Steering through the world of intellectual property can be intricate, particularly with patents. For inventors, entrepreneurs, and well-established firms, knowing what is or isn’t allowed to be patented makes for a vital first step in safeguarding the truly innovative ideas and inventions that they’ve brought forth. This article covers the basics behind securing a U.S. patent, with an emphasis on the laws that govern the whole affair and on recent court rulings that continue to make waves in the patent pond.

The Foundation of Patentability: 35 U.S.C. § 101

Any discussion of patentability must start at Section 101 of the Patent Act. This section outlines four categories of inventions that may receive patentability.

• Processes: A series of steps that leads to a certain result, like a method of manufacturing a product or a new software algorithm.
• Machines: A device with movable elements or circuitry that has function, from a simple mechanical device to a complex supercomputer.
• Manufactures: A physical product made by humans, examples would be a new type of biodegradable product or a uniquely designed furniture.
• Compositions of Matter: A new chemical mixture, compounds of ingredients, or new materials, such as a pharmaceutical drug or a synthetic material.

Other than being classified into these categories, the invention must also meet the three fundamental criteria to be patentable:

1. Utility: The invention must be useful. The bar for this is typically a lower, as many inventions have some degree of useful application.
2. Novelty: The invention must be novel, i.e., new, and cannot have been patented, previously described in a printed publication, in public use, on sale, or otherwise available to the public before the earliest filing date of the patent application.
3. Non-obviousness: The invention cannot nothing more than an obvious improvement of an existing technology as viewed by one of ordinary skill in the relevant art.

Judicial Exceptions: The Outer Edge of Patentability

Although the statutory categories are broad, the courts have held these three key exceptions to patentable inventions. The exceptions below are understood as typical and necessary tools of scientific and/or technological work that are ineligible to receive patent protection. They include:

• Laws of Nature: Basic scientific principles such as the force of gravity, or the equations such as energy and mass (E=mc²) are not patent eligible.
• Natural Phenomena: Patents cannot be obtained on newly identified entities that exist naturally, such as a plant, mineral, or gene in its unmodified form.
• Abstract Ideas: Theories not associated with a concrete application, like mathematical formulas or methods of organizing people (such as a new kind of business model), do not qualify for a patent.

The Modern Interpretation: Landmark Supreme Court Cases

More recently, the Supreme Court has handed down some key rulings influencing our understanding of what can be patented, especially in regards to software, medical methods, and biotechnological inventions.

Alice Corp. v. CLS Bank International (2014)

Alice set’s up a two-step test for determining whether patent claims are directed towards unpatentable abstract ideas. The “Alice test” queries:

1. Are the claims directed to patent-ineligible concepts (i.e., an abstract idea)?
2. If so, does the claim contain an “inventive concept” that is “sufficiently more” than the abstract idea itself?

The Alice ruling has greatly influenced the way we determine whether software and business methods are patentable. Taking an abstract idea and implementing it on a generic computer is not enough for patent-eligible. It must be specific and have inventive way the idea is applied which makes what the inventor is trying to patent worthy of a patent.

Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012)

The Mayo case tackled the issue of whether medical diagnostic methods could be patented. The Court held that if a claim at issue has a law of nature, it must include an “inventive concept” above and beyond simply restating the law. This decision obviously affects the patenting of medical diagnostic tests because it raises the standard by which these tests are judged.

Amgen Inc. v. Sanofi (2023)

In more recent litigation, Amgen v. Sanofi, the “enablement” requirement of patent law was discussed. Under 35 U.S.C. § 112, the specification of a patent must describe the invention in sufficient detail to allow a person “skilled in the art” to make and use the full scope of the claimed invention. That very much allows for a clear understanding of what it is that makes the invention functional.

The Supreme Court, in a unanimous ruling, stated that this requirement is, indeed, a high bar, particularly for broad claims that cover a wide range of potential embodiments, which is common in the fields of biotechnology and pharmaceuticals.

LKQ Corp. v. GM Global Technology Operations (2024)

This case was a major development for design patents when the U.S. Court of Appeals for the Federal Circuit, in an en banc decision, re-evaluated the obviousness test for design patents. This case may by interpreted to sync the obviousness standard for design patents closer with the standard for utility patents established by the Supreme Court in KSR v. Teleflex. This is a significant case to monitor for those involved in product design and development.

Conclusion

Determining patentability in the U.S. is not always cut and dried. The Patent Act offers a loose framework, but it is a series of court decisions that has wrought a strange and ever-shifting landscape for would-be patent holders. For inventors and businesses, it is crucial to understand not just the basic requirements for patentability—that an invention be not only novel but also useful—but also the ins and outs of the judicial exceptions to patentability, the heightened enablement requirement, and the standards that must be met when a software or business method is the thing that is to be patented. Given how complicated patent law is and how much is potentially riding on the outcome of a patent application, it is essential to consult with a qualified patent attorney.