Beginning in the 1970s, firms sought and obtained patents on newly cloned genes encoding therapeutic proteins (Eisenberg, 1990). These early patents typically claimed an “isolated and purified” DNA sequence corresponding to the amino acid sequence for the protein, along with recombinant materials incorporating that DNA sequence for use in making the protein in cultured cells.1 As a legal matter, the courts and the United States Patent and Trademark Office (USPTO) treated these inventions as chemicals or “composition of matter,”2 a characterization that provided an extensive body of precedent that could be consulted to establish the ground rules for patents in this emerging field. Having long ago decided that chemicals isolated from nature through human intervention were eligible for patent protection,3 the courts and USPTO had little difficulty allowing patents on newly isolated genes.

The gene-patenting pioneers in the new biotechnology firms of the 1980s saw themselves as high-technology drug developers, and in their search for a viable business model for therapeutic protein development, they emulated the patent strategies of major pharmaceutical firms. Patents on the genes that encoded therapeutic proteins secured exclusive franchises to manufacture these products. Such patents have been the focus of numerous judicial opinions concerning the requirements for patent protection,4 priority of invention,5 and determinations of infringement.6 The judicial opinions that resolve these disputes provide most of the existing legal precedent involving the patenting of DNA.

Following the first wave of patents on genes encoding therapeutic proteins, the development of new tools and techniques for detecting genetic differences among individuals enabled researchers to bypass the stages of protein isolation and characterization and to identify directly the genes associated with diseases

1  

See, e.g., U.S. Patent No. 4,757,006 (July 12, 1988), which claims, inter alia: 1. An isolated recombinant vector containing DNA coding for human factor VIII:C, comprising a polydeoxy-ribunucleotide having the [following] sequence: 4. A nonhuman recombinant expression vector for human factor VIII:C comprising a DNA segment having the [following] sequence: 5. A transformed non-human mammalian cell line containing the expression vector of claim 4.

2  

See, e.g., Amgen v. Chugai Pharmaceutical Co., 927 F.2d 1200, 1206 (Fed. Cir.), cert. denied sub nom. Genetics Institute v. Amgen, 502 U.S. 856 (1991) (“A gene is a chemical compound, albeit a complex one …”).

3  

E.g., Parke-Davis & Co. v. H.K. Mulford & Co., 189 F. 95 (S.D.N.Y. 1911) (adrenaline); Kuehmsted v. Farbenfabriken, 179 F. 701 (7th Cir. 1910), cert. denied, 220 U.S. 622 (1911) (prostaglandins); Merck & Co. v. Olin Mathieson Corp., 253 F.2d 156 (4th Cir. 1958) (vitamin B12).

4  

See, e.g., In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995) (nonobviousness); Regents of the University of California v. Eli Lilly, 119 F.3d 1559 (Fed. Cir. 1997) (nonobviousness); Genentech v. Novo Nordisk, 108 F.3d1361 (Fed. Cir. 1997) (enablement); Eli Lilly v. Genentech, 119 F.3d 1567 (Fed. Cir. 1997) (written description).

5  

See, e.g., Fiers v. Revel, 984 F.2d 1164 (Fed. Cir. 1993).

6  

See, e.g., Scripps Clinic & Research Found. v. Genentech, 927 F.2d 1565 (Fed. Cir. 1991); Genentech v. Wellcome Foundation, 29 F.3d.



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