Ethics & Patents – To Patent or Not?

The clash of law, innovation and values

The new technological developments are moving at a breathtaking speed. Artificial intelligence (AI), synthetic biology, genetic engineering and regenerative medicine are no longer the stuff of the future, but today's routine tools. But, while science surges exponentially, the legal frameworks entrusted with regulating it, remain static and anchored in another age. Patent law, for example, once built for cogs and pistons, now finds itself wrestling with questions of human dignity, morality and cultural values.

Patents are grounded in a simple bargain: an inventor is given a temporary monopoly, a reward for one's ingenuity in exchange for disclosing one's work to the public. In theory, everyone benefits.

In practice, however, this trade-off is anything but. It grows complicated when new inventions touch on life itself, material of human origin, genetic identity, sentient code, etc. Such a bargain becomes unsteady and this results in a collision between economic incentive, public good and ethical restraint.

Without clear guidance on how to address the moral and social implications of these new technologies, innovation reliant on patent protection risks turmoil, uncertainty and confusion.

The first contact

Before laws are (re)written or policies are drafted, new technologies almost always arrive first at the patent office.

This makes patents the frontline test of whether law can keep in line with science, the first real-world ethics filter. But as breakthroughs in AI and biotechnology advance, the central question is changing. It is no longer just about what we can invent, but what rights we should grant over those inventions. That makes ethics and above all, the principle of human dignity, central to the future of innovation.

Human dignity and patents

Human dignity is a universal idea. The idea that every person deserves respect.

This concept is frequently invoked in bioethical debates, from cloning and stem cell research to genetic engineering and the use of human material in inventions. At the heart of all these debates is a concern that life itself could be commercialised.

In Europe, this principle is enshrined in the Biotech Directive which makes it an obligation under patent law that it be applied to "respect the fundamental principles safeguarding the dignity and integrity of the person".

Yet, while human dignity is a universal norm, patent systems around the world differ in how they apply it and sometimes struggle to draw the line.

Europe's morality clause

Europe translates ethics directly into its patent law. Under Article 53(a) of the European Patent Convention (EPC), no patent can be granted if its commercial exploitation would be contrary to ordre public or morality. Europe's legal framework, including the EU Biotech Directive, requires that patent law is applied in a way that safeguards human dignity, as well as other values such as public safety, individual integrity and the environment.

The Biotech Directive even lists specific exclusions which include:

(a) processes for cloning human beings;

(b) processes for modifying the germ line genetic identity of human beings;

(c) uses of human embryos for industrial or commercial purposes;

(d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

This list is not exhaustive but it sets a strong signal.

Article 53(a) EPC (EPO guidelines) aims to "deny protection to inventions likely to induce riot or public disorder, or to lead to criminal or other generally offensive behaviour". This indicates a proactive attempt to integrate ethical safeguards directly at the patent examination stage.

In practice, Article 53(a) is used sparingly. It featured in the landmark WARF stem cells case, where the indirect destruction of human embryos meant a patent being refused.

More recently, in a case T 1553/22 concerning a human-pig chimera, the EPO Board of Appeal refused claims on human-pig chimeras. Specifically, the case involved a method to create human-pig chimeras for cultivating human organs. Even though the inventors used pluripotent (not totipotent) human cells, the claims were seen as broad enough that human cells might integrate in a chimera's brain or germ-line potentially endowing an animal with human-like cognitive or reproductive capacities. As a result, the patent was deemed an affront to human dignity under Article 53(a).

Another notable case that tackled Article 53(a) is T 2510/18 that dealt with traditional knowledge and what the morality clause is not. In that case, a patent on a malaria drug derived from indigenous traditional knowledge was challenged as "immoral" biopiracy.

Opponents argued that the research involved deception and a breach of trust. The opponents said that this equated to "biopiracy" and violated Article 53(a) EPC, which excludes from patentability inventions whose commercial exploitation would be contrary to ordre public or morality. The Board drew a line, clarifying that the morality clause applies to how an invention is commercially exploited, not how the invention was derived. Furthermore, given the dire need for antimalarial medication, the commercial exploitation was deemed beneficial, not immoral.

The European Commission seeks to modernise this framework now. In its 2024-2029 agenda, it announced plans for a European Biotech Act. The proposed legislation, now in development, aims to "enhance the single market for biotech" and accelerate the path "from lab to market" while preserving ethical safeguards.

The WARF decision

The morality clause was put to the test in the landmark WARF case at the EPO. The application involved stem cells and while the patent application did not explicitly claim it, it required the destruction of human embryos to actually work. That implication alone was enough for rejection.

The ruling highlighted a key challenge for Europe's patent system: the difficulty of consistently applying morality.

Despite the morality clause in the EPC, the EPO has been criticised for a "lack of substantive definition of morality" and inconsistent application of tests like the "public abhorrence test" or the "balancing test" (which weighs animal suffering against human usefulness). This results in uncertainty which can discourage research in Europe.

Different national attitudes add another layer of complexity. For instance, what is unpatentable in Germany might be granted in the UK, as definitions of when life begins or what counts as an embryo vary across countries. By contrast, in the US, WARF successfully secured patents on embryonic stem cells, underscoring a stark transatlantic divide.

The US

Patents in the US are generally available to any person who "invents or discovers any new and useful process, machine, manufacture or composition of matter or any new and useful improvement thereof". Patents typically expire after 20 years from the original patent application date.

Unlike Europe, US patent law has no morality clause. Historically, there was a doctrine called the moral utility doctrine, which authorised the refusal to grant inventions that were detrimental to the well-being, good policy, or sound morals of society. For example, gambling devices or fraudulent inventions.

However, the test vanished over time. The Federal Circuit decision of Juicy Whipp v Orange Bang brought down the morality doctrine to its knees ending future applications of it. It rejected moral utility as a basis for patentability: an invention that is operable and meets technical criteria cannot be denied a patent simply because the inventions serve immoral or illegal purposes. The court pointed out that it was not the patent system's role to serve as a general guardian of public morality, rather if Congress wants to exclude certain inventions on ethical grounds it must say so explicitly.

The result is a system with very few ethical safeguards. This ethical deficit has allowed for patents to issue related to human cloning methods and transgenic animals with human genetic material, often without generally following through on moral debates in the pre-grant phase. This could potentially lead to "legal and social mayhem" with "ghoulish" patents.

Critics warn that this approach is generating "ethical blind spots" and risks granting overly broad rights. These can stifle research and create costly legal disputes, as seen with the WARF human embryonic stem cell patents or Myriad Genetics' breast cancer gene patents.

When ethical problems arise, it is usually only after the patent has already been issued, or as one may put it, after "the horse has bolted". Congress did try to rectify this with the 2004 Weldon Amendment (now codified in the Leahy-Smith America Invents Act §33(a)) that bars patents on human organisms, reflecting a political consensus that no one should hold property rights over a human life. However the Amendment has left grey areas, especially in fields such as human-animal chimeras. Patents on human cells, tissues, genes, or stem cells, however, remain patent-eligible.

At present, Congress is actively revisiting the boundaries of patentable subject matter (Patent Eligibility Restoration Act or PERA), not to insert morality per se, but to redefine or undo what some perceive as overreach by the courts (for e.g., Mayo 2012, Myriad 2013, Alice 2014).

The Road Ahead

Can we spur a biotech boom without sacrificing our ethical compass? How should patent systems adapt to new technologies and societal expectations? Biotechnology stretches our concept of ownership and life. But, even in the most complex cases, ethics and morality can provide a compass. If guided by values such as dignity and fairness, patents can support innovation that benefits society. Without such guidance, the system risks exploitation.

There is a growing pressure for clearer legislation and international frameworks to address the ethical and moral dimensions of patent law. The old, "one size fits all" approach model is no longer enough for technologies that blend human biology, advanced materials and machine intelligence. Patents remain the first legal stop for emerging science, and they must serve not just markets, but humanity itself.

Where

ethics guide patents,

innovation servers humanity.

Without

ethical guidance,

it exploits.