Legal Aspects of Bulk Sequence Claims

Much of the focus of patenting attempts and granted patents for Arabidopsis genes (and those of many other organisms) have been towards patent protection in the US. Other countries, such as Australia, often use the US as a model for guiding their own patent office procedures. Hence, when considering the legal aspects of bulk sequence claims, we will be referring to the current state of affairs in the US and in particular the actions of the United States Patent and Trademark Office (USPTO) towards bulk sequence applications. To understand the basis for patent protection in the US, one must understand that:

A patent applicant is entitled to a patent on an invention if it is novel, inventive, has utility, and if the patent disclosure enables its use.

The default, with respect to applications, is that the applicant is entitled to the patent, and the applicant is given the opportunity throughout the examination process to edit the claims of the application to maximise the chance that a patent is issued. Hence the onus is on the patent office to prove that a patent application fails to meet the criteria for patentability. Patent examiners have a limited amount of time to spend examining an application.

It can be argued that such bulk sequence applications represent attempts to patent “discoveries” (which are not patentable) rather than “inventions“. Specifically, the applicant has added to the amount of human knowledge by disclosing something that occurs in nature, rather than adding to human knowledge through the creation of something new (a useful invention). Therefore, it could be argued that bulk sequence applications lack an inventive step.

For an application that claims many sequences, applicants have historically argued that novelty, inventiveness, and utility are met by such large sequence applications. They have done so by pointing out that such sequences can be used (inventiveness and utility) for particular purposes, including:

  • as a transgene to modify the phenotypes of other organisms
  • as probes to help locate homologous sequences in other organisms
  • to design primers for use in amplifying the gene, in diagnostics,…

These proposed uses bring to light another problem with such groups of sequences: Enablement.

The disclosure of information made in “payment” for the grant of a patent must enable a person “skilled in the art” to use the invention. A bulk sequence application may fail to adequately address this issue, since it would be extremely difficult for any applicant to give specific instructions on how to use all the sequences for the purposes listed above.

The USPTO has responded to attempts to patent large groups of sequences by strictly adhering to the requirement for enablement and substantial utility for such applications.

Recently, the USPTO’s commitment to these standards were challenged by Monsanto, who had previously applied for patent protection for 32,236 maize ESTs (US patent application 09/619,643), and were refused a patent. Monsanto appealed the USPTO’s decision in the Court of Appeals for the Federal Circuit. The appeal was denied by a majority of 2 out of 3 judges, based on a lack of utility and enablement (re Dane Fisher caseSee also this commentary link).

Since the re Fisher case was not a unanimous decision, a question still remains as to whether-or-not future large sequence claims will be successful.

Another important point to note about granted patents:

Under US law a granted patent is assumed to be valid.

This fact, in addition to the high cost of contesting a granted patent (generally around one million US dollars), provides an effective barrier to those interested in challenging a patent’s validity.