Over the past year, I have attempted to explain some of the basics of patent law. I have regularly mentioned the three basic tenets for obtaining a patent for an invention: the invention must be new, inventive and useful. While these tenets accurately describe the requirements for patentability, this isn’t the full picture. The final critical requirement for patentability is that the invention must constitute patentable subject matter.
What constitutes patentable subject matter? Let me provide you with an easy illustration. In an age when cloning animals is relatively straightforward, it’s likely that scientists could clone a human embryo. While a cloned human embryo may constitute an invention from the perspective of it being new, inventive and useful, higher life forms are not considered to be patentable subject matter.
In Canada, one contentious area concerns medicinal dosage regimens, for example, administering one to five milligrams per kilogram of body weight of a drug daily. As many readers who work in the pharmaceutical field would recognize, much research is conducted into making known drugs more effective by, for example, adjusting the dosage. New regimens can clearly constitute new, inventive and useful inventions. However, it is difficult to obtain broad protection for such inventions in Canada because they are not patentable subject matter. The reasoning behind this prohibition is: physicians should not be prevented from treating patients with known drugs (or any drug for that matter) when using their professional skill and judgment to find an appropriate dose for a patient, if such action then resulted in the infringement of a patent.
Patentable subject matter is also a hot topic south of the border, as a result of recent decisions from the United States Supreme Court (USSC). The USSC addressed the patentability of isolated DNA in Association of Molecular Pathology v. Myriad Genetics. In the mid-1990s, Myriad, a biotechnology firm specializing in human genomics, discovered genes in women that were linked to an increased risk for breast cancer (BRCA1 and BRCA2). Myriad isolated these genes and patented them, assuming they would be an important diagnostic tool for predicting breast cancer. One of the issues before the USSC was whether isolated genes constituted patentable subject matter. The court ruled that a naturally occurring DNA segment is a product of nature and is therefore not patentable subject matter.
As chemists, we may be able to breathe a little easier as the USSC’s decision in Myriad specifically concerned gene patents. However, there’s a good possibility that this decision may be used as a basis to argue that any product of nature is not patentable, which would certainly affect chemists who isolate natural products. In almost every issue of this magazine, I read articles in which chemists are isolating compounds from the most extraordinary places. Whether the compounds are isolated from marine sponges or cranberries, obtaining broad patent protection for a specific natural product without other limitations, such as purity of the compound, could become more difficult in the U.S. in the near future.
While it can be challenging to protect certain inventions, none of the above should stop a chemist from researching natural products or developing new dosage regimens. A skilled patent lawyer can likely find a way to protect your invention.
Over the past year, I hope I have convinced you of the importance of protecting your chemical inventions, in addition to providing you with basic information on how the laws of chemistry interact with the laws of patenting. Next year, I plan to delve into more advanced topics. Of course, I’d be happy to receive any suggested topics from you, the reader. See you in 2014!
Mike Fenwick is a patent lawyer with Bereskin and Parr LLP in Toronto and holds a master’s degree in organic chemistry.