Journal of Information, Law and Technology

Patenting Biotechnology

Dr. Georgios I Zekos
Attorney at Law 

gzekos@hotmail.com 

This is a refereed article published on: 30 April 2004 

Citation: Zekos, P'atenting Biotechnology ', 2004 (1) The Journal of Information, Law and Technology (JILT). http://elj.warwick.ac.uk/jilt/04-1/zekos.html. 

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] . 

Keywords: Patent Law, Biotechnology, 1952 Patent Act, Invention, Obviousness, DNA

1. Introduction
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 used to manipulate the DNA of bacteria and other organisms manufacturing biological products such as industry materials and drugs. Since the 1970s attention has been paid to the patentability of biotechnology focused on genetically modified organisms and other products derived from living systems using recombinant DNA and associated techniques. Does patent law protect these subject matters? Can biotech patenting be harmonized? The effects of biotech patenting have been politicized. The question is how traditional principles of patentability could be applied to the new form of technology. The arising question is the comparability of modern biotechnology with other forms of patentable technology asking whether it is similar to those forms of technology to be regarded as subject matter for patent protection[3] The Aim of the analysis based mainly on US law is to highlight the novelties of biotechnology patents in compare to established principles of patent law.

2. Patent Law Background

In US the 1952 Patent Act imposes only four requirements for patentability that the claimed subject matter: (1) have some practical utility; (2) be either a process or a physical embodiment of the invention; (3) not be disclosed, with limited exceptions, in the prior art; and (4) not be obvious based on the prior art. Patent protection does not extend to the laws of nature, physical phenomena or abstract ideas [4] . With respect to product patents, the product of nature doctrine has imposed a bar to patent protection and so the doctrine 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 issue, however, 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 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] . The patent system was meant to protect technology—actual machines, devices, and new chemical compositions—rather than pure concepts [15] which means that business methods are not tied to specific machinery or devices, they are undoubtedly not patentable under this view.

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 a 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. To that extent, the European Patent Office (EPO) has clarified its position that business methods are not of a technical nature, and so cannot receive patent protection as a process under the EPO system. The EPO has offered one possible definition by stating that a business method is any subject matter that is more concerned with financial, interpersonal, and societal relationships than with engineering. European systems require that mathematical algorithms imbedded in software provide a technical solution to a technical problem in implementing a process. Biotechnology products seeking a patent involve the use of electronic technology and the combination of different techniques incorporating various software products than any other conventional patented product and so their novelty and non-obviousness should formulate the valid of a biotechnology patent. 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 the application is not for a method of doing business “as such”but the subject matter of a patent must have a technical character and be industrially applicable. In the US software could be patented if it produced a ‘useful, concrete and tangible result’. The US offers as much protection as possible to its inventors in the existing legislation and case law interpreting 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] . It should be taken into account that Professor Lunney [18] proposes setting a marginal creative investment fraction to give rise to a presumption of non-obviousness. To that extent Internet patents 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 Internet environment is merely that software is instrumental in performing the method as opposed to “hardware”. 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, who wrote 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] and his American colleague Judge Clevenger, stating that “today . . . virtually anything is patentable,” [21] appear to have the same opinion. The EU [22] takes on an active role in introducing a legal framework for the emerging information society in which information and information technology play an essential part. Moreover, the Convention on the Grant of European Patents (EPC) 2000 provides in Article 52(2) a list of subject matter that shall be regarded as inventions [23] . The list excludes programs for computers and presentations of information. 3. Novelties of Biotechnology Patents

3. 1 Patentability Patent law is technology neutral in theory and technology specific in application. In other words, patent law has lost its primarily mechanical character branching out into biotechnology semi conductors, and computer hardware and software. The fundamental rules of patent law were set in a world in which inventions were mechanical and the old rules to new technologies has not been free from controversy. <>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 they can be used by all people.

Intellectual creations were not protectable unless good cause was shown [24] . Can we accept the patentability of processes per se? Process patents understood as physical transformations rather than mere abstractions crucial to the growing chemical industry of the early twentieth century. [25] Can be supported the view the biotechnology patents come to serve medical industry nowadays? Can the patent law protect only conventional “hardware” inventions? Manufactures and machines were 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 PTO was allowing too many exceedingly broad patents [26] . Have patents being used to hold up bona fide manufacturers? The author considers that commerciality has forced PTO in awarding broad patents and courts to validate them. 

Since the 1873 patenting of Louis Pasteur’s yeast, microbes have been historically considered patentable subject matter. The patentability of living micro organisms survived scrutiny, and was confirmed by the Supreme Court in Diamond v. Chakrabarty [27] , involved Ananda Chakrabarty’s invention of a new bacterium genetically engineered to degrade crude oil. In this case, the Supreme Court stated that new micro organisms not found in nature, such as Chakrabarty’s bacterium, were “manufacture” or “composition of matter” within the meaning of § 101 of the Patent Act and were so, patentable. It could be argued that if a product of nature is new, useful and non-obvious, it may be patented if it has 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. [28] The U.S. patent laws require that, to be patentable, an invention must pass the standard subject matter test [29] . 

The patentability of plant varieties was based on the debate concerned the ability of living things and natural substances to be regarded as new inventions amenable to individual ownership [30] . 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) [31] . Could modern biotechnology be distinguished from the plants and natural or living phenomena for which patents had 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 [32] . 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 [33] . After the development of modern biotechnology such products were understood to include genetically engineered micro-organisms and DNA sequences [34] . To that extent in Merck & Co. v. Chase Chemical Co. [35] 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 anaemia - the court noted first, that the identity of the anti-pernicious anaemia 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 anaemia factor in 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 [36] . A particular mixture or composite material is patentable when new or refined properties arise from the combination of raw materials [37] . 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 composed of one positron orbiting one antiproton created for the first time in 1995 by scientists working at CERN, the European Laboratory for Particle Physics near Geneva and a similar process probably has never occurred before in nature [38] . 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.

3.2 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 [39] . 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-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 [40] . 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 [41] imposes restrictions on the pantentability of human organs when their commercial exploitation would be contrary to public order or morality.

3.3 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 exist to protect? 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 product 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 [42] . 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 [43] . The criterion of eligibility has been written out of the biotech patenting equation and emphasis has given on its difference from chemical compounds and on its difference from classical inventions of all forms. Hence, the emphasis is shifted into inventiveness and enablement/disclosure regarded biotechnology product and patenting [44] . The eligibility restrictions are considered to offend the very purpose of the patent system in promoting new fields of technological endeavour [45] . The use of purposive reasoning to override eligibility restrictions is reflected in the context of informational products [46] . 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 [47] .Should the requirement of invention be removed in order patenting 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 decisive should be what technical contribution the invention makes to the known art. Should patentability be separated from notions of tangible and technological manifestation and placed to notions of expected investment and 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 practice in 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. 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. [48 Plants or animals inventions shall be patentable if the technical feasibility of the invention is not limited to a particular plant or animal variety [49] and naturally-occurring substances are considered to be patentable inventions provided they are isolated from their surroundings.
What is the nature of the inventive step involved? The author considers that 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 allows its implementation and applicability into producing something new into the real or virtual world. A digitized idea can be patentable if it is transformed into a new digital product, mechanism or both and its implementation brings something new that contains an invention (combination of idea and mechanism – not merely a mathematic calculation) applicable to e-commerce or cyberspace in general and not merely a common/normal idea or common business practice. Otherwise every simple observance can be considered patentable which means no use of the role of patents in economic life. In other words, common business practices can be automated by software and owners can claim a ‘new’ invention or natural characteristics of the human body discovered by the use of a new electronic technology with the help of new electronic software awarded a patent and so laws of nature will become part of commercial utilisation rather than the inheritance of humans

USPTO 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 [50]. The Federal Circuit commenting 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 [51]. 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 [52]. So, there is a need for an inventive step in order to render a patent to a new biotech finding and for instance 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 and sequence of a specific gene coding protein A by means of standard cloning procedures [53]. 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 [54] 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 [55] the court found claims directed to DNA coding for heparin binding growth factors (hbgfs) were 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 [56]. The predictability of a certain technique included in a biotech invention brings something new regardless than there is a prior art for similar for instance DNA sequences. A particular DNA sequence is not obvious merely because the prior art discloses general methods for isolating DNA [57]. An invention lacks patentable novelty if its elements are fully described in a prior art reference but biotechnology obviousness standard 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 [58] An invention has a well-established utility if a person of ordinary skill in the art would instantly value 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 [59]. Patent rights in the field of biotechnology should be confined to processes, rather than the genetic products deriving there from. According to articles 3(2) and 5(2), which follow the U.S. practice it is permitting the patenting of human material, which could either be synthesized by a process outside the body, or, removed from the body by a technical process [60]. So, inventions, which simply display nucleic acid sequences without comprehensible indication of a function, are not considered patentable invention [61]. 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 and has been allowed patents on ESTs based on their utility as probe [62]. 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 [63]. 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 micro organisms 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 [64]. 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 full-length gene sequence [65] The utility of an invention, in concert with its novelty and non-obviousness, merits the reward of patent protection [66]. Whether a claimed invention lacks utility presents a question of fact [67]. 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 [68]. 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 including the scope and content of the prior art, the level of ordinary skill in the art at the time of the invention, objective evidence of non-obviousness, and differences between the prior art and the claimed invention [69]. 

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 [70]. 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 [71]. So, an inventor does not conceive a DNA invention until he actually creates it [72]. 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 [73]. 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 that one skilled in the art could plainly conclude that the inventor had possession [74] of the claimed subject matter and the adequacy [75] of a written description is a question of fact [76] 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 [77] . The ability to articulate the inventive concept is an important starting point [78] . 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 [79] . Prior art is knowledge in the relevant field that is disclosed in patents or printed publications prior to the date of the claimed invention [80] . 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 invented a non-obvious product [81] . Although DNA sequences represent chemical compounds, they are more essentially carriers of information [82] . Hence, a DNA sequence can be non-obvious even though the information necessary for isolating the sequence is publicly available [83] . Can chemicals found in the human body be inventions under the positive law of patents withholding patents on isolated and purified DNA sequence? 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 biochemical in contravention of long established principles of patent law [84]. 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 [85]. In March 2001, the drug company Geron Corp [86] obtained a patent covering genes coding for human embryonic stem cells. Researchers hope of finding and monopolizing DNA sequences that may someday be used in product development. Is the new information for humans body pure science and medical knowledge and not an invention, which means production of something new? According to the author the mechanism of treatment expressed by medicines for treatment should be patented and not the medical knowledge, which is pure science. Moreover, according to some courts and scholars a patent applicant need not have invented the subject matter claimed – he/she may simply has discovered a pre-existing 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 [87]. Is enough a modicum of alteration over something merely found by the applicant to grant of a patent? The invention requirement was seen as so crucial to patent law that it 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 [88]. 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 [89]. In re Bergstrom [90] court accepted that “purified”, prostaglandins were patentable even though they occur naturally in every human being. The lower courts accept patentability of “purified” naturally occurring phenomena because the product does not occur in the prior art in its purified form and any purification of a natural substance, no matter how insubstantial from a scientific viewpoint, to create a new product justifying a patent, adding commercial or therapeutic value by itself creates a patentable new product or process. A discovery is not patentable subject matter unless it is an invention [91]. 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 [92]. 

Can a modified naturally occurring phenomenon becomes a “new” product or process for purposes of section 101 of the Patent Act in the sense of being the object of invention? Can something that exists in nature in to some extent different form can be said to be a new invention due to the newness of the form? 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 and 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 from what is found in nature to be deemed new and, consequently, within statutory subject matter. The European Union now seems to have taken a similar view [93]. 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 [94]. The author considers that medical discovery and new knowledge means a significant mental step as long as it is developed artificially a new gene that can be used for treatment and so the invention of the new gene can be patented. 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 from the one hand but allowing patents to 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 [95]. An inventor must create a new product that is significantly different in function from the naturally occurring phenomenon [96]. 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 or, a new character [97]. 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 [98].
Where is the new scientific knowledge when every new discovery in biotechnology is considered as an invention? There is a difference in producing a new product from discovering the characteristics of DNA using a new technique. Thus, there is a need to distinguish between medical- biotech knowledge and discovery and invention worthwhile to be valid for a patent and not every bit of new information to be considered as an invention at least until is presented/transformed into an applicable technique or a new product.

4. 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. Patent should be synonymous to invention 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 as an invention. The technique for the discovery is the 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 lead to the commercialization of human life. Finally, as patents became associated with rent seeking rather than innovation undermined the integrity of the patent system as a whole, and so reduce the incentive to innovate that patents are supposed to represent

Notes and References

* 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).

[4] Diamond v. Chakrabay, 447 U.S. 303, 307 (1980).

[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).

[15] Gottschalk v. Benson, 409 U.S. 63 (1972).

[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] Common Position to Council Directive 2000/29/EC of 14 September 2000 on the Harmonisation of Certain Aspects of Copyright and Related Rights in the Information Society, recital 9, available at http://europa.eu.int/search/s97.vts (Nov. 13, 2000), Official Journal L 167, 22/06/2001 P. 0010 – 0019. G. Zekos “Issues of Intellectual Property in Cyberspace” 2002 Journal of World Intellectual Property 233. 

[23] According to Article 52 (2) of the European Patent Convention 2000: (2) The following in particular shall not be regarded as inventions within the meaning of paragraph 1: (a) discoveries, scientific theories and mathematical methods; (b) aesthetic creations; (c) schemes, rules and methods for performing mental acts, playing games or doing business, and programmes for computers; (d) presentations of information. (3) The provisions of paragraph 2 shall exclude patentability of the subject-matter or activities referred to in that provision only to the extent to which a European patent application or European patent relates to such subject-matter or activities as such. (4) Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body shall not be regarded as inventions which are susceptible of industrial application within the meaning of paragraph 1. This provision shall not apply to products, in particular sub-stances or compositions, for use in any of these methods.

[24] Robert P. Merges, The Economic Impact of Intellectual Property Rights: An Overview and Guide, 19 J. CULTURAL ECON. 103 (1995). 

[25] Cochrane v. Deener, 94 U.S. 780, 788 (1877), See Hotel Security Checking Co. v. Lorraine Co., 160 F. 467, 469 (2d Cir.1908).

[26] 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).

[27] Diamond v. Chakrabarty, 447 U.S. 303 (1980). 

[28] 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).

[29] 35 U.S.C. § 101 (2002). 

[30] 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).

[31] 35 USC §161. 7 USC §§ 2321-2583. Plant Variety and Seeds Act, 1964, Ch 14 (amended 1997).

[32] 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).

[33] Funck Bross Seed 333 US 127 (refusing a patent for bacterial strains on the ground of want of invention).

[34] 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).

[35] Merck & Co v Olin Mathieson Chem Corp 253 F2d 156(Vitamin B12).

[36] 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.”

[37] 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"

[38] 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 

[39] 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. 

[40] 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 . 

[41] 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.

[42] American National Standards Institute, Guidelines for Implementation of the ANSI Patent Policy, available at http ://web.ansi.org/public/library/guides/-ppguide.html 

[43] Biogen/Hepatitis b T296/93 1995 EPOR 1 

[44] 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)

[45] 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)

[46] 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.

[47] 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. 

[48] 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. 

[49] ibid

[50] In re Bell, 991 F.2d 781, 785 (Fed. Cir. 1993). 

[51] In Re Deuel 51 F.3d 1552, 34 U.S.P.Q.2d 1210 (Fed. Cir. 1995).

[52] 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 

[53] 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

[54] In re Bell 991 F2d 781.

[55] In re Deuel 51 F3d 1552.

[56] 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).

[57] In re Deuel, 51 F.3d 1552, 1553-54 (Fed. Cir. 1995). 

[58] In re Baird, 16 F.3d 380 (Fed. Cir. 1994)). See In re Mayne, 104 F.3d 1339 (Fed. Cir. 1997). 

[59] 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.”

[60] 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

[61] 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 

[62] 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 

[63] 66 Fed. Reg. 1092-99 (2001).

[64] Courtney J. Miller, Patent Law and Human Genomics, 26 CAP. U. L. REV. 893, 911 (1997). 

[65] 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

[66] 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). 

[67] 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.”). 

[68] Kridl v. McCormick 105 F.3d 1446, 1447 (Fed. Cir. 1997). 

[69] Monarch Knitting Mach. Corp. v. Sulzer Morat GMBH, 139 F.3d 877, 881 (Fed. Cir. 1998).

[70] 35 U.S.C. § 112 (2001).

[71] 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).

[72] 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.

[73] Enzo Biochem v Gen-Probe 296 F3d 1316. US PTO 66 Fed. Reg. 1099, 1106.

[74] 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 

[75] 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); 

[76] 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.").

[77] Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 607 (1950); Winans v. Denmead, 56 U.S. 330 (1853). 

[78] Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994). Schendel v. Curtis 83 F.3d 1399. 

[79] In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990). 

[80] See 35 U.S.C.A. § 301

[81] 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). 

[82] 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”). 

[83] In re Donaldson, 16 F.3d 1189, 1192 (1994) (“Obviousness under section 103 is a question of law that this court reviews de novo.”).

[84] 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.”. 

[85] 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).

[86] 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). 

[87] 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”).

[88] 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).

[89] 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.)

[90] 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).

[91] 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.

[92] 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). 

[93] 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

[94] 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.

[95] 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)

[96] 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”).

[97] 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.”). 

[98] 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).