New Medical Technologies Bring New IP Challenges

LYON, FRANCE – At the cutting edge of medical technology lie new hopes for patients, but also serious ethical concerns and potential intellectual property snags.

Academic experts and industry representatives meeting in Lyon last week discussed two such areas of health research – using stem cells and robotics – and Intellectual Property Watch asked what these innovative developments might mean for patent law.

The event, called BioVision, takes place every two years in Lyon, France. It brings together scientists, academics, policymakers, industry leaders, civil society and public institutions representatives. The 6th edition, from 8 to 11 March, focused on challenges brought on by urban expansion. About 2,000 participants attended the event.

Stem Cell Research: An IP Minefield

Stem cell research is one of the most promising fields in life sciences. Alastair Kent, director of the Genetic Interest Group, a United Kingdom national alliance of patient organisations that support people affected by genetic disorders, said embryonic stem cells can help cure life limiting diseases about which nothing can be done at this time.

But the field is an “intellectual property minefield,” said Alan Lewis, president of the Juvenile Diabetes Research Foundation in the United States.

A key problem involves “submarine patents,” or grants on patents that emerge many years after the original filing, in most instances without the industry that may be using the innovation being aware that there were intellectual property rights on the technology (either because the application was unpublished or poorly publicised).

Many companies are trying to get patents on their discoveries or processes, but many patent applications are still in progress. The US Patent and Trademark Office lacked expertise in the field of stem cell research.

Although they are very willing to learn, this is a new field and they are “on a steep learning curve,” Lewis told Intellectual Property Watch later. There is a worry as to who is going to get the first patent rights. The companies that dominate the market are Geron, Osiris, Act and Cytori. They are all US-based, he said.

Stem cell research is based on two types of techniques: First, human embryonic stem cells (hESC), which are cells derived from human embryos. Those cells are pluripotent, which means that they are unspecialised and under certain conditions can be induced to become cells with special functions. Second, human-induced pluripotent stem cells (iPS), which are human cells that have been reprogrammed to have the same kind of capabilities as embryonic stem cells.

Ethical issues have been raised about the use of hESC because the technique involves destroying human embryos. A recent decision by the European Patent Office (Thomson/Warf) confirmed it was not possible to grant a patent for an invention that involves the use and destruction of human embryos in Europe.

On the other hand iPS, first generated in 2007 and described as a huge breakthrough, are under scrutiny for potential toxic effects and safety issues and could not at this point replace hESCs, speakers said.

Stem cell research was hindered in the United States since the Bush administration put restrictions on embryonic stem cell research. However, President Barack Obama signed an executive order on 9 March that lifted the restrictions, said Lewis.

Concerning the EU, the position on patenting research on human embryonic stem cells should not hamper research in the EU as there are plenty of opportunities to patent discoveries based on other stem cells research, such as iPS, Lewis told Intellectual Property Watch. The main point would be to have stem cell lines deposited in a central bank for use by all interested parties. That would help accelerate discoveries, he said.

The decision to use stem cells provides a scientific, ethical and financial challenge but “those cells have the potential to unlock the understanding of life-limiting diseases,” Kent said; however, there is a time scale: “Cutting edge science does not deliver tomorrow,” he added.

Some participants in the audience voiced concerns about the commodification of human life and Kent called for the creation of a clear and transparent regulation with appropriate standards and framework.

According to Laurence Dahéron, head of the Harvard Stem Cell Institute at Harvard University in Boston, the US Food and Drug Administration approved a first clinical trial of hESC-derived cells in patients with severe spinal cord injuries in summer 2009.

Robots!

Meanwhile, the future of surgery may become smaller and less human, as the robotics industry looks into medical applications.

“Inspiration from the natural world” can be used to “revolutionise surgery,” said Paulo Dario, a professor at Scuola Superior Sant’Anna in Italy. One example he cited during his talk on 10 March was research into how a robot modelled after the movement of worms might be able to perform a colonoscopy.

Microrobots – smaller than a millimetre, many even as small as 100 microns (a micron is one millionth of a meter), – are being explored as ways to deliver medicines directly to the site in the body where they are needed, Dario told Intellectual Property Watch in a later interview. They can be a platform for medical doctors, he said.

Intellectual property rights do not have as much history in robotics as they do with their pharmaceutical partners in the medical robotics venture. Dario said his students analyse both scientific and patent literature on the topics they research. But first priority is high-quality education, then high-quality research – and then papers or patents. Only after that is exploitation of the product considered. And here, there is a “mixed attitude” he said.

“What’s important,” he explained, “is not bringing a patent but bringing a product to market quickly.” A patent may be useful, he added, but can be misleading if too much attention is focussed on it. IP rights must be included “at the right moment in time.”

It also may be complicated, as robots themselves are more of a system than a single innovation. Dario compared it to a car – one does not tend to patent the entire vehicle, though there may be numerous patents on its different parts.

Even still, it is unlikely that licensing will be as much of an issue with robotics as it has been in recent years with traditional chemical medicines. Robotics in general are expensive: mechanical parts are expensive, electrical parts are expensive, and as they are yet to be made in large quantities there is no reduction in cost due to economies of scale, Dario said.

BioVision’s History

BioVision was started 10 years ago by Philippe Desmarescaux, former director general of French chemical and agrochemical company Rhône-Poulenc. The event was meant to become the “Davos” of life sciences, according to Alain Godard, agriculture consultant for BioVision (referring to a meeting of global political and business leaders that takes place yearly in Davos, Switzerland).

One of the goals was to bring people together to discuss life sciences issues and progress. BioVision is now an international platform organised by the Lyon Scientific Foundation in collaboration with the French Academy of Sciences.