Association For Molecular Pathology et al v. United States Patent and Trademark Office et al

Filing 169

DECLARATION of Dr. John Franklin Sandbach in Support re: 61 MOTION for Summary Judgment., 152 MOTION for Summary Judgment.. Document filed by Myriad Genetics, Lorris Betz, Roger Boyer, Jack Brittain, Arnold B. Combe, Raymond Gesteland, James U. Jensen, John Kendall Morris, Thomas Parks, David W. Pershing, Michael K. Young. (Attachments: # 1 Exhibit 1)(Poissant, Brian)

Association For Molecular Pathology et al v. United States Patent and Trademark Office et al

Doc. 169

UNITED S T A T E S D I S T R I C T C O U R T F O R T H E S O U T H E R N D I S T R I C T OF N E W Y O R K
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ASSOCIATION FOR -MOLECULAR PATHOLOGY; AMERICAN COLLEGE OF MEDICAL GENETICS; AMERICAN SOCIETY FOR CLINICAL PATHOLOGY; COLLEGE OF AMERICAN P A T H O L O G I S T S ; H A I G K A Z A Z I A N . MD; A R U P A G A N G U L Y , P h D ; W E N D Y C H U N G ) MD, P h D ; HARRY OSTRER, MD; DAVIn LEDBETTER, PhD; S T E P H E N W A R R E N , P h D ; E L L E N MATLOFF,M.S.; ELSA REICH. M.S.; BREAST C A N C B R A C T I O N ; . BOSTON WOMEN'S HEALTH BOOK COLLECTIVE; L I S B E T H C E R I A N I ; R U N I L I M A R Y; G E N A E GIRARD; PATRICE FORTUNE; VICKY THOMASON; KATHLEEN RAKER,

N o . 09 Civ. 4515 (RWS)
:ECF C a s e

Plaintiffs,
-against-

UNITED STATES PATENT AND TRADEMARI{ OFFICE; MYRIAD GENETICS; LORRIS BETZ. R O G E R B O Y E R , J A C K B R I T T A I N , A R N O L D B, C O M B E , R A Y M O N D G E S T E L A N D , J A M E S U. J E N S E N , . J O I l N KENDALL MORRIS, THOMAS P A R K S , D A V I D W. P E R S H I N G , a n d MICHAEL K. YOUNG, in their offioial capacity as Directors o f t h e University of Utah Research'Foundation, .

DECLARATION OF DR. JOHN F R A N K L I N SAND BACH

Defendants.

I, J o h n F r a n k l i n S a n d b a c h , d e c l a r e - u n d e r p e n a l t y o f p e r j u r y :

1.

I am b o a r d c e r t i f i e d i n h e m a t o l o g y and medical o n c o l o g y . I h a v e

t r e a t e d p a t i e n t s a s a p a r t n e r a t T e x a s O n o o l o g y , P . A . s i n c e 1994. I h a v e s e r v e d o n

t h e B o a r d o f Te){as O n c o l o g y s i n c e 2 0 0 2 .
2. I n 1 9 6 7 I r o c e i v e d a B . S . a n d in 1971 I r e c e i v e d a n M D , b o t h f r o m t h e

U n i v e r s i t y o f Kentucky. F r o m 1 9 7 1 - 1 9 7 2 I wag an i n t e r n i n the i n t e r n a l m e d i c i n e
d e p a ~ t m e n t a t t~e

U n i v e r s i t y o f N o r t h Carolina, from

1972-197~

I was a i n t e r n a l

1
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medicine r e s i d e n t , a n d from 1973 - 1 9 7 4 I w a s a f o l l o w i n h e m a t o l o g y a.t N o r t h C a r o l i n a M e m o r i a l H o s p i t a l . A f u l l c o p y . o f m y curriculum vitae, i n c l u d i n g a l i s t o f p u b l i c a t i o n s , i s a t t a c h e d as E x h i b i t 1.

3.

I r e c e n t l y h e a d e d t w o o l i n i c a l r e s e a r c h s t u d i e s i n t o h e r e d i t a r y bl'east

and ovarian canoer (HBOC) syndrome and t h e BRCA genes. I was aware t h a t

Myriad's patent rights covered certain aspects of the BRCA genes. 4. I n o n e s t u d y I l o o k e d a t BRCAJ IBRCA2 t e s t i n g i n a t r a d i t i o n a l l y

u n d e r s t u d i e d s e t t i n g : c o m m u n i t y o n c o l o g y c l i n i c s . We f o u n d t h a t m u t a t i o n r a t e s

a n d d e m o g r a p h i c s i n t h e s e c l i n i c s m i r r o r t h o s e f o u n d n a t i o n a l l y . We a l s o f o u n d a s i g n i f i c a n t l y h i g h e r than e x p e c t e d p r o p o r t i o n o f p a t i e n t s w h o s e f a m i l y h i s t o r y w a r r a n t e d B R C A l I B R C A 2 t e s t i n g . We c o n c l u d e d t h a t c o m m u n i t y o n c o l o g y pra"ctioes c a n e f f e c t i v e l y i d e n t i f y a n d t e s t w o m e n w h o a r e a t r i s k f o r BRCA1I2 m u t a t i o n s ) b u t t o do s o t h e s e p r a c t i c e s m u s t i m p l e m e n t a n e f f e c t i v e s c r e e n i n g method to identify patients, address patient reasons for declining testing, provide

.

.

comprehensive pre-

a~d

post-test consultation, and provide appropriate patient

management options.

5.

In a n o t h e r s.tudy, w h i c h Is o n g o i n g , I am l o o k i n g a t t h e r a t e o f
i n p a t i e n t s w i t h " t r i p l e - n e g a t i v o " b r e a s t c a n c e r (I.e.,

BR~AlIBRCA2 m u t a t i o n s

t u m o r s s h o w a n a b s e n c e o f e s t r o g e n , p r o g e s t e r o n e , a n d l-IER2/ncu r e c e p t o r s ) . I n

t h i s s t u d y w e a r e e v a l u a t i n g t h e h y p o t h e s e s t h a t p a t i e n t s who p r e s e n t w i t h t r i p l e n e g a t i v e b r e a s t c a n c e r have a signi.ficantly e l e v a t e d l i k e l i h o o d o f c a r r y i n g a m u t a t i o n i n B R e A 1 I 2 al.ld t h a t t h i s e l e v a t e d l i k e l i h o o d i s a l s o p r e v a l e n t a m o n g t h e s u b - s e t o f t r i p l e - n e g a t i v e p a t i e n t s t h a t do n o t . h a v e a f a m i l y h i s t o r y o f b r e a s t o r o v a r i a n c a n c e r . I f t r i p l e - n e g a t i v e b r e a s t ca.ncers a r e e n r i o h o d f o r B R C A I
2

mutations, t h e y m a y b e m o r e l i k e l y to r e s p o n d t o s p e c i f i c t h e r a p y s u c h a s c i s p l a t i n a n d PARP i n h i b i t o r s , t h u s p o t e n t i a l l y
in,r~8sing t h e

chance for meaningful

responses to therapy or improved cure rates in the adjuvant setting. Because
p a t i e n t s w i t h BRCA 1 m u t a t i o n s a r e also a t r i s k f o r s e c o n d b r e a s t c a n c e r s a n d

ovarian cancors, pre'Ventative measures and screening are crucial to early detection
and i m p r o v e d o v e r a l l s u r v i v a l . T h e r e f o r e i d e n t i f y i n g p a t i e n t s w i t h e l e v a t e d

l i k e l i h o o d for c a r r y i n g a B R e A l / 2 m u t a t i o n is a h i g h p r i o r i t y . I f t h e h y p o t h e s e s
l i s t e d above are true, this would comprise compelling evidence that genetic testing f o r BReAJl2 m u t a t i o n s i n p a t i e n t s w i t h t r i p l e - n e g a t i v e b r e a s t t u m o r s w o u l d b e il1dlcated) p r o v i d i n g a n o p p o r t u n i t y f o r l i v e - s a v i n g i n t e r v e n t i o n s partiCUlarly i n i n d i v i d u a l s w h o s e f a m i l y h i s t o r y w o u l d n o t h a v e i d e n t i f i e d t h e m as b e i n g a t s u f f i c i e n t l y high r i s k f o r t e s t i n g . Patients m e e t i n g t h e c r i t e r i a for inclusion i n t h i s s t u d y a r e r e c e i v i n g B R C A l I B R C A 2 t e s t i n g a t M y r i a d a t no c o s t .

7.

N e i t h e r t h e p a t e n t s a t issue i n t h i s s u i t n o r Myriad G e n e t i c s , I n c . h a v e

i n a n y w a y h a m p e r o d Illy r e s e a r c h . T o t h e c o n t r a r y , i n b o t h o f t h e s e r e s e a r c h

e n d e a v o r s I c o l l a b o r a t e d w i t h and e n j o y e d t h e c o n t r i b u t i o n o f M y t I a d r e s e a r c h e r s .

P u r s u a n t t o 28 U S C § 1746, I d e c l a r e u n d e r p,onalty o f p e r j u r y t h a t t h e f o r e g o i n g i s t r u e

and c r e c .

Executed on D e c e m b e r ; ; . J - ; 2009
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