In recent years, the area of American patent law has been fraught with issues that endlessly frustrate inventors. Under current law, as spelled out in 35 U.S. Code § 101, “Whoever invents or discovers any new and useful process, machine, [article of] manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor…”
This may seem simple, but from a legal perspective it’s very complicated. For the last 150 years, the U.S. Supreme Court has struggled to determine whether anything from a rubber tip pencil to a piece of computer software fits within one of these five categories. Patent lawyers have often despaired over the current state of the legal system governing patents with regard to patentable subject matter. The system is totally unworkable.
This is a uniquely American problem; no other county uses our bizarre definition of patentable subject matter. Soon, we may not use it either.
The recently negotiated USMCA Trade Agreement adopts the European approach to patentability, clarifying what is eligible for a patent.
In much of the rest of the world, including Europe and Asia, there are no categorical restrictions imposed upon the patent system. Rather, any invention useful in industry that is new and non-obvious can be patented. This avoids the confusion that has wrought havoc in U.S. patent courts in recent years, with major rulings such as Alice Corp. unexpectedly detonating decades of legal precedents which were confusing in the lower courts as well.
But the USMCA Trade Agreement, negotiated between the United States, Canada and Mexico, seeks to do away with this issue. In Article 20.F.1: Patentable Subject Matter, it essentially adopts the European approach, and updates the Patent Act to read, “Whoever invents any invention, whether a product or process, in all fields of technology, may obtain a patent therefor…”
There are some areas of technology that the parties to the agreement can declare to be not patentable subject matter. However, these must be specifically spelled out in statutes, rather than leaving it to the courts to determine what is unpatentable by defining limited categories of patentable subject matter. Areas of technology where exceptions can be created include:
- Protecting Public Order
Subject matter that is “necessary to protect ordre public [public order] or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to nature or the environment, provided that such exclusion is not made merely because the exploitation is prohibited by its law.”
The USPTO had previously used the Sensitive Application Warning System (SAWS) to selectively block patent applications, which would potentially have serious legal consequences or unduly undermine the patent system (i.e. patents involving cold fusion, human cloning, or perpetual motion machines). However, in recent years it became apparent that SAWS was being abused and used in a biased manner, and it was ultimately discontinued.
Requiring exceptions to be formally codified ensures that the discussion about what classes of invention should be barred from patentability occurs in the light of day, and in a fair and transparent manner rather than having a secret government program where an administrative agency makes that decision
- Methods for Medical Treatment
Subject matter that covers “diagnostic, therapeutic and surgical methods for the treatment of humans or animals.” Currently, subject matter under this umbrella is patentable in the United States, but in some cases you cannot get money damages for infringement.
The motive for barring the patenting of some critical medical treatments is to ensure that a patent does not prevent medical professionals from preventing, treating, and curing illnesses. For instance, suppose that the Whipple Procedure, a radical surgical intervention for some types of intestinal cancer, had been patented. This patent would have inevitably resulted in otherwise preventable deaths, due to surgeons being barred from legally utilizing the procedure.
- Biological Materials
Lastly, the USMCA provides for exceptions for subject matter that involves “Animals other than microorganisms, and essentially biological processes for the production of plants or animals, other than non-biological and microbial processes.” In the United States, human organisms currently cannot be patented. This means that if a researcher discovers a rare mutation in a person, which alters certain biological processes and, say, makes them immune to some types of cancer, or resistant to obesity, the genetic sequence responsible cannot be patented.
However, there are no other statutory restrictions, through there are some restrictions regarding judicial interpretations of patentable subject matter.
The USMCA carves out a much larger area of subject matter, allowing for the restrictions placed on human-based patents to be applied to animals and plants.
The net result of the United States adopting the measures spelled out in the USMCA Trade Agreement is that the effectiveness and fairness of American patent law will be significantly improved. It will provide more objective and better-defined standards for determining patentability.