Armour Pharmaceutical Co. v. Richardson-Merrell, Inc.

• Decision Date: 17 May 1968
• Docket Number: No. 16779.,16779.
• Citation: 396 F.2d 70
• Parties: ARMOUR PHARMACEUTICAL COMPANY, a Delaware Corporation v. RICHARDSON-MERRELL, INC., a Delaware Corporation, Appellant.
• Court: U.S. Court of Appeals — Third Circuit

396 F.2d 70 (1968)

ARMOUR PHARMACEUTICAL COMPANY, a Delaware Corporation v. RICHARDSON-MERRELL, INC., a Delaware Corporation, Appellant.

No. 16779.

United States Court of Appeals Third Circuit.

Argued December 18, 1967.

Decided May 17, 1968.

Charles J. Merriam, Merriam, Marshall, Shapiro & Klose, Chicago, Ill. (Allen H. Gerstein, Chicago, Ill., on the brief), for appellant.

Walter J. Blenko, Blenko, Leonard & Buell, Pittsburgh, Pa. (Max S. Bell, Jr., Wilmington, Del., Eugene F. Buell, Pittsburgh, Pa., Richards, Layton & Finger, Wilmington, Del., on the brief), for appellee.

Before BIGGS, McLAUGHLIN and VAN DUSEN, Circuit Judges.

OPINION OF THE COURT

BIGGS, Circuit Judge.

The plaintiff-appellee Armour Pharmaceutical Company (Armour) brought suit against defendant Richardson-Merrell, Inc. (RM) seeking a declaratory judgment of invalidity and non-infringement of United States Patent 3,004,893 ('93) issued to Dr. Gustav J. Martin and assigned to R. M.¹ Upon cross motions for summary judgment the District Court, basing its decision on stipulations, depositions, interrogatories and a hearing found the patent invalid for want of invention and entered summary judgment for Armour.² RM appeals from that judgment. Jurisdiction is based on Sections 1338 and 1291, 28 U.S.C.

The patent in dispute is for "Enteric Coated Trypsin and Chymotrypsin Anti-Inflammatory Compositions", issued on October 17, 1961.³ The facts here relevant were well stated by the court below as follows: "The '93 patent teaches the use of enteric coated proteolytic enzymes, notably trypsin and chymotrypsin, as orally administered anti-inflammatory agents. These enzymes are derived from pancreatin which is a substance derived from the freshly ground pancreas of hogs and cattle. Prior to the disclosures of the '93 patent pancreatin had long been used as a digestive aid, designed to supplement the natural secretions of the human pancreas and facilitate digestion of the complicated protein molecule. In this use as a digestive supplement, pancreatin had been enterically coated and orally administered to persons whose own production of proteolytic enzymes was insufficient. An enteric coating is applied to a medicament for the purpose of transporting the medicament unaltered through the acidic environment of the stomach and into the small intestine.

"After the digestive use of proteolytic enzymes, Dr. Irving Innerfield was responsible for the next major step in their utilization as therapeutic agents. Trypsin and Chymotrypsin had been previously isolated and identified as compounds found in pancreatin, but it was Innerfield who first saw their unique therapeutic value as anti-inflammatory agents. He tried injecting these compounds at the site of the inflammation (parenteral administration) and found them to be efficacious in reducing inflammation. Subsequently, other methods of administration were developed, notably the buccal method, which comprises putting a tablet in the pouch of the cheek, and the rectal method, which utilizes rectal suppositories. Unfortunately, all of these methods, although efficacious, had certain drawbacks. In addition to the customary antipathy on the part of the patient to the parenteral and rectal administrations, the buccal method was of only marginal utility because the proteolytic enzymes operated to partially digest the soft tissue lining the cheek causing the patient pain and discomfort.

"Given these disadvantages in the various methods of administering the enzymes, it would appear to the casual observer that oral administration would be a viable alternative. However, several factors * * * militated against the possibility of oral therapy. First, the human body naturally secretes, through the pancreas, concentrations of these enzymes far in excess of the normal therapeutic dosage. Hence the logic of oral therapy appeared questionable at the outset, for there seemed to be no advantage in any marginal increase such as that which would result from oral administration. Second, it was questionable whether these enzymes, because of their size, could be absorbed through the walls of the small intestine. Third, these proteolytic enzymes were capable of digesting each other, and therefore the introduction of trypsin or chymotrypsin into an environment in which other proteolytic enzymes were present would appear to be foolhardy.

"Despite this formidable catalogue of disadvantages, Dr. Innerfield decided that the enteric coated product might be useful after all, primarily as an anticoagulant. Accordingly, on November 25, 1952 Innerfield filed an application for a patent on the enteric coated product. The Innerfield application, which had been assigned to the National Drug Company (ND) — which later became a division of RM — was abandoned on September 23, 1954 with Innerfield's consent.

"Subsequently, Dr. Martin, a biochemist and Director of Research at ND, caused some vivisection work to be done on rats in the ND laboratories. Briefly, the small intestine of the rats was tied off and trypsin was injected below the tie. Unexpectedly, the trypsin was absorbed through the walls of the small intestine and proved effective in alleviating an artificially created edema in the rats' feet. Relying upon this work Martin caused a second application on enteric coated trypsin to be filed on February 15, 1956. Since the vivisection work had indicated that the optimal point of absorption was the ileum — the lower third of the small intestine — Martin's application directed that the trypsin be coated to resist disintegration until it reached the ileum. After several changes with respect to the size of the dosage, the '93 patent issued on October 17, 1961. Prior to the filing of the application there had been no clinical evaluation of the proposed product." See 264 F.Supp. 1013.

Stated simply, prior to Dr. Martin's discovery that the ileum would absorb orally administered trypsin,⁴ and consequently act as an anti-inflammatory agent, it was known that trypsin would act as an anti-inflammatory agent if administered by injection, by suppository or buccally (by holding the material in the mouth against the cheek wall through which it can be absorbed). It was also known that trypsin was effective as a digestive aid if taken orally. The process of enterically coating a medicament for the purpose of transporting it through the acidic environment of the stomach was well known prior to Martin's patent.

The court below held that Martin merely discovered the natural phenomenon that the ileum would absorb trypsin and subsequently applied that new discovery by a well-known process of enterically coating the trypsin enabling it to be effective if administered orally. The district court relied on the principles stated in Davison Chemical Corp. v. Joliet Chemicals, 179 F.2d 793, 794-795 (7 Cir.), cert. denied, 340 U.S. 816, 71 S.Ct. 45, 95 L.Ed. 599 (1950), as follows: "Consequently the question becomes one of whether, when Connolly discovered the scientific fact that temperature of the washing water directly affects the density of the washed product, he then devised a process for utilization of that scientific fact which amounted to invention. What the skilled scientist, having been informed of the newly discovered scientific fact, would have done, would amount only to the exercise of ordinary skill in his profession. * * * The artisan, knowing that the temperature determines the porosity, could very readily, by empirical methods, determine the particular pore size required for a particular use of the gel and then, by maintaining the wash water at the temperature at which such pore size was attained, procure the uniform product desired."

We will affirm the judgment of the court below.⁵

It has long been a principle of patent law that the discovery of a law of nature cannot form the basis of a patent. Le Roy v. Tatham, 14 How. 155, 156, 174, 14 L.Ed. 367 (1852). The purpose of that rule has been expertly stated as follows: "A patent for a process is a patent for the described combined use of all the laws of nature utilized by that process. A patent for a principle is a patent for only one of the laws of nature per se used in a process. If a patent for a principle were granted and sustained, it would be much broader than a patent for a process, because it would cover all processes which aim at the same result and which use the particular law of nature covered by the patent for a principle, no matter in which combination with other laws. A patent for a process, on the other hand, covers only its own method of using all of the laws of nature which it utilizes. To...