Germany: Will The Human Genome Soon Be Patented?

Since the anticipated announcement by Craig Venter of Celera Genomics -- relating to the successful sequencing of the human genome -- both scientific and lay people alike have been wondering out loud about the implications of such a historic feat. In particular, there appears to be great concern about the patenting of the human genome, and the potential extraction of this genetic information from the public domain. Of course, these concerns are expressed on a global scale.

The basic prerequisites for obtaining a European or German patent include an invention that is novel, has an inventive step, and finally, the invention must be susceptible to industrial application. This article presents several hypotheticals relating to the patenting of genetic sequences under the European Patent Convention. These hypotheticals represent exemplary situations of whether the above-mentioned prerequisites for a European patent are satisfied, with particular emphasis on the patenting of genetic sequences having known or unknown function.

The specification of a patent application generally discloses a full or partial sequence of a gene, without specific information directed to the function of the genetic sequence or the resulting amino acid composition. The specification also describes the use of the partial sequence to locate and characterize the corresponding complete gene sequence.

The specification of a patent application discloses a complete and/or partial sequence of a gene, the function of this genetic sequence, and the function of the encoded protein. However, the function of the encoded protein is merely speculative and simply based on a homology comparison with known nucleic acids and proteins.

As in Hypothetical B, the specification of a patent application discloses a complete and/or partial sequence of a gene in addition to functional information relating to the nucleic acid or the encoded protein. However, in this example, the function of the genetic sequence or encoded protein has been characterized using accepted scientific approaches.

Pursuant to Rule 23e(2) EPC ¹, a patent application that discloses and claims a full or partial sequence of a gene may qualify as a patentable invention. However, Rule 23e(1) EPC qualifies this rule by stating that the finding of a genetic sequence does not constitute a patentable invention by itself. In other words, the mere disclosure of a genetic sequence does not provide subject matter that qualifies as a technical teaching. Therefore, this disclosure fails to constitute a patentable invention. (See Art. 52(1) EPC which provides the basic definition of patentability). Furthermore, Rule 23e(3) EPC requires that the invention provide industrial applicability, i.e. a complete genetic sequence or a partial sequence of a gene must be described specifically. (See Art. 57 EPC). Thus, in the present hypothetical, at least two essential requirements for a European patent grant fail to be satisfied.

In contrast to the facts of Hypothetical A, the example presented in Hypothetical B constitutes patentable subject matter under the EPC. For example, the complete and/or partial sequence of a gene, and the function of this sequence and resulting encoded protein, constitute patentable subject matter under Art. 52(1) EPC (and associated Rule 23e(1) EPC). In addition, the prerequisite of industrial applicability is fulfilled, as well as novelty (under Art. 54 EPC) if the described sequence has not been published or described in any publication or patent.

However, in this example, the essential requirement of an inventive step (see Art. 56 EPC) presents an obstacle in obtaining the patent grant. Generally, there is no inventive step for a technical advancement which is obvious to the ordinary person skilled in the art, e.g. if the advancement is merely routine work for a corresponding scientist in the respective technical area. In Hypothetical B, the patent application resolves the speculative function of the genetic sequence or encoded protein by homology comparison with known nucleic acids and proteins. Such comparisons are routinely performed by using widely available computer programs for the prediction of protein structure derived from genetic sequences. Therefore, this requisite step to identify function fails to constitute an inventive step because of the obvious and routine nature of this critical task. Therefore, this patent application would fail to satisfy the essential prerequisite of an inventive step under Article 56 EPC and cannot result in a granted patent.

Similar to the result in Hypothetical B, the example presented in Hypothetical C constitutes patentable subject matter under the EPC. For example, the complete and/or partial sequence of a gene, and the function of this sequence and encoded protein, constitute patentable subject matter under Art. 52(1) EPC (and associated Rule 23e(1) EPC). In addition, the prerequisite of industrial applicability and novelty (under Art. 54 EPC) are similarly satisfied.

In the present hypothetical, the essential requirement of an inventive step (see Art. 56 EPC) is the decisive factor for the grant of a patent application which describes the function of a genetic sequence or encoded protein that has been characterized using accepted scientific approaches. The critical question of patentability will apply on a case-by-case basis, depending on how much information is already known about the genetic or protein sequence and any corresponding function. This notion also applies to any related homologous sequences. For example, no inventive step will be found for a patent application containing known sequences where a function for the corresponding gene or the encoded protein was publicly suggested.

In contrast, an inventive step will likely be found if a new gene and its corresponding function, or the function of the resulting encoded protein, are described in a patent application where the gene or the resulting encoded protein exhibit only a small degree or no degree of homology to known genes/proteins having a similar function.

Furthermore, an inventive step may likely be found even if the gene sequences and/or protein sequences exhibit a high degree of homology to known sequences, if a different function of the nucleic acid or protein is described or proved. This defined function must be different than would have been expected, or nonobvious in view of any homology comparison using the identified genetic or protein sequences.

Although there may be significant effort to secure patents for all human nucleic acid or amino acid sequences, it is unlikely that such patents will be immediately granted. The mere sequencing and the subsequent homology comparison of identified human genomic sequences do not by themselves satisfy the requirements for patentability under the EPC.

However, the recent characterization of the human genetic transcript presents great possibility for inventive concepts and thus, for patent applications. For example, a potentially patentable invention can include an already known sequence that may be modified to produce an unexpectedly high or low activity of the resulting protein. Furthermore, patentable inventions can also be based on using the known genetic sequences for novel medical or diagnostic applications. True, the potential of global commercial exploitation of the human genetic code is unknown, however, the numerous procedural safeguards present in the various patent systems may curtail the swift race to the patent office.

1Inserted by decision of the Administrative Council of 16.06.1999 (Adaption of the Implementing Regulations of the EPC to the Biotechnology-Guideline (Guideline 98/44/EC) which entered into force on 01.09.99