By Donald Zuhn --
An article in the October 10th issue of Science magazine presents the results of an analysis of litigated gene patents, and reaches the conclusion that "for the most part, fears expressed concerning human gene patents have not been manifested overtly in patent litigation." The article, entitled "Trends in Human Gene Patent Litigation" (the full text of the article can be obtained here for $10), was written by Dr. Christopher Holman (at right), an associate professor of law at the University of Missouri–Kansas City School of Law, and author of Holman's Biotech IP Blog.
The motivation behind Dr. Holman's analysis was the suggestion by gene patenting critics that gene patents pose a substantial threat to public health and the progress of science by adversely impacting the development and availability of diagnostic testing and by creating a patent thicket that stifles the development and utilization of technologies, such as DNA microarrays, that involve the use of multiple genetic sequences. As we reported last year, such fears served as the impetus behind a bill introduced by Congressman Xavier Becerra (D-CA) that, if passed, would have banned human gene patenting (see "The Continuing Threat to Human Gene Patenting").
In his study, Dr. Holman first searched the Lexis and Westlaw databases to identify patents containing the sequence identifier language "SEQ ID NO" and for which a notice of litigation had been filed (other search strategies were also employed to identify gene patents that may have been the subject of a lawsuit). For the patents identified in these searches, Dr. Holman then analyzed the asserted patents themselves as well as relevant court documents to identify cases involving an allegation of infringement of a human gene patent. In this manner, Dr. Holman identified 31 human gene patent litigations dating from 1987 to the present. With respect to the number of identified litigations, Dr. Holman states that:
As a point of comparison, he notes that since 2000, at least 1,294 lawsuits have been filed asserting drug patents, and 278 lawsuits have been filed asserting molecular biology or microbiology patents. Breaking down the 31 gene patent litigations, the article indicates that sixteen of the cases involved therapeutic proteins (of which only six were litigated to a final decision, with the patentee prevailing twice) and six involved diagnostic testing (with five being settled and the sixth being dismissed). To gene patenting critics warning of patent thicket problems, Dr. Holman counters that he "found no instance in which a human gene patent was asserted against the manufacturer or user of microarray technology."
In a finding that parallels the results of a study conducted by Ann Mills and Dr. Patricia Tereskerz (see "Nature Biotechnology Study Finds Declining Litigation Rates for DNA-based Patents"), Dr. Holman noted that the number of human gene patent litigations has decreased in recent years (as shown in a figure from his article):
(Holman, Science 322: 198-99 (2008)). Dr. Holman observed that this decline corresponds to a similar marked decline in the filing and issuance of DNA patents in the U.S since 2001.
Dr. Holman begins his article by stating that "[f]ew human gene patents have ever been asserted in court, so any chilling effect [of such patents] arises primarily from a perception of risk that may not comport with reality." His results, however, indicate that if gene patenting critics are worried about the chilling effect of human gene patent litigation, such fears are unfounded. Moreover, with respect to Congressman Becerra's attempts to ban gene patenting, Dr. Holman argues that the results of his analysis "provide little empirical support for a legislative bar to the patenting of genes or DNA."
Patent Docs thanks Dr. Larry Millstein of Holland & Knight for alerting us to the above article.
But the article presupposes litigation as the only measure of determining the stifling nature of patents. Many threats of lawsuits, internal due diligence, settlements prior to lawsuits, and licensing deals that may potentially impede development are not captured by merely looking at SEQ ID NOs in filed law suits.
Posted by: Critic | December 18, 2008 at 01:41 PM