Should companies and researchers be allowed to patent cells derived from human embryos?
The European Court of Justice said no in 2011, when it ruled in favor of Greenpeace in the case of Greenpeace vs. stem cell researcher Oliver Brüstle. The ruling, which made it illegal to patent a human embryo in the European Union, came down on the side of those who oppose the commercialization of this technology.
This is one of the case studies examined by students who study biotechnology as part of the LL.M. in Medical Law and Ethics at the University of Edinburgh.
“We’re looking at the relationship between law and social roles and politics, how those drive society,” says Gerard Porter, director of the University of Edinburgh’s Medical Law and Ethics Program. He added, “The focus of the course is to look at different areas of the life sciences but also to look at how law is used and how that relates to the bigger things that go on in society.”
As biotechnology has grown as a field over the past decades, so have LL.M.s that either focus on biotechnology or offer courses on biotech as part of a larger program examining science, patents, innovation or medical ethics. Filipe Fischmann, director of the Munich Intellectual Property Law Center, which offers an LL.M. in Intellectual Property, says that as biotechnology has become more affordable and widespread, the need for lawyers that understand the issues inherent in that technology has also grown.
“You get more companies that are working on [biotech], and more possibilities for conflict or collaboration in that sense, and then you need the lawyers to help the companies to cooperate or to solve a conflict that could go to litigation, for example,” Fischmann says.
Not surprisingly, many of the law schools that offer LL.M.s in this space are located in areas with a lot of biotech activity. John Riccardi, Assistant Dean for Graduate and International Programs at Boston University School of Law, says his school’s Intellectual Property program focuses on biotechnology because Boston is home to a hub of biotechnological innovation, centered in nearby Cambridge’s Kendall Square.
“It’s one of the most concentrated areas in the country for jobs in that field, because of related organizations, teaching hospitals here or the universities, each of which have their associated research institutes,” Riccardi says.
Besides Boston University, Munich and Edinburgh, Arizona State University also offers an LL.M. in Biotechnology and Genomics—the state of Arizona is home to a $14 billion biosciences industry, by some estimates—while Stanford University, in biotech-heavy Silicon Valley, affords students the opportunity to study biotechnology within its LL.M. in Law, Science and Technology.
In these and other programs, students must learn to understand the often-thorny ethical and moral questions inherent in biotechnological developments.
Gerard Porter says that Edinburgh’s program examines issues including whether human embryonic stem cell research should be permitted or regulated; whether genetics should be used as defense in court cases; whether biotechnology should be used to improve the human race, either through choosing children’s genes or enhancing adults’; and whether specific countries should be permitted to prevent, control or regulate the development of genetically modified foods.
Besides examining these ethical issues, these LL.M. programs also examine the legal practicalities of shepherding a technological innovation from its nascent stage in the laboratory to the marketplace.
Riccardi says at BU, students can examine this process in the class From Bench to Bedside: Translating Biomedical Innovation from the Lab to the Marketplace.
“That class helps law students understand how ideas in science eventually make their way to the real world and lets the law students get a soup-to-nuts exposure to the planning of launching a new innovation and getting the funding. A lot of it relates to transactional work, in the establishment of various joint ventures that form the business entities, which eventually bring the scientific discoveries to the marketplace,” Riccardi says.
These issues often lead students to examine patent issues, such as at Munich, where students pursue courses in topics such as the protection of biotechnological inventions and US patent law. One practical example of that course of study is the rules established by the International Union for the Protection of New Varieties of Plants, an organization that seeks to establish whether a modified or bred plant can be considered a new breed and therefore protected by patents.
“That is the question of to which extent life, animals, plants are able to be protected under patent law. There is a debate to which extent patent law is suitable for that. And then you also have the possibility to use protection to those, especially to plants,” says Munich’s Filipe Fischmann.
But patent rights and ethical issues are not separate fields of study. In fact, biotechnology LL.M. students often study them together, as they are deeply interrelated topics.
“When you are talking about human rights, for example, the availability of pharmaceuticals around the world is a human rights issue,” says BU’s Riccardi. “Ethical issues that arise as they relate to patent law, how long patents are held by these large companies, and whether or not that is a good thing for the distribution of drugs in lesser-developed countries.”
Lisa Boden studied just that when she pursued her LL.M. at Edinburgh. Boden is a veterinary epidemiologist who’s working for a consortium funded by the Scottish government, providing advice on animal disease outbreaks. She enrolled in the LL.M. at Edinburgh because she is interested in law, policy and ethics and how those fields impact pandemic planning—and her last essay examined the relationship between pandemic planning and patents.
“I was looking at how patents on elements might have an impact on accessibility to medication and how that would then impact pandemic planning,” Boden says.