What is patent-worthy?

Sandra Katzman

SUMMARY: Due to differing legal standards for patentability, applications for gene patents face different outcomes in various countries

EMBO Reports [European Molecular Biology Organization] 2, 88 - 90 (01 Feb 2001)

Due to differing legal standards for patentability, applications for gene patents face different outcomes I various countries.

The United States Patent and Trademark Office granted four gene patents to Sagami Chemical Research Institute in Sagamihara City for human cDNAs related to liver function and cell division, although the exact function and mechanism of the coded proteins were unknown. Earlier last year, the Japanese patent Office had rejected these applications, demonstrating, according to the Japanese business newspaper Nikkei (January 8, 2000), that the USPTO has more relaxed stance in granting gene patents.

Indeed, it is not unusual that a patent for the same invention is granted in one country and denied in another, because the legal tests for patentability are not the same in every jurisdiction. Although inventors can file under the Patent Cooperation Treaty with most patent offices in the world to receive protection of their invention, the individual outcome still depends on the patent office I each country. Particularly when it comes to granting patents for expressed sequence tag (ESTs)Ñwhen found by sequencing or by mere homology searches in databasesÑthe USPTO has been shown recently to decide differently from its European and Japanese counterparts.

However, a comparative statement, such as the one the Japanese newspaper made, may be too simplistic. ÔAmong patent practitioners, the laws of the US, «Europe and Japan are considered to be the most developed in the biotech field,Õ S. Peter Ludwig, senior member of Darby & Darby PC, an intellectual property law firm in New York, said, Ôbut they are certainly not Òequivalent.Ó In some respects Japanese law on patentability is more lenient than the US law, in others, more stringent.Õ

International differences in intellectual property laws and their consequences for the biotech industry were among the topics of the BioJapan 2000 symposium in September last year in Tokyo. Patent attorneys and patent officers from Japan, Australia, the UK, Germany and the United States expounded about international strategies for biotech patents. Among the speakers, Janis K. Fraser of Fish & Richardson PC, an intellectual property law firm in Boston, MA, compared the criteria for patentability of genes that the US, European and Japanese patent offices apply. All three accept patent applications for chromosomal genes, clones cDNA and virtual cDNA discovered by data mining. According to Fraser, all three patent offices ask the same questions: ÔFirst: is the full sequence of the gene disclosed? In Europe and Japan, if only a partial sequence is disclosed, is there a straightforward way to obtain the full sequence? Secondly: is the gene novel and non-obvious? And thirdly: is a specific and plausible use for the gene or its encoded protein disclosed?Õ Inconsistencies arise when patent offices make differing decisions based on the completeness of the genetic information disclosed in the application. For instance the policy of the UUSPTO does not now allow claims broad enough to cover a whole cDNA sequence if only a partial cDNA sequence has been disclosed, Fraser continued. In contrast, she said, Ôthe EPO (European Patent Office) and JPO (Japanese Patent Office) consider a partial sequence adequate if it were clear that the full sequence could b obtained without undue burden.Õ However, the EPO and JPO are not so lenient as the USPTO on the requirement for novelty and non-obviousness, Fraser said, because of fewer case laws in these countries. In the shrinking middle ground, the EPO considers a gene non-obvious Ôwhen neither the purified protein nor any homologous gene is catalogued in the prior art.Õ

As for the utility requirement, Fraser pointed out that USPTO demands a Ôspecific and plausibleÕ description of the intended use of an invention to accept a patent application. For example, the intended use of proteins as shampoo ingredients or of transgenic mice as snake food would not be sufficient. ÔA mere statement that a gene or protein could be used in therapy, though based on sound logic, is rarely enough to satisfy the USPTO,Õ she said. On this point, the utility rules of the EU and Japan are similar to the US, she added.

The differing standards for the patentability of a discovery, particularly regarding USPTOÕs policy, have already raised concerns and criticism. Researchers, economists and politicians fear that unfettered patenting of DNA sequences will eventually hinder research in academia as well as in the private sector. In a joint statement in March last year, President Clinton and Prime Minister Tony Blair urged private companies to Ômake raw [DNA] data publicly availableÕ and to make Ôresponsible use of patents.Õ Their statement seemed to be directed at the activities of certain private data marketing companiesÑ-such as Celera Genomics and IncyteÑ-that have been engaged in high-volume sequencing of human DNA and collection of genes and genetic variations. Earlier, in April 1999, the Japan Bioindustry Association offered opinions regarding the patentability of DNA fragments and strongly criticized a 1998 US patent for human kinase homologs granted to Incyte, Inc. in Palo Alto, CA. ÔWe are worried that if patenting of this type of invention becomes common practice it will seriously affect the entire global bioinudstry,Õ stated the industry trade group. ÔWe in JBA consider that applications in relation to this type of invention should not be patented.Õ However, JBA acknowledges the utility of an EST invention as a diagnostic probe Ôfor a specific disease where the association with the disorder is clearly established.Õ

The JBA opinion represents the approximately 250 member companies, which asked the JPO to consider their standpoint when discussing the matter with the US and EU, a spokesperson said. As a non-profit organization, JBA is chartered by the Japanese Ministry of International Trade and Industry, but is independent of it. JPO is officially a part of MITI, but in terms of policyÑ-especially the day-to-day rulings on patent applicationsÑ-it has substantially less autonomy.

In contrast to the UPSTO and the JPO, the EPO is not under the jurisdiction of any European government or the European Union. Rules are set up by the European Patent Organization, which represents the 20 contracting states Ðthe EU member states as well as Switzerland, Monaco, Turkey, Cyprus and Liechtenstein. Although independent of the EU, the EPO has largely adopted its guidelines for patenting in the biotechnology sector, which puts restrictions on the patenting of ESTs similar to the guidelines that the JPO follows.

ÔTo my knowledge, the USPTO is the only major patent office that has issued patents where the principal claims focus of the ESTs themselves,Õ Robert Kneller, Professor at the Intellectual Property Research Center for Advanced Science and Technology at the University of Tokyo said. ÔThe official position of the USPTO is that «êÿ claims should not be treated differently from other claims. Representatives o the EPO have made statements suggesting that the EPO does not believe that claims focused on ESTs are acceptable.Õ JPO has also stated that the likelihood of accepting EST claims is low. ÔNevertheless, I suspect that JPO agrees with [the JBA opinion] that if ESTs have a clear diagnostic utility and are part of the inventive process, patents claiming those ESTs for such a use could be issued,Õ Kneller said.

However, it is unlikely that the JBAÕs criticism will affect the USPTOÕs policy on granting patents for genes. ÔI do not think the JBA opinion by itself will affect the USPTO,Õ Kneller said, Ôand it certainly will not stop applicants from filing EST-based claims with the USPTO is they think there is a reasonable chance that the USPTO will grant patents.Õ On the other hand, there has been a steady drumbeat of criticism from other countries as well as from companies from the US, expressing concern that the USPTOÕs thresholds for finding utility and non-obviousness are too low, and that the patents it issuesÑ-in particular the Incyte kinase patentÑ-are too broad. ÔThe USPTO is sensitive to these criticisms and has tightened up it utility and enablement requirements,Õ Kneller described recent changes in the USPTOÕs policy. ÔIt is also seeking input from the scien6tific community as to what is obvious and predictable in the field of genome science.Õ

Indeed, changed are already underway. Ludwig cites a recent decision by the Court of Appeals for the Federal Circuit in Washington, DC (the court of appeal for all patent cases in the US0 that elaborated the standard for compliance with the written description requirement of US patent Law. To comply, a patent specification must include sufficient information to establish that the inventor is in possession of the claimed invention. ÔTo my knowledge there is no counterpart to this requirement in the patent law of most developed countries,Õ Ludwig said, Ôin this sense, US patent law is more stringent that the laws in these other countries.Õ

One of the newest changes to patent law if that the USPTO has shorted the publication time for patent application to 18 months. Shannon Mrksich of Brinks Hofer Gilson & Lione, a patent law firm in Chicago, expects that the November rule change will not be likely to accelerate academic research, but that industry will Ôbe reading the patents like nuts to see what competitors are up to, because lead time in development is everything.Õ On the other hand, she thinks that no company would refrain from filing a patent application with USPTO to avoid this potential competitive risk.