JILT 2004 (1) - Georgios I Zekos
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Contents
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Patenting Biotechnology
Dr. Georgios I Zekos
Attorney at Law
gzekos@hotmail.com
Abstract
Patents are a division of the larger field of law known as intellectual property law and it is recognized that some types of intellectual property should be granted legal protection.A patent is a contract between the government and an inventor under which, in exchange for the inventor’s complete disclosure of the invention to the public, the government grants the inventor the sole rights to prohibit others from making, using, selling or offering for sale the claimed invention for a limited period of time, in general twenty years after the date that the application for the patent was filed [1] .
Biotechnology is 'the application to industry of advances made in the techniques and instruments of research in the biological sciences.' [2] Modern biotechnology corresponds to the revolution in molecular biology precipitated by the Watson-Crick discovery of the double-helix structure of DNA in the early 1950s. Since the 1970s particular attention has been paid to the patentability of biotechnology focused on genetically modified organisms and other products derived from living systems. Does patent law protect such subject matters? Can biotech patenting be harmonized? How can the traditional principles of patentability be applied to new forms of technology? Should biotechnology be regarded as subject matter for patent protection? [3] The Aim of this analysis (based mainly on US law) is to highlight biotechnology patent novelties and compare them to established principles of patent law.
Keywords: Patent Law, Biotechnology, 1952 Patent Act, Invention, Obviousness, DNA.
This is a refereed article published on 30 April 2004.
Citation: Zekos,' Patenting Biotechnology ', 2004 (1) The Journal of Information, Law and Technology (JILT). <http://elj.warwick.ac.uk/jilt/04-1/zekos.html>. New citation as at 15/07/04: <http://www2.warwick.ac.uk/fac/soc/law/elj/jilt/2004_1/zekos/>.
1. Introduction
In the US the 1952 Patent Act imposes only four requirements for patentability on claimed subject matter: (1) the subject matter must have some practical utility; (2) the subject matter must be either a process or a physical embodiment of the invention; (3) the subject matter must not not be disclosed, with limited exceptions, in prior art; and (4) the subject matter must not be obviously based on prior art. Patent protection does not extend to abstract ideas. And according to the product of nature doctrine nor does it extend to the laws of nature or physical phenomena [4] . The product of nature doctrine thus prevents geologists from patenting a mineral discovered in the earth and biologists from patenting a plant found in the wild because these discoveries are 'manifestations of . . . nature, free to all men and reserved exclusively to none.' [5] The label ‘product of nature’ is not automatically synonymous with a material that exists in or can be derived from nature; in fact, such products are often the objects of invention. The doctrine, perhaps, has been used to safeguard the requirement of an inventive step. Moreover, patents are granted to any individual applicant who discovers or invents any new and valuable process, machine, manufacture, or composition of matter, or any new and useful upgrading thereof. [6]
An invention in order to be patentable must meet several requirements and the first requirement in obtaining a patent is that the invention must be novel. What constitutes novelty? An invention is not novel if the invention is not merely non-obvious given the prior art but is actually already found in the prior art, which means that the non-obviousness [7] facts are central to the novelty determination [8] . Unlike novelty, where the claimed invention is compared with a single prior art reference [9] , non-obviousness compares the claimed invention with the relevant prior art as a whole [10] . The second requirement in obtaining a patent is that of utility and the progress of useless arts is not encouraged. The final requirement is non-obviousness. So, a patent will not issued if the differences between the invention seeking the patent and other known, previously established inventions (called 'prior art'), 'are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains . . . .' [11] . Hence, an invention is novel if it is until that time unknown or undisclosed to the public, and an invention is obvious if prior art or knowledge would lead a practitioner skilled in the art in which the invention was made to conceive of the invention and teach that practitioner how to accomplish the necessary steps of the invention. Were an invention deemed obvious, by definition there would be nothing to disclose. Thus, this third requirement, like the previous two, is consistent with the bargain nature of patent law. In other words, usefulness, novelty, adequate disclosure, and non-obviousness are all required for a patent to be valid. Notwithstanding the simplicity of this requirement in the context of the bargain nature of patent law, it is perhaps patent law’s most complex concept, due to the difficulty in determining which inventions are and are not obvious. In the US the Supreme Court’s solution to the problem of differentiating processes has been to restrict patents to those processes that effect transformations in the physical world–for example, sifted flour [12] ;separated glycerine [13] ; or cured rubber [14] . .
A patent is enormously powerful because it protects novel and non-obvious ideas and not just the expression of those ideas. And in exchange for this powerful protection, an inventor must publicly disclose the subject matter of the patented invention. Obviousness is to be determined against the background of the prior art, the differences between the claimed subject matter and the prior art, and the normal level of skill in the art. The underlying ‘idea’ is that in business terms this ‘creation’ represents an asset to which monetary value can be attributed.
The patent system is meant to protect technology—actual machines, devices, and new chemical compositions—rather than pure concepts [15]. Business methods which are more concerned with financial, interpersonal, and societal relationships than with engineering.and which are not tied to specific machinery or devices are thus not patentable. The European Patent Office (EPO) recently clarified its position on the patentability of business methods by stating that business methods are not of a technical nature and so cannot receive patent protection as a process under the EPO system.
European systems presently require that mathematical algorithms imbedded in software provide a technical solution to a technical problem in implementing a process. Biotechnology products are manufactured using electronic technology. They are also manufactured using software products. More so than conventional patented products. The European Patent Office has drawn a distinction between computer software per se and its application towards the resolution of technical problems, excluding from patentability only the former class of inventions.
In the EU it is possible to patent a business method provided that it is technical in nature and industrially applicable. In the US software can be patented if it produces a ‘useful, concrete and tangible result’. The US offers as much protection as possible to its inventors. Existing legislation and case law are interpreted as broadly as possible. The patentability of software is well established and computer programmes can be patented. Since software is not a law of nature itself, insofar as it utilizes the physical resources of computer hardware, it should unquestionably be patent-eligible subject matter. While Europe [16] insists that its technical requirement bars inventions without at least some physical effect from patentability, the United States has abandoned the notion that patentable inventions must somehow exist in the physical world. This is noticeably reflected in unambiguously including business methods within patentable subject matter [17] .
Lunney [18] proposes applying a marginal creative investment requirement to presumptions of non-obviousness. Internet patents, for instance, seem to demand more creativity investment than traditional innovations such as chemical or pharmaceutical inventions, which require substantial investment for testing and implementation. E-commerce combines computer software development and business development. For Internet business model patents, the focus of the claims tends to be mainly on a method of doing business conducted in the environment of cyberspace. The innovation in an Internet business model patent lies not in the computer programming associated with implementing the model, but instead in the 'idea' of allowing a customer to order an item by a single action, or 'haggling' over the price of an item [19] . European Judge Steinbrener believes that 'it is legitimate to have a mix of technical and ‘non-technical’ features appearing in a claim, even if the non-technical features should form a dominating part' [20]. His American colleague Judge Clevenger seemingly agrees, stating that 'today . . . virtually anything is patentable,' [21] .
2. Novelties of Biotechnology Patents
2. 1 PatentabilityThe fundamental rules of patent law were set in a world in which inventions were mainly mechanical and intellectual creations were not protectable unless good cause was shown [22] Today patent law extends beyond the mere mechanical into such realms as biotechnology, semi-conductors, and computer hardware and software. But as patent law has always been technology neutral in theory and technology specific in application there currently exists a tension within patent law and whether or not the older rules can be applied to the newer technologies is a subject of great debate.
Courts have always had trouble with process patents because they are afraid that the claims in these patents are really drawn to principles of nature, which must remain in a domain where they can be used by all people. Can we accept the patentability of processes per se? After all, process patents, which involved physical transformations rather than mere abstractions, were crucial to the growing chemical industry of the early twentieth century. [23] Can the idea that biotechnology patents are crucial to the medical industry today be supported? Can patent law protect only conventional 'hardware' inventions? Manufactures and machines were formerly at the core of the patent system. Program writers, or 'software engineers,' labor to solve complex, demanding problems and just because the end product of today’s engineering mind is manifested in a string of bits, it is no less a piece of 'technology' than practical solutions of old, expressed in wood or steel. Moreover, the ubiquitous presence of computer technology allows inventors to characterize new businesses as essentially new combinations of hardware and software, and in some cases as new software packages per se.
There were several complaints in the early years of biotechnology and software patents that the USPTO was allowing too many exceedingly broad patents [24] . Take for example the case of living micro-organisms. Since the 1873 patenting of Louis Pasteur’s yeast, microbes have been historically considered patentable subject matter. The patentability of living micro-organisms was confirmed by the US Supreme Court in Diamond v. Chakrabarty [25] . The case revolved around Ananda Chakrabarty’s invention of a new bacterium genetically engineered to degrade crude oil. In the case, the Supreme Court found that microorganisms not found in nature, such as Chakrabarty’s bacterium, were patentable materials under § 101 of the 1952 Patent Act.
One can make the argument that if a product of nature is new, useful and non-obvious, it may be patented if it has been shaped by humans, such as in genetic engineering. A mere DNA sequence without indication of a function does not contain any technical information and is therefore not a patentable invention. The value of the patented invention regarding DNA (isolation or synthetization) lies in the encoded information programming the production of a protein or other substances. Nevertheless, the EPO appears to be more restrictive than the USPTO in allowing computer-related inventions. Overall, the term technology is construed more narrowly in Europe than in the US. [26] The U.S. patent laws require that, to be patentable, an invention must pass the standard subject matter test [27] .
Debates about the patentability of plant varieties have revolved around whether or not living things and natural substances can be regarded as new inventions amenable to individual ownership [28] . Many jurisdictions have introduced exclusive sui generis protection for plant varieties (plants as manifestations of nature should be free to all men and reserved exclusively to none) [29] . Can modern biotechnology be distinguished from the plants and natural or living phenomena for which patents have been denied? The first types of genetically engineered products consisted of DNA sequences and micro-organisms that had been derived in a laboratory and had a proven utility not possessed by the sequence or micro-organism in its natural state. Whilst processes of treating and breeding plants and animals typically involved the mere modification of natural conditions, a biochemical process is conducted in the artificial environment of a laboratory [30] . In other words microbiological methods were viewed as identical in all material respects to chemical processes and as suitable for patent protection on that basis [31] . After the development of modern biotechnology such products were understood to include genetically engineered micro-organisms and DNA sequences [32] . To that extent in Merck & Co. v. Chase Chemical Co.[33] the inventors were the first to isolate the vitamin B-12 in crystalline form from the fermentation products of a specific fungus and identify it as a B-vitamin useful as a treatment for pernicious anemia. The court noted first, that the identity of the anti-pernicious anemia factor was unknown before its isolation and second, that the inventors were the first to make the treatment available to the world and so both facts are evidence of novelty. So, there is not only information knowledge about the vitamin and its role in a disease but also the creation of a treatment for its cure. Additionally, the court also drew attention to the fact that the prior art was directed at the study of the anti-pernicious anemia factor in the liver, which tends to show that the invention was non-obvious. It could be argued that a newly baked perspective on the product of nature doctrine would be helpful [34] . A particular mixture or composite material is patentable when new or refined properties arise from the combination of raw materials [35] . Products of nature are only compositions of matter that can be taken directly from the environment and put immediately to use. Besides, Antihydrogen is the antimatter equivalent of elemental hydrogen. It is composed of one positron orbiting one antiproton and was created for the first time in 1995 by scientists working at CERN, the European Laboratory for Particle Physics (near Geneva),. Prior to 1995 a similar process probably never occurred in nature [36] . Hence, it could be argued that a product is not a product of nature when the probability to occur in nature is minimal and it is the product of a process involving new technical steps.
2.2 Biotechnology Patents as Chemical Compound
Is the subject matter of modern biotechnology analogous if not identical to chemical compounds? It is established that modern biotechnology involves the technological manipulation of living and or natural phenomena to produce structurally distinct chemical objects of new or improved utility. Many modern biotechnological products are carriers of information rather than physical objects of practical use [37] . Biotech patenting is part of the wider phenomenon involving use of the patent system to promote emerging information industries. Is there equivalence between chemical compounds and modern biotechnology? The difference between biotechnology and chemical compound results not from the physical structure of modern biotechnological products but rather from the relationship between those products’ structure and function. If the product of modern biotechnology is merely information then it is not subject matter that the patent law protects [38] . On the one hand, the US court of Appeals considers modern biotechnology products as equivalent to chemical compounds and as patentable on that basis. On the other hand, European courts question the suitability of patent system to accommodate the modern biotechnology products. Moreover, the EU[39] imposes restrictions on the pantentability of human organs when their commercial exploitation would be contrary to public order or morality.
2.3 Invention and Obviousness in Biotechnology
Are the products of modern biotechnology suitable for paten protection in the sense of falling within the scope of subject matter that patent law protects? The line is drawn between protectable inventions and un-protectable discoveries. Are the products of modern biotechnology inventions? The requirements of novelty, inventiveness, utility and sufficient description must apply to the product of modern biotechnology in order to be patentable. Patenting products of modern biotechnology on the basis of chemical inventions forces prospective patentees to wait until they have a structurally distinct object before obtaining a patent restricting the protection obtained to that object. It should be taken into account that the mutability of DNA and amino acid sequences is such that once a protein’s defining sequence is known, the information can be used to produce a functionally equivalent protein of different structure in a range of species and so the value of modern biotechnology lies in the information it conveys.
Industry standards often encompass proprietary technology, including technology already patented or the subject of pending patent applications [40] . In the absence of formal standard-setting a particular product or technology will become a de facto standard simply because it is preferred and adopted by the majority of industry participants. To that effect, many products of biotechnology may not be commercially viable but it might have great practical utility within the market boundaries of the industry itself [41] . The criterion of eligibility has been written out of the biotech patenting equation. Instead, emphasis has been placed on difference from chemical compounds and on difference from classical inventions of all forms. Hence, the emphasis has shifted into inventiveness and enablement/disclosure regardeding biotechnology products and patenting [42] .
The eligibility restrictions are considered to offend the very purpose of the patent system in promoting new fields of technological endeavour[43] . The use of purposive reasoning to override eligibility restrictions is reflected in the context of informational products [44] . Has eligibility been made conceptually redundant by new technologies? The argument of technological redundancy has been made in the context of plant and animal varieties and biological processes [45] . Should the requirement of invention be removed in order for patenting to promote innovation within a changing technological landscape? Everything that happened can be considered to be the work of nature and any patentable composite exemplifies the laws of nature. The distinction between discovery and invention is not precise. The inventive process involves the practical implementation of a discovery or idea but what should be decisive is what technical contribution the invention makes to the known art. Should patentability be separated from notions of tangible technological manifestations? Should more emphasis be placed on notions relating to expected investment and the value of the subject matter to society once produced? Can we move from useful inventions towards useful inventiveness in terms of inventive results of practical utility?
In the biotech field, both the utility and the non-obviousness requirements have been watered down. There is a European practiceof granting very broad patents in order to cover all possible functional variations of a protein in its natural form. Companies seek patents on hundreds of thousands of DNA sequences of unknown functions that they have been able to isolate quickly through routine, automated methods. DNA sequences are considered chemical compounds by the USPTO and are patentable as compositions of matter. Isolated and purified DNA is patentable because this form differs from the naturally occurring compound. If a patent application discloses only nucleic acid molecular structure for a newly discovered gene, and no utility for the claimed isolated gene, the claimed invention is not patentable. The EPC covers both formal and material aspects of patent law and regulates the filing and granting process of common European patents. Inventions that meet the EPC's definition of invention are patentable 'even if they concern a product consisting of or containing biological material or a process' so long as the patent is directed to the material isolated from the natural environment or the material was produced by means of a technical process. [46} Plant or animal inventions shall be patentable if the technical feasibility of the invention is not limited to a particular plant or animal variety [47] and naturally-occurring substances are considered to be patentable inventions provided they are isolated from their surroundings.
What is the nature of the inventive steps involved? A new creation in order to be patentable must contain an invention, which means not only an abstract idea but also its incorporation into a technical mechanism that produces something new in either the real or virtual world. A digitized idea should be patentable if it is transformed into a new digital product, mechanism or both and/or if its implementation brings into existence something new that contains an invention (combination of idea and mechanism – not merely a mathematic calculation) applicable to e-commerce or cyberspace in general. Common/normal ideas or common business practices should not be patentable. Otherwise common business practices automated by software would be 'new’ inventions and every simple observance would be potentially patentable. So too would natural characteristics of the human body discovered with the aid of new electronic technology and software. Laws of nature might end up being privatized instead remaining what they should be: the common inheritance of all humans.
The USPTO recently argued that the entire nucleotide sequence of the gene would be prima facie obvious when the amino acid sequence for that gene could be found in the prior art [48] . The Federal Circuit commented that the established relationship in the genetic code between a nucleic acid and the protein it encodes does not unavoidably cause a gene to be prima facie obvious over its corresponding protein because there are a number of nucleotide sequences that might encode for a specific protein as a result of degeneracy in the genetic code. A prior art disclosing the amino acid sequence of a protein does not mechanically make the particular DNA molecules encoding the protein obvious [49] . The existence of a general method of gene cloning in the prior art is not sufficient, without more, to render obvious a specific cDNA molecule [50] .
So, there is a need for an inventive step in order to render a patent to a new biotech finding and the denial of inventive step is based on the concept that if the amino acid sequence of protein A is known, it would be easy to try to isolate the sequence of a specific gene coding protein A by means of standard cloning procedures [51] . Hence, in the case of obviousness, the issue has been the presence of such factors in the prior act, rather than in the inventor’s disclosure. In re Bell [52], a claim to DNA coding for human insulin-like growth factor (HIGF) was not obvious even though the prior art disclosed the amino acid sequence for the HIGF proteins and a method for using that information to obtain the corresponding DNA molecule. In re Deuel [53] the court found claims directed to DNA coding for heparin binding growth factors (hbgfs) not obvious in light of prior art disclosure of a partial amino acid sequence and a method for using that information to obtain the corresponding DNA molecule. The actual sequence of the claimed DNA molecules was uncertain or unpredictable from the prior art [54] . The predictability of a certain technique included in a biotech invention brings something new regardless of whether there is a prior art for similar DNA sequences.
A particular DNA sequence is not obvious merely because the prior art discloses general methods for isolating DNA [55] . An invention lacks patentable novelty if its elements are fully described in a prior art reference but biotechnology obviousness standards require that the sequence of the DNA be predictable from the prior art and not necessarily explicitly described. So, DNA patents will be numerous but narrow. An inventor is shielded from obviousness by the lack of explicit and detailed disclosure in the prior art and everyone who has isolated and characterised a novel DNA molecule is certain to receive a patent on it. The prior art disclosure of a broad genus does not automatically render obvious a specific compound within the genus [56]
An invention has a well-established utility if a person of ordinary skill in the art can instantly recognize why the invention is useful based on the characteristics of the invention. According to the EPO, utility is defined as industrial applicability, which includes any kind of industry. The utility requirement is met when a DNA-related invention has well-established utility, which means that the utility is specific, substantial and credible [57].
Patent rights in the field of biotechnology should be confined to processes, rather than the genetic products deriving therefrom. Following US practice, articles 3(2) and 5(2) of the EPC allow human materials either synthesized by a process outside the body or removed from the body by a technical process to be patented [58] . So, inventions which simply display nucleic acid sequences without a omprehensible indication of their functions are not considered patentable inventions [59].
An EST (express sequence tags) is part of a sequence from a cDNA molecule, consequently, it can be used to recognize and locate an expressed gene. Patents have been allowed on ESTs based on their utility as probes [60].Nevertheless, a mere assertion of the utility of an EST as a probe without further disclosure of its precise function is considered not enough by USPTO to satisfy the utility and enablement requirement[61].
Biotechnology products and processes may be derived from the duplication of compounds found in living organisms or produced by naturally occurring animals or plants. It could be said that transgenic plants and animals, modified microorganisms, and isolated and purified DNA sequences are the results of human intervention and they are patentable subject matter, obviously because they are 'new' in the sense of having no previous existence in the state of the art[62]. Just as one chemical may not destroy the novelty of a different chemical ESTs, SNPs, or partial gene sequences will not destroy the novelty of a full-length gene sequence [63] The utility of an invention, in concert with its novelty and non-obviousness, merits the reward of patent protection [64] . Whether a claimed invention lacks utility is a question of fact [65] . In two competing patent applications that claimed the same, or to a large extent the same, biotechnology subject matter there is a need to establish priority of invention [66] . So, the first to invent is the only true inventor entitled to patent protection. The outcome of an interference proceeding typically leaves the winner with a patent and the loser without a patent. To receive patent protection an invention must be non-obvious at the time of the invention to one of ordinary skill in the relevant art. Additionally, the conclusion of non-obviousness is subject to underlying factual findings, which the Federal Circuit reviews for clear error [67] .
Moreover, in the United States, the Patent Act embodies a written-description requirement to make certain that an applicant has truly invented what is claimed and that the public will be in possession of the claimed invention after the expiration of the patent [68] . Disclosing a method for obtaining the DNA molecule is not the same as disclosing the molecule itself. A written description requires a description of the DNA itself and not reference to a potential method for isolating it [69] . So, an inventor does not conceive a DNA invention until he actually creates it [70] . Naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of the material. Biotechnology inventions must be described by structure but also be described by functional characteristics disclosing the correlation between function and structure [71] .
To obtain patent protection an inventor must set forth an adequate written description of the invention and a patent must describe an invention in adequate detail so that one skilled in the art can plainly conclude that the inventor not only has possession [72] of the claimed subject matter but the adequacy [73] of the written description is a matter of fact [74] Can a patented and merely purified gene bring forward infringement of previously patented genes? A product or process cannot avoid infringement liability simply by incorporating insubstantial changes over the patented claims [75] . The ability to articulate the inventive concept is an important starting point [76] . In the context of an ordinary chemical compound, the non-obviousness requirement is satisfied so long as there is no structurally similar compound in the prior art [77] . Prior art is knowledge in the relevant field that is disclosed in patents or printed publications prior to the date of the claimed invention [78] . A chemist who synthesizes a compound with a specific set of useful properties even though there is no prior available information regarding structurally similar compounds with similar properties is inventing a non-obvious product [79] . Although DNA sequences represent chemical compounds, they are more essentially carriers of information [80] . Hence, a DNA sequence can be non-obvious even though the information necessary for isolating the sequence is publicly available [81] .
Notwithstanding patents on isolated and purified DNA sequences, can chemicals found in the human body be inventions under the positive law of patents ? The Patent and Trademark Office (PTO) grants, and federal courts again and again uphold, patents on newly discovered, naturally occurring genes, DNA fragments, proteins, and other biochemicals in contravention of long established principles of patent law [82] . Recombinant DNA technology can be used to isolate a gene from one species of living organism and integrate it into the host cells of another species.
Concerns over potential impediments to biochemical patenting derive from the importance of biotechnology to the future of medicine [83] . Seeking to emulate the success of drug companies like Geron Corp [84] who in March 2001 obtained a patent covering genes coding for human embryonic stem cells, medical researchers are scrambling to dicover and monopolize DNA sequences that may someday be used in product development. Is the newly discovered information concerning the human body pure science and medical knowledge? Or is it something new? Is it an invention?
According to some courts and scholars a patent applicant need not have invented the subject matter claimed – he/she may simply has discovered a preexisting DNA sequence or protein- as long as the particular subject matter was unknown before the applicant discovered it. On the other hand, the patentable subject matter requirement is requiring not only discovery but also invention. In the field of biotechnology, this policy has resulted in widespread acceptance of patents on genes, proteins, and other biochemicals that are found and then 'isolated and purified' by commonly known techniques.
Can we allow patents on slightly modified, naturally occurring biochemicals? Naturally occurring phenomena are not patentable subject matter[85] . The invention requirement is so crucial to patent law that it has developed into a common law doctrine, encompassing certain subject matter and rejecting other a priori for lack of invention. Courts established that simple purification of an identified chemical, mineral, or other pre-existing or formerly known substance demonstrates inadequate ingenuity for a patent to issue thereon [86] . While the process for purifying the substance is inventive and the proper subject of a patent, the purified substance itself is not. An abstract fact or idea cannot be patented until it is reduced to practice in the form of a product or process. While the discovery of the chemistry and structure of DNA molecules did cause a revolution in genetics, the development of rapid gene sequencing technology has simply enhanced, not changed, the understanding of the predominant scientific paradigm. The commercial value of a biochemical must be the product of the applicant’s ingenuity [87] . In re Bergstrom[88] the court accepted that 'purified', prostaglandins were patentable even though they occur naturally in every human being. The lower courts accepted patentability of 'purified' naturally occurring phenomena because the product does not occur in the prior art in its purified form. Any purification of a natural substance, no matter how insubstantial from a scientific point of view, to create a new product adds commercial or therapeutic value and creates a patentable new product or process. A discovery is not patentable subject matter unless it is an invention [89] . The most fundamental basis of biotechnology is often the discovery of pre-existing building blocks of nature, with little emphasis on originality in terms of invention of products except at the level of applied biotechnology [90] .
Can a modified naturally occurring phenomenon become a 'new' product or process for purposes of section 101 of the Patent Act in the sense of being the object of invention? Both newness and novelty are preconditions for finding an invention patentable because the requirements of both sections 101 and 102 must be satisfied for a patent to issue. A patentable innovation must include a new genotype (new and useful DNA sequences) that expresses a novel, non-obvious, and useful phenotype. Such a genotype is new only if it does not already exist. The inventor must be the first to conceive of the genotype and reduce it to practice. Many courts have interpreted the Patent Act to allow the patenting of natural phenomena after a pro forma alteration, finding that newly discovered DNA molecules or other naturally occurring biochemicals, when 'isolated and purified', differ adequately enough from what is found in nature to be deemed new.
The European Union now seems to have taken a similar view [91] . The EPO now interprets the Directive to allow patents on isolated and purified genes and other biochemicals on the theory that isolation and purification adds a significant mental step [92] . Although the Directive on the Legal Protection of Biotechnological Inventions forbids patents on discoveries of components of the human body ( including DNA sequences), an 'isolated component' of a human body that is 'produced by means of a technical process' is considered patentable. However, the PTO and federal district and appellate courts have succumbed to the verbalism that a product of nature that has been 'isolated and purified' thereby becomes patentable creating a consequential gap in the fundamental concept of invention. Forbidding the patentability of discoveries of natural phenomena on the one hand but allowing patents on scientifically meaningless modifications to those same phenomena is a contradiction. Courts allow patents on naturally occurring phenomena when those phenomena are modified in minor ways and so any alteration from the natural state of a composition of matter results in patentability if increased therapeutic or commercial value is added.
It could be said that ingenuity or creativity is hardly ever a prerequisite to isolating or purifying DNA molecules using modern technology [93] . An inventor must create a new product that is significantly different in function from the naturally occurring phenomenon[94] . Section 101 of the Patent Act requires investigation into whether the natural product has been significantly transformed into a new and different product with a new biological function and new character [95] . A patent on an isolated and purified DNA molecule would not be barred on non-obviousness grounds if the claimed DNA molecule was discovered by the applicant because a recombinant molecule would not be considered obvious if the naturally occurring molecule on which it is based was beforehand unknown [96] .
Where is the new scientific knowledge when every new discovery in biotechnology is considered an invention? There is a difference between producing new products and discovering DNS characteristics using new research techniques. Thus, there is a need to distinguish between medical- biotech knowledge and discovery and invention worthy of being granted a patent. Not every bit of new information should be considered an invention; at least until it is presented/transformed into an applicable technique or a new product.
3. Conclusion
US Courts interpreting the 1952 Patent Act seized upon a simplistic reading of sections 101, 102, and 103, and in this manner overturned the long established prohibition on patenting naturally occurring phenomena in purified, concentrated, diluted, or otherwise insubstantially altered form. Patents should be synonymous with inventions and applicants must have created the claimed subject matter through an ingenious mental step. In order for a substance based upon a naturally occurring phenomenon to comprise an invention that substance must be significantly transformed from the state in which it naturally occurs and so the biological function of the chemical or tissue at issue must be different from its function in nature. The discovery of natural matters using a new technique cannot be considered an invention. The invention should bring forward a new practical usage of the new substance or a new product either material or intangible.
The commercialization of the new scientific discoveries regarding the human body will ultimately lead to the commercialization of human life. And as patents become increasingly associated with rent seeking rather than innovation, the integrity of the patent system as a whole will be undermined, further reducing the incentive to innovate that patents are supposed to represent.
* BSc(Econ), JD, LLM, PhD, Attorney at law/Economist, <www.diavlos.com/zekos>.
[1] GEORGIOS I. ZEKOS, Patent Law in the Cyberspace Era, Electronic Communication Law Review 9: 281–309, 2002.
[2] ENCYCLOPEDIA BRITANNICA, available at <http://www.britannica.com/search?query=Biotechnology&ct=&fuzzy=N>
[3] Diamond v Chakrabarty, 447 US 303, Biogen Inc v Medeva Plc 36 IPR 438 (Deciding that an isolate DNA sequence encoding the hepatitis B Virus could support a patent).
[5] Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 US 127, 130 (1948). The aggregation of bacteria and their collective benefits was an obvious application of a natural principle.
[6] An inventor is one who makes 'some contribution to the inventive thought and to the final result' of an invention. Monsanto Co. v. Kamp, 269 F. Supp. 818, 824 (D.D.C. 1967). One who merely suggests an idea without the means of reducing the idea to practice is not an inventor. Regents of the Univ. of Cal. v. Synbiotics Corp., 849 F. Supp. 740, 742 (S.D. Cal. 1994). Some describe the process of innovation as 'the search for, and the discovery, development, improvement and adoption of new processes, new products, and new organizational structures and procedures.' Thomas M. Jorde & David J. Teece, Innovation, Cooperation and Anti-trust, 4 High Tech. L.J. 1, 5 (1989). Invention, on the other hand, can be defined as that part of innovation that represents the ‘discovery’ aspect. Steven Cherensky, A Penny for Their Thoughts: Employee-Inventors, Pre-invention Assignment Agreements, Property, and Personhood, 81 Cal. L. Rev. 597, 609 (1993). 35 U.S.C. § 101 (1988).
[7] 35 U.S.C.§103 reads in part
A patent may not be obtained ...if the differences between the subject matter to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. 35 U.S.C.§103(a)(2000)
[8] In www.Wipo.int referred that an invention ' must be of practical use; it must show an element of novelty, that is, some new characteristic which is not known in the body of existing knowledge in its technical field. This body of existing knowledge is called "prior art". The invention must show an inventive step, which could not be deduced by a person with average knowledge of the technical field…scientific theories, mathematical methods, plant or animal varieties, discoveries of natural substances, commercial methods, or methods for medical treatment (as opposed to medical products) are generally not patentable.'
[9] Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000) ('Invalidity by anticipation requires that the four corners of a single, prior art document describe every element of the claimed invention, either expressly or inherently, such that a person of ordinary skill in the art could practice the invention without undue experimentation.').
[10] Graham v. John Deere Co., 383 U.S. 1, 34–37 (1966) (combining elements from prior art patents to conclude that claimed invention was obvious).
[11] 35 U.S.C. § 101, § 103(a). (1994).
[12] Cochrane v. Deiner, 94 U.S. 780 (1877).
[13] Tilghman v. Proctor, 102 U.S. 707 (1880).
[14] Diamond v. Diehr, 450 U.S. 175 (1981).
[16] European Patent Convention [E.P.C.] (1998) (originally enacted Oct. 5, 1973), available at: http://www.european-patent-office.org/legal/epc/index.html. R. 29(1). EU Parliament Votes for Real Limits on Patentability In its plenary vote on the 24th of September, the European Parliament approved the proposed directive on "patentability of computer-implemented inventions" with amendments that clearly restate the non-patentability of programming and business logic, and uphold freedom of publication and interoperation
[17] State St. Bank & Trust Co. v. Signature Fin. Group, 149 F.3d 1368, 1373-77 (Fed. Cir. 1998).
[18] M Lunney, E-obviousness, 2001 Mich.Tel.Tech. L.R. 363. Margo A. Bagley, Internet Business Model Patents: Obvious By Analogy, 7 Mich. Telecomm. Tech. L. Rev. 253 (2001). According to Bagley courts must consider the 'real' deficiencies attendant in the prosecution of many Internet business model patents when deciding whether application of the doctrine of equivalents is warranted for 'pseudo' pioneer innovations. Douglas Gary Lichtman, The Economics of Innovation: Protecting Unpatentable Goods, 81 MINN. L. REV. 693 (1997). Lichtman says that state laws forbidding the copying of unpatentable inventions do not conflict with federal patent law, as long as the cost of inventing a non-infringing substitute is satisfactorily low in comparison with the R&D cost of the original invention. So, the inventor of the non-patentable invention would be expected to license the invention to competitors and to earn a reward that does not exceed his R&D costs.
[19] Judge Rader in Overhead Door Corp. v. Chamberlain Group, Inc said that a 'well understood tenet of the computing art [that] . . . ‘any software process can be transformed into an equivalent hardware process, and any hardware process can be transformed into an equivalent software process.’ '194 F.3d 1261, 1269 (Fed. Cir. 1999); see also Pamela Samuelson et al., A Manifesto Concerning the Legal Protection of Computer Programs, 94 Colum. L. Rev. 2308, 2319 (1994) ('Computer science has long observed that software and hardware are inter-changeable.'). Steven I. Wallach, How Could They Patent That?, Corporate Intelligence (July 28, 2000), available at http://www.corporateintelligence.com/issues.cfm? Story=28&Author=Wallach (expressing the desire for the USPTO or the courts to announce a new rule addressing 'whether well-known bricks-and-mortar business methods that are adapted to the Internet are obvious or not').
[20] DeTeMobil Deutsche Telekom MobilNet GmbH et al. v. Comvik GSM AB, no. T 0641/00, slip op. at 5-6 (Tech. Bd. App. Sept. 26, 2002), available at: http://legal.european-patent-office.org/dg3/biblio/t000641ex1.htm. M. Herdegen, Patents on parts of the human Body, 2002 JWIP 145.
[21] Hughes Aircraft Co. v. United States, 148 F.3d 1384, 1385 (Fed. Cir. 1998) (Clevenger, J., dissenting).
[22] Robert P. Merges, The Economic Impact of Intellectual Property Rights: An Overview and Guide, 19 J. CULTURAL ECON. 103 (1995).
[23] Cochrane v. Deener, 94 U.S. 780, 788 (1877), See Hotel Security Checking Co. v. Lorraine Co., 160 F. 467, 469 (2d Cir.1908).
[24] Kenneth W. Dam, Some Economic Considerations In The Intellectual Property Protection Of Software, 24 J. LEGAL STUD. 321, 369-71 (1995) (stating many of the problems with patent quality that had been identified with respect to software patents, and voicing optimism that problems can be addressed). Andrew M. Riddles & Brenda Pomerance, Software Patentee Must Conduct Own Search: Prior-Art Searches Made By The Patent Office Often Are Not Thorough Enough To Be Trusted, NAT’L L.J., Jan. 26, 1998, at C19. (referring PTO of being little better than a 'registration process' for some kinds of software patents). Quantel, Ltd. v. Adobe Systems, Inc., 1997 U.S. Dist. LEXIS 16779 at 14-23 (D. Del. Sept. 22, 1997) (jury verdict invalidating software patents; special verdict form shows numerous 'prior public use' references).
[25] Diamond v. Chakrabarty, 447 U.S. 303 (1980).
[26] Commission of the European Communities, Proposal for a Council Directive on the Legal Protection of Databases, COM (92) 24 Final (May 1992). David R. Syrowik, International Software Protection, 70 Mich. B.J. 656, 657-58 (1991) IBM, Decision of the Technical Board of Appeal 3.5.1 dated 14 February 1989 T38/86, 1989 Official J. EPO, no. 10. Koch & Sterzel GmbH v. Siemens AG, Decision of the Technical Board of Appeal 3.4.1 dated 21 May 1987 T26/86, 1988 Official J. EPO, nos. 1–2. VICOM Systems Inc., Decision of the Technical Board of Appeal 3.5.1 dated 15 July 1986 T208/84, 1987 Official J. EPO, no. 1. Marshall A. Leaffer, Protecting United States Intellectual Property Abroad: Toward a New Multilateralism, 76 IOWA L. REV. 273, 287 (1991).
[27] 35 U.S.C. § 101 (2002).
[28] Exclusions from patentability for living phenomena has been justified by reference to the unpatentability of natural phenomena. Funk Bros. Seed Co v Kalo Inoculant Co 333 US 127. Parker v Bergy 438 US 902, 444 US 924. The exclusion of natural phenomena derives form the distinction between patentable technical objects and unpatentable abstract principles. Boulton v Bull 126 ER 651 (distinguishing between manufactures and abstract notions or elementary truths of the arts and since). Le Roy v Tatham 55 US 156 (a principle is not patentable because it is a fundamental truth and no one can an exclusive right).
[29] 35 USC §161. 7 USC §§ 2321-2583. Plant Variety and Seeds Act, 1964, Ch 14 (amended 1997).
[30] City of Milwaukee v Activated Sludge Inc 69 F2d 577 (a method of using bacteria in the treatment of waste was patentable because it involved physical methods and apparatus for handling).
[31] Funck Bross Seed 333 US 127 (refusing a patent for bacterial strains on the ground of want of invention).
[32] Bergstrom 427 F2d 1394 (prostaglandins). American Fruit Growers Inc v Brogdex Co 283 US 1 (an orange rendered decay-resistant by injection with borax was not patentable because the injection did not produce a new orange which was a product of nature and thus unpatentable).
[33] Merck & Co v Olin Mathieson Chem Corp 253 F2d 156(Vitamin B12).
[34] Dennis v. Pitner, 106 F.2d 142, 145 (7th Cir. 1939) '"The laws of nature," "the principles of nature," "the fundamental truths," etc., are not patentable, have been oft repeated but seldom understandingly used.'
[35] Treibacher Chemische Werke GmbH v. Roessler & Hasslacher Chem. Co., 214 F. 410 (S.D.N.Y. 1914). In General Electric Co. v. De Forest Radio Co., 28 F.2d 641, 643 (3rd Cir. 1928). A patent for elemental tungsten was held invalid as covering a product of nature because the tungsten that the inventor uncovered was the "tungsten of nature"
[36] CERN-European Organization for Nuclear Research, Why is Antihydrogen Interesting?, at http://athena.web.cern.ch/athena/ Anette Pahl et al., Antihydrogen at the MPQ: Introduction, http://www.mpq.mpg.de/~haensch/antihydrogen/introduction.html
[37] Genetics Institute Inc v Kirin-Amgen Inc 1998 IPR 325. Howard Florey/Relaxin 1995 EPOR 541. Biotech patentees seek protection for research results stored and managed in electronic form.
[38] Gottschalk v Benson 409 US 67 (phenomena of nature, mental processes and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work). IBM/Document abstracting and retrieving 1990 EPOR 98 .
[39] Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions Official Journal L 213, 30/07/1998 P. 0013 –0021 Matthias Herdegen 'Patents on Parts of the Human Body' 2002 Journal of World Intellectual Property 145. ECP Article 53 Exceptions to patentability European patents shall not be granted in respect of: (a) inventions the publication or exploitation of which would be contrary to 'ordre public' or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States; (b) 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.
[40] American National Standards Institute, Guidelines for Implementation of the ANSI Patent Policy, available at http ://web.ansi.org/public/library/guides/-ppguide.html
[41] Biogen/Hepatitis b T296/93 1995 EPOR 1
[42] Enzo Biochem Inc v Gen-Probe Inc 296 F3d 1316. Genetics Inst Inc v Amgen Inc 502 US 856 . The patenting of informational products has been permitted in Europe. Philips/Record Carrier T 1194/97 2001 EPOR 193. IBM/Computer Programs T 1173/97 2000 EPOR 219.(construing EPC art 52 narrowly to permit the patenting of computer programs)
[43] J Supply Inc v Pioneer Inc 534 US 124 (Denying protection under §101 would be inconsistent with forward looking perspective of the utility patent statute). Biogen inc v Medeva Plc 36 IPR 438 (support for an expansive view of patent eligibility in the context of modern biotechnology)
[44] AT&T Corp v Excel Communications Inc 127 F3d 1352 (permitting patents for mathematical algorithms contrary to the historical principles). In State Street Bank & Trust Co. v. Signature Financial Group, Inc., 149 F.3d 1368 (Fed. Cir. 1998), cert. denied, 119 S.Ct. 851 (1999). The Federal Circuit decision recognized business method patents involving a patent entitled 'Data Processing System for Hub and Spoke Financial Services Configuration.' keeping track of individual mutual fund investments ('spokes') which have been pooled into a single portfolio (a 'hub'). Leo I. Raskind, The Bad Business of Business Method Patents, 10 Ford. Intell’l Prop’y Media & Entertainment L.J. 57 (1999). Mathematical algorithms are patentable so long as they produce a 'useful' result, including something as non-physical as a final share value which means that methods of doing business were patentable subject matter. In Merrill Lynch Inc.’s Application [1988] R.P.C. 1, aff ’d, [1989] R.P.C. 561. the court came to a unquestionably different result than the State Street court, ruling that a computer program that causes a computer to calculate numbers to provide pricing information did not involve a technical step and was therefore unpatentable.
[45] J Supply 534 US 135. Lubrizo/Hybrid Plant T320/87 1990 EPOR 173 (construing EPC art 53b narrowly to exclude recombinant plants). Harvard/Onco-Mouse 1991 EPOR 525.
[46] Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, 1998 OFFICIAL J. EUR. COMMUNITIES O.J. (L 213) 13-21, available at http://europa.eu.int/eur-lex/pri/en/oj/dat/1998/l_213/l_21319980730en00130021.pdf.
[47] ibid
[48] In re Bell, 991 F.2d 781, 785 (Fed. Cir. 1993).
[49] In Re Deuel 51 F.3d 1552, 34 U.S.P.Q.2d 1210 (Fed. Cir. 1995).
[50] Trilateral Project B3b: Comparative study on biotechnology patent practices (Theme: Nucleic acid molecule-related inventions whose functions are inferred based on homology search), at http://www.european-patent-office.org/tws/sr-3-b3b_bio_search.htm
[51] Leslie G. Restaino, Steven E. Halpern and Dr. Eric L. Tang, Patenting DNA-Related Inventions in the European Union, United States and Japan: A Trilateral Approach or a Study in Contrast?, 2003 UCLA J.L. & Tech. 2
[52] In re Bell 991 F2d 781.
[53] In re Deuel 51 F3d 1552.
[54] Rhone-Poulenc Agro v Dekalb Genetics Corp 272 F3d 1335 (addition of second transit peptide to string of amico acids with transit peptide and fragment of a second transit peptide was not obvious because the amico acids were structurally different).
[55] In re Deuel, 51 F.3d 1552, 1553-54 (Fed. Cir. 1995).
[56] In re Baird, 16 F.3d 380 (Fed. Cir. 1994)). See In re Mayne, 104 F.3d 1339 (Fed. Cir. 1997).
[57] TRILATERAL PROJECT B3B: COMPARATIVE STUDY ON BIOTECHNOLOGY PATENT PRACTICES (THEME: PATENTABILITY OF DNA FRAGMENTS), at http://www.european-patent-office.org/tws/sr-3-b3b-ad.htm According to the Directive that: '[The] subject matter of an invention shall not be considered unpatentable for the reason only that it is composed of living matter.'
[58] COM(88) 496 (17 October 1988); OJ 1989 C 10, p. 3 at Article 2. Pay-Bas v. Parliament and Council, ECR 2000 I-06229 (25 July 2000). Pay-Bas v. Parliament and Council, Case C-377/98, ECR 2001 I-07079 (‘Judgment’). Pay-Bas v. Parliament and Council, Case C-377/98, ECR 2001 I-07079 Opinion of Advocate General Jacobs (‘Opinion’), para. 97. ROBERT N. WEEKES, Challenging The Biotechnology Directive A Letter from America [2003] EBLR 325
[59] European Patent Office, Guidelines for Examination in the EPO, Part C, Chapter IV: Patentability, Article 52(4), at http://www.european-patent-office.org/legal/gui_lines/e/c_iv_4.htm
[60] Robin Teskin, Human Gene Patenting - An Overview of Legal and Ethical Considerations, FOOD AND DRUG LAW INSTITUTE UPDATE Issue 3 May/June, 2001, available at http://www.fdli.org/pubs/Update/toc/2001/issue3.html AIPPI Report, Question Q 150: Patentability Requirements and Scope of Protection of Expressed Sequence Tags (ESTs), single Nucleotide Polymorphisms (SNPs) and Entire Genomes, available at http://www.aippi.org/reports/q150/gr-q150-e-questions.htm
[61] 66 Fed. Reg. 1092-99 (2001).
[62] Courtney J. Miller, Patent Law and Human Genomics, 26 CAP. U. L. REV. 893, 911 (1997).
[63] The British Group of AIPPI, Patentability Requirements and Scope of Protection of Expressed Sequence Tags (ESTs), Single Nucleotide Polymorphisms (SNPs) and Entire Genomes, 1 EUR. INTELL. PROP. REV. 39-42 (2000). JAPAN PATENT OFFICE, TRILATERAL PROJECT 24.1 – BIOTECHNOLOGY, COMPARATIVE STUDY ON BIOTECHNOLOGY PATENT PRACTICES COMPARATIVE STUDY REPORT, art. 2.1, at http://www.jpo.go.jp/torikumi_e/kokusai_e/tws/sr-3-bio.htm
[64] Brenner v. Manson, 383 U.S. 519, 534 (1966) ('The basic quid pro quo contemplated by the Constitution and the Congress for granting a patent monopoly is the benefit derived by the public from an invention with substantial utility.'); Cross v. Iizuka, 753 F.2d 1040, 1044 (Fed. Cir. 1985).
[65] Raytheon Co. v. Roper Corp., 724 F.2d 951, 956 (Fed. Cir. 1983). Rey-Bellet v. Engelhardt, 493 F.2d 1380, 1385 (C.C.P.A. 1974) (stating that 'conception of [an] . . . invention is not complete absent a conception of its utility.').
[66] Kridl v. McCormick 105 F.3d 1446, 1447 (Fed. Cir. 1997).
[67] Monarch Knitting Mach. Corp. v. Sulzer Morat GMBH, 139 F.3d 877, 881 (Fed. Cir. 1998).
[68] 35 U.S.C. § 112 (2001).
[69] Fiers v Revel 984 F2d 1164. Regents of the university of California v Eli Lilly 119 F3d 1559 (Describing the method of preparing a cDNA or even describing the protein that the cDNA encodes does not necessarily describe the DNA itself).
[70] Adang v Fischhoff 286 F3d 1346 (Disclosure of genetically altered tobacco plant did not enable claim to genetically altered tomato plant). Hitzeman v Rutter 243 F3d 1345 (conception of biotechnology invention simultaneous with reduction to practice) Amgen Inc v Hoechst Marion Rousell Inc 126 Fsupp 2d 69 ( paten for urinary erythropoietin preparations invalid under written description requirement because different preparations vary in glycocylation). Amgen Inc v Chugai Pharm. Co 927 F2d 1212.
[71] Enzo Biochem v Gen-Probe 296 F3d 1316. US PTO 66 Fed. Reg. 1099, 1106.
[72] 35 U.S.C. § 112 (2002). Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. ("Festo II").535 U.S. 722, 122 S. Ct. 1831 (2002) ("Festo II"). Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 234 F.3d 558 (Fed. Cir. 2000) (en banc) ("Festo I"). EDWARD R. ERGENZINGER JR., J.D., PH.D. AND W. MURRAY SPRUILL, J.D., PH.D The Doctrine of Equivalents After Festo: A Disparate Impact on Biotechnological Inventions? 2003 STAN. TECH. L. REV. 2 <http://stlr.stanford.edu/STLR/Articles/03_STLR_2>
[73] Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986) (specifying that no amount of experimentation is preclusive if merely routine in nature). PPG Indus., Inc. v. Guardian Indus., Corp., 75 F.3d 1558, 1564 (citing In re Vaeck, 947 F.2d 488, 495 (Fed. Cir. 1991)) (Fed. Cir. 1996) (providing the court’s standard of review on the enablement issue);
[74] In re Alton, 76 F.3d 1168 (Fed. Cir. 1996). In re Brana, 51 F.3d 1560. Johns Hopkins University v. CellPro, Inc., 152 F.3d 1342, 1361-62 (Fed. Cir. 1998). In re Fisher, 427 F.2d 833, 839 (C.C.P.A. 1970) (open-ended claim for ACTH variants was not enabled because upper limit of potencies was unobtainable "from his teachings plus ordinary skill"). But cf. Scripps Clinic & Research Fdn. v. Genentech, Inc., 927 F.2d 1565, 1572 (Fed. Cir. 1991) ("Open-ended claims are not inherently improper . . . . [and] may be supported if there is an inherent . . . upper limit and the specification enables one of skill in the art to approach that limit.").
[75] Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 607 (1950); Winans v. Denmead, 56 U.S. 330 (1853).
[76] Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994). Schendel v. Curtis 83 F.3d 1399.
[77] In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990).
[78] See 35 U.S.C.A. § 301
[79] Robert Blackburn, Evolving Patent Law in the New Age of Biomedical Science, 4 TEX. REV. L. & POL. 87, 88 (1999) (noting that in traditional pharmaceutical chemistry, the chemist makes many derivatives of a given 'lead compound' that has a desirable activity in the hope of finding a derivative that has similar activity but can be manufactured more efficiently).
[80] In re Deuel, 51 F.3d 1552. Rebecca S. Eisenberg & Robert P. Merges, Opinion Letter as to the Patentability of Certain Inventions Associated with the Identification of Partial cDNA Sequences, 23 AIPLA Q.J. 1, 32 (1996) (noting that the CAFC’s approach 'would seem to make all novel DNA sequences patentable, however trivial the scientific advance that led to their identification').
[81] In re Donaldson, 16 F.3d 1189, 1192 (1994) ('Obviousness under section 103 is a question of law that this court reviews de novo.').
[82] G. Kenneth Smith & Denise M. Kettelberger, Patents and the Human Genome Project, 22 AIPLA Q.J. 27 (1994). p60 'There is little dispute that defined, functional DNA sequences obtained through research in the human genome project will be, and should be, patented.' Paul J. Heald & Suzanna Sherry, Implied Limits on the Legislative Power: The Intellectual Property Clause as an Absolute Constraint on Congress, 2000 U. ILL. L. REV. 1119, 1164-65 (2000). Karen I. Boyd, Nonobviousness and the Biotechnology Industry: A Proposal for a Doctrine of Economic Nonobviousness, 12 BERKELEY TECH. L.J. 311, 312 (1997). 'Virtually cost-free to the public fisc, making patents slightly easier to get will satisfy the policy needs of the biotechnology industry and will be logically defensible.' Daniel L. McKay, Patent Law and Human Genome Research at the Crossroads: The Need for Congressional Action, 10 SANTA CLARA COMPUTER & HIGH TECH. L.J. 465, 495 (1994) (quoting Thomas D. Kiley, Patents on Random Complementary DNA Fragments?, 257 SCIENCE 915, 918 (1992)). 'lest we eliminate patent incentivesfor the development of important medicines.'.
[83] U.S. Patent No. 5,169,941 (issued Dec. 8, 1992) (regarding multiple sclerosis); U.S. Patent No. 5,220,013 (issued June 15, 1993) (concerning Alzheimer’s disease); U.S. Patent No. 5,324,641 (issued June 28, 1994) (pertaining to insulin precursors for diabetes treatment); U.S. Patent No. 5,362,623 (issued Nov. 8, 1994) (targeting malignant tumors); U.S. Patent No. 5,370,998 (issued Dec. 6, 1994) (concerning tuberculosis). U.S. Patent No. 4,766,075 (issued Aug. 23, 1988) (regarding human tissue plasminogen activator).
[84] Geron Gets Patent Tied to Human Embryonic Stem Cells, REUTERS NEWSWIRE, Mar. 13, 2001. U.S. Patent No. 6,057,434 (issued May 2, 2000) (involving mammary transforming protein); U.S. Patent No. 5,880,263 (issued Mar. 9, 1999) (concerning human chemotactic protein); U.S. Patent No. 5,597,709 (issued Jan. 28, 1997) (involving human growth hormone variants); U.S. Patent No. RE 32,011 (issued Oct. 22, 1985) (reissuing U.S. Patent No. 4,361,509 (issued Nov. 30, 1982)) (pertaining to human Factor VIII:C, used to treat hemophilia).
[85] Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) (finding a human-made micro-organism patentable, because it was a product of human ingenuity); Parker v. Flook, 437 U.S. 584, 593 & n.15 (1978) (noting that naturally occurring substances are not patentable, because they are mere discoveries of an existing phenomenon); Gottschalk v. Benson, 409 U.S. 63, 67 (1972) (disallowing a patent for conversion of numerals due to the abstractness of the claim and the traditional notion that an idea itself is not patentable); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) (invalidating a patent for product claims involving mixed culture bacteria because the qualities of the bacteria were 'the work of nature'); Le Roy v. Tatham, 55 U.S. (14 How.) 156, 175 (1853) (distinguishing an unpatentable scientific principle or natural law from the patentable application of such to a 'special purpose').
[86] Rebecca S. Eisenberg, Re-examining the Role of Patents in Appropriating the Value of DNA Sequences, 49 EMORY L.J. 783, 786 (2000). American Wood-Paper Co. v. Fibre Disintegrating Co. 90 U.S. (23 Wall.) 566 (1874). (mere purification of a preexisting substance does not create a new, patentable product without a significant alteration to the preexisting product.) Int’l Patents Dev. Co. v. Penick & Ford, Ltd., 15 F. Supp. 1038 (D. Del. 1936). The patentee’s invention was the novel process for creating dextrose artificially-the product itself was no different from that found in nature except that it was crystallized and purified. Sterling Drug, Inc. v. Watson, 135 F. Supp. 173 (D.D.C. 1955). Merck & Co. v. Olin Mathieson Chemical Corp., 253 F.2d 156 (4th Cir. 1958).
[87] Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 135 (1948) (Frankfurter, J., concurring) (Everything that happens may be deemed ‚the work of nature, and any patentable composite exemplifies in its properties ‚the laws of nature). Ex parte Reed, 135 U.S.P.Q. (BNA) 105 (Pat. Off. Bd. App. 1961). (because the appellants had developed a means by which to gather large amounts of products of nature, they merited patents on those products due to the resulting increased therapeutic value.)
[88] In r e Bergstrom, 427 F.2d 1394 (C.C.P.A. 1970). Parker v. Flook, 437 U.S. 584 (1978). In re Sarkar, 588 F.2d 1330, 1333 n.10 (C.C.P.A. 1978) (observing that novelty and nonobviousness are irrelevant to section 101 analysis).
[89] EU Commission, Legal Protection of Biotechnical Inventions: Frequently Asked Questions on Scope and Objectives of the EU Directive (98/44) (July 3, 2000), at http://europea.eu.int/comm/internal_market/en/intprop/indprop/2k-39.htm.
[90] Michael J. Malinowski & Maureen A. O’Rourke, A False Start? The Impact of Federal Policy on the Genotechnology Industry, 13 YALE J. REG. 163, 231 (1996). at 231 (Preexisting DNA molecules, proteins, and other biochemicals are not patentable subject matter because they are not 'inventions' as required by the Patent Act.). Abbott v. Coe, 109 F.2d 449, 450 (D.C. Cir. 1939) (observing that useful innovation is not patentable without invention, and innovation does not amount to invention unless it requires rare talent to create it).
[91] John Richards, International Aspects of Patent Protection for Biotechnology, 4 FORDHAM INTELL. PROP. MEDIA & ENT. L.J. 433, 450 (1993). European Parliament and Council Directive 98/44/EC on the Legal Protection of Biotechnological Inventions, recital 23, 1998 O.J. (L 213), 13
[92] See EU Commission, Legal Protection of Biotechnical Inventions: Frequently Asked Questions on Scope and Objectives of the EU Directive (98/44) (July 3, 2000), at
http://europea.eu.int/comm/internal_market/en/intprop/indprop/2k-39.htm.
[93] David E. Huizenga, Protein Variants: A Study on the Differing Standards for Biotechnology Patents in the United States and Europe, 13 EMORY INt’L l. REv. 629, 662 (1999) (noting that much of the work in DNA sequencing is automated)
[94] Precision Specialty Metals, Inc. v. United States, 116 F. Supp. 2d 1350, 1364 n.13 (Ct. Int’l Trade 2000) (noting that change of name does not, by itself, usually prove a substantial transformation). Hartranft v. Wiegmann. 121 U.S. 609 (1887). Graham v. John Deere Co. 383 U.S. 1, 14 (1966), '[a]n invention which has been made, and which is new in the sense that the same thing has not been made before, may still not be patentable if the difference between the new thing and what was known before is not considered sufficiently great to warrant a patent.' Reynolds-S.W. Corp. v. Dresser Indus., 372 F.2d 592, 595 (5th Cir. 1967) (finding that patent infringement occurs where allegedly infringing product 'perform[s] substantially the same function or accomplish[es] a substantially identical result by substantially identical means and the principle or mode of operation must be the same'); Merrill v. Builders Ornamental Iron Co., 197 F.2d 16, 20 (10th Cir. 1952) (holding that a patent is not infringed unless the allegedly infringing product 'produces substantially the same effect in substantially the same way as that taught in the patent'); Mesinger v. W. Auto Supply Co., 375 F. Supp. 1143, 1147 (S.D. Fla. 1974) (noting that 'infringement exists only where the accused device and the teachings of the patent in suit are substantially identical in structure, mode of operation, and results accomplished'). In American Fruit Growers, Inc. v. Brogdex Co. 283 U.S. 1 (1931), the Court rejected a patent on citrus fruit treated with borax to resist mold. In re Davis, 164 F.2d 626, 632 (C.C.P.A. 1947) (holding that an improvement in the degree of stability of the applicant’s chemical 'would not be sufficient to lend patentability to the product claims, since it is a difference in degree only'); In re Michalek, 161 F.2d 253, 255 (C.C.P.A. 1947) (holding that merely producing a more purified version of a preexisting chemical does not merit a patent because the resulting product does not 'differ in kind from that disclosed by the prior art'). Dewey & Almy Chem. Co. v. Mimex Co., 37 F. Supp. 36, 38 (E.D.N.Y. 1941), red in part, 124 F.2d 986 (2d Cir. 1942) ('It is a well recognized principle that the substitution of materials does not constitute invention unless indeed a wholly different effect results from the substitution. It is true that certain advantages are claimed but the mere difference in degree is not such as to warrant the finding of invention').
[95] Animal Legal Defense Fund v. Quigg, 932 F.2d 920, 923 (Fed. Cir. 1991) ('An article of manufacture or composition of matter occurring in nature will not be considered patentable unless given a new form, quality, properties or combination not present in the original article existing in nature in accordance with existing law.').
[96] In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995) Michael S. Greenfield, Recombinant DNA Technology: A Science Struggling with the Patent Law, 44 STAN. L. REV. 1051, 1079 (1992).
