Amgen, Inc. v. Chugai Pharm. Co.
927 F.2d 1200 (1991)
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Rule of Law:
For a patent on a purified and isolated DNA sequence, conception requires knowledge of the gene's specific chemical structure; a general plan or method for isolating a gene of a then-unknown structure is insufficient to establish priority of invention.
Facts:
- Erythropoietin (EPO) is a naturally occurring protein that stimulates red blood cell production, making it a valuable therapeutic agent.
- In 1981, Dr. Fritsch of Genetics Institute, Inc. (GI) conceived of a strategy to isolate the human EPO gene using two sets of fully-degenerate cDNA probes to screen a genomic library.
- At the time of Dr. Fritsch's plan, the precise amino acid sequence for EPO was not fully known, and the structure of the EPO gene was entirely unknown.
- Dr. Lin, a scientist at Amgen, Inc. (Amgen), was also working to isolate the EPO gene.
- In September 1983, Dr. Lin successfully used a similar probing strategy to become the first to isolate the purified human EPO gene and determine its nucleotide sequence.
- Dr. Fritsch of GI did not successfully reduce his strategy to practice and isolate the EPO gene until May 1984, after Dr. Lin had already succeeded.
- Amgen subsequently obtained U.S. Patent 4,703,008 ('008), which claimed, among other things, the purified and isolated DNA sequence encoding human EPO.
- GI had obtained U.S. Patent 4,677,195 ('195), claiming homogeneous EPO with a specific activity of at least 160,000 IU/AU.
Procedural Posture:
- Amgen, Inc. filed suit against Chugai Pharmaceutical Co. and Genetics Institute, Inc. (GI) in the U.S. District Court for the District of Massachusetts.
- Amgen alleged that GI infringed its '008 patent and sought a declaratory judgment that GI's '195 patent was invalid.
- GI and Chugai filed counterclaims, asserting that Amgen's '008 patent was invalid for reasons including prior invention by GI, and that Amgen infringed GI's '195 patent.
- The parties consented to a trial before a magistrate judge, whose findings were adopted by the district court.
- The district court held, in part, that certain claims of Amgen's '008 patent were valid and not anticipated by GI's work, but that other broader claims of the '008 patent were invalid for lack of enablement.
- The district court also held that some claims of GI's '195 patent were valid and infringed, while others were invalid for indefiniteness.
- GI and Chugai (defendants) appealed the district court's judgment to the U.S. Court of Appeals for the Federal Circuit, and Amgen (plaintiff) filed a cross-appeal.
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Issue:
For a patent on a purified and isolated DNA sequence, does an inventor achieve conception by devising a general strategy to isolate a gene of unknown structure, or is conception only achieved upon the gene's actual isolation and characterization (reduction to practice)?
Opinions:
Majority - Lourie, J.
No, an inventor does not achieve conception by devising a general strategy; conception of a gene is not achieved until the gene has been isolated and its structure is known. The court held that a gene is a complex chemical compound. Under established patent law, conception of a chemical compound requires a 'definite and permanent idea of the complete and operative invention,' which includes knowledge of the chemical's structure or defining characteristics sufficient to distinguish it from other materials. Merely having a goal to isolate a gene and a generalized plan to do so is not conception of the gene itself, but only a 'wish to know the identity of any material with that biological property.' Because neither inventor could envision the detailed chemical constitution of the EPO gene before it was actually isolated, conception did not occur until reduction to practice. Therefore, Dr. Lin, who was the first to reduce the invention to practice by isolating the gene, was the first to conceive, resulting in a simultaneous conception and reduction to practice.
Analysis:
This decision established a critical precedent for biotechnology patent law by effectively merging the concepts of conception and reduction to practice for newly isolated genes. By defining a gene as a chemical compound requiring knowledge of its specific structure for conception, the court set a high bar for inventorship. This prevents researchers from claiming priority based on a promising but unproven research plan, thereby rewarding the party who first successfully isolates and characterizes the biological material. The ruling has profound implications for patent races in genetics and molecular biology, emphasizing tangible results over theoretical approaches and shaping how research and development is documented and pursued in the industry.
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