Report 5 of the Council on Scientific Affairs (A-01) Full Text

Gene Patenting: Utility Examination Guidelines

Council on Scientific Affairs (CSA) Report 9 (I-00), Patenting of Genes and Their Mutations, discussed the status of gene patenting, changes proposed by the US Patent and Trademark Office (PTO) Revised Utility Examination Guidelines,¹ and the controversy between the biotechnology industry and the biomedical community.

Based on this report, at the 2000 Interim Meeting the House of Delegates amended American Medical Association (AMA) Policy H-140.944 (3) (AMA Policy Database) on gene patenting to read:

Reports by the public consortium headed by Francis Collins, MD, PhD, Director of the National Human Genome Research Institute, and Craig Ventner, PhD, of Celera appeared in  Nature  and  Science in November 2000. Interestingly, the total number of human genes is significantly lower than the 80,000 to100,000 genes that scientists had estimated over the last decade. The current estimate by both groups is of about 30,000 genes--not that much larger than the mustard weed. However, the human genome is much more complex, with a nearly infinite number of different proteins, representing the multiple messages that can be encoded by variable splicing of a single gene. Given the smaller number of individual genes, the issues raised by gene patenting demand continued monitoring of this area. 

The CSA was charged with monitoring progress within the area of patenting of genes and reporting back to the House of Delegates. This informational report responds to that charge.

On January 5, 2001, the United States Patent and Trademark Office (PTO) published revised guidelines to be used by their personnel in reviewing patent applications for compliance with the "utility" requirement of 35 U.S.C.101. The final guidelines reflect consideration of significant public comment received from 17 organizations and 35 individuals. The majority of the comments were in support of the three utility criteria set forth in the guidelines: specific, substantial, and credible. 

The following represents a brief review of the comments and responses as reported in the  Federal Register.²

Section I. Discussion of Public Comments. The PTO rejected any arguments that genes should not be patentable that were based on the view that (1) genes are not inventions, but discoveries and hence not patentable; (2) genes are not "new composition of matter" because they exist in nature; and (3) the human genome sequence is at the "core of what it means to be human and no person should be able to own/control something so basic." Discoveries are indeed patentable according to the U.S. Constitution (Article 1, Section 8, Clause 8) since the patent recognizes the isolation and processing of genes apart from their natural state. Related to these arguments were comments proposing that scope of patents should be limited to "applications or methods of using DNA." This argument was rejected on the basis that patents are issued for both processes and composition of matter, and that a DNA molecule should be considered in the same manner as any other chemical compound. 

A related comment argued that a limited DNA sequence should not be patentable because it (by itself) has little utility. The PTO disagreed with this view because there are circumstances in which a DNA sequence could satisfy the specific, substantial, and credible utility criteria. For example, a DNA sequence could be a specific marker for a disease gene. In such cases, the sequence could satisfy the utility criteria, thereby validating its patent value. The opposite view, that DNA sequences have inherent value, was not accepted because at least single uses fulfilling the utility criteria must be described. 

A number of comments took the perspective that patenting of genes will have an inhibitory effect on biomedical research. These were rejected on the grounds that patents are issued to spur further discoveries that are facilitated by the work covered by the patent. Despite the fact that a patent holder may not have cited the most important use of a gene, a subsequent researcher who finds a more important utility has benefited by the disclosure requirement of the original patent. It is on this issue that the PTO evaluated the role of ESTs (expressed sequence tags). It rejected the claim that patenting of ESTs will "impede complete characterization of genes and delay or restrict exploration of genetic materials for the public good." The rejection is rooted in the language of the statutes that the PTO administers; ie, "whoever invents or discovers any new and useful composition of matter may obtain a patent therefor." This same language also counters arguments that called for limitation of the scope of a given patent. Arguments were submitted that the patent would cover "any number of applications even though those uses may be unproven and unattainable." The patentee need only describe one utility, not all possible uses. Here the PTO notes that new and nonobvious methods of using an already patented compound are eligible for new process patents as opposed to the original composition patent. This potentially opens the door for the next level of complexity such as gene-gene interactions and proteomics. 

A number of comments focused on limiting the scope of patents to the disclosed utility and not to future utilities. This view is untenable because future discoveries are facilitated by the disclosure of original patents. The argument that patents should "allow for others to learn and improve the invention" was rejected as grounds for limiting the scope of the patent to a single specific utility. The PTO states that it is somewhat "rare for academic researchers to be sued by commercial patent owners for patent infringement." Given the integral role that industry plays in funding academic research currently, this latter statement does not provide significant protection to permit the "improvement of the invention" by academia. 

The use of computer-based analysis of nucleic acids to assign possible function to the nucleic acid product based on homology to other known nucleic acid products was not rejected by the PTO because the authors did not provide any "scientific evidence that homology-based assertions of utility are inherently unbelievable or involve implausible scientific principles." The PTO also did not accept the argument that such ascribed utility would be obvious. The acceptance or rejection will be made on the preponderance of all the evidence. Nonobviousness is considered separately from the utility requirement and is determined on the basis of relevant prior case law as cited in the  Federal Register.¹

The issue of well-established utility was the subject of a number of comments. Some suggested that even where there is a well-established utility the record should reflect that utility, as opposed to its only being implied. The guidelines have been revised to clarify that a "well established utility is a specific, substantial, and credible utility that must be readily apparent to one skilled in the art." Furthermore, the revised guidelines note that if the examiner does not perceive a well-established utility, a rejection should be entered (under section 101). Nor will a claim of general utility suffice; a specific/particular utility is necessary to fulfill the statutory requirement. The PTO includes a quote from Supreme Court case  Brenner v. Manson, " a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion." 

Section II. Guidelines for Examination of Applications for Compliance with the Utility Requirements: This section provides in outline form the sequential order by which the utility requirement will be examined. It is noted that the guidelines do not constitute rule-making and that rejections are made on the basis of the substantive law and hence can be appealed.

In conclusion, the PTO supported strengthening the utility requirements of gene-related patent applications, which is consistent with AMA policy. Continued monitoring of the impact of patenting on access to genetic testing and improved health outcomes remains of crucial importance. With the publication of the draft of the human genome, and the finding that there are fewer genes than originally postulated, it is even more important that our AMA continue to monitor this area for its potential to enhance understanding of the biology of human health. 

RECOMMENDATIONS

Because this is an informational report, there are no Recommendations.

References

1. Notices. Federal Register: December 21, 1999;64(244):71440-71442.
2. United States Patent and Trademark Office. Utility examination guidelines, Docket No. 991027289-0263-02. Federal Register. 2001;66(4):1092-1099.

Also see AMA's Genetics and molecular medicine Web Site

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