Patenting Biotechnology Inventions: Little Harmony in Europe

Did the BioTech Directive 98/44 EC (adopted by Europe's lawmakers roughly a decade ago) achieve its goal of harmonizing patent practice for the biotechnology sector? The answer most experts gave at a conference held by the European Patent Office in Brussels earlier this month was ‘No.'

The conference brought together some 120 policy makers, patent attorneys, scientists, industry and NGO officials as well as representatives from the IP realm. And most experts concluded that the directive was "imprecise", that it failed to set cross-border standards in Europe, and that numerous legal and moral issues were still up in the air, with many countries in Europe having put forward their individual interpretations of the directive.

Amid all those legal insecurities, the EPO is seen to be "the cement between its member states," said Johan Vanhemelrijk, the secretary general of EuropaBio, an industry group with more than 2 000 members.

But is that a burden the EPO should shoulder? Christoph Then of Greenpeace said ‘no'; he added that creating legal security and practical harmony "must be the legislator's job".

It was unhappiness with parts of the TRIPS agreement that drove patent attorney Sharon Bowles into politics, a career that culminated in 2005 in her election as a member of the European Parliament.

Ms. Bowles isn't particularly happy with the status quo ten years after the directive passed, but pointed out that - in contrast to a regulation - a directive "by nature is imprecise and a result of compromises."

However, writing a new directive (or turning it into a regulation) may open another Pandora's box: "Don't forget that between mandates, 70 percent of the parliament is exchanged," she said. "So every term, you have to start from scratch." The creation of such a policy would last years, observers predicted.

MEP calls for European Patent Court

Bowles nevertheless has plans to shape the European IP world: She strongly called for the installation of a European Patent Court to help avoid national divergences regarding the implementation of the directive, and spoke in favour of forging deeper co-operational ties between Brussels and the EPO, which she said was "no closed shop" but always open for dialogue.

"But a harmonisation of the European IP world cannot become reality without a European Patent Court," she warned.

Vanhemelrijk wouldn't mind harmonisation either; it would lend his branch security given high research costs and the long time (up to 25 years) it takes before biotech inventions enter the market. "We need to know what can and what cannot be patented," he said.

Greenpeace expert Then also spoke in favour of legal clarity, but his pendulum swung in another direction than the industry's: He argued that life forms should not be patented at all - first, he said, because it degrades life, and secondly, because too often, in the case of plant patenting, inventors use the current system to block access to samples and seeds.

Between these two antagonistic opinions sat Prof. Julian Kinderlerer, one of 15 members of the European Group on Ethics, which advises the EU on ethical issues. He gave an inside glimpse into the tough reasoning pro and contra biotechnology patenting, noting that a majority of his group believes that in the current system, the balance between knowledge protection and information dissemination is "skewed badly toward the inventor".

Quality takes time

That misbalance has caused companies to file numerous broad patent applications, resulting in a backlog having piled up at patent offices.

"We are under pressure to work fast, but quality takes time", said Dieter Schneider of the German Patent and Trademark Office.

Sjoerd Hoekstra, director of a biotechnology department at the EPO, agreed and underlined that the EPO's team of 260 examiners in biotechnology was proactively addressing the backlog and quality issue. "We are rejecting over 60 percent of applications; they are not worth [patenting because of] a lack of balance between disclosure and invention", he said. "We have managed to reduce backlog, and we're mastering this problem".

When it comes to DNA patenting, the backlog issue has already been solved, with University of Sussex researcher Michael Hopkins presenting nothing less than the "end of an era". The total number of DNA patent filings has steeply declined, he said, citing the results of an extensive study he undertook with three colleagues.

Because the EPO has raised the threshold for DNA patents, applicants are much less likely to file "speculative, broad claims in hope of obtaining what many would view as undue rewards", Hopkins said. "That's why patents that go through are more valuable".

Yet regarding harmonization, several problems are still waiting to be tackled. According to several experts, different national standards regarding DNA patenting continue to affect the work of IP specialists, researchers and enterprises alike.

Sven Bostyn of the University of Amsterdam and French patent attorney Jacques Warcoin revealed why some countries have adopted either purpose-bound or absolute protection, but the disharmony helps neither office in Europe, they concluded.

"It is really strange fruit the different national interpretation have brought forth", Warcoin said.

Controversial research

In the third panel, Aliki Nichogiannopoulou, a biotechnology examiner at the EPO, illuminated the ethical and philosophical challenges raised by plant and animal patenting.

Ralf Badur, an IP specialist at Syngenta, an agrochemical and seed company, stressed the need to improve the performance of crop plants - due to increasing demand and water shortages stemming from climate change - a project he said is burdened with high research costs and long time periods until the final crop can enter the market. That's why he called for allowing the patenting of marker-assisted selection methods in crop plants, which so far can't be patented because they lack a technical process. "But the identification of markers is not trivial", Badur protested.

Pierre Roger, an IP expert for the Group Limagrain, a plant breeding company, said if such methods are patented, he and his colleagues expect that their ability to use protected varieties for further breeding will not be reduced, but rather, that both methods "can coexist harmoniously".

Harmony isn't just the word that one thinks of the day's final panel, which dealt with one of the most controversial issues in biotechnology. Its title: "Stem cell patents - a road ahead?"

Using human embryos and their cells for scientific research remains a no-go area for many European lawmakers and also the patent system because "it is the first filter of moral responsibility," said Pierre Treichel, an expert in patent law at the EPO.

Yet disharmony also affects this delicate area of science: "There is no European consensus" on stem cell research, patent attorney Nick Bassil and Treichel found. While the EPO must refuse to process stem cell applications, the UK Intellectual Property Office, for example, is following a much laxer approach.

However, this approach doesn't have a chance of finding a European majority soon, said Kinderlerer, who noted that religion has established a "north-south divide" in Europe on stem cell research. "In any case, you have to respect the pluralities of European societies and find practicable solutions," he added.

"It was a tour d'horizon through all aspects of biotechnology," journalist Paul Meller, who moderated the experts' panels, concluded at the end of the conference. "The more this is discussed, the better."