinator of IP & Bioethics, at the Biotechnology Industry Organization (BIO).