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

Filing 162

DECLARATION of Jenny Lessman 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. (Poissant, Brian)

Association For Molecular Pathology et al v. United States Patent and Trademark Office et al Doc. 162 :i :i I ___ w_. , UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK . _ 'i , ,' I I ASSOCIATION FOR MOLECULAR PATHOLOGY; AMERICAN COLLEGE OF MEDICAL GENETICS; AMERICAN SOCIETY FOR CLINICAL PATHOLOGY; COLL'EGE OF AMERICAN PATHOLOGISTS; HAlO KAZAZIAN, MD; ARUPA GANGUL Y, PhD; WENDY CHUNG, MD, PhD; HARRY OSTRER, MD; DAVID LEDBETTER, PhD; S T E P H E N W A R R E N . , P h D ; E L L E N M A T L O F F . M.S.; E L S A REICH, M.S.; B R E A S T C A N C E 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 ; RUNT L I M A R Y ; G E N A E GIRARD; PATRICE FORTUNE; VICKY THOMASON; KATHLEEN RAKER, Plaintiffs, -againstUNITED STATES PATENT AND TRADEMARK OFFICE; MYRIAD GENETICS; LORRIS BETZ, ROGER BOYER, JACK BRITTAIN, ARNOLD B. COMBE, RAYMOND:GESTELAND, JAMES U. JENSEN, JOHN KENDALL MORRIS, THOMAS PARKS, DAVID W. P:ERSHING, andMICHAELK. Y O U N G , i n t h e i r officia1:capacity as Directors o f t h e University of Utah Re,search Foundation, Defendants, - - - - - - - - - - - - - - - - - - _ . _ - - - - - - - - - - - - - - _ . _ - - - - - ~ - - - - - - - -- - - - - - - - - -- i ,i i I N o . o,~ C i v . 4 5 1 5 ( R W S ) .i ,! I .1 E C F C a s e Declaration of Jenny L~ssman P . A . - C , , " 1, J e n n y L e s s m a n , d e c l a r e : A. General Background 1. I am a P h y s i c i a n ' s Assistant practicing in Obstetrics and Gynecology ~~ MeritCare in Detroit Lakes, M i n n e s o t a . ,! I I , , , i i i ,i , .! Dockets.Justia.com , , 2. As a P h y s i c i a n ' s Assistant, in collaboration w i t h a p h y s i c i a n , I specialize i n w e l l - w o m e n care , ! 'I ' :I i o f w o m e n o f all a g e s . T h i s i n c l u d e s y e a r l y e x a m s , b i r t h c o n t r o l couriiel'ing, p r e - a n d p o s t , 'I ' I. I' I m e n o p a u s a l care, h o r m o n e r e p l a c e m e n t theJ:apy and obstetrical p o s t p a r t u m care. 3. I r e c e i v e d m y d e g r e e in p h y s i c i a n assistant studies from t h e U n i v e r s i J o f N e b r a s k a Medical ,I ,i Center, O m a h a . I h a v e c o m p l e t e d n u m e r o u s clinical clerks hips at vari:ous sites i n N e b r a s k a , ! i I S o u t h D a k o t a and Minnesota. B. Professional Experience ,I i I I I I 4. I do a g r e a t deal o f w e l l - w o m a n e x a m s a n d h a v e the opportJDity to o~tIain, update, and I discuss f a m i l y h i s t o r i e s with patients, M y r i a d publishes m e d i c a l s o c i 4 y g u i d e l i n e s and o t h e r ,i h e r e d i t a r y c a n c e r 3;wareness i n f o r m a t i o n w h i c h J am able to u s e to d e t y n n i n e i f a n y o f m y p a t i e n t s , b a s e d o n t h e i r p e r s o n a l and f a m i l y h i s t o r y o f c a n c e r , a n d / o r t e s t i n g f o r g e n e t i c cancers. warran~ ~ f u r t h e r d i s c u s s i o n : : !' : :I :i ,! " i I 5. I h a v e i n c o r p o r a t e d genetic t e s t i n g i n m y p r a c t i c e since e a r l y 2 0 0 8 , i n c l u d i n g M y r i a d ' s B R A C A n a l y s i s t e s t , w h i c h t e s t s for m u t a t i o n s in t h e B R C A I a n d B R ~ A 2 g e n e s . I h a v e t e s t e d l e s s t h a n 10 p a t i e n t s , b u t have discussed the a p p r o p r i a t e n e s s o f ~enetic t e s t i n g to o v e r I I I i 5 0 patients. :I 6. 1 see females o f alI ages. I see several m e m b e r s o f the s a m e family. The results from I M y r i a d ' s B R A C A n a l y s i s test can help i.n the d e c i s i o n for surgical m a n h g e m e n t o f an affected p a t i e n t ; as weB as g u i d e appropriate and a f f e c t e d family members. I screeni~g a n d m e d i c a l '~lanageme*t o f o t h e r u n a f f e c t e d ! , I i i 7. B R A C A n a l y s i s t e s t i n g for a p a t i e n t is i m p o r t a n t w h e n m e d k a l l y necessary. A p o s i t i v e test r e s u l t is u s e f u l i n t h e decision for increased surveillance and surgical o p t i o n s f o r 2 .I :I i I I i I I m a n a g e m e n t . A p o s i t i v e test also affects o t h e r family members. A n~gative t e s t result can h e l p d e t e n n i n e i f a d d i t i o n a l f a m i l y m e m b e r s m a y n e e d t o be t e s t e d o r ! n o t . A n e g a t i v e t e s t i ; < ;' i : r e s u l t c a n h e l p d e t e u n i n e i f o t h e r c a u s e s o f c a n c e r n e e d to b e a d d r e s s ~ d . I t w i l l a l s o h e l p I. d e t e n n i n e m e d i c a ~ a n d strrgical m a n a g e m e n t o f a n u n a f f e c t e d p a t i e n t . l " 8. M y r i a d has representatives that visit clinics regularly to assist provid~~sin u n d e r s t a n d i n g t h e i m p o r t a n c e o f t e s t i n g , its i m p a c t , and h o w t o t e s t p a t i e n t s . I I i I. 9. T h r e e - f o u r t h s o f m y p a t i e n t ' s have h a d i n s u r a n c e coverage o n t h e i r B~CAnalysis testing, i thus m a k i n g testing an affordable o p t i o n f o r t h e m . C;:. P e r s o n a l E x p e r i e n c e 10. M y m o t h e r w a s d i a g n o s e d w i t h o v a r i a n c a n c e r at age 56. H e r only ;I ,! ! sis~er w a s d i a g n o s e d w i t h .i I t e r m i n a l b r e a s t c a n c e r 2 y e a r s l a t e r a t a g e 55. S h e d i e d t h i s year. W l i d n : m y m o t h e r w a s 'i . , v i s i t i n g h e r i n t h e h o s p i t a l a f t e r h e r m a s t e c t o m y , t h e y w e r e w a l k i n g th h a l l s o f t h e h o s p i t a l ; :I : . for exercise. T h e y s t o p p e d at a health fair. T h e y w e r e visiting w i t h a ~enetic c o u n s e l o r at h e r b o o t h . T h e c o u n s e l o r asked w h a t t h e y w e r e d o i n g at t h e h o s p i t a l . IThey e x p l a i n e d w h a t ! m y a u n t h a d j u s t h a d done. The c o u n s e l o r t a l k e d to them a bit m o r e af!.d found o u t a b o u t m y m o t h e r ' s o v a r i a n q m c e r . S h e a s k e d t h e m t o c o m e to h e r o f f i c e t h e n e ~ t day. S h e d i d a I i :i : I' : I i p e d i g r e e o f m y family. Based o n the p e d i g r e e , s h e recomme:nded testinIg: ( T w o maternal I g r e a t almts w i t h b r e a s t and ovarian c a n c e r as well). M y aWl:t was the q r s t to be tested. She I w a s p o s i t i v e for a B R C A l deletion. My m o t h e r t h e n t e s t e c a n d w a s ~ositive. I am the o l d e s t o f 3 daughters. I w a s rested and am positive. As a result o f t m s ! t e s t i n g , I A M A P R E V I V O R I ! ! I have started having yearly b r e a s t M R I s and p e l v i c U;1Vasounds. I am g o i n g I I I t o h a v e m y b r e a s t s a n d o v a r i e s p r o p h y l a c t i c a l l y r e m o v e d w h e n I a m fub~hed h a v i n g children. In t h e m e a n t i m e , i f they do fmd c a n c e r with this 3 surveiIlancp~, I am goi?g' to likely s u r v i v e I. ! I I I ,; ,! ,i b e c a u s e i t w i l l b e p a u g h t early. T h i s u n f o r t u n a t e l y w o n ' t s a v e m y a ~ t ' s l i f e , b u t I a m ;I , g r a t e f u l t h a t i t will l i k e l y s a v e m y l i f e , m a y b e m y s i s t e r ' s h v e s , a n d m y :I I c h i l d r e n ' s / n i e c c s / n e p h e w s l i v e s . M y m o t h e r h a d a p r o p h y 1 a c t i c mast~ctomy t h i s s u m m e r . . , , : M y i n s u r a n c e h a s p r o v i d e d a l m o s t full c o v e r a g e o n M R I s a n d u ) t r a s o t k d s b e c a u s e o f m y .I ' , , i B R C A - l result. T h e o p p o r t u n i t y w h i c h we n o w have f o r g e n e t i c t e s t i p g d e f i n i t e l y puts "teeth" i n the imp