*1 Godula, (Edmund A. Robert L. Niblack 50 CCPA Jr., HARTOP, Application of William L. Chicago, Ill., Kelton Watson Leavenworth Brandes. and Edward P. Taggart, City, & New and Carroll York Appeal Patent No. Palmer, counsel), appellants. F. United Court of Customs States Washington, Moore, C.D. Clarence W. Appeals. C., Washington, Schimmel, (Joseph D. Dec. counsel), for the Commissioner
Patents. RICH, Judge, WORLEY,
Before Chief Judges, SMITH, Associate MARTIN Judge R. JACK- Associate JOSEPH SON, Retired. Judge.
MARTIN, appeal This from a decision of the affirming Appeals Patent Office Board of rejection appealed the examiner’s 30-34, claims 38 and 39 of application, pat- 418,468, Serial No. for a Composition.” “Therapeutic ent on a Worley, J., J., Jackson, C. dis- from Certain were withdrawn con- claims sented. being “as not sideration the examiner species” and readable on the elected not before us. No claim has been al- lowed.
Each of the claims recites a “stable” aof “thiobarbituric acid com- solution pound.” represen- Claims 30 and 31 are tative : a “30. A stable solution of thio- having compound acid barbituric hypnotic properties anesthetic or comprising water-free a solution compound acid se- thiobarbituric consisting group lected from the therapeutically useful thiobarbi- and the water turic acid soluble salts
thereof, dissolved [sic] anhydrous alcoholic solvent consist- parenterally of a mixture of a acceptable water-miscible lower ali- monehydroxy phatic alcohol and a acceptable parenterally water-mis- aliphatic polyhydroxy cible lower al- having cohol, solvent said dissolved therein soluble alcohólate of a acceptable parenterally lower ali- phatic alcohol and an alkali metal in providing an an amount alkali metal substantially concentration in ex- required to of that maintain cess compound acid thiobarbituric said *2 therapeutically an alkali solution with a effective dissolved in said solvent concentration of the thiobarbiturate metal salt. yet organic a sol- concentration of solu- “31. A concentrated stable sufficiently vents and alkaline material com- acid tion of a thiobarbituric injection. low for safe hypnotic pound having anesthetic properties solvent, comprising Appellants prefer a substantial- use as a ly aliphatic monohydroxy a thio- a water-free solution mixture an compound ethyl selected an barbituric acid alcohol such as alcohol and consisting aliphatic polyhydroxy group thera- from the alcohol such propylene glycol, peutically acid neces- thiobarbituric both useful alcohols being thereof, sarily parenterally acceptable and and the soluble salts water regard anyhydrous alcoholic water-miscible. the al- dissolved With consisting material, specification of a mixture kaline solvent of a states: «# * * parenterally acceptable water-misci- necessary Since it is monohydroxy aliphatic al- ble lower therapeutic aqueous dilu- acceptable parenterally cohol tions thiobarbiturates poly- aliphatic water soluble lower pH preferably of about 10 and having hydroxy alcohol, said solvent precipitate 10.5 about to avoid a alcohólate it, dissolved therein a soluble forming diluting water, parenterally acceptable lower aof highly desirable to include in aliphatic metal alcohol and an alkali organic thiobarbiturate concentrated providing in an amount an excess parenterally solvent solution a ceptable ac- between about reagent 30% 5% alkaline weight weight alkali metal above provide amount sufficient metal of the alkali in an alkali metal aqueous pH dilution thereof with a acid salt of compound said thiobarbituric preferably of about 10 and 10.5. solvent.” dissolved in said example, For sufficient metal alkali incorporated alkoxide is con- According specification, non-aqueous centrated thiobarbitu- compounds and salts thiobarbituric acid provide rate solution to an amount important are as anesthetic thereof of an alkali metal between about 5 inducing agents, hypnotic especially for by weight in excess of the 30% surgical relatively anesthesia of short weight of the alkali metal contained purpose, For the latter dilute duration. alkali metal salt of thio- aqueous thio- solutions water-soluble barbiturate in solution parenteral- injected salts are barbiturate ly. effectively prevent precipitation aqueous These unstable solutions on dilution with water. shortly prepared and must be use before dissolving dry Ap- in water. salts concentrated, alkaline, It is the water- pellants it uneconomical to consider free, organic solvent solution of the thio- small, ampoules 'individual-dose compound acid appel- barbituric weight dry salts inconvenient to lants claim as their invention. handle solid materials when otherwise Although the examiner’s answer dis- preparing these solutions. grounds rejection cusses three appealed claims, Appellants have discovered that cer- the board reversed the grounds concentrated, alkaline, non-aqueous on two examiner tain and the claims rejected solely ground of thiobarbiturate salts now stand on a solutions lating relatively stable, utility have a suitable shelf of the claimed solu- just rejection life,1 parenteral and, before admin- tions. This intermingled involves several easily istration, conveniently can issues each of which produce may detail with water to discuss in infra. helpful clear diluted decomposition O, No evidence decrease after 13 months 40° or after 24 potency observed 100° these hours at O. solutions caseto set n pear closes -doubt tions when appropriate must be istered are: diluted solutions osition Patent Office understanding (1) of the of law demonstrated so forth humans, “safety” dilution, position used, three here into humans. specification at bar at this our involved main of the claimed in this (2) disposition of this by (3) solutions, after point points injecting case. is that what there “safety” admin- These prop- solu- *3 dis- ap- thiobarbiturate prised injecting test mg. logic testing of vein with and duration of body weight served. standard conducted “That the Pentothal solutions [*] procedure aqueous acute intravenously per diluted to [*] accordance Abbott’s mice of compound anesthesia toxicity cc. used for dilutions [*] Injection 18-25 “Pentothal” contain tests [*] with and were the bio- of the grams a tail were com- time [*] ob- 2.5 “safe” appellants’ are not for each mouse was 4 to 5 seconds. solutions by utility conven- was determined alleged use, re- lack LDS0 methods, groups of mice tional i. e.: by quired U.S.C. 101. § given graduated until were doses issues, we discuss the several Before the dose was found which would and comment on certain we set forth mice at that lethal 50% portions record. (cid:127)other LD50; This dose is dose. During prosecution appealed of the “That the above results of n application, .appellants an af submitted compositions prepared on tests by Henry Spruth,2 from C. which fidavit held under the forth conditions set following significant quote the ex designated following specific in the cerpts : examples said No. U. Serial S. 418,468 are as follows: supervision, under his solu- “That plication were the effect (cid:127)administered .herein (cid:127)of the above-mentioned .solution n tions of thiobarbiturates tests, and were studied to determine plication on the ic efficiency tests, held as designated specific examples specified the said thiobarbituric subjects; subjected above-identified hemoglobin acute patent ap- anesthet- prepared toxicity several ap- withdrawn ples rabbits after No. reported jection of the said [******] “That 418,468, the subjected awakening which had herein, from through patent application individual blood sam- nine of the results of which are 5 ml. of blood were analysis. from been anesthetised a heart Example puncture last subject Serial II hemoglobin “That the said readings anesthetic-effect “That tests were conducted in accordance analysis of the serum from ml. the 5 procedure with the standard estab sample of each of the nine blood rab- biologic testing for the lished of Ab mentioned above less than bits were “Pentothal” bott’s thiobarbiturate gram per 100 ml. and that all sam- Yz comprised compound injecting ples 0.2 tested were diluted to cc. of keg. body weight 1.2-2.0 rabbits of HC1; in 5 serum cc. of blood ' N/10 intravenously (25 mg./kg.) . in tJ marginal vein ear with stands “That above rabbits / aqueous therapeutic dilutions of blood had drawn which from ^ puncture placed test solution which i contained 25 were then heart /g. per overnight Induction, cages, depth, cc. Pentothal urine metabolism n Spruth Manager expressed regard 2. Mr. has been of Abbott to the conclusions Bioassay affidavit, questioned. Laboratories’ Laboratories since in this not been qualifications, particularly and his Spruth collected, sam- samples urine affidavit relate use of dilute aqueous ethyl-(1- urinalysis and ples subjected solutions of sodium that them are no hemoglobin determination, based on the above sults peutic tothal’ ences “That # Tables A and between effectiveness powder, [*] affiant’s B: reconstituted, significant comparative *4 of reported [*] regular 'Pen- conclusion, [*] herein differ- thera- data, [*] methylbutyl)-thiobarbiturate,3 tions.” useful as an in water. The latter Spruth ently a commercial material known to be dissolving pared stance either as a testing appellants’ “Regular comparison “stable anesthetic and aqueous ‘Pentothal’ “powder” solutions” or or control sub- dilution of one “stable solu- each powder” appar- pre- any compositions spe- of of Subsequent submitting Spruth to examples pat- the said S.U. cific ent affidavit, appellants also submitted an af- h-18,J¡.68 Serial No. Ralph fidavit Cox which demon- C. compositions and that safe, said aqueous strates solution 2.5% effective, pro- for reliable containing “commercial Pentothal sodium ducing therapeutic set effects pH 10.65, carbonate” has a specification.” [Empha- forth in the solutions, prepared other each two aqueous sis ours.] appellants’ dilution of one of briefly point, At this solutions, containing will comment each after dilution on the acid sodium, containing nature the “thiobarbiturie Pentothal one 2.5% compound” involved in this case. sodium, and the other excess 10% 30% specification pH states: respec- have tively.5 values of 11.3 and 11.7 acid principal thiobarbiturie “The pres- compound to illustrate the Coming issues, then to the various first readily has been the ent invention controversy we address ourselves to the compound, available thiobarbiturate concerning scope utility alle- ethyl- (1-methylbutyl) -thio- sodium gations appellants’ specification. Al- generally known barbiturate, more though appellants urged during Pat- be It should as ‘Pentothal’ sodium. prosecution Office ent this case and however, understood, here- that the urge continue to specification before us that their applicable to invention is in disclosed alleged “has never compoundscon- acid other barbituric competition” their use of and that there group taining or functional an atom specific representation is “no of useful- acid barbituric which causes the specification, in humans” ness in their compound precipitate form a to our one it is skilled in the water absence admixed with appellants’ which per- to art invention reagent, strongly alkaline such of a reading would tains conclude most of the thiobarbiturie acid as compounds. specification appellants intend the solutions, appropriate after dilu- injection Except experi- tion, will be useful of the anesthesia for two into hu- ments, data all of the set forth in the mans. ap- generic expressing degree “A name of this substance means of thiopental acidity basicity pears to sodium. “Pento- be solution. Thus temperature apparently at normal Abbott neutral thal” sodium solu- pure such as distilled water Laboratories trademark for the same sub- has a pH of about a tenth-normal solution stance. hydrochloric (* *) acid has a
4. The sodium carbonate was sufficient pH 1 and a near normal solution of a provide sodium. excess 30% strong hydrox- alkali such sodium According Rose, pH nearly Rose and “The Con- has a ide Dictionary,” densed Chemical 5th Ed. (1956), pH is defined as: thiopental position observed that “principal sodium is support our findWe compound appears near thiobarbituric acid following paragraph which present used to invention.” specification: illustrate the appellants’ the end of expected appellants’ It would be in addition “It is evident place claimed solutions would used in highly stable improved providing an compounds of solid thiobarbituric acid com- acid of barbituric solution pounds, thiopental prepare di- such as sodium thiobarbiturates, aqueous lute solutions for human ther- makes present also invention apy. Therefore, we hold that the dis- desiring possible for those utility appellants’ closed claimed in- only a thiobar- amounts small vention relates to hu- the treatment of purchase time one biturate mans. large solutions thiobarbiturate ther- the individual vials from turn next to the doubt which the readily pre- apeutic dilutions can expressed examiner as to the thereby purchasing pared avoid for hu- invention when used ampoules of dose individual small therapy. aspects man Several of this dry was heretofore acid salt as question merit shown discussion. As pur- necessary. Thus, the small *5 affidavit, supra, appel- the Cox two of doctor individual as the chaser such injection lants’ solutions diluted for into same economic can now obtain advantages higher human or lower animal veins have pos- heretofore as was pH comparable than values that of a solu- large only institutional for sible prepared tion from “commercial Pento- [Emphasis ours.] users.” containing thal sodium carbonate.” Al- para- in this the references We think though position completely his us, is not graph “the individual doctor” appears clear the examiner was “large can be con- institutional users” opinion pH of the that these differences logically only involve use of strued are sufficient that “clinical evidence of therapy. appellants’ invention in human damage freedom from vascular at the site injection proper requirement.” support is a of find further for our note, however, works, We that examiner has position standard reference two given no reason nor has he cited au- Index of Chemicals “The Merck Drugs,” thority position (1960) for Ed., pages this which seems 1039-1040 7th involved with his Dispensatory somehow statements of the United “The percent aqueous America,” pages that 2.5 Ed., solution of 25th of States thiopental previously (1955).6 sodium used these dis clini- Both 1419-1423 of cally pH “a aqueous about 10” and that and value of dilute the use cuss high enough pH thiopental “is to cause local lining in human such sodium solutions connection, of the venous therapy. thrombosis it should be In this study from a of the us record before in Ms brief has asked The solicitor this “Dispensa- judicial “Merck and the Index” notice of these two to take court tory” opinion cited elsewhere We do this and will works. reference “Regular powder” by again ‘Pentothal’ used hereinafter for other refer to them Spruth study as a control substance his reasons. comparative safety appellants’ of the footnote 3. See (see Spruth affidavit, quoted in solutions part opinion) elsewhere in this also con- noted the Cox The examiner affidavit quantity percent pH tains a substantial of the alka- solu- 2.5 value 10.65 material, Indeed, prepared sodium line carbonate. from “commercial Pento- by percent containing “commercial Pentothal” used Cox excess sodium thal” appears “Regular carbonate, to be the same as the but stated his as sodium powder” by Spruth. ‘Pentothal’ solutions “conventional answer appear pH would Hence do not contain 10.65 Sodium’ excess ‘Pentothal pH be a 10 would more real- rather and that therefore “their alkali” comparison value exam- pH istic than the lower” 10.65 value is even however, has made. reported conclude, iner Cox. We Spruth rapidly aspect injection dilu- tioned affi- of the were made so and, vessel davit of the with the concurrence the flow of blood in tion with argument, expressed it- buffering solicitor at oral value the blood safety immediately to reduce assume that and effectiveness serve self did not appellants’ have pH was dam- invention rabbits endothelium before the aged irritating Ap- been established. contact.” a too parently assumed examiner has has, however, The Patent Office asked pH injection 11.3 or with a solution proof safety for more than effec- likely, or, perhaps likely more 11.7 also apparent tiveness in rabbits. This is damage type and has vein to cause this from the statement examiner we in the art that one skilled not considered quoted supra. Further, have in a letter injections presum- parenteral would of ably subsequent answer, to his examiner degree previous use at least the stated: making injection so as when caution “Applicants affirmatively damage.10 avoid vascular demonstrated the humans merely So we highly solu- alkaline damage at the examiner that vascular employed. tions Tests in animals beings possible injection in human site phlebitis will not reveal or venous are diluted solutions produced by excessively thrombosis injected. excepting by alkaline materials au- topsy; humans, pain Spruth directs at- affidavit Next we consider symptoms early tention to appellants associated submitted as extremity.” prosecution inflammation or coolness of this case. In his noting answer, the tests de- after *6 in this affidavit are limited to scribed case, In its consideration of this laboratory animals, the stated: examiner interpreted position board the examiner’s “Applicants the fact that stress being ground based “on the that no not Examiner did attack suf- the ficiency convincing proof clear and has been ad- showing Spruth in the composition duced that the claimed point This affidavit itself. lacks safe, effective and reliable for the thera- since more extensive tests in merit peutic applica- effects set forth in the laboratory animals still would not tion.” rejection board The affirmedthe examiner’s question have served to settle possible ground. on that We think that damage by reason of its following statement from the second great alkalinity the blood vessel at represents board in this case ade- beings.” injection site in human quately correctly the board’s basic reason its affirmance: that this statement of the observe We “ * ** Spruth question pre- does not criticize examiner here appel- is whether sented as a demonstration affidavit will, fact, pur- is safe effective attain the lants’ solution pose for which it anesthesia in rabbits. is disclosed to induce as use- used Moreover, Judge ful. consider nowhere in the record before Holtzoff’s ques- Watson, decision in or the board Isenstead v. has examiner us [D. However, the examiner answer. also stated in Examiner’s Ms answer that these solutions “do not 5% substantially pointed higher pH a The examiner out his than has percent percent Thus, contrary 2.5 solution.” the 5 solutions answer thiopental suggestion solicitor, “which sodium were sometimes the fact percent past” thiopental employed that a not used 5 solution of in the now likely buffering diluting pow- sodium is more damage “the to cause because vascular percent injection than a 2.5 of the blood site solution is ers cope pH evidence solutions of often insufficient to 11.3 or were 11.7 likely required damage time, are more cause vascular effect unit so a two-fold frequently pHof thrombosis occurred.” than solutions venous 10 10.65.
255 dangerous U.S.P.Q. 408, have undesirable or did not F.Supp. C.] effects, remains the fact decision side applicable This here. doctors, useful, veteri- should useful to Patent Office states 'that the workers, useful perhaps narians and research very even careful and animal, patients, grant new both human and lower luctant to meaning and so has been are useful within the formula until medical successfully drugs in thoroughly U.S.C. tested and § frequently physician.’ medicine is of bal- a matter more one tried ancing “Safety” is life. risks save point out that point we wish to At this example a relative relevant matter. An affirming although board, the ex- commercially obviously useful, here is the necessity for aminer, referred to medically material, acceptable solid composition is proof “claimed thiopental sodium, by Spruth aas reliable,” safe, neither effective and appears control substance.11 It that this board, any given examiner nor the widely although material, apparently doubting the reasons effectiveness completely therapy, used in human is not reliability appellants’ sohitions in example, “safe” for For that use. inducing animal, anesthesia opinion, mentioned earlier in cluding humans, and will assume that we examiner dan- himself has discussed the showing upon in human ther- gers injection 2.5 and inherent apy, and the board would the examiner percent aqueous mate- solutions quali- as to all three have been satisfied Further, rial into human veins. the com- ties and would conceded regard, Index,” supra, “Merck under, same positions section 101. to be useful warns: important two Now we must consider (5% or “Concentrated i. v. solns. questions. The examiner and the board more) may thrombophle- local cause convincing upon have insisted “clear and injection bitis. Intraarterial causes solutions, proof” that the claimed after burning pain periphery severe appropriate dilution, are “safe” for in- extremity. Urticaria and skin jection into human veins. As we have reported.” rashes have been already agree supra, discussed the examiner and the board one Also, “Dispensatory of the United *7 reading skilled in this art would learn on States,” page supra, states 1420: at appellants’ specification that the claimed “ * * * per cent, A 2.5 or less solutions are so to used. be What then concentrated, thiopental solution of degree “proof” is “safe” and what is for in- sodium is used intravenous necessary in a ? case like this jection. per A has cent solution regard question, dangerous With to the first more been but it is “safety” may the nature of in the field of it cause thrombosis drugs medicaments, judicial alkalinity we take vein because many therapeutic sub notice valued Further, both of these references devote physi stances with desirable materials space much discussion of “Human ological properties, when administered to Toxicity,” “Toxicology” and “Contraindications.” humans, lower animals or entail certain 12 may risks or have undesirable side ef dangers In view of these known fects. True it is such substance using thiopental sodium in human ther- would be useful if more were not agent. Oxygen excerpts for inhala- 11. See footnote anesthetic from Spruth should available and used affidavit. rapidity (v.s.). The with which through patient passes “Dispensatory” example, the several For states thiopental part heading, “Toxicology,” under the of anesthesia levels recognize makes it difficult to as follows: sodium “Respiratory depression presence un- an excessive dose is the most injected present. problem apnea If it is is difficult til the use of many might subjects expected sex, physical apy, age, that a solution of what it conditions, degree appellants which etc. and what of vascu- such as that claimed damage, any, per- thiopental lar would be contains sodium13 would have been dangerous “safety,” “proof” for the same missible in a least as to use but unnecessary purpose. be com- Therefore it would to concern' ourselves appel- pletely with that insist matter because no clinical evi- unrealistic in hu- lants’ “safe” for use dence whátever has been But solutions be submitted. therapy. what that fact does no man do not know not mean that there is “safety” evidence of the Patent Office would have the case at bar. criterion relating Spruth rabbits, On the basis used had clinical of tests with studies use of in human stated in solutions his affidavit: “ * * * therapy submitted, we think significant are there * * proper appel- criterion is whether differences between the previ- lants’ are solutions regular safe powder, “Pentothal” re- ously widely commercially used and constituted, composi- acceptable pentothal solid form of sodium. specific examples tions of the of [the It is this which we have in mind criterion application at bar] considering the second of our two important points There are three degree questions, e., “proof” i. what volved in that qualifica- statement. necessary degree to demonstrate Spruth express opin- tions of such an “safety.” ion questioned (see have not been foot- 2); note Patent Office has insisted on clini- the rabbit tests involve a side- by-side tests, patients, comparison cal i. e. tests appellants with human of what “prove” claiming appellants widely used, solutions with a com- mercially therapy. medically “safe” for human acceptable We do mate- rial; opinion, know what sort of clinical tests would in our rabbits are “stand- experimental have satisfied the Patent i. e. ard how animals”14 test- for large single rapidly, tory Alone, doses or too obstruction. is inade- respiratory quate operations requiring arrest often results. com- respiration plete restored, being While muscular relaxation and it is not rapidly procedures the brain requiring becomes advised desaturated more painful operative stimulus in the 30 minutes. It is not used for patient; procedures. area often rouses the extensive intrathoracic tendency Thiopental is to administer another sodium is not advisable in large presence again dose of the of severe anemia. Cau- stops respiration. only required patients tion is This not with se- unsatisfactory hypotension my- sults in vere or hypertension, anesthesia but painful disease, congestive the effect of ocardial ure, stimuli on the in- heart fail- adequately patient may sepsis, obesity poor anesthetized severe and all *8 laryngeal spasm in result or other un- anesthetic risks. through toward effects stimulation of Appealed 13. claims 30-34 and encom- 38 system. the autonomic nervous pass compounds gen- “tliiobarbituric acid” heading, “Contraindications,” Under the including thiopental erally, sodium. Claim “Dispensatory” part: the states in thiopental 39 is limited to sodium recited “Thiopental sodium should not be systematic therein name. See foot- in the used home or officeas anes- note 3. combating thetic unless facilities for respiratory depression readily phrase experi the “standard available. It is not advocated for mental animals” as chil- we did in In re Krim * * * years mel, 948, age, 1116, under dren 10 of 292 F.2d CCPA 48 where although Holly found it use- we defined it as “whatever animal is usually ful in children if administered those care- skilled in the art fully. opera- particular pharmaceuti It is not advocated for establish the upper question.” respiratory tract, tions the in cal That case respiratory head or neck where decided after the ob- was case had been filed but briefs in the instant may develop struction as a result of before the oral operation. Although argument. specifically the in is it is not contraindicated patients dispnea respira- in the or stated record that rabbits are
257 917; 742, F.2d safety anes- 40 v. CCPA Schnick the thiobarbiturie of Fenn, 935, 277 F.2d 47 Al- CCPA thetics. though matter of those cases Bearing mind absolute in that widely, requirements each, varies in “safety” proof proposition of such a practice for an actual were reduction to impossible of a or is medicament issue, each, at and in made of use was “safety” “proof” and that of is relative laboratory experiments, certain labora- degree “proof” dependent on with the tory-scale tests,” equipment, “shop or quantity quality of the available attempt “bench in tests” to establish evidence, bearing in mind what evidence practice. reduction to some In “safety” has been submitted cases, the court found actual reduction bearing bar, in case at in mind that practice, established; had been in concept herent in of the “standard others, practice no actual reduction to experimental ability one animal” is running through However, was found. appropriate skilled in make the the art to expressed all nine cases cited is the same actually correlations the results between implied criterion, namely, or how would experiments observed with animal one in interpret skilled the art ex- probable ther in human results periments or tests. If the court was apy, appellants’ solu we hold convinced that one skilled in the art tions have been to be useful with shown accept particular would experi- or test meaning In of 35 U.S.C. § “possibility” ment as a or “reasonable holding do, we realize that we certainty” “probability” that was clinical as to evidence been submitted has “reasonably predictable” a tested in- “safety” There these solutions. operate alleged vention would or have lacking degree fore there utility alleged, practice reduction “proof” pro which such evidence would found; otherwise, the court found no However, vide. do not believe practice. reduction to degree “proof” necessary such a course, view of situation in case Of case differs from bar factual proba at bar. We think that sufficient above cases in that the former in- merely bility therapy parte has volves an ex establishment utility proof rather than demonstrated the ease at of an bar actual satisfy requirement practice priority reduction of 35 U.S.C. in a dis- pute. 101 Our invention use- citation of § those cases should suggestion ful. be construed aas that the proof applicable same standard of Although appears the case at bar types both of cases. court, any previously unlike before this regardless many However, support position we find for our the issuance of reduction-to-practiee the so-called under the circumstances bar, question cases this court. there is no decided Some of but that case at protected absolutely public these are as follows: Harrison al. v. must be et 1024; advertising 704, against Cadwell, 17 39 F.2d CCPA sale and oth- drugs, 798, Schulze, al. John et v. F.2d er distribution harmful medi- St. 1050; Payne situations, Hurley, F.2d like all v. and the CCPA cines ing includ- 1144; Lund, 21 CCPA Goodale v. 1148; this one such be case. We be- recognized F.2d v. 25 CCPA Chittick lieve *9 1382; 818, clearly Lyons, problem expressed and has 104 F.2d 26 CCPA its in- give statutory authority Taylor Swingle, 914, 136 v. F.2d 30 CCPA tent to and re- agen- 1219; Lustig Legat, sponsibility in area 154 33 to Federal v. F.2d given 991; Morway Bondi, than that al. v. 203 different the et cies Pat- CCPA ap- argument. experimental effect oral the same This animals” for “standard Krimmel, pellants’ purpose, rebutted the statement as defined in solici- Spruth affidavit are the indicates tor. appellants made a and statement such 258 Also, the Food’ Trade Commission Act.15 stand- the because This is so ent Office. given Drug and has been ad- Administration for statute ards established responsibility enforcing Fed
vertisement, use, or distribution sale Food, Drug, eral Act.16 re- and Cosmetic drugs quite different for quirements Act under argument anticipate the- example, patent. For issuance Federal Trade Commission Act and the Food, Drug, has been Federal Act and Cosmetic Federal Trade Commission enforcing protect against given responsibility public do not ad vertising Federal to the and amendments sale or other distribution Wheeler-Lea 16. 52 Stat. U.S.C. lar, See also 15 (1938), (1958). (a) See for thereof, sults from poration pose induce, directly metics; guilty of a tisements—Unlawfulness vices, or cosmetics.” ated, disseminate, person, partnership, deliver commerce application “§ of duce, fective use of tions commerce customary “§ 54. section chase of “§ 355. “(a) Any “Filing application; pose Secretary of subsection Such part: part: “(1) “(a) “(a) “(2) By “(b) which states: see penalties any drug inducing, injurious respect person (b) §§ any prescribed in the advertisement directly as In for introduction By Any It shall be No application 52(a) inducing, or commerce of or Same; penalties Imposition who violates foods, Dissemination New 301-392 amended, person, partnership, of this section example, particular, n false advertisement-— under such conditions U.S.C. any means, U.S.C. United States any commodity advertised misdemeanor, such use person or filed person may shall submit or or which is to health to such any means, of this title drugs Necessity or (1938), usual, drugs, new cause or (a) pursuant or which § indirectly, (1958). § indirectly shall introduce — 15 54(a), unlawful or 52 of this section. under the condi- see U.S.C. drug, any provision food, drug. contents for the to be devices, U.S.C. because of re- into interstate corporation [*] Stat. to the Secre- — file likely for mails, or in shall, is effective which states amended, to subsec- false drugs, provisions unless In dissemin- with the the likely for purpose respect §§ or cos- or 114-117 * particu to in- as are of ef- pur- pur- pur- adver- may states cor- 52-58 any de- § an 52 full ponents such not drug; full list of methods and tary statement of the to subsection not methods proposed labeling thereof; posed ing, ports thereof as the use under the conditions become effective ture, processing, drug; whether or not such drug is unsafe for use under such the facilities and controls the tions; due notice to the and of the he has insufficient information to de- “Grounds for before submitted to the termine whether such for use shall, prior conditions drug packing to quality, basis him as come recommended, or on the basis results “(d) v preserve him an application, (6) controls used reports as a include is safe for been made manufacture, processing, effective. to be of which are (5) him with (4) *10 permit part If the (3) specimens [*] of such reasonably applicable the information submitted to of such drug used under part articles used (1) such such or .the used opportunity purity; to the effective date of adequate full do not show that such (b) refusing application Secretary may require; is safe for # of the in, Secretary finds, articles methods samples tests issue investigations respect to show whether or drug Secretary pursuant drug; of this identity, strength, description applicant investigations, application, for, suggested application under other or 5}t drug such packing show that such required application (1) conditions, the manufac- used tests the facilities to such (4) of such labeling used for a hear- order refus- components information use; (3) such condi- section, prescribed, inadequate drug. [*] upon safe (2) to show of such of such is safe in, a full to be- which (2) drug, after com- drug pro- giv- for, up- [*] all do he to-
259 drugs Second, presumed comm in intrastate must be of harmful Congress Congress that, therefore, is aware that almost all of erce17 and legislation States enacted Patent Office have intended that must gives public degree protection to the would not of area. We in this limited act against First, advertising argument persuasive. and intrastate find this authority any statutory sale or other of distribution harmful observe that drugs regard which, many cases, approxi given Patent Office protection given by provision mates that the Fed from the would to stem Food, Drug, eral patentable in and Cosmetic Act.21 of that a 35 U.S.C. 101 § slightest comparison There not the indication that must “useful.” A vention Congress intended that provision pro with detailed 18 pat the course of its examination of visions the Federal Trade Commis applications, any up ent close small hiatus Drug, Food, sion Act and the Federal legislatures left of those several and us Cosmetic Act indicates to protect States who do not their citizens had intended use its consti against advertising authority intrastate and patent tutional under sale or other distribution of harmful new might clause19 do what it able drugs. As Krimmel, we said in In re su clause,20 under do commerce pra: drug legisla would have enacted “ * * * corresponding tion in detail to those two It is not us or acts. legislate Patent Office to and if the however, passing, note in the fol- been tested and has not been found to lowing suggestion of Earl Kintner in W. be unsafe for use under the conditions Regulation Federal prescribed, Trade Commission suggest- recommended, or Food, Drug and labeling Cosmetic Advertis- thereof, prior ined ing, Publishing, Entertainment, selling 1 offering Adver- or for sale such tising 8,Q., drug, Allied Fields L. 19 there has been filed with the (1961): -* application setting (a) “Under this reports [15 section § 52] U.S.C. investiga- forth full jurisdiction the Commissionhas when- tions which have been made to show appears ever it that false advertise- drug whether or not such is safe for prod- use; (b) ments these four classes a full list of the articles used (1) components ucts States drug; disseminated United by (c) of such mails, (2) commerce full statement of the (8) or means where drug; there is a (d) description local such a full dissemination an advertisement in, methods and for, facili- likely induce, directly which is ties controls used the manu- indirectly, purchase facture, packing processing, commerce.” [Emphasis drug; ours.] (3) samples such of such drug and of the articles used as com- 18. See footnotes and 16. 15 -* ponents thereof I, 8, 19. U.S.Const. § art. clause may require; specimens (f) labeling proposed the such to be used for I, 8, 20. U.S.Const. art. § clause 3. drug. Food, Section Uniform State “ * Drug accepted Bill, proper designation Cosmetic Insert of State Officer, Board, Department, endorsed the Association the Executive Committee of etc.” Drug According Food, Drug, of Food and Officials to CCH Cos States, L.Rep. (2d ed., of the United 1959), chang October reads metic part through May, 1962, follows: es this Section 16 or person (a) provision substantially “Section 16. No shall the same has sell, deliver, sale, offer for hold for been enacted law into the 50 give away any drug Moreover, sale or new un- States. this reference also (cid:127) (1) respect less remaining that most of the indicates legislation provid thereto has become effective under have enacted States ing varying degrees protection against Section Federal Act [21 355; labeling advertising, § U.S.C. pra.], see footnote su- and sale of un (2) drugs. when not safe Federal Act unless such *11 Drug Administration, give re- Food and the Congress this desires to dealing prep- pharmaceutical Office, in with new sponsibility Patent agree by arations. with the result reached statute.” do should so majority opinion in the have been judgment, Therefore, the board our in by fluenced some additional considera- rejecting appealed the in has erred are con- tions which the this appellants have held claims. We curring opinion. specification that their disclose their therapy. useful in invention is position of Patent Officein the the The expressed doubt Office has Patent present by case is follows stated as “safe” that the invention be solicitor his brief: Although appellants purpose. have not “Faced with to show that evidence concerning ac- supplied data clinical alkalinity percent of a 5 solution human ther- invention in tual use of their dangerous” may cause is “more apy, they supplied ex- evidence vein”, and faced “thrombosis laboratory pert experi- opinion based on with fact that the claimed com- rabbits, “standard ex- ments position actually upon showed dilu- purpose, perimental animal” for their pH up *, 11.7 it is widely as a invention is as safe their that the tribunals submitted accept- commercially medically used, carrying Patent were out their Office opinion, In evi- able our this material. statutory duty, they required probability dence indicates sufficient proof effectiveness invention safe as will be as * * *, and that man such therapy sat- in human latter material isfy quirement was not unreasonable statutory requirement that the light and circum- of the facts invention be useful. [Emphasis case.” stances of this added.] Although it is true that the ad
vertising and sale other distribution my opinion, In the condition to the invention human ther pharmaceutical grant patents apy much of intra in interstate and field which Patent Officehere seeks legally per state will not be commerce appellants impose supported is not experiments until with humans missible any provisions I find able to out, carried we do not think have been patent statute. authority responsi it is within 101, 102 and bility 103 make no Patent 35 U.S.C. §§ Officeto demand such particular between classes case inventions in view of distinction tests in patentability” However, “conditions of of record. im the evidence opens plication here that and section statement is intended clinical person patent entitled “A shall be to a demanded evidence should specificstatutory lists and then different circum under unless—” Patent Office patent grounds may on which a Each case must be be re- stances. decided on “Safety facts. in man” fused. effectiveness its own set conditions. these In enact- is not one foregoing reasons, we reverse For the ing statute, I am certain it Appeals. of the Board of the decision Congress many recognized inven- Reversed. danger in them an element of tions have necessity proceed up- must man Judge (concurring). SMITH, underlying assumption despite on an dangers, judge pat- possible we must majority has, herein such entability I be- public of the inventions on lieve,performed point- basis service intelligent those who of their enough out what established dangers respective to understand functions of the sufficiently may present and who Commission, Federal Trade *12 duty for their ments. This use inventions should not be exer- skilled to so cised, purposes.1 here, as it seems me that intended to it was important public to defeat one of the require- complied To with purposes patent laws, e., of the i. present ments of the Patent Office case, prompt publication of inventions. assumption of some based on Robinson his “Treatise on the Law “statutory duty” vaguely im- asserted (1890), Patents” refers in section 32 Office, posed would have Patent on the duty to “the which the state to owes delay proofs before meant extensive people them, to obtain for at the earliest “safety in man” ac- effectiveness and moment, practical every use of valu- ceptable have been to the examiner could able invention in the industrial arts” delay would have started secured. This securing “publication of the invention securing permission from the Food brought as soon it perfec- as is to such Drug to so test the Administration capable tion practical as be employ- to permission composition. Even after this ment.” granted new thera- and the tests of the is humans, proper peutic composition on The are made applied, test to be here it me, fact, can seems “safety it is well-known is not the ultimate judicial notice, properly man,” and by take even effectiveness in as contended necessarily test, tests conclusive. Patent such Thus, is the suggested by Robinson, to conduct tests which would con- whether “the clusively “safety brought and effec- per- establish vention been to such pharmaceutical prepa- capable practical tiveness” of the fection as to be em- ployment.” here well applied ration involved could mean If this is test delay years proof many present presented, before the here ap- it me seems to pellants application pat- clearly and the could allowed shown that their duty public primary brought The ent issued.2 invention had per- to such charged capable fection employment. which the Patent Office that it was practical 101, performing under U.S.C. §§ 103, patents applica- issue on is to “statutory duty” The to which so- statutory refers, require- licitor
tions which meet the seems also to underlie the ample dissenting opinion showing be an 1. The contains herein by persons the statement: when used skilled “ * * * competent ample The record contains this field. highly evidence that the caustic nature public drug, hypnotic used as a While interest demands that surgical anesthesia, applications patents all thoroughly to induce makes injected carefully dangerous by proper when it beings. examined ”* * * personnel, public Office inter- Despite careful est also consideration demands a reduction in the time lag herein, filing record I am applica- unable find what between the aof willing “ample Report I am consider final evi- tion and action. Of. ordered printed May 9, 1962, on this matter. dence” examiner’s Committee position Judiciary, seems Senate, since cited United States made damage Patents, literature discloses that venous its Subcommittee on Trade- injection likely highly Copyrights pursuant site is marks and to S.Res. injected, pres- Congress, Session, alkaline solutions 87th First ex- composition, pp. greater alkalinity, because of its ent tended A 12-13. considera- damage proofs cause thus is not tion for required reasonableness of the preparation. present a “safe” seems to me in a case such as the position amply would, me, way was rebutted seems it be one by appellants. lag filed the affidavits which the noted time could be reduced met, me, passing it seems issue is the in such cases. thus is- note in damage of whether or not venous now us sue before was filed over ago, eight years parent applica- caused of the claimed inven- and the purpose. tion for its intended on which it Standard was based was filed over laboratory showing years ago. on tests animals nine and one-half damage no such occurred seems me to 309,] Appeals C.C.A. decided [156 Board Eighth Circuit, that: held stated: where consideration “ “* *13 “useful,” pre- as question ‘The term contained here patent law, applied composition to a when is whether the sented machine, pur- means machine fact, the will, the in attain claimed accomplish practi- purpose will use- pose it is disclosed as the for which cally applied industry.’ Judge in Holtzoff’s We consider ful. Watson, [D. in Isenstead v. decision opinion is “This Court of the 408, USPQ F.Supp. 7, 157 115 utility C.] ap- the same test of sould be applicable This here. decision plied composition to a In of matter. Officeshould ‘that the Patent states words, other invention at- the very perhaps re- even careful purpose operate tain the and will it grant patent new a on a to luctant as disclosed and in- claimed the until it formula medical ventor ?” successfully thoroughly tested and utility Judge there- Holtzoff’s test physician.’ by more than one tried have been: “Will inven- fore seems to the though, not, the determine needWe purpose oper- attain the and will it testing neces- of the clinical extent sary as and claimed the in- ate disclosed pre- appeal does not because present However in examiner, ventor”? problem.” sent board, and the stance departed to me to have solicitor seem dic- The admonition contained “statutory from this test favor Watson, v. Isenstead tum court duty” from the dic- which derive F.Supp. 7, D.C., seems to 157 thus tum: become, by fiat, Office “statu- a duty,” tory extends to a deter- which even scrutiny “Great care and should proper “extent of clinical particularly mination testing.” taken in connection applications pat
with for medical granting pat ents. While of a “statutory appear these duties” Since legally ent a origins does constitute cer their Isenstead v. Wat- tificate that medicine to which son, supra, deci- a brief review this good relates ais medicine and will There are facts sion desirable. few successfully cure make the disease proceed- since stated do, which it Nothing test was intended to was “in camera.” granting nevertheless, the of such as to matter of the in- vealed gives patent impri a kind of official in issue other than that it re- vention question matur compound to the medicine medical “to a for the lated testing on which a moral some purpose matter the function public likely rejected members of 2 liver” and that claim rely. In adapted view these circumstanc “a of matter covered right es, proper consisting proteins, that the blood shift very opin- Patent Officeshould be careful substances.” In three different ion, grant perhaps even reluctant reference to 35 after U.S.C. § patent Judge statutory aon new medical formula relates the word Holtzoff thoroughly concept “utility” until it has been tested “useful” says: successfully tried more “ physician. ** one seems Court ‘Utility’ is a broad term that therefore the Patent among things implies other ca- and pacity public policy, a proper matter followed a perform the function or to (157 course in this matter.” ap- the result attain 9). F.Supp. at p. plicant in his disclosure. For ex- decision, ample, In more recent Common- in the case of Besser v. Mer- Engineering Company Co., wealth Ohio Core F. et rilat Culvert dissenting “imprimatur” (1961), F.Supp. which D.C., Ladd, v. al. judges issuance, prior would find in such Judge deci- his referred to Holtzoff Administration, Drug supra, Watson, Federal Food and v. in Isenstead sion statutory authority, remarks, I have the exercise of its his stated that drug. “dictum,” approval withheld previously characterized process in- equally applicable ato “are previously major pointed'out, As one for medical use.” tended public purpose se- law is to agree Judge cure the decision disclosure inventions Holtzoff’s possible discharging Engineering delay. the least case In in the Commonwealth *14 function, entirely right proper upholds it that Pat- is insofar as the proof applicant’s require reasonable of as- proof the dis- an ent that Office to utility required “useful,” serted I be the Patent closed think invention is but Office. What I the Isen- here criticize is the man- the recurrence of the of dictum requirements ner in which as here these stead case is unfortunate that beyond been extended it is and with- reasonable com- used stated out of context pliance statutory Judge requirements. I out the Holtzoff’s other benefit.of cogent reason, logic, justice, find no either in the Isenstead case. observations in public policy why grant patent or of a The theme of the dictum recurrent delayed pharma- here should be until the repetition the Isenstead case and its cological merits the disclosed inven- sug- Engineering the Commonwealth case tion are established clinical tests con- gests that as- Patent Office should may humans, ducted on when such merits obligation public safety sume as to the be evaluated quali- on the basis of other expression which here finds in its re- fied tests. quirement applicant supply must “safety proof of and effectiveness” composition “in WORLEY, man.” This con- dissenting, Judge, Chief cept analysis. will not stand JACKSON, Judge, joins. with whom goes dissenting opinion beyond The examiner, The members of the record here and refers “the now board, majority agree and the here all drug infamous thalidomide.” While I that the instant is to be pertinence can drug see no beings. this material Despite as a on human any presented, issue here I majority observe fact the holds that the Patent proof, that here is dramatic “authority be responsibility” Officehas no or needed, patent the issuance of a is require that, clinical evidence “imprimatur” not in applicants’ drug fact as to the beings, used on human any pharma- damage effectiveness of there is “freedom from vascular n product any purpose. ceutical for injection.” at the site It principle patent Congress is an elemental clearly Inasmuch as has grants law that a charged more no the Patent Officewith determin- legal right ing patentability exclude others from inventions, using making, selling thing pat- or requested the information since relates guarantee anything ented. no- to the usefulness of the on human gives right make, no one a beings, use or it would far more accurate to anything. sell public, therefore, is' hold that is this court which has no way protected grant- in no “authority either responsibility” strip withholding patent. statutory duty. of that Patent Office However, so Office, agency, reference to Patent other It is the dissenting thalidomide Congress always respon- will which held complete, determining it is here patentability noted that thalido- sible mide is matter of U. S. ventions. That Patent intends #2,830,991 which April issued 15, 1958. Office to continue role is Despite following patent, crystal issuance of this ex- and made clear in the D.C., F.Supp. East- 7. There Isenstead
eerpt of Senator the remarks from sought patent protection “a presenting on medicinal 1552:1 land S. “ testing compound purpose as to decision The final The ex function of human liver.” patentability would be left utility proof for that aminer held that Patents, as has Commissioner of purpose inadequate insufficient. past.” practice in the been the The upheld District Court board affirmed. The (Italics supplied.) stating: the Patent impos- Under such circumstances it “ * * * in a techni- This Court majority for me to reconcile sible position cal matter such as should not is a I am convinced with what lightly set decision aside the Congressional expression. clear Moreover, an inde- Patent Office. majority “the case concedes that pendent examination the Court any previously appears bar to be unlike proof of submitted as affidavits regret agree, before this court.” utility concur leads Court to necessary go majority to' that the finds it the view of the Patent Office *15 beyond reasons so far the record and the number tested and the of cases the sup appeal of in a fruitless search of results obtained are not sufficient holding. port unprecedented for its finding justify an to utility. affirmative of example, For find some de- seems to It must be borne in mind gree of comfort nine interference this connection that the burden below, cases, cited relied on or none or applicant prove on the to argued appeal was mentioned when this it, that is entitled he to there- cases, involving subject mat- here. Those the onus is on him to show that fore ranging spark plugs zipper ter fasteners, to from operate the invention will dis- foreign completely to the closed in and will subject matter, facts, and here. issues objective.” (Italics sup- achieve its dealing ex- In those cases the court was clusively plied.) sufficiency of evidence regarding by contesting parties offered disagree Presumably Isenstead did not priority practice and in- reduction to interpretation with that law since pos- vention. Those decisions could not appeal. Moreover, he took no sibly anticipated problems here. only change steps has not law, taken no any hold, therefore, To that authority but has reaffirmed the is, the case relevance whatever to at bar ****Indeed,applicants the Patent Office.3 logically respectfully suggest, I and le- question here do not the soundness of gally insupportable. challenge decision, authority or the Patent re such a make But decision which was cited Office quirement, attempt only bjr but board, to distin not discussed relied on by but guish from majority, Watson, facts. instant Isenstead v. upon, receipt any Congressional August 23, request, Record, 1. such conducted, page S.1552, or conduct cause to be such is now Sec. 308 may required.” Drug research Amendments Food, amends Sec. 702 of the Federal part: 372) Drug, (21 § 35 U.S.C. states and Cosmetic Act U.S.C. § by adding following “The United States Court of Cus- end thereof the at the Appeals, petition, toms Patent on new subsection: appeal Secretary shall hear and “(d) determine such The is authorized produced upon the evidence directed, request from before Patents, and the decision shall be to furnish Commissioner points complete set full and spect information with re- confined forth appeal. questions (Italics relating reasons to such supplied.) drugs may as the Commissioner sub- concerning patent application. mit supra. Secretary authorized, footnote is further See Surely drug reason to can no valid there Isenstead, is to be Here, inas drug hold, law, re- as matter beings. must be used on human here, prob- rabbits, drug composi- on mice or applicants’ membered complex ably prior have the effect on the same caustic tion is more even fallacy system body. human circum- part.4 Under art counter example reasoning, is even of that examiner requirement stances the remotely needed, re- is illustrated capricious, anything unreason- but was tragic in- experiences with the now only cent had arbitrary. He able drug famous thalidomide.5 responsibility authority, a clear evidence. dealing require clinical instant I see no relevance in the acts ample evidence contains The record Federal with the Trade Commission drug, highly of this Drug nature Administration, caustic nei- the Food and surgical induce hypnotic and to used as a ther of which was nor when cited below dangerous anesthesia, argued. appeal makes it If those acts Although beings. appli- jected showing purpose human cited for the posi- Congress agencies examiner’s not rebut the cants did intended other than evi- majority tion, police characterizes the Patent the sale Office “merely the ex- drugs cosmetics, dence as distribution of then support Certainly agreement. complete there aminer.” If, am how- one conclusion ever, they prove in this record for are cited to that Con- inject applicants’ gress art could skilled in this intended the Patent Office body caus- without into the restricted or relieved of its duties damage. Surely, that obli- garding patentability inventions, vascular *16 gation applicants, on not disagreement. on complete must rest I am in That is the Patent Office. saying much like Office the Patent should be relieved of its duties to deter- dangerous most weakest and the patentability guns, mine the of machine majority is its rationale element example, merely Congress because theory, adoption which is apparent might charge agency po- another nothing more, speculation, sheer licing their sale and distribution. drug given a certain effect on will have a Congress has, practical That as a mat- animal,” experimental what- “a standard recognized desirability cooper- ter, might be, “prob- animal it ever ation between the Patent Officeand other ably” human be- effect on same 6 agencies following: is from evident ings. applicants have the even the Not “ * * * The argue scientifically final decision toas temerity a such patentability reasoning would be left proposition. That is unsound Patents, unnecessary Commissioner of dangerously ex- blind a practice past. With a field in which this court into cursion help Department competent venture on its own. from 2,830,991. by appli- in U. S. Patent No. It affidavit of Cox submitted 4. The assigned to Chemie Grünenthal G.M. that a solution of the shows cants 2%% B.H., Rhineland, Stolberg, Germany. pH 10.65, prior has a art material priority patent claims based on a German solution of the claimed while 2%% May 17, higher filed drug alkalinity, 1954. has a Only recently, COPA, Fisher, pH in In being re of 11.3 to 11.7. 948, F.2d this court found as a fact: general appears prior appears matter “Thus art It 5. thalidomide, although knowledge concentrates are ef- ACTH useful for guinea jection ‘rats, pigs, beings, in human into and sim- as a sedative fective ** offspring born to wom- animals’ but in deformed ilar ‘most sulted during pregnancy. taken it be had cases carmot tolerated the hu- en who giv- being.’ (Italics supplied.) of those effects when neither had man experimental animals in ex- normal en August 23, Congressional Record, pat- perimental Thalidomide was doses. page April 15, on the United States ented Health, Education, as to vance and that should continue tobe stimulated Commissioner better kind whether new equipped new-product genuine to make the decision Patents will drug represents technical Welfare, competition ad- be Application Christopher CCPA United States and Robert Lieberman. and Patent Dec. Appeal Court Customs Appeals. No. 6858. L. WILSON by patent rights.” (Italics sup-
plied.) Surely question there can intends the Patent Office responsibility of determin- continue inventions, patentability all drugs including beings. use on human denying In that function to the Patent Office a rather odd is reached: result although argue applicants strenuously specification that their makes no mention beings; although they of human stress drug that the usefulness of has been their only by established on mice and tests rabbits; although they insist beings, no tests whatever human made on predictions and make no drug whether their ujill when used safe unsafe nevertheless, beings; the ma- jority applicants’ holds that “probably” beings safe for use on human applicants are, therefore, entitled to protection. unlimited am aware *17 parallel patent litigation, of no Congress cannot believe that intended an seventeen-year applicant to receive mo- nopoly under such circumstances. knowledge my To is the first time authority
the quire of the Patent Officeto re- relating clinical evidence “usefulness” of used on hu- beings challenged; indeed, man has been applicants challenge do not it here. That authority continuously has been exer- cised the Patent Officewith the full George Finnegan, Jr., B. and Hobart Congress. approval There can be Durham, City (John N. Vassil, New York C. logic in law valid reason inter- City, York counsel), New practice. fere with that appellants. regret say majority if the Moore, W. Washington, Clarence D. land, the law of remains (Jack Armore, Washington, E. C., C. D. Supreme unless the it must Court or counsel), for the Commissioner of straight, I sets us can the nothing see Patents. uncertainty trouble WORLEY, Before Chief Judge, ahead RICH, MARTIN, system always SMITH, it, known we have and AL- Judges. MOND, public.