Exclusivity is at the heart of intellectual property protection. Whether it’s patents, trademarks, or copyrighted materials, their value lies in the fact that they cannot be freely created, distributed, and used by just anyone for upwards of 20 years in most cases. But the value of this exclusivity also lies in the difficulty of earning a patent. Utility patents, for instance, are approved by the USTPO only 52% of the time.
But protecting IP is not the same in all circumstances. Those evaluating IP for its usefulness and novelty assess varying specifications depending on the type of IP at hand. This can result in industries and technological classes that are more difficult to win approval in than others.
Software (and its underlying code) is notoriously difficult to patent. The ubiquity of open-source software products and platforms is a major reason why. With only a handful of widely used programming languages, it is unlikely—even impossible—to receive a patent on the code itself.
It would be like patenting a letter of the alphabet based on a particular sentence. But similar to words, code can amount to more than the simple sum of its disparate parts. Therefore, for a code to be eligible, it would be filed under a type of utility patent called a process patent. Process patents are awarded for changes to the functionality or characteristics of a “material” in use. In this case, that material is a computer. And the changes are its processing.
This is where it gets tricky for those aiming to patent a software process. To qualify for a patent, software typically has to improve the functioning of a computer and produce the desired outcome. However, the novelty of the process is dictated by the code itself. Small changes to code are not typically enough to earn a patent even if they vastly improve a computerized output. Patented software must therefore rely on more varied code and dramatically improve output. However, two separate and different codes could receive patent approval if they arrive at similar outputs in novel ways.
For just about any inventor, especially those in mechanical, electrical, or chemical engineering, the USTPO’s strict (and at times controversial) rules against awarding patents for laws of nature are a big deal. Seemingly useful and novel ideas are frequently struck down for relying too much on nature and not enough on technology. The resulting confusion and frustration around what is patentable and what ineligible as a law of nature, natural phenomena, or scientific discovery have deep implications for inventors in a variety of industries. In no case is this clearer than the emerging biopharmaceutical industry where lives, livelihoods, and trillions of dollars of value are at stake.
The challenge of having biopharmaceuticals patented will rest on how the laws change and are applied over the next several decades. Several recent court cases have already altered the industry’s prospects. An initial turning point occurred in 2013 when the Supreme Court determined that genes, created by nature, are not patent-eligible, even with the millions of dollars Myriad Genetics spent taking medicine forward by identifying the role BRCA1 and BRCA2 genes play in many common and serious illnesses like breast cancer. The ruling threw into question thousands of patent claims and the gene editing therapy industry as a whole.
It isn’t just gene modification therapies. Biologic drugs and their patents have also faced scrutiny. An ongoing case going in front of SCOTUS in 2022 regarding the therapeutic Repatha has the potential to send shockwaves through the pharmaceutical industry. Repatha is a biological drug that works similarly to naturally produced chemicals in the body to lower cholesterol. The mimicking of natural substances made it difficult to patent based on the drug’s chemical composition, despite the novel process Amgen uses to synthesize it. The original patent focuses on the way it interacts with the body. Amgen argues that because the drug has the potential to interact with thousands more body receptors than its current formulation, the scope of the patent should cover all drugs in its class.
So Amgen has taken to litigation to protect a patent that was awarded by the specific physiological process and its effects. The company argues that because relatively simple changes can be made to Repatha’s formulation to affect additional physiological processes, its patent should cover all biologics in Repatha’s class, even if they aren’t listed among the original claims. Lower courts have asserted that Repatha’s patent struggles to meet basic thresholds of non-obviousnesses and by extension, enablement.
Repatha’s original patent attempted to cover this by attributing Repatha’s novelty to its functionality rather than its formulation. But basing a drug on its interactions requires demonstrating the exact conditions that would allow the drug to work in that way. But because these conditions are purely theoretical and not based on Amgen’s own research, they violate enablement requirements.