Center for Advanced Study & Research on Intellectual Property

 

CASRIP Newsletter - Fall 2005, Volume 12, Issue 2

A Comparative Study of DNA Sequence Patenting in the USA, Europe & Japan, and Suggestions for the Course of Action for India

By Aditi Mathur & Mr. Kshitij Dua[1] 


I. Introduction

"I'm not interested in the future. I'm interested in the future of the future."

ROBERT DONIGER, 1996 [2]

For many years, patenting of genes and DNA (deoxyribonucleic acid) sequences has been at the eye of a storm.  The debate has taken a different course at different times, but has continued unabated.  On one side are the proponents of gene patents, composed of the biotech, pharmaceutical and agricultural-bio industries, who argue that genes must be patentable to give companies the confidence to invest the time and money needed to develop gene-based drugs or biotech crops.  On the other end of the spectrum, critics of gene patents maintain that genes are not inventions at all, and that by allowing them to be patented, control is placed in the hands of a few - thwarting further research and restricting access to new treatments for the poor.

Despite these ongoing controversies, patent offices worldwide have issued thousands of patents on DNA sequences, most notable amongst them being the Unites States Patent and Trademark Office ("USPTO"), the European Patent Office ("EPO") and the Japanese Patent Office ("JPO").  The reason behind issuance of such patents being that inventions relating to emerging technologies are inventions that lead to the creation of new industries, and therefore, have a more profound impact on national economies and on international relations.[3]  As researchers move from mapping DNA sequences to decoding their functions and manipulating them for diagnostic and therapeutic purposes, the researchers' work will likely transform the way many diseases are treated.  Accordingly, the companies and countries that own key gene patents will benefit most from these developments.  Consequently, the controversy regarding gene patents in these countries has metamorphosed over the years from the basic question "whether genes should be patentable at all" to a more nuanced question such as to "what should be the scope of its patent protection."  Yet, in countries like India, where the biotech boom is on the horizon, the question facing policy-makers and law-framers is the same: "whether genes should be given patents." In this context, this article embarks on a comparative study of the stance taken by patent offices and courts in the United States, Europe and Japan regarding patenting of DNA sequences and then attempts to chart out what path India should tread, in light of the experience of these other countries.

II. Issues in Patenting DNA Sequences

Progress in scientific and medical research requires the contribution of many different areas of expertise. For this reason, free access to the fundamental information on human sequence and genes has been encouraged, and is an overriding priority for genome sequencing funded from government and charitable sources. Widespread concern has been expressed that restricted access to gene sequences may slow down the development of new cures if the information is not available to all who might use it[4]. Prior ownership of genes by one party may discourage investment in research on the same gene by another party.[5]  Conversely, the development of effective new methods for diagnosis, and drugs to alleviate symptoms and provide new and better cures, requires the continued investment of private as well as public funds, and return on these investments is obtained only by patenting inventive steps and new medicines.[6] Consequently, the field of human genome research is perpetually in the midst of debate concerning these issues. In particular, the fundamental question has always been whether or not gene sequences should be patented and, if so, whether such patents restrict access to the information and suppress subsequent research and innovation, or whether such patents secure the long-term future of the field of gene-based healthcare.

On a more specific level, DNA sequences raise numerous legal questions: questions regarding their 'novelty'  'non-obviousness' and 'utility'. Objectors have argued that gene sequences are naturally occurring 'products of nature'[7] and thus cannot be regarded as inventions to be patented since they are not new inventions, rather only a discovery. Secondly, due to recent advances in biotechnology and computer technology, the field of biotechnological research is steadily becoming more predictable, making non-obviousness less readily acknowledged.[8] Thirdly, because the role and significance of some of these sequences is unclear at present, they pose a problem in satisfying the utility requirements.[9]  Each patent office deals with these questions differently. The next section explores the way these issues are treated in the United States, Europe and Japan.

III. Comparative Legal Analysis

A. United States of America

1. Novelty

DNA sequences are considered by the USPTO to be large chemical compounds that may be patented as "compositions of matter."[10] Although patent claims for naturally occurring DNA sequences might be expected to trigger the "products of nature" rule, [11] courts have upheld patent claims covering 'purified and isolated' DNA sequences as new compositions of matter resulting from human intervention. If it is accepted that transgenic plants and animals, modified micro-organisms and isolated and purified DNA sequences are the results of human intervention[12] and they are patentable subject-matter, naturally, they are "new" in the sense of having no previous existence in the state of the art, having been isolated, purified, or modified to produce a unique form not found in nature.[13]

In its Utility Examination Guidelines,[14] the USPTO explains that an isolated and purified DNA molecule that has the same sequence as a naturally occurring gene is eligible for a patent:

(1) An excised gene is eligible for a patent as a composition of matter or as an article of manufacture because that DNA molecule does not occur in that isolated form in nature; or

(2) Synthetic DNA preparations are eligible for patents because their purified state is different from the naturally occurring compound.[15]

Expressed Sequence Tags ("ESTs"), Single Nucleotide Polymorphism ("SNPs"), partial gene sequences and full-length gene sequences are considered different chemicals.[16] One chemical is not novelty destroying to a different chemical; in the same way, ESTs, SNPs, or partial gene sequences forming a part of the state of the art are not novelty destroying to full-length gene sequences.  Similarly a full-length gene sequence forming a part of the state of the art is not novelty destroying to a section of the sequence.[17]

2. Non-Obviousness

Early DNA patent cases focused on the obviousness of the method used to isolate the sequence rather than the obviousness of the sequence itself.  In contrast, in In Re Bell[18] the Court of Appeals for the Federal Circuit ("CAFC") focused on the structure of a DNA sequence instead.  The Court reasoned that owing to the degeneracy (redundancy) of the genetic code, there were a vast number of nucleotide sequences that might code for a specific protein, and hence the gene is not necessarily rendered obvious when the amino acid sequence of its coded protein is known.[19] The CAFC followed the same reasoning in In Re Deuel,[20] but stated that a different result might occur if the prior art disclosed a small and simple protein so that all DNA coding for that protein would be obvious.  In 1995, the Biotechnology Patent Protection Act was signed into law to ensure that those patentable biotechnological processes using or resulting in a patentable composition of matter are in fact patented.[21]

3. Utility

An invention must be "useful" to satisfy the 35 USC § 101 utility requirement. What exactly constitutes a "useful" invention, however, is not always clear. The Supreme Court in 1966 in Brenner v. Manson[22] held that proof of utility requires that the claimed subject matter must provide a specific and substantial benefit in its currently available form.  The USPTO published Utility Examination Guidelines in 1995, which require a utility to be specific and credible.[23]  The USPTO then published revised Utility Examination Guidelines in 2001,[24] moving to a three-prong test for utility: Does the invention have (1) specific, (2) substantial, and (3) credible utility?[25]

In inventions of DNA fragments, the utility of ESTs [26] is a highly contentious issue.[27] According to the new Utility Examination Guidelines of the USPTO, if an isolated DNA fragment or EST has a specific, substantial, and credible utility, it satisfies the requirement of utility and a patent can be granted.  However, an EST whose use is disclosed simply as a 'gene probe' or 'chromosome marker' would not be considered to have a specific utility.[28]  The recent case of In re Fisher[29] is an instance where the Federal Circuit has upheld the rejection of claims relating to ESTs by the USPTO where their only described utility was as a marker.  The Fisher case presented the Court with its first opportunity to comment on the USPTO's 2001 Revised Utility Examination Guidelines and on the patentability of "research tools." It found that none of the seven claims of Fisher to ESTs met the specific and substantial utility tests.  Chief Judge Michel writing for himself and Circuit Judge Bryson observed:

Essentially, the claimed ESTs act as no more than research intermediates that may help scientists to isolate the particular underlying protein-encoding genes and conduct further experimentation on those genes . Accordingly, the claimed ESTs are, in words of the Supreme Court (Brenner, 383 U.S. at 535) mere "object[s] of use-testing," to wit, objects upon which scientific research could be performed with no assurance that anything useful will be discovered in the end.

B. European Union

1. Patentability

In the early phases, inventions such as DNA, genes or recombinant proteins including transgenic animals and plants became problematic in Europe with respect to what is known as the "ordre public" exception to patentability.  Essentially, the "ordre public" exception stipulates that no patent shall be granted on any invention that is liable to contravene public order or morality or public health.  It is based largely on ethical and religious grounds.  States have the right to protect the public interest, and patent law is not an exception to this general principle.  The term "ordre public," derived from French law, is not an easy term to translate into English, and therefore the original French term is used even in TRIPS.[30]  It expresses concerns about matters threatening the social structures which tie a society together, i.e., matters that threaten the structure of civil society as such. [31]

Europe announced its solution to the "ordre public" in the EU Directive, which is described below:[32]

Article 5

1. The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute a patentable invention.[33]

2. An element isolated from the human body or otherwise produced by means of a technical process, including the structure or partial structure of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. [34]

In its decision of June, 16 1999, the Administrative Council inserted a new Chapter VI titled "Biotechnological inventions" in Part II of the European Patent Convention ("EPC") Implementing Regulations.[35]  The European Patent Office has introduced four new rules, Rules 23b to 23e.  Rule 23b sets forth general matters and defines the meaning of biotechnological inventions, biological material, plant variety, and microbiological process.  Rule 23c[36] states patentable biotechnological inventions, including:

(a) Biological material isolated from their environment, even if known in nature. This particularly applies to genes that are isolated from their natural environment by means of technical processes and made available for industrial production.

(b) Plants or animals if the invention is not confined to a single variety.

This provision clarified the scope of Article 53(b) of EPC.[37]  Rule 23d[38] sets forth what is not patentable.  The list[39] gives concrete form to the concepts of "ordre public" and "morality."  Rule 23e[40] indicates what is and is not patentable with respect to the human body. The human body and its elements cannot be patented. However, elements of the body, when isolated from the body, may be patented. Thus, under these rules, gene sequences become eligible patentable subject matter as they are seen as chemical compounds purified and isolated from their natural form.

2. Non-Obviousness (Inventive step)

It has long been established by EPO Boards of Appeal that the disclosure of a protein renders obvious the nucleic acid sequence encoding that protein, irrespective of whether the actual nucleic-acid sequence has been disclosed.[41]  Exceptions to this general rule do exist - for example, when it can be shown that the nucleic acid sequence was particularly difficult to obtain and "inventive skill" was required in obtaining the sequence.  Moreover, if it can be shown that the nucleic acid has a "surprising" feature that could not be predicted from the disclosure of the protein, and that the feature is in some way advantageous, then such a nucleic-acid sequence could be deemed "inventive," despite the disclosure of the protein sequence.[42]

3. Utility

Concerning utility, the EU Directive includes the following provision requiring clear specification of the function:[43]

Recital 23

Whereas, in order to comply with the industrial application criterion it is necessary in cases where a sequence or partial sequence of genes is used to produce a protein or part of a protein, to specify which protein or part of a protein is produced or what function it performs.[44]

Thus, partial sequences and ESTs whose function is not clearly specified are not patentable in Europe.

C. Japan

1. Patentability

Japan is one of those nations where specific guidelines have evolved from the JPO to deal with patents concerning genetic inventions. Article 32 of Japan's Patent Law also provides an "ordre public" exception, however, in actual examination of genomics inventions, there are very few cases, if any, where problems regarding public order or morality or public health have been raised.[45]  Thus, they do not face problems of patentability.[46]

2. Non-obviousness

The JPO examines the obviousness of genes according to the Implementing Guidelines based on the "obvious-to-try" test.[47] This test differs from the test of structural obviousness of conventional-type chemicals.[48]  In the case of conventional-type chemicals, it is presumed that chemicals with analogous structures have similar properties, rendering one obvious in the light of the other.  However, with regard to gene-related substances such as DNA and recombinant proteins in the field of genomics, the presumption that an analogous structure has similar properties is not necessarily applicable, since the correlation between the chemical structure of a DNA, or a recombinant protein encoded thereby and the physiological activity of the protein is not yet clear given the current state of techniques.[49]

3. Utility

In 1997, the Japanese Patent Office published its "Implementing Guidelines for Inventions in Specific Fields," Chapter 2 of which is titled "Biological Inventions."[50] Inventions in the biotechnology field in the Guidelines are divided into four types: genetic engineering,[51] micro-organisms, plants and animals.  According to the guidelines, inventions of a gene, a vector, a recombinant vector, a transformant, a fused cell, a recombinant protein and a monoclonal antibody whose utility is not described in a specification or cannot be inferred, do not meet the requirement of utility.[52]

IV. Conclusion: Charting the Course for India

Upon a close analysis of the patent systems in the United States, Europe and Japan, it becomes clear that DNA sequences are not only patentable, but they are being given patents all around the globe, albeit with different standards and different doctrines being applied in each respective country.

In India, meanwhile, the Indian Patents Act, 1970 in its present form is silent on the question of patenting of genes and DNA sequences.  However, with the emerging biotechnology industry in the country and increased level for foreign investment flowing into this nascent sector, the Indian Patent Office will be grappling with a large number of such requests in the near future.  Therefore, it is imperative that before embarking on patenting DNA sequences, India should establish a special task force or committee of experts to identify the various issues involved, analyze international trends, consider India's economic requirements and then suggest the path that needs to be undertaken by the Patent Office while dealing with patenting of DNA sequences. 

While deliberating upon the various kinds of legal, social, ethical and economic issues involved in patenting DNA sequences, the emerging Indian economic scenario and India's position in the global marketplace also need to be considered.  First, the ever-increasing role played by venture capitalists in funding emerging technologies in India needs to be appreciated, as giving patents to gene sequences would help in inviting the much-needed foreign investment into the research and development in biotechnology in India.  This would in its wake bring more employment opportunities for the young professionals boosting the economy.

Second, evaluating the development occurring in India in every sector, including space exploration, information technology and nuclear power, it would be imprudent to block an industry from creating new technology through genetic research by refusing patents per se.  At the same time, the fear of skeptics that patents on key genetic inventions would hamper research can also be allayed because of the provision of compulsory licensing under the Indian Patents Law.[53]

In these circumstances, a refusal to patent genome sequences would be both impractical and unrealistic.  Rather, specific guidelines on the conditions under which such patents are granted would need to be developed. The example of patent guidelines specific to the needs of the biotechnological field, like those in Europe[54] and Japan[55] is an example worth emulating.  India could also formulate rules pertaining to patentability of biological inventions, categorizing them into sub-headings like genetic engineering, micro-organisms, plants and animals, akin to the Implementing Guidelines of Japan.  Furthermore, with respect to the utility requirement, the USPTO's Utility Examination Guidelines, 2001 providing for demonstration of specific, substantial and credible utility are worth replicating.



[1]  Ms. Aditi Mathur & Mr. Kshitij Dua, Students, B.A. LL.B. (Honours), National Law Institute University, Bhopal, INDIA. Ms. Aditi Mathur is 2005 CASRIP Summer Institute Alumnus.

[2]  As quoted in The Timeline, by Michael Crichton, the Author of the Bestseller Jurassic Park.

[3]  Patents of human DNA sequences are a recent example of industry-creating inventions.

[4]  See B. Looney, Should Genes be Patented? The Gene Patenting Controversy: Legal, Ethical and Policy Foundations of an International Agreement 26 L. & Pol'y Int'l Bus. 231, 240 (1994) ("Patents could impede the development of diagnostics and therapeutics by third parties because of the costs associated with using patented research data.").  See also, P.A. Lacy, Gene Patenting: Universal Heritage vs. Reward for Human Effort 77 Or. L. Rev. 783 (1998) ("Patent stacking (allowing a single genomic sequence to be patented in several ways such as an EST, a gene, and a SNP) may discourage product development because of high royalty costs owed to all patent owners of that sequence; these are costs that will likely be passed on to the consumer.").  For recent analysis, see Basher, S., Block Me Not: Genes as Essential Facilities, Institute of Intellectual Property, Tokyo, March 2004.  Another major argument against patenting genes is on ethical grounds.  A coalition representing more than eighty faiths and denominations including Catholics, Evangelicals, Protestants, Jews, Muslims and Buddhists, have declared their opposition to the patenting of genetically engineered animals, humans, genes, cells and organs. They believe, that humans and animals are creations of God, not humans, and as such should not be patented as human inventions. Patenting of genomic sequences, in their view, "represents the usurpation of the ownership rights of the sovereign of the universe."  For this view, see R. Stone, Religious Leaders Oppose Patenting Genes and Animals 268 Science 1126 (1995) and K. Woodward, Thou Shalt Not Patent! Newsweek, May 29, 1995 at 68.

[5]  Id.

[6] Within the context of biotechnology, proponents in favour of patenting genetic sequences argue that patents facilitate scientific research by encouraging investment in what would otherwise be a risky and financially unrewarding industry. They argue that the financial investment in research, secured by a patent, results in the development of new drugs and treatment, which in turn benefits humanity in general. Furthermore, it has been argued that it would be fundamentally unfair to require researchers and investors to expend vast resources, publicize results, and provide benefit to the public without the guarantee of a potential return on their investment. See G. Poste, The Case for Genomic Patenting 378 Nature 536 (1995); B. Healy, Special Report on Gene Patenting 9 N. Eng. J. Med. 664, 666 (1992).  For a recent analysis, seeNishi, T., Current Situation Surrounding Patents on Genes & Proteins-Protection From the Innovational Viewpoint, Institute of Intellectual Property, Tokyo, March, 2004.

[7] According to the product of nature theory, any kind of structure made by human hand is patentable, but things that exist in substantially the same form in nature (i.e., not made by human hand), namely "products of nature" are not patentable. This is a theory that has often been employed in U.S. patent case law. See Ex parte Latimer, 1889 Comm.n Dec. 13 (1889), Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), Parke-Davis & Co. v. H. K. Mulford & Co., 196 F.496, 116 C.C.A. 262 (2d Cir. 1912), Ex parte Snell, 86 U.S.P.Q. 496 (Pat. Off. Bd. of App. 1950). By examining these legal precedents, it becomes clear that the difference between a discovery and an invention is a difference in degree rather than in kind, and when the human and material resources inserted in research reach a certain level, the product of such research is protected under patent law. Judge Learned Hand's opinion in Parke-Davis & Co. v. H. K. Mulford & Co., 189 F. 95 103 (S.D.N.Y. 1911) amply illustrates that patents are not denied merely because products of nature are claimed. This suggests that if there is sufficient reason for granting a patent, then the subject matter requirement will be satisfied. In other words, patent applications are not rejected merely because they claim products of nature.

[8] Biotechnology was considered a field that is highly unpredictable, on par with the field of chemistry, because of which, it could have provided a framework in which non-obviousness would be more readily acknowledged. However, recent advances in biotechnology and computer technology have changed this situation. Due to ongoing progress in computer technology, advances in algorithms, and the accumulating body of experiments and results, fields such as hybridoma technology, combinatorial chemistry, drug design with computers, EST sequencing, and SNP genotyping are steadily becoming more predictable. Maintaining the current standard for non-obviousness in an environment in which unpredictability is steadily decreasing may lead to cases in which non-obviousness must be denied. See Hirai, A., Biotechnology and Legal Protection: Current Issues, CASRIP Newsletter (Winter 2001).

[9] The most recent controversy is regarding the threshold of utility required to be proved for getting patents on ESTs (Expressed Sequence Tags).  Full sequence and function often are not known for these gene fragments. The 300- to 500-base gene fragments called ESTs represent only 10 to 30% of the average cDNA, and the genomic genes are often 10 to 20 times larger than the cDNA (Complementary DNA). Patent applications for such gene fragments have sparked controversy among scientists, many of whom have urged the patent office not to grant broad patents in this early stage of human genome research to applicants who have neither characterized the genes nor determined their functions and uses. On pending applications, their utility has been identified by such vague definitions as providing scientific probes to help find a gene or another EST or to help map a chromosome.

[10] 35 U.S.C §101.

[11] The "Product of Nature" doctrine creates an important restriction in biotechnology, because biotechnology products and processes may be derived from duplication of compounds found in living organisms or produced by naturally occurring animals or plants. Courtney J. Miller, Patent Law and Human Genomics 26 Cap. U. L. Rev. 911 (1997), as quoted in Du,  Z. X., The Patentability of Biotechnological Inventions and Practices in China, BioScience Law Review, August 10, 2001, http://pharmalicensing.com/features/disp/997365145_3b72959963a57.

[12] "Anything under the sun created by man" as espoused in Diamond v Chakrabarty, 447 US 303 (1980). 

[13] A patent on a gene covers the isolated and purified gene but does not cover the gene as it occurs in nature. Thus, the concern that a person whose body 'includes' a patented gene could infringe the patent is unfounded. The body does not contain the patented, isolated and purified gene because genes in the body are not in the patented, isolated and purified form.

[14] See http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi.

[15] Id.

[16] Id.

[17] In "Biotechnology Comparative Study on Biotechnology Patent Practices Comparative Study Report" by the USPTO, EPO and JPO, there is a posited case. The prior art (Y) is a structural gene encoding a functional polypeptide, the whole sequence of which is disclosed. The claimed invention (Y') is a partial DNA fragment of Y. Does the claimed invention (Y') has novelty over the prior art (Y)?

The three Offices present a generally similar result, that is, such an invention that relates to this partial sequence is regarded as being novel when an invention relating to a partial sequence has not been disclosed in concrete terms in publicly known literature. It looks like a selection invention. It seems that the DNA fragment is new based on the reason of selection invention. But the invention selecting a DNA fragment from a full-length gene sequence is not a selection invention. The DNA fragment is an isolated compound that is different from the full-length gene compound. Because the DNA fragment and the full-length gene are different compounds, the full-length gene sequence forming part of the state of the art is not novelty destroying to the DNA fragment. If it is considered that an invention of a DNA fragment isolated from a full-length gene sequence is a selection invention, the DNA fragment invention will become a dependent invention of the full-length gene invention. The DNA fragment invention is not a dependent invention of the full-length gene invention. The two inventions are independent. See: http://www.jpo-miti.go.jp/saikine/contents.htm

[18] 991 F.2d 781 (Fed. Cir. 1993).

[19] The court cautioned that its view was 'not to say that a gene is never rendered obvious when the amino acid sequence of its coded protein is known' but that was not the situation in the present case. The art in question suggested use of only a short probe and the applicants apparently had to choose a longer probe in order to obtain the gene in question and thus had taken a step contrary to the prior art teaching. Thus, what the applicants had done was not obvious.

[20] 34 USPQ 2d 1210 (1995).  In this case, the CAFC stated that the existence of art disclosing a protein and a technique that can be used to determine the DNA sequence coding for that protein does not make obvious the specific claimed DNA sequence coding for that protein. Due to the redundancy of the genetic code, the disclosure of a partial protein sequence does not suggest a particular DNA sequence coding for the protein. The fact that one can conceive a general process in advance for preparing an undefined compound does not mean that a claimed specific compound was precisely envisioned and therefore obvious.

[21] The companion cases of In Re Ochiai, 37 USPQ2d 1127 (Fed. Cir. 1995) and In Re Brouwer, 37 USPQ2d 1663 (Fed. Cir. 1995) were the first time the CAFC dealt with the non-obviousness problem of biotechnological processes in light of the enactment of the Biotechnology Patent Protection Act. The Ochiai and Brouwer approach is simple, logical, and straightforward: if the novel and non-obvious starting material is a part of the otherwise obvious process, the process is non-obvious because, without the knowledge of the starting material, one would not have been able to choose it to make the product in the process. Likewise, if the novel and non-obvious resulting material is a part of the otherwise obvious process, the process is non-obvious because, without the knowledge of the resulting material, it would not have been obvious to someone with ordinary skills in the art how to make the resulting material. Jeremy (Je) Zhe Zhang, "In Re Ochiai, In Re Brouwer and the Biotechnology Process Patent Act of 1995: The End of the Durden Legacy?, 37 IDEA 436 (1997), http://pharmalicensing.com/features/disp/997365145_3b72959963a57.

[22] 383 U.S. 519, 148 USPQ 689 (1966)

[23] The 1995 Guidelines had thus omitted the requirement that the assertion of utility also be "substantial," as set forth by the Supreme Court in Brenner. This led to patenting of ESTs.  In 1997, the Patent Office further declared that since ESTs were acknowledged to have utility apart from the full-length sequences from which they were derived, an applicant would no longer be prevented from securing protection for an EST by the failure to specify the function of the full-length sequence from which that EST was derived.

[24] Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices,              http://www.uspto.gov/web/offices/pac/utility/utilityguide.pdf.

[25] The revised Guidelines now required that an applicant assert a specific and substantial utility for the claimed invention that would be considered credible by a person of ordinary skill in the art.  The Patent Office also issued Revised Interim Utility Guidelines Training Materials, which provided Examples indicating how the revised Guidelines were to be applied to thirteen different types of biochemical subject matter, including ESTs, as well as definitions of the three utility prongs.  In particular, the Training Materials defined "specific utility" as utility that is specific to the subject matter claimed, as contrasted with a general utility that would be applicable to the broad class of the invention; "substantial utility" as utility having a "real world" use (Utilities that require or constitute carrying out further research to identify or reasonably confirm a 'real world' context of use are not substantial utilities. 'Throw away' utilities do not meet the tests for a specific or substantial utility); and "credible utility" as utility that is believable to a person of ordinary skill in the art based on the totality of evidence and reasoning provided (An assertion is credible unless (a) the logic underlying the assertion is seriously flawed, or (b) the facts on which the assertion is based are inconsistent with the logic underlying the assertion.). 

[26] Supra, note 8.

[27] Opponents of EST patents have argued that permitting EST patents will encourage researchers to search for and patent ESTs rather than focus on characterizing full-length genes. It has also been argued that allowing the patenting of ESTs will disproportionately favor large pharmaceutical companies and that patenting ESTs will inevitably lead to costly disputes. Another argument is that too many EST patents will increase licensing complexity and costs, and lead to grave market inefficiencies. Proponents of EST patents have argued that, at one time, the electronics and computer industries faced similar objections, yet patent protection in those industries actually spurred innovation and lead to better and/or less expensive products.

[28] It satisfies the requirement of utility if for example use as a probe to diagnose a specific disease, is disclosed. On the other hand, a claim to a polynucleotide whose use is disclosed simply as a "gene probe" or "chromosome marker" would not be considered to be specific in the absence of a disclosure of a specific DNA target. Similarly, the use of a protein as an antigen is not a specific utility as essentially all proteins are antigens.

[29] http://fedcir.gov/opinions/04-1465.pdf

[30] Based on a long established tradition in patent law (particularly in the European context), Article 27 of TRIPS allows (but not mandates) two possible exceptions to patentability, based on ordre public and morality. The implementation of these exceptions, which need to be provided for under national law in order to be effective, means that a WTO Member may, in certain cases, refuse to grant a patent when it deems it necessary to protect higher public interests.

[31]http://www.iprsonline.org/unctadictsd/docs/RB2.5_Patents_2.5.3_update.pdf. 

[32] As cited in Hirai, A., Biotechnology and Legal Protection: Current Issues, CASRIP Newsletter (Autumn 2000).

[33] To interpret the term simple discovery, the product of nature theory may prove useful.

[34] Here, technical process is also a broad term, requiring the same interpretive work as for simple discovery in Paragraph 1.

[35] Notice dated July 1, 1999 concerning the amendment of the Implementing Regulations to the European Patent Convention, Official Journal EPO, Sept. 8, 1999, at 545 to 587. The new provisions entered into force on Sept. 1, 1999 and implemented the requirements of the EU Biotechnology Directive in European patent law.

[36] Id.

[37] Article 53(b) of the European Patent Convention (EPC) provides that European patents shall not be granted in respect of 'plant or animal varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof'.

[38] Id.

[39] This includes processes for cloning human beings, processes for modifying the genetic identity of human beings, using human embryos for commercial purposes and modifying the genetic identity of animals such as may cause them suffering without substantial medical benefit.

[40] Id.

[41] Soames, C .J. and Kowalski, T. J. Inventive Step And Genomics, 3 Nature Review 729  (September 2004), http://www.flhlaw.com/news/news_49.pdf.

[42] Id.

[43] Supra, note 32.

[44] Id.

[45] In Japan, even ESTs and SNPs, recently the subjects of active development, are not likely to encounter problems markedly distinct from those of conventional genomics inventions with respect to public order or morality. Contrast this with the position in Europe discussed Supra.

[46] See Hirai, A., Biotechnology and Legal Protection: Current Issues, CASRIP Newsletter, (Winter 2000), where it is observed that ".it is believed that public order or morality will not become a serious problem for genomics inventions in the future [in Japan]. This belief is largely based on two facts. The first is that the Japanese people are not as sensitive as the people of Europe and the United States to problems, including religious problems, of public order and morality. The second is that the Japanese Patent Office .is very restrained in its application of Article 32 of the Japanese Patent Law."

[47] Regarding the assessment of obviousness of these genes and gene fragments, the JPO's practice of applying the obvious-to-try test, is substantially the same as the EPO's practice. This is in complete contrast, however, to the US practice of applying the test of structural obviousness for determining the obviousness of genes and gene fragments, in compliance with the 1995 decision of the Court of Appeals for the Federal Circuit (CAFC) in In re Deuel, 34 USPQ 2d 1210 (1995). See Comparative Study on Biotechnology Patent Practices: Trilateral Project 24.1 - Biotechnology, published 1997 by the three patent offices: USPTO, EPO & JPO; and Comparative Study on Patentability of DNA Fragments by the Three Offices, published June 4, 1999. In these publications, the EPO indicates that assessment of the inventive step of genes, gene fragments and recombinant proteins is based substantially on the obvious-to-try test.

[48] In examination of the inventive step of a conventional chemical, if the chemical is strikingly different in structure from a publicly known chemical, it is unconditionally considered non-obvious according to the Implementing Guidelines Regarding Product Inventions published 1975. By contrast, if the chemical is similar in structure to a publicly known chemical, it is rejected in its examination as being prima facie obvious in view of the publicly known analogous chemical. Nishi, T., Current Situation Surrounding Patents on Genes & Proteins-Protection From the Innovational Viewpoint, Institute of Intellectual Property, Tokyo, (March 2004).

[49] For example, even if there is a difference in only a single codon encoding a certain amino acid, properties of the expressed protein may change drastically; or even if homology is high, the activity may be different between expressed proteins; or conversely, even if it is low, the activity may not substantially differ between expressed proteins. Hiraki, Y., Problems Regarding the Patentability of Genomics and Scope of Protection of ESTs in Japan, CASRIP Newsletter, Winter 2000.

[50] See Implementing Guidelines for Inventions in Specific Fields, Chapter 2, "Biological Inventions,",  http://www.jpo-miti.go.jp.

[51] Inventions relating to genetic engineering include those of a gene, a vector, a recombinant vector, a transformant, a fused cell, a recombinant protein, and a monoclonal antibody.

[52] Under Article 29(1) of the Japanese Patent law, utility means industrial applicability as prescribed in the main paragraph of Article. Inventions that are incapable of industrial application do not meet the requirement of utility. However, clear demonstration of the use is not necessary. Where there is a description in the specification from which it is possible to presume or predict the use, industrial applicability will not be denied on examination.

[53] Section 84 of the Indian Patents Act, 1970 provides for compulsory license on a patent if "the reasonable requirement of the public with respect to the patentable invention has not been satisfied" i.e. if the refusal of patentee to grant a license on reasonable terms results in prejudice to an existing or upcoming industry or commercial activity in India or market for export from India.

[54] Chapter VI entitled 'Biotechnological inventions' in Part II of the European Patent Convention (EPC) Implementing Regulations.

[55] Chapter 2 titled "Biological Inventions" in the "Implementing Guidelines for Inventions in Specific Fields."

Last updated 4/27/2012