Ethics in Intellectual Property: Navigating the Gray Areas

By Lexus Tatge, Director of IP Education

As scientists, we step into the lab for the first time, bright-eyed and bushy-tailed, eager to explore the endless possibilities the unknown holds. But with the unknown comes uncertainty—and the ethical implications that inevitably shape our discoveries. That's why, in graduate school, we're preconditioned early on to grapple with these questions. In our first year, we're required to take a mandated course on ethics—a non-negotiable rite of passage. In that course, we learn the foundational principles: lab etiquette, maintaining a meticulous lab journal to accurately document experiments for future manuscripts, and the delicate politics of authorship—who gets credit, why, and in what order. Should we simply acknowledge someone's contribution, or should they be sandwiched somewhere between ourselves as first authors and our PI as the senior author?

For those in clinical research, the rules extend further: anonymizing all files, testing only what's outlined in your protocols, and staying within strict ethical boundaries. And, of course, there are hard-and-fast consequences, like the $10,000+ fine for leaving a mouse out of the animal facility for more than 12 hours. We're also confronted with complex scenarios: what happens when a country you're collaborating with operates under a different ethical code? In all of these sessions, we dive into the gray areas through group discussions, where ethically sound, rule-abiding first-years spar with seasoned PIs who have decades of experience navigating these murky waters.

By the time you wrap up your first year and return for a refresher in your fourth, you've likely encountered these so-called gray areas in real-life situations, developing your own framework for navigating the nuances of peer-reviewed science. But here's the thing: academia isn't unique in facing ethical quandaries. Every career contends with them. That's where attorneys and judges step in—they're the captains steering the ship between lawmaking and ethical conduct.

What are the gray areas in patent law? Recent court cases have tackled questions of ethical injustice, deciding who retains their intellectual property and who does not. At its core, patent law defines patentable subject matter as four categories: processes, machines, manufactures, and compositions of matter. To secure a patent, the invention must also meet three critical criteria: it must be non-obvious, novel, and have utility. However, there are important judicial exceptions that set ethical boundaries around what can be patented: laws of nature, natural phenomena, and abstract ideas. These exceptions often spark debates on where to draw the line between protecting innovation and ensuring public good—especially when ethics come into play.

In this week's post, I wanted to highlight a few critical Supreme Court cases from the past 45 years that have everyday implications for what scientists can and cannot patent. If you have a groundbreaking idea you're hoping your lab can patent, I recommend reviewing precedent to avoid investing time in an application that may ultimately be deemed ethically ineligible.

Below are some ground-breaking cases that cover the ethics behind patentability.

Diamond v. Chakrabarty (1980)

Let's go back almost 45 years to Diamond v. Chakrabarty (1980), a landmark case that reshaped patent law and set the stage for the modern biotechnology industry. This case began when Ananda Chakrabarty, a scientist, applied for a patent on a genetically engineered bacterium capable of breaking down crude oil—an innovation with potential for environmental cleanup (how cool is that?). Initially, the U.S. Patent Office rejected the application, arguing that living organisms were not patentable subject matter. Chakrabarty appealed the decision to the Patent Trial and Appeal Board (PTAB) and eventually to the Supreme Court, which upheld the patent. The Court's reasoning was that the bacterium, though alive, was not a product of nature but a result of human ingenuity.

This ruling swung open the doors for biotechnology patents, making it clear that life forms modified through scientific innovation could be eligible for patent protection. However, it also ignited an ethical debate that continues to this day: Should we be able to patent life? The decision blurred the lines between scientific discovery and commercialization, raising concerns about ownership of genetically modified organisms and the broader implications for medicine, agriculture, and biodiversity; all of which are brought up in Association for Molecular Pathology v. Myriad Genetics.

Association for Molecular Pathology v. Myriad Genetics (2013)

Who owns your genes? Let's dive in—a landmark case that had everyone asking, "Can you really patent something found in nature?" aka, patent something that makes up who we are as humans. Myriad Genetics thought so when they claimed ownership over isolated BRCA1 and BRCA2 genes, which are crucial for assessing the risk of breast cancer. But the Supreme Court dropped the gavel with a firm nope. Naturally occurring DNA sequences, even if isolated, are not patentable.

So, what's the fine line between this case and Chakrabarty's bacterium? If we purified DNA from the bacterium that helps break down crude oil, it would still be patentable. Why? The key difference is that synthetic cDNA—a complementary, lab-engineered version of DNA—is patentable, keeping one foot in the door for biotech innovation. Why does this matter? This case walked a tightrope between rewarding groundbreaking discoveries and ensuring patients can access life-saving diagnostic tools without companies cornering the market on human biology. Myriad might have been trying to rewrite the genetic code, but the court drew the line at owning what nature made first. So, that takes us to our last case, who can change that genetic code and is that patentable?

The Broad Institute v. UC Berkeley (2018)

Who should be able to use a scientific discovery as big as CRISPR-Cas9? But first, what is CRISPR for the people in the back… CRISPR, a revolutionary gene-editing technology, allowing precise modifications to DNA. The CRISPR-Cas9 patent battle between The Broad Institute and UC Berkeley was nothing short of a scientific showdown. Both institutions laid claim to this revolutionary gene-editing technology, but the Broad Institute ultimately secured patents for CRISPR applications in eukaryotic cells.

UC Berkeley had applied first but was denied the patent due to insufficient evidence that they were the first to demonstrate CRISPR-Cas9 in eukaryotic cells. This case doesn't just expose the complexities of patent law—it forces us to confront the bigger questions: Who should control tools that can rewrite the genetic blueprint of life? And how do we balance rewarding innovation with ensuring equitable access to technology that has the power to change medicine, agriculture, and humanity itself? The CRISPR case reminds us that in science, collaboration is key—but when it comes to patents, competition can get cutthroat, especially when a Nobel Prize might eventually be involved.

These have been some of my favorite cases to learn about while studying for the patent bar. The ethics, innovation, and ownership— whether you're co-submitting a paper with a foreign collaborator or developing revolutionary gene-modifying technology – weave through all thing's science and technology. Each of these landmark cases forces us to confront the same fundamental question: where do we draw the line between incentivizing discovery and protecting the greater good? As scientists, it's easy to focus on the "what" and "how" of our work since many of us it's "basic" science research. But as these cases show, the "why" and "who" matter just as much. Because when science meets law, the stakes aren't just academic—they're human.

Sources:

https://supreme.justia.com/cases/federal/us/447/303/ 

https://supreme.justia.com/cases/federal/us/569/576/ 

https://cafc.uscourts.gov/opinions-orders/17-1907.opinion.9-10-2018.pdf 

https://alumni.berkeley.edu/california-magazine/2022-summer/berkeley-loses-the-crispr-war/#