Court Opinion

ID: 9448966
Source: CourtListenerOpinion
Date Created: 2023-08-03 23:51:12.065645+00
Date Added: 2024-06-11T17:31:37.869550
License: Public Domain

SMITH, Judge
(concurring).
The majority opinion herein has, I believe, performed a public service in pointing out what Congress has established as the respective functions of the Patent Office, the Federal Trade Commission, and the Food and Drug Administration, in dealing with new pharmaceutical preparations. I agree with the result reached in the majority opinion but have been influenced by some additional considerations which are the subject of this concurring opinion.
The position of the Patent Office in the present case is stated as follows by the solicitor in his brief:
“Faced with evidence to show that the alkalinity of a 5 percent solution is “more dangerous” and may cause “thrombosis of the vein”, and faced with the fact that the claimed composition actually showed upon dilution a pH up to 11.7 * * *, it is submitted that the tribunals of the Patent Office were carrying out their statutory duty, when they required proof of safety and effectiveness in man * * *, and that such requirement was not unreasonable in the light of the facts and circumstances of this case.” [Emphasis added.]
In my opinion, the condition to the grant of patents in the pharmaceutical field which the Patent Office here seeks to impose on appellants is not supported by any provisions I have been able to find in the patent statute.
35 U.S.C. §§ 101, 102 and 103 make no distinction between classes of inventions as to the “conditions of patentability” and section 102 opens with the statement “A person shall be entitled to a patent unless — ” and then lists specific statutory grounds on which a patent may be refused. “Safety and effectiveness in man” is not one of these conditions. In enacting the patent statute, I am certain it was recognized by Congress that many inventions have in them an element of danger to man and of necessity must proceed upon an underlying assumption that despite such possible dangers, we must judge patentability of the inventions on the basis of their use by those who are intelligent enough to understand such dangers as may be present and who are sufficiently *261skilled to use the inventions for their intended purposes.1
To have complied with the requirements of the Patent Office in the present case, based on its assumption of some vaguely asserted “statutory duty” imposed on the Patent Office, would have meant an extensive delay before proofs of “safety and effectiveness in man” acceptable to the examiner could have been secured. This delay would have started with securing permission from the Food and Drug Administration to so test the composition. Even after this permission is granted and the tests of the new therapeutic composition are made on humans, it is a well-known fact, of which we can properly take judicial notice, that even such tests are not necessarily conclusive. Thus, to conduct tests which would conclusively establish the “safety and effectiveness” of the pharmaceutical preparation here involved could well mean the delay of many years before the present application could be allowed and the patent issued.2 The primary public duty which the Patent Office is charged with performing under 35 U.S.C. §§ 101, 102 and 103, is to issue patents on applications which meet the statutory requirements. This duty should not be so exercised, as it seems to me that it was here, to defeat one of the important public purposes of the patent laws, i. e., the prompt publication of inventions.
Robinson in his “Treatise on the Law of Patents” (1890), refers in section 32 to “the duty which the state owes to the people to obtain for them, at the earliest moment, the practical use of every valuable invention in the industrial arts” and in securing “publication of the invention as soon as it is brought to such perfection as to be capable of practical employment.”
The proper test to be here applied, it seems to me, is not the ultimate “safety and effectiveness in man,” as contended by the Patent Office, but is the test, as suggested by Robinson, whether “the invention has been brought to such perfection as to be capable of practical employment.” If this test is applied to the proof here presented, it seems to me appellants have clearly shown that their invention had been brought to such perfection that it was capable of practical employment.
The “statutory duty” to which the solicitor refers, seems also to underlie the *262opinion of the Board of Appeals on reconsideration where it is stated:
“* * * The question here presented is whether the composition claimed will, in fact, attain the purpose for which it is disclosed as useful. We consider Judge Holtzoff’s decision in Isenstead v. Watson, [D. C.] 157 F.Supp. 7, 115 USPQ 408, to be applicable here. This decision states ‘that the Patent Office should be very careful and perhaps even reluctant to grant a patent on a new medical formula until it has been thoroughly tested and successfully tried by more than one physician.’ We need not, though, determine the extent of the clinical testing necessary because the appeal does not present this problem.”
The admonition contained in the dictum of the court in Isenstead v. Watson, D.C., 157 F.Supp. 7, thus seems to have become, by Patent Office fiat, a “statutory duty,” which extends even to a determination of the proper “extent of clinical testing.”
Since these “statutory duties” appear to have their origins in Isenstead v. Watson, supra, a brief review of this decision is desirable. There are few facts stated in the opinion since the proceeding was “in camera.” Nothing is revealed as to the subject matter of the invention in issue other than that it related “to a medical compound for the purpose of testing the function of the human liver” and that rejected claim 2 covered “a composition of matter adapted to shift blood proteins, consisting of three different substances.” In the opinion, after a reference to 35 U.S.C. § 101, Judge Holtzoff relates the statutory word “useful” to the concept of “utility” and says:
“ * * * ‘Utility’ is a broad term and implies among other things capacity to perform the function or to attain the result claimed by the applicant in his disclosure. For example, in the case of Besser v. Merrilat Culvert Core Co., 243 F. 611, 612, [156 C.C.A. 309,] decided by the Eighth Circuit, it was held that:
“ ‘The term “useful,” as contained in the patent law, when applied to a machine, means that the machine will accomplish the purpose practically when applied in industry.’ ”
“This Court is of the opinion that the same test of utility sould be applied to a composition of matter. In other words, will the invention attain the purpose and will it operate as disclosed and claimed by the inventor ?”
Judge Holtzoff’s test of utility therefore seems to have been: “Will the invention attain the purpose and will it operate as disclosed and claimed by the inventor”? However in the present instance the examiner, the board, and the solicitor seem to me to have departed from this test in favor of the “statutory duty” which they derive from the dictum:
“Great care and scrutiny should be particularly taken in connection with applications for medical patents. While the granting of a patent does not legally constitute a certificate that the medicine to which it relates is a good medicine and will cure the disease or successfully make the test which it was intended to do, nevertheless, the granting of such a patent gives a kind of official imprimatur to the medicine in question on which as a moral matter some members of the public are likely to rely. In view of these circumstances, it is right and proper that the Patent Office should be very careful and perhaps even reluctant to grant a patent on a new medical formula until it has been thoroughly tested and successfully tried by more than one physician. It seems to the Court that therefore the Patent Office, as a matter of public policy, followed a proper course in this matter.” (157 F.Supp. at p. 9).
In a more recent decision, Commonwealth Engineering Company of Ohio et *263al. v. Ladd, D.C., 199 F.Supp. 51 (1961), Judge Holtzoff referred to his prior decision in Isenstead v. Watson, supra, and stated that his remarks, which I have previously characterized as “dictum,” “are equally applicable to a process intended for medical use.”
I agree with Judge Holtzoff’s decision in the Commonwealth Engineering case insofar as it upholds the right of the Patent Office to require proof that the disclosed invention is “useful,” but I think the recurrence of the dictum of the Isenstead case is unfortunate in that as here used it is stated out of context and without the benefit.of Judge Holtzoff’s other cogent observations in the Isenstead case.
The recurrent theme of the dictum in the Isenstead case and its repetition in the Commonwealth Engineering case suggests that the Patent Office should assume an obligation as to the public safety which here finds expression in its requirement that applicant must supply proof of “safety and effectiveness” of the claimed composition “in man.” This concept will not stand analysis.
The dissenting opinion goes beyond the record here and refers to “the now infamous drug thalidomide.” While I can see no pertinence of this material to any issue here presented, I observe that here is dramatic proof, if any be needed, that the issuance of a patent is not in fact an “imprimatur” as to the safety and effectiveness of any pharmaceutical product for any purpose.
It is an elemental principle of patent law that a patent grants no more than the legal right to exclude others from making, using or selling the thing patented. It is no- guarantee of anything and gives no one a right to make, use or sell anything. The public, therefore, is' in no way protected either by the granting or withholding of a patent.
However, so that the reference to thalidomide in the dissenting opinion will be complete, it is here noted that thalidomide is the subject matter of U. S. Patent #2,830,991 which issued April 15, 1958. Despite the issuance of this patent, and the “imprimatur” which the dissenting judges would find in such issuance, the Federal Food and Drug Administration, in the exercise of its statutory authority, withheld its approval of the drug.
As previously pointed'out, one major public purpose of the patent law is to secure the disclosure of inventions with the least possible delay. In discharging this function, it is entirely proper that reasonable proof of an applicant’s asserted utility be required by the Patent Office. What I here criticize is the manner in which these requirements have been extended beyond a reasonable compliance with statutory requirements. I find no reason, either in logic, justice, or public policy why the grant of a patent here should be delayed until the pharmacological merits of the disclosed invention are established by clinical tests conducted on humans, when such merits may be evaluated on the basis of other qualified tests.
WORLEY, Chief Judge, dissenting, with whom JACKSON, Judge, joins.
The examiner, the members of the board, and the majority here all agree that the instant composition is to be used as a drug on human beings. Despite that fact the majority holds that the Patent Office has no “authority or responsibility” to require clinical evidence that, when applicants’ drug is used on human beings, there is “freedom from vascular damage at the site of injection.” ■
Inasmuch as Congress has clearly charged the Patent Office with determining the patentability of inventions, and since the information requested relates to the usefulness of the drug on human beings, it would be far more accurate to hold that it is this court which has no “authority or responsibility” to strip the Patent Office of that statutory duty.
It is the Patent Office, no other agency, which Congress has always held responsible for determining patentability of inventions. That Congress intends the Patent Office to continue in that role is made crystal clear in the following ex-*264eerpt from the remarks of Senator East-land in presenting S. 1552:1
“ * * * The final decision as to patentability would be left to the Commissioner of Patents, as has been the practice in the past.” (Italics supplied.)
Under such circumstances it is impossible for me to reconcile the majority position with what I am convinced is a clear Congressional expression.
The majority concedes that “the case at bar appears to be unlike any previously before this court.” I agree, but regret that the majority finds it necessary to' go so far beyond the record and the reasons of appeal 2 in a fruitless search of support for its unprecedented holding.
For example, it seems to find some degree of comfort in nine interference cases, none cited or relied on below, or mentioned when this appeal was argued here. Those cases, involving subject matter ranging from spark plugs to zipper fasteners, are completely foreign to the subject matter, facts, and issues here. In those cases the court was dealing exclusively with the sufficiency of evidence offered by contesting parties regarding reduction to practice and priority of invention. Those decisions could not possibly have anticipated the problems here. To hold, therefore, that they have any relevance whatever to the case at bar is, I respectfully suggest, logically and legally insupportable.
But a decision which was cited and relied on bjr the board, but not discussed by the majority, is Isenstead v. Watson, D.C., 157 F.Supp. 7. There Isenstead sought patent protection on “a medicinal compound for the purpose of testing the function of the human liver.” The examiner held that proof of utility for that purpose was inadequate and insufficient. The board affirmed. The District Court upheld the Patent Office, stating:
“ * * * This Court in a technical matter such as this should not lightly set aside the decision of the Patent Office. Moreover, an independent examination by the Court of the affidavits submitted as proof of utility leads the Court to concur in the view of the Patent Office that the number of cases tested and the results obtained are not sufficient to justify an affirmative finding of utility. It must be borne in mind in this connection that the burden is on the applicant for a patent to prove that he is entitled to it, and therefore the onus is on him to show that the invention will operate as disclosed in the application and will achieve its objective.” (Italics supplied.)
Presumably Isenstead did not disagree with that interpretation of the law since he took no appeal. Moreover, Congress has not only taken no steps to change the law, but has reaffirmed the authority of the Patent Office.3 ****Indeed, applicants here do not question the soundness of that decision, or challenge the authority of the Patent Office to make such a requirement, but attempt only to distinguish it from the instant facts.
*265Here, as in Isenstead, the drug is to be used on human beings. It must be remembered that applicants’ drug composition is even more caustic than its prior art counter part.4 Under such circumstances the requirement of the examiner was anything but capricious, unreasonable or arbitrary. He not only had the authority, but a clear responsibility to require the instant clinical evidence. The record contains ample evidence that the highly caustic nature of this drug, used as a hypnotic and to induce surgical anesthesia, makes it dangerous when injected in human beings. Although applicants did not rebut the examiner’s position, the majority characterizes the evidence as “merely an opinion by the examiner.” Certainly there is no support in this record for the conclusion that one skilled in this art could inject applicants’ drug into the human body without causing vascular damage. Surely, that obligation must rest on applicants, not on the Patent Office.
The weakest and the most dangerous element in the majority rationale is its apparent adoption of the theory, which is sheer speculation, nothing more, that if a given drug will have a certain effect on “a standard experimental animal,” whatever that animal might be, it will “probably” have the same effect on human beings. Not even the applicants have the temerity to argue such a scientifically unsound proposition. That reasoning is a dangerously blind and unnecessary excursion into a field in which this court is not competent to venture on its own.
Surely there can be no valid reason to hold, as a matter of law, that a drug used on mice or rabbits, as here, will probably have the same effect on the complex system of the human body. The fallacy of that reasoning, if an example is even remotely needed, is illustrated by the recent tragic experiences with the now infamous drug thalidomide.5
I see no relevance in the acts dealing with the Federal Trade Commission or the Food and Drug Administration, neither of which was cited below nor when this appeal was argued. If those acts are cited for the purpose of showing that Congress intended agencies other than the Patent Office to police the sale and distribution of drugs and cosmetics, then I am in complete agreement. If, however, they are cited to prove that Congress intended the Patent Office to be restricted or relieved of its duties regarding the patentability of inventions, I am in complete disagreement. That is much like saying that the Patent Office should be relieved of its duties to determine the patentability of machine guns, for example, merely because Congress might charge another agency with policing their sale and distribution.
That Congress has, as a practical matter, recognized the desirability of cooperation between the Patent Office and other agencies is evident from the following: 6
“ * * * The final decision as to patentability would be left to the Commissioner of Patents, as has been the practice in the past. With such help from the Department of *266Health, Education, and Welfare, the Commissioner of Patents will be better equipped to make the decision as to whether a new drug represents the kind of genuine technical advance and new-product competition that should continue tobe stimulated by patent rights.” (Italics supplied.)
Surely there can be no question that Congress intends the Patent Office to continue its responsibility of determining the patentability of all inventions, including drugs for use on human beings.
In denying that function to the Patent Office a rather odd result is reached: although applicants strenuously argue that their specification makes no mention of human beings; although they stress that the usefulness of their drug has been established only by tests on mice and rabbits; although they insist they have made no tests whatever on human beings, and make no predictions whether their drug ujill be safe or unsafe when used on human beings; nevertheless, the majority holds that applicants’ drug is “probably” safe for use on human beings and applicants are, therefore, entitled to unlimited patent protection. I am aware of no parallel in patent litigation, and cannot believe that Congress intended an applicant to receive a seventeen-year monopoly under such circumstances.
To my knowledge this is the first time the authority of the Patent Office to require clinical evidence relating to the “usefulness” of a drug to be used on human beings has been challenged; indeed, applicants do not challenge it here. That authority has been continuously exercised by the Patent Office with the full approval of the Congress. There can be no valid reason in law or logic to interfere with that practice.
I regret to say that if the majority opinion remains the law of the land, as it must unless the Supreme Court or the Congress sets us straight, I can see nothing but uncertainty and trouble ahead for the Patent Office, the patent system as we have always known it, and the public.

. The dissenting opinion herein contains the statement:
“ * * * The record contains ample evidence that the highly caustic nature of this drug, used as a hypnotic and to induce surgical anesthesia, makes it dangerous when injected in human beings. * * * ”
Despite careful consideration of the record herein, I am unable to find what I am willing to consider as “ample evidence” on this matter. The examiner’s position seems to be that since the cited literature discloses that venous damage at the injection site is likely when highly alkaline solutions are injected, the present composition, because of its alkalinity, will cause such damage and thus is not a “safe” preparation. It seems to me that this position was amply rebutted by the affidavits filed by appellants. The issue thus met, it seems to me, is the issue of whether or not venous damage is caused by the use of the claimed invention for its intended purpose. Standard tests on laboratory animals showing that no such damage occurred seems to me to be an ample showing of safety of the composition when used by persons skilled and competent in this field.

. While the public interest demands that all applications for patents be thoroughly and carefully examined by the proper Patent Office personnel, the public interest also demands a reduction in the time lag between the filing of a patent application and final action. Of. Report ordered printed May 9, 1962, of the Committee of the Judiciary, United States Senate, made by its Subcommittee on Patents, Trademarks and Copyrights pursuant to S.Res. 55, 87th Congress, First Session, as extended pp. 12-13. A greater consideration for the reasonableness of the proofs required in a case such as the present would, it seems to me, be one way in which the noted time lag could be reduced in such cases. I note in passing that the application now before us was filed over eight years ago, and the parent application on which it was based was filed over nine and one-half years ago.

. Congressional Record, August 23, 1962, page 16303. S.1552, is now Sec. 308 of the Drug Amendments of 1962 which amends Sec. 702 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 372) by adding at the end thereof the following new subsection:
“(d) The Secretary is authorized and directed, upon request from the Commissioner of Patents, to furnish full and complete information with respect to such questions relating to drugs as the Commissioner may submit concerning any patent application. The Secretary is further authorized, upon, receipt of any such request, to conduct or cause to be conducted, such research as may be required.”

. 35 U.S.C. § 144 states in part:
“The United States Court of Customs and Patent Appeals, on petition, shall hear and determine such appeal on the evidence produced before the Patent Office, and the decision shall be confined to the points set forth in the reasons of appeal. * * * ” (Italics supplied.)

. See footnote 1, supra.

. The affidavit of Cox submitted by applicants shows that a 2%% solution of the prior art material has a pH of 10.65, while a 2%% solution of the claimed drug composition has a higher alkalinity, it being at a pH of 11.3 to 11.7.

. It appears to be a matter of general knowledge that thalidomide, although effective as a sedative in human beings, resulted in deformed offspring born to women who had taken it during pregnancy. It had neither of those effects when given to experimental animals in normal experimental doses. Thalidomide was patented in the United States on April 15, 1958 in U. S. Patent No. 2,830,991. It is assigned to Chemie Grünenthal G.M. B.H., Stolberg, Rhineland, Germany. The patent claims priority based on a German application filed May 17, 1954.
Only recently, in In re Fisher, COPA, 307 F.2d 948, this court found as a fact:
“Thus it appears that the prior art ACTH concentrates are useful for injection into ‘rats, guinea pigs, and similar animals’ but * * * in ‘most cases carmot be tolerated by the human being.’ ” (Italics supplied.)

. Congressional Record, August 23, 1962, page 16303.