BioWorld International Correspondent
BRUSSELS, Belgium European academics favor the introduction of a “grace period” in patent law covering biotechnology inventions, so they can continue publishing their results early, but the European biotechnology industry is firmly against the idea.
The difference has emerged from a survey undertaken by the European Commission into the implications for basic genetic engineering research of failure to publish, or late publication of, papers on subjects that could be patentable under the European Union’s 1998 rules on the legal protection of biotechnological inventions, which still is being implemented across Europe.
The call for a grace period, which would permit limited disclosure of an invention without rendering it non-patentable, is inspired largely by the need of public research organizations (and smaller spin-off and start-up companies) to provide some information to potential investors in order to win financing to develop an invention. They argue that they should be allowed to reveal some elements of their findings without paying the penalty of losing all rights to subsequent patenting. European patent law now precludes patenting of any invention if information about the invention already has fallen into the public domain. Academics also argue that they should be not be penalized for maintaining the tradition of early publication of their findings in the academic press, as they are now. And academics claim that a grace period would protect them against the consequences of inadvertent disclosure before patent filing.
But the industry and particularly larger companies is strictly against such a grace period, which is seen as likely to generate legal uncertainty in an already uncertain patent environment for biotechnology inventions, and thus discourage investment. Generally, industry favors instead the use of provisional patent applications a new and still-evolving mechanism in European patent law, which allows early patent filing (and the consequent establishment of legal protection for the invention) on the basis of only skeletal information.
Industry respondents to the Commission survey say that public-sector scientists are simply not sufficiently aware of the possibilities for both publishing and protecting their data, and that a process of education on patent law would be preferable to bringing a grace period provision into European law. For instance, they claim that scientists are still often unaware that the level of detail required in a patent application is lower than that required for a successful scientific publication. Scientists, they say, should prepare the patent application at an earlier stage than the submission of the scientific paper for publication, thus eliminating publication delays without sacrificing patent rights.
The issue has arisen from the broader ambition to boost the competitiveness of the EU biotechnology industry, which, the Commission believes, will be increasingly influenced by protection of scientific results from basic genetic engineering research conducted in the public research sector and its exploitation through contract research, licensing to industry, or generation of spin-off companies. European scientists energetically generate inventions, but Europe’s record of exploiting inventions under patent is still strikingly below U.S. levels.
“Research institutes, universities and small biotech companies may wish to file patent applications but at the same time they will want to disclose as quickly as possible the results of their research to the scientific community and/or investors,” the Commission said. “The conflict between these protection’ and publication’ strategies may lead to a delay in publication of scientific results and hinder the rapid dissemination of scientific knowledge, thereby slowing down scientific progress.”