Gene patenting (June 2002)
- ICSU opposed attempts to patent complementary DNA (cDNA) sequences corresponding to portions of unknown messenger RNAs (mRNA), since such patents would distort the patent process, which is designed to protect applications, methods and products, on the basis of proven facts and not mere expectations, and normally serves society by stimulating the investments and developments necessary to provide useful products and services.
- At the same time ICSU urged the relevant authorities to take due account of the possible implications when considering such applications and to ensure a strict application of established patenting principles.
- ICSU in conclusion stated that it would welcome a formal international agreement on this issue.
Since the 1992 Statement important developments in law and science have taken place:
- On July 6, 1998 the European Union adopted the Directive 98/44/EC of the European Parliament and of the Council on the Legal Protection of Biotechnological Inventions (OJ No. L213/13 of 30.7.98), which contains important provisions on patenting of DNA Sequences. The United States Patent and Trademark Office (US PTO) in late 2000 responded to concerns on its patent granting policy for so-called Expressed Sequence Tags (ESTs) expressed in particular by the National Institutes of Health (NIH) and adopted Revised Examination Guidelines concerning the requirements of written description and utility.
- In June of 2000 publicly and privately funded endeavours to sequence the entire human genome ended with the announcement that the raw sequence has been entirely deciphered. That Statement was preceded by a Joint Statement of the British Prime Minister Tony Blair and the US President Bill Clinton, released in March 2000, in which the two political leaders requested that raw fundamental data on human genome, including the human DNA sequences and its variations, should be made freely available to scientists everywhere and that unencumbered access to this information will promote discoveries that will reduce the burden of disease, improve health around the world and enhance quality of life for all.
- ICSU took also note of the Statement of Patenting of DNA Sequences, which the Human Genome Organisation released in April 2000 in Vancouver.
- In view of these developments ICSU reaffirms its statement of 1992 and notes that some of the concerns expressed therein have been paid due attention since then. In particular, the EU Directive, which, in principle approved the patentability of DNA Sequences, clarified that:
- the human body, at various stages of its formation and development, and the simple discovery of the sequence or partial sequence of a gene, i.e. without indication of a function, cannot constitute patentable inventions,
- the industrial application of a sequence or a partial sequence of a gene must be disclosed, e.g. the encoded protein and its function indication, in the patent application,
- overlapping patented sequences are to be viewed independently, in case they overlap in parts not essential to the invention.
Also the Revised US Examination Guidelines now require that:
- the disclosed utility is specific and substantial to the subject matter claimed, as well as credible, and
- one skilled in the art can reasonably conclude from the written description that the inventor was in possession of the claimed invention at the time the application was filed.
- ICSU realises and welcomes the impact, which these new rules, if strictly applied by the competent authorities, will play in counteracting attempts to patent purely speculative, thus unfinished inventions. They should also efficiently prevent components of the human body in its native environment from being patented.
- Along the lines of the HUGO Statement ICSU views the EU Directive’s dependency rule, which states that overlapping potential sequences be reviewed independently, as crucial, provided that:
- the notion ‘are not essential to the invention ‘ is to be interpreted in the light of the function unambiguously disclosed by the respective applicant (patentee) and not on the bases of its objective (natural), not disclosed, importance as such, and
- that claims of the broad ‘having ‘ and ‘comprising ‘ type, which cover not only the disclosed DNA sequence and its use but also products ‘having ‘ or ‘comprising ‘ that sequence, will be allowed only exceptionally when the information disclosed for the overlapping part is sufficiently enabling to the claimed invention.
- ICSU urges the law makers to closely monitor whether these newly adopted rules provide for a sufficiently balanced system, i.e. offer enough incentives to stimulate the investments and developments necessary to provide useful products and services, on the one hand, but secure (free) access to fundamental genetic data and cooperation among scientists, on the other.
- If a formal international agreement on this subject cannot be reached, the law makers are encouraged to harmonise the respective statutory law provisions and practices.
- As an international non-governmental organisation whose mandate includes the promotion of cooperation in the basic sciences, and the safe-guarding of the principle of the universality of science and of the free flow of scientific knowledge, ICSU strongly supports the efforts being made towards an international harmonization of patent policies. In this regard, ICSU emphasises the importance of a ‘grace period ‘, which exists in patent laws of many countries with strong genomic research commitment, but not in the Member States of the European Union. Since scientific publications should have the same legal effects all over the world, i.e. should or should not preclude later patenting of the results at hand, ICSU urges the European law maker to join those states having a ‘grace period ‘ and thus end the situation discriminating against European scientists.
About this statement
This statement was approved by the ICSU Executive Board in June 2002. As of December 2010, it is being reworked to adequately reflect the current debate.