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

Citation264 F. Supp. 1013
Decision Date01 March 1967
Docket NumberCiv. A. No. 2421.
PartiesARMOUR PHARMACEUTICAL COMPANY, a Delaware corporation, Plaintiff, v. RICHARDSON-MERRELL, INC., a Delaware corporation, Defendant.
CourtUnited States District Courts. 3th Circuit. United States District Court (Delaware)

Aaron Finger and Max S. Bell, Jr., of Richards, Layton & Finger, Wilmington, Del., Walter J. Blenko and Eugene F. Buell, of Blenko, Hoopes, Leonard & Buell, Pittsburgh, Pa., and Carl C. Batz, Chicago, Ill., of counsel, for plaintiff.

Edmund D. Lyons, of Morris, James, Hitchens & Williams, Wilmington, Del., Charles J. Merriam, Jerome B. Klose, Allen H. Gerstein, of Merriam, Marshall, Shapiro & Klose, Chicago, Ill., and Harvey W. Edelblute, New York City, of counsel, for defendant.

OPINION

CALEB M. WRIGHT, Chief Judge.

Plaintiff, Armour Pharmaceutical Company (Armour), brings this declaratory judgment seeking to have defendant, Richardson-Merrell's (RM) patent Number 3,004,893 ('93) invalidated. RM has counterclaimed for infringement. Currently before the Court are cross motions for summary judgment. Armour moves for a summary judgment of invalidity, and RM seeks a "partial summary judgment" of infringement. The uncontested facts are 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.1 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.2 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.3

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.4 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.5 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 mitigated 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.6 Second, it was questionable whether these enzymes, because of their size, could be absorbed through the walls of the small intestine.7 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.8

Despite this formidable catalogue of disadvantages, Dr. Innerfield decided that the enteric coated product might be useful after all, primarily as an anti-coagulant. 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.9

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.10 Relying upon this work Martin caused a second application on enteric coated trypsin to be filed on February 15, 1956.11 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,12 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.13

The Court is of the opinion that the '93 patent must fall for want of invention. What Martin did was to discover that trypsin was absorbable through the walls of the small intestine. Concededly, it had been thought that the trypsin molecule because of its size could not penetrate the intestinal wall. But nothing Martin did increased the permeability of the intestinal wall or altered the characteristics of trypsin to facilitate its absorption. The discovery that the molecule could penetrate the intestinal wall, although unexpected, was nothing more than the discovery of a natural phenomenon. And, it is a well-settled principle of patent law that patents do not issue for the discovery of natural processes or properties. Davison Chemical Corp. v. Joliet Chemicals, Inc., 179 F.2d 793 (7th Cir. 1950), cert. denied, 340 U.S. 816, 71 S.Ct. 45, 95 L.Ed. 599.

The Davison case sets forth in detail the considerations to be mobilized when the patentability of a natural phenomenon is urged. There the patent related to the manufacture of silica gel for use as a desiccant. When silica gel is used as a desiccant various degrees of porosity are required. Silica gel is manufactured by mixing sodium silicate with acid under violent agitation; the resulting product is permitted to set, then it is broken into small pieces, washed with water and dried. The manufacturing process summarized above was covered by another patent. Connolly, the Davison patentee, discovered that there was a definite relationship between the temperature of the wash and the porosity of the resultant silica gel. The Seventh Circuit held that such a discovery, although useful, was not patentable since it merely unearthed a hitherto unsuspected natural phenomenon. The Seventh Circuit continued.

"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." 179 F.2d at 794.

The Court went on to examine Connolly's process, and found it to be unpatentable, since the improvements he made based upon the discovery of the relationship between the temperature of the wash water and the porosity of the final product would have been obvious to an artisan armed with the same knowledge.

"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." 179 F. 2d at 795.

Davison is strikingly analogous to the present case. Here Martin, faced with the task of developing an orally administrable trypsin, and having been told that the intestinal wall would not absorb these large molecules, discovered that a certain portion of the small intestine — the ileum — would in fact absorb these molecules. Certainly that discovery is not patentable. It is a natural phenomena, the natural occurrence of which is in no way attributable to the scientific skill of Martin, who merely unveiled it. Further, having made the discovery, Martin did nothing out of the ordinary to render his discovery commercially operable. Once the discovery that trypsin could penetrate the intestinal wall was made, the rest was obvious. To get an effective anti-inflammatory all that remained to be done was to coat the trypsin so that it would pass through the stomach and upper small intestine to the ileum, unaltered by the acidic environment of the upper digestive tract. That Martin hit upon the device of an enteric coating was not particularly ingenuous since these coatings were well-known in the pharmaceutical field and had been employed successfully for many years. Nor can RM take refuge in the fact that the enterically coated product proved to be an effective anti-inflammatory. Because of Innerfield's previous work with the parenteral, rectal and buccal forms of trypsin the anti-inflammatory properties of the enzyme were well-known. Once it was found that the enzyme could penetrate the walls of the small intestine and thus enter the...

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