i GOVERNMENT W h a t A b o u t Drug Patents? Patent office studies utility requiremeRts / stumbling block in issuing new drug patents plete, clear, and convincing evidence will overcome t h e examiner's rejection *' 1 ".l^WKTtNG^Ij must meet three for lack of utility. • Effect On I n d u s t r y . Watson says 'W£$$^&$& tests-it must be useflll must be that members of t h e d r u g industry h a v e l i S i ^ ^ ^ i . i l ^ ^ S novel, and it must told h i m that t h e rather reactionary involve "inven- attitude of the Patent Office in r e tion" over t h e prior art. In t h e case quiring rigid proof of t h e utility of of a m e c h a n i c a l device, it is compara- pharmaceutical inventions is keeping tively easy to show how useful it is. the industry from advancing as rapidly But t o demonstrate to t h e satisfaction as it otherwise could. In developing of t h e Patent Office the usefulness of n e w pharmaceuticals today, industry a n e w pharmaceutical m a y be a very says t h a t years may elapse from t h e initiation of the research program until difficult task. Noting that some members of t h e t h e d a y when a n e w medicine is placed pharmaceutical industry a r e concerned on t h e market. Since a patent is t h e over r e c e n t rulings of the Patent Office prime means of recovering t h e cost on p a t e n t applications for inventions of research, filing a p a t e n t application of pharnaaceutical nature, Commis- must b e deferred until t h e invention sioner of Patents Robert C. Watson has proved its utility, a procedure outlined t o t h e luncheon meeting of which forces a research group t o work the Division of Medicinal Chemistry in complete secrecy for a very l o n g the Government's position in regard to period of time. issuing pharmaceutical patents. To protect inventors w h o have d i s • P r o v i n g Utility. T h e statutory re- covered n e w substances which may b e q u i r e m e n t t h a t inventions, to b e pat- developed into beneficial medicines, entable m u s t be useful presents a but which have not y e t been shown t o problem t o t h e examiner of pharma- b e effective for any purpose, industry ceutical applications which is often suggests that patents b e granted f o r more difficult to resolve than t h e same pharmaceutical inventions that h a v e requirement applied to inventions of "scientific" utility instead of ultimate o r other types, W a t s o n says. In t h e past, commercial utility. Watson is not s u r e very little attention was paid t o t h e that h e fully understands what is meant requirement for disclosure of utility in by scientific utility. Nevertheless, h e chemical cases. Some chemical pat- says, " W e are studying this suggestion ents, W a t s o n says, were issued with with care and will continue to do s o , specifications reciting t h e barest sug- until w e have decided diat it is a feagestions of uses claimed for t h e new sible one or cannot, for good reason, compounds. b e adopted." • P r e s e n t Criteria. Meanwhile t h e However, the Patent Office h a s recently ceased to b e as lenient a s it h a d Patent Office will continue to apply t o been in requiring a satisfactory disclos- applications for patents o n n e w p h a r ure of utility. I t is n o t too difficult, maceuticals t h e present rigid requireWatson says, to insert in a patent appli- ments for utility. As spelled out b y cation a n assertion of utility a n d to Commissioner Watson, some of t h e s e indicate possible \xses. But t h e appli- requirements a r e : cant still faces another problem-—he • T h e preparation of a n e w commust prove t o t h e satisfaction of the P a t e n t Office t h a t his assertions are p o u n d without a disclosure in t h e original specification of some use for well f o u n d e d . T h e a m o u n t of proof required, Wat- the compound is not sufficient to s u p son says, varies w i t h t h e difficulty of port a patent. • A general assertion of a field of treating t h e disease for which t h e pharmaceutical i s claimed t o have utility, such as "for medical p u r p o s e s / ' therapeutic value. Thus, in an alleged may n o t b e sufficient. t r e a t m e n t for diseases regarded as •Assertions of therapeutic value fui difficult to cure, only t h e most com- a particular abnormal condition of t h e
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Patent Office difficulties in determining usefulness of n e w , patentable drugs are described by Commissioner of Patents Robert C. W a t s o n a t D i vision of Medicinal Chemistry lunch body without supporting evidence should not b e considered sufficient t o meet t h e requirement. • Evidence required should b e d e pendent on inherent probabilities. Asserted cures for ordinarily incurable conditions such a s cancer a n d t h e common cold require more persuasive evidence than assertions of alleviation of sunburn. • Evidence should b e commensurate with assertions. A n assertion that a particular phenol would impart germicidal qualities to a n ointment for external use might b e acceptable without evidence, but assertion that t h e ointment would cure skin cancer should not b e accepted without evidence. • Assertions of usefulness should b e confined t o what h a s b e e n established by evidence. Evidence of control of a particular strain of tumor in mice does not support assertions of alleviation or cure of cancer in h u m a n bodies.
Who Points Out Prior Art? Proposed change for patents throws r e s p o n s i b i l i t y f o r literature search on applicant T h e majority of p a t e n t s challenged in t h e courts in t h e past few years have b e e n found invalid—usually bei_*ctuac; Ixxc patent Claims div^. not distinguish t h e invention from previous
d e v e l o p m e n t s , or "prior art," a s t h e lawyers put it. Often this prior art had b e e n d e s c r i b e d in pertinent literature w h i c h t h e Patent Office h a d failed to find and a p p l y . A t the Industrial and E n g i n e e r i n g Chemistry Division Edward S. Irons o f Burns, D o a n e , Benedict, & Irons a n d E d u a r d Farber of Timber E n g i n e e r i n g p r o p o s e d a c h a n g e in patent p r o c e d u r e in order to prevent this. T h e y w o u l d l i k e to s e e a large part of the responsibility o f investigating and e v a l u a t i n g the prior art shifted from t h e Patent Office to t h e persons interested in getting trie patent. This would b e d o n e b y r e q u i r i n g a n a p plicant t o p r o v i d e a s t a t e m e n t under oath, preferably by the applicant's attorney, that a careful and thorough search of the prior art has b e e n m a d e , and that the claims in the application are c o n s i d e r e d patentable. An a n a l o g o u s requirement is already i n force in ca>ses w h e r e t h e currently normal three t o . four year time for o b t a i n i n g a p a t e n t w o u l d b e a hardship a n d t h e application is m a d e "special." B e s i d e s preventing applicants from filing o n i t e m s u n r e a s o n a b l y close t o prior art and gambling that the patent would b e g r a n t e d , t h e p r o p o s e d procedure w o u l d s a v e a great d e a l of the p a t e n t examiners" time—60% of which is n o w taken u p by searching. A s e c o n d , c o m p l e m e n t a r y proposal calls for the publication of a patent's claims i n t h e Official Gazette of the Patent Office. T h e file of t h e application w o u l d b e m a d e available t o t h e public for a reasonable period, say 3 0 days. D u r i n g t h i s t i m e anyone w o u l d b e able t o o p p o s e the patent—but only b y s u b m i t t i n g references to prior art. This p r o c e d u r e is similar to t h e o n e already used for trademarks and p a t e n t interferences (where more t h a n o n e applicant claims t h e s a m e i n v e n t i o n ) . Irons p o i n t s o u t t h a t t h e primary responsibility for protecting the public must remain w i t h the p a t e n t office, b u t the p r o p o s a l s are one possible m e a n s of alleviating s o m e o f the difficulties which n o w b e s e t the p a t e n t system.
Potomac
Postscript
• First a t o m i c r e a c t o r in W a s h i n g ton, D . C.„ to b e o p e r a t e d b y the Naval Research Laboratory, is ready t o g o on s t r e a m . After a preoperational inspection, t h e Atomic E n e r g y Commission has i s s u e d a license to N R L , to o p e r a t e t h e research reactor until April, 1 9 7 5 . The pool t y p e reactor f u e l e d by Xj235^ will operate at a n initial power l e v e l of 1 0 0 k i l o w a t t s .
Applied Physics
Corporation/Pasadena/California
Radioactivity Measurements Made Faster, Cheaper with Vibrating Reed Electrometer M e a s u r e m e n t of radioactivity in radioisotope determination, r e a c t o r control, air c o n t a m i n a t i o n studies, oil w e l l logging", and other p r o b l e m s inv o l v i n g precise m e a s u r e m e n t o f small c u r r e n t s , v o l t a g e s and c h a r g e s , such a s precise p H d e t e r m i n a t i o n a n d m a s s s p e c t r o m e t r y , c a n n o w be m a d e faster, s i m p l e r and c h e a p e r b y using" t h e C a r y Model 31 Vibrating Reed Electrometer. U n u s u a l l y h i g h s e n s i t i v i t y plus h i g h z e r o s t a b i l i t y a n d e a s e of i n s t a l l a t i o n a n d o p e r a t i o n are responsible f o r the g r e a t e r speed a n d s a v i n g s . T h e Model 3 1 d e t e c t s a s little a s 10- 1 7 a m p e r e s , a n d m e a s u r e s up t o 10"6 a m p e r e s w i t h a precision o f 1 % . Zero drift is l e s s t h a n 0.2 mV i n 24 hours a n d l e s s t h a n .02 m V per hour.
T h e Model 3 1 c a n be used in a n y l a b o r a t o r y and. d o e s n o t r e q u i r e costly, vibratioxi-free m o u n t i n g s or other special conditions of installation o r operation. F o r additional information o n t h e Model 31, w r i t e for bulletin CN-16 t o d a y . I t g i v e s y o u d e tails o n applications, references, performance, o p e r a t i n g principle, specifications, modifications, a c c e s s o r i e s . •Wil?t>ach. Brown. Kaplan. Science. 118, 522-523 (1953) Witf'jacrt.Van Dyken. Kaplan.Anal. Chem..26.88Q (1954) WHzbach. Sykes. Science 120,494-496(1954).
C 1 *, H3 DETERMINATIONS SIMPLIFIED One w i d e s p r e a d application in w h i c h t h e Model 31 h a s been o f part i c u l a r v a l u e is in determining- C 1 4 , BE3, a n d S 3 5 . W i l z b a c h and h i s cow o r k e r s at A r g o n n e National Labor a t o r y h a v e developed procedures* w h i c h s i m p l i f y t h e s e determinations i n a w i d e v a r i e t y of org-anic comp o u n d s . S a m p l e s are c o n v e r t e d dir e c t l y t o a g a s suitable f o r m e a s u r e m e n t w i t h a n ionization c h a m b e r and t h e Model 3 1 . T h i s s i m p l e procedure e l i m i n a t e s t h e n e c e s s i t y f o r u s e of a precipitate, w i t h i t s i n a c c u r a c y and t i m e - c o n s u m i n g , tedious preparation. S i n c e a s little a s 10" 1 2 c u r i e s of r a d i o a c t i v i t y c a n be detected, u s e of e x p e n s i v e " t a g g e d " materials c a n be g r e a t l y reduced, often enough t o ret u r n t h e c o s t of the i n s t r u m e n t in a r e l a t i v e l y s h o r t time.
The Cary Model 31 Vibrating Reed Electrometer is capable of detecting a current as small" as 1.0 X 10- * 7 amp>eres originating in a high impedance source. Charges as small as 5 X 10-' coulombs and voltages as small as .02 mV can be measured.
CARY MODEL 36 VIBRATING REED AMPLIFIER IMPROVES MASS SPECTROMETER PERFORMANCE The Cary Vibrating Reed Amplifier, Model 36, is being used in a n increasing number of m a s s spectrometer installations where high molecular weight analy s e s make rapid scanning of mass numbers desirable. The Model 36 combines rapid response with high sensitivity. Response is critically damped, w i t h an 0.1 sec. natural period (98.6 percent response i n 0.1 second). Thus a range of 100 mass numbers can be accuratelyscanned in a s little as one minute. Sensitivity and range are such that a.s little
o
as 10-^5 amperes* and up to 10-H amperes can b e measured to a reproducibility of 0.2 percent without change of range. The stability of the Model 36 is superior too—zero drift is less than 10-15 amperes. The Model 31 is preferred for mass spectrometer applications where e x treme response speed is not required, such as isotope determinations. Sensitivity of the Model 31 is 10-17 amperes, and like the 36 it has high stability-less than 5 x 10-17 amperes zero drift.
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SPECTROPHOtOMlTERS • ^ R A M A N SPECTROPHOTOMETER^ VIBRATING REED AMPLIFIERS* • lNFRARE> ANALV^bkS.. "-. Ul APPLIED PHYSICS CORPORATION
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