How to Claim a Gene: Application of the Patent Disclosure Requirements to Genetic Sequences

• Publication year: 2010

Georgia State University Law Review

Volume 27 , ,

t _1c ■ Article ⁶

Issue 3 Spring 2011

3-1-2011

How to Claim a Gene: Application of the Patent Disclosure Requirements to Genetic Sequences

Patrick Brian Giles

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Recommended Citation

Giles, Patrick Brian (2010) "How to Claim a Gene: Application of the Patent Disclosure Requirements to Genetic Sequences," Georgia State University Law Review: Vol. 27: Iss. 3, Article 6. Available at: http://digitalarchive.gsu.edu/gsulr/vol27/iss3/6

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HOW TO CLAIM A GENE: APPLICATION OF THE PATENT DISCLOSURE REQUIREMENTS TO GENETIC SEQUENCES

Patrick Brian Giles*

Introduction

Prior to 1980, the only source of insulin for diabetics was the pancreas of animals, such as cows or pigs.¹ While supply was not a problem, this source did carry the risk of infection and allergic reaction. other therapeutic proteins, such as growth hormone, were previously only available in minuscule amounts from the pituitary glands of human cadavers. However, by 1980 the emerging field of biotechnology provided methods for producing mass quantities of human proteins such as insulin and growth hormone using the science of genetic engineering.⁴ These laboratory methods generally involve inserting a gene⁵ that encodes the desired therapeutic protein into a deoxyribonucleic acid (DNA) vector.⁶ The product of this "DNA recombination" is then introduced to appropriate cells, the cells are cultured in the laboratory, during which time the cells produce the

* J.D. Candidate, 2011, Georgia State University College of Law, Ph.D.; registered patent agent.

1. Regents of Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1562 (Fed. Cir. 1997); Tests Begin on Insulin Synthesized from Bacteria Through Gene-Splicing, N.Y. Times, July 24, 1980, at D18; Cristine Russell, FDA Approves Insulin Made by Splicing Genes, Wash. Post, Oct. 30, 1982, at A6.

2. Lilly, 119 F.3d at 1562; Tests Begin on Insulin Synthesized from Bacteria Through Gene-Splicing, supra note 1, at D18; Russell, supra note 1, at A6.

3. See, e.g., Sandra Blakeslee, Supply of Growth Hormone Brings Hope for New Uses, N.Y. Times, Feb. 10, 1987, at C1.

4. See supra notes 1-3; Cynthia Robbins-Roth, From Alchemy to IPO 11 (Perseus Publishing

2000).

5. Gregor Mendel was the first to appreciate that certain traits, such as flower color, do not blend in offspring, but are instead inherited based on the passage of a discrete factor, later termed a "gene," to the offspring from both the mother and the father. It is now known that these genes are discrete segments of deoxyribonucleic acid (DNA), which contain instructions for producing functional units, such as proteins. See generally Mark B. Gerstein et al., What is a Gene, Post-ENCODE? History and Updated Definition, 17 Genome Res. 669-81 (2007).

6. See Harvey Lodish et al., Molecular Cell Biology 176-98 (6th ed. 2008), for a description of many of the principles involved in molecular biology and recombinant DNA technology.

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recombinant protein along side their natural proteins, and the recombinant protein is then collected and purified.

Not surprisingly, biotechnology companies have sought patent protection for these novel genes and their uses. Of course, these efforts are futile if a competitor can circumvent the patent by making changes to the claimed DNA sequence while preserving, or possibly improving, the therapeutic efficacy of the encoded protein.⁹ In fact, a competitor can routinely engineer non-naturally occurring variants using one of many recombinant techniques.¹⁰ Notably, in some cases, 50% or more of the amino acid positions within the sequence of a protein can be substituted without substantially altering protein function.¹¹ Inventors of novel genes and recombinant technologies, therefore, have sought patent protection beyond the scope of the

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specific genetic sequence they exemplified. While this can be done by specifically reciting each and every possible alternative sequence,

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to do so would be impractical. Instead, it is far more feasible to refer to the gene genetically (e.g., by name or function), thereby describing a genus of genetic sequences covered by the claim.¹⁴ The

7. Id. at 194-96.

8. Christopher M. Holman, Learning from Litigation: What Can Lawsuits Teach Us About the Role of Human Gene Patents in Research and Innovation?, 18 Kan. J.L. & Pub. Pol'y. 215, 221-22 (2009) [hereinafter Holman, Learning from Litigation] (noting the early "belief that patent protection could prove critical in providing the necessary incentive for the development of drugs based on newly identified human genes").

9. Id. at 226-27 ("[A] form of human insulin with a single amino acid change . . . renders the product faster acting than native insulin.").

10. Christopher M. Holman, Protein Similarity Score: A Simplified Version of the BLAST Score as a Superior Alternative to Percent Identity for Claiming Genuses of Related Protein Sequences, 21 Santa Clara Computer & High Tech. L.J. 55, 60 (2004) [hereinafter Holman, Protein Similarity Score] (noting that it is routine to make mutations in a protein and screen those mutants for one that retains the desired function).

11. Id. at 59.

12. Id. at 57.

13. A protein is a polymer of amino acids linked together in a chain. See id. at 72 n.70. There are twenty different amino acids to choose from for each position in that chain. Id. Thus, for a typical protein having three hundred amino acids residues, there are nineteen alternative amino acids at each of the three hundred positions. Id. Using the equation ((19 x 300) + (19 x 300)(19 x 299)), this results in over thirty-two million possible protein variants that have a single amino acid change. See id.

14. When an aspect of an invention includes one of multiple alternative embodiments, a generic term may be used to represent each of those alternatives. Robert C. Faber, Faber on Mechanics of Patent Claim Drafting § 6:9 (6th ed. 2008). For example, the term "mammal" represents a genus encompassing the species mice and humans. See id. Note that the genus can also cover a subgenus. Id. For example, "rodents" is a genus covering mice and rats, but it is also a sub-genus of mammals. See id.

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problem, however, is that an overreaching genus claim may not satisfy the patent disclosure requirements codified in the first paragraph of 35 U.S.C. § 112,¹⁵ which (according to the most current interpretation of the statute)¹⁶ requires that the disclosure (1) contain an adequate written description of the invention; (2) enable one to make and use the invention; and (3) disclose the inventor's best mode

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for carrying out his invention.

Prior to 1997, the courts relied primarily on the enablement

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requirement to invalidate overreaching claims. However, in Regents of the University of California v. Eli Lilly & Co.,¹⁹ a court, for the first time, invalidated an original—arguably overreaching—claim for

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lack of written description. Specifically, the Lilly court concluded that the patentee's description of the rat insulin DNA sequence was not a sufficient disclosure to support claims to vertebrate,

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mammalian, or human insulin DNA. As a consequence, inventors have had to find other ways to describe and claim genetic sequences in a manner that would cover predictable variants while at the same time not running afoul of the Lilly written description requirement.

15. 35 U.S.C. § 112 (2006) ("The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.").

16. See discussion infra Part II.A.

17. Under § 112, first paragraph, as enacted as part of the Patent Act of 1952, the inventor must adequately set forth and describe three items: (1) the invention (the description requirement); (2) the manner and process of making and using the invention (the enablement requirement); and (3) the best mode contemplated by the inventor of carrying out his invention (the best mode requirement). 3 Donald S. Chisum, Chisum on Patents § 7.01 (2010).

18. E.g., In re Fisher, 427 F.2d 833, 839 (C.C.P.A. 1970) (arguing that an inventor should be allowed to dominate future patentable inventions based on his teachings so long as the scope of the claims "bear a reasonable correlation to the scope of enablement provided by the specification"); see also Christopher M. Holman, Is Lilly Written Description a Paper Tiger?: A Comprehensive Assessment of the Impact of Eli Lilly and Its Progeny in the Courts and PTO, 17 Alb. L.J. Sci. & Tech. 1, 12 (2007) [hereinafter Holman, Paper Tiger] (noting that prior to Lilly, the enablement requirement was sufficiently robust to limit patent claims "to a scope commensurate with the inventor's disclosure").

19. Regents of Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997).

20. Holman, Paper Tiger, supra note 18, at 4.

21. Lilly, 119 F.3d at 1568.

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one approach taken by inventors, and originally endorsed by the

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Patent Office, was the claiming a genus of genetic sequences based

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on percent identity to a reference sequence—generally the naturally

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occurring gene—that is limited by a functional limitation. However, the Patent office has recently reversed its position²...