You’ve heard of intellectual property in the art world, but what about intellectual property in the ART world? I’m referring to intellectual property in assisted reproductive technology (ART), a field that’s grown with fervor in the past few decades.
This term encompasses a broad range of medical procedures that help couples have a baby using some or all of their genetic material. These procedures are utilized by families or individuals, such as same-sex couples or those struggling with infertility, who desire to grow their families.
Some common ART procedures include in-vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), and intra-uterine insemination (IUI), with IVF being the most frequent.
There is already a dense layer of ethical questions in the medical field surrounding the creation of human embryos through these procedures. What about the ethics of applying intellectual property rights in this realm? The intensity of this question has compounded due to an emerging technology called in vitro gametogenesis (IVG).
Advances in Reproductive Science & IP Possibilities
An expansion on IVF, IVG allows scientists to take non-gamete cells and turn them into sperm and egg cells, which can then be combined to fertilize in the same fashion as IVF. This circumvents one of the most difficult parts of IVF, the stimulation and collection of enough eggs. You can imagine how this might exponentially expand fertility potential for couples.
Currently, IVG is too nascent (pun intended) to be practiced in the real world – it’s probably one or two decades away from human subjects. However, the IP questions are already bubbling, especially regarding patents. Is it commercially profitable to patent aspects of IVG? Is it necessary? And is it ethical? Let’s go through some of the most complex issues that have come up.
A Fundamental Human Right
Patents surrounding IVG may be met with intense scrutiny for the main reason that IVG’s ideal outcome creates human life and, with it, parents and families. It also offers the potential of genetically engineering one’s offspring, which is, simply put, a lot of power in the hands of whoever employs and regulates it.
Many nation-states view reproduction as a fundamental human right, placing fertility technology more in the public sphere than, say, an app that helps people find somewhere to eat. Adding to that, the patentability of medical techniques varies across jurisdictions, reflecting an already existing ethical debate on what parts of healthcare can be monopolized. The gravity of reproductive rights and lack of consensus on the premise that medical techniques can even be intellectual property rights further demonstrates how fraught this area of IP is with ethical concerns.
Public Order and Morality
A patent registration can be denied if it interferes with “public order and morality.” While this phrase can be interpreted in lengthy discussion, it generally means that your invention or process cannot be patented if it involves something illegal, immoral, or offensive. Prominently, the European Patent Office (EPO) denied patents for stem cells generated from human embryo destruction on those grounds. In comparison, the USPTO has allowed some narrow patents for technology involving stem cells; so the “morality” determination differs between jurisdictions and how they construe those terms.
Does IVG implicate potentially illegal or immoral elements? The extent of control it allows over embryo production and the selection of embryos based on genetic qualities certainly present concerns. How much should we interfere? Are we creating “better” babies or an unforeseen genetic monoculture disaster?
The USPTO and other IP regimes don’t allow patenting of natural or biological processes. This operates on the principle that some aspects of nature are public or universally owned, like the human genome. For example, you can’t monopolize and keep others from using the process that produces sunlight. However, you could patent a solar panel design that further utilizes the sunlight in a new and novel way. Patent regimes will have to decide where to draw the line for IVG.
The patenting of medical procedures is a complicated area. In the U.S and many countries, a medical procedure cannot be patented to the extent that it affects the judgment of physicians. Essentially, these IP law restrictions establish a policy choice that doctors need to access the right treatments to cure their patients – healing is not to be obstructed based on one’s ability to pay a licensing fee.
If infertility is seen as a condition in need of curing, which parts of IVG will lie beyond patentability?
Patent Pros & Cons
From a commercial and research development standpoint, is there a purpose to patenting certain aspects of IVG? There are arguments for each side here, too.
Pros: Competition, Innovation, & Motivation
The pros of patenting IVG technology remain consistent with the pros of patenting in general. Companies receive temporary protection (usually a couple of decades), incentivizing them to both make the ideas more public and expeditiously develop them – with the aim of monetizing the practical aspects of research.
Cons: Lessened Collaboration & Patient Access
While patents can encourage collaboration – in that patent owners feel safe to disclose ideas after they’re protected – the sense of competition and individual ownership can also close down research collaboration. As a real-world example, this very detailed article about patents in assisted reproductive technology describes how IVF developed rather innocently, without many researchers claiming patents along the way. This happened for two major reasons, which illustrate the benefits of light IP focus in research:
- IVF research could be conducted in a low-cost way because of its light regulation. This meant doctors and scientists could try techniques without expensive clinical trials – trials which often motivate companies and researchers to acquire patents so they can capitalize on their discoveries and recover those high research costs.
- The spirit of early IVF research was patient-centered. Since it was regarded as a way to get results for patients, ideas and technology were shared freely between colleagues engaged in the same professional service.
According to these early IVF researchers, the “winners” in this approach are the patients and science itself, which was enough – especially when overhead was so low.
Intellectual Property in Assisted Reproductive Technology: The New, Expensive Frontier of IVG
You may wonder why these questions are coming up with such fervor for IVG. The same article that dives deep into the patent history of IVF also describes how IVG patents seem to be trending, so far. Researchers are filing far more patents for distinct and overlapping aspects of IVG, and venture capitalists are supercharging the field with investment, though it is decades away from common use.
Since IVF remains largely an unpatented world, many of these IP and ethical questions have been left for its powerful cousin, IVG. It’s uncharted territory for intellectual property in assisted reproductive technology. Does IVG warrant monopolizing discrete medical processes through patent recognition to incentivize further development? More importantly, will patients benefit from it? These are policy questions that will frame not only future development in this field – but access to the fruits of that development.