MUCH ADO ABOUT GENE PATENTS: THE ROLE OF FORESEEABILITY Michael John Gulliford∗ INTRODUCTION Since Gregor Mendel1 discovered the gene, scientists have sought to unravel the intricacies of life’s blueprint—the genetic code.2 Today, insights into molecular biology and genetic engineering3 fuel biotechnology, an industry promising to touch every aspect of human life.4 Already, biotechnology has enabled major advances in medical therapeutics and diagnostics, and has spawned complex new fields such as genomics5 and proteomics.6 Given the major role of gene-based technologies in biotechnology, gene patents are among a biotechnology company’s most valuable assets.7 Patents are government issued grants providing ∗ J.D. Candidate 2004, Seton Hall University School of Law; B.A. Neuroscience and Behavior, 2000, Columbia University. 1 See infra text accompanying notes 47-50 for a discussion of Mendel’s work. 2 See infra Part II for a discussion of the scientific discoveries that enabled the deciphering of the genetic code. 3 Genetic engineering involves the use of processes (i.e., genetic manipulation, genetic modification, genetic technology, recombinant DNA technology) to move genes from one organism to another, often to solve medical or agricultural problems, with the goal of creating organisms with novel genetic make-ups. MICHAEL J. REISS & ROGER STRAUGHAN, IMPROVING NATURE? 1, 2 (1996). 4 Examples of biotechnology’s focus on genetics include the development of genetically engineered organisms that remove hazardous waste from the environment, the development of animals that make human products such as insulin, and the development of genetically engineered drugs for treating heart disease, cancer, AIDS, and strokes. See JEREMY RIFKIN, THE BIOTECH CENTURY: HARNESSING THE GENE AND REMAKING THE WORLD 15-24 (1998). 5 The goal of genomics is to study the functions and interactions of all genes in the genome. See Alan Guttmacher & Francis Collins, Genomic Medicine: Genomic Medicine-A Primer, 347 NEW ENG. J. MED. 1512, 1513 (2002). 6 Proteomics involves the study of proteins, their biological functions, and the mechanisms by which they interact. HOWARD C. ANAWALT & ELIZABETH E. POWERS, IP STRATEGY: COMPLETE INTELLECTUAL PROPERTY PLANNING, ACCESS, AND PROTECTION § 4:21 (2002). 7 RIFKIN, supra note 4, at 37 (referring to genes as the “green gold” of biotechnology). 711 712 SETON HALL LAW REVIEW Vol. 34:711 their owner the right to exclude others from “making, using, offering for sale, or selling [their] invention”8 for a period of twenty years from the date of filing.9 In offering protection, patents also create incentives.10 Barring exclusion, competitors could copy a patented invention and undersell the patent owner, who, unlike the competition, has incurred research and development costs.11 The right of exclusion, however, prevents competitors from “making, using, offering for sale, or selling” the patented invention.12 In so doing, the exclusionary right provides opportunity for economic recovery and gain, which in turn creates incentives to invest the time, effort, and money necessary for the creation of new and useful products.13 The importance of obtaining patent protection for commercially valuable genes has created a race to the United States Patent and Trademark Office (“USPTO”).14 Given the pressure to file first, biotechnology companies often choose to file broad patent applications in the early stages of research, before they understand the commercial applications of their inventions.15 Biotechnologists defend these broad filings, arguing that limiting their patents to the “specific and narrow” lab results will make cost recovery an impossibility.16 Legal commentators, clinicians, and researchers, however, argue that gene patents have the real potential of undermining biomedical research, health care, and the free exchange of information among researchers.17 For instance, a gene patent holder may lawfully prevent the scientific community from conducting research or developing valuable therapeutic applications based on the patented gene’s DNA sequence.18 Even when the patent holder is willing to license the gene or DNA sequence, the cost of acquiring the license can be prohibitive.19 This Comment explores the key role American patent law plays, 8 35 U.S.C. § 271(a) (2001). 9 35 U.S.C. § 154(a)(2) (1994). 10 CHISUM ET AL., PRINCIPLES OF PATENT LAW 70-76 (2d ed. 2001). 11 Id. at 69. 12 35 U.S.C. § 271(a) (2001). 13 See CHISUM ET AL, supra note 10, at 70-76. 14 See RIFKIN, supra note 4, at 59. 15 ERIC S. GRACE, BIOTECHNOLOGY UNZIPPED: PROMISES AND REALITIES 204 (1997). 16 See id. 17 See infra Part IV for an in-depth examination of the policy issues surrounding the issuance of gene patents. 18 See Part IV.A. 19 See id. 2004 COMMENT 713 and must continue to play, in preventing the ills associated with broad gene patents. Part I offers a basic explanation of genes and their functions. Part II provides an introduction to the biotechnology industry. This section examines the history of biotechnology with an emphasis on current technology and the scientific goals of the industry. Part III gives an overview of the American patent system. Part IV considers both the negative and positive implications of issuing gene-based patents. Also, this section briefly discusses various options for lessening the negative effects of gene patents. Part V suggests that the United States Court of Appeals for the Federal Circuit adopt a biotechnology-specific application of the foreseeability standard articulated in Judge Rader’s concurrence in Johnson & Johnston Associates, Inc. v. R.E. Service Co., Inc. 20 Under this objective foreseeability-based limit on the doctrine of equivalents,21 the patent applicant “has an obligation to draft claims capturing all reasonably foreseeable ways to practice the invention,”22 and may not rely on the doctrine of equivalents to capture “subject matter that the patent drafter reasonably could have foreseen,”23 but failed to claim. Judge Rader advocated the foreseeability standard as a general, rather than biotechnology-specific, patent law principle.24 This section, however, argues for a biotechnology-specific application of the foreseeability standard.25 It posits that applying a heightened, more restrictive version of the doctrine of equivalents in biotechnology cases will effectively limit gene patent scope, thereby promoting biotechnological progress.26 I. THE GENE This Comment aspires to offer an in-depth examination of the challenges that gene patents pose, and the manner in which courts have and should continue to limit gene patent scope. However, in order to appreciate a gene’s scientific value, gene patent case law, 20 285 F.3d 1046, 1056-59 (Fed. Cir. 2002) (en banc) (per curiam) (Rader, J., concurring) (agreeing with the court’s decision, but arguing that the court should have decided the issue under a foreseeability approach to the doctrine of equivalents). 21 See infra text accompanying notes 131-42 for a discussion of the doctrine of equivalents. 22 Id. at 1057 (Rader, J., concurring). 23 Id. at 1056 (Rader, J., concurring). 24 See id. at 1056-59 (Rader, J., concurring). 25 See infra Part V. 26 See id. 714 SETON HALL LAW REVIEW Vol. 34:711 and the philosophical questions surrounding gene patents, it is helpful to comprehend the structure and function of the gene itself. Deoxyribonucleic acid, also known as DNA, is the primary repository for genetic information in the human body.27 DNA is located on chromosomes,28 which are located in a cell’s nucleus.29 Although it may be difficult to understand the function of DNA, “[its] structure is really quite simple.”30 DNA, in its double helix form, resembles a twisted rope ladder. The rope element (a strand) is composed of alternating molecules of sugar and phosphate.31 Each step of the ladder is composed of a pair of bases (nucleotides) joined by chemical bonds.32 There are four such bases: G (guanine), T (thymine), C (cytosine) and A (adenine).33 The bases are complementary in that they always pair up the same way: A with T, and C with G.34 Thus, each step of the ladder is either an A-T, T-A, C-G or G-C.35 More importantly, the complementary nature of the bases means that the sequence of bases on one strand always complements the sequence along the other strand in the same way.36 DNA’s incredible ability to store information lies in the bases, the arrangement of which makes up a gene.37 A useful way to visualize a gene is as follows: imagine splitting the ladder in half down the middle, so as to separate each base pair. Now, imagine walking up one of the ropes, “reading off the bases as you go.”38 The sequence of bases might read ATGCTCCG. Another section might read an entirely different sequence of bases. Each section of bases is a particular gene, the lengths and sequences of which vary.39 Many people mistakenly believe that genes are the determinate 27 WAYNE BECKER ET AL., THE WORLD OF THE CELL 56 (3d ed. 1996). 28 Chromosomes are thread-like strands containing nucleic acids that are located in a cell’s nucleus. Id. at 83. 29 The nucleus is the cell’s control center, located near the middle of the cell. Id. at 89-99. 30 REISS & STRAUGHAN, supra note 3, at 13. 31 BECKER ET AL., supra note 27, at 60. 32 Id. at 60-61. 33 Id. at 61. 34 Id. at 60-61. 35 Id. 36 Thus, if one strand of the DNA contains the bases TAATCG, its complement will read ATTAGC. Id. at 60-61. 37 GRACE, supra note 15, at 17. 38 Id. 39 Id. 2004 COMMENT 715 factor of our physical characteristics.40 In actuality, genes do not directly determine our physical features.41 Rather, they are the instructions for making proteins, the biological compounds directly responsible for making us what we are.42 Proteins are “the very foundation of living systems,”43 and are involved with nearly every product and process necessary for cell survival.44 II. OVERVIEW OF THE BIOTECHNOLOGY INDUSTRY Although the word “biotechnology” conjures up thoughts of modern, cutting edge technology, its history dates back thousands of years.45 The roots of traditional biotechnology trace back 12,000 years, when humans independently domesticated plants and animals in the Middle East, the Far East, and the Americas.46 Such domestication involved farmers selecting various plants and animals, and breeding them to produce the largest and healthiest specimens.47 One of the most prolific and important figures in the era of traditional biotechnology was Gregor Mendel,48 the founder of the study of genetics, which has enabled the success of modern biotechnology.49 While observing the common pea plant in his monastery’s garden, Mendel made numerous important discoveries known as Mendel’s laws of inheritance. 50 Importantly, Mendel discovered that discrete “factors” (known today as genes) determine the traits of most organisms.51 The Twentieth Century scientific community witnessed numerous landmark discoveries that paved the way for the era of modern biotechnology.52 Modern biotechnology is primarily 40 Id. at 18 (commenting that “[t]o the average person, a gene is something that gives you, say, blue eyes or brown eyes”). 41 Id. at 20-25 (noting how genes code for proteins, which in turn are the foundation of living systems). 42 Id. at 21. 43 GRACE, supra note 15, at 21. 44 Proteins’ functions are vast and varied. Id. at 21. Some of their functions include carrying oxygen in the blood, carrying messages between cells, making up muscle, activating the immune system, and activating essential chemical reactions by acting as enzymes. Id. 45 REISS & STRAUGHAN, supra note 3, at 3. 46 Id. 47 Id. 48 See BECKER ET AL., supra note 27, at 509. 49 See GRACE, supra note 15, at 6, 8. 50 BECKER ET AL., supra note 27, at 509. 51 Id. 52 See GRACE, supra note 15, at 28-29 (discussing monumental discoveries such as 716 SETON HALL LAW REVIEW Vol. 34:711 concerned with developing “commercially valuable therapeutic, biomedical, and pharmaceutical products and processes . . . that revolve around the manipulation of DNA molecules and their encoded proteins.”53 What separates “modern biotechnology” from “traditional biotechnology” is not the use of organisms to accomplish goals, but rather the processes employed in doing so.54 Modern processes such as genetic engineering, specifically recombinant DNA technology, allow biotechnologists to “reach further into the genetic structure of organisms and to manipulate the building blocks of life directly.”55 Recombinant DNA technology involves isolating and replicating the desired gene of one species and inserting it into the genome of another species.56 Once transfected, the host cells become capable of producing (“expressing”) the protein for which the foreign gene codes.57 For example, recombinant DNA technology makes it possible for bacteria to mass produce lifesaving substances such as human insulin, growth hormones and blood clotting factors, previously available only in limited quantities.58 Importantly, recombinant DNA technology made the Human Genome Project a reality.59 Launched in 1990 by the Department of Energy and the National Institute of Health, the Human Genome Project (“HGP”) is a $250 million publicly funded international endeavor focused on sequencing the entire human genome.60 In 2001, the HGP accomplished its first goal of mapping and sequencing all 100,000 genes of the human genome.61 The information, in the form of three billion base pairs, is “enough to fill more than 200 telephone the recognition that DNA carries genetic information, DNA’s helical structure, and the use of restriction enzymes to cut and splice genetic material). 53 CHISUM ET AL., supra note 10, at 646. 54 GRACE, supra note 15, at 2. 55 See ANAWALT & POWERS, supra note 6. 56 BECKER ET AL., supra note 27, at 520-27. 57 Id. 58 Aaron Xavier Fellmeth & Linda J. Demaine, Reinventing the Double Helix: A Novel and Nonobvious Reconceptualization of the Biotechnology Patent, 55 STAN. L. REV. 303, 308 (2002) (presenting the manner in which gene patents harm research and innovation, and suggesting a substantial transformation test that only allows patenting of truly novel gene-based inventions). 59 See GRACE, supra note 15, at 69-70. 60 Mary Breen Smith, Comment, An End to Gene Patents? The Human Genome Project Versus the United States Patent and Trademark Office’s 1999 Utility Guidelines, 73 U. COLO. L. REV. 747, 754 (2002). 61 See id. at 754-55. 2004 COMMENT 717 books.”62 The next wave of research in understanding human development and illness is proteomics.63 Whereas the HGP focused on sequencing the entire human genome, proteomics seeks to understand all proteins, their biological functions and the mechanisms by which they interact.64 Involved in the pursuit of this goal is the field of structural genomics, a subset of proteomics, which seeks to uncover the biological functions of proteins through study of their three-dimensional structure.65 Although modern biotechnology’s applications are widespread, “its greatest impact so far has been in healthcare.”66 Equipped with the knowledge resulting from the Human Genome Project, biotechnology companies are currently developing innovative drugs and diagnostic tools.67 Since many medical ailments are created by defective genes, knowledge of the location, structure and function of these genes will allow researchers to develop drugs and diagnostic kits that treat and diagnose disease at the genetic level, thus leading to safer and more effective treatments.68 Today, biotechnology companies, along with government and corporate laboratories, are mapping and sequencing the genomes of many species, from humans to bacteria, “with the goal of finding new ways of harnessing and exploiting genetic information for economic purposes.”69 Given the economic incentives, researchers will continue to seek broad patent protection for their genetic and biotechnological discoveries.70 It is the role of the Federal Circuit and USPTO to maintain an appropriate level of patent protection that creates incentives while also preventing overly broad gene patent scope.71 62 Id. at 754. 63 ANAWALT & POWERS, supra note 6. 64 Id. 65 Id. 66 Sara Dastgheib-Vinarov, Comment, A Higher Nonobvious Standard for Gene Patents: Protecting Biomedical Research from the Big Chill, 4 MARQ. INTELL. PROP. L. REV. 143, 145 (2000) (arguing that given the detrimental effects of broad gene patents on biomedical research, they should be made more difficult to obtain by means of a heightened non-obvious standard) (quoting WILLIAM BAINS, BIOTECHNOLOGY FROM A TO Z V (1993). 67 ANAWALT & POWERS, supra note 6. 68 Id. 69 RIFKIN, supra note 4, at 190. 70 See Arti Kaur Rai, Regulating Scientific Research: Intellectual Property Rights and the Norms of Science, 94 NW. U. L. REV. 77, 105-06 (1999). 71 See Clarisa Long, Side Bar: The Brouhaha Over Expressed Sequence Tags, in CHISUM 718 SETON HALL LAW REVIEW Vol. 34:711 III. PATENT LAW BACKGROUND DNA-based inventions have provided special problems for patent law.72 In order to understand these challenges, including the issue of broad gene patents, it is necessary to understand the American patent law system. The constitutional basis for the American patent law system is found in Article I, Section 8 of the United States Constitution, which gives Congress the power “[t]o promote the Progress of Science and the useful Arts by securing for limited times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.”73 Given colonial usage and syntax, the clause can be reworked as follows: (1) “To promote the Progress of Science . . . by securing for limited times to Authors . . . the exclusive Right to their . . . Writings; and (2) To promote the Progress of . . . useful Arts, by securing for limited times to . . . inventors the exclusive Right to their . . . Discoveries.”74 Although this interpretation highlights the framers’ intent of encouraging the useful arts, “it does not however, define the exact nature of the patent grant, such as its appropriate balance or scope, and subject matter.”75 The founding fathers left that duty to Congress,76 which enacted the first patent statute in 1790.77 Since then, Congress has enacted several statutory revisions leading up to the 1952 Patent Act.78 Under the 1952 Patent Act, an invention may only receive a patent if it is “new and useful,”79 “novel”80 and “non-obvious” to a person of ordinary skill in the art.81 Furthermore, the patent application’s specification82 must adequately disclose the invention to ET AL., supra note 10, at 725 (noting that one of the most critical issues surrounding the intersection of biotechnology and patent law is the appropriate scope of claims to genetic material). 72 See CHISUM ET AL., supra note 10, at 273. 73 U.S. CONST. art. I, § 8, cl. 8. 74 Karl B. Lutz, A Clarification of the Patent Clause of the U.S. Constitution, 18 GEO. WASH. L. REV. 50 (1949). 75 Michael S. Greenfield, Note, Recombinant DNA Technology: A Science Struggling with the Patent Law, 44 STAN. L. REV. 1051, 1056 (1992). 76 Id. (citing Graham v. John Deere Co., 383 U.S. 1, 6 (1966)). 77 CHISUM ET AL., supra note 10, at 18. 78 See id. at 18-21 for a complete history of the patent statutes. 79 35 U.S.C. § 101 (2001). 80 35 U.S.C. § 102 (2001). 81 35 U.S.C. § 103 (2001). 82 The specification consists of the written description and the claims. See CHISUM ET AL., supra note 10, at 92. The written description provides background, drawings, and a detailed description of the invention. See id. at 93-102. The claims 2004 COMMENT 719 the public.83 Pursuant to 35 U.S.C. § 101, an invention must be “new and useful.”84 “For an invention to be useful within the meaning of the statute, a substantial and practical purpose must be discovered and disclosed.”85 The utility requirement is part of the patent system’s quid pro quo.86 In exchange for the right to exclude, the invention is required to work for its intended purpose.87 Unlike mechanical and electrical inventions, which often show an end result, proving utility of biotechnology inventions is more difficult88 because biotechnology inventions “possess an evolving utility,”89 and “are more like building blocks rather than a completed building.”90 That is, many biotechnology inventions involve methods for producing intermediary products or products with unknown results.91 Under § 102, only novel inventions may be patented,92 ensuring that the invention contributes something new to society.93 To be considered novel, the invention must not have been “known or used” in the United States or “patented or described in a printed publication” either in the United States or abroad.94 In patent terminology, an invention that is not new is anticipated by prior art.95 That is, the prior art reference discloses every element of the invention’s claims and enables one skilled in the art to make and use the invention.96 In addition to the novelty requirement, § 102 define the metes and bounds of the invention and as the “[f]ederal circuit has stated time and again, ‘[c]laims are infringed, not specifications.’” Id. at 103 (quoting SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 (Fed. Cir. 1985)). A patent application generally has numerous claims, which often vary in scope. See id. at 104. Since the claims define the outer bounds of an invention, when we refer to broad inventions, we are in fact referring to a patent with broad claims. Id. A broad claim is one that lacks limitations, which results in a wider scope. Id. 83 35 U.S.C. § 112 (2001). 84 35 U.S.C. § 101. 85 Greenfield, supra note 75, at 1061 (citing Cross v. Iizuka, 753 F.2d 1040 (Fed. Cir. 1985)). 86 CHISUM ET AL., supra note 10, at 707. 87 Id. 88 Id. 89 Id. 90 Id. 91 Id. 92 35 U.S.C. § 102(a). 93 See CHISUM ET AL., supra note 10, at 323. 94 35 U.S.C. § 102(a). 95 Prior art is a term used in patent law that refers to all known technical information. CHISUM ET AL., supra note 10, at 93. A patent’s novelty and obviousness are judged in light of all known prior art. See id. 96 See id. at 400. 720 SETON HALL LAW REVIEW Vol. 34:711 contains a statutory bar forbidding patenting when, more than a year before filing a patent application, “the invention was patented or described in a printed publication” either in the United States or abroad, or the invention was “in public use or on sale” in the United States.97 The non-obvious requirement of § 103 is referred to as “the most significant obstacle that a patent applicant faces”98 and the “final gatekeeper of the patent system.”99 The non-obvious requirement serves to prevent the patenting of inventions that while novel, are not that different from the prior art.100 An invention is non-patentable if, based on all existing knowledge at the time of invention, those skilled in the art would have considered the invention obvious.101 That is, a single prior art reference does not disclose each and every limitation in the claim (thus not novel), but a variety of references, when combined, do contain all of the limitations and show the invention was already in the public domain.102 Further, in order for the references to be combinable, they must suggest to a person of ordinary skill in the art that he make the invention and that if made, the invention will have a reasonable likelihood of success.103 Finally, a patent specification must meet the disclosure requirements of § 112.104 These requirements provide that the specification must (1) contain a “written description” that (2) provides sufficient information to “enable” any person skilled in the art to make or use the invention, and (3) sets forth the “best mode” contemplated by the inventor of making the invention.105 The specification must also contain claims “particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.”106 The first of the three requirements set forth in paragraph one of § 112 is that the specification contain a written description.107 The written description provides the technical and background 97 35 U.S.C. § 102(b). 98 See CHISUM ET AL., supra note 10, at 514. 99 Id. (quoting ROBERT PATRICK MERGES, PATENT LAW AND POLICY 479 (2d ed. 1997)). 100 See id. at 515. 101 See Greenfield, supra note 75, at 1061. 102 CHISUM ET AL., supra note 10, at 514. 103 Id. at 584. 104 35 U.S.C. § 112. 105 Id. 106 Id. 107 Id.