An invention must fit under one of the four categories of process, machine, manufacture, or composition of matter to be patent eligible. Abstract ideas, laws of nature, or natural phenomena are not patentable. Recent case law can have a major impact on the patenting of some aspects of biotechnology innovations such as pharmacogenomics and related diagnostic applications.
In In re Bilski, an en banc Federal Circuit substantially modified its previous standard for patent-eligibility determination for process claims. The court held that a process is patent-eligible subject matter if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing. The new standard could make it difficult to broadly patent certain biotech methods, particularly those that relate to biological processes and mechanisms of action. The decision could mean that, to the extent a method claim covers all potential ways to influence a biological process, the claim has become a claim on a natural phenomenon.
It is still too early to assess the full impact of Bilski. For one thing, the Supreme Court on June 1 granted certiorari and will review the Federal Circuit’s decision during the next term. If affirmed by the Supreme Court, Bilski would make it easier for courts to invalidate claims that are directed to collecting or processing human genetic information.
Patent drafters should consider including physical components or processes such that a method claim is not simply a data-gathering or -processing exercise. If certain assays are preferred, consider multiple claims of “performing a Y assay for X” with different assay types, for example, rather than simply claim “assaying for X.” Where innovative sample collection or preparation is pertinent, such features could help. Data presentation, especially if it allows more advantageous use of the data, should be considered as well. Naturally, one should be cognizant of the business value of a claim with too many limitations.
An invention must be useful to be patentable. The utility requirement, as explained by the Supreme Court in Brenner v. Manson, stems from the U.S. Constitution and the congressional intent that to receive a patent monopoly the invention must have a substantial utility and a specific current benefit.
An area where the utility requirement has had a significant impact is the patenting of genes and gene products such as biomarkers and their uses. In In re Fisher, the Federal Circuit held that expressed sequence tags are not patentable unless the functions of the corresponding gene are known or identified. It is increasingly clear that such uses as research intermediates or tools for monitoring gene expression (or other for-further-research types of utility) are not enough where the underlying gene lacks substantial and specific utility.
It is often the case that a patent application on a therapeutic or a diagnostic invention is filed before any clinical trial result is available. In fact, in many cases no human trials have even begun before patent filing. In general, one does not have to show a definitive correlation between a particular activity and an asserted therapeutic use of a compound, nor is evidence needed of actual success in treating humans. What is required is a reasonable correlation between the biological activity and the use asserted in the claims.
If appropriate, one way to satisfy the utility requirement is to include evidence of structural similarity between claimed compounds and a compound known to have a particular therapeutic, diagnostic, or pharmacological utility. Also worth noting is that data from in vitro assays or animal models, if reasonably correlated to the particular therapeutic, pharmacological, or diagnostic utility, may be sufficient to satisfy the utility requirement.
It should be noted that the nature and amount of evidence needed depends on the claim sought by the patent applicant. If one claims that a compound is useful in “treating a symptom” of an incurable disease it is likely to need less evidence or support than where one claims that the compound is useful in “curing” the disease.
Similarly, claims directed to the use of broad classes of agents, or treatment for multiple conditions, will generally require more written support than claims that are directed to a particular class or condition. Patent counsel should be apprised of the desired claim scope and the available evidence that could support the asserted utility.