Chapter 3: Genome Patenting Issues

There are many issues associated with genome patenting that make it different from patenting articles of manufacture. This chapter discusses some of the issues relating to the patenting of genes, for example, why gene sequences are patentable, how patent craft has evolved in the post-genomic era, and how to search for biological sequences that are the subject of a patent or patent application.

Why are gene and protein sequences patentable?

The mantra is that “anything under the sun made by man” is patentable. Using this criteria, it would appear that genes and proteins, which exist naturally within living organisms, would not be patentable. However, patent laws in many jurisdictions, including the United States, Europe and Australia, allow patent applications to claim nucleotide and amino acid sequences as compositions of matter as long as they have been isolated from their cell of origin. Isolated nucleotide and amino acid sequences claimed under “composition of matter” claims in a U.S. patent are like any other patented technology in this respect. If used in a way that is covered by the claims of a patent that is in force, the user may be subject to being stopped by injunction or be required to pay royalties.

The road to allowing patents on sequences began with a U.S. Supreme Court case involving a genetically-engineered bacterium for cleaning up oil spills.  In this oft-cited case of Diamond v. Chakrabarty (447 U.S. 303 (1980)), the Supreme Court had no difficulty finding that a living, genetically-altered organism may qualify for patent protection.  From there, patent law in the U.S. evolved to allowing patents on many types of biotechnology products, including transgenic plants and eventually for DNA and protein sequences.  The rationale for concluding that DNA sequences – and by extension, protein sequences – are patentable is that the claimed sequences are human-made; they are “purified and isolated” sequences (Amgen, Inc v. Chugai Pharm. Co. Ltd., 13 U.S.P.Q. 2d 1737 (D. Mass. 1989), aff’d in part, rev’d in part, vacated in part, 927 F.2d 1200 (Fed. Cir. 1990), cert.denied, 502 U.S. 856 (1991)).  This view is very controversial and at times contentious, even within the U.S. courts.

In the 1990s, the U.S. Patent Office granted many patents claiming “purified” or “isolated” nucleotide and amino acid sequences.  The year 2001 however, brought a change that severly limited the ability to obtain claims reciting sequences.  The U.S. Patent Office released the “Utility Examination Guidelines”, which set out procedures for ensuring that patent applications complied with the utility requirement of patent law (Federal Register, Vol. 66, 1092-1099).   A claimed invention now had to have a “specific and substantial” or a “well-established” utility.  The impact was huge for claims to sequences.  Under these rules, a claim to “A cDNA consisting of the sequence set forth in SEQ ID No: 1.” is unpatentable unless there is a known function for the sequence.  In addition, more restrictive rules may well be implemented in the near future.

Thus, in the United States, after a period of granting expansive patent claims, it has become increasingly more difficult to obtain patent claims to DNA or amino acid sequences.