American Hosp. Supply Corp. v. Travenol Laboratories, Inc.
| Citation | 745 F.2d 1,223 USPQ 577 |
| Decision Date | 26 September 1984 |
| Docket Number | No. 83-1401,83-1401 |
| Parties | , 223 U.S.P.Q. 577, 2 Fed. Cir. (T) 138 AMERICAN HOSPITAL SUPPLY CORPORATION and Massachusetts General Hospital, Appellants, v. TRAVENOL LABORATORIES, INC., Pfrimmer & Company, and U.S. International Trade Commission, Appellees. Appeal |
| Court | United States Courts of Appeals. United States Court of Appeals for the Federal Circuit |
E. Anthony Figg, Washington, D.C., argued for appellants. With him on brief were G. Franklin Rothwell and Scott M. Daniels, Washington, D.C.
Granger Cook, Jr., Chicago, Ill., argued for appellees, Travenol Laboratories, Inc., et al.
John R. Crossan, Chicago, Ill., Paul C. Flattery, Lawrence W. Flynn and Max D. Hensley, Deerfield, Ill., of counsel.
William E. Perry, Washington, D.C., argued for appellee Intern. Trade Com'n. With him on brief were Michael H. Stein, Gen. Counsel, and Michael P. Mabile, Asst. Gen. Counsel, Washington, D.C.
Before SMITH, Circuit Judge, SKELTON, Senior Circuit Judge, and NIES, Circuit Judge.
In this unfair competition case under 19 U.S.C. Sec. 1337 (1982), appellants American Hospital Supply Corporation and Massachusetts General Hospital (American) appeal from the determination of the U.S. International Trade Commission (Commission), that appellees Travenol Laboratories, Inc., and Pfrimmer & Company (Travenol) are not in violation of section 1337 because they do not infringe Fischer, U.S. patent No. 3,950,529 (the Fischer '529 patent). We affirm.
The Fischer '529 patent, which is assigned to American, relates to an amino acid nutritional formulation for patients with liver disease, and a method of using that formulation. The formulation is a mixture of amino acids falling within a specific range of proportions. The formulation can be administered either intravenously or orally.
Liver-diseased patients need to receive sufficient protein for adequate nutrition, yet, these patients sometimes develop intolerance to protein which can result in hepatic encephalopathy, 1 which can in turn lead to coma or death. By restricting protein intake, the tendency of a liver-diseased patient to develop hepatic encephalopathy can be reduced; however, limitation of protein intake can lead to malnutrition. The claimed Fischer formulations are intended to provide adequate nutritional support while reducing the incidence or severity of hepatic encephalopathy. They are also used as a treatment for hepatic encephalopathy.
Claim 1 of the Fischer '529 patent is representative of the claims alleged to be infringed:
An amino acid formulation for administration to human patients with liver disease, comprising a mixture of the following essential and nonessential amino acids combined in proportions defined by the following interrelated molar ranges:
Amino Acids Molar Ranges
---------------------------------
L-isoleucine 0.549-0.0823
L-leucine 0.0670-0101
L-valine 0.0574-0.0861
L-tryptophan 0.000816-0.00441
L-phenylalanine 0-M
L-tyrosine 0-0.00300
L-lysine 0.0333-0.0500
L-methionine 0.00491-0.0147
L-threonine 0.0228-0.0454
L-alanine 0.0686-0.103
L-arginine 0.0275-0.0413
L-histidine 0.0124-0.0186
L-proline 0.0556-0.00834
L-serine 0.0152-0.0571
glycine 0.0451-0.144
L-aspartic acid 0.0451
L-glutamic acid 0.0702
L-ornithine 0-0.0382
L-cysteine 0-0.00228
---------------------------------
wherein M represents the upper limit of the range for phenylalanine and is equal to 0.009 minus the respective molar amount of tyrosine present in said mixture, the combined molar amounts of phenylalanine and tyrosine being at least equal to 0.002 on the same respective molar basis, the respective molar proportions of isoleucine, leucine, valine, tryptophan, phenylalanine, and tyrosine being selected from the above molar ranges thereof so that the ratio of the combined molar proportions of isoleucine, leucine, and valine to (a) the molar proportion of tryptophan is within the numerical range from 40 to 300, and to (b) the combined molar proportion of phenylalanine and tyrosine is within the numerical range from 15 to 135.
In 1949, Dr. William C. Rose published studies establishing minimum amounts of 20 amino acids needed by healthy persons--the "Rose pattern." Of these, eight amino acids are identified as essential, 2 two are sometimes identified as semi-essential, 3 and the balance are deemed non-essential. 4 The principal function of the normal liver in the human body is to regulate the levels of certain amino acids in the blood.
Proteins are normally obtained from food and are broken down into amino acids before they can be used for nourishment in the human body. Due to illness, surgery, or injury, however, some persons cannot gain nutritionally adequate quantities of protein through the alimentary tract and quickly develop malnutrition. Intravenous administration of amino acids formerly compensated partially for a patient's protein deficit. In the 1940's amino acid hydrolysates were prepared from proteins such as milk protein or hen's egg protein. By the mid-1960's, however, all of the amino acids necessary for human nutrition had become available in pure form at a reasonable cost. Further, surgical techniques for administration of nutritionally adequate quantities of amino acids had also become available.
The technique of providing nutritionally adequate quantities of amino acids intravenuously--hyperalimentation 5--could not be used with all patients, however. Most people with liver disease can be treated by controlling their diet. Some patients with liver disease, particularly cirrhosis, develop hepatic encephalopathy or coma when fed protein. Consequently, malnutrition presents a serious problem to these patients.
Ammonia is formed in the gut from the breakdown of proteins. Based on observations showing an abnormally high ratio of ammoniagenic amino acids in the plasma of patients with certain liver diseases, it is thought by some that when the liver is not functioning properly excess ammonia builds up resulting in hepatic encephalopathy. In the early 1970's ammonia was thought to be the principal cause of hepatic encephalopathy and this theory is still widely accepted.
In a 1973 paper, 6 Dr. Rudman classified the ammoniagenic tendencies of amino acids metabolized in patients with liver disease. 7 Conventional treatments for controlling plasma ammonia levels, however, were not always successful; they sometimes caused malnutrition and did not always prevent hepatic encephalopathy.
In 1971, Dr. Fischer published an article 8 presenting an alternative hypothesis that some of the neurological and cardiovascular complications of hepatic failure could be caused by abnormally high levels of "aromatic" amino acids 9 relative to "branched chain" amino acids 10 in the plasma of liver-diseased patients. Fischer suggested that the aromatic and branched chain amino acids compete for passage into the brain, across the "blood-brain barrier." Branched chain amino acids are not regulated by the liver but, rather, through other metabolic pathways independent of the liver. The levels of aromatic amino acids in the plasma are regulated by the liver and, consequently, there is some relationship between a damaged liver and abnormally high levels of aromatic amino acids in the plasma. In liver-diseased patients the levels of aromatic amino acids are elevated, while the levels of branched chain amino acids are decreased. Fischer thought that aromatic amino acids were precursors of false neurotransmitters which disrupted normal brain functioning in patients with hepatic encephalopathy. Thus, Fischer proposed that hepatic encephalopathy may be caused by the excessive levels of aromatic, relative to branched chain, amino acids in the plasma.
It was known that certain amino acids were elevated in patients with specific types of liver disease. Prior to 1974, "normalization" of amino acid levels for patients with a specific enzyme deficiency was known. In normalization, a diet abnormally low in certain amino acids is given to patients whose levels in those amino acids prior to treatment were abnormally high, and vice versa. Normalization was not, however, a conventional treatment for patients with liver disease.
In 1972, Fischer entered into a collaborative research effort with American to formulate an amino acid product for patients with liver disease. The work initially involved two intravenous amino acid formulations: FreAmine, an amino acid product for patients with kidney disease, and FreAmine E, an experimental formulation. The results of that research effort, up to early 1973, were published in 1974. 11
In the 1974 article Fischer suggested modifying amino acid formulations to normalize the pattern of amino acids in the plasma of patients with liver disease. The FreAmine E preparation tested by Fischer consisted of only the eight essential amino acids conforming to the Rose pattern. To Fischer's surprise, FreAmine E failed to increase the low plasma concentration of branched chain essential amino acids even though FreAmine E contained 2 1/2 times the minimum requirements of branched chain amino acids recommended by Rose.
Following oral presentation in May 1973 of the report later published as the 1974 Fischer article, Fischer and Dr. Yoshimura devised a modified formulation intended to normalize plasma amino acid levels in liver-diseased patients. They called the formulation "F080." The ratio of branched chain to aromatic amino acids was much higher in the F080 formulation than in FreAmine. Fischer performed animal tests with the F080 formulation in 1974. Animals in a coma or near comatose states with simulated liver disease awakened when given the F080 formulation.
On August 17, 1972, Ghadimi filed an application for an "Injectable Amino Acid Composition Commensurate to the Anabolic Need of the Body and Method...
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